cyrilzakka/clinical-trials huggingface dataset:
The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease

The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:

Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?

Participants will:

Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.

Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen.


Eligibility Criteria:
Inclusion Criteria:

* Body fat percentage \>20% or BMI \>24
* The diagnostic result of abdominal ultrasonography is fatty liver
* No regular exercise under guidance in the past 3 months
* No medication taken in the last month
* No binge eating or heavy drinking in the past two weeks

Exclusion Criteria:

* Long history of alcohol consumption, equivalent to more than 30g/day of ethanol
* Viral hepatitis
* History of autoimmune or genetic diseases
* History of drug-induced liver disease
* History of total parenteral nutrition
* History of cardiovascular, respiratory, or other diseases that necessitate avoidance of intense physical activity.
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting \>7 days but ≤12 months) or long-standing \[long-lasting\] persistent (\>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
* Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
* Signed informed consent form (ICF).

Exclusion Criteria:

* AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
* Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
* Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
* Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
* Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding
* Subjects with any contraindication for anticoagulant agents.
Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors

The aim of this study is to investigate the effects of regular forest therapy under guidance of a licensed nature therapist on patients with metabolic syndrome and cardiovascular risks

It is assumed that nature and forest experience has sustainable benefits for the physical and mental health of individuals with metabolic syndrome and cardiovascular risk profile. Especially co-therapeutic effects in terms of resilience and salutogenesis might effectively and sustainably promoted by nature and forest therapy.

The main objective of this study is to measure the effects of nature and forest therapy in subjects with manifest metabolic syndrome and cardiovascular risk factors. The intervention is a stay in the nature of the Düppeler Forest (Berlin-Wannsee) under the guidance of trained nature guides (90 minutes, 1x/week over 2 months), who teach exercises on the perception of nature and the connection between nature and health, movement and mindfulness. Subjects are also motivated to experience forest nature as regularly as possible (recommended ≥ 30 minutes daily). Participants of the control group will be offered a later participation in the therapy program after completion of the last study visit after 4 months (waiting list control group).

Eligibility Criteria:
Inclusion Criteria:

* Definition of Metabolic Syndrome according to the International Diabetes Foundation (IDF):
* waist circumference: at least 94 cm for men, at least 80 cm for women
* plus at least two of the following risk factors:
* fasting blood glucose levels of \> 100 mg/dl (\> 5.6 mmol/l) measured in blood plasma or diagnosed diabetes mellitus
* elevated triglycerides \> 150 mg/dl (\> 1.7 mmol/l) or therapy already initiated to lower triglycerides
* low HDL cholesterol: \< 40 mg/dl (\< 1.05 mmol/l) in men and \< 50 mg/dl (\< 1.25 mmol/l) in women or already initiated therapy to increase HDL
* Hypertension (from \> 130 mmHg systolic and \> 85 mmHg diastolic) or already treated hypertension

Exclusion Criteria:

* Serious acute or chronic illnesses
* Immobility or limitation of mobility due to orthopedic, neurological or other medical cause
* Participation in another study
* Serious mental illness
* Pregnancy and lactation
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)

This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.

None provided.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions
2. Male and female subjects at least 40 years of age with a medical diagnosis of COPD (i.e. persistent presence of dyspnea, cough or sputum production and a history of exposure to risk factors for the disease, such as tobacco smoke)
3. A current or prior history of at least 10 pack-years of cigarette smoking and a baseline breathlessness severity grade of \>=2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at randomization.
4. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study by using adequate contraception at study entry and throughout the trial. WOCBP will be advised to notify the Investigator of any change in their pregnancy status. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
5. Able to complete all aspects of the study through the end of the study, including all visits and tests, and self-administration of study medications.

Exclusion Criteria:

1. A medical diagnosis of asthma. Indication of a past history of asthma that is deemed inaccurate to a subject's current condition by the Investigator must be adequately addressed in the medical history.
2. Clinically significant abnormal chest x-ray (CXR) (within the past 12 months) diagnostic of active/significant disease other than COPD.
3. Evidence of any unstable or clinically significant hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than COPD that, in the opinion of the Investigator, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
4. Subjects who had radiation or chemotherapy within the previous 12 months.
5. An abnormal laboratory test at screening deemed clinically significant and exclusionary by the Investigator.
6. A history of hypersensitivity to study drugs or their components, including albuterol rescue.

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The Effects of Sapropterin Dihydrochloride Supplementation on in Vivo Redox Status in Patients With Classical PKU

This study is an independent sub-study of the protocol titled PKU-016: A double-blind, placebo-controlled, randomized study to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuro-psychiatric symptoms in subjects with phenylketonuria (PKU ASCEND).

The primary objective of this study is to determine oxidative stress in patients with classical phenylketonuria (PKU) enrolled in PKU-016, using a brain scan (called an HMPAO SPECT) at baseline and 26 weeks, and blood redox biomarkers.


Eligibility Criteria:
Inclusion Criteria:Sub-study Inclusion criteria same as main study:

* ≥ 8 years of age
* Confirmed diagnosis of PKU
* Willing to continue current diet (typical diet for the 3 months prior to study entry)unchanged while participating in the study
* Willing and able to provide written, signed informed consent or in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study and for at least 30 days following the last dose of sapropterin dihydrochloride
* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or have had total hysterectomy
* Willing and able to comply with all study procedures

Exclusion Criteria:All other sub-study Exclusion criteria same as main study:

* Has known hypersensitivity to sapropterin dihydrochloride or its excipients
* Subject breastfeeding at screening or planning to become pregnant (subject or partner) at any time during the study
* Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to the completion of all scheduled study assessments
* Received sapropterin dihydrochloride within 16 weeks of randomization • Have initiated or adjusted medication for treatment of ADHD, depression, or anxiety ≤ 8 weeks prior to randomization
* Taking medication known to inhibit folate synthesis (eg, methotrexate)
* Any condition requiring treatment with levodopa or any PDE-5 inhibitor
* Concurrent disease or condition that would interfere with study participation, compliance or safety as determined by the Investigator
* Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or not completing the study
Early Range of Motion Following Arthroscopic Rotator Cuff Repair

The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients who are between 18 years and 70 years of age
* full thickness rotator cuff tear on ultrasound and MRI
* failed conservative management

Exclusion Criteria:

* concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
* history of neuromuscular or degenerative disease
Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma (PAAD) patients following surgeries are prone to relapse shortly, while it is not well understood by current biomarkers. Given the potential associations of human leukocyte antigen class I (HLA-I) genotype with oncogenic mutational profile and immunotherapy efficacy, we aimed to assess whether differential HLA-I genotype could predict the postoperative outcomes in resected PAAD patients.


Eligibility Criteria:
Inclusion Criteria:

* Radically resected pancreatic adenocarcinoma (stage I-III)
* Resected tumor tissues and matched blood cells available
* Signed informed consent

Exclusion Criteria:

* Pancreatic cancer except pancreatic adenocarcinoma
* Non-radical resection
Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump

Secundary purposes:

* Motor complications evolution at 6 months, 2 and 3 years
* MDS UPDRS III score at 6 months, 1, 2 and 3 years
* non motor complications evolution at 6 months, 1, 2 and 3 years
* cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years
* cutaneous and digestive complications at 6 months, 1, 2 and 3 years
* neuropathy occurrence at 6 months, 1, 2 and 3 years
* medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years


Eligibility Criteria:
Inclusion criteria:

* Parkinson disease (UKPDSSB criteria)
* Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump
* MOCA \>20
* patient \>21 years of age
* patient who has signed protocol acceptation

Exclusion criteria:

* patient who did not give his acceptation for the protocol
* patient with another parkinsonian syndrome than Parkinson' s disease
* MOCA\<20
* Patient who does not need second line treatment
Superficial Cervical Plexus Block for Postoperative Analgesia

The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.


Eligibility Criteria:
Inclusion Criteria:

1. Elective suboccipital retrosigmoid approach approach craniotomy;
2. Age between 18 and 65 years;
3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

1. The patients or legal clients refuse to provide informed consent;
2. Local infection;
3. Preoperative impairment of consciousness and cognitive function;
4. Uncontrolled hypertension;
5. Inability to communicate;
6. Allergies to experimental drugs;
7. History of drug abuse;
8. History of chronic headache;
9. Aphasia and hearing impairment;
10. Patients undergoing second craniotomy;
11. Body mass index \< 18.5 kg/m2 or \> 35.0 kg/m2;
AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV) infection.

* Primary endpoint: significant drop in viral load AV2-DM versus placebo
* Secondary endpoint:the number of patients with adverse events


Eligibility Criteria:
Inclusion Criteria:

1. Women between 25 and 40 years
2. Patient has been recently (up to 6 months) Quantitatively (Viral Load) and Qualitatively (HPV types) diagnosed with HPV.
3. Ability and willingness to participate in the study.
4. Subject agrees to refrain from using prescription or supplemental antiviral medications without obtaining permission of the Treating Doctor.
5. Voluntary written informed consent.

Exclusion Criteria:

1. Subject has been vaccinated against HPV
2. Interval between a delivery and T0 is less than 3 months
3. Subject has a gynecologic surgical intervention between T0 and T1
4. Subject is diagnosed HPV negative at T0
5. Subject has a (adeno)carcinoma in situ.
6. Females with child bearing potential who are not using a reliable, medically accepted method of birth control
7. Pregnant or breast-feeding female, or women planning to become pregnant during the trial.
8. Medical history of immunosuppression by radiotherapy, chemotherapy, immuno-modulatory drugs, or HIV.
9. Participation to another clinical trial concerning HPV infections within 6 months before the application of AV2-DM antiviral spray.
10. Medical history of any severe diseases like hepatitis, renal or liver dysfunction, car-diovascular, gastrointestinal, malignant tumor(s), or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator.
11. Intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of AV2, or patients who plan to take such drugs during the trial.
12. Known or suspected allergic or adverse response to the investigational product AV2-DM Antiviral spray, it's components, olive oil or d-limonene.
13. Inability to follow the study protocol.
LoewenKIDS - Infections and the Development of the Immune System

The purpose of this study is to determine in what way infections, microbiome, and vaccinations during childhood interact in shaping the development of immunity and tolerance. The investigators collect and use data from a birth cohort focusing on infectious diseases during childhood and apply a life course perspective.

The goal of the study is to capture the complete history of exposure towards microbial challenges in the first six years of life and to study interactions between different components of microbial exposure as well as effects on the development of immunity. The investigators apply a diary in which parents document symptoms of respiratory and gastrointestinal infections of their child, and collect nasal swabs and stool samples obtained on first day of symptoms. In addition, the investigators collect nasal swabs and stool samples once per year during an asymptomatic period. The investigators intend to collect venous blood from children participating in the study at the age of six years. In a subsample (called intensive subcohort), the investigators collect asymptomatic probes three monthly during the first two years of life and obtain venous blood of the children at the age of one and two years.

The study sample is 782 participants, with 285 participants in the intensive subcohort.

Symptomatic samples will be analyzed by means of multiplex polymerase chain reaction (PCR). In addition, the investigators will assess microbial compositions based on next generation sequencing and apply multiplex panels to study parameters of unspecific humoral immune response. The study will allow to assess homologous and heterologous effects of infections and vaccinations measuring specific humoral immune response. In collaboration with immunologists, immune phenotypes will be studied and functional tests will be conducted.

The investigators will use allergic dermatitis at the age of two as a primary proxy outcome and target asthma at the age of six years as a definitive clinical endpoint.

Eligibility Criteria:
Inclusion Criteria:

* newborn in a study region

Exclusion Criteria:

* parents \< 18 years old
* insufficient knowledge of the German language (parents)
A Comparison of Bile Duct Injuries Following Open Cholecystectomy Versus Laparoscopic Cholecystectomy

In this prospective study the investigators compared common bile duct injuries (CBDI) following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35 patients in each group. To date, no detailed study concerning this matter has been published. LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD, they were located closer to the liver hilus, and they were more extended.


Eligibility Criteria:
Inclusion Criteria:

* Major common bile duct injury

Exclusion Criteria:

* Minor common bile duct injury
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer

Exclusion Criteria:

* Structural or metabolic diseases/conditions that affect the GI system
* Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects

The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants: 12 to \< 18 years old (Cohort 1), 6 to \< 12 years old (Cohort 2), 2 to \< 6 years old (Cohort 3), Weighing \> 8 kg to \< 2 years old (Cohort 4), and 28 days old to weighing ≤ 8 kg (Cohort 5).
* Undergone 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor and source for hematological malignancies or disorders. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
* Clinically suspected Grade II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any GVHD prophylactic medication.
* Evidence of myeloid engraftment.

Exclusion Criteria:

* More than 1 allo-HSCT.
* Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration.
* Presence of GVHD overlap syndrome.
* Presence of an active uncontrolled infection.
* Known HIV infection.
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
* Evidence of relapsed primary disease or have been treated for relapse after the allo-HSCT was performed.
* Any corticosteroid therapy for indications other than GVHD at doses \> 1 mg/kg once daily of methylprednisolone (or equivalent) within 7 days of the first study drug administration.
* Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study.
* Receipt of JAK inhibitor therapy after allo-HSCT for any indication.
* Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.