cyrilzakka/clinical-trials huggingface dataset:
The Possible Effects of Roflumilast on Obesity Related Disorders

Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
2. Obese subjects (BMI ≥30 kg/m2 and \<40 kg/m2).

Exclusion Criteria:

1. Patients with morbid obesity (BMI \> 40 kg/m2).
2. Patients already on weight lowering agents or weight loss program.
3. History or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant.
4. Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
5. Women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study.
6. Patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity.
7. Diabetic patients and patients with any inflammatory disease.
8. Smokers.
9. Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability


Eligibility Criteria:
Inclusion criteria:

* healthy male according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years (incl.)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
* Serum creatinine laboratory value outside the normal range
* estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula \< 90 ml/ min
* Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
* Any evidence of a concomitant disease judged as clinically relevant by the investigator Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
* Serum creatinine laboratory value outside the normal range
* estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula \< 90 ml/ min
* Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
ATI Evidence-based Guide Investigating Medical and Preventative Services

The investigators goal is to provide a mechanism that allows for a better understanding of athlete management from injury prevention through maintenance of health or development of injury and rehabilitation. The goal is to describe best practice for prevention and treatment to maximize return to health, sport, and patient reported outcomes following time. This includes collection of pre-existing risk factors, prevention program participation, treatment initiatives, functional outcomes measured by standardized and validated tools from the published literature. It incorporates comorbidities and patient demographic characteristics. All of these components come together to form a remarkably comprehensive picture of athlete health, influencing factors, and their associated outcomes.

The investigators goal is to provide a mechanism that allows for a better understanding of athlete management from injury prevention through maintenance of health or development of injury and rehabilitation. The goal is to describe best practice for prevention and treatment to maximize return to health, sport, and patient reported outcomes following time. This includes collection of pre-existing risk factors, prevention program participation, treatment initiatives, functional outcomes measured by standardized and validated tools from the published literature. It incorporates comorbidities and patient demographic characteristics. All of these components come together to form a remarkably comprehensive picture of athlete health, influencing factors, and their associated outcomes.

Data are collected via the athletic training electronic medical record system EMR and integrated with data from the investigators proprietary EMR system and are genuine to the community through clinical process. The data are collected in real-time with athletes and patients and the scores are immediately provided to the providing athletic trainer and therapist as well as archived for later Registry and scientific use.

Subsequent reporting can be adjusted to any variable collected which yields robust insights as to athlete health. However, no PHI information will be available.

Eligibility Criteria:
Inclusion Criteria:

Active in an Organized Sports Team,

Exclusion Criteria: None
Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration

The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration


Eligibility Criteria:
Inclusion Criteria:

* Subject is a habitual wearer of planned replacement soft contact lenses
* VA correctable to 0.3 LogMar or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index

The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.

The purpose of this study is to Effectiveness of Modified Health Belief Model Based Intervention to change behavior to Reduce Body Mass Index for Age in Overweight Junior High School Students.

Eligibility Criteria:
Inclusion Criteria:

* junior High School Students
* age 12 - 15 years
* bmi for age ≥ median +1 SD
* Read and write Thai Language
* Agree to participate voluntarily .

Exclusion Criteria:

* students with medical conditions diagnosed by a physician and a barrier to participation .
Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)

To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study;
* Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study;
* Subject is willing and able to comply with the specified follow-up evaluation schedule;
* Life expectancy \>30 days;
* No prior embolization in the target territory.

Exclusion Criteria:

* Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure;
* Coexisting signs of peritonitis or other active infection;
* Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening;
* Uncorrectable coagulopathies such as thrombocytopenia \<40,000/ μL, international normalization ratio (INR) \>2.0;
* Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media;
* Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization;
* Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO);
* More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study.
A Psychosocial Dyadic Programme for Patients With Heart Failure and Their Family Caregivers

The overall aim of the study is to evaluate the effects of a psychosocial dyadic intervention on mutuality, psychological strengths (i.e., resilience and self-compassion), psychological distress (i.e., anxiety and depression), and QoL outcomes of HF patients and caregivers. The HF patient-caregiver dyads will be randomly allocated to the intervention group to receive a 12-week relationship-focused psychosocial dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.

Heart failure (HF) is the terminal stage of various cardiovascular diseases. HF patient-caregiver dyads, who need to undertake the majority of HF care responsibility in the community, often experience a challenging adaptive process. There is a desperate need to develop and evaluate psychosocial dyadic interventions in HF patients and caregivers, as well as examine the working mechanism of such interventions. This sequential mixed-methods study consists of a single-blinded, two-arm randomized controlled trial (RCT) and a qualitative study. The dyads will be randomly allocated in a 1:1 ratio to the intervention group to receive a 12-week relationship-focused psychosocial dyadic programme, or to the control group to receive the usual care provided by the clinical team in the hospital. Besides, an empowerment-based approach will be employed in this programme to work together with patients and caregivers to set goals and develop an action plan to facilitate goal attainment. For the patients, Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Minnesota Living with Heart Failure Questionnaire, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. For the caregivers, the Mutuality Scale, Connor-Davidson Resilience Scale, Self-Compassion Scale Short Form, Family Caregiver Quality of Life Scale, and Hospital Anxiety and Depression Scale will be administered at baseline, immediate and 3-month post-intervention. A pilot study will be conducted to determine the feasibility, acceptability and preliminary effect of the intervention first. Afterwards, a full-scale mixed-methods study will be conducted to evaluate the effects of the intervention and the mechanism underlying the intervention.

Eligibility Criteria:
Inclusion Criteria:

* patients and caregivers aged 18 years or older
* patients diagnosed with heart failure
* able to identify one family caregiver who provides unpaid daily caregiving≥3.5hr/ day to participate
* patients and caregivers able to read simplified Chinese and communicate in Mandarin
* have access to a telephone at home.

Exclusion Criteria:

* psychiatric problems requiring active treatment
* other terminal illnesses, such as advanced cancer
* with mechanical circulatory support, on the heart transplant list or with a history of heart transplant
Bioequivalence Study of Idalopirdine in Healthy Subjects

The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women with a body mass index (BMI) of \>18.5 and \<30 kg/m2.

Exclusion Criteria:

* pregnant or lactating women
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Eligibility Criteria:
Inclusion Criteria:

* no contraindications to misoprostol
* uterine size was not larger than 12 weeks
* there were no signs of severe infection
* haemodynamically stable
* in general good health
* willing to provide contact information

Exclusion Criteria:

* an IUD in place
* ectopic pregnancy
* aged below 18 years and had no accompanying adult to provide informed consent
Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults. MAAT-G is a series of 10 workshops delivered by a trained health profession via videoconferencing technology. The feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Be age 65 or older
2. Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)56 - a score \>14.5 will define ability to independently provide informed consent. For patients scoring \<14.5, or if investigators have additional concerns, we will require that their health care proxy participate in the consenting process and sign an informed consent and patients will required to provide assent.
3. Able to read and understand English
4. Have a prior diagnosis of cancer and completed curative intent chemotherapy. Patients are permitted to be receiving maintenance therapy (e.g. endocrine therapy) in the adjuvant setting.
5. Have a clinical diagnosis of MCI, a score \<26 on the Montreal Cognitive Assessment (MOCA), or a score \<18 on the Montreal Cognitive Assessment-BLIND (MOCA-BLIND). If the patient had a MOCA evaluation completed as a part of routine clinical care in the preceding 3 months prior to consent date, this may be used for eligibility purposes.
6. Be independent in Activities of Daily Living (ADL)
Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)

The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* 18 years older;

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* Congestive heart failure
* Severe arrhythmia
* Nursing or pregnant women
* Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* Active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
A Study of Acequias Contamination & Association of Infectious Diseases in Peru

A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation canals that are utilized by the agriculture industry for the cultivation of consumables. Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses. Contamination studies on the acequias in the Lambayeque region have not been performed to date. The purpose of this study is to test contamination of acequias in 9 districts in Lambayeque and determine if a difference in infection rates exists in districts with contaminated acequias vs. districts without contaminated acequias for the following diseases: H. pylori, Adenovirus, Rotavirus.


Eligibility Criteria:
Inclusion Criteria:

* Currently reside in one of the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana
* 18 years of age or older
* Consent to participate

Exclusion Criteria:

* Currently taking antiviral or antimicrobial medication
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent;
* Adults Male and Female ≥ 18 years old;
* Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);

Exclusion Criteria:

* Pregnancy and Lactation or women without effective contraception;
* Relevant clinical diseases;
* Obesity associated to genetic syndrome;
* Decompensated Diabetes;
* Psychiatric disorders;
* Alimentary disorders;
* Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
* Patients using cyclosporine or amiodarone;
* Patients with bowel disease;
* Prior bariatric surgery;
* Anemia;
* Hemoglobinopathies and coagulopathy;
* History of cancer in the past five years;
* Use of corticosteroids, oral or injectable, in the last 30 days.
Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.
2. Have not received complement inhibitor therapy ;
3. LDH \> 1.5×ULN;
4. Hemoglobin level \< 10 g/dL.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
5. Positive of HIV, HBsAg or HCVAb.
The Use and Effectiveness of Balloon for Endobronchial Ultrasonography

Although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. Furthermore, it is uncertain whether this leads to a better diagnostic yield. To our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with EBUS. We hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.The aim of this study is to analyse whether the use of balloon during linear EBUS 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.


Eligibility Criteria:
Inclusion criteria:

* Adults aged ≥18 years
* Patient referred for EBUS guided TBNA of mediastinal LNs
* The para-tracheal lymph node (LN) station 4R is planned to be biopsied.

Exclusion criteria

-Patient referred for EBUS and 4R is NOT planned to be biopsed
Bloodtranfusions After Aortic Surgery

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

Cardiothoracic surgery (CTC) is associated with blood loss and an increased risk for impaired coagulation by the use of a CBP. Coagulation is a process of primary hemostasis by adhesion of trombocytes and aggregation, followed by secondary coagulation and fibrin formation. During CTC fibrinogen is the first coagulation factor which reaches critical concentration necessary for clotting. Point of Care clotting assay with thromboelastography (TEG) provides qualitative information on coagulation factors and clot strength. Specific coagulation factor correction of impaired clotting improves clot strength and may reduces the number of perioperative allogeneic blood transfusions, resulting in possible reduction of postoperative blood loss and reduction of the risk of re-operation in the short and long term. The hypothesis of this study is that a single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions in patients with clinically impaired clotting, verified by TEG.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery for thoracic aneurysm

Exclusion Criteria:

* Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration \<1g/L