cyrilzakka/clinical-trials huggingface dataset:
Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects if using adequate anti-contraception or is sterile
* Body Mass Index (BMI) of 18-30 kg/m\^2 (both inclusive)
* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* Willing and capable to self-administer a subcutaneous injection

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
* Impaired renal function
* Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min
* Any clinically significant abnormal ECG
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Known or suspected allergy to trial product(s) or related products
* Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
ShapeUp Empower Study

This randomized controlled trial will evaluate patterns of use and health outcomes of the ShapeUp Empower online program with and without financial incentives for program engagement.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Body mass index (BMI) between 25 and 45 kg/m2
* English speaking
* Have access to the Internet via a computer and smartphone compatible with Empower and Commercial Apps, and basic knowledge of how to use this technology.
* Agree to sharing of data entered in the Empower and Commercial Apps intervention systems.
* Agree to ShapeUp's privacy policy and user agreement.

Exclusion Criteria:

* Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
* Are planning to move outside of the greater Providence area within the next 12 months
* Report any cognitive or physical limitations that preclude use of a personal computer
* Have participated in a study conducted by the WCDRC in the past 2 years
* Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
* Weight loss of ≥ 5% of initial body weight in the last 6 months
* History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
* Previous surgical procedure for weight loss
* Currently taking weight loss medication\\
* Treatment of cancer within the last 6 months
* Have any medical or psychological condition, or life situation, that would make participation in a weight loss program inadvisable in the opinion of the principal investigator.
The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study

To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Glycated hemoglobin \<12.0%
* Signing of informed consent
* Presence of an abnormality of nerve conduction study
* Symptoms and signs of diabetic polyneuropathy

Exclusion Criteria:

* Pregnancy and lactation
* Foot ulcers
* Treatment with statins
* Antioxidant drug and/or supplements one month previous to enrolment
* Inability to mobilize
* Renal and/or hepatic failure
Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study

AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age.
* Subjects must present to the hospital with one or more signs or symptoms of acute heart failure (AHF). Signs and symptoms include shortness of breath from walking, rales or crackles, galloping heart rhythm, jugular venous distension, trouble breathing at rest or when lying down, waking breathless at night, using more than 2 pillows to sleep, tiring easily, swelling of feet, ankles or legs, frequent coughing, a cough that produces mucous or blood-tinged sputum, or a dry cough when lying flat.
* Subjects must receive IV diuretics, or there must be an intent to treat with IV diuretics.
* Subjects must be willing and able to comply with all aspects of the protocol.
* Subjects must provide signed informed consent.

Exclusion Criteria:

* Subjects that present with symptoms consistent with acute coronary syndromes (AMI or UA) as the chief cause of the current episode of AHF.
* Subjects already on dialysis prior to enrollment or if dialysis initiation is already planned during the current hospital visit.
* Subjects that have had any major organ transplant (heart, lung, kidney, or liver).
* Subjects that have participated in a drug treatment study within the past 30 days or if they have already been enrolled as a subject in this study.
* Women who verbally report being pregnant at the time of screening and anyone belonging to a vulnerable population that is deemed inappropriate for inclusion into the study by the IRB/EC.
Antiacne Medications Pseudotumor Cerebri

The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.

Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.

Eligibility Criteria:
Inclusion Criteria:

* Antiacne medication treatment indicated by dermatologist
* age \> 18 years
* contraception if indicated

Exclusion Criteria:

- age \< 18 years
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors

This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.

The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.

Eligibility Criteria:
Inclusion Criteria (main):

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology;
4. Patients with biopsy-proven PD-L1 positive;
5. ECOG score ≤ 0\~1; Life expectancy of at least 3 months;
6. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects.

Exclusion Criteria(main):

1. Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded.
2. Patients with systemic or locally severe infections (CTCAE ≥ 2);
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot undergo PET/CT imaging;
5. Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);
6. Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;
7. Patients have significant QT/QTC interval prolongation during the screening period;
8. Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;
9. Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;
10. Previously received CD137 agonist or immune checkpoint blocking therapy;
11. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L;
12. HIV antibody positive, active hepatitis B/C, and TB positive;
13. Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol);
14. Patients with symptomatic ascites, pleural effusion, or hydropericardium;
15. Pregnant or lactating women, or planning to become pregnant or have children during this trial.
MIVetsCan: Can-Coach Trial (Phase 1)

The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

All study interactions will be done virtually and recruitment data is exploratory.

Eligibility Criteria:
Inclusion Criteria:

* United States Veteran
* Experiencing chronic pain (pain lasting 3 or more months)
* Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
* Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
* Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
* Willingness to attend all study visits (conducted virtually)
* Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)

Exclusion Criteria:

* Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
* Participant states participant is pregnant
* Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
* Current diagnosis or past history of bipolar disorder
* Unable to attend study visits
* Risk for eminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members
* Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
Effect of African Drumming in Mood Disorders

This pilot study evaluated whether participating in an African drumming activity for 45 minutes immediately improved mental well-being among 13 adults diagnosed with acute mood disorders who were attending a private mental health clinic. The drumming intervention was completed by occupational therapists.

This pilot study evaluated the effectiveness of an occupational therapy-led African drumming group on mental well-being among adult psychiatric inpatients with mood disorders. A secondary purpose was to test a protocol for the delivery of African drumming interventions to adults with acute mood disorders.

A quasi-experimental uncontrolled one-group pre-test-post-test design was used to collect data during six drumming groups at an acute mental health clinic. Thirteen adults completed assessments of different aspects of mental well-being, including mood and enjoyment, before and after the intervention. Because this was a pilot study, participants were not assigned to any comparison groups. In addition, in-patients at the clinic received the intervention whether they participated in the study or not.

Improvement in mental well-being across different domains of mental well-being was expected, including feelings of anger, tension, confusion, depression, fatigue and vigour. The researchers also expected the intervention to be more effective in participants with previous drumming experience, and in those with lower levels of anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Attending mental health clinic
* Diagnosed mood disorder
* Voluntarily attending drumming group

Exclusion Criteria:

* Psychosis
A Study to Compare Health Care Costs Between Apixaban and Low Molecular Weight Heparin in Patients With Venous Thromboembolism and Cancer

The purpose of this study is to evaluate the health care resource utilization and costs associated with treating patients diagnosed with cancer and venous thromboembolism with apixaban or low molecular weight heparin. This is a retrospective database analysis of health care claims data. All-cause costs as well as costs associated with recurrent VTE, major bleeding, and clinically relevant nonmajor bleeding will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Venous thromboembolism (VTE) diagnosis between January 1 2017 and October 31 2021
* Evidence of active cancer
* At least 1 claim for apixaban or low molecular weight heparin (LMWH)
* Age 18 years or older

Exclusion Criteria:

* diagnosis of atrial fibrillation/flutter
* procedure for mechanical heart valve or inferior vena cava filter
* VTE diagnosis in the baseline period
* anticoagulant therapy in the baseline period
* pregnancy
Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth

The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births


Eligibility Criteria:
Inclusion Criteria:

* Understanding written and spoken German
* Declaration of consent

Exclusion Criteria:

* under 18 years
* incomplete answered questionaire
Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program

Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Patients with chronic nonspecific neck pain (CNSP) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. However, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. For this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. Therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with CNSP.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with nonspecific neck pain by a doctor,
* To be between the ages of 18-65,
* Having neck pain for more than 3 months
* No previous neck or shoulder surgery,
* No shoulder pain due to any cause,
* A tumour or inflammatory disease underlying the neck pain not to be found,
* A clinically underlying stenosis or discogenic problem not to be present.
* Negative results from the following clinical examination tests;

  * Spurling test,
  * Lhermitte test,
  * Cervical distraction test,
  * Adson test,

Exclusion Criteria:

* Not meeting the inclusion criteria,
* Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
* Systemic rheumatological or metabolic diseases or cancer
* Refusal to participate in the study,
* Failure to complete treatment,
* Having any neurological problem
* Severe psychological illnesses
Trial of Mongolian Medicine ZhenBao Pills for Upper-limb Dysfunction After Stroke

The trial was designed to test the hypothesis that treatment with Mongolian Medicine ZhenBao Pills has a positive effect on upper-limb motor recovery after acute ischemic stroke.

The study is a randomized, double-blinded, placebo-controlled, multi-center trial.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (male or female ≥18 years).
2. The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
3. Patients with prestroke modified Rankin scale score 0-1.
4. FAM-UE score of 20-57 at randomization.
5. The patients and legal guardians signed informed consent.

Exclusion Criteria:

1. Cranial CT or MRI findings of hemorrhage or other pathologic brain disorders, such as vascular malformations, tumors, abscesses, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis).
2. Chronic liver disease or elevated ALT, AST (greater than two times the upper limit of normal), renal insufficiency or elevated blood creatinine (greater than 1.5 times the upper limit of normal).
3. Coagulation disorders or history of systemic hemorrhage.
4. Life expectancy is less than 3 months.
5. Unable to complete the study due to mental illness, cognitive or emotional impairment.
6. Suspected or known allergy to the components of the trial medication.
7. Pregnancy, breastfeeding or potential pregnancy.
8. Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.
9. Within three months or currently participating in another investigational study.
10. Other patients who, in the opinion of the investigator, are not suitable for participation of the study.
The Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults.

A high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. Health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. The main aim of the current study is to investigate the effects of protein from cod fillet and cod residuals on serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27 kg/m2
* Fasting blood glucose ≤7 mmol/L
* Physically inactive
* Percent body fat \> 25 % for men and \> 35 % for women

Exclusion Criteria:

* Allergies towards fish, milk, egg, gluten
* Tobacco use \> 10 cigarettes (or snus) per day
* Diseases affecting the heart, intestinal function, kidney function or insulin secretion
* Medications targeting cholesterol -or glucose metabolism, hypertension
* Use of dietary supplements
* Pregnancy or lactation
Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto

The objective of this pilot study is to determine if the presence of bacteria with probiotic characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk, control some measures that indicate cariogenic processes.

Dental caries is a disease caused by a shift in pH balance, resulting in the formation of a biofilm composed mainly of cariogenic microflora. The interaction between this microflora and host factors conditions the deceleration or acceleration of the disease. Some biotechnology tools have been tried based on all this research, including probiotics, intended for a selective control of the etiological agents of caries and the maintenance of oral homeostasis.

Methodology: In this study, preschool children belonging to public preschool in Villavicencio and Pasto, Colombia will be invited to participate. After obtaining parent´s informed consent, the children will start commercial milk (nanPro3 Nestlé) intake without probiotic for 3 months. One week after, they will start commercial milk with probiotic during others 3 months. Clinical and microbiological testing of saliva at baseline, 3 m, and 6m will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and Established decay tooth (according to ICDAS) and quantification of Streptococci of the mutans group. Expected results: Statistically significant decrease in pH drop, demineralization in decay tooth and quantification of Streptococci of the mutans group.

Eligibility Criteria:
Inclusion Criteria:

* Pre-school children from age 3 to 5.
* Healthy children from a general health perspective, with early stage decay and established decay

Exclusion Criteria:

* Children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.
* Children who don't like milk.
* Children whit severe decay
Effects of Peppermint Oil in Mild-moderate Hypertension.

Cardiovascular and associated hypertensive diseases are the leading health burden and cause of mortality worldwide; therefore, the necessity for effective interventions is paramount. Dietary interventions to improve cardiovascular health are highly sought after as they possess less risk and financial burden than pharmacological drugs. Our previous randomized trial has shown that oral peppermint can improving systolic blood pressure and other cardiovascular/ blood lipids in healthy individuals. However, to date, no research has explored this using a placebo randomized intervention in patients with hypertension.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in participants with mild-moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18-65 years
2. Systolic blood pressure 120 to 139 mmHg
3. Not taking prescribed medicine for blood pressure management
4. have the ability to complete written questionnaires independently
5. Able to provide informed consent

Exclusion Criteria:

1. Diagnosed with diabetes mellitus and/ or coronary heart disease
2. Pregnant and lactating women
3. Allergy to peppermint
4. Habitual consumption of peppermint products
5. Regular consumption of antioxidant supplements

(5) Body mass index larger than 40.0 kg/m2 (6) Current enrolment in other clinical trials of other external therapies