cyrilzakka/clinical-trials huggingface dataset:
Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract

Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.

The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.

Eligibility Criteria:
Inclusion Criteria:- adult (at least 18 years of age);

* diagnosed with knee osteoarthritis (OA) ;
* body mass index (BMI) of less than 40;
* willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;
* willing and able to monitor blood glucose levels if diabetic;
* willing to abstain from caffeine-containing drinks and food before coming into a study visit;
* able to read and understand English and have the cognitive capacity to give consent;
* willing to abstain from use of the following during participation in the study: prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, Advil, Motrin, Nuprin, Naproxen, etc.); any dietary supplements (St. John's Wort, etc.); and, grapefruit and/or products containing it.

Exclusion Criteria:- cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (CABG), arrhythmia, high or low blood pressure;

* recurrent stomach upset, or gastric or duodenal ulcers;
* gallstones or gall bladder disease (cholelithiasis);
* liver or kidney disease;
* alcohol use of more than two drinks per day on a regular basis;
* Coumadin or anti-platelet drug use;
* at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome;
* pregnant or breast feeding, or intention to become pregnant during the study;
* pronounced allergies, or known allergy to study product or corn starch (placebo);
* have had an injection to treat OA within the past three months;
* currently taking NSAIDs, unless they are willing to stop for a 1-week wash-out period;
* currently on a selective serotonin reuptake inhibitor (SSRI) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and,
* reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., NSAIDs), and any dietary supplements; grapefruit and/or its products; and, St. John's Wort.
PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking

The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.

The investigators have developed a new model for the treatment of obesity, which emphasizes the role of memory on food consumption in an overweight population.The pilot study will be an open label trial of a memory+behavioral weight loss (M+BWL) group treatment. The treatment will be administered in 14 group sessions over 16 weeks. The investigators will recruit adults with overweight and obesity and will assess them at baseline (prior to treatment), during treatment, post-treatment (immediately following treatment), and follow-up (3 months after treatment). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be overweight (BMI between 25-45)
2. Participant must be between the ages of 18-65
3. Participant can read at a minimum of an 5th grade level in English
4. Participant is willing to participate and to commit to 16 weeks of treatment and attendance at assessments
5. Participants must consent to audio-taping of assessment interviews and treatment group sessions.
6. Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.

Exclusion Criteria:

1. Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
2. Participants will not be moving out of the San Diego area for the duration of their study enrollment (7 months).
3. Participants will not be pregnant, planning to get pregnant during the 7-month study period or lactating.
4. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
5. Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous, or would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status will not be included.
6. Participants cannot have a history of bariatric surgery
7. Participants cannot currently be enrolled in an organized weight control program.
Heart Failure Management in Azerbaijan

This study is proposed to determined a national database of the etiologies, clinical and the demographic profile, using diagnostic tests and treatment of outpatients with chronic heart failure in Azerbaijan population.

Chronic heart failure remains the leading cause of hospitalization for those over the age of 65 and expected to increase over the next 25 years with advancing life span. Being a progressive syndrome, CHF decreases the quality of life and place an economic burden on health care system.

Advanced technologies in interventional cardiology, better organization of angiographic laboratories and primary prevention of coronary artery disease as the leading cause of HF, allowed warning its development in CAD patients. But the incidence and prevalence of CHF continue to increase with age as heart failure with preserved ejection fraction predominates in elderly patients. For the moment more than 23 million people over the world suffer from heart failure.

The prevalence of these patients remains very high even in USA - over 5.8 million.However, there is no any database for heart failure patient in Azerbaijan.The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests and management of outpatients heart failure in Azerbaijan population.

Eligibility Criteria:
Inclusion :

* Patients \>18 years olds
* Clinical diagnosis of heart failure
* NYHA class II-IV heart failure

Exclusion :

* Patients \<18 years old
* Failure to obtain informed consent
* Pregnant or lactating

Previous cardiac transplantation
Clinical Validation of BBCT-hip

The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* caucasic post-menopausal women resident in Emilia-Romagna
* menopause (\>= 45 years)

Exclusion Criteria:

* tumours
* not free living
* Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
* Long-term continuous therapy (\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
* Previous femur fractures
* Presence of hip/knee prosthesis

only for the fracturegroup:

* presence of fixation devices after the fracture
* femur fracture due to high energy trauma
Cardiovascular Effects of Chronic Snus Use

The current study proposes to investigate the effects of chronic snus use on the blood vessels. Several cardiovascular endpoints are measured using various methods in healthy daily snus users as well as in healthy matched controls.

The Swedish moist oral snuff known as "snus" has previously been found primarily in Scandinavia. In Sweden approximately 1 in 5 men are habitual users of snus. It is estimated that 3-4% of the female population are regular users. However, the last few years has seen a shift in the global tobacco industry towards finding novel ways of entering the smokeless tobacco (ST) markets. In the United States both Camel and Marlboro brands, among others, have launched an array of ST products similar to Swedish snus. Since its launch in 2007, the US snus market has continued to grow at an exponential rate and now sells approximately 50 million cans a year.

Smoking has been studied extensively and been undoubtedly linked to a range of detrimental health effects, including cardiovascular disease. As snus has until recently been available in a limited Scandinavian market, few experimental and epidemiological studies have been performed.

A recent meta-analysis found snus to be associated with heart failure and higher risk of fatal myocardial infarctions and stroke. Following myocardial infarction, discontinuation of snus use was associated with a 50% decreased risk of mortality.

With new emerging markets worldwide publicizing the product as a discrete and healthier alternative to cigarettes, it has become all the more imperative to study the health effects of this smokeless tobacco. Using well validated methods the investigators intend to study the possible effects of chronic snus use on vascular endothelial function, thrombosis, circulating microparticles in blood and arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Normal clinical examination
* Normal ECG
* Normal routine blood test including serum lipids and HbA1C

Exclusion Criteria:

* Any form of cardiovascular disease
* Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
* Active allergy within 4 weeks of the study
* Symptoms of infection or inflammation within 4 weeks of the study
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.


Eligibility Criteria:
Inclusion criteria:

Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus.
* Male and female patients on diet and exercise regimen who are:
* Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.

or

* Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: \>=1500 mg/day or maximum tolerated dose or maximum dose according to local label.
* HbA1c of \>= 7.5 % and \<= 10.5 % at Visit 1 and 3.
* Age \>= 18 yrs.

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>270 mg/dL (\>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
* Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
* Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
* Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
* Indication of liver disease.
* Moderate to severe renal impairment.
* Bariatric surgery within the past two years.
* Treatment with anti-obesity drugs 3 months prior to informed consent.
* Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU

Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres.

We hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres.

The main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres.

The main endpoint is all-cause mortality at hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\> 18 years old)
2. Active malignancy;
3. ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;
4. Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.

Exclusion Criteria:

1. Isolated HIV infection or AIDS;
2. ICU admission complicating scheduled surgery,
3. Treatment-limitation decisions at admission;
4. No coverage by the French statutory health insurance system,
5. Pregnant or breastfeeding
Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions

Many conditions and cardiovascular diseases (including stroke) are better managed with regular exercise training. The expected effects are partial reversal of adverse effects on heart and blood vessel structure and function, improved glycemic, tension and weight control.

Physiologically, the aorta maintains low left ventricular after-load, promotes optimal sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow. Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular exercise training is likely to decrease the pulse wave velocity (a measure of the aortic compliance). Some subjects seem more responsive than others, and they may not expect the same benefit of exercise training. To the best of our knowledge, this has not been explained yet.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 50-69 years, with moderate or high cardiovascular risk

Exclusion Criteria:

* any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.
Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch

The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.

Not needed

Eligibility Criteria:
Inclusion Criteria:

1. No current history or past history of neck pain; able to lie on back or stomach without difficulty

Exclusion Criteria:

1. 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
2. History of neck whiplash injury
3. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
6. Prior surgery to your neck or upper back
7. A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
8. Diagnosis from your physician of fibromyalgia syndrome
9. Currently pregnant, or could be pregnant
"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"

The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. The clinical criteria "mental status with risk" (AR) identifies patients among whom 10 in 40 % will make a psychotic transition in the year.

Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our project is to evaluate a therapy for stress management in at risk patients, compared to a conventional monitoring, and implement a longitudinal follow-up concerning the reduction of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these interventions offer an alternative to antipsychotics all the more interesting since they should also reduce the risk of depression and suicide.


Eligibility Criteria:
Inclusion Criteria:

* Aged 15 to 25 years
* Help-seekers in one of the specialized clinics for adolescents or young adults 9
* Meets CAARMS criteria for 'at risk mental state' (ARMS)

Exclusion Criteria:

* situations of emergency.
* prengnancy, breast-feeding
* Forced hospitalization or individuals under legal guardianship.
* schizophrenia (DSMIV-TR criteria)
* Low IQ (\<70) ,
* Mother tongue and primary educational language other than French
* Blindness, deafness, muteness, sensorimotor or language deficits
* any severe medical condition,
* Daily cannabis use in the last week
* Current depression (\>20 MADRS scale)
* Substance dependence or abuse (except nicotine) for more than 5 years.
* Treatments by benzodiazépine (\> 10 mg amount diazépam) or stop of less than 5 days
* Previous treatment by antipsychotics in a superior dose in more than 100 mg equivalent Chlorpromazine if at least a sequence lasted more than 12 weeks
* Treatment by antipsychotics measures \> 100 mg eq. CPZactuel (superior dose in more than 100 mg equivalent Chlorpromazine) so introduced for less than three weeks
* Antidepressant treatmentsbegun for less three weeks
* Treatment by corticoids (except local treatment)
* Exclusion period of another study;
* The usual contraindications for MRI
* Absence of social insurance
Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults

The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.

It is estimated that the incidence of osteoarthritis (OA) is increasing exponentially worldwide, with serious consequences, not only on the quality of life and functionality of the subjects, but also a high burden on the social and health care systems of the countries. Existing treatments for OA are either invasive, and therefore risky for the subject and high cost, or have side effects and cannot be maintained over time. Therefore, there is a high demand to find effective and safe therapies to prevent and/or treat OA, such as functional ingredients or compounds present in food. In this regard, our experimental bioactive compound has been developed and shown to be safe and effective in reducing joint pain and improving quality of life in a previous study.

The aim of this study is to evaluate the effect of the consumption of our bioactive compound, in healthy Spanish individuals with mild joint discomfort in the knee.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants (men and women) between 35 and 65 years of age with knee discomfort.
2. Mild knee joint pain (visual analog scale between 3 and 6 cm).

Exclusion Criteria:

1. People with clinical osteoarthritis or any other degenerative joint disease.
2. Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening.
3. Persons receiving intra-articular injections in the knee joint in the 3 months prior to the study.
Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation

This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age older than 18 years.
* Germline BRCA1/2 mutation.
* Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.
* Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.
* Availability of FFPE breast and ovarian tumor samples.

Exclusion Criteria:

* Other malignancies in the last 2 years.
* Prior chemotherapy or radiation therapy for other malignancies.
An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of chronic hepatitis C
* Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label

Exclusion Criteria:

* Contraindications against Pegasys or Copegus
* Not willing or unable to sign written informed consent form