cyrilzakka/clinical-trials huggingface dataset:
CBD, Nutrient Metabolism and Energy Intake

CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.


Eligibility Criteria:
Inclusion Criteria:

• Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and \<30.0

Exclusion Criteria:

* Currently engage in \>10 hours moderate or vigorous intensity physical activity per week
* Have consumed CBD or cannabis at all within the past two months
* Have used CBD or cannabis regularly (\>2x in a week) within the past four months
* Are suffering from any clinically significant illness
* Have regularly used tobacco within the previous 6 months (\> 2/week)
* Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers)
* Have given a standard blood donation within 30 days of screening
* Are currently pregnant or lactating
* Are allergic/intolerant to any ingredients in food items provided during the study
Financial Health Educational Program for Increasing Financial Literacy Among Underserved Communities in Western New York

This clinical trial evaluates a financial health educational program to educate and increase knowledge for financial health and well-being, and to ensure access to financial knowledge and resources among underserved community members in Western New York. Financial well-being consists of a person's ability to meet financial obligations, feelings of financial security, ability to make choices related to financial matters. Information gathered from this study may help researchers learn how a financial health educational program may increase financial literacy for financial health and well-being among underserved community members in Western New York.

PRIMARY OBJECTIVES:

I. Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about financial literacy.

II. Reach medically underserved, high risk community members. III. Enhance financial literacy knowledge among medically underserved, high risk community members.

OUTLINE:

Participants attend financial health educational program over 60 minutes. Patients also receive educational materials on study.

After completion of study intervention, patients are followed up to 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old

Exclusion Criteria:

* Adults unable to consent
The Effect of Virtual Reality Exercises on Patients With Post-SARS-CoV-2 Syndrome

The aim of this study is to investigate the effectiveness of virtual reality exercises on pain, cardiopulmonary capacity, mood and quality of life in patients with post-COVID syndrome.

This study, which will be conducted in Sivas Cumhuriyet University, Physical Medicine and Rehabilitation Clinic, was diagnosed with COVID-19 from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago with polymerase chain reaction, whose symptoms have continued since the diagnosis of COVID-19, and inpatient treatment. 63 adult female and male post-COVID syndrome patients who did not develop pneumonia or organ failure findings will be included. Those who have had acute myocardial infarction in the last 6 months, have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure, have undergone fracture or orthopedic surgery in the last 3 months, have a known chronic respiratory system disease, cause widespread pain such as fibromyalgia syndrome Those who have a disease or cannot be mobilized independently will not be included in the study. The sample size was determined as d=0.80 α=0.05 p=0.80410 n=54 using the G\*Power 3.1.9.4 program. Considering the 15% drop-out risk, 63 patients were planned to be included.

Demographic data of all participants, including age, gender, height, weight and body mass index, and the time elapsed since the diagnosis of COVID-19 will be recorded. In addition, participants' pain intensity, functional capacity, general health status, mood, and fatigue levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with COVID-19 by polymerase chain reaction from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago, whose symptoms have continued since the diagnosis of COVID-19

Exclusion Criteria:

* have been hospitalized due to COVID-19,
* have developed pneumonia or organ failure findings.
* have had an acute myocardial infarction in the last 6 months,
* have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure,
* have undergone fracture or orthopedic surgery in the last 3 months,
* have a known chronic respiratory system disease,
* have widespread pain such as fibromyalgia syndrome
Effect of ACP on Surgical Repair of Rotator Cuff Tears

The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.

The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.

In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this.

We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.

Eligibility Criteria:
Inclusion Criteria:

* Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
* Suture bridge technique
* No pregnancy at the date of the surgery for women of childbearing potential
* Signed consent form

Exclusion Criteria:

* Partial reconstruction of the rotator cuff (PASTA)
* Open reconstruction
* Tendon transfer (latissimus dorsi or pectoralis major)
* Revision surgery
* Omarthrosis (Level ≥ 2 Samilson \& Prieto)
* Systemic arthritis
* Rheumatoid arthritis
* Diabetes (insulin treated)
* Requiring surgery in reconstruction of the subscapularis tendon
* Progressive fat inclusion (fatty infiltration of the rotator cuff musculature Goutallier level IV
* Acute or chronic infection
* Pathological bone metabolism
* Insufficient perfusion in the affected arm
* Neuromuscular disease in the affected arm
* Non compliance of the patient
* Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome

The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events.

The aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.

In this randomized study, the investigators aim to investigate whether additional self-monitoring of cholesterol values by patients leads to more effective LDL reduction and quicker achievement of the target LDL range versus usual care.

This study systematically and prospectively examines the benefits of self-monitoring and control of cholesterol levels for the first time.

The patients in the intervention arm will receive a device for self-measurement of cholesterol values and will be trained in its use. These patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control arm is treated according to local standards, which includes control of the cholesterol values twice a year at the visit in out-patient clinic. Patients in both study arms will be followed up for at least 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value
* Signed informed consent

Exclusion Criteria:

* Persons unable to understand the study
* Persons unable or unwilling to perform self-measurements
* Persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the LDL target
* Pre-menopausal women without contraception
* Use of experimental drugs or investigational products within 30 days prior to screening
* Employees or contractors of the institution conducting the study or family members of the Principal Investigator, Co-Investigator, or financial supporter
Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire

The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.

Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Eligibility Criteria:
Inclusion Criteria:

* indication to primary ERCP
* ASA (American Society of Anesthesiologists) 1, 2, 3

Exclusion Criteria:

* pancreas neoplasia
* pancreatitis
* ampulloma
* duodenum stenosis
* under mucous membrane haematoma
Optimization of Darunavir Therapy and Dosage Recommendations

This study will assess and characterize the variability observed in the response to darunavir therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV). More specifically, it aims to quantify variations in the drug's blood concentrations and determine the sources of such variability, both genetic and non-genetic. In light of this information, current dosage guidelines will then be reviewed.

Data will be used to create a population pharmacokinetic model. Inter- and intra-individual pharmacokinetic variability will be quantified and linked to patient-specific covariates, both genetic and non-genetic in nature. Pharmacokinetic-pharmacodynamic relationships will be established, linking drug exposure to efficacy (as measured by CD4 cell count and viral load reduction) and toxicity (as measured by frequency and degree of adverse events). Simulations will be conducted for specific patient profiles and current dosage guidelines reviewed.

Pharmacokinetic design : combined sparse/intensive sampling

* Sparse sampling : One blood sample collected in each individual at a random post-intake time (during a routine visit to the hospital), up to three times over the course of the study period (months 1-18).
* Intensive sampling : Eight blood samples collected over six hours in a subset of twelve individuals (during an additional observation period, months 19-22).

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* HIV-positive
* Routinely followed at the Cliniques universitaires Saint-Luc
* Treated with darunavir

Inclusion Criteria (intensive sampling):

- Perfect adherence to treatment (as assessed by anamnesis and based on available PK data for each patient)

Exclusion Criteria:

- N/A
Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients

The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.

Background:

Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial.

Study Intervention:

Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients \> or = 18 years old
* 2 or more organ failures related to acute illness

Exclusion Criteria:

* \> 24 hours from admission to ICU
* Patients who are moribund
* Lack of commitment to aggressive care
* Absolute contraindication to enteral nutrients
* Severe acquired brain injury
* Routine elective cardiac surgery
* Primary admission of burns \> 30% body surface area
* Weight \< 50 kgms or \> 200 kgms
* Pregnant or lactating patients
* Previous randomization in this study
* Enrollment in a related ICU interventional study
* Child's class C liver disease
* Metastatic cancer with life expectancy \< 6 months
* Seizure disorder requiring anticonvulsant medication
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

  1. Smoking history of at least 10 pack-years.
  2. Forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 50% of the predicted normal value.
  3. Post-bronchodilator FEV1/Force vital capacity (FVC) \< 0.7.

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with alpha-1-antitrypsin deficiency.
* Patients with contraindications for tiotropium treatment.
* Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects

To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age ranges from 20 to 30 years old
* No history of neurological or psychiatric diseases, no history of chronic illness
* No positive results were found in the examination of the nervous system
* All right-handed according to Edinburgh Handedness Inventory
* The subjects voluntarily participated in this study and signed an informed consent form

Exclusion Criteria:

* Individuals with severe illnesses
* Previous history of brain surgery or epilepsy
* Individuals who experience changes in physical condition during the experiment
* Individuals with metal implants, such as pacemakers, DBS therapists, stents, etc
* Alcoholics
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required


Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 79 years old
* Triglyceride level 6.8 mmol/L at screening
* LDL-C of 5.7 mmol/L at screening

Exclusion Criteria:

* Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. The latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly.
* Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins other than atorvastatin
* Subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. Subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening
* Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease.

OBJECTIVES: I. Determine the toxicity and response to high dose chemotherapy and peripheral blood stem cell support in patients with recurrent or refractory Hodgkin's disease. II. Determine the maximum tolerated dose of etoposide when combined with carboplatin and cyclophosphamide in these patients.

OUTLINE: This is a dose escalation study of etoposide. Patients undergo total nodal radiotherapy twice a day on days -35 to -31, -28 to -24, and then radiotherapy boost once a day on days -21 to -17. Patients then receive etoposide IV continuously and carboplatin IV continuously on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Autologous peripheral blood stem cells are infused on day 0. Patients who have received prior extensive radiation (at least 2000 cGy to any site) only receive chemotherapy and peripheral blood stem cell infusion. Cohorts of 4-8 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 4 or 2 of 8 patients experience dose limiting toxicity. Patients are followed every 1-3 months for 2 years, then every 3 months until death.

PROJECTED ACCRUAL: At least 4 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard therapy OR Relapsed following initial complete remission Measurable or evaluable disease Hepatic involvement must be histologically proven to be considered sole area of measurable disease If referred following successful induction therapy, measurable or evaluable disease not required No CNS disease

PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the past 3 months No significant arrhythmia requiring medication Ejection fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude chemotherapy HIV negative No clinical evidence of AIDS

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Prospective & Retrospective Data Collection of Breast Cancer Cases From 2000 to Present

Prospective \& Retrospective data collection of breast cancer cases from 2000 to present


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer