cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262

This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.

On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers in general good health.
* Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
* Individuals between 18 and 55 years of age inclusive at the time of screening.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2.
* All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
* All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days
Biopsychosocial Factors in Resistance Exercise in Individuals with Knee Pain

The purpose of this research is to examine changes in pain sensitivity during high fatigue exercise, low fatigue exercise, and no treatment in individuals who are currently experiencing knee pain. Dosing dynamic resistance exercise intensity based on fatigue level is a novel, clinically feasible method. Dynamic resistance exercise at a high intensity (75% 1 repetition maximum (RM)) produces significant hypoalgesia at local sites compared to no treatment; however, dosing intensity based on 1RM can be challenging to implement in the clinical setting. Fatiguing endurance tasks produce local and systemic reductions in pressure pain threshold with low intensity isometric exercise completed until failure resulting in the largest exercise induced hypoalgesia effects. Fatigue may be an important mediator in pain response to exercise.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing knee pain symptom intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria:

* non-English speaking
* history of knee surgery or fracture within the past 6 months
* history of quadriceps tendon rupture
* history of a chronic pain condition, such as fibromyalgia
* systemic medical conditions that affect sensation, such as uncontrolled diabetes or neurological conditions
* blood clotting disorder, such as hemophilia
* known presence of cardiovascular, pulmonary, or metabolic disease
* current use of tobacco products
* contraindication to the application of ice, including blood pressure over 140/90 mmHg, -conditions that cause hives or blood in urine when exposed to cold, and any reductions in blood flow to arms or legs.
* not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire + (PAR-Q+)
* pain during active knee range of motion 0-90 degrees (examined during screening)
* Pregnant
* unable to attend 4 sessions
Tuberculosis Diagnosis by Flow Cytometry

Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.

Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:

1. Activated TB assay for differentiation of latent and active TB infection using blood samples and
2. Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)

Eligibility Criteria:
Inclusion Criteria:

* Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
* Patients with multi-drug resistant TB (MDR-TB)
* Paediatric patients (\< 15 years old)
* Patients suspected of extra-pulmonary tuberculosis
* Patients with TB/HIV co-infection

Exclusion Criteria:

* Unable/unwilling to sign Informed consent
Westlake Personalized Nutrition and Health Cohort for Drug Addicts

This is a prospective cohort study of drug addicts confined in Zhejiang rehabilitation centers. The primary aim of this study is to investigate the association between diet and health status among drug addicts. The second aim is to characterize the continuous blood glucose response to dietary intakes over 2 weeks. The third aim is to describe the dynamic changes of gut microbiota at three time points in drug addicts during compulsory detoxification and to evaluate the association between gut microbiota, diet and addiction severity.

Over recent decades, there is a growing trend of drug addiction in China that poses great public health challenges. Drug abuse can lead to many health related problems such as malnutrition and mental disorders along with reduced quality of life. Dietary intervention plays a pivotal role in disease prevention and drug rehabilitation for drug addicts, but the associations between dietary intake and health related outcomes among drug addicts remain unclear.

In addition, the relationship between the human gut microbiota and its response to addictive drugs as a newly arisen subject is given wide attention in recent years. However, the underlying mechanism requires further investigation. The dynamic changes of gut microbiota among drug addicts during compulsory drug rehabilitation period are in vague.

Under the same diet exposure, different drug addicts may have different blood glucose responses as well as gut microbiota profiles. Therefore, in order to examine the association between diet, gut microbiota and drug addiction, our study design will include three components: (1) the measurement of dietary intake using FFQ while the menu offered by drug rehabilitation center and food diary; (2) the measurements of blood glucose over 2 weeks using continuous glucose monitors; and (3) the measurements of gut microbiota at three time points using 16s rRNA sequencing techniques.

Eligibility Criteria:
Inclusion Criteria:

* Drug addicts aged between 18 yrs and 65yrs.
* Drug addicts lived in Zhejiang drug rehabilitation centers.
* Drug addicts who have stayed in drug rehabilitation center for no more than 6 months.

Exclusion Criteria:

* Drug addicts diagnosed with cancer or other serious physical and mental disorders.
The Effect of Brief Versus Individually Tailored Dietary Advice on Change in Lipids, Blood Pressure, and Diet in Patients With Inflammatory Joint Disease

A randomized controlled study comparing brief dietary intervention with a personal, tailored dietary advice (60 min) on change in LDL-c and change in diet.

Patients with inflammatory joint diseases (IJD) as rheumatoid arthritis (RA), spondylo arthropathy (SpA) and psoriatic arthritis (PsA) are at high risk of atherosclerotic cardiovascular disease. International recommendations for the prevention of cardiovascular disease recommend smoking cessation, physical activity, and dietary changes as part of treatment. Despite the evidence that behavioral counseling reduces overall cardiovascular risk, it is often an overlooked and underemphasized by clinicians. As of today, there is a knowledge gap regarding the efficacy of less intensive counseling sessions needed to obtain changes in dietary habits and clinical effects on CVD risk factors. Therefore, a brief dietary advice would be preferable if it could give a positive change in dietary habits and cholesterol. We have previously shown in a pilot study (8) that a 4 min. brief advice compared to a 60 min. personal tailored advice by a dietician on heart-friendly diet gave a similar change in dietary habits and LDL-c after 8 weeks in patients with IJD. The aim of the Diet Study is to perform a randomized controlled study comparing brief intervention (4 min) with a personal tailored dietary advice (60 min) on change in LDL-c and change in diet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with either RA, PsA, or AS, between 30-80 years with an increased risk of future CVD, estimated using the CVD risk calculator. i.e. any risk \&gt; 5 -10 % predicted by Systematic Coronary Risk Evaluation (SCORE2) algorithm. Also, patients with very high risk (predicted risk \&gt;10%) as well as established atherosclerotic CVD (ASCVD) including previous myocardial infarction, coronary intervention (coronary artery bypass grafting or percutaneous coronary intervention), transient ischemic attack/strokes, atherosclerotic diseases of arteries as in the carotid artery or peripheral arterial disease (PAD) will also be included.

Exclusion Criteria:

1. Heart failure with systolic EF\&lt;40%
2. Kidney failure with GFR \&lt; 35
3. Liver failure
4. Mental disorder rendering the patient unable to comply with the protocol
5. Being able to speak the language of the country
6. Reduced cognitive function
7. Substance abuse
Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

1. To assess the feasibility and safety of applying a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of thrice-weekly in-center hemodialysis.

   Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented in the context of ongoing thrice-weekly in-center hemodialysis.
2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on: inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water, ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning, energy fatigue, and general health scores.

Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will:

1. reduce inter-hemodialytic weight gain\*
2. enable achievement of lower hemodialytic dry weight
3. reduce total body water
4. improve ambulatory blood pressure control
5. reduce serum phosphorus
6. minimize per-hemodialytic changes in serum potassium and pH
7. have favorable effects on indices of physical function and global health

   * Indicates co-primary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients who are functionally anuric (urine volume \<100ml/day)
* receiving chronic maintenance dialysis for treatment of end-stage renal disease
* transitioning from hemodialysis (HD) to peritoneal dialysis (PD)
* transitioning from PD to HD
* receiving PD and have a functional arteriovenous access already in place

Exclusion Criteria:

* \< 18 years of age
* anticipate living related kidney transplant or transfer of care away from a participating unit within the next 6 months
* have anticipated survival \<6 months
* have contraindications to PD therapy
* history of complicated bowel or abdominal aortic surgery
* known abdominal wall defects
* pregnancy (including pre-menopausal women not surgically sterilized or on hormonal contraception)
* indwelling trans-abdominal prosthetic devices (e.g., feeding or biliary tubes)
* known hypersensitivity to peritoneal dialysate
Effect of Brisk Walking on Primary Dysmenorrhea

Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy. We will measure the effect of brisk walking on primary dysmenorrhea among medical students.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18-25
* regular menstrual cycles

Exclusion Criteria:

* Marriage or previous sexual activity
* medical disorders
* previous abdominal or pelvic surgery
* skeletal disorders
* hormonal or psychiatric treatment
* atheletes
Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study)

A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.

As airway management continues to evolve the investigators do not have an accurate statement of the success of direct laryngoscopy in daily clinical practice. The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to direct laryngoscopy. An international, multi-center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study
Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C

It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks.

hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.

Multicenter , Phase IV, open labeled, non-randomized trial to assess the Efficacy of Hansenula-derived recombinant pegylated interferon α 2a (Reiferon Retard® in treatment of naïve chronic hepatitis c virus Egyptian patients.

Each participant will be subject to thorough history taking, complete clinical examination, Biochemical laboratory and hematological tests, U/S imaging as well as histologic assessment of liver disease stage and severity to ensure his/her eligibility to be enrolled in the study according to predetermined inclusion and exclusion criteria .

Eligible subjects will be treated with Reiferon Retard® 160 µg once weekly by subcutaneous injection for 48 weeks treatment plus weight-based Ribavirin orally (1200 mg/kg daily for those \> 75 Kg or 1000mg/Kg daily for those ≤ 75 kg in divided doses). HCV RNA will be assessed at week 12 of initiation of therapy to identify Early Virologic Response (EVR), at week 24 to identify breakthrough viremia, at week 48 to identify End of treatment Response (ETR), and at week 72 to identify Sustained Virologic Response (SVR).

All subjects will be followed up during the study as described in the table below (Section 4 Study Design).

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \< 60.
2. BMI ≤ 30
3. Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
4. F1 stage (by Metavir scoring system) with elevated aminotransferases.
5. Compensated liver disease; serum bilirubin \< 1.5 mg/dl, INR no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
6. Acceptable hematological and biochemical indices (hemoglobin ≥ 11g/dl; total leukocytic count ≥ 3000/cmm, absolute neutrophil count ≥ 1500/cmm and serum creatinine \< 1.97 mg/dl.
7. Willing to be treated and to adhere to treatment requirements.

Exclusion Criteria:

1. Major uncontrolled depressive illness.
2. Solid organ transplantation.
3. Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
4. Untreated thyroid disease.
5. Pregnant or unwilling to comply with adequate contraception.
6. Severe concurrent medical disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes (HbA1C \> 8.5 %), and chronic obstructive pulmonary disease.
7. Known hypersensitivity to drugs used to treat HCV.
Effect of Squash Exercise Intervention on Sleep and Mental Health Among Young Adults

Dear Squash Enthusiast, Hello!

First of all, thank you for participating in this survey! This questionnaire is part of a joint study conducted by the Sports and Brain Science Research Team at Tsinghua University and the Squash program students from Nanjing Sport Institute. The study focuses on promoting squash, understanding the exercise experiences of squash participants, and examining the effects of squash on sleep and mental health. Completing the questionnaire will take approximately 5 minutes.

This research strictly follows the guidelines of the Tsinghua University Ethics Review Committee. All tests are harmless to the body, and there are no right or wrong answers to the questions in the survey. Please respond according to your personal situation. Your personal information will only be used for statistical purposes, and we will ensure that your information is kept strictly confidential.


Eligibility Criteria:
Inclusion Criteria:

* (1) healthy young adults ; (2) without chronic diseases or psychiatric disorders between the ages of 18 and 35; (3) absence of regular exercise for the past half year; (4) right-handedness; (5) Neither color blindness nor color weakness exist.

Exclusion Criteria:

* the exclusion criteria includes individuals with a history of cardiovascular, metabolic, or neurological disorders (such as hypertension, diabetes, epilepsy, or other significant medical conditions), as well as those with current or past psychiatric disorders, including depression, anxiety, schizophrenia, or other mood or behavioral disorders. Participants who have engaged in regular physical exercise or athletic training within the past six months will also be excluded, as their activity levels may interfere with the results. Left-handed individuals will be excluded, as handedness can affect motor performance and brain activity patterns. Additionally, individuals with any visual impairment affecting color perception, such as color blindness or color weakness, will be excluded. Those currently using medications that affect cognitive function, mood, or physical performance (e.g., antidepressants, anxiolytics, or beta-blockers) will also be excluded, as will individuals with a history of substance abuse or current substance use. Participants with sleep disorders, such as insomnia or sleep apnea, will be excluded to avoid confounding sleep-related outcomes. Lastly, pregnant or breastfeeding individuals, as well as those currently participating in other clinical trials or studies that could interfere with this research, will be excluded from the study.
Community Dissemination of Tai Ji Quan

The overarching objective of this project is to assess the potential public health impact of delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through local community dissemination partners (e.g., senior service providers), in the selected counties in the state of Oregon.

The program, Tai Chi: Moving for Better Balance, developed by ORI scientists (2003; 2004; 2008, a,b) was implemented in this dissemination project. Class duration was 90 minutes, 2-times per week over a 12-month period. During the initial 2 weeks, practice involved learning and performing 2 forms practiced in one set of 8 repetitions (for each form) and increased to a set of 10 repetitions for up to 5 forms between Week 3 and Week 5. Although additional forms were learned as the intervention progressed, starting in Week 6, training focused on 10-12 repetitions of the combination of forms rather than single forms. Once all 8 forms were learned ( Week 10), training was maintained at between 10-15 repetitions of the 8-form routine. Exercise activities were accompanied by music. Each Tai Chi practice session included (a) a 10-15 minute warm-up, (b) 60 minutes of Tai Chi practice, and (c) a 10-minute cool-down period. Instruction comprised (a) learning new movements and (b) reviewing movements learned from previous sessions. In addition, copies of the videotape/DVD and user's guidebook were distributed to all participants who were encouraged to use these materials for additional home practice.

All participating individuals were assessed at baseline, 6 months (mid-point), 12 months (intervention termination), and 6 months following the intervention (post-intervention follow-up) on measures of health, fall history, functional ability, and quality-of-life. Each evaluation session lasted about one hour and was conducted by a trained research assessor in various centers where these classes were held.

Eligibility Criteria:
Inclusion Criteria:

(a) 65 years of age or over, (b) physically mobile (i.e., can walk one or two blocks with or without an assistive device), and (c) medical clearance by a healthcare provider.

Exclusion Criteria:

(a) severe cognitive deficits defined by Mini-Mental State Evaluation, and (b) unable to commit for the 12 month duration of the study.