cyrilzakka/clinical-trials huggingface dataset:
Project MATLINK: Development and Evaluation of a Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program for Opioid Dependent Prisoners and Probationers Transitioning to the Community

The purpose of this study is to evaluate the efficacy a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for linking opioid dependent individuals currently incarcerated or in probation in Moldova, Kyrgyzstan, and Ukraine to opioid substitution therapy in the community after release or during their probation period.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Within 180 days of release or possible release (eligible for parole) to the community, but greater than 7 days to release to the community OR currently in probation.
3. FOR THOSE IN PRISON: Relocating to a location within 30 km (approximately 60-minute commute) of the referred Narcology center. Each participant will be asked the address he/she is planning to reside under that will be immediately checked on the map to determine the travel time. A participant then will be asked if he/she would be willing to travel the distance to a particular OAT site. If a person does not meet this inclusion criterion, he/she will be referred to a local harm reduction center.
4. Meets ICD-10 screening criteria for pre-incarceration opioid dependence

   FOR THOSE IN PROBATION:
5. Living within 30 km of an OAT delivery site
6. Not having received OAT in the last 15 days.
7. Positive for OUD

Exclusion Criteria:

1. Pregnant or may become pregnant
2. FOR THOSE IN PRISON: Will be released from prison in 7 days or less.
Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

The purpose of this study is to continue follow up of conservatively treated CHI patients and to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing treatment and incidence of diabetes mellitus in the long term.


Eligibility Criteria:
Inclusion Criteria:

* conservatively treated CHI patients who are in remission for at least one year

Exclusion Criteria:

* none
Effect of Sleep Extension in Prevention to Sleep Deprivation

The approach of a competition can be associated to a decrease in sleep duration and quality which can negatively impact athlete's performance and health (injury risk, fall, accident). Ultra-endurance competitions even involve partial and/or total sleep deprivation over one or several nights. Studied investigating this question suggest that endurance performance under sleep deprivation is altered, mainly because of an effect on the rate of perceived exertion (RPE), which regulates effort intensity. One of the methods used by athletes to limit the impact of sleep deprivation in competition is to implement sleep extension in the days prior to a competition. However, few studies have investigated the impact of sleep deprivation et its reproducibility on performance and fatigue during a prolonged running exercise, as well as the efficiency of prior sleep extension. The importance of such a preventive measure might also depend on individual resistance to sleep deprivation, which is variable between persons and could have genetic determinants. This aspect remains under-studied, particularly regarding the impact of sleep deprivation on physical performance. Therefore, this study aims at investigating the effects of sleep deprivation and prior sleep extension on prolonged duration performance.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer who signed the written consent form.
* Man or woman.
* Aged 18-50.
* Physically active and running at least one session of more than one hour per week.
* Haven't participated in any competition in the month before the first visit.
* Not participating in any competition during the study.
* Usual sleep time between 6h-8h per night.

Exclusion Criteria:

* - Any chronic pathology.
* Working night shift.
* Having sleep disorders: score \> 5 at Pittsburg Sleep Quality Index.
* Excessive sleepiness: score \>10 at Epworth Sleepiness scale.
Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

The general research question posed was 'How effective is a healthy lifestyle intervention using behavioural change strategies in the prevention of Type 2 Diabetes Mellitus (T2DM)?'.

The main aim was to assess the effectiveness of a healthy lifestyle intervention implemented for 12 weeks via face-to-face group sessions and by using social media tools (Facebook and WhatsApp) for young adults at risk of T2DM.

The hypothesis was that this healthy lifestyle intervention may be effective in terms of initiating an increased physical activity (PA) level and a healthy balanced dietary intake resulting in improvements of other T2DM risk factors at 12 weeks.

The specific research question posed was 'Is a healthy lifestyle intervention using Social Cognitive Theory (SCT)-based PA and dietary strategies implemented for 12 weeks through face-to-face group sessions and social media tools effective in the initiation and maintenance of increased PA level and healthy balanced dietary intake, resulting in improvements of T2DM risk score, anthropometrics, metabolic parameters and SCT-related psychosocial factors among Bruneian young adults at risk of T2DM?'.

Study design was two-arm parallel, stratified with simple randomisation, and assessor-blinded randomised controlled trial. Participants were randomly allocated into intervention group and control group. Participants were students and alumni of Universiti Brunei Darussalam and Universiti Teknologi Brunei who were overweight-obese at risk of T2DM with a mean age of 23.1 (2.48) years old. Intervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks, while the control group only received leaflets on healthy lifestyle with no further guidance. Outcomes measured were changes from baseline at week 0 to post-intervention at week 13 between intervention and control groups. Outcomes were changes in diabetes risk score, anthropometrics, metabolic parameters, PA, dietary intake and SCT-related psychosocial factors, with repeated-measures ANOVA as the main analysis.

Eligibility Criteria:
Inclusion Criteria:

* Bruneian including permanent residents
* BMI from 25.00 to 39.99 kg/m2
* American Diabetes Association (ADA) diabetes risk score of at least 3 and maximum score of 8
* Mentally and physically fit with no chronic conditions
* Without medical conditions that could influence glucose metabolism and insulin resistance
* Answered 'No' to all 6 questions in questionnaire-based pre-exercise risk assessment
* Not actively participating in other healthy lifestyle programmes
* Had access to computer or mobile phone with Internet
Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

This study aimed to investigate the efficacy of vitamin B1 in patients with familial adenomatous polyposis, and to determine the inhibitory effect of vitamin B1 on the size and number of colorectal adenomas by administering oral vitamin B1 therapy for 1 year and colonoscopy follow-up every 3 months

We will mark a region with a diameter of no more than 5 cm, containing at least 3 polyps, each with a diameter of 5-15 mm. Continuous video recording will be conducted throughout the colonoscopy procedure to provide baseline reference images of the colorectal polyps. Patients with familial adenomatous polyposis were given 100mg bid dose of vitamin B1 orally for one year, and colonoscopies were followed every 3 months to observe changes in the size and number of polyps in the designated area.

Eligibility Criteria:
Inclusion Criteria

1. Patients with a confirmed diagnosis of classical familial adenomatous polyposis (FAP) based on colonoscopy, histopathology, and genetic testing.
2. Aged between 18 and 80 years, with no restriction on gender.
3. No history of total colectomy, with remaining bowel segments available for evaluation.
4. Presence of more than 10 adenomatous polyps in the colon or rectum.
5. Normal liver and kidney function.
6. Willing to participate in vitamin B1 therapy and commit to regular follow-up appointments.

Exclusion Criteria

1. Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect colorectal polyps, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), ω-3 polyunsaturated fatty acids, rapamycin, and curcumin.
2. Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect vitamin B1 absorption, metabolism, or excretion, including aminoglycoside antibiotics, thiazide diuretics, oral contraceptives, antiepileptic drugs, and antituberculosis drugs.
3. Attenuated familial adenomatous polyposis (AFAP).
4. Allergy to vitamin B1.
5. Contraindications to vitamin B1, such as liver or kidney dysfunction, or severe neuropsychiatric disorders.
6. History of total colectomy, with no remaining bowel segments.
7. Pregnant or breastfeeding individuals.
8. Presence of advanced colorectal cancer or metastatic cancer in other locations.
9. Previous radiotherapy, chemotherapy, or tumor immunotherapy.
10. History of alcohol or other substance abuse.
Detection of SARS-CoV-2 RNA in Coughed Droplets From Patients With COVID-19

The purpose of this study is to learn how to better detect infection and understand how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes lung disease and is spread. The novel device called PneumoniaCheck is a safe way to collect material from the lung from coughs. Study participants will collect cough specimens over a 24 hour period.

A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was detected in association with cases of severe respiratory illness and pneumonia (COVID-19) in Wuhan City, Hubei Province, China in December 2019. The virus subsequently spread widely throughout China and globally. Addressing this unprecedented global pandemic is requiring all available tools to diagnose infection, manage ill patients, understand disease pathogenesis and virus transmission to guide efforts to decrease transmission and rapidly develop anti-viral drugs and vaccines. The researchers of this study propose to use the PneumoniaCheck™, a device developed collaboratively by investigators at the Georgia Institute of Technology (GA Tech) and the Centers for Disease Control and Prevention (CDC), to help address these issues. This device, non-invasively, captures coughed droplets onto a filter with minimal contamination from upper airway secretions. In preliminary studies in cystic fibrosis, mycobacterium tuberculosis (TB) patients and control patients, the researchers detected bacterial DNA by PCR, inflammatory cytokines and chemokines by multiplex Luminex assays, surfactant by enzyme immunoassay (EIA), and amylase by enzymatic assay. These data show that this device can provide high quality specimens from the lung with minimal risk to the patient and healthcare provider and much lower risk than invasive procedures such as bronchioloalveolar lavage. In addition, with this device, the researchers can acquire specimens from patients who do not have a productive cough (dry cough), a commonly reported symptom for COVID-19, and specimens with minimal upper respiratory contamination unlike a sputum specimen. Thus, this device can provide lung secretion specimens to improve detection of SARS-CoV-2 RNA (lung specimens are better for detecting virus than upper respiratory tract specimens) and detect inflammatory and other biomarkers to explore pathogenesis of disease, identify inflammatory processes that might be amenable to intervention, and identify biomarkers of disease severity for patient management and evaluation of vaccines and anti-viral drugs. The goal of this study is to determine how PneumoniaCheck™ can help diagnose, manage, and understand pathogenesis of disease and transmission risk of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Being treated for an acute respiratory illness either as inpatients or outpatients at Emory University Hospital
* English is a primary spoken language

Exclusion Criteria:

* none

Inclusion Criteria for Healthy Volunteers:

* Prior registration in an adult participant database and agreed to be contacted for future studies
* English is a primary spoken language
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification

Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.

Investigators will recruit 30 subjects between ages 7-17 with heel pain and also invite their parent/guardian to participate in this research study. Participants will be evaluated at baseline, 4-weeks, 8-weeks and 12-weeks. Data collections at each assessment visit will be identical except for the baseline visit. The baseline evaluation will consist of questionnaires related to past medical history in addition to all other procedures. All evaluations will include patient-reported outcome measures, clinical measures, and measurement of tendon structure, mechanical properties, and muscle-tendon function Treatment sessions will occur immediately following the evaluation sessions (4 total). During treatment sessions, participants will be provided with education, therapeutic exercise instruction, and discussion of their training diary and home exercise program. Treatment sessions will last 30-45 minutes. In addition to the 4 in-person treatment sessions, virtual visits will take place 2 weeks in between each in-person visits, (one virtual visit maximum every 4 weeks) as needed. Virtual visits will be no longer than 30 minutes to discuss patient needs.

Eligibility Criteria:
Inclusion Criteria:

* Insidious onset of heel pain with running or jumping activities lasting at least three weeks
* Location of pain is focal at the calcaneus over the Achilles tendon attachment and/or the Achilles tendon

Exclusion Criteria:

* Subjects having an underlying diagnosis predisposing to heel pain (spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
* History of calcaneal fracture or foot/ankle surgery in the past 6 months
* Another injury that limits the ability to perform exercises on the injured leg
Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled for baseline measures and then instructed and given supplies necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months, whereupon follow-up measures will be taken. Subjects will be asked to resume their typical (unsupplemented) diet for another three months and a second set of follow-up measures will be taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall hypothesis (based upon our work in men at risk for prostate cancer and data from one case-study conducted in a woman with confirmed PCOS) is that during the time women receive flaxseed supplementation they will experience reduced serum levels of testosterone, and total and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of this study, statistical analyses will be limited to simple descriptive statistics. We have observed no negative side effects, other than minor gastro-intestinal occurrences (i.e., temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed supplementation will be discontinued if indicated and the events reported to the institutional review board.


Eligibility Criteria:
Inclusion Criteria:

* limited to women aged 18-45
* diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually), Ferriman-Gallwey score \> 8, and/or hyperandrogenemia defined as bioavailable T\>8.4ng/dL (Zawdaki \& Dunaif 1992)
* mentally competent
* English speaking/writing
* telephone access and/or email access

Exclusion Criteria:

* Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the past 3 months;
* Long-term or chronic use of oral antibiotics;
* Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal hyperplasia;
* Hysterectomy;
* Onset of menopause;
* Pregnancy/Lactation;
* Consumption of flaxseed within the past month; and
* Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia

This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.


Eligibility Criteria:
Inclusion Criteria:

* Administered obinutuzumab under the approved indications in Korea at investigator's discretion
* Previously untreated with obinutuzumab

Exclusion Criteria:

* Out-of locally approved indications, dosage, and administration
* Pregnant women, breastfeeding women
* Hepatic disease
* Participate in other clinical trials
Competing Risk of Death and ESRD in Incident CKD Patients

Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed.

Methods: From a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2. Investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years
* first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004
* and present for at least 3 months
* residing in the given geographical area (the Urban Community of Greater Nancy (UCGN))

Exclusion Criteria:

* \<18 years
* prevalent CKD patient : CKD diagnosis before January 1st, 2004
* patients on dialysis or renal transplanted
* refusal of participation
Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude

High altitude (\>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. However, no device is currently available that can supply a constant low dose of CO2 during free movement at high altitude. We have recently invented a portable device which is small and light enough for supplement of low dose CO2 during field exercise at high altitude.

Objective: To determine whether the supplement of low-dose CO2 by the novel device could improve exercise performance at high altitude.

Methods: The lowlanders (\<500m) who have no history of travelling to high altitude (\>1000m) a year before the study will be recruited. And the subjects who are high-altitude residents and have not left high altitude over the last twelve months will also be recruited for the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during endurance shuttle walking test (ESWT). Blood gases will be measured before and after inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2), and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared during inhalation of CO2 and during inhalation of ambient air.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy lowlanders (\<500m) who have no history to travel to high altitude (\>1000m) a year before the study.
2. Healthy high altitude (4500m) residents who have not left the inhabited area over the last twelve months before the study.

Exclusion Criteria:

1. Subjects with cardiovascular diseases, respiratory diseases and neuromuscular diseases which could affect exercise.