cyrilzakka/clinical-trials huggingface dataset:
ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity

Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in 9th or 10th grade at participating schools

Exclusion Criteria:

* blood pressure in the range of stage 2 hypertension
* previously diagnosed type 1 or type 2 diabetes
* use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia
* inability to perform moderate to vigorous physical activity
* not ambulatory
* a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure
* developmental disorders that affect weight or ability to understand the study procedures or counseling
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms.

The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written Informed Consent
* Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein
* Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication
* Life expectancy \>1yr
* Reflux time \>1s in the superficial femoral and/or popliteal vein

Key Exclusion Criteria:

* Any prior deep vein intervention within 6 months prior to the Index Procedure
* History of 2+ DVTs
* Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC
* Current IVC Placement
* History of pulmonary embolism within 6 months
* Conditions that increase the risk of device thrombosis or patient bleeding
* Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure
* Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol
Autologous Fat Grafting to the Face With Use of the Viality™ System

The purpose of this research is to collect data on the short and long-term effects of facial fat grafting by injectable tissue replacement and regeneration in the midfacial zone, with the use of the VialityTM system. The Viality system is a US Food and Drug Administration (FDA) cleared device.

Autologous fat transfer (AFT) is a minimally invasive medical procedure that includes aspirating adipose tissue from one part of the body and washing, filtering, and reinjecting the processed fat tissue into a different part of the body with the primary purpose of adding volume.

A 2013 survey of the American Society of Plastic Surgeons indicated that 80% of the responding physicians use AFT.

Several published studies conclude that using a filter mesh to concentrate the fat by removing surgical tumescent fluid and blood improves fat graft retention (Salinas et al., Girard et al., Ansorge et.al.). Furthermore, washing and filtration of the autologous adipose tissue produces a fat graft with higher tissue viability (Zhu et al., Girard et al., Barbour et al.)

Viality is a lipoaspirate wash system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister.

Viality is to be used to filter and wash aspirated, harvested autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. Viality is not intended to process autologous adipose tissue other than for aesthetic body contouring uses.

Eligibility Criteria:
Inclusion Criteria:

* Female patients \> 18 years and \< 65 years of age.
* Patients undergoing an aesthetic fat grafting procedure to the face.
* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
* Patients must be non-smokers.
* Patients with available/adequate harvest sites for fat grafting.
* Anticipated harvested fat volume between 60 and 100 cc.
* Anticipated fat injection volume 40-55 cc.
* Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in diet or lifestyle during the study.

Exclusion Criteria:

* Skin rash in the treatment area.
* Patients who smoke or use nicotine products.
* Patients with bleeding disorders or currently taking anticoagulants.
* Patients with history of trauma or surgery to the treatment area.
* Active, chronic, or recurrent infection.
* Compromised immune system.
* Hypersensitivity to analgesic agents.
* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
* Untreated drug and/or alcohol abuse.
* Pregnant or breastfeeding.
* Any issue that, at the discretion of the investigator, would contra-indicate the patient's participation.
* Patients who do not wish to have the study area photographed.
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women
2. Age 18 to 70 years old
3. Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
4. Readiness to comply with trial procedures, including in particular:

   * Use of IP as recommended
   * Filling in diary
   * Keeping habitual life-style, including diet and physical activity level
   * No use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment)
5. Women of child-bearing potential:

   * Have to agree to use appropriate contraception methods
   * Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature,

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the investigational product
2. History and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

   * Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery
   * Asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. chronic cough of any origin)
   * Acute psychiatric disorders
   * Any other acute/chronic serious organ or systemic diseases
3. Influenza vaccination within the last 3 months prior to V1 and during the study
4. Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1
5. Pregnancy or nursing
6. History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
7. Participation in the present study of a person living in the same household as the subject
8. Inability to comply with study requirements according to investigator's judgement
9. Participation in another clinical study in the 30 days prior to V1 and during the study
Screening Study for Participants With Malignant Tumors

The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.


Eligibility Criteria:
General Inclusion Criteria:

* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
* Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial

Inclusion Criteria for Participants with Stage III NSCLC

* Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment

* Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
* Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
* Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
* Representative FFPE tumor specimen obtained prior to the start of any treatment
* ECOG Performance Status of 0 or 1

General Exclusion Criteria:

* History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
* Any condition that may affect the interpretation of study results
* Significant liver or cardiovascular disease
* Prior allogenic stem-cell or solid-organ transplantation
Effects of Monarda Didyma Extract Supplementation on Biological Ageing

This research aims to explore the potential benefits of supplementation of a natural ingredient, the Monarda didyma extract, to reduce / delay the biological aging of a susceptible population, thus contributing to two relevant topics in science with important social and economic implications: anti-aging strategies for wellness and healthy aging and environmental sustainability using natural products.


Eligibility Criteria:
Inclusion Criteria:

* The subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
* Age: 45 - 65

Exclusion Criteria:

* Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular disease (e.g., stroke, heart attack))
* Chronic intake of medication/dietary supplements with impact on stress levels (psychologically and physiological)
* Consumption of any dietary/nutritional supplements or functional foods
* Smokers
* High caffeine intake \> 5 coffee cups / day
* Gastrointestinal diseases/conditions (ulcerative colitis, Crohn's disease, peptic ulcers, celiac disease)
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Known allergies against the mint family (labiate), especially lemon balm (la cedrella, la melissa, la citronella)
* Pregnancy, breastfeeding or intention to become pregnant during the study
* Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
* Blood donation within 4 weeks prior to study start (screening) or during the study
* Anticipating any planned changes in lifestyle for the duration of the study
* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

This study will explore the effects of cognitive behavioral therapy for insomnia (CBTI) compare to health educations in patients with type 2 diabetes (T2DM) with insomnia symptoms.

This study will recruit participants with T2DM with insomnia symptoms and randomize them to weekly CBTI or health education for 8 weeks. Outcomes will be measured at baseline and 8 week, and 16 weeks (8 weeks post intervention).

Primary outcome will be subjective sleep quality as assessed by Pittsburgh Sleep Quality Index Secondary outcomes will be fasting glucose, hemoglobin A1C, insulin levels, high sensitivity c-reactive protein, objective sleep parameters from accelerometer, depressive symptoms, daytime sleepiness, quality of life, anxiety symptoms and stress symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus age 30 to 65 years old
* Hemoglobin A1C ≥ 6.5 but ≤ 10 %
* Have poor sleep quality as assessed by Insomnia Severity Index ≥ 15
* Receive the same hypoglycemic treatments 3 months before the intervention
* If using sleep aid, the dose needs to be stable for 3 months prior to the enrollment
* Ability to use the electronic devices (computer, tablet) and assess the internet
* Willing to attend all of the 8 sessions activities

Exclusion Criteria:

* Type 1 diabetes mellitus
* Night shift work
* Insulin therapy
* Severe hypoglycemia who required hospitalization or emergency department visit in the past 6 months
* History of diabetic ketoacidosis in the past 6 months
* Medically unstable conditions eg. renal replacement therapy, liver failure, heart failure, active cancer, epilepsy, unstable cerebrovascular disease
* Psychosis, uncontrolled depression
* Untreated obstructive sleep apnea or STOP-BANG ≥ 5
* Language/communication/hearing/sight disability
* Pregnancy or lactation
* Care giver of infant
* Harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)
Oral Testosterone for the Treatment of Hypogonadism

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4.

A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.


Eligibility Criteria:
Inclusion Criteria:

* Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \< 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
* Men over the age of 18 years with a body mass index (BMI) \< 39.0 kg/m2 and weighing ≥ 55 kg
* Hemoglobin levels at screening and baseline \> 12.5 g/dL
* Testosterone treatment not contraindicated
* No evidence of suspected reversible hypogonadism
* Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
* Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria:

-
RCT Comparing 19Ga vs 22Ga EBUS-TBNA Needles in Carcinoma.

EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

Eligibility Criteria:
Inclusion Criteria:

* (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
* requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis

Exclusion Criteria:

* uncontrolled coagulopathy
* tracheal stenosis
Acupuncture for Patients With Function Dyspepsia

Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia

Design:

* A single blind randomized controlled trial
* 200 participants will be included
* Two arms: acupuncture and sham acupuncture group

Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.

Eligibility Criteria:
Inclusion Criteria:

* Consistent with the diagnostic criteria of functional dyspepsia.
* Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
* Include postprandial distress syndrome.
* Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
* Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

* Patients with any contraindications of Itopride.
* Patients who are unconscious, psychotic.
* Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
* With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
* Pregnant women or women in lactation.
Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis

To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.

The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.The patients in control group also will undergo Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.

Eligibility Criteria:
Inclusion Criteria:

1. ICU patient
2. Clinical diagnosis of sepsis

Exclusion Criteria:

1. Expired within 3-days