bioihbjkbjnl/mcl2 huggingface dataset:
Multi-media Obesity Prevention Program for Adolescents
Condition: Physical Activity; Nutrition; Obesity Prevention
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this project was to evaluate a population-based, computerized tailored
      intervention that addresses recommended guidelines for three target behaviors related to
      obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and
      vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV
      viewing (2 hours or less of TV each day).
    


Intervention name(s): Health in Motion
Intervention type(s): Behavioral
Intervention description(s): Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal
      study participants following a single dose of BMT with or without a single 8 mg po dose of
      Zofran given 30 minutes before BMT dosing.
    

Detailed description: 
      This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal
      study participants following a single dose of BMT with or without a single 8 mg po dose of
      Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period
      for subject eligibility followed by a 1-day double-blind period in which all subjects receive
      a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran
      (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study
      sites in the United States. Safety and tolerability of BMT administration will be summarized
      and assessed.
    

Intervention name(s): Bremelanotide; Zofran; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sterile aqueous solution for injection, provided as an autoinjector pen; 8 mg tablet (over-encapsulation in a capsule); capsule
Other intervention name(s): BMT; ondansetron
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nausea; Bremelanotide; BMT; Zofran; ondansetron; premenopausal; healthy women
Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the
      bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and
      Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. All dosed subject samples will be analyzed and their data will be
      included in the final study report.

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Gleptomet 50/1000(Metformin HCl & Sitagliptin); Janumet 50/1000(Metformin HCl & Sitagliptin)
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Other intervention name(s): Janumet; Janumet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Intermediate Cervical Block Under Ultrasound for Thyroid Surgery: Impact on Per and Postoperative Opioid Consumption
Condition: Local Anesthesia; Analgesia Disorder
Study type: Interventional

Summary: 
      The investigators included prospectively 35 patients undergoing an intermediate cervical
      block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients
      without a block (GP2).
    

Detailed description: 
      The investigators performed prospective trial with 70 patients randomized in two groups each
      of 35:

        -  Group 1 (GP1): bilateral echo-guided intermediate cervical plexus bloc (ICB) by 10 ml of
           isobaric Bupivacaine (0.25%).

        -  Group 2 (GP2): control.

      Ten minutes after ICB, general anesthesia was realised. Total dose of Remifentanil is
      calculated upon awakening, the postoperative pain is determined by visual analog scale from 0
      to 10 (VAS) statements to H0, H2, H4, H6, H12 and H24. Whenever VAS is greater than or equal
      to 4, a morphine titration was administered.

      Total dose consumption, side effects and satisfaction are noted at the end of protocol.
    

Intervention name(s): bilateral cervical plexus block
Intervention type(s): Procedure
Intervention description(s): with a linear probe and after disinfection vascular neck axis are identified at first. At the cricoid cartilage we conducted an apical scan to locate the carotid bifurcation.at this level is carried out a lateral translation to the visibility of the deep cervical space below the sternocleidomastoidien muscle then a needle 50 is introduced in plane. we proceed in inundation of cervical space
Other intervention name(s): GP1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical plexus block; thyroidectomy; opioid consumption
Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the
      Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines
    


Intervention name(s): CKDB-501A; Botox®
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection CKDB-501A; Intramuscular injection Botox®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose for this protocol is to perform an open-label human clinical pilot study on the
      effects of consumption of two nutraceutical blends in subjects with long-term unexplained
      fatigue interfering with daily living.
    

Detailed description: 
      This is an open-label human clinical study to evaluate the effects of consumption of the
      nutraceutical product ATP-Fuel, compared to the nutraceutical product ATP-II. The study
      participants will be randomized to one of three groups: consuming ATP-Fuel (5 capsules, twice
      daily); consuming ATP-II (3 capsules, once daily); or consuming ATP-II (3 capsules, twice
      daily). The study is of 8 weeks' duration, with evaluation at baseline, 1, 4, and 8 weeks of
      product consumption.

      At each visit the following measurements and procedures are performed: Blood pressure,
      questionnaires pertaining to fatigue, pain and wellness, and a blood draw. The blood is used
      for testing of lipid peroxidation and mitochondrial volume and metabolic activity.
    

Intervention name(s): ATP-Fuel; ATP-II; ATP-II
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 5 capsules daily with breakfast and 5 capsules daily with lunch; 3 capsules daily with breakfast; 3 capsules daily with breakfast and 3 capsules daily with lunch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Continuous vs. Intermittent Caloric Restriction on Fat Los
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this research study examines fat mass loss using a continuous calorie
      reduction protocol versus continuous caloric restriction interspersed with "diet refeeds" and
      "diet breaks" over 12 weeks.
    

Detailed description: 
      In order to lose weight, an individual must sustain an energy deficit (whereby caloric intake
      is significantly lower than expenditure) over time. However, a rich base of evidence suggests
      that weight loss often results in a decreased metabolic rate. This decrease, likely the
      result of a number of physiological and behavioral mechanisms, makes the continuation of
      weight loss more difficult as well as increases the likelihood of weight regain, or the
      "rebound" effect (1, 2). One proposed method of promoting the retention of a higher metabolic
      rate through a period of caloric restriction, and therefore preventing the regain of excess
      weight after energy restriction is discontinued, is the use of intermittent rather than
      continuous caloric restriction. Intermittent energy restriction (IER) involves undulating
      one's energy intake throughout a dieting period as opposed to sustaining a continuous energy
      deficit.

      Research in overweight and obese individuals has shown that periods of moderate caloric
      restriction interspersed with periods of consuming a diet in balance with one's daily energy
      needs (caloric maintenance) is at least comparable to continuous energy restriction in terms
      of weight and fat loss outcomes (3) and may even bestow unique benefits by promoting greater
      retention of fat-free mass and a higher metabolic rate (4). However, to date, no published
      research has examined continuous caloric restriction compared to Intermittent energy
      restriction (diet breaks and diet refeeds) in females only with Obesity.
    

Intervention name(s): Continuous Caloric Restriction versus Intermittent Caloric Restriction on Fat Loss
Intervention type(s): Behavioral
Intervention description(s): This intervention seeks to investigate two different caloric restriction protocol on fat mass.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants were randomized in a balanced fashion and stratified by body fat percentage into either one of the two intervention groups.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Weight Loss, Telehealth, health Coaching, Diet Breaks
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue
      oxygenation in healthy volunteers under controlled hypoxia.
    


Intervention name(s): Masimo O3 Regional Oximeter
Intervention type(s): Device
Intervention description(s): Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Influence of Tart Cherry Juice Intervention on Vascular Function
Condition: Dietary Exposure; Metabolic Disturbance
Study type: Interventional

Summary: 
      Diets containing fruit rich in anthocyanins have been shown (in meta-analyses) to be
      beneficial for health, but intervention trials have shown inconsistent results. In this
      preliminary study we want to investigate the influence of a tart-cherry juice intervention on
      vascular function and explore metabolite profiles that may offer insight into their mechanism
      of action
    

Detailed description: 
      Cardiovascular disease (CVD) is the primary cause of morbidity and mortality. Tart cherries
      (TC) can positively impact major risk factors of CVD, activities thought to be related to
      their phytochemical content. However, data from human trials is less clear. TC have been
      shown to reduce systolic blood pressure (SBP) after acute, short-term and chronic intake, and
      to improve vascular dysfunction, presumably due to their antioxidant and anti-inflammatory
      activities. Other studies have not shown benefits of TC on SBP or vascular function and
      studies are difficult to interpret with different populations, dosing and durations being
      used as well as a lack of understanding for any underlying mechanisms. To account for the
      latter, the use of metabolomics has become increasingly popular in nutritional research.
      Therefore, the aim of this preliminary study was to characterise the effects of TC
      supplementation on vascular function with a 4-week intervention and explore if metabolomics
      can provide mechanistic evidence and this will inform for future chronic studies with TC
      juice.
    

Intervention name(s): Cherry juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A tart cherry juice intervention; A tart cherry juice placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cherry; anthocyanin; vascular function; metabolomics
The Effectiveness of tDCS on Internet Game Addiction
Condition: Addiction; Internet Gaming Disorder
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the investigators aimed to investigate the effect of transcranial direct
      current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status
      of Internet game addiction includes severity of addiction symptom, subjective craving for
      gaming, response inhibition and cue reactivity. The investigators hypothesized that real
      stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on
      severity of addiction symptom, subjective craving for gaming, response inhibition and cue
      reactivity rather than sham stimulation with tDCS.
    


Intervention name(s): tDCS with real stimulation; tDCS with sham stimulation
Intervention type(s): Device; Device
Intervention description(s): tDCS is a non-invasive brain stimulation. Real stimulation includes 2mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.; Sham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with internet gaming disorder will be randomly allocated into 1) actual real stimulation with tDCS group, and 2) sham stimulation with tDCS group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Internet game addiction; Internet gaming disorder; transcranial direct current stimulation; response inhibition; craving; cue reactivity
FMT for Post-infectious IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Considering that PI-IBS is brought on by infection and gut microbiota may be associated with
      the onset of symptoms, the modification of altered gut microbiota with nonabsorbable
      antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment.
      Research in recent years has also shown the potential benefits of fecal microbiota
      transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota
      with fecal material from a healthy donor. Even though the only officially approved indication
      for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT
      is nevertheless being studied for the treatment of other gastrointestinal and
      non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled
      studies have been conducted to study the effectiveness of FMT for IBS, and most of them have
      demonstrated positive results. The investigators have not come across studies devoted to the
      study of the effectiveness of FMT in patients with PI-IBS in the available literature. So,
      the aim of the current study was to conduct single-centre, randomized clinical trial to
      assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.
    


Intervention name(s): Fecal transplantation; OTILONII BROMIDUM; multi-strain probiotic
Intervention type(s): Biological; Drug; Dietary Supplement
Intervention description(s): Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.; OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment; multi-strain probiotic, oral, 1 capsule BID for 1 month
Other intervention name(s): Fecal microbial transplantation; Spasmomen®
Intervention MeSH terms: Octylonium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; fecal microbiota transplantation; postinfectious irritable bowel syndrome
Nicotine TMS EFT Smoking Pilot Study
Condition: Smoking; Nicotine Dependence; Addiction; Smoking, Cigarette
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Prior and recent evidence suggests a role of medial prefrontal cortex (MPFC) in cigarette
      smoking. Episodic Future Thinking (EFT) has also been shown to be associated with increased
      delayed discounting and reduced cigarette self administration. In the present study, we will
      examine whether a single administration of theta-burst transcranial magnetic stimulation
      (tbTMS) can increase Episodic Future Thinking and delayed discounting while reducing craving
      for nicotine.
    

Detailed description: 
      The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS)
      as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique
      that uses magnetic pulses to temporarily stimulate specific brain areas in awake people
      (without the need for surgery, anesthetic, or other invasive procedures). This study will
      test whether tbTMS over the forehead can produce a reduction in things that may prompt
      individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug
      Administration as an investigational tool as well as a therapy for depression. However, TMS
      is not approved by the Food and Drug Administration as a treatment for nicotine cravings and
      other addictions.

      This study consists of one consent session and one TMS session. Participants will be asked to
      complete a series of questionnaires and computer assessments about nicotine both before and
      after a single tbTMS session.
    

Intervention name(s): Real cTBS; Sham cTBS
Intervention type(s): Device; Device
Intervention description(s): This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).; This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Stimulation
A Study to Assess Efficacy of Supporting Properties and Safety of ARTNEO in Patients With Knee Osteoarthritis
Condition: Osteoarthritis; Osteo Arthritis Knee; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of the interventional study is to assess the effectiveness of the supporting
      properties and safety of the dietary supplement ARTNEO (ARTNEO®), capsules with an average
      weight of 585 mg, in patients with osteoarthritis of the knee joint of both sexes aged 40 to
      75 years. The main questions it aims to answer are:

        1. To evaluate the effectiveness of the supporting properties of dietary supplement ARTNEO
           (ARTNEO®) in patients with knee osteoarthritis in comparison with active control;

        2. To evaluate the safety of the dietary supplement ARTNEO (ARTNEO®) in patients with knee
           osteoarthritis
    


Intervention name(s): ARTNEO; Artra
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Dietary Supplement: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)
Release form: capsules with an average weight of 585 mg. Active ingredients: MCM (methylsulfonylmethane) 300 mg, vitamin C (ascorbic acid) 80 mg, boswellia extract (65% boswellic acids) 50.05 mg, undenatured (native) type II collagen 40 mg, vitamin D3 (cholecalciferol) 400 IU.
Suggested Use: Adults, 1 capsule daily with meals.; Active ingredients:
Glucosamine hydrochloride 500 mg Chondroitin sulfate sodium 500 mg
Excipients:
dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate.
Orally; adults and children over 15 years of age are prescribed 1 tablet 2 times a day for the first three weeks; 1 tablet 1 time per day for the next weeks and months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: undenatured type ii collagen; collagen; Boswellia serrata; methylsulfonylmethane; osteoarthritis; knee pain