bioihbjkbjnl/mcl2 huggingface dataset:
The Activity of Tissue Engineering Skin Substitutes
Condition: Difficult to Heal Wounds
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this experiment was to evaluate the activity of tissue engineering skin
      substitutes safety and efficacy studies for the treatment of difficult to heal wounds
    

Detailed description: 
      This study for 6 months for a single center, open, randomized, controlled clinical trials
      before and after itself, test contains preliminary screening, treatment and follow-up after
      discharge of the patient.After treatment in patients with early debridement, in the case of
      no infection of living tissue engineering skin substitute transplantation, observe the wound
      healing after transplantation, chronic wound evaluation activity of tissue engineering skin
      substitutes in the efficacy and safety of wound healing after transplantation.
    

Intervention name(s): liveness tissue skin
Intervention type(s): Biological
Intervention description(s): liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus
      Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV
    

Detailed description: 
      According to classification, this is a phase 2 randomized parallel group prospective
      controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L.
      crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years
      suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that
      oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential
      efficacy in rBV.

      Qualifying women received a combination of the three probiotic strains with a half daily
      recommended dose of vitamin C or just vitamin C without probiotics, a control
      supplementation, via oral route of administration for up to 120 days. During the intake of
      active or control formulations, participants kept a structured 120-DSD, where they recorded
      test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance
      events.

      Based on repeat physical examination with application of Amsel and Nugent criteria the main
      conclusions over the efficacy of probiotic strains were made.
    

Intervention name(s): Lactogyn; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules; capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of Rifampicin on the Pharmacokinetics of Apatinib
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate potential pharmacokinetic interaction in
      healthy volunteers when apatinib is administered in combination with rifampicin. Secondary
      objective is evaluating the safety and tolerability of apatinib alone and when
      co-administered with rifampicin.
    


Intervention name(s): Apatinib Mesylate Tablets; Rifampicin Capsules
Intervention type(s): Drug; Drug
Intervention description(s): apatinib was administered in the morning after an overnight fast of at least 10 h; rifampicin was administered in the morning 2 hours after breakfast
Other intervention name(s): apatinib; rifampin
Intervention MeSH terms: Rifampin; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Background:

        -  New Nordic diet guidelines advocate a reduction in consumption of protein from animal
           sources such as beef and pork, due to environmental concerns.

        -  Instead, intake of protein from vegetable sources such as legumes and pulses should be
           increased.

        -  A previous study showed that a meal enriched with vegetable protein increased the
           subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI)
           compared to animal protein.

        -  This study did, however, not document that vegetable protein per se is more satiating
           than animal protein as the vegetable meal had higher fiber content. Fiber is a likely
           confounder.

        -  The protein from egg is sparingly investigated in relation to appetite. Few studies have
           found that eggs have a high satiety index but further investigation is needed.

      Objective:

      - To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and
      ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg
      with similar distribution of macronutrients and content of dietary fibers.

      Design:

      Single-blind randomized 4-way crossover meal study

      Subjects:

      33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.

      End points:

        1. Subjective appetite (VAS) (every 30 min for 3 hours)

        2. Ad libitum EI (3 hours after lunch test meal)
    


Intervention name(s): Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake
Intervention type(s): Other
Intervention description(s): 4-arm crossover study with the objective to examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum EI) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protein sources; Appetite; Dietary fibers; Meat; Egg; Legumes
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected
      with SARS-CoV-2.
    

Detailed description: 
      Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo,
      an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open,
      controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients
      infected with SARS-CoV-2.
    

Intervention name(s): Ganovo+ritonavir+/-Interferon nebulization
Intervention type(s): Drug
Intervention description(s): Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
Intervention MeSH terms: Interferons; Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary
      objective of this study is to investigate the effect of Org 25935 on ketamine-induced
      impairments in immediate recall.
    


Intervention name(s): Ketamine and Org 25935; Placebo and Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of Org 25935 16 mg and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes); Oral administration of placebo and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ORG 25935; Ketamine; healthy subjects
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of a single
      dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions
      compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following
      oral administration and to investigate the effect of food on the exposure with TF2 (TF2a,
      TF2b).
    


Intervention name(s): BI 1358894 (B); BI 1358894 (C); BI 1358894 (D); BI 1358894 (E); BI 1358894 (A)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet formulation 2 (TF2a), fed; Tablet formulation 2 (TF2a), fasted; Tablet formulation 2 (TF2b), fed; Tablet formulation 2 (TF2b), fasted; Tablet formulation 1 (TF1), fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of insulin VIAject with Regular Human
      Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.
    


Intervention name(s): Regular Human Insulin; Insulin Lispro; Insulin VIAject™ (75%); Insulin VIAject™ (90%)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.; 90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.; 75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal; 90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Moderate Bleeding in Cardiac Surgery Post Operative
Condition: Heart Surgery
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the
      drainage system to define moderate bleeding postoperative cardiac surgery and define the
      population.
    

Detailed description: 
      Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the
      drainage system to define moderate bleeding postoperative cardiac surgery and define the
      population.

      Secondary objectives:

      To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative
      transfusion.

      To evaluate the prognostic impact of the SPO moderate in terms of post-operative
      complications.

      Determine predictors of moderate SPO.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients admitted to intensive care after surgery for heart surgery
Migrant Workers' Responses to the COVID-19 Pandemic
Condition: Coronavirus; Trust; Misinformation
MeSH terms: Coronavirus Infections
Study type: Observational

Summary: 
      Rumors circulate widely during public health crises and have deleterious consequences. In
      this study, we seek to document the base rates of migrant workers' rumor exposure and
      identify predictors of rumor hearing, sharing and belief.
    

Detailed description: 
      Rumors circulate widely during public health crises and have deleterious consequences.
      Vulnerable populations such as migrant workers tend to lack access to accurate health
      information, which can put them at higher risk for receiving and spreading misinformation.

      In this study, we seek to document (i) the base rates of migrant workers' rumor exposure and
      (ii) identify predictors of rumor hearing, sharing and belief. These predictors include trust
      in institutions, risk perceptions, online habits and socio-demographic variables.

      Data was taken from the COVID-19 Migrant Health Study, a cross-sectional study of male
      migrants employed in manual labor jobs within Singapore.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consist of male migrant workers employed in manual labor jobs within
        Singapore
      
Keywords: Migrant workers; Singapore; Vulnerable; Trust; Rumours; Resilience
Effects of Human Leptin Replacement
Condition: Obesity; Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the hypothesis that leptin contributes to the regulation of the dynamics
      of human endocrine function.
    

Detailed description: 
      The study aims to elucidate the role of leptin in the regulation of human endocrine function
      approached by a carefully designed, prospective clinical study of the rapidly-sampled
      dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only
      three adult individuals identified in the world so far who are leptin-naive due to a
      functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding
      factors and pitfalls, because the only bioactive leptin to which they will be exposed is the
      exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain
      the endocrine effects of human leptin.
    

Intervention name(s): Recombinant methionyl human leptin
Intervention type(s): Drug
Intervention description(s): Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
Other intervention name(s): Metreleptin; r-metHuLeptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congenital leptin deficiency; Obesity; Metabolic syndrome; Diabetes
Use of Blood Flow Restriction Therapy Following ACL Tear
Condition: Anterior Cruciate Ligament Tear; Knee Injuries; Sport Injury
MeSH terms: Wounds and Injuries; Knee Injuries; Athletic Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior
      cruciate ligament tear
    

Detailed description: 
      The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR)
      therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a
      tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen
      depleted environment and the ability to induce muscle adaption at lower maximum repetition
      via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus,
      physical therapy is used in the peri-operative period to regain strength with the ultimate
      goal of returning to activity.

      The goal of this investigation is to determine if using BFR during perioperative therapy
      would lead to increased and expedited strength gains. Additionally we would like to determine
      if BFR helps patients to pass the standard rehabilitative functional tests and return to play
      sooner. We will also look at patient reported outcomes metrics and pain scores to determine
      if BFR has a significant impact on the patient experience surrounding ACL tear and
      reconstruction.
    

Intervention name(s): Blood flood restriction cuff
Intervention type(s): Device
Intervention description(s): Blood flow restriction cuffs will be used as an augment to physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel randomized controlled trial with a treatment and control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
ThermRheum Version 1
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      Childhood arthritis is a diagnosis made by clinicians based upon their clinical examination,
      during which patients are assessed for signs of swelling, warmth and restricted movement of
      the joints using the sensation of touch. Clinicians use investigations such as blood tests
      and scans which may be costly, associated with waiting times, can cause the patient stress or
      anxiety. Patients with childhood arthritis can often present with flares of their condition
      even when on medical treatment, which may require further investigations to determine the
      nature of the problem. Studies in adult Rheumatology have demonstrated that a thermal imaging
      camera (which detects heat given off by the body) can be useful in assessing for signs of
      inflammation in arthritis. The use of this camera could provide an alternative to the tests
      described; it does not require any contact with the patient, is quick and easy to use, and
      does not emit any radiation. The investigators hope that this pilot study will demonstrate
      that thermal imaging can be used to complement the standardised assessments of joint
      inflammation as done routinely in clinic and may lead to further work comparing thermal
      imaging with other tests such as MRI scanning and ultra-sound.

      The investigators will recruit 20-50 children with arthritis affecting either knee or ankle
      joints. The investigators will use a highly sensitive thermal imaging camera to take pictures
      and short video recordings of each ankle and knee joint, recording skin temperature and
      colour. The investigators will compare this with the clinicians' assessment of whether the
      knee and ankle joints are inflamed or not. The investigators are interested in finding out
      whether the information recorded using the camera mirrors the assessment made by the
      clinician.
    


Intervention name(s): Thermal Imaging
Intervention type(s): Device
Intervention description(s): Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test an exercise treatment that includes behavioral
      strategies to improve blood sugar control in women with type 2 diabetes who are depressed and
      overweight.This research study may lead to a potentially useful treatment for diabetes
      management when depression is present.
    


Intervention name(s): Exercise group
Intervention type(s): Behavioral
Intervention description(s): 24 week group exercise class supplemented with behavioral activation strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Acute Anxiolytic Effects of Riluzole on Subjects With Social Anxiety Disorder
Condition: Social Anxiety Disorder; Performance Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of the current proposal is to examine if sublingual riluzole can reduce anxiety in
      people with social anxiety disorder during a public speaking task.
    

Detailed description: 
      The investigators propose conducting a double-blind, placebo controlled crossover study
      examining the effects of BHV-0223 on public speaking anxiety. Twenty participants with DSM-5
      defined social anxiety disorder and clinically significant public speaking anxiety on the
      Impromptu Speech Task will be enrolled in a challenge study. Participants will be given
      BHV-0223 (or placebo) under double-blind crossover conditions 1 hour prior to performing each
      of 2 impromptu speech tasks. The two study days involving BHV-0223 (or placebo)
      administration and impromptu speech task will be separated by 2 to 10 days to allow for
      medication washout. There will be a final follow-up visit 2 to 10 days later to perform a
      complete Physical exam and do follow-up liver function testing and a Complete Blood Count.
      Our primary outcome will examine BHV-0223's effects (compared to placebo) on self-rated
      anxiety during the impromptu speech task. The investigators will also collect physiological
      measures of anxiety, clinician-rated measures of anxiety, and measures of speech performance
      as secondary outcomes.
    

Intervention name(s): BHV-0223; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours.; a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours.
Other intervention name(s): sublingual riluzole
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cross-over study; Riluzole; Double-blind study; Speech task; Social Anxiety Disorder
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study will assess the effects of hepatic impairment on the pharmacokinetics
      of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment
      (Child-Pugh class A or B) and in matched control subjects with normal hepatic function.
      Subjects will receive a single oral dose of aleglitazar, with assessment of the
      pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled
      subject is approximately 6 weeks.
    


Intervention name(s): aleglitazar
Intervention type(s): Drug
Intervention description(s): single oral dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)