bioihbjkbjnl/mcl2 huggingface dataset:
A First-in-Man Study of the Firesorb BVS (FUTURE-I)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular
      Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is
      to access the preliminary safety and efficacy of Firesorb implantation in the human body, and
      to provide evidence for subsequent large-scale, multi-center, randomized controlled clinical
      trials. Then provide the basis for the formal application of the product in China.
    

Detailed description: 
      This study is a prospective, single-center clinical trial. The investigator design to recruit
      45 subjects. After implanting the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
      (Firesorb) successfully, all the subjects will be randomly assigned to queue 1 (n=30) and
      queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6
      months,1 year,2 years,3 years,4 years and 5 years after scaffold implantation.
      Angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after scaffold
      implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and
      3 years after scaffold implantation in queue 2. The primary endpoint of the study is target
      lesion failure (TLF) at 30 days after scaffold implantation, the secondary endpoints are
      series of imaging outcomes, for evaluation of feasibility and preliminary safety and efficacy
      of the product.
    

Intervention name(s): Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Intervention type(s): Device
Intervention description(s): Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Other intervention name(s): Firesorb
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-Eluting Stents,Absorbable Implants,Stents
Insomnia and Osteoarthritis Study
Condition: Osteoarthritis; Insomnia
MeSH terms: Osteoarthritis; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This research is being done to evaluate the effects of a sleeping pill (eszopiclone,
      Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This
      study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in
      patients with knee pain.
    


Intervention name(s): Placebo; Eszopiclone
Intervention type(s): Drug; Drug
Intervention description(s): 3mg placebo capsule, once daily at bedtime; 3mg capsule, once daily at bedtime
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eszopiclone; insomnia
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Observational

Summary: 
      GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV)
      vaccine in several countries. In view of its registration in the Philippines, the present
      study will collect data on the safety of the vaccine in the local target population as per
      the Bureau of Food and Drugs Directive.
    

Detailed description: 
      The protocol was amended to reflect a change in the prescribing information. The age of the
      infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first
      vaccination. This protocol posting has been amended in order to comply with FDA AA.
    

Intervention name(s): Rotarix; Data collection
Intervention type(s): Biological; Other
Intervention description(s): Two doses of the oral vaccine; Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Filipino subjects aged at least 6 weeks at the time of first vaccination
      
Keywords: safety; Post-marketing surveillance (PMS); Rotarix; oral; Filipino; Rotavirus; Gastroenteritis; Human Rotavirus (HRV) vaccine
Effects of the Myofascial Induction Technique Versus a Control Laser
Condition: Foot Diseases; Myofascial Pain
MeSH terms: Foot Diseases
Study type: Interventional

Summary: 
      The objective is to determine the effectiveness of myofascial Induction effects on plantar
      pressures variables. Forty healthy subjects will be recruited for a simple blind clinical
      trial. All subjects will be randomly distributed in two different groups: control group (sham
      Laser) and experimental group (myofascial Induction). Outcome measurements will be foot
      plantar pressure area (footprint) by a validated platform. Two trials will be recorded before
      and after intervention in standing position.
    


Intervention name(s): Sham Laser; Myofascial Induction
Intervention type(s): Other; Other
Intervention description(s): Sham Laser in plantar fascia; Myofascial Induction in plantar fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have
      been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia
      with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation
      may become difficult sometimes and endangers patients life. Using SGAs as a conduit for
      tracheal intubation helps in securing airway. This will be further facilitated by using
      ventilating bougie, as it maintains oxygenation.
    

Detailed description: 
      SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients
      were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and
      then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its
      position was confirmed and then ventilating bougie was inserted through it. It's position was
      confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie
      and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed
      and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA
      was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was
      confirmed.
    

Intervention name(s): Tracheal Intubation using I-gel and ventilating bougie; Tracheal Intubation using C-LMA and ventilating bougie
Intervention type(s): Device; Device
Intervention description(s): Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.; Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: C-LMA; I-gel; ventilating bougie; intubation
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy, safety, and tolerability of different
      doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants
      with diarrhea-predominant irritable bowel syndrome.
    


Intervention name(s): Eluxadoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets twice daily; Oral tablets twice daily
Other intervention name(s): JNJ-27018966
Intervention MeSH terms: Eluxadoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518
      in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1
      (Protocol No. P04695)
    


Intervention name(s): Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron); Drug: SCH 900518 Biologic: Peginterferon alfa-2b; Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron); Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: SCH 900518
Biologic: Peginterferon alfa-2b(PegIntron)
Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days .
Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.; Drug: SCH 900518
Biologic: Peginterferon alfa-2b
Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days
Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.; Drug: SCH 900518
Drug: Ritonavir (RTV)
Biologic: Peginterferon alfa-2b (PegIntron)
Period 1: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension + ritonavir (200 mg BID) (2-100 mg oral capsules) for 7 days.
Period 2: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension+ ritonavir (200 mg BID) (2-100 mg oral capsules) + PegIntron (1.5 µg/kg QW) for 14 days.; Drug: SCH 900518
Drug: Ritonavir (RTV)
Biologic: Peginterferon alfa-2b (PegIntron)
Period 1, Amorphous SCH 900518 (400 mg) or placebo BID administered as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) for 7 days.
Period 2, SCH 900518 (400 mg) or placebo BID as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) +PegIntron (1.5 µg/kg SC QW) for 14 days.
Other intervention name(s): narlaprevir, PegIntron; narlaprevir, PegIntron; narlaprevir, norvir, PegIntron; narlaprevir, norvir, PegIntron
Intervention MeSH terms: Ritonavir; Peginterferon alfa-2b; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of co-administration of itraconazole or
      verapamil on the drug levels of MYK-224 in healthy participants.
    


Intervention name(s): MYK-224; Itraconazole; Verapamil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986435
Intervention MeSH terms: Itraconazole; Verapamil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MYK-224; Itraconazole; Verapamil
A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and in the United States of America (USA). The aim of this
      trial is to investigate the absorption and effect in the body of NN1218 in subjects with type
      1 and type 2 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart; Faster-acting insulin aspart; Faster-acting insulin aspart; Faster-acting insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin)
Other intervention name(s): NN1218; NN1218; NN1218; NN1218
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of Minocycline to Treat Children With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional

Summary: 
      This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of
      age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a
      controlled trial of minocycline, an antibiotic commonly used in children for infection or for
      treatment of neurodegenerative disorders. We are investigating its use in FXS because it
      lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also
      strengthens brain connections in the animal models of FXS. We hypothesize that minocycline
      will likely be helpful for language, behavior and/or cognition in fragile X patients.
    

Detailed description: 
      This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of
      age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a
      controlled trial of minocycline, an antibiotic commonly used in children for infection or for
      treatment of neurodegenerative disorders. We are investigating its use in FXS because it
      lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also
      strengthens brain connections in the animal models of FXS. We hypothesize that minocycline
      will likely be helpful for language, behavior and/or cognition in fragile X patients.

      The aim of this study is to carry out a double-blind placebo controlled trial of minocycline
      treatment in children with FXS who are 3.5 to 16 years of age. At baseline, we will assess
      behavior and perceptual and cognitive development. After the children have been treated for 3
      months with either minocycline or placebo, they undergo the same baseline testing. They will
      then cross over and be treated for a second 3 months. We will carry out testing again at the
      end of the second 3 month period. We will also assess the side effects of minocycline
      treatment throughout the study.
    

Intervention name(s): minocycline hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Minocycline hydrochloride dosed orally once a day for 3 months.; Placebo will be given daily for 3 months.
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fragile X syndrome; minocycline; targeted treatment
Efficacy of Metformin in Preventing Diabetes in China
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicentred, randomized, open study to evaluate the efficacy of metformin in preventing
      Diabetes.
    

Detailed description: 
      The increasing prevalence of prediabetes had been documented in the recent national
      surveillance in China. Prediabetes is an important risk factor for developing overt Diabetes
      and macro/micro vascular diseases. Pharmaceutical medications such as metformin had been
      proved effective in preventing Diabetes. Local studies are in need to guide the clinicians in
      their daily practice to prevent Diabetes in China. Therefore, China Diabetes Prevention
      Program（China DPP）is designed and conducted to compare the efficacy of metformin combined
      with lifestyle intervention versus lifestyle intervention alone in preventing Diabetes.
    

Intervention name(s): metformin; Standard lifestyle intervention
Intervention type(s): Drug; Other
Intervention description(s): Metformin tablets will be administrated in the experimental arm.; Standard lifestyle advice will be united for all subjects by providing special booklet.
All participants will receive 20-30 minutes individual or group session with assigned nurse addressing the harm of prediabetes and the importance of a healthy lifestyle for preventing Diabetes.
The amount of energy intake of the participants will be calculated based on the ideal body weight and physical activity levels. The sample recipe will be explained by the nurse and provided in the diet instruction.
Moderate intensity physical activity (150 minutes per week) is recommended.
Smoking cessation is encouraged for the smoker.
Excessive alcohol intake is encouraged to avoid.
Other intervention name(s): Glucophage immediate release formulation
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers
Condition: COVID; Corona Virus Infection
MeSH terms: Coronavirus Infections; COVID-19
Study type: Observational

Summary: 
      The medical and paramedical staff of the front-line services are potentially exposed to
      SARS-CoV-2. Therefore, despite the application of standard protective measures, it is
      possible that a certain number of these personnel have already contracted SARS-CoV-2,
      including in its asymptomatic form. Serological testing in this context would be useful for
      deploying immune healthcare workers as to limit the risk of viral infection and transmission.
      Therefore, it is of utmost importance to prove that the serological response entails the
      production of neutralizing antibodies.
    


Intervention name(s): Specific anti-SARS-CoV-2 antibodies
Intervention type(s): Biological
Intervention description(s): A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.
All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).
Intervention MeSH terms: Antibodies
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Age-stratified sample from general population with 3 subgroups:

          1. Healthcare workers (HCWs), comprising frontline doctors, nurses, health attendants,
             and receptionists.

          2. Healthy blood donors and healthy subjects in blood bank or laboratory (routine
             examinations as pre-employment, likely to be representative of the general population

          3. Convalescents
3 Minutes Chair Rise Test (3CRT) in Patients With COPD
Condition: Evaluations; Rehabilitation; COPD
Study type: Interventional

Summary: 
      Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation
      program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside
      specialized centers.

      In order to monitor the eventual decline of patients in the course of their RHB management,
      Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The
      goal of this prospective, multicenter, real-life study is to compare the change in several
      functional function tests and questionnaires of quality of life and dyspnea related to daily
      activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related
      to COPS Tool) were specified.
    


Intervention name(s): Chair Rise Tests and short questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency.
This test is combined with a questionnaire to collect quantitative and qualitative information:
dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise
Saturation at rest, and at the end of the exercise
the number of total a chair rise
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Exercise tests; COPD; Rehabilitation