bioihbjkbjnl/mcl2 huggingface dataset:
Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma
Condition: Asthma; Moderate Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of this study is to assess the safety and tolerability of multiple ascending
      subcutaneous doses of REGN3500 to moderate asthmatics.
    


Intervention name(s): REGN3500; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): REGN3500 dose; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Praziquantel Bioequivalence Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg)
      Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in
      healthy male participants. Praziquantel (PZQ) is the active ingredient for Cisticid and
      Biltricide tablets.
    


Intervention name(s): Cisticid; Biltricide
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).; Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Other intervention name(s): Praziquantel; Praziquantel
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability; Bioequivalence; Praziquantel; Cysticide; Pharmacokinetics
Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and
      200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of
      controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety
      of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) when administered in
      combination with a single-dose of controlled release levodopa/benserazide 100/25 mg.
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled, crossover study with five
      single-dose treatment periods, with a washout period between doses of 5 days or more. In each
      of the five consecutive treatment periods, eligible subjects were admitted to the UFH in the
      day prior to receiving the study medication. On the morning of the dosing day, subjects
      received BIA 6-512/Placebo concomitantly with Madopar® HBS 125 in fasting conditions (at
      least 8 hours) and remained in the UFH until at least 24 h post-dose; then, they were
      discharged and returned for the next period or the follow-up visit. Blood samples for the
      assay of plasma BIA 6-512, levodopa and 3-O-methyldopa (3-OMD) were taken at the following
      times: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
    

Intervention name(s): Madopar® HBS 125; Placebo; BIA 6-512 25 mg dose; BIA 6-512 50 mg dose; BIA 6-512 100 mg dose; BIA 6-512 200 mg dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.; 2 capsules of placebo; 1 capsule of 25 mg plus 1 capsule of placebo; 2 capsules of 25 mg; 1 capsule of 100 mg plus 1 capsule of placebo; 2 capsules of 100 mg
Intervention MeSH terms: Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Adiponectin and Ethnic Differences in Insulin Resistance
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this protocol is to measure and compare levels of the circulating protein
      adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and
      non-Latino white subjects. The investigators also aimed to examine associations between
      nutritional factors and adiponectin levels.
    


Intervention name(s): none- observational study
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: insulin resistance; ethnic disparities; adiponectin
Placebo Controlled Study of Sublingual Salvinorin A
Condition: Pharmaceutical Preparations
Study type: Interventional

Summary: 
      In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to
      4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose,
      placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will
      receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two
      doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and
      4000µg) will be single-blind.
    


Intervention name(s): Salvinorin A; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Salvinorin A
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Salvia divinorum; Salvinorin A
Comprehensive Triaged HIV Prevention in Tanzania
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce
      population-level HIV incidence. The study design is a two-arm community randomized controlled
      trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV
      center which will provide free HIV testing and counseling, (b) Educational activities related
      to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime
      provision of a small amount of food or health products for sex partners of persons testing
      positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A
      post test support club for persons infected with HIV, (f) An income generation training
      program for people testing positive for HIV, (g) Transportation assistance in visiting the
      HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h)
      Counseling and transportation support for those on medical treatment for HIV to assist them
      in attending scheduled appointments, and receiving and taking their medications as
      recommended by the clinic staff. The study will take place within two communities located in
      Kisarawe district, Tanzania. The intervention will occur over an 18-month period with
      outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals
      in the intervention community will have a lower incidence of sexually transmitted infections
      (STIs) than those in the control community.
    


Intervention name(s): Comprehensive Triaged HIV Prevention (CTHP)
Intervention type(s): Behavioral
Intervention description(s): HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members.
Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings.
Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive.
Incentives & Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; Behavioral intervention; Community-randomized trial
Long-Term Lithium Treatment for Aggressive Conduct Disorder
Condition: Conduct Disorder; Aggression
MeSH terms: Aggression; Conduct Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the long-term effects of lithium used to treat children and
      adolescents with aggressive conduct disorder (severe aggression).
    

Detailed description: 
      Psychotherapeutic agents are often administered without sufficient testing to children and
      adolescents, often on a long-term basis, to reduce aggression. Many pressures, including
      managed care, will increase the utilization of pharmacotherapy in the outpatient setting to
      treat serious problems. Lithium is the most promising agent for the treatment of aggression
      in children and adolescents. However, it has not been shown that lithium is an effective
      treatment for these patients in the outpatient (non-hospital) setting, or on a long-term
      basis. The purpose of this study is to examine the long-term effects of lithium used to treat
      children and adolescents with aggressive conduct disorder (severe aggression).

      The proposed study is a two-phased clinical trial of lithium for the treatment of aggression
      in conduct disorder. Both phases are double-blind and placebo-controlled with randomization
      and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial,
      with twice as many subjects randomized to lithium as placebo, increasing the pool of
      potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from
      Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define
      responders to lithium.
    

Intervention name(s): Lithium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lithium 600 mg to 2700 mg per day; Matching placebo
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggressive conduct disorder; Adolescence; Child; Conduct Disorder; Female; Lithium; Male; Placebos; Conduct Disorder -- *drug therapy; Lithium -- *therapeutic use
Monopolar Scissors vs Bipolar Vessel Sealer vs Ultrasonic Shears: A Prospective Randomized Study in Laparoscopic Colorectal Surgery
Condition: Colorectal Disease
Study type: Interventional

Summary: 
      Monopolar electro surgery scissors (MES), electro thermal bipolar vessel sealer (BVS) and
      ultrasonically coagulating shears (UCS) are all applied in laparoscopic colorectal surgery.
      We aimed to compare the different devices with regard to dissection time, blood loss,
      technical aspects and costs.

        -  Trial with surgical intervention
    


Intervention name(s): Laparoscopic colectomy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of NSAIDs on Bone Metabolism Following Exercise
Condition: Bone Resorption; Stress Fracture; Bone Injury
MeSH terms: Bone Resorption; Fractures, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of a single dose of non-steroidal
      anti-inflammatory drugs on post-exercise markers of bone and muscle metabolism.
    

Detailed description: 
      This protocol intends to determine how consuming a single dose of a non-steroidal
      anti-inflammatory drug (NSAID) affects circulating bone metabolism biomarkers and markers of
      damage skeletal muscle in response to a bout of plyometric exercise. This will be
      accomplished using a four trial, placebo-controlled crossover design with trials examining
      ibuprofen, celecoxib, flurbiprofen and placebo. These particular NSAIDs were chosen because
      of their widespread use in military populations and differing molecular mechanisms, which
      could cause differing effects on bone and muscle. Two hours after of consuming a single dose
      of an NSAID, participants will perform 10 sets of 10 plyometric jumps to induce a mechanical
      loading stimulus the bone and muscle tissues. Blood, urine, and muscle biopsy samples will be
      collected before and up to four hours after exercise. Biomarkers representing bone and muscle
      metabolism will determine the magnitude of adaptive responses to plyometric exercise while
      using NSAIDs.
    

Intervention name(s): Ibuprofen 800 mg; Celecoxib 200mg; Flurbiprofen 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ibuprofen taken orally 2 hours prior to exercise; Celebrex taken orally 2 hours prior to exercise; Flurbiprofen taken orally 2 hours prior to exercise; Inert placebo taken orally 2 hours prior to exercise
Other intervention name(s): Advil; Motrin; Celebrex; Ansaid
Intervention MeSH terms: Ibuprofen; Celecoxib; Flurbiprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4 trial, block randomized crossover design. Three NSAIDs and one placebo trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
Condition: Kwashiorkor
MeSH terms: Kwashiorkor
Study type: Observational

Summary: 
      This research may explain whether a shortage of three special compounds called aromatic amino
      acids is responsible for the severe illness and high death rate of children with the
      kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in
      the treatment diet will speed up recovery from this condition. We propose that decreased
      availability of the aromatic amino acids may be the reason why children with kwashiorkor are
      sicker and more difficult to treat.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By
        the Wellcome Classification patients will have marasmus (< 60 % weight/age and no edema),
        marasmic-kwashiorkor (< 60 % weight/age plus edema) or kwashiorkor (< 80 % weight/age plus
        edema)
      
Biospecimen description: 
      plasma, expired breath
Risk of Uncomplicated Peptic Ulcer in the General Population
Condition: Peptic Ulcer [Iowa Type (107680.0010)]
MeSH terms: Peptic Ulcer; Ulcer
Study type: Observational

Summary: 
      The analyses are conducted in a previous population-based cohort study using The Health
      Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses
      are:

      To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with
      use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the
      general population To estimate the dose-response and duration-response associated with use of
      these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low
      dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI)
      (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the
      general population To investigate the management of low dose ASA/oral antiplatelets after UPU
    

Detailed description: 
      Risk of uncomplicated peptic ulcer in the general population
    

Intervention name(s): Risk of symptomatic peptic ulcer
Intervention type(s): Drug
Intervention description(s): Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study is conducted using The Health Improvement Network database in the UK. Patients
        aged 40-84 years between January 1997 and December 2005 with a registration status of
        permanent or deceased, who were enrolled for at least 2 years with a GP and had 1 year of
        electronic prescription history. Patients with a code for cancer, peptic ulcer (both
        uncomplicated and complicated), upper GI bleeding, oesophageal varices, Mallory-Weiss
        disease, alcohol abuse, liver disease, or coagulopathies before beginning date were
        excluded from the source population. All patients in the study population were followed up
        until the end of the study period (December 2005), or until they reached the age of 85,
        died, met any of the exclusion criteria (including receiving a diagnosis of complicated
        peptic ulcer disease), or received a diagnosis of uncomplicated peptic ulcer
        disease.Patient records were manually reviewed to validate cases.
      
Keywords: Uncomplicated peptic ulcer; Low dose aspirin (ASA); Acid-suppressing drugs; Epidemiology
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending
      oral dose administration in healthy adult subjects under fasted conditions.
    

Detailed description: 
      Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based
      on the collective clinical and nonclinical data of ziresovir.

      The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg,
      respectively.

      A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6
      subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in
      each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.
    

Intervention name(s): Ziresovir; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Planned treatments are:
Cohort 1: 300 mg of ziresovir
Cohort 2: up to 600 mg of ziresovir
Cohort 3: up to 900 mg of ziresovir; Planned treatments are:
Cohort 1: 300 mg of placebo
Cohort 2: up to 600 mg of placebo
Cohort 3: up to 900 mg of placebo
Other intervention name(s): AK0529
Intervention MeSH terms: Ziresovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional

Summary: 
      This study examines contrast advantages and disadvantages of elective or prophylactic nodal
      irradiation in the treatment of esophageal cancer with three-dimensional conformed
      radiotherapy.
    

Detailed description: 
      Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis
      to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable
      design the clinical target volume of lymph node drainage area has always been controversial,
      one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved
      lymph node area according to different sites, in order to contrast advantages and
      disadvantages of the two kind of target area design，so the study was designed.
    

Intervention name(s): Involved Field Irradiation(IFI); docetaxel and cisplatin; Elective Nodal Irradiation (ENI)
Intervention type(s): Radiation; Drug; Radiation
Intervention description(s): Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV（primary tumor）：66-70Gy/33~35F，once a day, 5 times per week PTV-CTV（Clinical target,primary tumor extended 3cm in Axial）：50-56Gy/33~35f，once a day, 5 times per week PTV-GTVnd（positive node）：66-70Gy/33~35F，once a day, 5 times per week.; Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.; The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.
Other intervention name(s): chemothrrapy
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; Concurrent chemoradiotherapy; Clinical target volume; Safety; Prognosis