bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
Condition: Chronic Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of
      BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).
    

Detailed description: 
      The study will consist of a 37-day Screening period (including a 7-day Run-In period), a
      4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last
      dose of study drug.
    

Intervention name(s): BLU-5937; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of BLU-5937 tablets; Oral administration of matching placebo for BLU-5937 tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BLU-5937; Chronic Pruritus; Atopic Dermatitis; P2X3 receptor antagonist
Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      A randomised controlled trial will be performed to evaluate the effects of lung volume
      reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress,
      endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will
      lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood
      pressure and to improved endothelial function.

      For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary
      emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving
      immediate LVRS and group 2 receiving LVRS after a delay of 3 months.

      Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness
      and blood pressure will be measured at baseline and 3 months after surgery and no surgery,
      respectively (group 2 receiving surgery only after a delay of 3 months will serve as control
      group) to investigate the effects of LVRS on the described outcomes.
    

Detailed description: 
      Not desired
    

Intervention name(s): Lung volume reduction surgery
Intervention type(s): Procedure
Intervention description(s): Lung volume reduction surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Condition: Onchocerciasis
MeSH terms: Onchocerciasis; Intestinal Volvulus
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to determine the safety and tolerability of moxidectin
      in subjects infected with Onchocerca volvulus (a parasitic worm).
    

Detailed description: 
      This was a phase 2, randomized, ivermectin-controlled, double-blind, single-ascending-dose,
      parallel design, inpatient/outpatient study of moxidectin administered to subjects of both
      sexes with different degrees of severity of O. volvulus infection. The study was conducted at
      a single site in Ghana.

      Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial
      indication of the efficacy in terms of long term effect on skin microfilaria levels and an
      indication of the effect on the macrofilaria that may underlie the effect on skin
      microfilaria levels.

      Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg, 4 mg or
      8 mg or moxidectin or ivermectin 150 µg/kg by severity of infection, based on the mean of the
      skin microfilariae densities at each of 4 body locations, both iliac crests and calves.
    

Intervention name(s): 2 mg moxidectin; ivermectin 150 mcg/kg; 4 mg moxidectin; 8 mg moxidectin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single-dose, tablet encapsulated for blinding; Single-dose, tablets encapsulated for blinding; Single dose, tablets encapsulated for blinding; single dose, tablets encapsulated for blinding
Intervention MeSH terms: Ivermectin; Moxidectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: onchocerciasis; onchocerca volvulus; river blindness; ivermectin; moxidectin
Francis Biomechanics Study
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of a range of pre-formed orthoses on function of the
      foot and leg to generate technical data on how the individual insoles impact gait,
      distribution of load and stability in a healthy population.
    


Intervention name(s): Insoles; Standard shoe
Intervention type(s): Device; Other
Intervention description(s): Orthotic Insoles; Standard shoe
Other intervention name(s): Non-Investigational product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
12-Week-Combined Physical Training In Heart Failure Patients
Condition: Heart Failure Patients
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of
      life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and
      resistance physical training (CPT) supervised by physical educator is better than only
      prescription of unsupervised exercise. The aim of this study is to compare the effects of a
      CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the
      practice medical routine prescription of regular physical activity and correlate these
      findings with clinical and echocardiographic variables.

      Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly
      divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients
      undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving
      only medical prescription to practice regular physical exercise. All patients were submitted
      to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire
      before and after the study protocol. Student t test or Mann-Whitney test were performed for
      groups comparison and correlation tests for the same group variable associations.
    


Intervention name(s): Combined aerobic and resistance physical training program
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; quality of life; healthy; cardiac remodeling
Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the safety, tolerability and pharmacokinetics of
      ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy
      male subjects.
    


Intervention name(s): JTK-853 or Placebo
Intervention type(s): Drug
Intervention description(s): Tablets, single dose, fasted, fed or high-fat fed condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JTK-853; single dose
Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this randomized controlled trial (RCT) is to measure the effects of specific
      thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both
      normotensive and hypertensive humans.
    

Detailed description: 
      OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP)
      and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR.
      However, many of those studies have been criticized for various study flaws, and accused of
      drawing erroneous conclusions, due to small sample size and various methodological concerns.
      The purpose of this randomized controlled trial (RCT) is to measure the effects of specific
      thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both
      normotensive and hypertensive humans.
    

Intervention name(s): Activator IV Adjusting Instrument
Intervention type(s): Device
Intervention description(s): Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
Other intervention name(s): Activator adjusting instrument; http://www.activator.com/products-page/
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chiropractic; Blood pressure; Pulse Rate; Thoracic
A Trial on Ultrasound-assisted Spinal Anaesthesia
Condition: Spinal Anaesthesia; Ultrasound
Study type: Interventional

Summary: 
      A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with
      manual palpation to identify landmarks for performance of spinal anaesthesia.
    


Intervention name(s): Ultrasound scan
Intervention type(s): Procedure
Intervention description(s): Pre-procedural ultrasound scan was performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role of Neutrophil Activation
Condition: Patients Requiring Endotracheal Intubation
Study type: Interventional

Summary: 
      Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal
      lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique.
      Specimen samples obtained by wall suction will be collected at 2 time points following
      intubation.

      Blood samples will be obtained at 2 time points, simultaneous with the collection of the
      tracheal specimens.
    


Intervention name(s): tracheal lavages
Intervention type(s): Procedure
Intervention description(s): tracheal lavages obtained during endotracheal intubation.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: endotracheal; intubation
Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Condition: HIV
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients
      with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from
      plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of
      HD sessions.
    

Detailed description: 
      The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in
      the HIV-positive population. This means that an increasing number of HIV-infected patients
      will need renal replacement therapy.However, little is known about DTG removal from plasma by
      HD in patients with ESRD.

      Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma
      concentrations at steady state in HIV-infected patients with ESRD undergoing HD.
    

Intervention name(s): Dolutegravir
Intervention type(s): Drug
Intervention description(s): Dolutegravir 50mg/day per 5 days
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hemodialysis; HIV-infection
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of the trial was to examine the independent effects of equivalent diet- or
      exercise-induced weight loss on obesity and related cardiovascular health risk factors. We
      hypothesized that exercise would result in greater reductions in obesity and health risk
      factors that equivalent diet (caloric restriction).
    


Intervention name(s): Diet Weight Loss; Exercise Weight Loss; Exercise Without Weight Loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: obesity, exercise, diet, insulin resistance
Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      Children born to obese women are at risk of increased adiposity and later adverse metabolic
      outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP
      study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant
      women were randomized to either lifestyle intervention or routine obstetric care. This
      present study follows the children until 3 years of age. We have the hypothesis, that the
      intervention during pregnancy results in a lower degree of adiposity and metabolic risk
      factors in the offspring. Clinical examination is taking place at age 2.5-3 years including
      anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring
      metabolic markers.In addition, we have included an extra control group of children born to
      normal weight women, who were not part of a lifestyle intervention program during pregnancy.
      We have the hypothesis that the children of the normal weight women have a better metabolic
      profile than the children born to the obese women.
    


Intervention name(s): Lifestyle intervention during pregnancy
Intervention type(s): Behavioral
Intervention description(s): Energy requirements for each participants´ mother were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups of children at the ages of 2.5 til 3 years.
      
Biospecimen description: 
      We have created a biobank of bloodsamples
    
Keywords: Childhood adiposity; Metabolic risk factors; Bone mineralization
The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to further access the utility of biochemical and clinical
      biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against
      which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult
      healthy volunteers.
    


Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized. Subjects are to be dosed each morning for 7 days. A 14 day washout period is required between each period. Prednisone was supplied in the 2.5 and 20 mg dosage strengths.; Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: Glucocorticoids, Biomarkers, Dissociated Agonist of the Glucocorticoid Receptor
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
Condition: Full Thickness Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      This project will involve planning and implementing a two-arm prospective pragmatic cohort
      clinical trial in patients with known rotator cuff tears.
    

Detailed description: 
      This project will involve planning and implementing a two-arm prospective pragmatic cohort
      clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical
      trials reflect real world settings and thus have greater external generalizability than
      efficacy trials. The evaluation component in this trial will be three-fold: first, the study
      team will compare the success of patients undergoing operative versus non-operative
      management and identify which variables predict success in each group; second, investigators
      will attempt to predict which patients end up choosing, along with their care giver(s),
      operative versus non-operative management by examining the predictive capability of a
      selection of variables; third, investigators will evaluate the clinical research site(s),
      personnel, and implementation processes for their capability to implement clinical trials
      with the intent of planning for a future large multi-site clinical trial building on the
      results of the present study.
    

Intervention name(s): Operative management
Intervention type(s): Procedure
Intervention description(s): Rotator cuff surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as
        determined by surgeon opinion and imaging
Mood Lifters Online for Graduate Students and Young Professionals
Condition: Depression; Anxiety Disorders; Mood Disorders; Mental Illness; Stress
MeSH terms: Anxiety Disorders; Mental Disorders; Mood Disorders
Study type: Interventional

Summary: 
      Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated
      strategies in a supportive group setting. This study will test two new versions of the
      program designed specifically for graduate students and young professionals.

      Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on
      helpful mental health strategies and skills. Participants will be encourage to practice what
      the participants learn at home in order to improve their mood or mental wellness.
      Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to,
      at the end of the program, 1 month after the program and 6 months after the program.
    


Intervention name(s): Mood Lifters
Intervention type(s): Behavioral
Intervention description(s): Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to look at two doses of long-acting injectable risperidone
      (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every
      two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better
      at improving symptoms of schizophrenia or schizoaffective disorder.
    

Detailed description: 
      This six month double-blind,randomized trial is designed to compare the efficacy of high dose
      long acting risperidone ( 75 mg-100 mg q2 weeks or its equivalent) with standard doses of
      long acting risperidone (≤50 mg/q 2weeks) for Total Psychopathology, positive, negative, and
      depressive symptoms, and cognition in patients who are considered to be poor responders by
      themselves, significant others, or clinicians. This will include two types of inadequately
      responding patients-those who are treatment resistant by research criteria (Kane et al.,
      1988) and those with inadequate response
    

Intervention name(s): long-acting injectable risperidone; long acting injectable risperidone; long acting injectable risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).; Study dose remains 50 mg for the length of the study.; Beginning dose 75 mg. Can be increased to 100 mg at Week 6.
Other intervention name(s): Risperidone Consta; Risperidone Consta
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; long acting injectable; treatment resistant
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has
      immunomodulating properties. In a previous clinical study laquinimod showed evidence of
      biological activity by reducing the number of acute brain lesions.

      The duration of the current study is 36 weeks.
    


Intervention name(s): laquinimod 0.3; laquinimod 0.6; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): laquinimod 0.3mg; laquinimod 0.6mg; Blinded Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing Remitting Multiple Sclerosis