bioihbjkbjnl/mcl2 huggingface dataset:
First in Human Study of ANXV (Recombinant Human Annexin A5) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an adaptive, randomised, double-blind, single-centre, placebo-controlled phase I,
      First in Human study designed to evaluate the safety, tolerability and pharmacokinetics of
      single and multiple intravenous dosing of ANXV in healthy male subjects.
    

Detailed description: 
      This First in Human study is divided in two parts. Part I, Single Ascending Dose (SAD), will
      explore safety, tolerability and PK of single intravenous doses of ANXV. Part II, Multiple
      Ascending Dose (MAD), will explore safety, tolerability and PK of multiple doses (five
      consecutive daily doses) of intravenous ANXV.

      The objectives of this study are:

      Primary objective:

      - To evaluate the safety and tolerability of single/multiple ascending doses of ANXV in
      healthy male subjects.

      Secondary objective:

      - To determine the PK profile of single/multiple ascending doses of ANXV in healthy male
      subjects.

      Exploratory objectives:

      - To evaluate ADA to ANXV and other relevant parameters.
    

Intervention name(s): ANXV; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate whether a 4-week physical fitness training (target
      intervention) in stroke patients (subacute stage) increase the walking speed and activities
      of daily living compared with a control intervention (relaxation exercises). The target or
      control intervention is performed in addition to standard rehabilitation treatment.
    


Intervention name(s): physical fitness training; relaxation
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physical activity, relaxation, activities of daily living, motor functions, cognitive functions
The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of individualized doses
      (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of
      chronic migraine headaches over a period of 16 weeks.
    

Detailed description: 
      Previous studies have shown that topiramate is effective in preventing chronic migraine
      headaches. This study will start with a 4-week baseline period in which no treatment is
      given, followed by a 12-week period in which each patient's dose is adjusted and then kept
      stable for the last 4 weeks of the 16-week double-blind phase. The individualized dose will
      start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once
      weekly and then raised to either the target--100 milligrams per day--or the maximum dose that
      is well tolerated up to 200 milligrams per day. Patients who are randomized to receive
      topiramate will remain on the optimized dose. The comparison phase of the study is a 16-week
      period in which the change in migraine days of patients on topiramate (taking at least 50
      milligrams per day) is compared with the change in migraine days for patients on the placebo.
      Also studied will be the patients' health-related quality of life as assessed by
      questionnaires filled out at specific visits as well as the patients' views of the safety and
      tolerability of topiramate. The study hypothesis is that the number of migraine days,
      periods, and attacks from the baseline period to the last 4 weeks in the double-blind period
      is reduced more in the topiramate group than the placebo group. During the 16-week comparison
      period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate
      daily.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic migraine; Migraine; Headache; Migraine headache; Topiramate
Genetics in the Effect of Caffeine on Fat Oxidation
Condition: Genetic Predisposition; Caffeine; Fat Burn
MeSH terms: Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise
      has been studied in active and healthy population performing an incremental test on a cycle
      ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max).
      Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine;
      c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect
      calorimetry. The influence of the CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a polymorphisms was
      evaluated to determine the effects on fat oxidation during exercise
    

Detailed description: 
      Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its
      performance-enhancing effect, caffeine has the potential of increasing fat utilization during
      aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as
      a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal
      muscle and liver for exercise situations where carbohydrate availability may be a challenge.
      Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of
      interest for improving health outcomes as it may increase the rate of change in body
      composition in exercise programs. Genetic factors like CYP1A2 c.-163A>C, GSTP c.313A>G and
      PGC1a c.1444G>A and C>T polymorphisms could be associated with the capacity for fat oxidation
      during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the
      same proportion during morning and evening exercise trials in women. For this reason, the aim
      of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a
      polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy
      population. The authors hypothesised that genetics would increase fat oxidation and MFO
      during exercise and this effect would be of similar magnitude at several caffeine doses.
    

Intervention name(s): Acute caffeine supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients
Condition: Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      The objective is to study the cognitive functions in patients with chronic obstructive lung
      disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy
      controls. The cognitive functions are tested with and without oxygen therapy to clarify the
      effect of oxygen therapy. Driving simulations is used to test the cognitive functions.

      The hypothesis is that patients with chronic lung disease have decreased cognitive functions
      and that oxygen therapy will increase their cognitive functions.
    


Intervention name(s): oxygen therapy
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years
      of age and in young women 16 to 26 years of age. From this study, the goal was to establish
      that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and
      girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that
      is not inferior to that observed in young women 16 to 26 years of age who received the
      standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503
      efficacy).
    


Intervention name(s): V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Intervention type(s): Biological
Intervention description(s): V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Role of Famotidine in the Clinical Improvement of COVID-19 Patients.
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is aimed to investigate the effect of Famotidine in the clinical recovery of
      COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there
      is no specific medication against it. Like other countries of the world, Besides antiviral
      drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE
      came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The
      study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail
      history of each participant with comorbidity will be taken and will be examined carefully.
      The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study.
      Critically ill patients who require ventilator support will not be included in this study.
      The outcome of the Famotidine treatment will be evaluated and compared with a control group.
    


Intervention name(s): Famotidine 20 MG
Intervention type(s): Drug
Intervention description(s): Famotidine; tablet Famotac 20mg oral form.
Other intervention name(s): Famotac 20mg
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID 19; Famotidine; Bangladesh
Robot Assisted Radical Prostatecomy and Positional Injury
Condition: Peripheral Nerve Injuries
MeSH terms: Peripheral Nerve Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Although a condition for surgery, robotic interventions applied with steep
      Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy
      if good position is not achieved on the operating table. This study will be a 7-year
      retrospective examination of postoperative positional injury (PPI) in patients undergoing
      robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
    

Detailed description: 
      Patients who underwent RARP between 2008-2014 will be evaluate. Patients with known
      peripheral neuropathy, lumbar-cervical discopathy, or history of orthopaedic surgery or
      trauma will exclude. The demographic data of patients, ASA, Charlson Comorbidity Index (CMI),
      Body Mass Index (BMI), operating time (OT) and Trendelenburg time (TT) will obtain from
      patient records. Patients will be questioned as to whether or not PPI had developed, if so,
      in which extremity, in what form (sensory-motor), duration, whether or not a doctor had been
      consulted, if so, what treatment had been given and whether or not the PPI had continued.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing robot-assisted radical prostatectomy (RARP) for prostate diagnosis.
      
Keywords: Robotic Surgical Procedures; Trendelenburg Position
Niacin Skin Flush Response in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin
      test accuracy is not well studied in these patients. The study evaluated the niacin skin test
      accuracy in adult hospitalized schizophrenia patients and their first degree relatives,
      bipolar disorder patients, and healthy controls.
    


Intervention name(s): Niacin skin test
Intervention type(s): Biological
Intervention description(s): Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.
Other intervention name(s): Methyl nicotinate
Intervention MeSH terms: Niacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair
Condition: Inguinal Hernia; Femoral Hernia
MeSH terms: Hernia; Hernia, Inguinal; Hernia, Femoral
Study type: Observational

Summary: 
      Pain after laparoscopic groin hernia repair consist of different pain components (overall
      pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out
      which of these pain components that is most severe, so intervention can be targeted.
    

Detailed description: 
      Details about the components of early pain after laparoscopic groin hernia repair are
      lacking. A description of each component (overall pain, shoulder pain,incisional pain and
      visceral pain) is needed, so intervention against the different pain components can be
      targeted.

      Patients fill out questionnaires about pain before operation and day 0-3 after operation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are consecutively included in this study. They are all undergoing elective
        laparoscopic groin hernia repair.
      
Keywords: Pain pattern; overall pain; incisional pain; shoulder pain; visceral pain
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data
      when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.

      The study is divided into one single dose part, one part to compare pharmacokinetics between
      gender and one multiple dose part.
    


Intervention name(s): LEO 29102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Comparator: LEO 29102 vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults
Condition: Periodontal Disease; Atherosclerosis
MeSH terms: Periodontal Diseases; Atherosclerosis
Study type: Observational

Summary: 
      We propose to examine a population of Native Americans who have had little or no dental care,
      and to determine if periodontal disease is associated with early signs of vascular
      dysfunction or systemic inflammation. We then propose to treat the periodontitis and
      re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis
      is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated
      with vascular function.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population comprises 200 Native Americans seeking health care at the Indian
        Health Council.
      
Biospecimen description: 
      Serum, dental scrapings and saliva
    
Keywords: Periodontal disease; Atherosclerosis; Oral Pathogens; Native Americans; Inflammatory cytokines; Microbial metagenomics
Patient Activated Controlled Expansion (PACE) Trial
Condition: Breast Cancer; Mastectomy; Breast Reconstruction
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a patient controlled tissue expander can
      improve the results and patient experience in breast reconstruction. The study hypothesis is
      that patient controlled expansion will lead to rapid and more comfortable outcomes than
      historical precedents.
    

Detailed description: 
      Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing
      Controlled CO2 Inflation

      Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the
      AirXpanders tissue expander in patients undergoing breast reconstruction surgery following
      mastectomy.

      Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the
      first 5 patients, the sponsor will determine if additional subjects will be recruited to
      further evaluate treatment outcome.

      Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s)
      should have the necessary qualifications and sufficient experience (minimum of 12 breast
      tissue expanders placed per year) to participate in the trial.

      Duration of Patient Participation: Eligible patients will be enrolled over approximately 2
      months.

      Patients will be instructed on the tissue expansion protocol pre-operatively and undergo
      post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by
      the treating surgeon.

      Each patient will be followed through removal of the tissue expander.

      Study Population:

      The study population will consist of up to 10 patients. Eligible patients are females between
      the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery
      following mastectomy. Eligible patients must be able to provide informed consent and
      understand protocol components.
    

Intervention name(s): Patient Activated Controlled Expansion Device
Intervention type(s): Device
Intervention description(s): Patient activated controlled expansion for post-mastectomy breast reconstruction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; breast cancer; mastectomy; breast reconstruction; reconstruction; tissue expansion; two-stage breast reconstruction; tissue expander; AeroForm; AirXpander
Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then
      de-intensification management strategy in adolescents with mild immunosuppression and compare
      changes in CD4% from baseline to week 48 and then during de-intensification.
    

Detailed description: 
      This is a randomized, proof of concept study of youth 18- 24 years of age with confirmed HIV
      after age 9 with CD4+ T cells above 350 cells/mm3 who are randomized 3:1 to begin HAART
      consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone
      with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the
      experimental group who achieve virologic control by week 24 and maintain good control through
      48 weeks will then de-intensify to ATV/r alone and will be followed for two years. Subjects
      randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred),
      AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS
      standard of care.
    

Intervention name(s): Early Initiation of Highly Active Anti-Retroviral Therapy; Standard Care
Intervention type(s): Procedure; Procedure
Intervention description(s): Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.; Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atazanavir/Ritonavir (ATV/r); highly-active antiretroviral therapy (HAART); Treatment Naive
Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
      tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®
      (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to
      demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability
      parameters after single subcutaneous injection. Each dtug will be administered to each
      volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least
      14 days.
    

Detailed description: 
      Each dtug (BCD-033 and Rebif) will be administered to each volunteer at a dose of 44 µg as a
      single subcutaneous injection with an interval of at least 14 days.
    

Intervention name(s): Interferon beta-1a
Intervention type(s): Drug
Intervention description(s): Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.
Other intervention name(s): BCD-033; Rebif
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: interferon beta-1a; pharmacokinetics; pharmacodynamics; volunteers