bioihbjkbjnl/mcl2 huggingface dataset:
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole
Condition: Mammographic Density
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from
      subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women
    

Detailed description: 
      The trial is of open label single centre design. The serum concentrations of testosterone and
      plasma concentrations of anastrozole will be measured in 12 premenopausal women. Participants
      will be stratified in a 50:50 manner in two BMI (Body Mass Index) groups, <25 and 25 kg/m2,
      respectively. There will be a lead group of two participants in whom the serum/plasma
      concentrations will be examined after the first four weeks, to determine whether the sampling
      schedule adequately describes the serum/plasma concentration-time profiles or should be
      adjusted.
    

Intervention name(s): testosterone anastrozole
Intervention type(s): Drug
Intervention description(s): subcutaneous testosterone and anastrozole
Other intervention name(s): testosterone; anastrozole
Intervention MeSH terms: Methyltestosterone; Anastrozole; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Intervention model description: open labelled pharmacokinetic study
Masking: None (Open Label)
Primary purpose: Prevention
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Condition: Low Back Pain; Shoulder Pain; Neck Pain
MeSH terms: Shoulder Pain; Back Pain; Low Back Pain; Neck Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of tramadol
      hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to
      severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to
      the bones) outpatient or emergency setting.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), non-randomized,
      multi-center (when more than one hospital or medical school team work on a medical research
      study) and prospective (study following participants forward in time) study of tramadol
      hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol
      hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram
      [mg] and paracetamol 325mg). Participants may be given the additional dose according to the
      clinical requirement. The total treatment duration will be 6 hours. The total study duration
      will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief.
      Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours
      respectively after the first dose; and the drug efficacy and overall satisfaction level at
      the end of 6 hours after the first dose. Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Tramadol HCl-Paracetamol
Intervention type(s): Drug
Intervention description(s): Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.
Intervention MeSH terms: Acetaminophen; Tramadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; Shoulder pain; Neck pain; Tramadol hydrochloride; Paracetamol
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the effect of normal and impaired kidney function on the pharmacokinetics,
      pharmacodynamics and safety of BI 10773
    


Intervention name(s): BI 10773; BI 10773; BI 10773; BI 10773; BI 10773
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration; oral administration; oral administration
Intervention MeSH terms: Empagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established
      in 10 cases.

      ESS cut off point for menstruation and pregnancy was 6.
    

Detailed description: 
      Out of 112 high risk patients for POF, diagnosis was established in 10 cases. Endometrial
      fractional biopsy was taken, stained with H&E stain and by immubohistchemical (IH) staining
      by stem cell marker OCT4. IH expression of stem cell marker OCT4 was evaluated before and
      after transplantation according to Edessy Stem Cell Score (ESS).

      After laparoscopic injection of stem cell sample in the ovaries, participants were followed
      up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming
      menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell
      (stem cell positivity and scoring according to ESS).

      These cases were of ESS 5 and 6.
    

Intervention name(s): Stem Cell
Intervention type(s): Biological
Intervention description(s): Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
Other intervention name(s): - Edessy Stem cell Score.; - Laparoscopic stem cell transplantation.; - Hormonal Analysis; - Ultrasonic evaluation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: POF; ESS; stem cell
Classical Ballet Dance as a Recreational Activity for Adults Women
Condition: Occupational Therapy
Study type: Observational

Summary: 
      Classical ballet dance has just used therapeutically in recent years and can be a good
      recreational activity option at occupational therapy. The purpose of this study was to
      investigate whether participation in classical ballet dance activity for at least 3 months is
      associated with psychological distress, depression, anxiety, and well-being.
    

Detailed description: 
      A total of 128 adults participated in the study, sixty-four for Ballet Group (BG) and Control
      Group (CG). The psychological distress of the participants were evaluated with the Distress
      Tolerance Scale (DTS), anxiety and depression evaluated with Hospital Anxiety and Depression
      Scale (HADS), and well-being and quality of life evaluated with the World Health Organization
      Well-Being Index (WHO-5).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Accepts Healthy Volunteers
      
Keywords: Dancing; occupational therapy; mental health; adults
A Study of the Safety and Antiretroviral Activity of 3BNC117
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying
      rebound of viral load during a brief treatment interruption of standard ART, and its safety
      during a brief analytical interruption of antiretroviral therapy.
    

Detailed description: 
      The proposed study is a Phase II, open label study to evaluate the safety, antiretroviral
      activity and pharmacokinetics of four infusions of 3BNC117 in HIV-infected individuals on
      combination ART and during a brief analytical treatment interruption (ATI).

      Study participants will be administered four intravenous infusions of 3BNC117, administered
      at 30 mg/kg on day 0, week 12, week 24 and week 27. Antiretroviral therapy will be
      discontinued 2 days after the third 3BNC117 infusion (week 24), until week 36.

      The ART regimen will be resumed at week 36 or sooner if plasma HIV-1 RNA level is ≥ 200
      copies/ml, CD4+ T cell count drops < 350 cells/microliter, and results are confirmed upon
      repeat measurement during the next weekly scheduled visit. If plasma HIV-1 RNA level is ≥
      1,000 copies/ml, the participant will be asked to return for a repeat measurement prior to
      the next scheduled visit, and ART will be resumed if results are confirmed. ART will also be
      resumed early if the participant becomes pregnant or if otherwise clinically indicated. If
      ART is resumed before week 27, the fourth 3BNC117 infusion will not be administered.

      Participants will be followed weekly during the analytical treatment interruption phase for
      safety assessments and for monitoring plasma HIV-1 RNA levels. CD4+ T cell counts will be
      monitored every 2 weeks during the analytical treatment interruption phase.

      Participants may remain off antiretroviral therapy after week 36, with weekly viral load
      monitoring, if viral rebound does not occur by week 36.

      All participants will be followed for a total of 60 weeks from enrollment.
    

Intervention name(s): 3BNC117; Antiretroviral Treatment Interruption
Intervention type(s): Drug; Other
Intervention description(s): 3BNC117 infusions; Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
Other intervention name(s): 3BNC117 antibody; Treatment Interruption
Intervention MeSH terms: Anti-Retroviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; 3BNC117; Broadly neutralizing antibody
A High Protein Diet and Weight Maintenance
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      An investigation into long term weight maintenance using a high protein or high carbohydrate
      diet, after a large and rapid weight loss.
    


Intervention name(s): VLED followed by a high protein or high carbohydrate diet
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Weight maintenance; VLED
"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement
Condition: Catheter Complications; Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Internal jugular, subclavian, or femoral veins are often used for central venous catheter
      (CVC) placement. Regardless of which vein is preferred, the "Seldinger" technique is used
      most frequently. The most commonly used method with ultrasound is the short-axis out-of-plane
      approach. The main problem in this method is that the correct needle tip is missed, and it
      causes some complications by causing posterior wall punctures. The "Syringe-free" technique
      is first reported by Matias et al. in adults; it is a technique that allows full real-time
      monitoring of the guidewire insertion into the vein without blood aspiration. It is a great
      advantage in CVC placement, especially with the long-axis in-plane approach. When the
      literature is reviewed, no study other than a 12 case study in which brachiocephalic vein
      catheterization related to CVC placement was performed using this technique in children was
      found. There is no randomized study comparing the "Syringe-free" Long-Axis In-Plane technique
      with the classic Short-Axis Out-of-Plane technique in pediatric patients.

      This study compares these two techniques' efficacy and complication rates in critically ill
      children requiring CVC placement.
    


Intervention name(s): Long-axis syringe free in-plane; Short-axis out-of-plane
Intervention type(s): Device; Device
Intervention description(s): Long-axis syringe-free in-plane catheter placement; Short-axis out-of-plane catheter placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ultrasound; catheter; long axis; short axis; pediatrics; syringe free
Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis
Condition: Ambulatory IPF
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent research studies have suggested that proteins called antibodies that are produced by
      the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis
      (IPF). Antibodies produced by the immune system normal help to fight infections by attacking
      bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence
      that certain antibodies (called autoantibodies) attack the lung and contributes to the injury
      and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear
      to have excessive autoantibody levels in blood and lungs that might make their disease worse.

      Rituximab is a medication approved by the Food and Drug Administration (FDA) for the
      treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by
      destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce
      autoantibodies. In this research study, rituximab will be given into a vein to reduce the
      autoantibody levels that we believe might be contributing to the lung damage in IPF.

      This study is being conducted to determine if rituximab provides beneficial effects for IPF
      patients by decreasing further lung injury.
    

Detailed description: 
      This is a double-blinded, Phase II trial in which 58 ambulatory IPF patients at any of four
      medical centers (University of Pittsburgh, University of Chicago, Geisinger Medical Center,
      and Temple University) will be randomized equally to 1. placebo or 2. two doses of rituximab
      1 gm i.v., with a 14 day interval inbetween doses.

      Subjects will be followed for 9 months.
    

Intervention name(s): Rituximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): i.v. rituximab given on two occasions 14 days apart.; Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable.
Other intervention name(s): Placebo (D5W) i.v.
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lung; Fibrosis
Selegiline in Outpatient Treatment for Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in
      the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging,
      MRI) post-hoc as a possible variable for future stratification in clinical trials.
    


Intervention name(s): Selegiline
Intervention type(s): Drug
Intervention MeSH terms: Selegiline
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
Condition: Gastrointestinal Microbiome; Nutrition, Healthy; Healthy Aging
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy
      men and women. This is an exploratory study to assess the effect of a novel dietary
      supplement on blood markers of nutrient status and the gut microbiome.
    


Intervention name(s): AG1 - Nutritional Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients; Maltodextrin placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo Controlled Design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Condition: ALLERGIC ASTHMA
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The researcher proposes to assess levels of sputum inflammatory markers (eosinophils,
      eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in
      a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma
      symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

      Associations will be assessed between the types of sputum inflammatory markers and the
      patient's atopic status and level of asthma control as indicated by the following measures:

        1. pulmonary function test (PFT)

        2. asthma symptoms based on the Asthma Control Test (ACT)
    

Detailed description: 
      Objectives:

      Primary: Describe inflammatory cell types in study patients and compare changes in
      inflammatory cell patterns before and during anti-IgE therapy.

      Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma
      symptom improvement based on ACT and PFT

      Hypotheses:

      Differences in inflammatory response after the addition of anti-IgE therapy can be described
      in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.

      Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while
      eosinophilic asthmatics will respond well.

      Sputum inflammatory markers are sensitive markers of inflammation and can predict response to
      new asthma treatment modalities such as anti-IgE therapy.
    

Intervention name(s): ANTI-IGE THERAPY (XOLAIR)
Intervention type(s): Drug
Intervention description(s): Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Community-Driven Cervical Cancer Prevention in Western Kenya
Condition: Human Papilloma Virus Infection; Carcinoma in Situ of Uterine Cervix
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms; Papilloma; Carcinoma in Situ
Study type: Interventional

Summary: 
      There are many challenges to implementation of cervical cancer prevention in resource-limited
      countries, despite evidence based screening and treatment strategies. The investigators
      hypothesize that self-collected HPV specimens offered in a community health campaign setting
      will
    


Intervention name(s): Community-based testing with standard linkage to care; Community-based HPV testing with enhanced linkage to care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).; Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cervical cancer screening; human papillomavirus testing; Kenya; implementation science
A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      Dimebon following single ascending doses. A formal single ascending dose study of this nature
      has not been performed to date in the Dimebon development program.
    


Intervention name(s): Dimebon; Dimebon; Dimebon; Dimebon
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet; 20 mg Dimebon, single dose; Oral tablet; 40 mg Dimebon, single dose; Oral tablet; 60 mg Dimebon, single dose; Oral tablet; placebo, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: oral, single ascending doses; CYP2D6 metabolizer status; healthy subjects; safety, tolerability, pharmacokinetics
Medical College of Georgia FitKid Project
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This project will determine whether exposing youths to a "fitogenic" after-school environment
      that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body
      composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and
      cardiovascular disease risk profile. The environmental intervention will be provided in nine
      schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison
      schools. Children in the 3rd grade will be recruited to participate. They will be followed
      for 3 years, through the 5th grade. Measurements will be made at the beginning and end of
      each school year. The 2-hour after-school intervention will be offered every school day. It
      will consist of three components: (1) homework assistance; (2) a healthy snack; and (3)
      exercise designed to improve skills and fitness.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention