bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
Condition: Infertility; Endometriosis
MeSH terms: Infertility; Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study of endometriosis patients we compare a common treatment of surgical therapy and
      medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In
      both cases they immediately start In Vitro Fertilization (IVF) treatment.
    


Intervention name(s): Zoladex
Intervention type(s): Drug
Intervention description(s): after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometriosis; pregnancy; In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI); peritoneal implants; embryo quality
Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to
      evaluate the safety and tolerability of maintenance lenalidomide after allogeneic
      hematopoietic stem cell transplantation (HCT).

      Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a
      starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed
      depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg
      given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from
      first dose of study drug.

      Patients will be followed until 28 days from completing the 12th planned cycle of
      lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first,
      (14 to 15 months after receiving the allograft) or discontinuation of study drug.
    


Intervention name(s): lenalidomide
Intervention type(s): Drug
Intervention description(s): Lenalidomide maintenance therapy will start within 60 to 90 days after allogeneic HCT at a starting dose of 10mg PO once daily.
Dose escalation and de-escalation are performed depending on tolerability of lenalidomide.
The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).
Other intervention name(s): Revlimid
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; lenalidomide; Revlimid; Allogeneic Hematopoietic Cell Transplantation
YCFM (Youth Correctional Facilities Males)
Condition: Chlamydial Infection
MeSH terms: Infections; Chlamydia Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is
      designed primarily to determine the frequency of chlamydia treatment failure following
      azithromycin in males who do versus do not have urethral symptoms of urethral discharge
      and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,
      with subject participation duration of 28 days and study duration of 4 years. The primary
      objective of the study is to assess the microbiological efficacy of azithromycin in
      uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms
      in YCFs.
    

Detailed description: 
      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males residing in
      long-term gender-segregated YCFs. This study is designed primarily to determine the frequency
      of chlamydia treatment failure following azithromycin in males who do versus do not have
      urethral symptoms of urethral discharge and/or dysuria. Males age 12 to 21 years in good
      health (based on vital signs and provider's clinical evaluation documented in medical
      records) who are residing in long-term gender-segregated (not co-ed) YCFs (usual stay > 3
      weeks) and who are identified as chlamydia-infected comprise the study population. The
      anticipated enrollment is 446 males with subject participation duration of 28 days and study
      duration of 4 years. The primary objective of the study is to assess the microbiological
      efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with
      versus without urethral symptoms in YCFs; in essence, this study will assess the frequency of
      chlamydia treatment failure to azithromycin at the Day 28 follow-up visit (Visit 2) in males
      with urethral symptoms compared to males without urethral symptoms. The secondary objective
      is to evaluate the association of laboratory findings (enrollment chlamydia load and OmpA
      genotype) and other participant characteristics (demographics, sexual behaviors, etc.) to
      chlamydia treatment failure in males after azithromycin treatment.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): Azithromycin 1 gm PO single dose given as directly observed
Intervention MeSH terms: Azithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Azithromycin; Chlamydia; Correctional; Facilities; Symptoms; Urethral; Urogenital; Youth
World Digital Detox Program for Enhancing Youth and Family Well-being
Condition: Psychological Well-Being; Adolescent Behavior; Family
Study type: Interventional

Summary: 
      The pervasive presence of digital devices and technology has reshaped contemporary society,
      providing numerous benefits but also prompting concerns about prolonged screen time,
      particularly with smartphones and social media. These concerns extend to their impact on
      interpersonal relationships and mental well-being. The Zep Foundation's World Digital Detox
      Program to address the challenges posed by excessive screen exposure, social media usage, and
      digital screen dependency.

      This study aimed to assess the efficacy of the digital detox family intervention, endorsed by
      the World Digital Detox Day program, in curbing the use of digital devices-specifically
      smartphones and social media-and enhancing the overall well-being of youth and families.
    


Intervention name(s): World Digital Detox Family Program
Intervention type(s): Other
Intervention description(s): The Self-Help World Digital Detox Family Program spans four weeks and offers a structured approach to tackle the rising issues associated with the overuse of screens, social media, and digital devices within families. This intervention provides practical tools and strategies to be implemented on a weekly basis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II
      (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class
      IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who
      meet the FDA approved indications for HM II LVAD destination therapy.
    

Detailed description: 
      The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for
      use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV
      symptoms.

      The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational
      study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal
      medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not
      dependent on intravenous inotropic support and who meet the FDA approved indications for HM
      II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD.
      Together with the investigator, the subjects will decide which cohort to enter into at their
      baseline visit. This study will include experienced HM II LVAD implant centers as well as
      community centers that care for a large volume of heart failure patients. Study patients will
      be followed for up to 24 months post enrollment for survival, quality of life and functional
      status.
    

Intervention name(s): HM II (HeartMate II LVAD); OMM (Optimal Medical Management)
Intervention type(s): Device; Drug
Intervention description(s): The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.; Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
Other intervention name(s): Left Ventricular Assist Device; Medical Management
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HM II implanting centers and community/referral heart failure clinics
      
Keywords: HeartMate II; heart-assist device; medical management; optimal medical management; Heart Failure NYHA Class IIIB/IV; Thoratec Corporation
Quantification of Human Adipogenesis
Condition: Healthy
Study type: Observational

Summary: 
      This pilot study is using a novel technology to measure the rate of turnover of new fat
      cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling
      new volunteers.
    


Intervention name(s): 15N-Thymidine, 2H-Water
Intervention type(s): Biological
Intervention description(s): Stable isotope 15N-thymidine, infused IV (15mg/hour) for 72 hours (phase 1 pilot).
Stable isotope 2H-water, ingested by mouth once per day for 3 days (phase 1 pilot) or 28 days (phase 2 pilot).
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of
        illicit substance abuse.
      
Biospecimen description: 
      Fat biopsy. Oral mucosal smear. White blood cells.
    
Keywords: No specific experimental conditions
Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas
Condition: Glioma; Low-grade Glioma; Astrocytoma
MeSH terms: Glioma; Astrocytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to learn if the study drug RAD001 can shrink or slow
      the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001
      is a drug that may act directly on tumor cells by inhibiting tumor cell growth and
      proliferation.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the response of children with chemotherapy-refractory or progressive
           low-grade gliomas to everolimus. Secondary

        -  To evaluate pharmacogenetic polymorphisms of cytochrome P450 3A4 & 3A5 alleles and
           P-glycoprotein/MDR for their influence on the metabolism of everolimus in this patient
           population.

        -  To evaluate the role of Apolipoprotein E genotypes as predictors for development of
           hyperlipidemia during therapy with everolimus.

        -  To assess preliminary correlations of response with changes in pharmacodynamic
           parameters including p70s6 kinase activity in peripheral blood mononuclear cells.

        -  To describe the toxicity of everolimus when administered to this patient population.

        -  To characterize the pharmacokinetic profile of everolimus when administered to this
           patient population.

      STATISTICAL DESIGN:

      This study used a one-stage design to evaluate response to everolimus. If at least 3
      responders are observed in 20 evaluable patients, then everolimus will be considered
      promising. If the true response rate is 5% (null hypothesis), the chance of concluding the
      treatment is active is 0.08 (Type I error). If the true response rate is 25% (alternative
      hypothesis), the chance of concluding the treatment is active is 0.91 (power).
    

Intervention name(s): everolimus
Intervention type(s): Drug
Other intervention name(s): RAD001
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RAD001
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at how the new medicine called NNC0480-0389 works in the body of Chinese men
      when it is given at different doses together with a fixed dose of semaglutide. Participants
      will get one injection of NNC0480-0389 and one injection of semaglutide - which dose of
      NNC0480-0389 participants get is decided by chance.

      NNC0480-0389 is a new medicine that has not been previously approved. It means that the
      medicine has not yet been approved by the health authorities.

      Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels
      in people with type 2 diabetes.

      NNC0480-0389 is being developed to be given together with semaglutide. NNC0480-0389 targets a
      different part of the system that regulates sugar levels in the body than semaglutide.
      Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively
      lower sugar levels in the blood in people with type 2 diabetes.

      Participants will get 2 injections of the study medicine (one of each). It will be injected
      with a needle into a skin fold on participants abdomen.

      The study will last for a maximum of 72 days. Partcicipants will have 10 scheduled visits
      with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5
      nights). The study includes blood sampling.
    


Intervention name(s): NNC0480 0389; Semaglutide
Intervention type(s): Drug; Drug
Intervention description(s): Participants will get 1 injections of NNC04800389. It will be injected with a needle into a skin fold on the abdomen.
The study will last for a maximum of 72 days; Participants will get 1 injections of semaglutide. It will be injected with a needle into a skin fold on the abdomen.
The study will last for a maximum of 72 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.
    

Detailed description: 
      This is a single-center, open-label, sequential cohort, single-dose study of ARC-520
      administered intravenously to healthy adult volunteers. Eligible subjects will receive a
      single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40
      subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion
      rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will
      be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study
      clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks
      including follow-up telephone calls at Days 30, 60 and 90.

      Participants will undergo the following evaluations at regular intervals: medical history,
      physical examinations, bee venom allergy blood test, vital signs measurements, weight,
      adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females),
      concurrent medication, blood sample collection for hematology, coagulation, chemistry,
      pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.
    

Intervention name(s): ARC-520; cetirizine; diphenhydramine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Diphenhydramine; Promethazine; Cetirizine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventing Mental Health Problems After Childhood Severe Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      This is a randomized trial in which caregivers of children suffering from malaria will be
      assigned to two treatment conditions to prevent mental health problems in the children. A
      psycho-education arm (control) and a behavioral arm (intervention). Pre- and
      post-intervention assessments for behavioral problems in the child and mother will be carried
      out.
    

Detailed description: 
      This study is designed to prevent mental health problems in children after an episode of
      severe malaria. The effect of the intervention on the mother's psychological wellbeing will
      also be assessed. Both caregivers and children will be assessed on the ward before being
      randomly assigned to the treatment arms. The interventions in both arms will be done in three
      phases with the third phase being done at home after discharge. Post-intervention assessments
      will be done on both the caregivers and mothers 6 months after discharge.
    

Intervention name(s): Psychoeducation; Behavioral
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention has three phases occurring the same time as the Psychoeducation intervention. Phase I provides verbal and written information about the paediatric acute care unit services and policies. Phase II consists of: (a) verbal and written information about the general paediatric unit and its policies, and (b) a parent-child activity having ''control'' activities like reading a story not related to hospital stay. Phase III of the control program consists of a telephone call 2-3 days after discharge during which time mothers were informed that they should contact their primary healthcare providers if their children were having any problems or unusual symptoms. They also were asked to comment on their children's hospital stays during this telephone call.; This is an educational-behavioural intervention that educates the parent about the children's likely emotional and behavioural problems that may result from ICU admission. Phase I will be delivered within 6 to 16 hours of admission to the hospital where caregivers are provided with information about the child's likely emotional reactions during admission in hospital. Phase II will be delivered within 2 to 16 hours of transfer to the general ward and will consist of: (a) verbal and written information to reinforce information provided in Phase I and (b) a parent-child skills building activities. Phase III of the COPE intervention program will occur 2 to 3 days after hospital discharge and will consist of a telephone call during which a 5 minute script will be read that reinforces young children's typical post-discharge emotions and behaviours and parenting behaviours which would continue to facilitate positive coping outcomes in their children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Satiety Effects of Pulses Compared to Matched Protein Smoothie
Condition: Food Selection
Study type: Interventional

Summary: 
      The satiety effects of pulses compared to a matched smoothie will be measured.
    

Detailed description: 
      The investigators will compare satiety and food intake after consumption of purses or a
      calorie/protein matched smoothie
    

Intervention name(s): purses; a calorie/protein matched smoothie
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): food intake
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption, metabolic pathways and excretion
      of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg
      (0.5 mg/mL solution) of 14C-JNJ-39823277.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) and single-arm
      (group) study. The study consists of 3 phases including, the screening phase (within 3 weeks
      prior to the start of study medication), treatment phase (8 to 15 days), and the follow-up
      phase (up to 6 days after the discharge from the hospital). Approximately 6 participants will
      be receiving the 14C-JNJ-39823277 in the study. Safety will be evaluated by the assessment of
      adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical
      laboratory tests which will be monitored throughout the study. The total duration of study
      will be up to approximately 6 weeks.
    

Intervention name(s): 14C-JNJ-39823277
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Healthy male participants; 14C-JNJ -39823277; TPI 1062; Tianeptine; Absorption; Metabolism; Excretion; Pharmacokinetics