bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in
      healthy participants. The secondary objectives of the study are to:

        -  Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461
           and evaluate the effects of baseline covariates on PK profile

        -  Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in
           overweight and obese participants

        -  Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight
           and obese participants

        -  Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of
           lipid-regulating proteins levels over time

        -  Assess the immunogenicity of single and repeated doses of REGN4461
    

Detailed description: 
      This is a 2-part study of the safety, tolerability, PK and pharmacodynamic (PD) of single and
      repeated doses of REGN4461 in healthy participants. In Part A, healthy lean or overweight
      participants will be enrolled to evaluate the safety, tolerability, PK, and PD of single
      ascending intravenous (IV) and subcutaneous (SC) doses. Interim PK and safety information
      from Part A will be used to select the dose level, frequency, and mode of administration (IV
      or SC) for repeat dosing in Part B. In Part B, overweight/obese participants with body mass
      index (BMI) 25-40 kg/m2 will be enrolled to evaluate the safety, tolerability, PK, and PD of
      repeated doses of REGN4461 in 4 distinct cohorts defined by baseline leptin levels.
    

Intervention name(s): REGN4461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): REGN4461; Placebo-matching REGN4461
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Sexuality After Reduction Mammaplasty
Condition: Sexual Function; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The aim of this study is to determine the impact of reduction mammaplasty on sexuality and
      depression predictors in women with macromastia.
    

Detailed description: 
      Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective
      and well established procedure performed for the relief discomfort associated with breast
      hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of
      this study is to determine whether reduction mammaplasty could influence sexual function and
      depression predictors on women with breast hypertrophy.
    

Intervention name(s): Reduction mammaplasty
Intervention type(s): Procedure
Intervention description(s): Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Other intervention name(s): Breast reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: breast hypertrophy; mammaplasty; sexuality; depression
Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects on the quality of life and BMI of new
      contraceptives.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
Intervention type(s): Drug
Intervention description(s): Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.
Intervention MeSH terms: Drospirenone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Females requiring contraceptives
Diabetes and Gastric By- Pass
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the mechanisms leading to rapid postoperative
      improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and
      compare the changes in glucose level, beta-cell function, and insulin resistance induced by a
      week of very low calorie liquid diet and those induced by a week of matched very -low calorie
      liquid diet occuring in the context of routine postoperative care following RYGB.
    

Detailed description: 
      Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and
      controlled diet and activity, separated by a 4-10-week washout period.

      Study Period #1:

      This first study period is 9 days/nights long and requires you to be closely supervised at
      our Clinical and Translational Research Center (CTRC). During this time you will receive the
      same diet and are expected to have the same activity level you will be prescribed in the
      immediate post-operative period.

      Wash-out period:

      During this study period you are expected to return to your usual diet and exercise level.

      Study Period #2:

      This last study period is also 9 days/nights long, includes the EXACT same diet you have
      received during the first study period, and in addition you will undergo the planned gastric
      by-pass surgery.

      Procedures during the research:

      Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for
      each study period. This test allows the investigators to evaluate how much insulin your body
      is producing and how well this insulin is processed.

      Measurement of resting energy expenditure will be done four times during the entire study.
      This test tell us how much energy your body is burning up in a resting state.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Bariatric surgery clinical roster or by the treating physician in the bariatric surgery
        clinic.

        This study does NOT pay for the By-pass surgery, eligible participants should have planned
        their surgery by their own physician, at their own expense.
      
Biospecimen description: 
      whole blood samples, plasma, serum, urine,
    
Keywords: Type 2 diabetes; Bariatric surgery; Obesity; Weight loss
Biologic Predictors of Leiomyoma Treatment Outcomes
Condition: Uterine Leiomyomas; Fibroids; Uterine Fibroids; Myomas
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      The purpose of this study is to search for the hereditary (genetic) causes of uterine
      fibroids. Some women with uterine fibroids may have one or more genes that make them more
      likely to develop uterine fibroids. We are trying to identify these genes to better
      understand how and why uterine fibroids develop and to design better treatment options for
      women with uterine fibroids. This information may also help us to understand and treat other
      problems that may be caused by these genes.
    

Detailed description: 
      There is little information to predict outcomes of leiomyoma therapies. It is clear that both
      environmental exposures and genetic predisposition influence disease manifestations. Our work
      has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We
      therefore propose to prospectively collect biologic samples that will allow us to analyze
      gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing
      leiomyoma clinical treatments using the same methodology used previously. Specifically we
      will collect serum aliquots, genomic DNA and information using a genetic epidemiology
      questionnaire. In the short term we will also be able to use prospectively obtained
      information on epidemiologic and anthropomorphic data to characterize women undergoing
      treatment.
    

Intervention name(s): DNA analysis; Hormonal analysis
Intervention type(s): Genetic; Other
Intervention description(s): At a future time DNA analysis will be performed; Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will
        either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.
      
Biospecimen description: 
      Serum aliquots and genomic DNA samples will be collected, processed and stored in the
      Biospecimen Accessioning Processing (BAP) lab at Mayo Clinic in Rochester, MN.
    
Keywords: Uterine leiomyomas (fibroids or myomas); Uterine fibroids; Fibroids; Uterine leiomyomas
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
Condition: Postoperative Pain; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      To find out if a drug called tapentadol administered by mouth safely relieves pain in
      children. Look at the amount of tapentadol in the blood after a single oral dose.

      Tapentadol oral solution for children is still being tested and is not yet registered.
      Tapentadol tablets are effective in treating both acute and chronic pain in adults. This
      trial will help to understand how tapentadol oral solution works in children.
    

Detailed description: 
      The lower age limit for the clinical trial was initially set to 3 years of age in the
      protocol. The trial planned for the inclusion of participants in three age categories. Age 3
      to less than 6 years (young children), age 6 to less than 12 years (older children) and age
      12 to less than 18 years of age (adolescents). There was a request by the Paediatric
      Committee (PDCO) at the European Medicines Agency to include participants 2 years of age
      (very young children). The protocol amendment thus planned to combine the two youngest age
      groups into a single reporting group. The protocol amendment only planned that the very young
      children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale
      and for the presentation of the serum concentrations, because the pharmacokinetic sampling
      scheme used in the 2 year old participants was different from the young children group (aged
      3 to less than 6 years).
    

Intervention name(s): Tapentadol
Intervention type(s): Drug
Intervention description(s): Tapentadol oral solution single dose (1mg/kg body weight)
Intervention MeSH terms: Tapentadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tonsillectomy; Dental surgery; Ear surgery; Nose surgery; Throat surgery
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      If tigecycline clearance increases with body size then serum exposure values will be lower in
      obese class III compared to normal weight subjects because exposure changes inversely with
      clearance when the dose is fixed without regard to weight.
    

Detailed description: 
      Not required
    

Intervention name(s): Tigecycline
Intervention type(s): Drug
Intervention description(s): 100 mg IV as a single infusion over 30 minutes
Other intervention name(s): Tygacil
Intervention MeSH terms: Tigecycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of
      each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in
      the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this
      regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along
      with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall
      survival among women with breast cancer .Primary objective of this study is to compare the
      efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy
      (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer
      patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in
      this trial. All eligible patients receive single subcutaneous injection of study drugs 24
      hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and
      safety assessments will be assessed based on the incidence of severe neutropenia in
      combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of
      serious adverse events.
    


Intervention name(s): pegcyte; Neulastim
Intervention type(s): Drug; Drug
Intervention description(s): Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.; Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Other intervention name(s): pegfilgrastim; pegfilgrastim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss
Condition: Muscle Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      A decrease in muscle mass can have a profound impact on quality of life, as it can lead to
      decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this
      study we investigate whether ingesting leucine or getting a ND injection will reduce the loss
      of muscle mass and strength.
    


Intervention name(s): Inactivity; ND; Leu
Intervention type(s): Behavioral; Drug; Dietary Supplement
Intervention description(s): Inactivity; 1 nandrolone decanoate injection; Leucine supplements
Other intervention name(s): Nandrolone; Leucine
Intervention MeSH terms: Nandrolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
Condition: Midlife Obese Adults With Cognitive Decline
MeSH terms: Weight Loss; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes
      following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF)
      intervention compared to an health education control (HEC) in 50 obese, stressed mid-life
      adults to explore outcomes related to cognitive function, metabolism and associated lifestyle
      behaviors.
    


Intervention name(s): Prolonged nightly fasting; Health Education Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.; Weekly health education video viewing related to general health topics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with 2 groups (intervention and control).
Masking: None (Open Label)
Primary purpose: Prevention
Nimotuzumab in Adults With Glioblastoma Multiforma
Condition: Adults With Glioblastoma Multiforma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
    

Detailed description: 
      The objective of the present study is a comparison of treatment of patients with newly
      diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms
      when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus
      Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will
      receive standard radiotherapy plus Temozolomide treatment.
    

Intervention name(s): nimotuzumab
Intervention type(s): Drug
Intervention description(s): monoclonal antibody
Intervention MeSH terms: Nimotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma multiforma
Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Aims: During the last decades overweight/obesity has increased markedly. They are associated
      with a high risk for diabetes and death. Effective intervention is mandatory. Following
      participation in treatment programmes children/adolescents often fail to reach sufficient
      long-term weight reduction. The present trial aims to integrate telemedical support in
      therapy to improve long term outcome.

      Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6
      years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score
      [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and
      eating habits electronic health technology was used (Fraunhofer-Institute). The system
      consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind,
      intensity and duration of physical activity and eating habits.
    


Intervention name(s): motion detection with a motion sensor
Intervention type(s): Device
Intervention description(s): To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: differences between patients´ self-assessment and objective perception of physical activity and eating habits
Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in
      patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention
      (PCI) with drug eluting stent(s. Interindividual variability in platelet response to
      clopidogrel has been reported, with several mechanisms being implicated for high
      post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated
      with an increased risk of adverse events after PCI. Studies in patients on chronic
      clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently
      present and independently predictive of adverse events. Optimization of platelet inhibition
      in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12
      inhibitors is a controversial issue, mostly studied in post PCI patients, while no data
      exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel
      treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled
      will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg
      a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR
      measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours
      after the last study-drug dose, will follow by crossover directly to the alternate therapy
      for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will
      return for the clinical and laboratory assessment as did on Day 14 visit.
    


Intervention name(s): Clopidogrel; prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 14 days we will change their therapy with standard dose of prasugrel (crossover).; Patient will be randomized to this intervention will receive in the first time the standard dose of prasugrel and after 14 days we will change their therapy with high dose of clopidogrel (crossover).
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antiplatelet effect; prasugrel; clopidogrel; ACS
Non-Invasive Management of Chronic Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Observational

Summary: 
      The purpose of this study is:

      -item one to use two new non-invasive technologies to evaluate scarring and swelling
      associated with chronic venous insufficiency.

      The study hypothesis:

      - item one non-invasive technologies can provide a tool for assessing risk of ulcer
      development based on the tissue edema and alteration.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CVI subjects will be recruited from University of Utah vascular surgery service.Control
        group will be recruited from the community.
      
Keywords: edema; blood supply; lower legs; venous stasis