bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label study to evaluate the effect of albiglutide on the
      pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon).
      The primary objective of this study is to demonstrate the lack of effect of albiglutide doses
      on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.
    

Detailed description: 
      This study will be an open-label study in at least one center to evaluate the effect of
      albiglutide administration on the pharmacokinetics and pharmacodynamics of a standard oral
      contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the
      lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl
      estradiol in healthy female subjects.
    

Intervention name(s): albiglutide; Oral contraceptive (Brevicon)
Intervention type(s): Biological; Drug
Intervention description(s): albiglutide 50mg weekly subcutaneous injection; Oral contraceptive (Brevicon)
Intervention MeSH terms: Contraceptive Agents; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Contraceptives, Oral; rGLP-1 protein
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; GSK716155; Brevicon; albiglutide; healthy female volunteers; oral contraceptive
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of an intravenous (IV)
      administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard
      (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed
      Product (FVP) (IV) to create the IV solution.
    


Intervention name(s): Guselkumab
Intervention type(s): Drug
Intervention description(s): Guselkumab will be administered as IV solution derived from FVP or PFS-U.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tremfya
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Condition: Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to investigate the use of amlodipine, a drug that blocks the uptake of
      calcium into cells, in the prevention and treatment of iron overload in patients with
      thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and
      other organs, blocking these channels might help to prevent the accumulation of iron in these
      tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive
      amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be
      monitored through one year with an additional year of follow up after the group using
      amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as
      well as live and heart T2* by MRI.
    


Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): 5mg po for 12 months
Intervention MeSH terms: Amlodipine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: thalassemia major; calcium channel blockade; magnetic resonance imaging
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age
Condition: Infectious Disease by Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate and compare the immunogenicity and safety of
      LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™
      at vaccination in healthy infants at their 2, 4, and 6 months of age.
    


Intervention name(s): LBVH0101 (Hib vaccine); Hiberix™ Vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
Condition: Secondary Amenorrhea
MeSH terms: Neoplasm Metastasis; Amenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in
      women of reproductive age with secondary amenorrhea
    


Intervention name(s): PROMETRIUM® 300 mg; PROMETRIUM® 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles; 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
Condition: Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be
      achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been
      receiving oral bisphosphonate therapy for at least 3 years.
    

Detailed description: 
      The study was originally planned for a duration of 2 years and included efficacy analysis of
      a 15 mg MK-5442 treatment arm. Amendment 1 of the protocol eliminated the 2nd year of the
      study as well the 15-mg arm. Enrollment into the 15-mg MK-5442 arm was stopped as a result of
      the amendment and all participants who had been randomly assigned to the MK-5442 15-mg
      treatment arm were discontinued from the study.
    

Intervention name(s): MK-5442; Placebo to MK-5442; Alendronate Sodium; Vitamin D3; Calcium carbonate; Placebo to Alendronate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months; Matching placebo to MK-5442 taken orally, once-daily, for 12 months; Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months; Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months; Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months; Placebo to alendronate once-weekly for 12 months
Other intervention name(s): FOSAMAX®; Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy
Condition: FSHD - Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral; Disease Progression
Study type: Observational

Summary: 
      An investigation of disease progression in adult danish patients with facioscapulohumeral
      muscular dystrophy. The disease progression is followed for a year with two test-days,
      including functional muscle tests and a MRI scan of muscles in the back and legs.
    

Detailed description: 
      A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to
      perform a MRI scan to describe the relation between backpain and disease affection in back
      muscles. After one year they are re-invited to perform another MRI scan to follow the disease
      progression.

      The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh
      and calf. Further, investigators investigate the muscle function by measuring of muscle
      strength in legs and in the back together with three functional tests. A walking test (6MWT),
      a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by
      a standardized questionnaire about backpain.
    

Intervention name(s): MRI
Intervention type(s): Other
Intervention description(s): MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the
        study.
      
Keywords: FSHD; MRI; Disease progression
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Condition: Lipodystrophy; HIV Infections
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth
      Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
    

Detailed description: 
      HIV lipodystrophy affects a significant proportion of patients treated with combination
      antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss
      of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance.
      Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated
      that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV-
      infected patients with excess of abdominal fat accumulation for 26 weeks resulted in
      decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and
      subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations
      made during the first Phase 3 study.
    

Intervention name(s): Tesamorelin; Placebo for Tesamorelin
Intervention type(s): Drug; Drug
Other intervention name(s): Egrifta
Intervention MeSH terms: Tesamorelin; Growth Hormone-Releasing Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Lipodystrophy; Abdominal fat accumulation; Growth hormone releasing hormone; HIV-associated lipodystrophy; Treatment experienced
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1
Condition: Advanced Solid Tumor; B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first-in-human clinical trial of CN1 to evaluate the safety, tolerability,
      pharmacokinetic (PK) profile and preliminary efficacy of CN1 in patients with advanced solid
      tumors or B-cell lymphoma. This study will provide a basis for further clinical development
      of CN1.
    

Detailed description: 
      CN1 could promote T cell activation and cytokine secretion, thereby enhancing the function of
      CD4+ and CD8+ T cells, and could also regulate Treg cells, thus CN1 is considered to enhance
      the anti-tumor immune response and have potential antitumor activity.

      In this multicenter, open-label, dose-escalation Phase I study six dose levels are planned.
      Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). After
      completion of treatment cycles, the participant will be assessed by the Principal
      Investigator and/or Safety Monitoring Committee (SMC).
    

Intervention name(s): CN1
Intervention type(s): Drug
Intervention description(s): Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). The 5 planned dose levels are 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study will develop and evaluate the efficacy of an Internet-based education program
      incorporating virtual coaching. For this study, the virtual coach will consist of online
      videos aimed at providing acne education and promoting behaviors that support healthy skin.
      The use of Web-based technologies and virtual coaching in acne-related patient education is
      novel, and may significantly improve clinical outcomes and quality of life in acne patients.
      We hypothesize that an interactive Internet-based education and counseling program will be
      more effective than Internet-based education alone in improving clinical outcomes and quality
      of life in acne patients.
    


Intervention name(s): Virtual Counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
ACY-6 Oral Administration of Acyline
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine
      if this potentially useful compound is safe and effective at suppression of gonadotropins
      after oral dosing in man.

      Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol
      and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the
      suppression will increase with increasing doses of Acyline.
    

Detailed description: 
      The purpose of this study is to test how the body responds to a new oral form of acyline and
      to also look at the safety of oral acyline.

      Acyline temporarily blocks the production of the hormone testosterone in normal men. It has
      been given to over 100 men in an injection form. This study will be testing acyline in a pill
      form. This is the first time the pill form has been tested in humans.

      This study may help develop an oral form of a testosterone-blocker, which may be useful in
      the treatment of diseases such as prostate cancer, premature puberty and possibly in a male
      contraceptive.

      This study requires three 12-hour blood draw periods for pharmacokinetics (PK) testing. PK
      testing looks to see how much study drug is in the blood. This gives information about how
      the body handles and gets rid of the study drug.
    

Intervention name(s): Acyline
Intervention type(s): Drug
Intervention description(s): 10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.
Intervention MeSH terms: Acyline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Contraception; Acyline
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)
      on the levodopa pharmacokinetics when administered in combination with a single-dose of
      immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)
    

Detailed description: 
      Single centre, double-blind, randomized, placebo-controlled, crossover study with four
      consecutive single-dose treatment periods. The washout period between doses was to be at
      least 14 days. On each treatment period, after completion of pre-dose assessments, BIA
      9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® 100/25;
      post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.
      Subjects were to attend four treatment periods and were to receive a different dose of BIA
      9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.
    

Intervention name(s): BIA 9-1067; Placebo; Sinemet® 100/25
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OPC, Opicapone; PLC, Placebo; Immediate-release levodopa/carbidopa 100/25 mg
Intervention MeSH terms: Carbidopa, levodopa drug combination; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); Opicapone; BIA 9-1067
Nutrients and Hormones: Effects in Boys With Disordered Growth
Condition: Constitutional Growth Delay; Nutrition Disorders; Growth Disorders
MeSH terms: Nutrition Disorders; Puberty, Delayed; Growth Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to find out if patients with constitutional delay of growth have
      a mismatch between energy intake and utilization (as measured by doubly labeled water) and to
      compare the improvement in growth and energy balance between a group of boys treated with
      growth hormone (GH) alone versus those given GH plus added nutritional supplements for one
      year.
    

Detailed description: 
      Two groups of boys 7-10 years old who are very short and below average in weight but
      otherwise healthy will be studied. One group will be observed initially for 6 months and then
      receive GH injections every day for the subsequent 12 months. Another group of boys will get
      a high-calorie drink every day for 6 months, and then receive GH injections plus the
      supplement every day for the next 12 months. We will compare how well boys grow in height,
      weight and the changes in body composition. We will compare diet and energy usage using the
      doubly labeled water technique. A battery of hormonal and nutritional tests will be
      performed, as well as body composition assessment.
    

Intervention name(s): Pediasure; GH
Intervention type(s): Drug; Drug
Intervention description(s): With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.; Growth Hormone will be 0.3mg/kg/week, given SC once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GH; Delayed Growth; Energy Expenditure; Puberty; Nutrition; Short Stature
Weight Loss in Pre-diabetic, Obese Women
Condition: Obesity
MeSH terms: Prediabetic State; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a six (6) month, single center, randomized, double-blind, parallel,
      controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra)
      in pre-diabetic obese women.
    


Intervention name(s): Low calorie diet; Olestra
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): low calorie diet; low calorie Olestra diet
Intervention MeSH terms: Sucrose polyester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pre-diabetic; obese
Management of Distal Ulna Fractures Using Hook Plate
Condition: Distal Ulna Fractures
MeSH terms: Fractures, Bone; Ulna Fractures
Study type: Interventional

Summary: 
      The aim of this current prospective study is to evaluate the effectiveness of an open
      reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp)
      in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal
      radius fractures.
    

Detailed description: 
      The distal ulna is an important component in the forearm and wrist motion.
      Pronation-supination is a complex movement, combining the rotation of the radius around the
      ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper
      anatomical position maintaining its original length with significant residual angulation at
      the fracture site, and separation of the DRUJ in a transverse axis, then a more severe
      limitation of forearm motion
    

Intervention name(s): Hook plate
Intervention type(s): Procedure
Intervention description(s): We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured
Other intervention name(s): Distal ulna anatomical plate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PRIME vs Usual Care for Clinical High Risk
Condition: Clinical High Risk Syndrome for Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether specialty care is superior to usual care in
      the treatment of patients at clinical high risk for psychosis.
    

Detailed description: 
      This study is a randomized clinical effectiveness trial for patients at clinical high risk
      for psychosis that compares two treatments: 1) specialty care delivered in a specialized
      clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the
      community.
    

Intervention name(s): PRIME care; Usual care
Intervention type(s): Other; Other
Intervention description(s): Specialist medication, cognitive behavior therapy, family-focused therapy; Medication and psychotherapy as available form community providers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: prodrome; cognitive behavioral therapy; family focused therapy