bioihbjkbjnl/mcl2 huggingface dataset:
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of ascending single doses of subcutaneously (SC)
      administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.

      Secondary Objectives:

        -  To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum
           low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as
           total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density
           lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides,
           Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).

        -  To assess the Pharmacokinetic profile of a single SC dose of alirocumab.

        -  To assess the immunogenicity of a single SC dose of alirocumab.
    

Detailed description: 
      4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks
      (106 days) for each participant.
    

Intervention name(s): Alirocumab (Solution); Alirocumab (Lyophilized formulation); Placebo (Solution); Placebo (Lyophilized formulation)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: lyophilized formulation
Route of administration: Subcutaneous
Other intervention name(s): SAR236553; REGN727; SAR236553; REGN727
Intervention MeSH terms: Alirocumab; Pharmaceutical Solutions; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional

Summary: 
      Muslims all over the world fast during the month of Ramadan from dawn until dusk. There is
      little data regarding the best timing of levothyroxine intake during the month of Ramadan
      where taking it on an empty stomach represents a challenge to most patients.This study aims
      to compare two-time points of levothyroxine intake during Ramadan in terms of change in
      thyroid stimulating hormone (TSH), compliance and convenience.
    

Detailed description: 
      Hypothyroidism requires regular replacement with levothyroxine to achieve euthyroidism
      (thyroid hormone status within the normal range). Usually, levothyroxine is taken orally in
      the morning on a daily basis. In clinical practice, the investigators have observed that this
      levothyroxine replacement is sub-optimal resulting in higher levels of thyroid stimulating
      hormone. Based on this observation, the investigators conducted this study to examine whether
      timing of oral intake of levothyroxine during the holy month of Ramadan will affect
      achievement of euthyroidism. They recruited 96 hypothyroid patients taking levothyroxine,
      attending Hamad endocrine outpatient clinics, who were fasting during Ramadan( May-June
      2017)and for whom there is no clinical contraindication to fasting. Patients were randomly
      assigned to two time points for taking levothyroxine:

      A. 30 minutes before the Iftar meal B. 30 minutes before Suhour The primary outcome was the
      change in thyroid stimulating hormone (TSH) before and after Ramadan. The null hypothesis is
      that there is no difference in TSH between the two groups.

      The findings from the study will help in the clinical care of patients with hypothyroidism in
      Ramadan. Hypothyroidism is common worldwide and many Muslims will require the appropriate
      advice regarding management of hypothyroidism in Ramadan.
    

Intervention name(s): timing of receiving the drug
Intervention type(s): Other
Intervention description(s): each group took levothyroxine in different timing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients were block randomized into two groups according to the time they are going to take the leovthyroxine tablet
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fasting
iCanCope With Pain: Usability and Feasibility Testing of a Smartphone Application to Manage Pain in Youth With Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      This study will look at the use and impact of smartphone application (app) for adolescents
      with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project
      will include three studies. First, the investigators conducted usability sessions with
      adolescents with JIA to refine the app so that it is usable, acceptable and understandable.
      The aim of this study is to look at (a) how regularly the "iCanCope with Pain" app is used
      and (b) any effect the app has on young people's health. This study will compare two groups
      of young people: one that is using the new app, and one that receives usual medical care.
    


Intervention name(s): iCanCope app; iCanCope attention control app
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to standard medical care, adolescents in the experimental group will receive access to the "iCanCope" smartphone app for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component.; The control group is designed to control for the potential effects on outcomes of time, attention, and smartphone use during the intervention. In addition to standard medical care, adolescents in the attention control group will receive access to the "iCanCope" control app, with limited functionality.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Arthritis; Self-management; Pain
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Condition: Acute Unilateral Vestibulopathy (AUV)
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and
      safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4
      days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
    


Intervention name(s): SENS-111 100mg; SENS-111 200mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.; SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.; Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute unilateral vestibulopathy, AUV
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
Condition: Vulvovaginal Atrophy; Menopause; Dyspareunia; Painful Intercourse
MeSH terms: Dyspareunia; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of a new formulation of vaginal estradiol for
      the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
    


Intervention name(s): Estradiol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VVA; Painful Sex; Postmenopausal
Naltrexone Neuroimaging
Condition: Eating Disorders; Binge Eating; Purging (Eating Disorders)
MeSH terms: Bulimia; Feeding and Eating Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this open-label, pilot study is to evaluate fMRI as a biomarker of opioid
      antagonism in adolescents with ED. Modulation of brain activation will be examined in regions
      of interest by fMRI using a food-specific and general reward task in adolescents with ED in a
      pre/post design.
    

Detailed description: 
      This is an open-label, interventional trial to evaluate reward system modulation (detected by
      neuroimaging) in response to opioid antagonism (i.e., naltrexone) in adolescents aged 13-21
      years with an eating disorder characterized by the target behaviors of binge eating and/or
      purging (e.g., AN-BP, BN, BED). A pre/post design completed on the same day will be employed
      to quantify within-individual change while reducing potential confounding due to known
      neuroimaging variables (e.g., menstrual phase, treatment changes) that may occur with time
      elapsed between study visits. Self-report data regarding will be captured via electronic
      surveys using validated instruments (where possible), structured interview, study records.

      Reward System Modulation by fMRI. Each scan will last approximately 1 hour and involve two
      reward activation paradigms: passive food view (PFV) and monetary incentive delay (MID).
      These two reward activation paradigms provide distinct insight and will generate pilot data
      to support the choice of the optimal paradigm for further testing of reward system modulation
      in adolescents with eating disorders. PFV provides a paradigm that is relevant to the target
      behaviors (i.e., binge eating, purging), has been evaluated in ED patients, in response to
      naltrexone in adults, and is expected to activate food cue-reactivity regions (e.g.,
      prefrontal cortex). MID is a widely used paradigm in adolescents to detect reward
      anticipation and receipt particularly in the striatum and is currently being used to study
      the developmental trajectory of reward processing in the longitudinal Adolescent Brain
      Cognitive Development (ABCD) trial. To the greatest extent possible, we will harmonize our
      fMRI parameters with those published for ABCD.

      Opioid Antagonism and exposure-response linkage. A single oral dose of naltrexone
      hydrochloride 50 mg tablet will be administered. Plasma and urine will be obtained to measure
      systemic exposure to naltrexone and it primary, active metabolite, 6-beta-naltrexol, using a
      validated UPLC-MS/MS assay.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): naltrexone 50 mg PO x 1
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pediatric; Adolescent; Eating Disorder; Neuroimaging; Naltrexone
A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled study in subjects with
      acne vulgaris.
    

Detailed description: 
      After a screening visit and a one-week washout (if applicable), three sequential ascending
      doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of
      subjects. Each group of subjects will be randomized to receive the planned doses of B244 or
      placebo BID
    

Intervention name(s): B244; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment and Outcome of Early Onset Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the effectiveness in the maintenance of continuing adjunctive
      atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the
      maintenance treatment of adolescents with bipolar disorder.
    

Detailed description: 
      In children and adolescents, bipolar disorder is often accompanied by symptoms such as
      hallucinations, delusions, or paranoia that require acute treatment with a combination of an
      atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary
      to continue treatment with the atypical antipsychotic medication after the child's symptoms
      have remitted.

      Participants in this study are treated with lithium, divalproex (Depakote), and one of the
      following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal)
      or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun
      combination therapy with at least one of the mood stabilizers and atypical antipsychotic
      medications listed above are also encouraged to enroll in this study. After participants have
      been on combination therapy for at least 24 weeks they will then be randomly assigned to one
      of two groups. The first group will continue to receive active mood stabilizer and atypical
      antipsychotic medication. The second group will receive active mood stabilizer and placebo.
      Participants are assessed weekly and followed for up to 18 months.
    

Intervention name(s): Lithium; Olanzapine; Divalproex; Risperidone; Quetiapine; Ziprasidone; Aripriprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Valproic Acid; Olanzapine; Risperidone; Quetiapine Fumarate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adolescence
Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after
      single/multiple dosing.
    


Intervention name(s): KM-023; Placebo for KM-023
Intervention type(s): Drug; Drug
Intervention description(s): -KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.; -Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV
Stem Cells in Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the effect of treatment with granulocyte-colony
      stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to
      develop new blood vessels in the myocardium after an acute myocardial infarction.
    

Detailed description: 
      Intracoronary infusion of bone-marrow stem cells after a ST elevation myocardial infarction
      (STEMI) seems to improve cardiac function. An alternative strategy is increase of circulating
      stem cells by mobilisation from the bone marrow with Granulocyte-Colony Stimulating Factor
      (G-CSF).

      Objective: To determine the short-term (30 days) safety of G-CSF therapy after a STEMI
      treated with acute percutaneous coronary intervention (PCI).

      Methods: Patients with STEMI treated with PCI <12 hours after symptom onset were randomised
      (1:1) to G-CSF (10 μg/kg/d) or placebo for 6 days in a double-blind design. Other inclusion
      criteria: age 20-70 years, culprit lesion in a large coronary artery, and peak CKMB >100
      microgram/L. Follow-up was done after 1, 5 and 6 months, with an angiogram at 5 months.
    

Intervention name(s): Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)
Intervention type(s): Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: ST-elevation myocardial infarction; granulocyte-colony stimulating factor angiogenesis; stem cells
Evaluation of the Baha SoundArc in Pediatric Patients
Condition: Hearing Loss, Conductive; Hearing Loss, Mixed; Hearing Loss, Unilateral
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural
Study type: Interventional

Summary: 
      The purpose of this study is to gather clinical performance data on the Baha SoundArc
    

Detailed description: 
      Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an
      alternative non-surgical option for using their Baha Sound Processor. The subjects will be
      tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with
      the Baha SoundArc where they will perform a one month take home trial. At the end of this
      trial, the subject will return for testing and evaluation of their experience with this new
      fitting option.
    

Intervention name(s): SoundArc
Intervention type(s): Device
Intervention description(s): non-surgical attachment method for wearing a bone conduction hearing system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Reactivity in Kidney Disease Patients
Condition: Kidney Failure, Chronic; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Dialysis patients suffer from many problems with blood vessels and this is even more so for
      patients with the added complication of diabetes. Diabetics have a number of reasons for
      vascular disease and one of the new areas of research is looking at the cells that line the
      blood vessels, called endothelial cells. It is thought that the number of red blood cells in
      the blood (haemoglobin concentration) affects the function of these cells. There is very
      little information available on what haemoglobin level is best for dialysis patients. As
      diabetics account for almost 40% of dialysis patients worldwide it is important to understand
      the effect different haemoglobin levels will have on the blood vessels.

      Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are
      affected by different haemoglobin concentrations [Hb] in dialysis patients.
    

Detailed description: 
      This project is going to ask dialysis patients (both diabetic and non-diabetic) to undergo a
      series of tests at three different time points over a one year period: a baseline set of
      tests, tested when haemoglobin is maintained at 130-140g/L and repeat the tests when
      haemoglobin is maintained at 105-115g/L. The current recommendation for haemoglobin is
      110-120g/L. Patients will not be required to take any study medication but a specialist
      kidney doctor, using their usual medications of iron and erythropoietin therapy, will change
      their haemoglobin levels.
    

Intervention name(s): Changing hemoglobin concentration
Intervention type(s): Procedure
Intervention MeSH terms: Chrysarobin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Hemoglobin; Dialysis; Vascular reactivity
Treatment of Anovulatory Infertility in PCOS Patients
Condition: Infertility; Polycystic Ovary Syndrome; Anovulation
MeSH terms: Polycystic Ovary Syndrome; Infertility; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in
      patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound
      between them should be initially administered. The aim of the study will be to compare in a
      clinical setting the efficacy of CC and metformin as first-line approaches for treating
      anovulation in infertile PCOS patients.
    

Detailed description: 
      Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index
      (BMI)- and age-matched groups (experimental and control groups).

      Forty patients will receive the experimental treatment consisting of six months of 1700
      mg/day metformin administration (experimental group), whereas other forty patients will
      receive CC administered using a traditional incremental-doses protocol (control group). In
      both groups, patients who will ovulate under treatment will continue the therapy for a total
      of six months.

      During the study, the clinical and reproductive outcomes, and the adverse experience will be
      evaluated in each patient.
    

Intervention name(s): Clomiphene citrate; Metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anovulation; Clomiphene citrate; Infertility; Metformin; PCOS; Treatment
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of AZD1446
      following single dose administration.
    


Intervention name(s): AZD1446
Intervention type(s): Drug
Intervention description(s): oral, single dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: single dose; pharmacokinetics; safety; healthy volunteers; food interaction; AZD1446