bioihbjkbjnl/mcl2 huggingface dataset:
Glyburide Healthy Volunteer Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Glyburide is a medication that has been safely used for several decades to treat non-insulin
      dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the
      lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and
      cognitively. The investigators are hopeful that the results of this study will provide the
      necessary foundation to evaluate this medication's use on a larger scale to determine the
      feasibility of using glyburide in soldiers either prophylactically or for the treatment of
      brain injury.
    

Detailed description: 
      This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21
      healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs. placebo
      while under careful medical monitoring in an inpatient Clinical Research Unit (CRU)within the
      Center for Applied Research Sciences (CARS) at the Washington University in St. Louis Medical
      Center for a duration of 7 days and nights (24 hours per day). Interested subjects who call
      for more information about the study will be scheduled for a screening visit. Subjects will
      participate first in an informed consent process, and those wishing to take part will be
      asked to undergo a comprehensive interview detailing their past medical history and formal
      physical examination (which includes laboratory tests of the urine and blood). If a subject
      is deemed appropriate by the team, he/she will be asked to perform an exercise test
      (treadmill for 30 minutes) and will have an Electrocardiogram (ECG) completed to further
      determine eligibility. Individuals who do not meet inclusion criteria based on screening
      activities will be notified immediately that they are not eligible. Volunteers meeting all
      eligibility criteria will be scheduled for the week long in-patient evaluation.

      Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition
      to receiving oral glyburide or placebo each day for one week.
    

Intervention name(s): Glyburide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Micronase; Glybencamide; Sugar Pill (capsule)
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: glyburide; glybenclamide; hypoglycemia
Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      A prospective intervention study to evaluate the effectiveness of the developed toolset for
      remote physical activity monitoring to improve arterial stiffness and other cardiometabolic
      parameters and to increase physical activity levels and the compliance to the prescribed
      exercise in individuals with metabolic syndrome.
    

Detailed description: 
      At first, all subjects of the prospective study participated in the 2-month outpatient
      aerobic exercise program, which consisted of 40 aerobic training sessions on a cycle
      ergometer 5 times/week for 40 min. During all training sessions, heart rate was maintained at
      the targeted level, which was obtained individually by cardiopulmonary test. After 2 months,
      during individual motivational consultations, all participants received recommendations for
      home-based training and were randomly allocated to the intervention or the control group.
      Then only the intervention group subjects participated in the 6-month home-based aerobic
      exercise program using a wearable heart rate monitor, which was connected to the smartphone
      via Bluetooth. The intervention group subjects used a smartphone application created for the
      study. The control group participants were asked to exercise at home for 6 months without
      wearables and smartphone application. The evaluation of the study participants was performed
      at baseline (1st visit), after 2 months (2nd visit) and after 8 months (3rd visit).
    

Intervention name(s): Usage of a wearable heart rate monitor and a smartphone with the application for home-based exercises
Intervention type(s): Device
Intervention description(s): Physical activity self-monitoring using a wearable heart rate monitor and a smartphone with specially designed application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metabolic syndrome; Physical activity; Telemonitoring; Smartphone application; Wearables; Cardiovascular prevention; mHealth; Digital health
Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Condition: COVID-19; Vaccine; Menstrual Irregularity; Menopausal Bleeding
MeSH terms: COVID-19; Uterine Hemorrhage; Hemorrhage; Menstruation Disturbances
Study type: Observational

Summary: 
      Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection
      among the general population, reducing significantly both morbidity and mortality.

      Nevertheless, after the first and second doses of vaccination (regardless of the type of
      vaccine used) several women required gynaecological visits claiming menstrual Irregularities
      or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was
      designed to investigate systematically whether menstrual Irregularities or abnormal uterine
      bleeding occurred in a significant percentage of women undergoing first and second doses of
      covid-19 vaccination.
    


Intervention name(s): Covid-19 vaccine
Intervention type(s): Biological
Intervention description(s): First dose or complete cycle of Comirnaty (Pfizer/BioNTech) vaccine
First dose or complete cycle of Spikevax (Moderna) vaccine
First dose or complete cycle of AstraZeneca/Vaxzevria vaccine
Complete cycle of vaccination using one type of vaccine for the first dose and a different type for the second dose
Janssen (Johnson & Johnson) vaccine (single dose)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the
        type of vaccine used.
      
Keywords: Covid-19 vaccine; Menstrual Irregularity; Menopausal Bleeding
Effect of Growth Hormone on Insulin Signaling in Muscle Tissue
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a physiological bolus of growth
      hormone on insulin signaling pathways in muscle tissue in healthy lean men.
    


Intervention name(s): Physiological Bolus of Growth Hormone
Intervention type(s): Device
Intervention description(s): 0,5 mg Norditropin
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Growth Hormone; Insulin Signaling; GH signaling
Effects of Atorvastatin in Graves' Orbitopathy (GO)
Condition: Thyroid Associated Ophthalmopathy; Hypercholesterolemia
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease
      (GD), being observed in ~25% of patients. Besides genetic and demographical variables, risk
      factors associated with the development of GO in GD patients are known to be inadequate
      control of hyperthyroidism, radioiodine treatment, and smoking. In a large retrospective
      study conducted in more than 8,000 individuals with GD it was observed that treatment with
      3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, better known as statins, is
      associated with a ~40% reduced risk of developing GO in GD patients. The findings were
      interpreted as the consequence of the anti-inflammatory action of statins, being GO
      notoriously an autoimmune, inflammatory conditions.

      Statins are widely used for the treatment of hypercholesterolemia, for which they are quite
      effective. The possibility that their "protective" effect in terms of GO development in GD
      patients, as observed by Stein et al., was simply due to their hypolipemic actions was not
      considered. To evaluate the possibility that the findings reflected lowering of cholesterol
      rather than a direct anti-inflammatory effect of statins a prospective, observational study
      to assess the association between GO and high cholesterol levels and/or the relationship
      between the degree and/or activity of GO and hypercholesterolemia is ongoing. Preliminary
      findings suggest that GO is more severe and active in patients with high cholesterol levels.
      On the basis of these observations, the present randomized clinical trial was designed to be
      performed in hypercholesterolemic patients with GD and moderate-to-severe and active GO,
      aimed at investigating if lowering of cholesterol levels with statins is associated with a
      better outcome of GO.
    


Intervention name(s): Atorvastatin; Methylprednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 20 mg daily; 500 mg of methylprednisolone weekly for 6 weeks, followed by 250 mg weekly for another 6 weeks, for a total dose of 4.5 mg.
Other intervention name(s): Statins; Intravenous glucocorticoids
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Atorvastatin; Prednisolone hemisuccinate; Prednisolone phosphate; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Resourcefulness Group Intervention on Recovery and Quality of Life
Condition: Chronic Schizophrenia; Quality of Life; Recovery
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study was to test the effects of resourcefulness group intervention on
      facilitating recovery and improving the quality of life in patients with chronic
      schizophrenia.
    

Detailed description: 
      Purpose: This study aimed to explore the effects of resourcefulness group intervention on
      facilitating recovery and improving the quality of life in patients with chronic
      schizophrenia.

      Methods: A longitudinal and interventional study with a quasi-experimental research design
      and convenience sampling were used in this study. Patients with chronic schizophrenia from a
      psychiatric hospital in northern Taiwan were recruited as subjects and were divided under
      random assignment into the experimental group and the control group with twenty participants
      in each. The twenty participants in the experiment group were further randomly distributed
      into two groups. Both received resourcefulness group intervention weekly for six weeks, while
      the control group followed regular care routines and underwent conventional treatment. All
      participants took a pretest before the intervention, the first posttest after six rounds of
      intervention, and the second posttest four weeks after the group intervention was completed.
      Data were collected using structured questionnaires, including the Chinese version of the
      Resourcefulness Scale (C-RS), the Chinese Questionnaire about the Process of Recovery (QPR),
      the WHOQOL-BREF Taiwan Version, and other personal information.
    

Intervention name(s): Resourcefulness Group
Intervention type(s): Behavioral
Intervention description(s): The content of the Resourcefulness intervention group includes 6 sessions such as session 1 to introduce resourcefulness skills; sessions 2-4 to discuss personal resourcefulness skills including planning daily activities, and positive self-talk; sessions 4-5 to discuss social resourcefulness skills including relying on family or friends, and seeking professional assistance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Resourcefulness; Chronic Schizophrenia; Resourcefulness Group; Recovery; Quality of Life
A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered
      with tyramine
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to
      determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine
      in healthy adult male and female volunteers.
    

Intervention name(s): TR-701 FA with Tyramine; Placebo-controlled withTyramine
Intervention type(s): Drug; Drug
Intervention description(s): TR-701 FA 200 mg oral and Tyramine; Placebo-controlled and Tyramine
Other intervention name(s): Tedizolid Phosphate
Intervention MeSH terms: Tedizolid phosphate; Tedizolid; Tyramine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers
Condition: Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14
      days will be safe and well tolerated in healthy volunteers. To determine the effect on food
      on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg
      and 8mg.
    


Intervention name(s): PF-04457845, FAAH inhibitor; PF-04457845, FAAH inhibitor; PF-04457845, FAAH inhibitor; PF-04457845, FAAH inhibitor; PF-04457845, FAAH inhibitor; PF-04457845, FAAH inhibitor
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral solution of 0.5mg given once daily for 14 days.; Oral solution of 1mg given once daily for 14 days.; Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days.; A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase; Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days.; A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy volunteers
Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients
Condition: Parkinson Disease (PD)
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This is an open-label, postmarketing, observational study to document health outcomes, in
      Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa
      (levodopa/carbidopa intestinal gel).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient population will consist of patients eligible for DUODOPA treatment according to
        the DUODOPA Product Monograph (DPM) approved by Health Canada and according to the
        reimbursement criteria accepted by the Canadian Provincial Health Authorities or private
        insurance companies.
      
Keywords: Cadence; Duodopa; Parkinson's disease; LCIG; Levodopa-carbidopa intestinal gel; Observational
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is designed to evaluate the safety and immune modulatory effects of oral
      administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the
      metabolic syndrome.
    

Detailed description: 
      PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.
    

Intervention name(s): OKT3
Intervention type(s): Drug
Intervention description(s): Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other intervention name(s): Omeprazole
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of Iron Deficiency Anaemia in Pregnancy Study
Condition: Anemia, Iron Deficiency
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

Summary: 
      The burden of anaemia remains unacceptably high during pregnancy. Over a third of women are
      anaemic by their third trimester of pregnancy. The most common cause is iron deficiency. One
      key factor is rising iron requirements throughout pregnancy. There are risks associated with
      anaemia for the mother and infant. Anaemia in the first and second trimester has been
      significantly correlated with low birth weight and pre-term birth, and is associated with
      impaired neurological development of the baby. It also increases the risk of intrauterine
      fetal death, and the likelihood of the mother requiring blood transfusions during or after
      delivery.This study is a prospective cohort study, which aims to better define the natural
      history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant
      women. This includes documenting the impact of treatment on anaemia symptoms, side effects,
      and the level of success of iron therapy using several haematological tests. Pregnant women
      will be invited to participate in this study and treated using a treatment schedule as
      described in national guidelines. Additional blood samples will be taken for subsequent
      detailed analysis of pathways of iron metabolism to better predict the response to oral iron
      therapy during pregnancy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anaemic (iron-deficient) pregnant women receiving oral iron replacement therapy.
      
Biospecimen description: 
      Blood samples
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To compare the glucose control during treatment with a new formulation of insulin
           glargine and Lantus in adult participants with type 1 diabetes mellitus

      Secondary Objectives:

        -  To compare a new formulation of insulin glargine and Lantus given in the morning or in
           the evening

        -  To compare the incidence and frequency of hypoglycemic episodes

        -  To assess the safety and tolerability of the new formulation of insulin glargine
    

Detailed description: 
      -  Up to 4-week screening period;

        -  16-week open-label comparative efficacy and safety treatment period;

        -  4-week post-treatment safety follow-up period.
    

Intervention name(s): HOE901-U300 (new formulation of insulin glargine); Lantus (insulin glargine)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective of this study is to evaluate safety and tolerability of flavocoxid administered at
      the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in
      association with steroids (deflazacort on alternate days) started at least one year before.
      The investigators will also perform a multidimensional clinical evaluation covering
      functional and muscle strength and quality of life (QoL)assessments.
    


Intervention name(s): Flavocoxid
Intervention type(s): Drug
Intervention description(s): Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Flavocoxid; Duchenne muscular dystrophy; pilot study
A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in
      participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation,
      including those who have received prior treatment with a B-cell receptor inhibitor.
    

Detailed description: 
      Following the Screening period, all eligible participants initiate venetoclax on a once daily
      (QD) dosing schedule. To mitigate the risk for tumor lysis syndrome (TLS), dosing will start
      with a 5-week dose titration phase.

      Participants may receive venetoclax for up to 2 years provided they continue to tolerate the
      drug, have no evidence of disease progression (based on investigator assessment), do not have
      unacceptable toxicity and do not meet any of the criteria for subject discontinuation. In
      countries where venetoclax is not commercially available, participants who continued to
      derive benefit after 2 years of treatment may extend their treatment for up to 2 additional
      years in an extended access phase. Participants in the extended access phase of this study
      who continue to derive benefit from venetoclax after the 2-year extension and are
      transferring to the venetoclax extension study, Study M19-388 (NCT03844048), may remain in
      Extended Access for up to 1 additional year or until the extension study is approved and
      initiated at the site, whichever is sooner.
    

Intervention name(s): Venetoclax
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration
Other intervention name(s): ABT-199; VENCLEXTA®
Intervention MeSH terms: Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology; Chronic Lymphocytic Leukemia; 17p Deletion; TP53 Mutation; Relapsed; Refractory; B-Cell receptor inhibitor