bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD); Healthy Volunteers
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      RV1162 is a new medicine being developed for possible treatment of smoking related lung
      disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of
      this study is to investigate the safety, tolerability and pharmacokinetics of single and
      repeat doses of RV1162.
    


Intervention name(s): RV1162 single dose; RV1162 matching placebo single dose; RV1162: 7 day repeat dose; RV1162 matching placebo: 7 day repeat dose; RV1162: 14 day repeat dose; RV1162 matching placebo: 14 day repeat dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single escalating doses; Safety and tolerability of single escalating doses; Safety and tolerability of a repeat dose; Safety and tolerability of a repeat dose; Safety and tolerability of repeat escalating doses; Safety and tolerability of repeat escalating doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate
      on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue
      medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be
      inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose
      level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a
      treatment period (24 weeks). The study will provide further data on safety and tolerability
      of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Fluticasone propionate
Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms
Condition: Skin Flaccidity Inner Thighs Knees Arms
Study type: Interventional

Summary: 
      The objective of this study is to investigate the efficacy of the "SUNEKOS® Body" in woman
      aged 40-65 years with skin flaccidity of the inner thighs, knees and arms.
    


Intervention name(s): SUNEKOS ® Body
Intervention type(s): Device
Intervention description(s): SUNEKOS ® Body is a medical device (class III). The study product was injected at level of the inner thighs, knees and arms by needle (29 G) using the interstitial fluid technique (IFT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Turmeric Efficacy for Mobility and Joint Function
Condition: Knee Discomfort; Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD®
      supplementation to reduce joint discomfort.
    

Detailed description: 
      The aim of this clinical study is to determine whether oral administration of Turmipure GOLD®
      can contribute to the improvement of mobility and joint function in adult population with
      knee discomfort and with distinct Kellgren-Lawrence (K&L) knee radiographic scores.
    

Intervention name(s): Turmipure GOLD®; Turmeric rhizome PE 95% curcuminoids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed; STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed; Placebo: Maltodextrin - 4 capsules once daily- as prescribed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mobility; Joint function; Turmeric; Curcuminoids
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
Condition: Advanced Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicentre phase II study to evaluate the results of high dose simplified folfiri in
      advanced colorectal cancer
    


Intervention name(s): Administration of high dose simplified folfiri
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bupropion as a Smoking Cessation Aid in Alcoholics
Condition: Alcoholism; Smoking
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in
      patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients
      will receive either a time-released bupropion or placebo. Both groups will receive nicotine
      replacement therapy during the 9 week study. A final followup assessment will be conducted 6
      months from the start of treatment.
    


Intervention name(s): bupropion (Wellbutrin)
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute
      mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy
      of acetazolamide prophylaxis in reducing the incidence of acute mountain sickness (AMS) in
      lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek
      area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude
      clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be
      administered before departure at 760 m and during the stay at altitude. Outcomes will be
      assessed during the stay at 3'100 m.

      An interim analysis will be carried out when 80 participants will have completed the study or
      after the first year. The Peto's method will be used and the trial will be stopped when
      pre-specified futility boundaries were crossed.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: healthy participants older than 40 years; altitude; prevention; acetazolamide
Evaluation of an Automatic Segmentation Software (Pixyl.Neuro) to Track Lesions in Multiple Sclerosis Patients Via Cerebral MRI
Condition: Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Using an automatic software tool, Pixyl.Neuro, to conduct a retrospective analysis (detection
      of lesions + segmentation of images + tracking over time) of cerebral MRI images acquired
      during a prospective study of patients presenting with clinically isolated syndrome, and
      comparing the results against manual analysis.
    


Intervention name(s): Analysis of cerebral MRI with automatic segmentation software
Intervention type(s): Other
Intervention description(s): Pixyl.Neuro software versus manual analysis of lesions
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subset of patient data collected for the project D-Lay-MS: NCT01817166
Time Restricted EATing (TREAT) Pilot Study
Condition: Overweight and Obesity; Pre Diabetes
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the
      duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight
      or obesity. This pilot study will allow the investigator to collect preliminary data for the
      design of a larger study.
    

Detailed description: 
      Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily
      eating duration into hours normally reserved for sleep, is a recognized risk factor for
      impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have
      dysmetabolism. Restricting the eating window in these mice improves their metabolism.

      Data will be collected to examine the feasibility and effect of a lifestyle intervention,
      aiming to reduce body weight in metabolically unhealthy individuals with overweight and
      obesity. The TREAT pilot study employs the use of mobile application to document eating
      behavior, when, what and how much people eat. In addition, the participants will receive
      reminders and complete in-person study visits to monitor their eating and sleeping schedule.
    

Intervention name(s): TREAT pilot intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will be asked to use the app and take pictures of everything they eat and drink, from the time they get up to the time they go to bed, regardless of size of meal/snacks/drink, for 2 weeks. This will generate data on their eating pattern and eating duration. Participants will be reminded through app, call or text by study staff based on personalized eating schedule. The sleep schedule will also be recorded.
Other intervention name(s): TREAT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Time restricted eating; Overweight; Obesity; Metabolic syndrome; Diabetes treated with metformin and/or diet and HbA1C< 7%; Pre Diabetes; Circadian rhythm
A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of VX-993 at different doses in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-993; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Suspension for oral administration.; Suspension for oral administration.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prognostic Factors of Acute Splenic Sequestration
Condition: Anemia; Drepanocytic
Study type: Interventional

Summary: 
      Acute splenic sequestration is a frequent and life threatening complication occurring in
      approximately 10 % of homozygous children. Maximal incidence is between 6 and 18 months.

      The investigators formulate the hypothesis that there are clinical, biological and genetic
      markers predictive of severe complications notably acute splenic sequestration in SCD
      children. The present research project thus aims at analyzing in a forward-looking way the
      profile of severity by analysing clinical, biological and genetic characteristics in a
      multicentric cohort of 60 SCD children
    

Detailed description: 
      A prospective multicentric analysis will be conducted in a cohort of 150 SS or S ß ° children
      diagnosed at birth, included at 3 -5 months and followed up to the age of 24 months.

      Five visits, superimposed to the usual follow-up of SCD children, (Recommendations of the
      High Authority of Health) at 3 months, 6 months, 12 months, 18 months and 24 months will
      allow a clinical evaluation and an additional sampling of blood (5 mL) at each visit.

      The samples will allow 1.analysis of the red blood cell phenotype (adhesion and
      deformability) and densities 2. the genetic profile 3.to establish a cell bank, a sera bank
      and a DNA bank, Spleen function in the cohort will be estimated by spleen scintigraphy,
      coupled with blood markers (pitted cells, Howell-Jolly bodies counts)
    

Intervention name(s): blood samples and scintigraphy
Intervention type(s): Procedure
Intervention description(s): at 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood of 5 mL at each visit Scintigraphy at 6 months and 18 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
Condition: Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis; Inflammatory Bowel Diseases
MeSH terms: Arthritis, Psoriatic; Inflammatory Bowel Diseases; Psoriasis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165
      capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie
      meal and increased gastric pH on the BMS-986165 tablet formulation.
    


Intervention name(s): BMS-986165 Capsule; BMS-986165 Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral tablet
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)
Condition: Disorders of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      Preferred music improves cognitive function in patients with disorders of consciousness
      (DOC). However, it is still unknown whether it is a general effect of music (because of its
      acoustic features) or an autobiographical effect (because of its emotional and meaningful
      contents).

      The aim of the present study was to investigate the effect of sensory modality (auditory
      versus olfactory) and preference (preferred versus neutral) of the testing context on the
      performance of four items from the coma recovery scale-revised
    


Intervention name(s): sounds and odors
Intervention type(s): Behavioral
Intervention description(s): presentation of sounds and odors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: vegetative state; minimally conscious state; music; preference
Side Effects of Atropine (SEA) Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will perform several objective and subjective measurements of the eye and vision
      before and after a week of using 0.01% concentration atropine drops. These measurements will
      help to obtain a comprehensive understanding of the side effects of this concentration of
      atropine and determine if the drops would be tolerated as a possible preventative treatment
      for nearsightedness.
    

Detailed description: 
      Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also
      slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the
      progression of myopia 60% to 83% while causing less side effects than high concentration
      (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is
      a prospective cohort study in which several objective and subjective measurements will be
      taken before and after the use of 0.01% atropine for a week to determine the effect of this
      concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability,
      accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity,
      drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these
      drops have on the eye and whether or not patients would be willing to use them as a possible
      preventative treatment for nearsightedness. The investigators expect to find that the drops
      will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but
      not clinically meaningfully), cause some light sensitivity, and have no effect on eye
      pressure. The investigators expect that patients would be willing to use these drops to
      control nearsightedness even after experiencing the side effects.
    

Intervention name(s): 0.01% concentration atropine drops
Intervention type(s): Drug
Intervention description(s): One drop of 0.01% concentration atropine in each eye at night for seven days.
Other intervention name(s): Atropine Sulfate
Intervention MeSH terms: Atropine
Intervention model: Single Group Assignment
Intervention model description: Subjects will take drops for one week and measurements will be taken before and after treatment period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atropine; photophobia; pupil; reading speed; myopia; Surveys and Questionnaires
Sun Protection Factor Assay (SPF Assay 201/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987516
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code: Z46-100)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ibuprofen (MOMENT ACT ANALGESIC Granules) Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen
      after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male
      and female subjects, under fasting conditions.
    


Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention description(s): ibuprofen 400 mg single dose oral solution
Other intervention name(s): MOMENTACT
Intervention MeSH terms: Ibuprofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics; MOMENTACT; ibuprofen 400 mg; oral; granules
the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD
Condition: Diabetic Nephropathy Type 2
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      Efficacy and Safety of treatment with Traditional Chinese Medicine HuangQi Decoctions in
      Patients with early stage of Diabetic Kidney Disease.
    

Detailed description: 
      The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is
      performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai
      Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to
      Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital
      of Integrated Traditional Chinese Medicine and Western Medicine, China.
    

Intervention name(s): HuangQi Decoction; HuangQi Decoction placebo
Intervention type(s): Drug; Drug
Intervention description(s): HuangQi Decoction 150ml twice a day for 24 weeks; traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks
Other intervention name(s): Astragalus and other TCMs Decoction; Astragalus Decoction placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Kidney Disease，Traditional Chinese medicine
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
    

Detailed description: 
      The participants will be enrolled in one investigational site. Subjects meeting eligibility
      criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment
      (baseline).

      Following the scintigraphy, the subjects will receive Tulip Device treatment - 2
      capsules/day.

      After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo
      additional gastric emptying test with a capsule intake prior to the test meal.
    

Intervention name(s): Epitomee Device
Intervention type(s): Device
Intervention description(s): medical Device designed to enhance the feeling of early satiation and prolonged satiety
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment