bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
Condition: B-cell Malignancies; Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551)
      in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated
      dose (MTD), or if not reached, at optimal biologic dose (OBD).
    

Detailed description: 
      To determine the MTD or OBD of MEDI-551 in participants with relapsed or refractory advanced
      B-cell malignancies.
    

Intervention name(s): MEDI-551; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.; Rituximab will be administered IV on Days 1, 8, 15, and 22 (28- day cycle). The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent.
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer
Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Signaling Pathways
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of leucine and branched-chain amino acids
      supplementation on skeletal muscle remodeling signaling pathways induced by resistance
      exercise.
    


Intervention name(s): Leucine supplementation; BCAA supplementation; Alanine supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine; 1 bout of resistance exercise and supplementation of 4.0 g of leucine + 2.8 g of isoleucine + 2.8 g of valine; 1 bout of resistance exercise and supplementation of 9.6 g of alanine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: leucine supplementation; BCCA supplementation; resistance exercise-induced muscle remodeling
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators hypothesize that it is feasible and safe to deliver a conservative approach
      to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on
      average,10 days).
    

Detailed description: 
      1. Identify patients likely to require ventilation until the day after tomorrow (a time
           frame of 36 hours of average)

        2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of
           10 days)

        3. Target an oxygen saturation between 90 and 92%

        4. Adjust FiO2 to achieve target SaO2 at all times

        5. Assess percentage of time patient is within target

        6. Assess for safety of this approach
    

Intervention name(s): conservative O2 therapy; standard care
Intervention type(s): Other; Other
Intervention description(s): target lower O2 saturation
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oxygen; critical illness; mechanical ventilation
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Condition: Physiological Effect of Drugs; Morphine; Analgesics; Analgesics, Opioid; Central Nervous System Depressants; Narcotics
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural
      morphine administration will be not inferior to the effect of epidural 2% lidocaine with
      1:200,000 epinephrine on total opioid use for 24h
    


Intervention name(s): 2% lidocaine with 1:200,000 epinephrine and epidural morphine; 3% 2-chloroprocaine and epidural morphine
Intervention type(s): Drug; Drug
Intervention description(s): Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.; Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
Intervention MeSH terms: Lidocaine; Epinephrine; Morphine; Chloroprocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cesarean delivery; c-section; chloroprocaine; lidocaine; morphine; post-operative pain; post-cesarean analgesia
Effects of 2 Weeks Treatment With Dapagliflozin in Subjects With an Impaired Glucose Homeostasis on Nocturnal Substrate Oxidation
Condition: Prediabetic State; Substrate Oxidation
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of 2 weeks dapagliflozin treatment in
      individuals with a disrupted glucose homeostasis on the switch between carbohydrate and lipid
      oxidation during the night
    

Detailed description: 
      To investigate if dapagliflozin improves nocturnal substrate oxidation expressed as
      respiration quotient (RQ) during the sleeping period in comparison with placebo after 2-weeks
      double blind treatment in subjects with a disrupted glucose homeostasis.
    

Intervention name(s): Dapagliflozin 10mg; Placebo matching to Dapagliflozin 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.
The subject may be administered dapagliflozin 10 mg during Period 1 or Period 2.; The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.
The subject may be administered placebo during Period 1 or Period 2.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dapagliflozin; Disrupted glucose homeostasis; Nocturnal substrate oxidation; Glucose metabolism
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
Condition: Syndrome of Obstructive Sleep Apnea and Hypopneas
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Observational

Summary: 
      The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular
      Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
    


Intervention name(s): Mandibular Advancement Devices
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years
        and at the latest 5 years.
A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697).
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
      clinical development for the treatment of human immunodeficiency virus (HIV) infection.
      Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is
      expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and
      Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved
      by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been
      adopted to "standard of care" in combination with pegylated interferon and ribavarin. This is
      a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult
      subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24
      evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive
      DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg
      once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment
      C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK
      samples will be collected during each treatment period.

      Subjects will have a screening visit within 30 days prior to the first dose of study drug,
      two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.

      This study will be conducted at one center in the US, with healthy adult male and female
      subjects.
    


Intervention name(s): DTG; BCV; TVR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg q24h; 800 mg q8h; 750 mg q8h
Other intervention name(s): Dolutegravir; Boceprevir; Telaprevir
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dolutegravir, GSK1349572, DTG, BCV, TVR, drug interaction
Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Condition: Lupus Erythematosus, Systemic; Adverse Effects
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The purpose of this study is to investigate the relationship between the side effects of
      cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and
      the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of
      cyclophosphamide.
    

Detailed description: 
      Cyclophosphamide is a widely applied agent in treatment of systemic lupus erythematosus. As
      an alkylating agent, cyclophosphamide is able to induce several side effects, including
      thinned hair, loss of appetite, nausea, vomiting, infection, myelosuppression, etc. However,
      the remarkable variability of the reactions to the drug -- the incidence of side effect or
      the outcome of the treatment -- has been observed among patients. Cyclophosphamide is a
      pro-drug, which require some enzymes in the liver to transform it into an active chemical to
      arouse alkylating function. And then it undergoes a series of detoxification steps catalyzed
      by the specific metabolic enzymes. This study is designed to explore the genetic variation
      among individuals in the key processes of the activation and elimination of cyclophosphamide
      in order to find out whether these genetic factors are associated to the side effects or
      efficacy. The further understanding into the factors concerning on the drug might imply
      possible solution to minimize the incidence of side effects in patients of systemic lupus
      erythematosus.
    

Intervention name(s): Polymorphism Analysis; Cyclophosphamide; Pharmacokinetic analysis
Intervention type(s): Genetic; Drug; Other
Intervention description(s): Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide; intravenous injection, 0.2g, once every two days; laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma
Intervention MeSH terms: Cyclophosphamide
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        SLE patients receiving treatment with cyclophosphamide
      
Biospecimen description: 
      Whole blood for DNA extraction as well as for pharmacokinetic studies
    
Keywords: Myelosuppression; Infection; Nausea
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Condition: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Low Back Pain; Nociceptive Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a
      fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients
      that require long-term NSAID treatment.
    

Detailed description: 
      HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving
      non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor
      antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms
      of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at
      risk of developing ibuprofen-associated upper gastrointestinal ulcers.
    

Intervention name(s): HZT-501
Intervention type(s): Drug
Intervention description(s): Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSAID; Chronic Pain; Osteoarthritis; Rheumatoid Arthritis
Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and
      efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.
    


Intervention name(s): WO3979; WO3970; WO3992; Placebo (WO3988)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Application of cream to each axilla; Application of cream to each axilla; Application of cream to each axilla; Application of cream to each axilla
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Excessive sweating
Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate
      Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in
      Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one
      of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate
      ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.
    

Detailed description: 
      Same as above.
    

Intervention name(s): clobetasol propionate spray; clobetasol propionate ointment
Intervention type(s): Drug; Drug
Intervention description(s): Apply twice daily; Apply twice daily
Other intervention name(s): Clobex® Spray
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Condition: Children Born Extremely Premature; Disturbance of Visuo-spatial Working Memory
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      Prematurity tends to increase in France in recent years and more children born extremely
      premature infants survive. If severe impairments have stabilized, the majority of former
      extremely premature children have neuropsychological disorders and moderate appearance
      behavior disorder, but with a significant impact both family, school and social persisting
      into adulthood.

      Executive functions (EF), in general, and working memory (MT), in particular, are frequently
      altered in older children preterm infants compared to controls born at term.

      The identification process of loss in certain diseases, as well as improving knowledge of
      brain functioning, and development with the possibility of neuronal plasticity has led
      research teams to develop intervention programs focused on process cognitive qualified of
      "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered
      cognitive functions. MT can be improved by encouraging the operation of the spots mental
      stimulant. These programs are effective on MT but do not have the expected impact on other
      FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive
      remediation remains controversial.

      Improving mental functions untrained as nonverbal MT, attention and secondarily learning is
      possible but still unproven on wide population. Similarly, randomized trials are needed to
      test this type of cognitive remediation among preschoolers old very premature.
    


Intervention name(s): computerized cognitive remediation program; standard remediation
Intervention type(s): Other; Other
Intervention description(s): a computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session.; A speech therapy and / or academic support is realized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
Condition: Bulimia Nervosa; Binge Eating
MeSH terms: Bulimia; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      The current study will be one of the first to develop and test a passive data collection
      technique to detect both meal consumption and disordered eating symptoms in patients with
      clinically significant binge eating and the first just-in-time adaptive interventions
      (JITAIs) systems using passive sensing technology for eating pathology to be empirically
      evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off,
      B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target
      engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The
      hypothesis that larger decreases in dietary restriction will be observed during SenseSupport
      On phases compared to SenseSupport Off phases will be tested in this clinical trial.
    


Intervention name(s): CBT with smartphone application SenseSupport
Intervention type(s): Behavioral
Intervention description(s): SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology
Intervention model: Single Group Assignment
Intervention model description: Participants will receive 12 sessions of in-person CBT delivered over 12 weeks. In weeks 1-2, participants will wear the CGM devices, but will not receive JITAIs and therapists will not have access to the clinician portal. During weeks 3-4, JITAIs will be "turned on" such that patients begin to receive push notifications based on CGM data and therapists will have access to the clinician portal. The A/B periods will be repeated (weeks 5-6 and 9-10, SenseSupport Off; weeks 7-8 and 11-12 SenseSupport On) to ensure that improvements in dietary restriction are due to SenseSupport and not simply to the effect of time in treatment. Similar to the approach used in prior studies, participants will be ran in small waves (n= 3-5 per wave). During each wave, feasibility, acceptability, and target engagement will be assessed, and if acceptable milestones have not been achieved, SenseSupport will be modified before beginning the next wave.
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil
      fumarate (TDF).
    

Detailed description: 
      This is a randomized, open-label, active-controlled study whose primary objective is to
      evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the
      safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days
      of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of
      GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.
    

Intervention name(s): GS-7340; Tenofovir disoproxil fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.; Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Other intervention name(s): Viread
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; HBV; GS-7340; TDF; Tenofovir disoproxil fumarate; Gilead; Viread
Androgens for Poor Responders in In Vitro Fertilization
Condition: Ovarian Response
Study type: Interventional
Phase: Phase 3

Summary: 
      it has been shown that androgens in non human primates may favour follicular growth in the
      ovaries when animals are treated with gonadotropins which are the hormones used in patients
      receiving treatment with in vitro fertilization. Therefore, this study investigates the
      potential usefulness of testosterone treatment preceding gonadotropin administration in in
      vitro fertilization patients having a previous poor response to gonadotropins alone.
    


Intervention name(s): Transdermal testosterone
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Keywords: Poor; Response; Ovarian; Stimulation; IVF; Patients