bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
Condition: Pediatric Oncology
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether combined endurance and resistance training
      can improve muscle strength in children and adolescents with cancer during the intensive
      treatment phase.
    


Intervention name(s): Exercise Training
Intervention type(s): Behavioral
Intervention description(s): Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Condition: SARS-CoV-2 (COVID-19) Severe Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched
      to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not
      requiring mechanical ventilation.
    


Intervention name(s): Efzofitimod 1 mg/kg; Efzofitimod 3 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Concentrate for solution for infusion; Concentrate for solution for infusion; Concentrate for solution for infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; CoV-2; ATYR1923 (efzofitimod); acute respiratory distress syndrome; ARDS; SARS-CoV-2 Infection; COVID-19; Severe Pneumonia
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Metformin increases the pregnancy rate when added to the standard treatment of
           anovulatory polycystic ovary syndrome (PCOS).

        2. Metformin in combination with clomiphene, is more effective than clomiphene alone or
           metformin alone improves fertility outcomes in women with PCOS of reasonably healthy
           body weight (BMI </= 32).

        3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
    


Intervention name(s): Metformin; Placebo; Metformin + Clomiphene; Metformin; Clomiphene
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500mg tds for 6 months; One tablet tds for 6 months; 500mg tds + Ovulatory dose for 6 months; 500mg tds for 6 months; Ovulatory dose for 6 months
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; PCOS; Anovulation; Infertility; Anovulatory polycystic ovary syndrome (PCOS)
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the changes in cardiac function during a Lexiscan
      pharmacologic stress test using cardiac magnetic resonance imaging test.
    


Intervention name(s): Regadenoson
Intervention type(s): Drug
Intervention description(s): Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.
Other intervention name(s): Lexiscan
Intervention MeSH terms: Regadenoson
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of
      two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI
      730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1
      (Reference, R).

      The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF
      side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test
      coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF
      batch of BI 730357 with regularly milled API (Reference, R).
    


Intervention name(s): BI 730357 (Test); BI 730357 (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hypnotherapy to Improve Coping With Stress
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This prospective controlled study aims to test a 5 week group hypnosis training as
      intervention to improve coping with perceived psychological stress.
    


Intervention name(s): Hypnosis; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 session of group hypnosis, each 90 minutes, to reduce subjective levels of stress, improve coping with stress. Additional audiotapes of hypnosis sessions as homework.
Participants receive a health education booklet on improving coping with stress.; Participants receive a health education booklet on improving coping with stress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
Condition: Diabetic Foot; Wound Heal; Collagen Diseases
MeSH terms: Rheumatic Diseases; Diabetic Foot; Foot Ulcer; Collagen Diseases
Study type: Interventional

Summary: 
      Objective: investigate The effect of combined red and infrared lasers on histopathology
      collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned
      randomly into three equal groups, each group consist of 15 patients, group A received laser
      therapy in sequential mode, group B received laser therapy in separate mode and the control
      group C receive conventional wound care treatment
    

Detailed description: 
      Objective: investigate The effect of combined red and infrared lasers on histopathology
      collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned
      randomly into three equal groups, each group consist of 15 patients, group A received laser
      therapy in sequential mode, group B received laser therapy in separate mode and the control
      group C receive traditional wound care Outcomes: the primary outcomes were the wound surface
      area measurement, % of wound complete closure and % of collage formation before and after
      receiving the treatment protocol for two consequetive months
    

Intervention name(s): laser therapy
Intervention type(s): Device
Intervention description(s): All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care:
(I) Use red & infrared laser therapy device with 4 different wavelengths in a synchronized mode:
980 nm for wound decontamination, improve circulation, lymphatic drainage
915 nm enhances O2 delivery
810 nm increases ATP production
650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive conventional wound care treatment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infrared laser; red laser; chronic diabetic foot ulcer; collagen formation
A Study of Danavorexton in Anesthetized Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the study are:

        -  to assess the safety profile of danavorexton when it is administered with anesthetics.

        -  to learn what effect danavorexton has on anesthetized adults.

      On Day 1, participants will receive a single intravenous (IV) infusion of danavorexton or a
      placebo after participants have been anesthetized for about 40 minutes. Clinic doctors will
      arrange a follow-up visit by phone or video on Day 7.
    

Detailed description: 
      The drug being tested in this study is called danavorexton or TAK-925. Danavorexton is being
      tested to evaluate safety, tolerability, PK, and pharmacodynamics (PD) in healthy
      participants.

      The study will enroll approximately 28 participants. This study consists of 4 cohorts:
      Cohorts A1, A2, A3 and P (healthy participants aged 18 to 55 years). In each of the 4
      cohorts, participants will be randomly assigned (by chance) to receive danavorexton or
      danavorexton placebo-matching -which will remain undisclosed to the participant and study
      doctor during the study (unless there is an urgent medical need):

        -  Cohort A1: Danavorexton Low Dose

        -  Cohort A2: Danavorexton Middle Dose

        -  Cohort A3: Danavorexton High Dose

        -  Cohort P: Danavorexton TBD

      Additional optional cohorts may be added to the study based on the outcomes from the
      mandatory cohorts described above.

      This trial will be conducted in the United States. The overall time to participate in this
      study is 37 days including screening period, residential period, and safety follow up period.
      A follow-up visit by phone or video will be conducted on Day 7.
    

Intervention name(s): Danavorexton; Danavorexton Placebo; Propofol; Sevoflurane; Propofol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Danavorexton intravenous infusion.; Danavorexton placebo-matching intravenous infusion.; Propofol intravenous bolus.; Sevoflurane inhalation.; Propofol intravenous infusion.
Other intervention name(s): TAK-925
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
Study of a Pandemic Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The World Health Organisation has warned that an influenza pandemic is inevitable. The avian
      influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic.
      Children are likely to be a special target group for vaccination; therefore, this study will
      test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.
    


Intervention name(s): H5N1 pandemic influenza vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Pandemic; Influenza; Prevention; Vaccine; Prevention of Pandemic Influenza
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm crossover study will evaluate patient reported preference for either once monthly
      Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal
      osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12
      weeks; they will then cross over to receive the alternative treatment for a further 12
      weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample
      size is 100-500 individuals.
    


Intervention name(s): Risedronate; ibandronate [Bonviva/Boniva]
Intervention type(s): Drug; Drug
Intervention description(s): 35mg po weekly for 12 weeks; 150mg po monthly for 3 months
Intervention MeSH terms: Risedronic Acid; Ibandronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examined the effects of two commonly prescribed HIV drugs on the way the body
      metabolizes glucose, insulin and fat.
    


Intervention name(s): Atazanavir/Ritonavir/Lopinavir/ritonavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide treatment to eligible subjects who have successfully completed one of the
      following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or
      A1281088 (NCT00143351).
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): 20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-label extension Ziprasidone study in Schizophrenia
Interscalene Block Versus Superior Trunk Block
Condition: Joint Disease; Pain; Pain, Acute; Pain, Chronic
MeSH terms: Joint Diseases; Acute Pain; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block
      (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,
      stabilization, rotator cuff repair).
    


Intervention name(s): Bupivacaine; Ultrasound
Intervention type(s): Drug; Device
Intervention description(s): Anesthetic that will help treat pain and sensation after shoulder arthroscopy; Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
Condition: Menopause; Menopause Related Conditions; Perimenopausal Disorder
Study type: Interventional

Summary: 
      A combination of synergistic dietary supplements is hypothesized to significantly improve
      self-reported measures of menopausal symptoms when compared with a baseline without the
      intervention.
    


Intervention name(s): Semaine Menopause Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Synergistic Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Menopause; Perimenopause
Phase 1/2 Study in Boys With Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy,
      pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in
      pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to <8
      years of age will be enrolled.

      Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a
      molecule that is activated from infancy in DMD and which is central to causing muscle damage
      and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper
      leg muscles, physical function (including timed function tests) and muscle strength will be
      studied.
    

Detailed description: 
      Part A was a 1-week, open-label study to assess safety, tolerability, pharmacokinetics and
      biomarkers for three dose levels of edasalonexent and is now complete.

      Part B was a randomized, double-blind, placebo-controlled, multiple dose study to evaluate
      the safety, efficacy, PK, and PD of edasalonexent over 12 weeks. Patients who participated in
      Part A also participated in Part B, along with newly enrolled patients. Patients received
      either edasalonexent 67 mg/kg/day, edasalonexent 100 mg/kg/day, or placebo in Part B. Part B
      is now complete.

      Following completion of Part B, patients receive edasalonexent for 138 weeks in Part C, the
      open-label portion of the MoveDMD study. Patients on the 67 mg/kg/day treatment moved to the
      100 mg/kg/day treatment. Patients on the 100 mg/kg/day treatment remained on the 100
      mg/kg/day treatment. If clinically indicated, concomitant treatment with eteplirsen (Exondys
      51™) may be acceptable in patients with amenable gene mutations during Part C after the
      patient has been exposed to edasalonexent for 6 months.

      **Following completion of MoveDMD Part C, access to edasalonexent for trial participants will
      continue through the open-label extension study, GalaxyDMD.**
    

Intervention name(s): Edasalonexent; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): CAT-1004; Edasa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Muscular Dystrophies; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Duchenne muscular dystrophy; DMD; dystrophin; dystrophy; Duchenne
Adapting Cognitive Behavioral Therapy (CBT) for Chinese Americans
Condition: Major Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is
      effective in treating depressed Chinese Americans, b) to develop and test the effectiveness
      of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.
    

Detailed description: 
      It is now known that ethnic minorities are less likely to receive quality health services and
      evidence worse treatment outcomes when compared with other groups (IOM, 1999; USDHHS, 2001).
      Moreover, there continues to be a shortage of systematic investigations examining the
      efficacy of evidence-based treatments (EBTs) with ethnic minorities, especially among Chinese
      Americans. Developing interventions that are both empirically grounded and that are
      culturally sensitive and compatible with Chinese culture is one promising strategy that may
      improve treatment outcomes for this understudied group. The goal of this study is to
      culturally adapt a cognitive-behavioral therapy manual for use with depressed Chinese
      American patients. This study will be among the first to develop a culturally adapted EBT for
      use with this ethnic group and will involve three study phases. Phase I of the study will
      focus on modifying and refining a CBT intervention protocol into a manualized treatment for
      Chinese Americans. Phase two involves a randomized controlled trial (RCT) comparing the
      effects of the culturally adapted CBT treatment manual with nonadapted CBT. Phase three will
      involve further refinement of the treatment manual, data analysis, and report writing.
      Patients will be recruited from an ethnic-specific mental health center that specializes in
      treating Asian American clientele to participate in the study. Patients will be randomly
      assigned to either the adapted CBT treatment or the nonadapted CBT treatment. Moreover,
      feedback from patients and therapists in both conditions will be used to further refine the
      new treatment manual, provide valuable information about salient issues in treating depressed
      Chinese Americans, and will provide initial estimates of treatment parameters that will be
      used in preparing a larger R01 proposal to further test the adapted intervention.
    

Intervention name(s): cognitive behavioral therapy; culturally adapted cognitive behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cognitive behavioral therapy. 12 sessions.; culturally adapted cognitive behavioral therapy for Chinese Americans. 12 sessions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; cognitive behavioral therapy; culture; Chinese Americans; psychotherapy
A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three
      gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK
      of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.
    


Intervention name(s): Omeprazole; Omeprazole; Gefapixant; Gefapixant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 mg oral capsules administered once daily for 10 days; 40 mg oral capsules administered twice daily for 10 days; Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days; Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days
Other intervention name(s): Prilosec; Prilosec; AF-219; MK-7264; AF-219; MK-7264
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteers