bioihbjkbjnl/mcl2 huggingface dataset:
Diurnal Variation of Exercise on Metabolic Health
Condition: Aerobic Exercise; Acute Exercise; Circadian Rhythm Sleep-Wake Disorders, Unspecified Type; Glucose Metabolism; Lipid Metabolism; Diurnal Variation; Young Adults
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      The main objective of this project is to study the diurnal variation of the effect of
      exercise on glycemic metabolism and fat oxidation in humans.
    

Detailed description: 
      Strong scientific evidence supports the beneficial effects of exercise on cardiovascular
      health, the regulation of glucose metabolism, and fat oxidation. Physical performance
      capacity is known to fluctuate throughout the day, however, it is unknown whether there is an
      optimal time of day to maximize the effects of exercise on health, and specifically on blood
      glucose metabolism and fat oxidation. Finding the ideal time to perform physical exercise is
      of clinical and public health interest. Likewise, optimizing the timing of physical exercise
      to coincide with the greater physiological response of each individual would mean increasing
      the potential of exercise as a therapeutic tool.

      Specific aims of this project are a) to describe possible differences dependent on sex in the
      diurnal variation of the effect of exercise on glycemic metabolism and fat oxidation, and b)
      to characterize the molecular mechanisms implicated.

      18 men and 17 women with normal weight will be randomized into two conditions (morning and
      evening) with at least 3 days of separation in between. Each evaluation will conform the
      following tests:

        1. Basal metabolic rate assessment through indirect calorimetry during 30 minutes.

        2. Fuel oxidation and energy expenditure assesment during a 60 minutes bout of aerobic
           steady-state exercise (cycling), through indirect calorimetry.

        3. Fuel oxidation and energy expenditure assesment after exercise during 30 minutes,
           through indirect calorimetry.

        4. Blood samples assesment before, inmediately after, and 90 minutes after exercise.

        5. Quadriceps biopsies before, and inmediately after exercise. *This will be done only in a
           sub-cohort.

        6. Visual analog scales to assess appetite before, inmediately after, and 90 minutes after
           exercise.

        7. Continous glucose monitoring from the previous 24 hrs to first session day, until 48 hrs
           after the last exercise session.

      Previous to this, participants' body composition and fitness level will be assesed via
      densitometry and a maximal exercise test, respectively.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aerobic Exercise; Diurnal Variation; Circadian Rhythm; Glucose Metabolism; Lipid Metabolism; Young adults
Music Therapy Intervention During Kidney Biopsy.
Condition: Kidney Diseases; Kidney Dysfunction; Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease
      in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety
      and pain. Pain is considered one of the worst experiences for patients and anxiety affects
      the sympathetic nervous system, the endocrine system and the immune system. The aim of this
      preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological
      intervention on heart rate variability, anxiety and pain and promote more compliant
      behaviours during KB.
    


Intervention name(s): music therapy intervention
Intervention type(s): Other
Intervention description(s): Received a customize playlists prepared by a certified music therapist to listening to during KB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: music therapy; anxiety; pain; heart rate variability; satisfation
The Church as a Bridge to Deliver Health Resources Via Telehealth
Condition: Obesity; Diet, Food, and Nutrition; Church; Healthcare Disparities; Minority Health; Mobile Health; Telehealth; Community-based Participatory Research; Primary Health Care; Weight Loss Programs; Health Behavior
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The proposed Church Bridge intervention project will provide an innovative, evidence-based
      and technology supported, health intervention model for Southern, African American, and rural
      populations who continue to be disparately burdened by obesity and associated co-morbidities
      (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50
      years of age) with families, the project will contribute to the long-term reduction of
      preventable chronic disease and related health care costs for the public.
    


Intervention name(s): Church Bridge Project
Intervention type(s): Behavioral
Intervention description(s): Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TransForm™ Occlusion Balloon Catheter Registry
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational [Patient Registry]

Summary: 
      The primary objective of this registry is to collect real world data on the safety and
      performance of the TransForm™ Occlusion Balloon Catheter when used in current
      neurointerventional procedures
    

Detailed description: 
      -  This is a prospective, single-arm, non-randomized, multi-center, observational registry.

        -  The expected duration for study enrollment is approximately 6 months-1 year.

        -  Study participation for each subject will be completed upon removal of the guide
           catheter post-procedure.

        -  Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be
           allowed to enroll a maximum of 20 subjects.

        -  Enrollment in the registry occurs after a signed Informed Consent Form has been
           obtained, and the index procedure starts.
    

Intervention name(s): TransForm™ Occlusion Balloon Catheter
Intervention type(s): Device
Intervention description(s): TransForm™ Occlusion Balloon Catheter
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care/hospitals
      
Keywords: Coil embolization; TransForm™ Occlusion Balloon Catheter; Registry; Neurointerventional procedures
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Condition: Varicella
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured
      with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly
      administered with M-M-R II in healthy children.
    

Detailed description: 
      This treatment has been approved for sale to the public.
    

Intervention name(s): Varicella Virus Vaccine Live (2007 Process) (Oka/Merck); Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck); Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart; VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart; M-M-R II in two 0.5 mL doses by injection ~6 weeks apart
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of
      AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
    

Detailed description: 
      A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of
      Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In
      Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the
      Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
    

Intervention name(s): AMT-126; Placebo; Radioactive Tablet (Part 2 Only)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single or daily dosing at doses A, B, C, D, E, F; G, H, and I; Single or daily dosing at doses A, B, C, D, E, F; G,H, and I; Single dose in two periods in Part 2 (optional)
Other intervention name(s): no other name applicable; no other name applicable; no other name applicable
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
NBMI - Clinical Study on COPD
Condition: COPD; COPD Bronchitis
MeSH terms: Bronchitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A pilot study to explore safety of the treatment with the antioxidant and metal chelator NBMI
      in COPD patients.

      Investigational product: NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide

      Indication: Mild, moderate and severe COPD with bronchitis

      A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days
      pilot study in subjects with COPD with bronchitis.
    


Intervention name(s): Emeramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lipophilic, membrane passing Metal chelator and anti oxidant; 14 days treatment with placebo
Other intervention name(s): NBMI; Irminix
Intervention MeSH terms: N,N'-Bis(2-mercaptoethyl)isophthalamide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days and 28 days follow up
Masking: Single (Participant)
Primary purpose: Treatment
The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines
Condition: Orthodontic Patients Requiring Canine Retraction
Study type: Interventional

Summary: 
      In this study, two distractors will be used to retract maxillary canines into the extraction
      sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands
      connected to a canine and a molar; and the second one is a similar to the first one but with
      the addition of a third arm.

      The purpose of this investigation is to compare the two distractors in terms of: final
      position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the
      appliance.
    

Detailed description: 
      The retraction of the canines is one of the longest and most important stages in the
      orthodontic treatment of cases that require premolars extraction. The retraction phase of the
      canines into an extraction site with conventional treatment method usually lasts about 4 to 6
      months under normal circumstances. The use of dentoalveolar distraction (DAD) technique has
      been considered a very important step in this field. It has been shown by early case reports
      that this technique can be employed to retract canines within 10 to 14 days.

      Although DAD is thought to accelerate tooth movement during canine retraction, a significant
      amount of tipping (distal tilting) was observed in many case reports. So in this study, there
      is an intention to apply a modified DAD device on one side of the mouth and to compare it
      with the conventional one applied on the opposite side of the mouth in each participating
      patient.
    

Intervention name(s): modified dentoalveolar distractor
Intervention type(s): Device
Intervention description(s): Here, the modified distractor is going to be used when retracting the canine.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: canine retraction; acceleration of tooth movement; dentoalveolar distraction osteogenesis
Improving Hospitalizations for Children With ASD
Condition: Autism Spectrum Disorder; Autistic Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study aims to implement and test a specific brief Applied Behavior Analysis model for
      assessing and responding to severe challenging behavior during acute medical and behavioral
      hospitalization for children with ASD. The investigators will evaluate the impact of this
      program by conducting a randomized trial across both medical and psychiatric hospital
      settings.
    


Intervention name(s): Brief Analogue Functional Analysis; No Brief AFA
Intervention type(s): Behavioral; Other
Intervention description(s): The Brief AFA seeks to identify the function of the challenging behavior by creating controlled test conditions in which specific responses are provided for challenging behavior (e.g., attention, escape from task demands, access to tangible - including variants of each as needed), as well as a control condition in which continual access to attention and preferred items is provided. It consists of a 30-90-minute abbreviated analysis comprised of a single exposure to 2-5-minute test and control conditions, along with replication of applicable test conditions and a treatment probe, which provides evidence of challenging behavior function faster than other methods.; These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Autism Spectrum Disorder; Autism
Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain
      in patients with painful diabetic neuropathy.
    

Detailed description: 
      The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial.
      Each patient received two series of ten treatments of either FREMS or placebo in random
      sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and
      night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity,
      sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous
      microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at
      baseline, after FREMS/placebo series and after 4 months follow-up.
    

Intervention name(s): Frequency-modulated electromagnetic neural stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Complications of diabetes; Neuropathies; Electromagnetic stimulation; Neuropathic pain
XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma
Condition: Bronchial Asthma; Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, double-blind, randomized, pilot study in parallel groups to assess the
      efficacy and safety of XC8 at a dose of 100 mg versus placebo over a 12-week treatment period
      in non-smoking patients with a confirmed bronchial asthma (BA) and the eosinophil blood level
      2 times within 1 week interval of ≥ 300 cells/μl.

      Study design was developed by Chemlmmune Therapeutics LLC, Russia in cooperation with Eurrus
      Biotech GmbH, Austria.
    

Detailed description: 
      The study consists of 3 periods: screening (2 weeks), treatment period (12 weeks) and
      follow-up (2 weeks). All eligible patients are randomized into one of two treatment groups in
      a ratio of 1:1. During the study patients will continue to receive stable doses of inhaled
      corticosteroids (ICS) with or without the long-acting β2-agonists; when required, patients
      will receive short-acting β2-agonists.The randomized patients will be stratified by the site,
      baseline forced expiratory volume (FEV1) in the range of 55 to 70% and 71% to 85%, and
      therapy of BA (inhaled corticosteroids (ICS) with or without long-acting β2 agonists).

      The Study drug is produced by Hennig Arzneimittel GmbH und Co., Germany.
    

Intervention name(s): XC8 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period.; 1 tablet of placebo once daily in the morning during 12 weeks of treatment period.
Other intervention name(s): Histamine glutarimide
Intervention MeSH terms: Histamine; Glutarimide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At Visit 3, Week 0 all patients were randomized into 2 groups in 1:1 ratio (35 patients to group of XC8 100 mg and 35 patients to Placebo group).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double blind; active-controlled parallel groups study
      enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe,
      simvastatin, or the combination once daily for 8 weeks to determine the effect on
      LDL-cholesterol.
    


Intervention name(s): Ezetimibe + Simvastatin; Simvastatin; Ezetimibe
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks; simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks; Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks
Other intervention name(s): SCH 58235; SCH 58235
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Multi-center, open-label, multiple dose safety, tolerability and efficacy study
    

Detailed description: 
      This is a 24-week, open-label, multiple dose safety, tolerability and efficacy study. There
      is a 12-week run-in phase when all subjects receive Insulin Lispro and Insulin Degludec for
      12 weeks. After completing the run-in period, subjects then are randomized to a treatment
      group of either HDV- Insulin lispro + Insulin Degludec (Degludec dose reduced by 40%) or
      HDV-Insulin lispro+ Insulin Degludec (Degludec dose reduced by 10%) for 12 weeks of
      treatment.
    

Intervention name(s): HDV-Insulin Lispro and Insulin Degludec (-40%); HDV-Insulin Lispro and Insulin Degludec (-10%)
Intervention type(s): Drug; Drug
Intervention description(s): HDV-Insulin Lispro and Insulin Degludec (-40%); HDV-Insulin Lispro and Insulin Degludec (-10%)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Scapular Exercise on Patients With Scapulocostal Syndrome
Condition: Scapular Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of scapular exercise on pain related
      parameters including pain intensity, 24 hours pain intensity, pressure pain threshold,
      anxiety and muscle tension in patients with scapulocostal syndrome.
    


Intervention name(s): scapular exercise
Intervention type(s): Other
Other intervention name(s): The participants will receive thirty minutes session of scapular exercise for 12 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scapular exercises
Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia
Condition: Pre-Eclampsia; Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional

Summary: 
      Use of Postpartum uterine curettage in reducing hospitalization time or in improving the
      clinical evolution of the patient with preeclampsia/eclampsia.
    

Detailed description: 
      To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters
      in patients with preeclampsia or eclampsia.

      A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage
      (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed
      at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.
    

Intervention name(s): Curettage; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.; No procedure after delivery of the placenta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pre-eclampsia; Eclampsia; Postpartum uterine curettage