bioihbjkbjnl/mcl2 huggingface dataset:
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions
      using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study
      in treating 18 recipients with ischemic limb diseases.
    

Detailed description: 
      Ischemic limb disease remains one of the major causes of morbidity and mortality in the
      industrialized world despite the development of several new therapeutic modalities. Based on
      experimental data demonstrating that infusion or injection of stem/progenitor cells enhances
      blood flow in models of cardiovascular diseases, clinical trials were initiated in 2001 to
      treat patients with critical limb ischemia or cardiac ischemia with circulating blood or bone
      marrow-derived cells. Despite all promises, pending uncertainties and practical limitations
      attenuate the therapeutic use of stem/progenitor cells for ischemic limb disease. The main
      theme and method in the current program project, based on expertise, track record, and
      preliminary results of PI's laboratory, is to focus on clinical studies of using allogenic
      mesenchymal stem cells (MSCs), expanded under hypoxic conditions (1% O2), in treating
      ischemic limbs. This project is an integrated and coordinated effort aimed to overcome the
      regulation of cell product, and the barriers of preclinical and clinical studies. For the
      purposes, we have specially set up the core laboratory for stem/progenitor cells production
      and quality control in Cell Therapy Clean Room on the 9th floor of Medical Science Technology
      Building in Taipei Veterans General Hospital. We have also completed the preclinical studies
      in using allogenic hypoxic mouse MSCs in treating limb ischemia. In the current project, bone
      marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using
      medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in
      treating 18 recipients with ischemic limb diseases in three years.
    

Intervention name(s): Allogenic MSC; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Hypoxia-cultured human bone marrow derived mesenchymal stem cells
Other intervention name(s): Biochymal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Separate and Combined Extrapancreatic Effects of the Incretin Hormones
Condition: Pancreatectomy; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and
      glucagon-like peptide 1 (GLP-1) is secreted from intestinal cells in relation to a meal and
      increase insulin secretion from the pancreas. The hormones also exert effects outside the
      pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1
      based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes
      and obesity. Nonetheless, a new drug is in clinical development: a combined
      GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone.
      The mechanism behind these impressive effects are unknown and in this study, the
      investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and
      combined and thus elucidate the mechanisms of action of this new drug class.
    


Intervention name(s): Intravenous infusion; Intravenous infusion; Intravenous infusion; Intravenous infusion
Intervention type(s): Other; Other; Other; Other
Intervention description(s): GIP receptor antagonist (GIP(3-30)NH2); GLP-1 receptor antagonist (exendin(9-39)NH2); GIP(3-30)NH2 and exendin(9-39)NH2; Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
Condition: Sleep Bruxism, Childhood
MeSH terms: Bruxism; Sleep Bruxism
Study type: Interventional

Summary: 
      The aims of this study were to determine the relationship between sleep bruxism, oral habits,
      and sleep habits and establish treatment approaches in children.
    

Detailed description: 
      This cross-sectional study was conducted on children aged between 6-and 13 years, diagnosed
      with sleep bruxism (SB). Initially, 82 children with a diagnosis of SB were evaluated. Among
      those, 37 children volunteered were followed for 8 weeks to investigate the effects of the
      education, sleep hygiene and therapeutic exercise program.

      Sleep hygiene education includes routines about bedtime, sleeping room environment, and
      timing for exercise.

      Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular
      posture exercises which included jaw muscle and neck muscle stretching and strengthening
      exercises. They were asked to repeat each exercise 5 times and 5 times a day for 8 weeks.
    

Intervention name(s): Education and Exercise Therapy Group
Intervention type(s): Other
Intervention description(s): 82 children were evaluated. Among those, 37 volunteered children were trained and demonstrated in practice about bruxism, parafunctional oral habits, sleep hygiene education, and 5x5 therapeutic exercises. Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise with 5 set and 5 times a day for 8 weeks.
Sleep hygiene education was given to parents and children with explanation of the parafunctional oral habits to raise awareness about being conscious about the oral habits. Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bruxism; Sleep Habits; Oral Habits; Children
Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC)
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis
      supplying the drug to close contacts of confirmed cases.
    

Detailed description: 
      This is a randomized, double-blind, and controlled clinical trial that aims to evaluate the
      use of oral ivermectin in COVID-19 prophylaxis. The study has two arms in a relationship of
      2:1: Experimental Group (EG n=500) and Placebo Group (CG n=250).

      The sample size was calculated by applying a two-proportion comparison test. Type of
      two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% P1
      (proportion in the placebo group), 65% P2 (proportion in the new treatment or intervention
      group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724
      sample adjusted for losses.

      The hypothesis of the study is that treatment with ivermectin may decrease the chance of
      occurrence/progress of clinical manifestations and onset of severe disease. Whereas control
      of the contagion on the first days of development of the disease, this treatment with
      ivermectin in suspected cases of COVID-19 (by epidemiological nexus) would contribute to the
      control of contagion at the first part of the infection, even in the absence of symptoms.

      Categorical variables will be represented with frequencies and proportions, while continuous
      quantitative variables will be expressed as mean ± standard deviation (SD) or as median and
      interquartile range (IQR). The proportions will be compared using Pearson's Chi-square test
      or Fisher's exact test as appropriate, and continuous quantitative variables with Student's t
      test. The estimation of the efficacy of intensive treatment with Ivermectin will be
      calculated using Kaplan-Meier curves and the differences will be analyzed by means of the
      log-rank test. The risk will be calculated as a ratio of advantages for Intensive treatment
      with Ivermectin (Odds Ratio, OR) with its 95% confidence intervals (95% CI). A value of p
      <0.05 will be considered significant. Analyzes will be performed using Stata 11.2 software.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0,6mg/kg of weight orally on days 1 and 7; A substance with similar physical characteristics as ivermectin, without the active drug ingredient
Other intervention name(s): Iver
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled. Experimental and Control Group in relationship of 2:1
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ivermectin; Prophylaxis; COVID-19; Epidemiological link
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
Condition: Post Lasik Surgery Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Efficacy/Safety of antibiotic steroid combination compared with individual administration in
      inflammation Post-LASIK
    

Detailed description: 
      antibiotic/steroid combination compared to individuals components 15 days of treatment
    

Intervention name(s): antibiotic/steroid combination; moxifloxacin/dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 1gtt, 4x/d, 15 days; 1gtt, 4x/days, 15 days
Other intervention name(s): moxifloxacin/dexamethasone; moxifloxacin / dexamethasone
Intervention MeSH terms: Anti-Bacterial Agents; Moxifloxacin; Dexamethasone; Dexamethasone acetate; Norgestimate, ethinyl estradiol drug combination; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prevention of post inflammation in LASIK surgery
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
Condition: Neonatal Seizures
MeSH terms: Seizures; Hypoxia-Ischemia, Brain
Study type: Interventional
Phase: Phase 2

Summary: 
      LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment
      strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this
      study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam
      as first line treatment in term newborn babies with seizures in hypoxic-ischemic
      encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures
      in newborns.
    

Detailed description: 
      Article Focus

        -  The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined
           as the highest efficient dose under toxicity restrictions for treating neonatal
           seizures.

        -  LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose
           levels of levetiracetam.

      Strenghts and limitation of study

        -  For the first time, levetiracetam will be used as the first-line treatment of neonatal
           seizures and not as an add-on therapy.

        -  Statistical model is designed for a rare clinical situation with a sequential adaptive
           method updating in real time the dose allocation for next patient by using all available
           data from previous participants.

        -  The targeted population, i.e. the newborn less than 3 days of life, is particularly
           sensitive and the written consent of both parents is required before the levetiracetam
           administration.
    

Intervention name(s): Intravenous Levetiracetam
Intervention type(s): Drug
Intervention description(s): Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Intervention model description: LEVNEONAT-1 is an open and sequential dose-finding study with 1 loading dose of 30, 40 and 50 mg/kg and 8 quarter-loading maintenance doses for a 3-day treatment. The optimal dose will be the one estimated to be associated with a toxicity not exceeding 10% and an efficacy higher than 60%. Efficacy has been defined by a seizure burden reduction of 80% after the loading dose. A 2-patient cohort will be necessary at each dose level to consider an upper dose level assignment with a dynamic consideration of each participant data. The maximal sample size expected is 30 participants patients.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seizures; neonates; anticonvulsant treatment; levetiracetam; hypoxic-ischemic encephalopathy; electroencephalography
Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
Condition: Substance Abuse; Bipolar Depression
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the safety and efficacy of divalproex extended release
      (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use
      disorder
    

Detailed description: 
      Patients will be screened up to seven days at which time the following assessments will be
      completed: the Structured Clinical Interview for DSM-IV (SCID), general medical history,
      psychiatric history, physical examination, physicians assessment, and laboratory tests.
      Patients who are on mood stabilizers and oral neuroleptics prior to study enrollment and are
      not responding fully to these medications will be tapered off of the medication for a washout
      period of 48 hours. After the completion of screening, only patients who are determined to be
      eligible for the study will be randomized to study medication (divalproex or risperidone) in
      a 1:1 double-blind fashion. Scheduled study visits will occur every two weeks for a total of
      12 weeks. Assessments for each visit, from the baseline visit to the week 12 visit are as
      follows: the Clinical Global Impression (CGI), Global Assessment of Functioning (GAF),
      Alcohol and Drug Use Inventory, clinician alcohol and drug use scales, self report scales,
      adverse events, vital signs and weight, concomitant medications, urine drug screen, and study
      medication accountability. Designated research staff will complete assessments weekly.
      Investigators will be blinded to laboratory tests completed at week 2, 4, and 12 visits.
      Patients randomized to Depakote ER will begin 500mg BID on day of randomization and remain on
      this dose for 5 days, then on day 6 increase to 20mg/kg to achieve valproic acid levels of
      80-100 (blinded laboratory reporting). Patients randomized to risperidone, initially start
      with 2mg QD with an increase to 4mg at day 5 and increase (as tolerated or required) up to
      6mg/d.
    

Intervention name(s): divalproex sodium ER; risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valproic Acid; Risperidone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: divalproex sodium; risperidone; dual diagnosis; substance use; bipolar
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Consumers are increasingly encouraged to consume more plant-based foods and lower their
      consumption of foods from animal origin. However, the consequences of such a transition on
      muscle mass still remains to be explored. This is of particular importance in the older
      population, where sarcopenia is highly prevalent. The aim of this randomized controlled
      cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on
      daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet
      in 35 community-dwelling older adults.

      Participants will follow a fully controlled vegan diet, directly followed by a fully
      controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of
      the vegan diet to the effect of the omnivorous diet.
    


Intervention name(s): Vegan diet (intervention); Omnivorous diet (control)
Intervention type(s): Other; Other
Intervention description(s): The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.; The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus in Healthy Subjects
Condition: Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Sirolimus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics (PK) of sirolimus after single dose administration.
    

Detailed description: 
      Subjects will receive a single dose of sirolimus on Day 1 followed by a 21 day wash-out
      period (time from sirolimus dosing to isavuconazole dosing). On Days 22 and 23, isavuconazole
      will be dosed three times daily (TID). On Days 24 through 34, isavuconazole will be
      administered once daily (QD). All subjects will be administered a single dose of sirolimus on
      Day 26.
    

Intervention name(s): isavuconazole; sirolimus
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): BAL8557; Rapamune
Intervention MeSH terms: Sirolimus; Isavuconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; sirolimus; BAL8557; Healthy Volunteers
Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance
Condition: Achilles Tendinopathy; Diastasis Recti
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determinate de efectiveness of eccentric exercise combined
      with vibration or cryotherapy in achilles tendinopathy and its effects on the anterior rectus
      abdominis muscle.

      The investigators hypothesis is the combined eccentric exercise with vibration get better
      results than cryotherapy with eccentric exercise in rectus abdominis muscle parameters.
    


Intervention name(s): Cryotherapy and eccentric exercise; Vibration and eccentric exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): 12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion. Previously subjects should cold their leg in ice water during sexteen minutes at a temperature of 8ºC (+/-2ºC); 12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion.During the exercise subjects will be subjected to vibration. Vibrations parameters: Frequency: 35Hz, Amplitude: 4 milimeters, Force: 3,9G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Achilles Tendinopathy; Rectus Abominis; Vibration; Cryotherapy; Eccentric Exercise
Promoting Successful Weight Loss in Primary Care in Louisiana
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this trial is to develop and test the effectiveness of a 24 month,
      patient-centered, pragmatic and scalable obesity treatment program delivered within primary
      care, inclusive of an underserved population. Half of the clinics received a behavioral
      intervention delivered in a primary care setting and half of the clinics received usual care.
    

Detailed description: 
      This study is a cluster-randomized, two-arm controlled trial in primary care settings. A
      total of 18 primary care clinics inclusive of low income populations with a high percentage
      of African Americans from urban and rural areas across Louisiana were randomized to either 1)
      intervention or 2) usual care. The sample includes 803 patients with obesity (BMI 30-50
      kg/m2) (18 clinics, median of 40.5 patients / clinic). The primary aim of this trial is to
      develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable
      obesity treatment program delivered within primary care, inclusive of an underserved
      population. Patients in the intervention arm attended weekly (16 in-person) sessions in the
      first six months, followed by monthly sessions for the remaining 18 months. The behavioral
      intervention was delivered by a trained health coach embedded in the primary care clinic.
      Primary Care Practitioners in the intervention arm received a series of webinars on obesity
      science to help them manage and treat obese patients. Patients assigned to the usual care arm
      will continue to interact with their Primary Care Practitioner according to their usual
      schedule, and will receive a series of newsletters on topics of interest, including
      importance of sleep for health, brain and memory health, goal setting, smoking cessation,
      etc. Primary Care Practitioners in the usual care arm received a webinar describing the
      current Centers for Medicare and Medicaid Services (CMS) approach to reimbursing for obesity
      treatment, and a reminder informational brochure will be sent to the Primary Care
      Practitioners each year. Patients in both arms were assessed on primary and secondary outcome
      measures at baseline, and at 6, 12, 18 and 24 months of intervention.
    

Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary care; pragmatic trial; weight loss; overweight; diet; physical activity; PCORI