bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699
Condition: Diabete Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple
      ascending oral dose administration.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple
      ascending oral dose administration.

      The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.
    

Intervention name(s): YG1699; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): YG1699 at Multiple Doses; Placebos
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single Ascending Dose and Multiple Ascending Dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes
Bioavailability of Apixaban Crushed Tablet
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the bioavailability of apixaban crushed
      tablets suspended in water or mixed with applesauce is similar to the bioavailability of
      apixaban whole tablets administered orally.
    

Detailed description: 
      This study will investigate the bioavailability of apixaban administered as crushed tablets
      suspended in water and as crushed tablets mixed with applesauce compared with that of whole
      tablets. The study results may allow enhancement of the apixaban label to include alternative
      methods of apixaban administration, which may be of benefit to patients who have difficulty
      swallowing.
    

Intervention name(s): Apixaban
Intervention type(s): Drug
Other intervention name(s): Eliquis®
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for
      frequent and timely monitoring is now feasible. The investigators propose to leverage this
      new technology to provide children and families with appropriate interventions to help manage
      their diabetes.
    

Detailed description: 
      The investigators will collect insulin dosing via pump records, blood glucose meter,
      continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100
      children with diabetes. The investigators hypothesize that with the collection and analysis
      of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with
      diabetes the investigators can identify glucose patterns and predictors of acute events.

      The 100 children will be randomized to either conventional therapy (data upload group) or
      intensive remote therapy (weekly review group). Conventional therapy will consist of routine
      quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated
      by the family, between study visits. Intensive remote therapy will consist of routine
      quarterly visits to the clinic along with weekly remote review of insulin and blood glucose
      data by the research staff, and additional communication with the family, initiated by the
      diabetes staff as needed, between visits. The investigators hypothesize that with weekly,
      manual review of real-time insulin, glucose, and activity data in children with diabetes, and
      recommended regimen changes based on the data, the investigators will be able to lower HbA1c
      values in children in the weekly review group as compared to children in the data upload
      group.
    

Intervention name(s): Weekly Review; FitBit
Intervention type(s): Other; Device
Intervention description(s): Subjects will wear a FitBit activity monitor and continue to use their insulin pump. Fitbit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (CDE, NP and/or MD) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.; All subjects will wear a FitBit activity monitor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resveratrol for Pain Due to Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to verify whether the use of 40 mg of resveratrol per day associated with
      monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic
      pain at the end of 2 months of treatment, compared to the use of the pill with placebo.
    

Detailed description: 
      Endometriosis is a disease that affects 176 million women around the world, and it is present
      in about 60% of adolescent women with chronic pelvic pain and dysmenorrhea. Some researchers
      have investigated the antiproliferative effect of resveratrol in endometriosis using animal
      models and humans. The reduction in the size and activity of the endometriotic implants has
      been observed with the use of resveratrol. The reduction of pain in patients with
      endometriosis is an important aspect of the quality of life. The use of a medication with few
      side effects and the lack of clinical quality trials justify this study, which aims to verify
      whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill
      reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with
      placebo. This study will be randomized, prospective, double blind with two arms of 22
      patients; the CONSORT parameters will be followed. The degree of pain by visual analog scale,
      prolactin levels (ng / mL) and the carcinoembryonic antigen levels (CA125) (IU / L) will be
      measured at the begging and at the end of trial. These parameters will be the outcomes.
    

Intervention name(s): Placebo; Resveratrol
Intervention type(s): Drug; Drug
Intervention description(s): 40mg of starch; 40mg of resveratrol (powder)
Other intervention name(s): Starch
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: resveratrol
Comparison of the Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head
Condition: Anesthesia, Endotracheal; Airway Management
Study type: Interventional

Summary: 
      This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during
      tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of
      head.

      The investigators will performed the ipsilateral rotation of head against the fixed tube in
      half of participants or the contralateral rotation of head in the other half.
    

Detailed description: 
      The inflation of the endotracheal tube cuff is very useful to prevent aspiration of
      contaminated substances into lung past endotracheal tube and leakage of gas during positive
      pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently
      causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness,
      and coughing after surgery.

      Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective
      in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study.
      However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube
      significantly increased after a positional change from the supine to the lateral flank
      position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty,
      the investigators need to rotate head for proper position.

      In this study, therefore, the investigators investigate the difference of the endotracheal
      tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral
      rotation of head against the fixed tube during tympanoplasty.
    

Intervention name(s): Ipsilateral rotation of head; Contralateral rotation of head
Intervention type(s): Procedure; Procedure
Intervention description(s): Ipsilateral rotation of head against fixed tube; Contralateral rotation of head against fixed tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
The Longevity of Trichuris Trichiura Colonization
Condition: Helminthiasis; Helminth Infection
MeSH terms: Helminthiasis
Study type: Observational

Summary: 
      The aim of the study was to study the longevity of Trichuris trichiura colonization
    

Detailed description: 
      The present study investigates the longevity of Trichuris trichiura colonization in a human
      volunteer as measured by regular fecal sampling.
    

Intervention name(s): Trichuris trichiura
Intervention type(s): Biological
Intervention description(s): Infective eggs from human whipworm, Trichuris trichiura
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A singlex healthy volunteer
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS
    


Intervention name(s): BIBW 2948 BS for oral inhalation; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Condition: Menopause
Study type: Observational

Summary: 
      Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various
      menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced
      peri or post-menopausal women.
    

Detailed description: 
      Participants will be receiving a customized bioidentical hormone regimen which may include a
      combination of estrogens, progesterone, and testosterone.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.
      
Keywords: Bioidentical Hormone Replacement Therapy
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Condition: Children; Anorectal Disorder; Anorectal Atresia; Hirschsprung Disease
MeSH terms: Hirschsprung Disease; Rectal Diseases; Anorectal Malformations
Study type: Interventional

Summary: 
      3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function
      and 3D topographic picture of pressures along the anal canal.

      Until now, it has been used only in adult population to evaluate defecatory disorders.

      Congenital anorectal disorders are severe conditions and may present wide spectrum of
      symptoms from gastrointestinal tract.

      The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal
      disorders such as Hirschsprung's disease and anorectal malformations.

      It may help for better understanding of pathophysiology of anorectal area and allow for
      planning improved procedures in these patients.

      Moreover, the investigators study may elucidate the real usefulness of the procedure in
      management of disorders of gastrointestinal tract in pediatric population.
    


Intervention name(s): 3D high resolution anorectal manometry
Intervention type(s): Device
Intervention description(s): Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: high resolution manometry; children; congenital anorectal disorder; surgery
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
Condition: Sciatica; Back Pain
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims at assessing the short and long-term effectiveness and patient perception of
      benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc
      disease at a single level from L2 to L5.
    

Detailed description: 
      This study is a multi-center, prospective, randomized, controlled trial. Patients will be
      randomized in 2 groups:

      Investigational group: a single level herniectomy procedure, followed by placement of the
      DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure;
      After surgery, patients will be followed for a 2 years period with required follow up visits
      at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).
    

Intervention name(s): DIAM™ Spinal Stabilization System; Herniectomy
Intervention type(s): Device; Procedure
Intervention description(s): The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.; Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Study of 3D229 in Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects
    

Detailed description: 
      A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and
      tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in
      Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation
      cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses
      of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study
      intervention (3D229) or matching placebo.
    

Intervention name(s): 3D229; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 3D229 is an investigational drug.; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Condition: Leucocytosis
MeSH terms: Leukocytosis
Study type: Interventional
Phase: Phase 1

Summary: 
      BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety
      of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
    


Intervention name(s): Leucostim®; Neupogen®
Intervention type(s): Biological; Biological
Intervention description(s): Leucostim® is filgrastim biosimilar.
Other intervention name(s): filgrastim; filgrastim
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: neutrophil count; filgrastim; granulocyte colony-stimulating factor
Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      Our target population will have been adequately treated with one of three selective serotonin
      reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks
      and continue to experience symptoms of depression that have prompted them to seek additional
      treatment. Escitalopram, citalopram, and sertraline were selected for use in this study
      because they are among the most commonly selected SSRIs and they are associated with a
      reduced likelihood of drug-drug interactions with aripiprazole. After completion of the
      screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15
      mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician,
      in conjunction with study participation. Symptom severity will be assessed on a weekly basis,
      and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We
      hypothesize that aripiprazole augmentation will be associated with reductions in symptom
      severity, and with improved performance on measures of psychosocial and cognitive function.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): varied dose (5, 10, 15 mg qd) for 6 wks
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive function; psychosocial function; augmentation; treatment refractory depression
Gluten-free Diet in Women With Autoimmune Thyroiditis
Condition: Autoimmune Thyroiditis
MeSH terms: Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease
Study type: Interventional

Summary: 
      The purpose of this interventional study was to check if the elimination of gluten from the
      diet of women with autoimmune thyroiditis affects their health and thyroid function, quality
      of life, and the gut microbiome composition.

      The main questions it aimed to answer were:

        -  Does the gluten-free diet worsen the gut microbiome composition?

        -  Does the gluten-free diet improve thyroid function, measured as thyroid stimulating
           hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid
           peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)?

        -  Does the gluten-free diet improve the quality of life?

      Participants:

        -  followed normocaloric gluten-free diet for 8 weeks

        -  after first 4 weeks were randomly assigned to one of two groups. One group over next 4
           weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and
           second group - rice starch (placebo).

      Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks
      of diet (T2) (total of 3 samples per participant). Also each participant completed the
      ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three
      time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).
    


Intervention name(s): Gluten-free diet; Gluten capsules supplementation; Placebo capsules supplementation
Intervention type(s): Other; Other; Other
Intervention description(s): Diet with gluten elimination followed by all participants for 8 weeks; 2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8); Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants followed normocaloric gluten-free diet for 8 weeks. After first 4 weeks participants were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo).
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: diet; gut microbiome; thyroid; gluten-free diet
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics
      as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years
      of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of
      detrusor overactivity (overactive bladder) for determination of the recommended dose in
      children.
    


Intervention name(s): propiverine hydrochloride
Intervention type(s): Drug
Intervention description(s): coated tablets containing 5 mg
consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.
Intervention MeSH terms: Propiverine
Masking: None (Open Label)
Keywords: propiverine; anticholinergics; urinary incontinence; overactive bladder; children; dose-finding in children aged 5-10 years
Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression
Condition: HIV Infections; Diabetes; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to plan and develop an international collaboration for research
      on the health effects of yoga. This study will also determine the effects of yoga on people
      who are at an increased risk for developing diabetes and people with both HIV and depression.
    

Detailed description: 
      In recent years, western health practitioners have become increasingly aware of the potential
      health benefits of yoga. This study will comprise two substudies that will evaluate the
      effects of yoga in two distinct populations.

      Participants in the first study will be people who are at risk for developing diabetes;
      participants in the second study will be people with both HIV and depression. All
      participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be
      done and weight and blood pressure measurements will be taken in study 1 participants;
      questionnaires will be used to measure depression and stress in study 2 participants. All
      study participants will be assessed at entry and at 3 and 6 months.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Yoga; Meditation