bioihbjkbjnl/mcl2 huggingface dataset:
Somatropin Treatment to Final Height in Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger
      than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin)
      treatment in promoting linear growth to final height.
    

Detailed description: 
      A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner
      syndrome at least 7 years old and younger than 13 at study entry.

      Core study objectives are to determine the efficacy of Humatrope in promoting linear growth
      to final height in girls with Turner syndrome, and to assess the safety of this treatment.
      Core study completion criteria (protocol final height) are that the patient has both a height
      velocity < 2 cm per year and a bone age of 14 years or greater.

      Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the
      Control arm of the Core study and who discontinued from the study on or after December 19,
      1997.

      Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing,
      tympanic membrane function and other specific areas of interest with respect to the safety of
      growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function
      (glucose metabolism) in patients previously enrolled in the Core study.

      Addendum 3 objective is to determine the parental origin of the retained X chromosome of an
      appropriate subset of patients currently or previously enrolled in the Core study, and to
      determine whether this parental origin holds any predictive value for spontaneous growth or
      for response to growth hormone therapy.
    

Intervention name(s): Somatropin; Ethinyl estradiol; Medroxyprogesterone acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).; escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.; 10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
Other intervention name(s): Humatrope; Growth hormone
Intervention MeSH terms: Medroxyprogesterone Acetate; Ethinyl Estradiol; Medroxyprogesterone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: syndrome; Turner; Turner's; height; growth; growth hormone; somatropin; short stature; short; hearing; glucose metabolism
Bed and Breakfast (B&B) Study
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic
      Responses (GR) interventions at breakfast or at dinner is the most effective for lowering
      glycemic response of the subsequent standard meal.
    

Detailed description: 
      Consumption of low Glycemic Index (GI) foods has been shown to not only attenuate blood
      glucose response during the postprandial period immediately following a meal but to have also
      positive metabolic effects at the subsequent meal, known as the "second-meal effect" by
      reducing glucose excursion beyond actual meal. The relative importance of the timing of the
      glycemic load variation (e.g., breakfast or dinner) on the overall, 24h, glycemic control has
      not been investigated in detail.

      We hypothesize that eating low GI foods in a single meal either for breakfast or for dinner
      would have different consequential effects on glycemic control over the following meal and
      thereafter during 24 hours. In order to establish the relative importance of breakfast or
      dinner in predicting glycemic control/response of the following meal and for a 24-hour period
      this study will use comprehensive methods including Continuous Glucose Monitoring Systems
      (CGMS) as well as measuring postprandial blood glucose and insulin.
    

Intervention name(s): Low GI Breakfast; High GI Breakfast; Low GI Dinner; High GI Dinner
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Intake of low GI breakfast; Intake of high GI breakfast; Intake of Low GI dinner; Intake of high GI dinner
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glycemic response; Glycemic index; Meal intervention; Chinese population
Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic
Condition: Surgery
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral
      nerve block.

      The aim of the study is to determine the minimum volume of local anesthetic to achieve an
      ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.
    


Intervention name(s): median nerve block
Intervention type(s): Procedure
Other intervention name(s): lidocaine with epinephrine (20 mg/ml)
Intervention MeSH terms: Lidocaine; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ascending dose model
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program
Condition: Financial Stress; Pediatric Cancer
MeSH terms: Financial Stress
Study type: Interventional

Summary: 
      The overall objective of this study was to develop and evaluate FINassist (Financial and
      Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology
      financial and legal navigation program. The program leverages Medical Legal Partnerships to
      enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist
      optimizes the team-based care model by integrating clinicians, social workers, financial
      navigators, and legal advocates who work in tandem to enhance cost of care conversations with
      patients and caregivers, identify and intervene on patient socio-legal needs, and advocate
      for system-level changes.
    


Intervention name(s): FINassist; FINassist
Intervention type(s): Other; Other
Intervention description(s): The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved; The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Financial toxicity; Hardship; Cost conversations; FINassist
Dural Puncture Epidural Technique For Vaginal Procedures
Condition: Gynecologic Diseases Requiring Vaginal Hysterectomy
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      25G Dural Puncture Epidural Technique will be compared with Conventional Standard Lumbar
      Epidural Technique During Anesthesia of Laparoscopic Assisted Vaginal Hysterectomy.
    


Intervention name(s): Conventional Epidural Technique; 25G Dural Puncture Epidural Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard Lumbar Epidural Technique at L4-5 interspace using Tuhoy needle (18G) then epidural catheter (20G) inserted, then 15ml 0.5% Bupivacane and 50ug fentanyl given.; 25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Music Therapy on Cognition in Neurorehabilitation
Condition: Dementia; Stroke; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Music therapy has received more attention with its surging application in
      neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation
      research conducted in Malaysia, this pilot study intended to investigate the effect of active
      and passive music therapy interventions versus the standard care condition in cognition among
      adults with neuro-rehabilitation needs.
    

Detailed description: 
      Music therapy has received more attention with its surging application in
      neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation
      research conducted in Malaysia, this pilot study intended to investigate the effect of active
      and passive music therapy interventions versus the standard care condition in cognition among
      adults with neuro-rehabilitation needs.

      Thirty subjects participated in this study. Each participant received one session of each of
      the following: active music therapy intervention, passive music therapy intervention, and
      standard card. Mini-Cog tests were conducted before and after each session and the scores
      were collected for data analysis. Throughout the study, observations ensured the
      troubleshooting of any potential flaws for future recommendations.
    

Intervention name(s): Passive Music Therapy (P); Active Music Therapy (A); Standard Care Control Condition (C)
Intervention type(s): Other; Other; Other
Intervention description(s): Music Therapy Intervention; Music Therapy Intervention; Without any intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: participant will receive one passive music therapy session consisting of relaxation to music, one active music therapy session consisting of instrument-playing, and one control condition.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music therapy; Active; Passive; neurorehabilitation needs; Cognition
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and
      bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a
      scored fixed dose combination (FDC) tablet (DRV/COBI) compared to the co-administration as
      the separate available tablet formulations (DRV and COBI), under fed conditions in healthy
      participants.
    


Intervention name(s): Darunavir; Cobicistat; Darunavir/Cobicistat FDC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of Darunavir tablets orally as per assigned treatment sequence.; Participant will receive a single dose of Cobicistat tablets orally as per assigned treatment sequence.; Participants will receive a single dose of darunavir and cobicistat FDC tablets orally as per assigned treatment sequence.
Other intervention name(s): TMC114; JNJ-48763364
Intervention MeSH terms: Darunavir; Cobicistat; Cobicistat mixture with darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Opioid Free Anesthesia in Maxillofacial Surgery
Condition: Maxillofacial Surgery
Study type: Interventional

Summary: 
      Opioid free anesthesia is a promising practice in anesthesia. Studies already carried out
      have compared OFA to an opioid or "opioid anesthesia" (OA) protocol without the use of
      antihyperalgesic in the OA protocol. Most of the studies currently available have been
      carried out in Europe, America and a few in Asia under conditions other than those available
      in precarious situations.That's why we decide to conduct a study to evaluate the
      effectiveness of an OFA protocol in maxillofacial surgery in Burkina Faso.
    

Detailed description: 
      The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso
    

Intervention name(s): opioid free anesthesia
Intervention type(s): Other
Intervention description(s): Maintenance of anesthesia was done with halothane. The incision was allowed at 1.2 MAC of halothane. This halogen was administered according to the hemodynamic parameters and the habits of the anesthesia team. Before waking up, all the patients benefited from preventive analgesia with 1 g paracetamol combined with 20 mg nefopam by slow intravenous injection over approximately 15 minutes.
Intervention MeSH terms: Analgesics, Opioid; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were randomized during the pre-anesthetic visit in two groups 1 and 2. They were randomized in blocks of four so that, in each block of four patients, there were two patients for the protocol 1 and two patients for the protocol 2.
Masking: Single (Participant)
Primary purpose: Other
A Study of NPC-22 in Healthy Adult Males
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22
      administered in a single ascending dose in healthy adult males.
    

Detailed description: 
      The healthy adult males will be randomized into six arms, and will receive single dose of
      NPC-22 (five doses, placebo)
    

Intervention name(s): NPC-22; NPC-22; NPC-22; NPC-22; NPC-22; NPC-22 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single administration of low dose NPC-22; Single administration of low/middle dose NPC-22; Single administration of middle dose NPC-22; Single administration of middle/high dose NPC-22; Single administration of high dose NPC-22; Single administration of NPC-22 Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety Study of Nicotinamide to Treat Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and
      effective in the treatment of Alzheimer's disease.
    

Detailed description: 
      The goal of this proposal is to show that, nicotinamide (NA), a B3 vitamin, is safe and
      effective for the treatment of patients with mild to moderate Alzheimer's disease (AD). NA is
      known to block the ability of certain proteins to regulate other proteins by removing their
      acetyl groups. Recent evidence has demonstrated that inhibitors such as NA prevent nerve cell
      degeneration in models of Huntington's disease (HD), Parkinson's disease and Lou Gehrig's
      disease (or ALS). Despite these beneficial effects in many different animal models, there
      have been no studies to date using these inhibitors in AD. In some of our recent studies we
      found that the potent inhibitor, NA, significantly improves learning and memory in transgenic
      mice that develop AD. NA treatment also resulted in striking changes in tau, a protein that
      abnormally accumulates in AD. NA has been extensively used in clinical studies over the last
      40 years and is generally safe and well-tolerated. As NA is a safe and readily available
      vitamin supplement, our recent results provide a strong argument for a study of NA in
      patients with AD. We therefore propose to treat 50 patients with mild to moderate AD with
      either NA (1500 milligrams twice a day) or an identical but inactive drug (placebo) for 24
      weeks. At 6 week intervals we will assess functions such as learning and memory, and ability
      to carry out daily activities as well as caregiver reports using standardized tests. We will
      also perform spinal taps at the beginning and end of the study to measure the level of
      abnormal tau protein in the cerebrospinal fluid. Blood tests will periodically be done to
      assess liver function and complete blood counts. The results of this study may provide the
      basis for a more extensive study of NA for the treatment of mild to moderate AD.
    

Intervention name(s): Nicotinamide; Enduramide placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1500 mg twice a day for 6 months; 1 tab twice a day
Other intervention name(s): Enduramide
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nutraceutical, dementia, cognition, HDAC inhibitor
SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Condition: ESRD; Social Behavior; Physical Disability
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This research is being done to find out the best ways to help people with end stage kidney
      disease take care of their daily lives and improve their social functioning.

      Investigators want to learn whether services in the Community Aging in Place, Advancing
      Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening,
      balance training, pain management, changes to houses and improved social support can be
      tailored to fit the needs of older adults with kidney disease to help improve their ability
      to balance, walk, and take care of themselves.

      People aged 60 years and older who have end stage kidney disease and have been receiving
      dialyses for at least 6 months, may join.
    

Detailed description: 
      Questionnaires:

      Participants will be asked to answer questions about:

        -  social support and social functioning

        -  pain and depression

        -  physical function

      Study intervention:

      Participants will be randomly assigned (by chance, like the flip of a coin) to one of two
      groups: participant either will receive SOCIABLE (Seniors Optimizing Community Integration to
      Advance Better Living with ESRD) services now, or will receive the same services in six
      months from now. Participants have a 50:50 chance of getting into each group

      SOCIABLE services involve receiving visits with a nurse interviewer. Participants will decide
      how you want to improve your social function and social support.

      Participants will also receive:

        -  a group of services called CAPABLE which include home visits from a nurse (RN) and an
           occupational therapist (OT) and a handyman for repairs if you need them and

        -  help with improving social support

      All participants will receive 10 home visits (6 OT, 4 RN) plus minor home repairs and
      assistive devices over a 4 month period of time.
    

Intervention name(s): SOCIABLE
Intervention type(s): Behavioral
Intervention description(s): SOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease. There is particular emphasis on supporting the social function and the physical and everyday living function.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Molecular Quantification of Insulin mRNA
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The objectives of this study are to:

        1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in
           selected groups of subjects,

        2. determine the gene expression of markers of white cell activation in the white cell
           fraction of whole blood in selected subjects,

        3. determine the identity of the white cell responsible for expression of insulin mRNA and

        4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white
           cell activation.
    

Detailed description: 
      Indicators of active immune or chemically mediated beta cell destruction would be helpful for
      predicting the development and severity of autoimmune diabetes and monitoring the success of
      islet transplants. Currently there are no reliable indicators readily available.

      Insulin mRNA in the white cell fraction of blood has been detected or elevated under several
      circumstances including:

        1. normal animals

        2. after islet cell transplantation

        3. hyperglycemic induced expression and

        4. during induction of diabetes with streptozotocin

      The investigators propose that quantitative measurement of insulin mRNA may be an accurate,
      innovative and minimally invasive indicator of beta cell destruction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital and clinic patients and their siblings.
      
Keywords: Type 1 diabetes mellitus; Insulin mRNA