bioihbjkbjnl/mcl2 huggingface dataset:
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder
      that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2).
      Cysts begin to develop primarily in renal collecting tubules in utero and continue to form
      and expand throughout the patient's life. One of the goals of the study is to formulate a
      water prescription for use in clinical trials to determine the effect of sustained water
      diuresis on the progression of ADPKD.
    

Detailed description: 
      The proposed study will devise a quantitative model to estimate the amount of water an
      individual would need to ingest in order to lower the 24 h mean urine osmolality to a level
      below plasma (~285 mOsm/Kg). This osmolality goal is chosen because the 24h median urine
      osmolality of humans is ordinarily ~753 mOsm/Kg, much greater than 285 mosm/Kg (6, 7). In
      other words, normal humans are usually anti-diuretic during waking hours and while asleep.
      Median 24h urine volume is ~1225 ml (range 1051 - 2270). In temperate climates the insensible
      losses of water in sweat, respiration and stool are nearly balanced by the water ingested in
      solid and semi-solid foods and derived from metabolism. Thus, daily urine volume measured
      upon arising in the morning is a reasonably good indicator of the volume of fluids drunk over
      the preceding 24 h.
    

Intervention name(s): Water prescription
Intervention type(s): Other
Intervention description(s): Water prescription in 12 to 16 equally divided doses
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADPKD
An Observational Study of Childhood Food Allergy
Condition: Food Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity; Milk Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to observe the natural course of food allergy, including both
      the development of peanut allergy in infants at high risk for developing this allergy, and
      the resolution of both egg and cow's milk allergy.
    

Detailed description: 
      This observational study will investigate the developmental immunology of peanut, egg, and
      milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut
      allergy. This strategy will help to delineate, compare, and contrast biological markers and
      immunologic changes associated with the development of peanut allergy and loss of egg and
      milk allergy, while simultaneously evaluating important clinical and environmental influences
      likely to account for the recent rise in the prevalence of these allergies. The hallmark of
      food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies
      that represent an end result of a T helper 2 (Th2) influenced immune response. Currently,
      there is only a limited understanding of the mechanisms involved in the developmental course
      of food allergies. To effectively prevent or reverse the progression of food allergy, immune
      interventions will be needed. Furthermore, it is likely that successful strategies will need
      to be directed to those persons at identifiable risk (e.g., who have biomarkers associated
      with development of peanut allergy).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with milk or egg allergy who are at risk for peanut allergy
      
Biospecimen description: 
      Buccal swab (DNA)
    
Keywords: Food Allergy
Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
Condition: Neck Pain; Back Pain; Spasm
MeSH terms: Spasm; Back Pain; Neck Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess the effect of cyclobenzaprine hydrochloride (HCl)
      extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated
      with acute painful musculoskeletal conditions.
    

Detailed description: 
      The drug being tested in this study was cyclobenzaprine hydrochloride (HCl) extended-release
      (CER). CER was being tested to treat participants who had muscle spasms associated with acute
      painful musculoskeletal conditions. This study looked at medication helpfulness, relief from
      muscle spasms and pain, and improvement in range of motion and daily living activities.

      The study enrolled 180 participants. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the two treatment groups which remained undisclosed to the
      participant and study doctor during the study:

        -  CER 15 mg

        -  Placebo (dummy inactive pill) - this was a capsule that looks like the study drug but
           had no active ingredient

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the Russian Federation. The overall time to
      participate in this study was up to 45 days. Participants made multiple visits to the clinic,
      and were contacted by telephone after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Cyclobenzaprine HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cyclobenzaprine HCl extended-release capsules; Cyclobenzaprine HCl extended release placebo-matching capsules
Other intervention name(s): Myorix®; AMRIX®
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
Condition: ST-Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Diabetes Mellitus; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial
      infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent
      implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI
      undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in
      terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg)
      in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug
      administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study
      drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI
      with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD
      administration. All patients must will be naïve for platelet P2Y12 receptor inhibition
      therapy. A subanalysis will be performed between two study groups according to insulin
      treatment.
    


Intervention name(s): ticagrelor; prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to this arm to receive loading dose of ticagrelor; Patients will be randomized to this arm to receive loading dose of prasugrel
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; antiplatelet effect; prasugrel; ticagrelor; STEMI; Insulin
A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To examine the feasibility of improving stroke patients' physical functional recovery and
      social participation through improving caregiver's care capability.
    

Detailed description: 
      In the hospital, most rehabilitation units are like sheltered workshops and the therapists
      work with stroke patients in well-designed, but non-home-like, environment to improve the
      stroke patient's functional ability. After returning home, stroke patients face new
      challenges and also need to assume more responsibility for daily activities. Without
      continuing rehabilitation training or proper support, the patients can easily fall into a
      sedentary lifestyle and lead to declines in functional ability.However, providing home-based
      exercise by therapists directly would increase the health care cost and may not be practical
      for chronic stroke patients. Hence, the objective of the present study was to determine
      whether a caregiver-mediated, home-based intervention program is effective for improving
      stroke patients' functional ability and social participation.
    

Intervention name(s): Care-giver mediated training
Intervention type(s): Other
Intervention description(s): A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Chronic stroke patients; Stroke rehabilitation; Caregiver; Caregiver-mediated intervention
Application of Early Goal-directed Sedation in Patients With Severe Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      EGDS management strategy was implemented in ICU patients with severe brain injury, the depth
      of sedation and GCS score were monitored, and the protective effects of EGDS strategy and
      standard sedation strategy on the brain of patients with severe brain injury were discussed.
    


Intervention name(s): Early goal-directed sedation programs
Intervention type(s): Other
Intervention description(s): A. Provide sedation at the beginning of the titration of dextrometomidine; b. Optimize sedation when dextrometomidine is used alone and at a maximum dose not sufficient to provide comfort and safety to the patient and to achieve a level of sedation at any time specified by the treating physician. C. Provides immediate recovery and sedation, and can control sudden agitation at any time
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Brain Injuries; Early Goal-directed Sedation
Study of the Choroidal Thickness Variations After Ingestion of RedBull® Energy Drink
Condition: Choroid
Study type: Interventional

Summary: 
      The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to
      the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's
      blood. The choroidal thickness fluctuates according to the state of fullness of its
      constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium)
      are intimately linked and are subject to modifications during the ingestion of caffeine and
      taurine combined. Several authors have shown a significant decrease of the choroidal
      thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may
      be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in
      the retina. Recent studies have shown the importance of this amino acid in the physiology of
      both, retinal pigmentary epithelium and retinal ganglion cells.

      RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the
      equivalent of a coffee mug) and 1 g of taurine.

      This pilot trial aims to study the variations of the choroidal thickness and to describe
      possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and
      taurine. The results of this study will act as a reference for an ulterior trial aiming
      specific choroidal pathologies of young patients, such as the central serous chorioretinitis.
    


Intervention name(s): RedBull® energy drink
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects consume 25 mL of RedBull® energy drink
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Energy drink; Choroid
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of
      a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data
      for the design and conduct of subsequent studies.
    


Intervention name(s): Pegylated-Somatropin; YPEG-Somatropin; YPEG-Somatropin; YPEG-Somatropin; YPEG-Somatropin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.; Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.; Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.; Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.; Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: somatropin; PK; PD; male; pharmacokinetics; pharmacodynamics; safety
Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b
      (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after
      previous treatment.
    


Intervention name(s): MP-424; Ribavirin; Peginterferon Alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks
Other intervention name(s): Telaprevir
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients
Condition: Polyomavirus
MeSH terms: Nephritis
Study type: Observational

Summary: 
      Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus
      nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and
      renal transplant biopsies of patients affected by polyomavirus.
    

Detailed description: 
      Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus
      nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and
      renal transplant biopsies of patients affected by polyomavirus.
    

Time perspective: Prospective
Keywords: Monitoring; Polyomavirus; Kidney; Pancreas; Transplant
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice
      daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes
      mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and
      sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg
      b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from
      baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d.
      is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in
      HbA1c at 24 weeks.
    


Intervention name(s): Sitagliptin; Metformin; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose); Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks; Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks; Placebo to match metformin 250 mg tablets, orally, for 24 weeks
Other intervention name(s): MK-0431/ONO-5435
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Growth Mindset Psychoeducation for Modifiable Risk Factors for CMD
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The present study aims to determine the effect of presenting psychoeducation emphasizing
      "growth-mindset," and information on modifiable risk factors (e.g., social contact, physical
      activity) on engagement with modifiable risk factors. The investigators hypothesize that
      psychoeducation emphasizing that mental health is malleable will increase the participant's
      engagement with risk factors outlined in the intervention.
    


Intervention name(s): Growth mindset; Modifiable risk factor (MRF) information; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 10 minute interactive article describing neuroplasticity; 10 minute interactive article describing modifiable risk factors for depression and anxiety; 10 minute interactive article describing activity scheduling
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency; Endocrine System Diseases; Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A 38 week dosing trial of lonapegsomatropin, a long-acting growth hormone product,
      administered once-a-week versus placebo-control. A daily somatropin product arm is also
      included to assist clinical judgement on the trial results. Approximately 240 adults (males
      and females) with growth hormone deficiency will be included. Randomization will occur in a
      1:1:1 ratio (lonapegsomatropin : placebo : daily somatropin product). This is a global trial
      that will be conducted in, but not limited to, the United States, Europe, and Asia.
    


Intervention name(s): Lonapegsomatropin; Placebo; Somatropin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.; The placebo for lonapegsomatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin.; Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, parallel group with subjects randomized into 3 treatment groups (1:1:1); lonapegsomatropin once-weekly, placebo for lonapegsomatropin once-weekly, somatropin daily.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Human Growth Hormone; hGH; rhGH; GHD; Adult Growth Hormone Deficiency; Long Acting Growth Hormone; Lonapegsomatropin; Prodrug; Growth Failure; Growth Hormone Replacement Therapy; Sustained Release Growth Hormone; Growth Hormone Deficiency; TransCon hGH
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
Condition: Physical Disorder; Mental Health Wellness; Social Function Disorder, Childhood or Adolescent; Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      India's poor tribal communities have far worse health and social indicators than the general
      population. Most tribal people live in remote forested or desert areas where illiteracy,
      trying physical environments, malnutrition, inadequate access to potable water, and lack of
      personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya
      initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and
      economically disadvantaged children of the tribes and to provide a fair opportunity to all.
    


Intervention name(s): Chhatralaya
Intervention type(s): Other
Intervention description(s): Chhatralaya, home for children provide living resources along with spiritual practices.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children selected from Udaipur tribal areas, Rajasthan, India