bioihbjkbjnl/mcl2 huggingface dataset:
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The main objective is to assess the efficacy and safety of overnight automated closed loop
      glucose control using a computer-based algorithm compared with conventional insulin pump
      therapy in adults with type 1 diabetes following the consumption of a moderate amount of
      alcohol at dinnertime.
    

Detailed description: 
      People with type 1 diabetes need regular insulin injections or continuous delivery of insulin
      using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk
      of long term complications involving the eyes, kidneys and heart. However, achieving
      treatment goals can be very difficult as the tighter we try to control blood glucose levels,
      the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia).
      One solution is using a system where the amount of insulin injected closely matches the blood
      sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop
      system" where a small glucose sensor placed under the skin communicates with a computer
      containing an algorithm that drives a subcutaneous insulin pump. This system is being
      developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes.
      Results thus far show that the system is very effective at preventing hypoglycaemia and
      maintaining blood glucose levels in target range.

      We plan to test the closed loop in various challenging conditions faced by patients in daily
      life. One of these is the consumption of alcohol, which can give rise to delayed
      hypoglycaemia in patients with diabetes. The studies will be done in a clinical research
      facility under supervised conditions. Subjects will attend for two study nights where they
      will receive a specific volume of alcohol with an evening meal. On one night this will be
      followed by closed loop algorithm control of their insulin overnight. On the other (control)
      night subjects will remain on their usual pump therapy regime overnight.
    

Intervention name(s): Closed loop; Conventional insulin pump delivery
Intervention type(s): Device; Device
Intervention description(s): Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings; Subcutaneous delivery of Novorapid insulin according to usual pump regime
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to compare the effectiveness of combination therapy of
      microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it
      aims to answer are:

        -  Is there an increase in hair density with combination therapy of microneedling and
           minoxidil versus minoxidil monotherapy?

        -  Is there an increase in hair diameter with combination therapy of microneedling and
           minoxidil versus minoxidil monotherapy?

      Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy,
      and the second one will receive a combination therapy of microneedling and minoxidil.
      Researchers will compare those 2 groups to see if there is a difference of effectiveness
      based on hair density and diameter.
    


Intervention name(s): Minoxidil 5% Topical Solution; microneedling
Intervention type(s): Drug; Device
Intervention description(s): Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks; Patient will be given microneedling treatment every 4 weeks
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Fasting in the Bahá'í Faith
Condition: Health Behavior; Healthy
Study type: Observational

Summary: 
      The aim of the study is to find out the effects a specific religious fast (i.e. Bahá'í fast)
      has on certain metabolic parameters, hydration, psyche and circadian clock. In a follow-up
      questionnaire series in 2019 we want to additionally validate a specific questionnaire for
      Bahai fasting, which was developed in 2018.
    

Detailed description: 
      Followers of the Bahá'í Faith worldwide follow a yearly fasting tradition, where they fast
      intermittently for nineteen days. The intermittent fast is defined as abstinence from any
      food, drink and smoking from sunrise until sunset. These nineteen days are always in March
      and so do not coincide with climatic extremes in any country worldwide. This makes this kind
      of fasting a good model to study the psychological and medical effects of intermittent
      fasting in humans.
    

Intervention name(s): Intermittent Fasting
Intervention type(s): Other
Intervention description(s): Intermittent Fasting with abstinence from food and drink daily from sunrise to sunset for nineteen consecutive days in March 2018
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Members of the Bahá'í community residing in Germany
      
Biospecimen description: 
      Blood, urine
    
Keywords: Intermittent Fasting; Religious Fast; Bahá'í; Hydration; Calorimetry; Microdialysis; circadian clock; circadian rhythm; spirituality; self-efficacy
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy
      and safety of daprodustat administered three-times weekly compared to epoetin alfa, the
      current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment
      Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62
      weeks. Approximately 402 subjects will be randomized to receive either daprodustat three
      times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.
    


Intervention name(s): Daprodustat tablets; Matching placebo tablets; Epoetin alfa vials; Saline vials or bags
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.; Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.; Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.; 0.9% sodium chloride saline vials or bags administered by the IV route.
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive either daprodustat or epoetin alfa in a parallel manner. .
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143
Condition: Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3
      sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A).
      There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to
      assess alternative dose levels or formulations, if required.

      In each study part, each subject will receive a single dose of investigational medicinal
      product PWT-143 in each of 2 study periods (total of 2 single doses).
    

Detailed description: 
      This first-in-human study will comprise 2 parts. In each part, each subject will receive a
      single dose of investigational medicinal product (IMP) in each of 2 study periods (total of 2
      single doses).

      Part 1 (Single Ascending Dose) This is an open-label, single dose design. It is planned to
      enroll up to 3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects,
      respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects,
      to assess alternative dose levels or formulations (described below), if required.

      The starting dose, dose increments and dose range are based on available pre-clinical data.
      Current planned dose levels are: 10, 30, 60, 90 and 150 mg (dose levels 1, 2, 3, 4 and 5,
      respectively); however, doses above 10 mg will be selected based on a review of emerging data
      from this study.

      It is planned to use Formulation 1 for dose administration in Part 1 (Group A), selected from
      3 test formulations. However, based on the exposure seen in the emerging data, an alternative
      formulation may be selected for dose comparison or escalation.

      Part 2 (Food Effect Assessment) This is an open-label, randomised, single dose, 2-way
      crossover design to assess a selected formulation of PWT-143 in the fed and fasted states.
      Subjects will be administered a single dose of investigational medicinal product in the fed
      and fasted states across 2 study periods according to the randomisation schedule. There will
      be a minimum washout period for PWT-143 of 7 days between dose administrations in Periods 1
      and 2.

      It is planned that 1 group comprising 8 subjects will participate in Part 2. Subjects will be
      considered evaluable if they have received both treatments (ie, fed and fasted) and have
      completed safety assessments and PK sampling up to 24 h post-dose.
    

Intervention name(s): PWT-143
Intervention type(s): Drug
Intervention description(s): phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Gingival Recession Treatment Using Two Different Surgical Techniques
Condition: Gingival Recession; Root Planing
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Coronally the advanced flap is considered a predictable treatment of gingival recession but
      in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG)
      which is considered as the gold standard treatment approach.

      This randomized controlled trial compares the clinical benefits and effectiveness of a
      xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the
      subperiosteal connective tissue graft (CTG).
    


Intervention name(s): xenogeneic collagen matrix
Intervention type(s): Procedure
Intervention description(s): xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: root coverage; mucoderm; connective tissue; grafts
Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a
      non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site
      palatal wound.
    

Detailed description: 
      Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival
      graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor
      and receiving sites, coverage of gingival recession, and the gain of attached gingiva.

      A total of 20 subjects will be invited to participate in this study from the patients seeking
      treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University.

      The study has been approved by the investigator's local Review Board. Subjects will be
      recruited according to specific inclusion criteria. After completion of medical and dental
      history questionnaires, patients will sign a consent form after being advised about the
      nature of the study.

      Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF)
      dressing will be used in both donor and receiving sites in the test group, while a
      non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the
      control group .

      Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP)
      will be evaluated.
    

Intervention name(s): A free gingival graft; A Platelet-Rich Fibrin dressing; A non-eugenol-based dressing
Intervention type(s): Procedure; Device; Device
Intervention description(s): A free gingival graft will be used for the treatment of gingival recession; A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.; A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: autografts; gingival recession; free gingival graft; Attached gingival width; Platelet-Rich Fibrin dressing
Effect of Plyometric Exercises on Upper Extremity Function in Children With Unilateral Cerebral Palsy
Condition: Sports Physical Therapy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Plyometric training includes muscle contraction that moves rapidly from the eccentric to the
      concentric phase of movement while using proper biomechanics. It is an effective
      neuromuscular stimulus that can improve motor functions of children with CP. In plyometric
      training, muscles exert maximum force in short intervals of time, with the goal of increasing
      power.
    

Detailed description: 
      This is a prospective double-masked randomized controlled trial.
    

Intervention name(s): Designed physical therapy; Occupational therapy; Conventional Therapy; Plyometric training
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Attention is given to improve motor function, conducted for 30 minutes; included exercises facilitating hand skills, conducted for 30 minutes; aimed to improve the affected upper extremity function, conducted for 30 minutes; basically focuses on upper extremity strength training conducted for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: plyometric exercises; Unilateral Cerebral Palsy; cerebral pslay; hand grip strength; upper extremity function; selective motor control
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Condition: Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      First in Human single ascending dose followed by multiple ascending doses in healthy
      volunteers.
    


Intervention name(s): BLD-2660
Intervention type(s): Drug
Intervention description(s): Randomized to active product or placebo
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pivotal Study of the Al-Sense Study Protocol
Condition: Amniotic Fluid Leakage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner
      (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between
      wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is
      caused by urinary incontinence.
    


Intervention name(s): AL-SENSE Diagnostic Absorbent Panty liner; AL-SENSE Diagnostic Absorbent Panty liner
Intervention type(s): Device; Device
Intervention description(s): worn for 12 hours; Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours
Other intervention name(s): AL-SENSE Amniotic Leak Test Kit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: amniotic fluid leakage; urinary incontinence; pregnancy; home test; vaginal wetness
Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment
Condition: Sport Nutrition; Probiotic
Study type: Interventional

Summary: 
      Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as
      GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on
      increasing muscle mass, muscle strength, physical performance and improving body composition
      when combined with resistance exercise training. Method: The experiment adopts a double-blind
      design. After screening, 52 subjects (20 males and 32 females) were randomly divided into two
      groups, each with 10 males and 16 females: (1) placebo without GKEX probiotics Capsule group
      (Placebo) (2 capsules/day), (2) GKEX group (GKEX) (1x1010 CFU/capsule, 2 capsules/day). All
      subjects received daily supplementation samples for 6 weeks and received resistance exercise
      training three times a week. Before the intervention and 6 weeks after the intervention, the
      diet evaluation, systemic and resistive body composition, muscle ultrasound, muscle strength,
      maximum oxygen uptake, explosive power, anaerobic power, etc. were detected respectively.
    


Intervention name(s): GKEX; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): GKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use.; The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
Condition: Healthy; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label (both the physician and healthy volunteer know which treatment will be
      administered), single-dose, 4-period study to characterize the pharmacokinetics (process by
      which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and
      effect of food on the pharmacokinetics of JNJ-31001074. The study consists of three phases: a
      screening phase to determine eligibility, an open-label 4-period treatment phase and an
      end-of-study/early withdrawal assessment phase.
    

Detailed description: 
      This is an open-label (both the physician and healthy volunteer know which treatment will be
      administered), randomized (treatment order determined by chance), single-dose study to
      characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed,
      metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of
      JNJ-31001074. The study consists of three phases: a screening phase to determine eligibility,
      an open-label treatment phase and an end-of-study/early withdrawal assessment phase. During
      the screening phase, healthy volunteers will be evaluated to see if they meet selection
      criteria as specified in the protocol. Healthy volunteers who meet these criteria will report
      to the study center on Day -1 to begin treatment. The open-label treatment phase will consist
      of 4 periods. In each period, volunteers will receive one of the following treatments:
      Treatment A 1 mg JNJ-31001074, Treatment B 3 mg JNJ-31001074, Treatment C 10 mg JNJ-31001074,
      and Treatment D 10 mg JNJ-31001074. Treatment A, B and C will be administered under fasting
      conditions (no food or beverages for 10 hours prior to dosing) and Treatment D will be
      administered after a high-fat meal. The order in which volunteers will receive each treatment
      will be determined in a random fashion (like flipping a coin). Each treatment will be
      separated by a 7-14 day washout period. Multiple blood and urine samples will be collected
      for 72 hours after each dose. Safety and tolerability will be assessed throughout the
      volunteer's participation. Volunteers will be instructed to report any adverse events that
      occur up to 30 days after their last dose of study drug. The maximum study duration for each
      volunteer is expected to be 66 days. JNJ-31001074 1, 3 or 10 mg will be administered orally
      on Day 1 of each of the 4 treatment periods (dose depends on participant's treatment
      sequence)
    

Intervention name(s): JNJ-31001074
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer; Phase I; Non-childbearing potential; JNJ-31001074; Food; Pharmacokinetics
Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR
      versus subjects receiving placebo.

      Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global
      evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric
      Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects
      receiving placebo.
    


Intervention name(s): DVS-233 SR
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Depression, Involutional