bioihbjkbjnl/mcl2 huggingface dataset:
Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal
      supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months
      postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial
      (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant
      neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by
      the addition of repeated biochemical measures from mother-child dyads.
    

Detailed description: 
      A double-blinded, randomized, placebo controlled trial would be conducted among pregnant
      women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d
      algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants
      would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be
      taken before the enrollment of the participant in the study. The mother-child dyads would be
      followed through infant age 1 year and anthropometric measurements and biochemical
      investigations would be used to assess the effect of maternal DHA supplementation on infant
      neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale
      for Indian Infants (DASII).
    

Intervention name(s): Docosa Hexaenoic Acid (DHA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum.; 400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.
Other intervention name(s): Omega 3 Fatty Acid; Corn/Soy oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blinded, parallel arm hospital based trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: DHA; Docosa Hexaenoic Acid; Omega 3 fatty acid; Birth Outcome; Birth Size; Gestational Age; DASII; Prenatal and Postnatal Supplementation; Randomized Controlled Trial; Neurodevelopment; Pregnancy; Lactation
An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Condition: Hyperphosphatemia
MeSH terms: Kidney Failure, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a
      4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety
      and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients
      on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either
      receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.
    

Detailed description: 
      The study consists of a screening visit, a wash out period of up to 3 weeks, when existing
      phosphate lowering medication is withheld, an 8-week treatment period, in which all groups
      receive tenapanor, and a 4-week placebo-controlled, randomized withdrawal period, during
      which patients are re-randomized 1:1 to either remain on their current tenapanor treatment or
      placebo.

      Depending on the increase in serum phosphate levels, subjects can be randomized 1,2, or 3
      weeks after being taken off their phosphate lowering medication.
    

Intervention name(s): Tenapanor; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791, AZD1722
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cerebral Microembolism During Hemodialysis
Condition: Complication of Dialysis; Thrombus Due to Renal Dialysis Device, Implant, or Graft; Cerebral Embolism
MeSH terms: Intracranial Embolism; Embolism
Study type: Observational

Summary: 
      There is increasing evidence that renal replacement therapy (= continuous veno-venous
      hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler
      ultrasound.

      The aim of this study is to monitor patients with transcranial Doppler under two conditions:
      during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load
      is detected during 30 minutes).

      The study hypothesis is that during hemodialysis the cerebral embolic load is significantly
      higher than in the hemodialysis-free interval.
    


Intervention name(s): Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)
Intervention type(s): Device
Intervention description(s): Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.
Other intervention name(s): Continuous veno-venous hemodialysis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population incloses patients who are in renal failure needing renal replacement
        therapy under intensive care conditions.
Role of Metabolites in Nicotine Dependence (4) - 13
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of cotinine with or without a
      transdermal nicotine replacement on tobacco withdrawal symptoms.
    

Detailed description: 
      Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the
      effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects
      of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to
      replicate and extend these findings and examine the effects of various doses of cotinine base
      compared placebo on withdrawal symptom as well as drug preference among abstinent smokers
      while using the nicotine patch. We hypothesized that cotinine will reduce the beneficial
      effects of the nicotine patch in reducing withdrawal symptoms and that placebo will be
      preferred over cotinine during the forced drug choice period.
    

Intervention name(s): Cotinine fumarate
Intervention type(s): Drug
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nicotine dependence
Comparative Study Between Conventional Crystalloid Cardioplegic Solution With Modified Del Nido Cardioplegia
Condition: Mitral Valve Surgery
Study type: Interventional

Summary: 
      Mitral valvuloplasty for correction of chronic mitral regurgitation carries a lower operative
      mortality and morbidity and improved long-term survival than does mitral valve replacement.
      Unfortunately, mitral valvuloplasty is not possible in all patients with chronic mitral
      regurgitation because of unfavorable pathology or lack of experience with this technique
    

Detailed description: 
      Cardioplegia is a fundamental component in providing heart protection, limiting metabolic
      activity and increasing the myocardium's capacity to resist ischemia for prolonged periods,
      thus being essential for good surgical outcomes.

      Numerous cardioplegia solutions exist with different compositions to provide sufficient
      myocardial protection. However, there is no standard for the optimal or ideal composition and
      delivery technique. Cardioplegia solutions are crystalloid or blood-based solutions with
      various chemical compounds.

      Despite improvements in myocardial protection, prosthetic valves, surgical techniques, and
      postoperative care, the operative mortality and morbidity of mitral valve replacement for
      chronic mitral regurgitation remains high in comparison with other commonly performed heart
      operations.

      The timing of the administration of cardioplegia is extremely important in terms of
      preventing myocardial dysfunction. Conventional multidose cardioplegias should be repeatedly
      administered in every 15 to 20 min. Frequent interruption of the surgical process, even for a
      short time, before each cardioplegia delivery leads to a loss of time during open heart
      surgery, where time is extremely important, and disrupts the coherence of the operation and
      the surgical concentration.

      Crystalloid cardioplegic solutions achieve cardioplegic arrest through inhibition of either
      fast-acting sodium channels or calcium-activated mechanisms. Hyperkalemia can be used to
      inhibit the fast-acting sodium channels as it is in the St.Thomas Hospital solution and its
      modifications.
    

Intervention name(s): Crystalloid Cardioplegic solution
Intervention type(s): Drug
Intervention description(s): To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.
Other intervention name(s): Modified Del Nido Cardioplegia
Intervention MeSH terms: Cardioplegic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to compare the
      pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire
      observation phase from the time of administration and the efficacy period) and the
      pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a
      treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily
      and biphasic human insulin 30 administered once daily in type 2 diabetic subjects
    


Intervention name(s): biphasic insulin aspart 30; biphasic human insulin 30
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MOVIPREP® Versus NaP Pivotal Phase III Study
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium
      phosphate solution already on the market. Efficacy of each bowel preparation, safety and
      acceptability will be assessed.
    

Detailed description: 
      Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in
      patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994
      gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium
      phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy.
      Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be
      randomised. One of the two tested products will be delivered by a pharmacist, blindly from
      the gastroenterologist. The assigned product will be taken the day before the coloscopy
      according to the information leaflet. Efficacy of the two tested preparations will be
      measured on video-tape record of each colonoscopy by a final grading i.e. "the overall
      quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient
      questionnaire administered by a nurse on the morning before colonoscopy will assess clinical
      tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be
      withdrew before intake of the preparation and one more blood sample will be performed after
      the intake on the morning, before the coloscopy.

      After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last
      visit is performed.
    

Intervention name(s): macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate; Sodium Phosphate Solution
Intervention type(s): Drug; Drug
Intervention description(s): 2L gut lavage solution; 1 x 45ml solution, BID
Other intervention name(s): MOVIPREP®; Fleet Phospho Soda®
Intervention MeSH terms: Ascorbic Acid; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colon cleansing
Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
Condition: Dry Skin
Study type: Interventional

Summary: 
      All subjects used the placebo sample on the left side of their face and the investigational
      sample on the right side of their face, respectively. The moisturizing levels were detected
      before use (0 week), after 2 weeks and after 4 weeks. The wrinkles of subjects were also
      measured on the same date interval as the skin moisture level test.
    

Detailed description: 
      Twenty-two subjects were initially enrolled in the clinical trial. One subject was excluded
      by non-compliance with the plan of trials. All subjects used the placebo sample on the left
      side of their face and the investigational sample on the right side of their face,
      respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and
      after 4 weeks. The crow's feet of subjects were also measured on the same date interval as
      the skin moisture level test.
    

Intervention name(s): Hs-hWE cream; Placebo cream
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The cream was applied to the faces of subjects, the left facial area was put on the 0.5% Hs-WE cream.; The cream was applied to the faces of subjects, the right facial area was put on the placebo cream.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
Condition: Uterine Fibroids; Leiomyoma; Menorrhagia
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia
Study type: Interventional

Summary: 
      The purpose of the current study is to evaluate the technical success, safety and procedure
      feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women
      who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based
      cryoablation needles
    

Detailed description: 
      Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing
      therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical
      myomectomy), or minimally invasive (uterine artery embolization, or myolysis).

      Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential
      alternative method of fibroid treatment. Cryotherapy is a well-established technique for the
      treatment of various benign and malignant conditions. Cryoablation has been described for the
      treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and malignant
      breast tumors.

      Galil Medical's proposed feasibility study is looking to examine the technical success,
      safety and feasibility of a hysteroscopic approach for the treatment of symptomatic fibroids.
      This technique involves the insertion and placement of Galil Medical's 17-gauge cryoablation
      needle(s)guided by a hysteroscopic device. Ultrasound provides real-time monitoring of the
      needle insertion, placement and iceball propagation during the cryoablation procedure.

      This treatment offers the patient to preserve her uterus by a minimally invasive procedure.
      The type of the fibroids intended for treatment (Type II submucous myomas)are often very
      difficult to completely and safely remove hysteroscopically and are often treated through an
      open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal
      intervention and is therefore expected to be associated with less intra-operative and
      post-operative complications.

      The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self
      resolving discomfort. The patient should be able to return to her normal activity within
      24-48 hours.
    

Intervention name(s): Cryoablation for the treatment of uterine fibroids
Intervention type(s): Procedure
Intervention description(s): Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.
Other intervention name(s): Presice Cryoablation System; 17-gauge IceBulb™ needle Lot G3021
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine fibroids; Leiomyoma; Menorrhagia; Hysteroscopic cryoablation; Minimally invasive
Efficacy of Topiramate for Hospitalized Patients With Alcoholism
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with
      alcoholism
    


Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): Topiramate 100-300 mg/day orally twice per day
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcohol dependence; Alcoholism; Topiramate
Treadmill Training With Functional Electric Stimulation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of the treadmill training with
      functional electric stimulation on sensorimotor cortical reorganization and functional
      improvement in subjects with chronic stroke.
    


Intervention name(s): Treadmill training with functional electrical stimulation; Treadmill training without functional electrical stimulation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
Condition: Infantile Colic; Constipation; Infantile Diarrhea; Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux; Colic; Food Hypersensitivity; Constipation; Diarrhea; Diarrhea, Infantile
Study type: Interventional

Summary: 
      This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing
      clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of
      gastrointestinal tract and skin symptoms of food allergies in children between the ages of
      one and four months inclusive.

      The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB
      30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal
      reflux, atopic dermatitis/eczema in full-term newborns during the first months of life,
      laboratory parameters of microbiome will also be assessed.

      A prospective study comparing two treatment groups:

      Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The
      study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy
      includes defoamers (simethicone-based preparations), carminative preparations (dill water
      (fennel)), etc.
    


Intervention name(s): Lactobacillus Reuteri; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus Reuteri NCIMB 30351; Sunflower oil
Other intervention name(s): BioAmicus Lactobacillus drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in
      China
    

Detailed description: 
      This is a multicenter, randomized, double-blind and placebo-controlled study. The
      investigational drug is HBM9161 injection, and the indication is MG.

      The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6
      weeks' double-blind treatment period followed by an open-label extension treatment period.
      The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of
      HBM9161 in patients with attack of MG in China.
    

Intervention name(s): HBM9161 Injection (680mg and 340 mg); Placebos; HBM9161 Injection (340 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HBM9161 Injection (680mg and 340mg); Placebo, HBM9161 Injection (340mg); HBM9161 Injection (340 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MG
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect
Condition: Cartilage Diseases; Osteoarthritis
MeSH terms: Osteoarthritis; Cartilage Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of human umbilical cord
      mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
    

Detailed description: 
      Human articular cartilage has limited repair potential.Cell-based strategies have explored
      chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical
      studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus
      in cartilage repair is shifting toward mesenchymal stem cells.

      To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients
      will be enrolled and receive 4 times of hUC-MSC transplantation.
    

Intervention name(s): Human umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
Other intervention name(s): hUC-MSC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Umbilical Cord Mesenchymal Stem Cell; Mesenchymal Stem Cell; Osteoarthritis