bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a global multi-center , case-driven, randomized, double-blinded, and
      placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured
      by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the
      efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in
      participants aged 6 months to 17 years.
    

Detailed description: 
      This study is a global multi-center , case-driven, randomized, double-blinded, and
      placebo-controlled phase Ⅲ clinical trial in participants aged 6 months to 17 years.The
      purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR
      confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.The
      experimental vaccine and placebo were both manufactured by Sinovac Research & Development
      Co., Ltd. A total of 14,000 healthy participants aged 6 months to 17 years will be enrolled,
      and randomly assigned into 2 groups at a ratio of 1:1 to receive 2 doses of experimental
      vaccine (600SU) or placebo with an interval of 28 days.
    

Intervention name(s): Inactivated COVID-19 Vaccine; Controlled vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The inactivated COVID-19 vaccine was manufactured by Sinovac Research& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection; The placebo was manufactured by Sinovac Research& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
Other intervention name(s): CoronaVac; Placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional

Summary: 
      Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The
      operative time, recurrence rate, post-operative constipation, and effect on fecal
      incontinence, were reported and evaluated for each group Results:
    

Detailed description: 
      Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient
      and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar
      university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative
      constipation, and effect on fecal incontinence, were reported and evaluated for each group
    

Intervention name(s): Laparoscopy
Intervention type(s): Device
Intervention description(s): Laparoscopic Procedures for Rectopexy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Rectal Prolapse; Laparoscopy; Mesh; Rectopexy; pediatrics
Investigate the Efficacy and Safety of GSK1070806 in Obese Subjects With T2DM
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine
      interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the
      efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese
      subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the
      mechanism by which GSK1070806 exerts its therapeutic effects.
    

Detailed description: 
      The study will be a randomised, single-blind (sponsor-unblinded), placebo-controlled, study
      to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of
      repeat intravenous infusions (2 doses 4-weeks apart) of GSK1070806 in obese patients with
      T2DM. The primary objective of the study will be to assess improvements in fasting and
      postprandial glucose control. This will be a parallel-group study in 30 obese subjects with
      T2DM who are poorly controlled on metformin monotherapy (HbA1C>7% but <9.5%), and who have
      levels of microalbuminuria indicative of progressive kidney disease i.e. 30-300mg/L albumin
      in urine or ACR ≥3.5 mg/mmol (female) or ≥2.5 mg/mmol (male) and ≤30mg/mmol. There will be
      three treatment groups comprising two active and one placebo arm with 10 subjects per dose
      group. The study contains a broad range of biomarker assessments, the purpose of which is to
      evaluate the mechanistic basis by which GSK1070806 exerts its therapeutic benefit in subjects
      with T2DM.

      Subjects will be randomised into one of the three treatment groups where they will receive
      two intravenous infusions of GSK1070806 or placebo twenty-eight days apart. A MMT challenge
      will be conducted on Day 1, Day 29, Day 57 and Day 85 for evaluation of the primary
      endpoints.
    

Intervention name(s): GSK1070806; Placebo (saline); GSK1070806
Intervention type(s): Biological; Other; Biological
Intervention description(s): To investigate the efficacy and biomarker changes of GSK1070806 after 0.25mg/kg IV administration; To compare the efficacy and biomarker changes between placebo and active groups; To investigate the efficacy and biomarker changes of GSK1070806 after 5mg/kg IV administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Efficacy; Obese; T2DM; IL-18; Monoclonal antibody (mAb)
DVD-Based Training Program in Self-Hypnosis for Children
Condition: Vesicoureteral Reflux
MeSH terms: Vesico-Ureteral Reflux
Study type: Interventional

Summary: 
      The proposed study is designed to utilize a self-hypnosis DVD home-training program for
      parents to use with their children to teach self-hypnosis techniques for inducing relaxation
      and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory
      anxiety, distress, and pain during an invasive medical procedure, for example, voiding
      cystourethrography (VCUG). The study will examine the efficacy of this intervention for
      children undergoing VCUG procedures.
    

Detailed description: 
      Pediatric care professionals and parents seek safe ways to make invasive medical procedures
      less stressful and traumatic for children. However, for unpleasant procedures that require
      child cooperation, this task becomes difficult. Home-training in self-hypnotic relaxation may
      provide an inexpensive, yet systematic method for improving the overall medical care of
      children undergoing invasive medical procedures. The proposed study is designed to utilize a
      self-hypnosis DVD home-training program for parents to use with their children to teach
      self-hypnosis techniques for inducing relaxation and hypnotic analgesia. The study will
      examine the efficacy of this intervention for children undergoing urethral catheterization
      for VCUG procedures. Parents will be instructed to watch the DVD and practice the
      self-hypnosis exercises every day for a week with their child prior to the upcoming
      procedure. Parents are encouraged to practice self-hypnosis during their child's VCUG
      procedure. Both parents and children will be asked to complete a series of questionnaires
      before and following the procedure.
    

Intervention name(s): DVD Self-Hypnosis Training Program
Intervention type(s): Behavioral
Intervention description(s): The DVD training program contains instructional materials developed by an experienced psychiatrist and psychologist at the Department of Psychiatry at Stanford University School of Medicine. Parents will be instructed to review these materials, watch the DVD, and practice the self-hypnosis exercises every day for a week with their child prior to the upcoming procedure. Parents are encouraged to practice self-hypnosis during their child's VCUG procedure.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: VCUG; Child; Hypnosis; Relaxation; Voiding cystourethrography
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as
      co-formulation of pramlintide and A21G human insulin analogue product will be compared with a
      current standard treatment, insulin lispro. During a four months treatment period doses in
      both treatment arms may be adjusted and optimised under outpatient conditions to allow a
      meaningful comparison of both treatments with respect to their effects on body weight,
      achievable glycaemic control, safety and tolerability, treatment satisfaction and well-being.
    

Detailed description: 
      After a run in period in case of basal insulin switch or Continuous Glucose Monitoring (CGM)
      initiation, eligible subjects will enter a 3 weeks baseline recording period.

      Subjects will then be randomized to either M1 Pram P037 treatment or active comparator
      treatment (insulin lispro). Both investigator and enrolled subjects will be unblinded to
      treatment. Study participants will use CGM until follow-up visit.

      Treatment period will last 16 weeks. Throughout the 4-month treatment period, basal insulin
      and investigational products administration will be individually adjusted. Treatment
      Satisfaction Questionnaire and WHO-5 well-being index will be completed by subjects at day 0
      and after 2 months (Visit 9) and 4 months (Visit 11) of treatment.

      A safety follow-up visit, 7 to 14 days after the last administration of IMP, will mark the
      end of the clinical trial for the subjects.
    

Intervention name(s): M1 Pram P037; Insulin lispro
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.; Subcutaneous administration of insulin lispro in combination with a basal insulin.
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
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 trial is to assess the safety and
      tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming
      at establishing the Maximum Tolerated Dose (MTD)
    


Intervention name(s): semaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 0.625, 1.25, 2.5, 5, 10, 20, 40 or 80 μg/kg semaglutide will be administered subcutaneously (s.c. under the skin).; A single dose of placebo will be administered subcutaneously (s.c. under the skin)
Other intervention name(s): NNC 0113-0217
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic
      (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of
      macitentan/tadalafil (10 milligram [mg]/40 mg) and coadministered as a free combination
      (reference) of 10 mg macitentan (Opsumit) and 40 mg Canada-sourced tadalafil (Adcirca) in
      fasted conditions in healthy adult participants (Group 1) and to evaluate the effect of food
      on the primary PK parameters of macitentan and tadalafil administered as an FDC of
      macitentan/tadalafil (10 mg/40 mg) in healthy adult participants (Group 2).
    


Intervention name(s): FDC of Macitentan and Tadalafil; Macitentan; Tadalafil
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): Fixed dose combination (FDC) of 1 film-coated tablet containing 10 mg of macitentan and 40 mg of tadalafil will be administered orally.; Macitentan 10 mg tablet will be administered orally as free combination.; Tadalafil 40 mg tablet will be administered orally as free combination.
Other intervention name(s): Opsumit; Adcirca
Intervention MeSH terms: Tadalafil; Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Fatigue
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The objective of the study is to examine the effect of the addition of intravenous
      dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid
      consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery
      with laparotomy under general anesthesia.

      This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of
      dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side
      effects.

      Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior
      to placebo in providing post-operative pain control, lower analgesic consumption, prevention
      of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery
      profile. No dose response study has been done. The investigators hypothesize that a higher
      dose of dexamethasone may have an incremental beneficial effect.
    


Intervention name(s): Dexamethasone (0.1 mg/kg); Dexamethasone (0.2 mg/kg); Saline
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Dose = 0.1 mg/kg; Dose = 0.2 mg/kg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy; through a lower transverse or low midline incision under general anesthesia
Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Condition: Albinism
MeSH terms: Albinism
Study type: Interventional
Phase: Phase 2

Summary: 
      This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized,
      placebo-controlled, double-masked clinical trial to see if vision can be improved in
      individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these
      individuals may increase melanin pigment production. Increased melanin has previously been
      shown to be associated with improved vision.
    

Detailed description: 
      A group of 45 individuals with the clinical findings of oculocutaneous albinism (OCA) will be
      randomly assigned to one of 3 treatment groups: treatment with 0.76 mg/kg/d with 25%
      carbidopa, 0.51 mg/kg/d levodopa with 25% carbidopa [divided into 3 doses/d), or placebo.
      Subjects will be between ages 3 and 60 years. Blood will be drawn to determine the
      mutation(s) in the genes that causes OCA. Primary outcome will be binocular best-corrected
      visual acuity measured with the EVA. Enrollment and 20 week examination will be complete eye
      exam with fundus photos. At weeks 5, 10, and 15, exams will include just vital signs and
      BCVA. At all visits, a review of potential side effects will be conducted. Between visits,
      subjects will be contacted to determine if any side effects have occurred. The study will
      remain double masked until the last study examination on the last subject has been performed.
      At that time, the data will be statistically analyzed and subjects will be informed re:
      treatment assignment, mutations found, and the study results.
    

Intervention name(s): Levodopa; Levodopa; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution taken orally three times a day.; Solution taken orally three times a day.; Solution taken orally three times a day.
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Levodopa; Albinism; Vision
Neurological Outcomes Following Carpal Tunnel Wound-closure Techniques
Condition: Carpal Tunnel Syndrome Bilateral
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      single-centre randomised prospective trial will conducted at the University Hospital of Split
      in Croatia. The investigators plan to enrol 100 patients, randomly assigned to suture-based
      wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin
      adhesive Glubran Tiss 2®. The neurological outcomes will assessed postoperatively during the
      follow-up period at intervals of 2, 6, and 12 weeks respectively.
    

Detailed description: 
      All surgical procedures will be performed with a tourniquet and local anaesthesia using 2%
      lidocaine in the palmar soft tissues and carpal tunnel. For all subjects, the standard carpal
      canal decompression procedure will began withskin incision in the radial half of the palm,
      followed by carpal ligament transection and cutting. Following primary closure, two different
      techniques were used depending on the subject's randomization group:

        1. The skin will be stitched with transcutaneous nylon sutures (polypropylene-polyethylene
           monofilament, non-absorbable surgical suture) 4-0.

        2. After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 ; a two-component
           skin adhesive, Glubran Tiss 2® will be applied. Each subject will received 0.35 mL of
           Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 seconds
           for a polymerization process.

      The neurological outcomes will assessed postoperatively during the follow-up period at
      intervals of 2, 6, and 12 weeks respectively.
    

Intervention name(s): two-component skin adhesive Glubran Tiss 2®; skin stitched with transcutaneous nylon suture
Intervention type(s): Procedure; Procedure
Intervention description(s): After subcutaneous stitches with 4-0 Coated VicrylTM Plus PS-2, 3/8 (Ethicon Inc., USA); a two-component skin adhesive, 0.35 mL of Glubran Tiss 2® (GEM S.r.l., Viareggio, Italy), will be applied in the open wound. Before bandaging, subjects will rest for 20 seconds for a polymerization process.; The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU
Condition: Peripheral Arterial Disease; Diabetic Foot
MeSH terms: Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is being conducted to assess the safety and determine the maximum
      tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower
      leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will
      look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer
      healing. This study will also help to find the best dose of PDA-002 to use in future studies.
    

Detailed description: 
      The goal of this study is to determine a safe dose of PDA-002 [human placenta-derived cells]
      for further study. This is a dose-escalation study where each of four dose levels will enroll
      three to six subjects. Doses will be range from 3 million up to 100 million cells. If one
      dose is considered safe after all treated subjects have been evaluated and reviewed, then the
      next group of subjects will be enrolled to receive the next higher dose. This will continue
      until either the highest dose is reached, until at least 2 subjects at a dose level have ≥
      Grade 2 allergic reaction that is suspected to be related to PDA-002 or 2 or more subjects at
      a dose level experience an unexpected, treatment-related serious adverse event or dose
      limiting toxicity within 14 days following the initial dose of PDA-002. This is an open-label
      study where all subjects will be taking the study drug and all study personnel will know the
      dose each subject receives.
    

Intervention name(s): 3 x 10^6 cells; 10 x 10^6 cells; 30 x 10^6 cells; 100 x 10^6 cells
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3 x 10^6 cells administered on Study Days 1 and 8; 10 x 10^6 cells administered on Study Days 1 and 8; 30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8; 100 x 10^6 cells administered on Study Days 1 and 8
Other intervention name(s): PDA-002; PDA-002; PDA-002; PDA-002
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral arterial disease; diabetic foot