bioihbjkbjnl/mcl2 huggingface dataset:
Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs.
      placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview
      (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although
      behavioral and educational therapies and a variety of medications may play a role in the
      management of some autistic symptoms.
    

Detailed description: 
      This study compares divalproex sodium and placebo in the treatment of autistic disorder.
      Twenty six child or adolescent outpatients, with age ranges from 5-17, will be randomized
      into a 12-week double-blind, placebo-controlled parallel treatment study. During the 12
      weeks, patients will be monitored by the treating psychiatrist and assessed by an independent
      evaluator (IE). The IE will perform study assessments while remaining blind to medication
      regimens (including possible tapering) as well as any side effects. Study assessments will be
      administered at designated time points
    

Intervention name(s): Divalproex sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug.; Placebo comparator.
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; aggression; irritability; divalproex sodium
Acamprosate in Youth With Fragile X Syndrome
Condition: Fragile X Syndrome; Autism Spectrum Disorders
MeSH terms: Fragile X Syndrome; Syndrome; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS
      is inherited from the carrier parent, most often the mothers. FXS is associated with severe
      interfering behavioral symptoms which include anxiety related symptoms, attention deficit
      hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also
      meet criteria for autistic disorder. The hypothesis of this study is that treatment with
      acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social
      deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate
      the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to
      assess the potential psychophysiological differences between FXS and autism spectrum
      disorders.
    


Intervention name(s): Acamprosate
Intervention type(s): Drug
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fragile X Syndrome; Acamprosate
A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
Condition: Normal Tension Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Study type: Observational

Summary: 
      The objective of this study is to determine whether systemic blood pressure in the body is
      related to the development and progression of normal tension glaucoma in the eye. The study
      aims to clarify whether subjects with episodes of hypotension (low blood pressure) at night
      are at increased risk for sight loss and the development of normal tension glaucoma.
    

Detailed description: 
      Glaucoma is an eye disease that leads to damage of the optic nerve, visual field loss and can
      progress to blindness. Traditionally, glaucoma and its treatment have been closely linked to
      intraocular pressures. In normal tension glaucoma, damage to the optic nerve occurs without
      any increase in intraocular pressure. Normal tension glaucoma most often occurs in the
      elderly and can lead to loss of sight and significant disability. Subjects with progressive
      visual field loss are often a highly motivated group of subjects, ready to take an active
      part in the treatment of their condition. Investigating the risk factors that contribute to
      the development of normal-tension glaucoma may shed light on the progression of the disease.

      Subjects with normal tension glaucoma will have their demographic and clinical
      characteristics recorded and their eyes examined at baseline, 6-months and 12 months.
      Subjects will wear an external blood pressure cuff for 48 hours that will record blood
      pressure every 30 minutes. This same blood pressure recording procedure will be performed at
      baseline, at 6 months, and at 12 months. At these same time intervals, visual fields will
      also be measured, as per routine clinical care, by the treating ophthalmologist. The results
      of the visual field testing will be recorded. The primary outcome of the study will be visual
      field abnormalities and their relationship to dips in systemic blood pressure. Results will
      be published and will be used as a base for future projects that may impact treatment and the
      understanding of risk factors of normal tension glaucoma.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Normal Tension Glaucoma
Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
Condition: Infertility; Intrauterine Adhesions
MeSH terms: Infertility; Tissue Adhesions
Study type: Interventional

Summary: 
      Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by
      collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to
      provide clinical evidence of safety and effectiveness for the treatment of uterine
      infertility.
    

Detailed description: 
      Infertility is defined as a women fails to become pregnant after having a normal sex life for
      two years without contraception. There is limited treatment to the infertility caused by
      severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation.
      The existing drugs, physical or surgical treatments had no significant effects to severe
      recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix
      with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and
      achieved good results. In this study, collagen scaffold and umbilical cord blood-derived
      mesenchymal stem cells are combined, and they showed good biological safety.
    

Intervention name(s): UC-MSCs therapy
Intervention type(s): Procedure
Intervention description(s): Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
Intervention model: Single Group Assignment
Intervention model description: treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates four vaginal ring groups with respect to relief of primary
      dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant
      treatment efficacy in relief of primary dysmenorrhea.
    

Detailed description: 
      The study investigates four vaginal ring groups with respect to relief of primary
      dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant
      treatment efficacy in relief of primary dysmenorrhea. The intake of ibuprofen rescue
      medication and the impact on daily life is investigated: change from baseline data of these
      two variables will be compared between each of the four active ring groups, separately, and
      the placebo ring group. Furthermore, the study assesses the measurement characteristics and
      psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding
      pattern and general safety and tolerability will also be evaluated.
    

Intervention name(s): Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR); Etonogestrel containing contraceptive vaginal ring (ENG-CVR); Placebo; Ibuprofen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles; Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles; Placebo to match vaginal ring, intravaginally for two 28-day cycles; Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)
Other intervention name(s): SCH900121; MK-8175A; SCH900432; MK-8342B; Motrin
Intervention MeSH terms: Ibuprofen; Contraceptive Agents; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics and safety of a controlled
      release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR)
      pitavastatin in healthy adult volunteers.
    


Intervention name(s): A: NK-104-CR 8 mg; B: Pitavastatin IR 4 mg; C: Pitavastatin IR 8 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NK-104-CR 8 mg (Controlled Release single 8-mg tablet); Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet); Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based
      high intensity interval training program (HIIT) to improve physical function in patients with
      knee osteoarthritis (OA).
    

Detailed description: 
      All participants will be assigned to the single-arm of the study in which all participants
      will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the
      feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms
      ranging from mild to severe. The investigators will determine adherence to and tolerability
      of HIIT, acceptability, and recruitment and retention rates during the 12 week program.
      Additional outcomes will include physical function, knee OA symptomatic burden (pain), static
      standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and
      body composition.
    

Intervention name(s): High intensity interval training (HIIT)
Intervention type(s): Behavioral
Intervention description(s): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Intervention model: Single Group Assignment
Intervention model description: Single Group assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee osteoarthritis
Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)
Condition: Smoking; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the present study is to assess if a personal care program of smokers hospitalised
      for acute coronary syndrome can change the smoking habits as compared with similar patients
      in conventional care program at 6 months. The program includes a cognitive-behavioural
      approach associated with a nicotine replacement treatment presented as an obligatory non
      optional treatment. Patients are men and women of less than 70 years old hospitalised for
      acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The
      program includes a cognitive-behavioural approach based on the specific technique of
      "exposure" and the prescription of nicotine patch considered as other usual cardiologic
      treatments for at least 6 months. The end point is the smoking habits at 6 months classified
      as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by
      the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors
      sites.
    

Detailed description: 
      The cognitive behavioural approach group : This group will receive an inclusion visit at
      first, then two "cigaret exposures cessions" during hospitalisation. Thereafter-one week
      after he's out- the patient will come for 5 follow up visits consisting in the specific
      technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six
      months, will tell us if the patient is an effective non smoker or not; We'll be also
      collecting psychological and medical informations (such as the treatment, IMC, cardiovascular
      check up and psychological tests). The control group : This group is managed as "usual" : the
      nurse gives very rapid recommendations to the patients concerning smoking cessation.
      Nicotinic substitutes are proposed to the patients but the patient must find them by itself.
    

Intervention name(s): Technique of in-vivo exposure (cigarette) and mental image exposure (craving); conventional follow-up
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nicotine replacement; nicotinic substitutes
Other intervention name(s): Reduce the urge to smoke; Strategies to avoid the relapse; recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smoking; nicotine replacement; psychological behaviour; Smoking > 5 cigarettes per day; Hospitalisation for acute coronary syndrome
Preoperative Nutritional Support in Malnutritional Cancer Patients
Condition: Pancreatic Cancer; Biliary Cancer; Malnutrition
MeSH terms: Pancreatic Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      Malnutrition patients are known to have more postoperative complications and mortality. And
      most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and
      mortality rate. Therefore for the malnourished patients anticipating major surgery,
      preoperative nutritional support is recommended according to the ASPEN (American society of
      parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral
      nutrition) guideline. However there is no prospective trial to prove the clinical impact of
      preoperative nutritional support for malnourished patients.

      The purpose of this study is to evaluate the clinical impact of preoperative nutritional
      support for malnourished cancer patients anticipating HBP surgery. Primary objective is to
      compare the complication rate and secondary object is to compare the quality of life,
      hospital stay and cost.
    

Detailed description: 
      This is single arm study with historical comparison. The historical control group did not
      receiving nutritional support. In previous results show that about 25% complication rates.
      Complication rates are expected in the group receiving nutritional support is less than 10 %
      ( previous studies (NCCNCS-11-460)).

      For support group, preoperative nutritional support is given for 5 or more days
      preoperatively by nutritional support program. Nutritional support program is briefly
      described below.

      Interval: 5-10 days Contents: admission is required

        -  Calories: 30-35Kg, via enteral or parenteral

        -  Protein: 1.2-1.5g/Kg

        -  Lipid : 1-1.5g/Kg

        -  Mineral and vitamins supply

        -  Blood glucose control

        -  Daily monitoring by dietician and specialized nurse
    

Intervention name(s): nutritional support program
Intervention type(s): Dietary Supplement
Intervention description(s): Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
Calories: 30-35Kg, via enteral or parenteral
Protein: 1.2-1.5g/Kg
Lipid : 1-1.5g/Kg
Mineral and vitamins supply
Blood glucose control
Daily monitoring by dietician and specialized nurse
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malnutrition; nutrition; nutritional support; hepatobiliary pancreatic cancer; hepatobiliary pancreatic surgery
First in Human Study for PF-06667272
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is the first clinical trial proposed with PF-06667272. It is designed to
      evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of
      PF-06667272 under fed and fasted conditions, in healthy adult subjects.
    


Intervention name(s): PF-06667272; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single ascending dose of PF-06667272; Single dose of placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring
      hospitalization of infants and young children in developed and developing countries and can
      be a frequent cause of death in children less than 5 years of age. GSK Biologicals has
      developed a vaccine against human rotavirus gastroenteritis. In this study, the
      immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or
      reconstituted in circumstances different from the recommendations: i.e. when not
      reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In
      addition, the effect of feeding will be explored for HRV vaccine reconstituted without
      buffer.
    

Detailed description: 
      Assess the effect on immunogenicity of administration of vaccine without buffering agent &
      assess heat stability in terms of immunogenicity, reactogenicity & safety of GSK Biologicals'
      oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy
      infants previously uninfected with human rotavirus
    

Intervention name(s): Live attenuated human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in
           comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment
           of Cervical dystonia.

        2. double blind, randomised, multi center, crossover study
    

Detailed description: 
      1. Prospective, randomized, head-to-head, double-blind, cross-over study.

        2. Total patients: A group 51, B group 51

        3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to
           receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4
           weeks of wash out period, then the patients get the other treatment (i.e, Patients who
           have got Dysport will be then administered with Botox)

        4. Compare the TSUI change score from baseline to 4 weeks after injection.
    

Intervention name(s): Dysport® (abobotulinumtoxinA); Botox® (onabotulinumtoxinA)
Intervention type(s): Drug; Drug
Intervention description(s): Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units; Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Other intervention name(s): Dysport® (abobotulinumtoxinA)injection; Botox® (onabotulinumtoxinA)injection
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical dystonia; botulinum toxin
Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor
      biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.
    

Detailed description: 
      This is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the
      effects of emixustat in subjects with PDR. Subjects will be randomly assigned to either
      emixustat or placebo arms and treated once daily (QD) for 12 weeks. Doses of emixustat will
      be doubled on a weekly basis until week 4 after which all subjects will be held at a stable
      dose for the remainder of the 12-week dosing regimen. Subjects in the placebo group will be
      mock-titrated on the same schedule as those in the emixustat arm.
    

Intervention name(s): emixustat hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet for oral administration; Placebo tablets for oral administration contain only inactive ingredients
Other intervention name(s): ACU-4429, Emixustat HCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment