bioihbjkbjnl/mcl2 huggingface dataset:
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial was to establish the dose-response relation of sugammadex (Org
      25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane
      anesthesia for Japanese participants.
    


Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.
Other intervention name(s): Org 25969; MK-8616; Bridion®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause
      the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the
      adrenal glands from making androgens. Giving radiation therapy with or without goserelin
      after surgery may kill any tumor cells that remain after surgery. It is not yet known whether
      radiation therapy is more effective with or without goserelin in treating prostate cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see
      how well they work compared with radiation therapy alone in treating patients who have
      undergone surgery for recurrent or refractory prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in
           terms of biological and/or clinical progression-free survival, in patients who have
           undergone surgery for recurrent or refractory prostate cancer.

      Secondary

        -  Compare overall survival of patients treated with these regimens.

        -  Compare metastases-free survival of patients treated with these regimens.

        -  Compare the immediate and delayed toxicities of these regimens.

        -  Compare the delay in reaching the prostate-specific antigen nadir in patients treated
           with these regimens.

        -  Compare the quality of life at 1 and 5 years after radiotherapy in these patients.

        -  Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75
           years and over.

      OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

        -  Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin
           subcutaneously on day 1 and again 3 months later.

      Quality of life is assessed periodically.

      After completion of study therapy, patients are followed periodically for 10 years.

      PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.
    

Intervention name(s): goserelin acetate; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Other intervention name(s): ZOLADEX
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; recurrent prostate cancer; stage IV prostate cancer
Management of Thirst, Nursing Care, Postoperative Care
Condition: Postoperative Care; Nursing Caries
Study type: Interventional

Summary: 
      The study was conducted to determine the effect of oral water and ice popsicle on management
      of thirst in the immediate postoperative period as experimental.
    

Detailed description: 
      Also, it is aimed to evaluate validity and reliability of "Safety Protocol for Management
      Thirst in the Immediate Postoperative Period Protocol" which is used to take oral water and
      ice of patients in the immediate postoperative period, as administrative. The study was
      conducted with 150 patients who are transferred to the postanesthesia care unit (PACU) after
      their operation and met study criteria. Patients divided into three groups as the study
      (water group=50, ice group=50) and control (n=50). Patients in the study group were performed
      oral water/ice popsicle after their accession to PACU. However, the control group patients
      have performed rutin treatment and care without any other intervention. Physiologic variables
      and symptoms with thirst were followed in every three group patients at certain times. Data
      were evaluated by using NCSS (Number Cruncher Statistical System) 2007 program.
    

Intervention name(s): WATER; ICE APPLICATION
Intervention type(s): Other; Other
Intervention description(s): ORAL WATER; ICE APPLICATION
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMIZED CONTROLLED STUDY GROUP
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Perioperative nursing; Postanesthesia care; Thirst; Water; Ice
A Prospective Study Investigating the Effects of a Novel Weight Management Program
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and efficacy of a weight management program
      composed of dietary supplements and a reduced calorie eating program.
    


Intervention name(s): Dietary Supplements and TR90 Eating Plan; Placebo and Low Fat Eating Plan
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Myoelectric GutPrint-Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      A feasibility study for assessing and recording myoelectric activity in patients for early
      detection of flare in patients with Crohn's disease and differentiating the myoelectric
      signals from Crohn's disease patients in remission state and healthy controls.
    

Detailed description: 
      Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares
      despite aggressive therapy. Flares are often difficult to predict. The goal of disease
      monitoring is to identify patients at risk for flare in order to treat earlier, with the hope
      of maintaining remission and avoiding irreversible bowel damage such as fistulas and
      strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows
      in some cases ability to predict flare and determine deep remission, this procedure is
      invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal
      pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with
      alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility
      patterns in CD flare and remission states may be helpful for prediction of flare for guiding
      appropriate therapy.

      The goal of this study is to determine whether the motility patterns measured by the G-Tech
      non-invasive, wireless patch system can provide useful insight for routine CD care. Three
      G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch
      to carry with them for the next 3-6 days. Data from the patches is processed offline to
      obtain motility patterns of the stomach, small intestine and colon. These patterns represent
      a rich trove of data that can be studied in multiple ways to provide comparisons and insight.
      Some examples are the overall strength of motor activity in each of the organs, the duration
      and rhythmicity, the correlation with meals, pain events and bowel movements, day to day
      variations and their correlation with symptoms, and diurnal effects.
    

Intervention name(s): G-Tech Gutcheck Myoelectric recording device
Intervention type(s): Device
Intervention description(s): Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other intervention name(s): Gastro-intestinal electrical recording
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects without gastrointestinal symptoms or history of gastrointestinal
        surgeries.

        Patients with Crohn's disease in remission state or flare state (exclude severe Crohn's
        disease due to complexity of disease, complication, and potential needs for surgery; on new
        medications 【e.g. within 3 months of enrollment】 known to alter GI motility or bowel
        surgeries due to potential impact on the G-Tech results)
Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women
Condition: HIV/AIDS; Contraception
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the frequency of ovulation and cervical mucus quality of
      HIV-infected women on efavirenz (EFV)-based antiretroviral therapy (ART) using either a
      single etonogestrel (ENG) implant or two ENG implants for at least one year.
    

Detailed description: 
      Due to drug-drug interactions between efavirenz (EFV) and progestins, HIV-infected women on
      EFV-based antiretroviral therapy (ART) and using the etonogestrel implant have significantly
      lower systemic ENG concentrations than HIV-infected women not on ART. This finding has raised
      concerns regarding the contraceptive efficacy of the ENG implant for women on EFV-based ART
      and clinical studies have an increased rate of pregnancies for women on EFV-based ART and
      using a contraceptive implant. This study a randomized, open-label, longitudinal
      pharmacodynamic study to compare frequency of ovulation between a control group of
      HIV-infected women on efavirenz-based antiretroviral therapy receiving standard dose
      etonogestrel (ENG) implant and a treatment group receiving increased dose ENG implant. The
      overall goal is to assess the pharmacodynamic significance of the known drug-drug interaction
      between EFV and ENG and to determine if the increased dose will overcome this interaction.
      Overall, this study will improve long-acting reversible contraceptive treatment options for
      women living with HIV and prevent unintended pregnancy.
    

Intervention name(s): etonogestrel implant
Intervention type(s): Drug
Intervention description(s): The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
Other intervention name(s): Nexplanon; Implanon
Intervention MeSH terms: Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: etonogestrel; efavirenz; antiretroviral therapy; HIV
Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa
Condition: Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the effectiveness of family-based therapy versus individual
      psychotherapy for the treatment of adolescent anorexia nervosa.
    

Detailed description: 
      In adolescents, anorexia nervosa severely affects physical, emotional, and social
      development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few
      studies have focused on the effectiveness of various types of psychotherapy treatment.
      Family-based therapy may be an effective approach to treating adolescent anorexia nervosa.
      This study will compare the effectiveness of family-based therapy versus ego-oriented
      individual psychotherapy for the treatment of adolescent anorexia nervosa. Simultaneously, it
      will examine potential predictors, mediators, and moderators of weight gain, psychological
      concerns about weight and shape, and changes in family functioning.

      Participants in this open-label study will be randomly assigned to receive one of two types
      of therapy: family-based therapy or ego-oriented individual psychotherapy. Both types of
      therapy will be given for a total of 24 hours over the course of 12 months. Physical and
      psychological assessments will be completed during study visits at baseline, immediately
      post-treatment, six months post-treatment, and one year post-treatment. Amount of weight gain
      will be evaluated, along with changes in weight and body shape concerns, as measured by the
      Eating Disorder Examination.
    

Intervention name(s): Family Based Therapy; Ego-Oriented Individual Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family therapy will be given for a total of 24 hours over the course of 12 months.; Individual therapy will be given for a total of 24 hours over the course of 12 months.
Other intervention name(s): FBT; EOIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Adolescents; Family therapy; Individual therapy
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Condition: Venous Ulcers
MeSH terms: Varicose Ulcer; Skin Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to evaluate the effect of a biological dressing on the healing
      process of venous ulcers. The dressing is a reconstructed skin substitute made with the
      patients own cells.
    

Detailed description: 
      The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin
      substitute, created by the LOEX could be as high-performant, or even better, than the one's
      already existent in North America for the wound care. We anticipate showing on 6 patients
      that ulcer that did not close with conventional treatment, will heal or at least improve with
      this treatment.
    

Intervention name(s): self assembled skin substitute (SASS)
Intervention type(s): Device
Intervention description(s): Wound care with self assembled skin substitute (SASS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee; Menopause
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether shortwave diathermy is effective in
      reducing knee pain and increasing function of the patients with knee osteoarthritis.
    

Detailed description: 
      Osteoarthritis (OA) is the most common degenerative joint disease, resulting in significant
      morbidity and health care expense. It affects more than 60% of Western World adults over the
      age of 65 years. It causes pain and dysfunction in 20% of elderly persons. It can affect any
      joint containing hyaline cartilage; knee is the most commonly affected joint. There are many
      strategies for the treatment of knee OA but a curative method has not been found. Treatment
      is therefore aimed to relief symptoms and to prevent further functional deterioration. It is
      unclear whether any of the treatment modalities is efficacious. Shortwave diathermy (SWD) is
      one of deep heat widely applied to alleviate the symptoms associated with OA. The efficacy of
      SWD for the treatment of OA knee is still inconclusive. The outcome of treatment in previous
      reports varies from null to positive effect. This discrepancy is largely due to the different
      research methodology, the inadequate sample size, the methods used in outcome assessment, and
      the treatment protocols.

      Comparison(s): Peri- or postmenopausal women with OA knee are randomized into two groups,
      receiving a course of either therapeutic SWD or sham SWD. The main outcome measured is the
      change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index.
    

Intervention name(s): Shortwave diathermy
Intervention type(s): Device
Intervention description(s): continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diathermy; Short-wave therapy; Osteoarthritis; Knee
Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Condition: Acromegaly; Olfactory Disorder
MeSH terms: Acromegaly
Study type: Interventional

Summary: 
      A prospective, controlled, single blinded study was planned. 20 patients with Acromegaly
      (Acromegaly Group) and 20 healthy subjects (Control Group) were planned to include in the
      study. Connecticut Chemosensory Clinical Research Center (CCCRC) test was applied to evaluate
      olfactory functions. Olfactory bulb(OB) volumes were measured with a 1.5 T General Electric
      Signa Excite MRI scanner.
    

Detailed description: 
      Acromegaly patients were assessed at the Endocrinology Department for their clinical
      symptoms, and the nasal examination and olfactory evaluation were done at the Department of
      Otorhinolaryngology. OB volume was evaluated by a single blinded radiologist. Control group
      patients that had similar demographical characteristics with the Acromegaly Group were
      recruited in the study.

      The CCCRC test is composed of n-butanol odor threshold test and odor identification test.
      Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was
      calculated as the total CCCRC test score. OB measurements were done individually on the right
      and left olfactory bulbs and the mean OB volume was calculated in cubic millimeters.
    

Intervention name(s): OB volume; CCCRC test
Intervention type(s): Other; Other
Intervention description(s): The mean OB volume was calculated in cubic millimeters and compared between the two groups.; CCCRC test was done for olfactory function assessment and compared between the two groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Acromegaly; Olfaction; Olfactory disorder
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Single Dose Vupanorsen In Healthy Chinese Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the
      pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and
      160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.
    


Intervention name(s): Vupanorsen; Vupanorsen
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg subcutaneous injection; 80 mg subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355
      in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are
      intended to explore the anticipated clinical dose range.
    


Intervention name(s): PF-00610355; PF-00610355; PF-00610355; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): dry powder inhaler, 1472 mcg, single dose; dry powder inhaler, 736 mcg, single dose; dry powder inhaler, 368 mcg, single dose; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus
      50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Vildagliptin; Vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 50 mg vildagliptin; 1 tablet contains 50 mg vildagliptin
Other intervention name(s): Gliptus; Galvus
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)