bioihbjkbjnl/mcl2 huggingface dataset:
Sportcheck Follow-Up
Condition: Cardiovascular Diseases; Childhood Obesity; Hypertension
MeSH terms: Cardiovascular Diseases; Pediatric Obesity
Study type: Observational

Summary: 
      The study resembles a four-year follow-up on the influence of physical activity and fitness,
      blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the
      predictive value of retinal vessel diameters for the development of childhood hypertension.
    

Detailed description: 
      The study aims to examine the usefulness of retinal vessel analysis in childhood
      cardiovascular prevention. It investigates the long-term influence of physical activity and
      fitness on retinal vessel diameters, blood pressure, BMI and psychosocial stress in children.
      The study aims to set new standards for an integrative primary prevention concept to initiate
      healthy ageing from childhood to adulthood.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will be designed as a four-year follow-up of the 2014 Sportcheck. All
        first-graders of primary schools in the canton Basel-Stadt took part in measurements of
        height, body weight and physical fitness during physical education lesson. From the 1255
        children, 540 (43%) were allowed by their parents to join additional measurements of blood
        pressure and retinal vessel diameters and filled in questionnaires. In the year 2018, all
        fifth-graders of Basel-Stadt will be invited to take part in the same measurements as in
        2014. All children will again conduct physical fitness tests and measurements of height and
        body weight during physical education. All children with an informed consent will
        participate in the same medical tests that were performed four years previously.
      
Keywords: retinal vessels; physical activity; children; psychosocial health
The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits
Condition: Obesity
Study type: Interventional

Summary: 
      This study evaluates the efficacy of a stress-focused tailored weight loss intervention
      compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0)
      African American women.
    

Detailed description: 
      Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors
      (e.g. diet and exercise) among African American women. African American women consistently
      lose less weight than their Caucasian counterparts in weight loss interventions. One reason
      for this disparity may be due to the failure of most weight loss interventions to address
      stress management adequately or in a culturally competent way.

      The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight
      loss intervention compared to a standard weight loss intervention on weight loss in severely
      obese (BMI > 40.0) African American women. The stress-focused weight loss intervention will
      incorporate stress management content throughout the entire intervention and will include
      content that is culturally tailored. The standard weight loss intervention will cover stress
      management techniques during one of the 14 sessions and the material will be more generic in
      nature (e.g. not culturally tailored).
    

Intervention name(s): Standard Weight Loss Intervention; Stress-Focused Weight Loss Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14-session/6-month standard behavioral weight loss intervention; 14-session/6-month tailored behavioral weight loss intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: African American, Women; Weight Loss
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium
      Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese
      end-stage renal disease (ESRD) patients on chronic haemodialysis.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to determine the safety and
      efficacy of SZC in ESRD subjects with hyperkalaemia and on stable haemodialysis. This study
      consists of a screening period, an 8-week randomized treatment period, and a follow-up
      period. Approximately 134 stable haemodialysis subjects with persistent pre-dialysis
      hyperkalaemia will be enrolled in the study across research sites in China.
    

Intervention name(s): Sodium Zirconium Cyclosilicate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days.; Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
Other intervention name(s): SZC; Lokelma; ZS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188)
      relative to placebo in adult patients (18-60 years of age) with acute exacerbation of
      schizophrenia.
    


Intervention name(s): Placebo; Cariprazine; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo was supplied in capsules.; Cariprazine was supplied in capsules; Risperidone was supplied in capsules
Other intervention name(s): RGH-188; Risperdal
Intervention MeSH terms: Risperidone; Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Traditional vs Oral Fluid Management in Total Knee Arthroplasty
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been
      established in patients undergoing orthopaedic surgery. Recent randomized trials in major
      abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital
      stay. This study will investigate the effects of two regimens of intraoperative fluid
      management ("traditional" vs. "oral") with physiologic and patient function as primary
      outcome measures after surgery.
    

Detailed description: 
      Evidence-based guidelines on optimal perioperative fluid management have not been established
      in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid
      management has been arbitrary without evidence based guidelines established following total
      joint replacement. The investigators have observed many patients post-operatively with side
      effects such as fluid overload leading to medical complications requiring either prolonged
      hospitalization or readmission. Additionally, this overload may lead to wound healing
      complications secondary to fluid shifts which may be devastating in this patient population.
      Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid
      may increase morbidity and hospital stay. Additionally, this increase fluid may be
      detrimental in patients with anastomosis leading to failure and/or complications in this
      patient population. The investigators have defined to specific groups of interest to study in
      this patient population with regards to fluid management. The first group is the
      "traditional" IV fluid group where the anesthesiologist gives an unspecific amount of fluid
      intraoperatively and post-operatively the patient gets a set amount of fluid based on
      "protocol" on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the
      protocol utilized by most orthopaedic practices throughout the United States. The second
      group is defined as patients who are given a specific protocol preoperatively to optimize
      hydration, followed by limited fluids intraoperatively based on physiologic parameters. This
      study will investigate the effects of two regimens of intraoperative fluid management
      ("traditional" vs. "oral") with
    

Intervention name(s): Pre Operative Oral Fluids
Intervention type(s): Other
Intervention description(s): Patients will be self hydrating prior to their total knee replacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fluid Management
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Condition: Myocardial Infarction; Unstable Angina; Malignancy; Cognitive Decline; Diabetes Mellitus; Metabolic Syndrome
MeSH terms: Myocardial Infarction; Angina, Unstable; Metabolic Syndrome; Infarction; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of the consumption of two different
      dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular
      events of persons with coronary disease.
    

Detailed description: 
      Randomized clinical trial involving 1002 patients with coronary disease that are undergoing
      one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat
      500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14%
      monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b)
      Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).

      Primary Objective:

      Combined apparition of hard cardiovascular events (myocardial infarction, revascularization,
      ischemic stroke, documented peripheral artery disease or cardiovascular death).

      Secondary Objectives:

      Those related in the Outcome Measures section of this webpage
    

Intervention name(s): Mediterranean Diet; Low Fat Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).; Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular events; Blood pressure; Incidence of Cancer; Cognitive decline; Mediterranean Diet; Secondary Prevention; Low fat diet
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type
      2 diabetics being treated with basal insulin.
    


Intervention name(s): MK-0941; Placebo; LANTUS insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2.; 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.; LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Other intervention name(s): LANTUS
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion
Condition: Spinal Fusion
Study type: Interventional
Phase: Phase 3

Summary: 
      Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in
      latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine,
      a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also
      the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not
      been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during
      posterior spinal fusion surgery before and after Dexmedetomidine administration.
    

Detailed description: 
      Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for
      elective posterior spinal fusion surgery were enrolled in this prospective study. After
      induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed
      after 15min (in order to wash out the propofol used for induction). Infusion of
      Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral
      Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was
      maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37)
      and data were analyzed over that period.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.
Other intervention name(s): Control-no dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine, spinal fusion, SSEP
Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's
      Laboratories Limited under fed conditions.
    

Detailed description: 
      randomized, 2-way crossover; bioequivalence study of citalopram hydrobromide 40 mg tablets
      and celexa 40 mg tablets administered as

      1 x 40 mg tablet in healthy subjects under fed conditions.
    

Intervention name(s): Citalopram Hydrobromide
Intervention type(s): Drug
Intervention description(s): Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): Celexa Tablets 40 mg
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Citalopram
A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Condition: Bioequivalence
Study type: Interventional

Summary: 
      A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin
      Hydrochloride Liposome Injection Under Advanced Breast Cancers.
    

Detailed description: 
      Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection , 20 mg:10 mL (CSPC OuYi
      Pharmaceutical Technology Co, Ltd), and Caelyx®, 20 mg:10 mL (Janssen-Cilag International
      NV), in Advanced Breast Cancers.
    

Intervention name(s): Doxorubicin Hydrochloride Liposome Injection
Intervention type(s): Drug
Intervention description(s): 50mg/m2,IV on Day 1 of each cycle
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator
Condition: Fat Reduction in the Upper Arm
Study type: Interventional

Summary: 
      This study is being performed to reduce unwanted fat in the arm using a new applicator for
      the Zeltiq System.
    

Detailed description: 
      The primary objective of the study is to evaluate the safety and performance of the CoolFlex
      applicator in the flat configuration for reduction of fat in the upper arms.
    

Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Condition: Relapsed or Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in
      patients with relapsed refractory multiple myeloma.
    

Detailed description: 
      A multicenter, non-randomized, open-label, dose-exploration study evaluating two new
      formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed
      refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate
      the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate
      the formulations of oprozomib administered at increasing dose levels (dose escalation) in
      combination with pomalidomide and dexamethasone.
    

Intervention name(s): Immediate Release (IR) Formulation; Gastro-Retentive (GR) Formulation; Dexamethasone; Pomalidomide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Immediate Release (IR) Formulation; Gastro-Retentive (GR) Formulation; Dexamethasone; Pomalidomide
Intervention MeSH terms: Dexamethasone; Pomalidomide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective of this study is to investigate the safety, pharmacokinetics and efficacy of
      KDT-3594 in patients with early Parkinson's disease without a concomitant medication of
      L-dopa.
    


Intervention name(s): KDT-3594
Intervention type(s): Drug
Intervention description(s): oral administration, dose titration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal
      candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will
      be conducted to compare the therapeutic efficacy, safety and tolerability of three different
      doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
    


Intervention name(s): arasertaconazole nitrate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arasertaconazole nitrate pessary, placebo pessary; placebo, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VVC; candidiasis; vaginal candidiasis
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Condition: Enoxaparin Sodium is Administered to Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      -  The primary objective of the trial is to assess the single-dose relative bioavailability
           of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by
           subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.

        -  The secondary objective of the trial is to assess safety and tolerability of Chemi
           Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection,
           under fasting conditions in healthy volunteers.
    

Detailed description: 
      This is an open-label, randomised, single-dose, 2-way crossover study to determine the
      comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL)
      with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose
      administration in healthy male and female subjects.

      Each subject received each treatment over two separate treatment periods under fasting
      conditions. Each dosing day for male subjects will be separated by a washout period of at
      least 7 days. The study comprised a pre-study screen (within 14 days of the first dose),
      followed by 2 Treatment Periods (1 and 2). During each treatment period, subjects will reside
      at Simbec from the evening before dosing (Day 1), until at least 36 h post dose (evening of
      Day 2). On admission (Day -1), subjects will provide a urine sample for a drugs of abuse
      screen; this sample will also be tested to confirm a negative pregnancy result in female
      volunteers.

      A single dose of the randomised treatment will be given on the morning of Day 1 following an
      overnight fast and blood PK/PD samples collected from pre-dose up to 36 h post dose (14
      samples). Safety will also be evaluated at specified times throughout the study.

      The post study visit will be conducted on Day 2 (36 h post-dose) of Treatment Period 2.
    

Intervention name(s): Enoxaparin Sodium; Enoxaparin Sodium
Intervention type(s): Drug; Drug
Intervention description(s): comparison of bioavailability of generic Enoxaparin Sodium and Clexane; comparison of bioavailability of generic Enoxaparin Sodium and Clexane
Other intervention name(s): Clexane; generic Enoxaparin Sodium
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other