bioihbjkbjnl/mcl2 huggingface dataset:
Effect of B. Longum 1714™ on Sleep Quality
Condition: Subjective Sleep Quality; Objective Sleep Quality
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effect of supplementation with the B. longum 1714™
      strain on subjective and objective sleep quality in healthy participants.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel group study, designed to
      assess the effectiveness & safety of the B. longum 1714™ strain, when consumed once daily, on
      sleep quality. The 8-week intervention study will be conducted in otherwise healthy
      participants with a Pittsburgh Sleep Quality Index (PSQI) score of greater than, or equal to
      5, a HADS-A and HAD-D score less than or equal to 14 and an Insomnia Severity Index of less
      than 11. Participants (N=90) will be pre-screened online, then visit the study site 4 times
      during the course of the 8 - 10 weeks' study (2 weeks screening period, followed by 8-week
      intervention). The first visit will be for screening, second visit will be baseline (and
      start of intervention - either active or placebo), third visit will be mid-intervention, and
      fourth visit will be at the end of intervention. Questionnaires will be administered at visit
      2, 3 and 4, and research blood and saliva will also be collected at these time points. Hair
      sample will be taken at visit 2 and 4 while stool sample will be collected at visit 4.
      Participants will wear an actigraph and fill in a sleep eDiary for the whole intervention
      period (from visit 2 to visit 4).
    

Intervention name(s): Probiotic capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each probiotic capsule contains 1 x 10^9 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsules will be supplied by PrecisionBiotics Ltd.; Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bifidobacterium longum 1714™; probiotic; sleep quality; PSQI; actigraphy; sleep latency; sleep efficiency
Ziprasidone in the Treatment of Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: The aim of this double-blind, placebo-controlled study was to evaluate the
      efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline
      Personality Disorder (BPD).

      Method: Sixty BPD patients were included in a 12-week, single-center, double-blind,
      placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a
      1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use
      in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports
      related to affect, behavior, psychosis, general psychopathology domains and clinical safety
      were included.
    

Detailed description: 
      The American Psychiatric Association (APA) Guidelines for the Treatment of Borderline
      personality disorder recommend that pharmacological treatment for BPD has an important
      adjunctive role, especially for diminution of symptoms such as affective instability,
      impulsivity, psychotic-like symptoms, and self-destructive behavior. Studies conducted with
      low doses of conventional antipsychotics have showed significant improvements in specific
      symptoms such as hostility, impulsiveness, mood, and psychotic symptoms.

      The introduction of atypical antipsychotics, with a more favorable tolerance profile,
      increases clinicians' options for treating BPD. Olanzapine has proven its efficacy in four
      double-blind, placebo-controlled clinical trials in patients with BPD. Ziprasidone is an
      atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and
      adrenergic receptors. It has proven to be effective for schizophrenia, schizoaffective and
      acute mania disorders and the incidence of side effects is low.

      Although clinical findings and the pharmacological activity of ziprasidone suggest the drug
      may have therapeutic benefits in BPD patients, no controlled studies have yet been conducted
      in these patients. We carried out a randomized, double-blind, placebo-controlled study to
      evaluate efficacy and tolerability of ziprasidone in the management of BPD patients with
      moderate-high clinical severity.
    

Intervention name(s): ziprasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose flexible from 40 to 200 mg/d during 12 weeks; flexible doses from 40 to 200 mg/d during 12 weeks
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Borderline Personality Disorder; ziprasidone
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
Condition: Type 2 Diabetic Patients; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will
      undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety
      state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will
      evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima
      Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform
      MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability
      Score)questionnaires.
    


Intervention name(s): type 2 diabetic patients
Intervention type(s): Other
Intervention description(s): males; type 2 diabetic patients
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        males with type 2 diabetes mellitus
      
Keywords: type 2 diabetes mellitus; male; erectile dysfunction
Assessment of an Automatic Closed-loop Insulin Delivery System
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The overall aim of this research proposal is to determine the safety, feasibility and
      efficacy of an automatic closed-loop insulin delivery system.
    

Detailed description: 
      This study will be completed in two parts.

      The initial part of this study will be an inpatient evaluation of the system with the primary
      goal of assessing safety and feasibility. This will involve 8 subjects with type 1 diabetes,
      aged 14 - 40 years, admitted for up to 60 hour. Plasma glucose levels will be collected
      hourly and tested by YSI (YSI 2300, Yellow Springs Instrument). These studies will be
      performed at Stanford University and will include group sporting activities to mimic the
      diabetes camp environment. Capillary blood glucose testing will be performed every 2-3 hours
      before meals, snacks, exercise, and prebed by subjects with research staff supervision during
      the day and at 00:00, 03:00 and 07:00 by research staff. These data will be reviewed by the
      DSMB before proceeding to camp studies.

      The second part of this study will be to test the efficacy of the system during diabetes
      summer camps. We will test the system in subjects with type 1 diabetes, aged 14-40 years,
      attending diabetes camp. There will be 20 subjects recruited, with 10 subjects randomized to
      the control arm Medtronic 530G system with threshold suspend (control group) and 10 subjects
      randomized to the automatic closed-loop insulin delivery (intervention group). Capillary
      blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise and
      prebed by subjects with research staff supervision and at 00:00, 03:00 and 07:00 by research
      staff. The primary aim of this study is to generate preliminary data of system safety and
      efficacy in a closely supervised environment that challenges glucose control.
    

Intervention name(s): Automatic closed-loop insulin delivery; Control
Intervention type(s): Device; Device
Intervention description(s): Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes.; Threshold suspend
Other intervention name(s): 530G Pump
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Infusion Systems; Continuous Glucose Monitors
Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three-way, three-sequence, two treatment, partial
      replicate, crossover, open-label study to determine the bioequivalence of Budesonide from
      Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) versus Uceris 9 mg Extended Release
      tablets (Man. for: Salix Pharm., a division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A.,
      Italy by license of Cosmo Tech. Ltd., Ireland, Product of France) 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): Ekmasonid; Uceris (first dose); Uceris (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 extended release tablet contains 9 mg Budesonide; 1 extended release tablet contains 9 mg Budesonide; 1 extended release tablet contains 9 mg Budesonide
Other intervention name(s): Uceris; Uceris; Uceris
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      The Motor Function Measure (MFM), a reliable tool assessing motor function and its
      progression in most neuromuscular diseases, is widely used in France in many teams. It can be
      used regardless of the severity of the motor impairment or the ambulatory status of the
      patient, allowing its use throughout the whole follow-up period of the patient, even in case
      of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally
      validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items
      originally validated for patients between 2 and 6 years old (MFM-20).

      In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and
      reliably monitor the evolution of the motor function of children treated with Nusinersen, we
      propose in this project to study the sensitivity to treatment-induced change of MFM-32 and
      the validity of the scale in this population.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Boys and girls with Type 1 or 2 Spinal Muscular Atrophy, genetically confirmed

          -  Aged 2 to 6 years old

          -  Treated by Nusinersen for at least two months

          -  With parental assent
      
Keywords: Spinal Muscular Atrophy, Motor Function Measure,Nusinersen
Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether the food matrix has an influence on the
      prebiotic efficacy (bifidobacteria growth) of chicory-derived Orafti® inulin in healthy adult
      volunteers. The main question it aims to answer is:

      Does the food matrix influence the prebiotic effect of chicory-derived inulin in terms of
      stimulation of bifidobacteria in the gut microbiota Participants will receive one of three
      food items containing inulin or pure inulin dissolved in water daily for 10 days. The food
      items or pure inulin powder will deliver 10 g/d inulin split into two dosages of 5 g/d. They
      will provide stool samples before and at the end of the intake period. They will record any
      gastrointestinal sensations and bowel habits in a diary. Urinary samples will be collected at
      baseline and end of intervention for analysis of metabolites with Nuclear Magnetic resonance
      (NMR).
    


Intervention name(s): Inulin
Intervention type(s): Other
Intervention description(s): Each intervention provided 10 g/d inulin split into two dosages of 5 g.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: gut microbiota, prebiotic intake, Bifidobacterium
Efficacy and Dose Ranging Study of Seroguard
Condition: Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled,
      phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic
      adhesive disease in Study centres in Russia.
    

Detailed description: 
      In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a
      study design meeting the set objectives was selected: prospective, multi-center,
      double-blind, randomized, parallel group, placebo-controlled study.

      Given the fact that comparison with placebo is considered the best way to prove efficacy and
      safety of a drug and that currently there are no drugs with a similar mechanism of action at
      the pharmaceutical product market, a placebo-controlled, parallel group study design was
      selected.

      A randomized, parallel group study design was chosen in order to ensure minimization of a
      selection bias.

      Subjects were randomized into four groups (two groups of the test drug and two placebo groups
      corresponding to the two doses) to enable a comparison of Seroguard administration at two
      doses.

      A double-blind study design was selected in order to ensure minimization of an outcome
      evaluation bias.
    

Intervention name(s): Seroguard; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Seroguard 0.41 g/L solution; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adhesion; Efficacy
Hannover Dialysis Outcome Study
Condition: Acute Kidney Failure
MeSH terms: Acute Kidney Injury; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Mortality rates of patients with acute kidney injury in the intensive care unit have changed
      little over the past few decades despite significant advances in supportive care. Few
      interventions have been shown to result in an improvement of in-hospital mortality of these
      patients, with dose of renal replacement therapy (RRT) being one of the most important.
      Patients undergoing continuous veno-venous hemofiltration had better outcomes with
      ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h.
      In a different trial, intermittent hemodialysis on a daily basis resulted in better control
      of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute
      renal failure than thrice weekly hemodialysis. In the present study we examine survival and
      renal recovery in critically ill patients with acute kidney injury that are treated with a
      currently recommended (standard) dose of RRT, and patients that receive intensified RRT.
    


Intervention name(s): Standard extended dialysis; Intensified extended dialysis
Intervention type(s): Device; Device
Intervention description(s): Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L); Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Extended dialysis; Acute kidney injury; Intensive care unit; Renal replacement therapy; Survival; Dialysis
Changes in Functional Movement Scores Associated With Multimodal Chiropractic Care: a Pilot Feasibility Study
Condition: Chiropractic
Study type: Interventional

Summary: 
      Emergency medical services (EMS) personnel are at high risk of injuries, often related to
      overexertion while lifting or carrying patients or equipment. They require a high level of
      functional fitness to operate safely and avoid injuries. The purpose of this pilot study was
      to explore feasibility and assess effects of multimodal chiropractic care on Functional
      Movement Screen (FMS) scores among EMS students.
    

Detailed description: 
      EMS students at a local community college voluntarily completed baseline FMS testing. Those
      who obtained 14 or less, a sign of movement dysfunction, were recruited to participate in a
      study to evaluate effects of multimodal chiropractic care on FMS scores. Participants
      received multimodal chiropractic care with an emphasis on spinal manipulation and corrective
      exercise for up to 6 weeks.
    

Intervention name(s): multimodal chiropractic care
Intervention type(s): Other
Intervention description(s): functional movement score followed by intervention of multimodal chiropractic care including spinal/extremity manipulation and exercise recommendation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: single group pilot study to determine feasibility and potential effect size
Masking: None (Open Label)
Primary purpose: Other
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section
Condition: Hypotension; Nausea; Vomiting
MeSH terms: Hypotension; Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in
      caesarean deliveries. This is usually associated with maternal hypotension and other adverse
      side effects. Prophylactic intravenous administration of ondansetron immediately and 5
      minutes preoperatively have shown to provide a protective effect against hypotension while
      other studies have shown little effect on the incidence of blood pressure drop in healthy
      parturients.

      The investigators will study the effect of different doses and timing of intravenous
      ondansetron in full term obstetric patients undergoing elective lower segment caesarean
      section under spinal anaesthesia on the incidence and severity of hypotension and other
      adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine
      and fentanyl.
    

Detailed description: 
      This prospective randomized double-blind placebo-controlled study will include 150 American
      Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for
      elective caesarean delivery under spinal anaesthesia.

      Patients will be randomly allocated into three groups (n = 50) to receive intravenous
      ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or
      placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.

      Hemodynamic variables and other adverse effects will be assessed at 16 time points
      intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation,
      nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus,
      perioperative vasopressor requirements and patients' satisfaction.

      Participants will be randomly allocated preoperatively as per randomizer.org software and
      will be blinded from other anaesthetists performing the spinal block and following patients
      intraoperatively.
    

Intervention name(s): Ondansetron; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): ondansetron was administered 20 minutes prior to spinal anesthesia.; Placebo of 10 mL normal saline was administered.
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ondansetron; hypotension; nausea and vomiting; cesarean section