bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals'
      liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first
      dose of vaccination.
    


Intervention name(s): GSK Biologicals' human rotavirus vaccine 444563; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Oral, two doses.; Oral, two doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human rotavirus vaccine
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Condition: Contraception
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone
      acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The
      current study will assess the steady-state pharmacokinetics and pharmacodynamics of
      medroxyprogesterone acetate (MPA) and estradiol (E2) after administration of Cyclofem® and
      will provide critical information to determine similar bioavailability of Cyclofem to Lunelle
      in women residing in the United States of America.
    

Detailed description: 
      Concept Foundation, an international nonprofit organization based in Bangkok, Thailand, was
      given the commercial rights to Cyclofem® by the World Health Organization (WHO) for use
      internationally. The brand names that the Concept Foundation has registered internationally
      include Cyclofem®, and Novafem® (Pharmacia Pharmaceuticals, Peapack NJ, formerly (Pharmacia
      and Upjohn of Kalamazoo, Michigan). The company launched its product under license from
      Concept Foundation with their own brand name, Lunelle™ in the US market. Lunelle™ was
      approved by the Food and Drug Administration (FDA) in October, 2000 following which
      approximately 350,000 women had used the product. However, following the acquisition of
      Pharmacia and Upjohn by Pfizer and due to several production problems, Pfizer withdrew
      Lunelle™ from the United States (US) market. Concept Foundation has licensed Sun
      Pharmaceutical Industries Ltd, Mumbai, India to manufacture and market Cyclofem® in India and
      other developing countries. United States Food and Drug Administration (US FDA) approval of
      Cyclofem® is pivotal to the ultimate acceptance of such products in many countries because of
      the rigorous standards applied by the Food and Drug Administration (FDA) for drug safety and
      efficacy. This initial pharmacokinetic (PK) study is the first step on the road to Food and
      Drug Administration (FDA) approval with the ultimate goal to expand the access and range of
      methods available to women in the public sector. Approval of Cyclofem® by the United States
      Food and Drug Administration (US FDA) would also allow the reintroduction of CICs to the
      United States (US) market.
    

Intervention name(s): Injection Cyclofem
Intervention type(s): Drug
Intervention description(s): Injection Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection.
Other intervention name(s): Cyclofem
Intervention MeSH terms: CycloProvera
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraceptive; Injectable
PK Study of T-817 in Subjects With Hepatic Impairment
Condition: Healthy; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and
      T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment
      compared to matched healthy control subjects.

      The secondary objective is to determine the safety and tolerability of single-dose T -817MA
      (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
    


Intervention name(s): T-817MA
Intervention type(s): Drug
Intervention description(s): A single oral dose of 448 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether longer locomotor training results in a mor
      favorable outcome in patients with incomplete spinal cord injury.
    

Detailed description: 
      About half of patients who experience a traumatic spinal cord injury (SCI) have still motor
      and/or sensory function below the level of the lesion. A large proportion of these patients
      become ambulatory within the first six months after the SCI. In order to optimally train the
      walking function patients are partially unloaded from their body weight while they walk on a
      moving treadmill. In severe cases therapists have to assist the leg movements which is an
      exhaustive work limiting training time. In the last few years robotic devices have been
      developed which enable longer training time. Studies evaluating the training of patients with
      hemiparesis showed that longer training time is associated with a better outcome. The present
      study aims at evaluating the effect of training time within the robotic device on the
      recovery of ambulatory function. Subject with an acute incomplete SCI will be included. The
      intervention consist of a walking training which lasts at least 50min, the training of the
      control group last at maximum 25min. Both groups will undergo 3-5 trainings per week. Group
      assignment will be performed at random. The study lasts for 8 weeks. The primary outcome will
      be the self selected walking speed which will be assessed bi-weekly during the training
      period and 4 months later.
    

Intervention name(s): Locomotor training using a robotic device; Locomotor training using a robotic device
Intervention type(s): Device; Device
Intervention description(s): 50min walking time, 3-5 trainings/week.; 25min walking time, 3-5 trainings/week.
Other intervention name(s): Lokomat, Hocoma AG, Volketswil/Switzerland; Lokomat, Hocoma AG, Volketswil/Switzerland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Spinal Cord Injuries, Locomotor training, Dose-Response
Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy
Condition: Lymphoma, Mantle- Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in
      participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy
      and who had received at least one prior antineoplastic agent other than Velcade®, either
      separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade®
      therapy was determined by the study investigator based on clinical evaluations. Participants
      were considered refractory to Velcade® if they have documented radiological progression on or
      within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of
      the last dose of the last component of a combination therapy which included Velcade®.
    


Intervention name(s): Everolimus
Intervention type(s): Drug
Intervention description(s): Everolimus tablets
Other intervention name(s): RAD001
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mantle Cell Lymphoma; Lymphoma; B-Cell Lymphoma; Mantle Zone Lymphoma; Refractory Lymphoma; Aggressive Lymphoma; PILLAR-1
The Initiation of Swallowing Can Indicate the Prognosis of DOC
Condition: Minimally Conscious State; Vegetative State
MeSH terms: Persistent Vegetative State
Study type: Observational

Summary: 
      This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it
      is a good item as a stimulus and to detect the relationship between the initiation of
      swallowing act and the prognosis of DOC patients.
    

Detailed description: 
      Studies suggest that the initiation and patterning of swallowing of the pharyngeal phase is
      also under active cortical control for both spontaneous as well as volitional swallowing in
      awake humans and non-human primates. A recent study found that most patients of disorders of
      consciousness (DOC) would recover their swallowing ability quickly. And there is no study
      about detecting the initiation of swallowing act in DOC patients. This study is aimed to
      detect the initiation of swallowing act in DOC patients, to find if it is a good item as a
      stimulus and to detect the relationship between the initiation of swallowing act and the
      prognosis of DOC patients. DOC patients were recruited (standard diagnosis procedure is 4
      times CRS-R testing within 2 weeks). The different four stimuli were as follows: 1) One
      command (as recommended in CRS-R) which was "open your mouth". 2) Put a spoon in front of the
      patient's mouth without a command. 3) One command with a spoon in front of the mouth, the
      command is "there is a spoon and open your mouth". 4) One command with a spoon full of water
      in front of the mouth, the command is "there is a spoon with water and open your mouth". We
      presented these stimuli orderly in front of the patient's mouth and presented any one of them
      over 4 trials at 15 second intervals.
    

Intervention name(s): Coma Recovery Scale-Revised
Intervention type(s): Diagnostic Test
Intervention description(s): Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected four stimuli: 1) only a command (as recommended in CRS-R), which was "open your mouth"; 2) only a spoon without a command; 3) a spoon and a command, the command was "there is a spoon and open your mouth"; 4) a spoon with water and a command, the command was "there is a spoon with water and open your mouth". In brief, we presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with disorders of consciousness
      
Keywords: disorders of consciousness; swallowing; prognosis prediction; minimally conscious state; vegetative state
EaseVRx for the Reduction of Chronic Pain and Opioid Use
Condition: Chronic Low-back Pain
MeSH terms: Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a
      prescription pain management tool that manages the symptoms associated with chronic pain and
      reduces or eliminates the risk of opioid dependence. The investigators will conduct a
      proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as
      a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering
      pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid
      pharmacotherapy, and improving pain-related quality of life.
    

Detailed description: 
      EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a
      prescription pain management tool that manages the symptoms associated with chronic pain and
      reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of
      cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction,
      biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation
      programs. The investigators will conduct a proof-of-concept randomized study to assess the
      feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100
      chronic low back pain patients by gathering pilot data on the efficacy of the intervention in
      decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related
      quality of life. While VR has been tested in academic medical centers and shown to be
      efficacious in the management of acute pain, this study will investigate the feasibility of
      VR use at home to manage chronic pain in preparation for a larger efficacy trial.
    

Intervention name(s): EaseVRx headset; Active control VR sham program
Intervention type(s): Device; Device
Intervention description(s): EaseVRx is a virtual reality therapy intended to treat chronic pain; VR, 2d visual wildlife scenes similar to some EaseVRx content
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl In Hysteroscopıc Operations.
Condition: Deep Sedation; Ambulatory Surgery; Ambulatory Surgical Procedure
Study type: Observational [Patient Registry]

Summary: 
      In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and
      remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics,
      recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of
      the ambulatory surgery.
    

Detailed description: 
      This study was conducted prospectively after the approval of Van Yüzüncü Yıl University
      Ethics Committee. A total of 80 participants in 2 groups of 40 ASA I-II, aged 18-65 years
      were included in the study. On the day of the operation, vascular access was established with
      a 20 G branule in all patients before the procedure. The participants who were taken to the
      gynecology table were routinely monitored in the supine position as required by the
      procedure.

      All participants were premedicated with 0.025 mg/kg Midazolam (Demizolam®, Dem, Turkey) after
      starting oxygen at 2 lt/min with a nasal cannula. The participants were randomly divided into
      two groups as Group DP and RP. Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia )
      1mg/kg bolus was administered to both groups. Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK
      FARMA Turkey)

      1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion
      dose was started. After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline,
      Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was
      started.Hemodynamic data and respiratory parameters of the groups before and after sedation
      were recorded. The depth of anesthesia was recorded using the Ramsey sedation scale, and the
      recovery scores were recorded with the Modified Aldrete score. The facial pain scale was used
      to evaluate pain. Depth of anesthesia was provided so that the Ramsey Sedation Scale of the
      patients was greater than four. Patients with RSS&lt;4 were excluded from the study by
      administering additional propofol.
    

Intervention name(s): Propofol-Dexmedetomidine
Intervention type(s): Combination Product
Intervention description(s): Propofol-Dexmedetomidine AND Propofol-Remifentanil
Other intervention name(s): Propofol-Remifentanil
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        This study was conducted prospectively after the approval of Van Yüzüncü Yıl University
        Ethics Committee. A total of 80 patients in 2 groups of 40 ASA I-II, aged 18-65 years were
        included in the study.
      
Keywords: Ambulatory Anesthesia; Hysteroscopy; Sedation; Dexmedetomidine; Remifentanyl
Evaluation of Spine Surgery Analgesic Pathway
Condition: Posterior Spine Surgery
Study type: Interventional

Summary: 
      Investigators plan to study the role of spine surgery analgesic pathways - for procedures
      with high risk of postoperative pain - in improving the quality of recovery
    

Detailed description: 
      This is a randomized controlled trial comparing "spine surgery analgesic pathway" with "usual
      care" in improving postoperative quality of recovery and pain management in spine surgery
      patients. At the time of surgery office visit or at the time of preoperative assessment by
      anesthesia care team, risk factor for suboptimal pain management will be identified and
      documented. Patients will be assessed at the time for surgical office visit for their risk
      for severe post-operative pain. Patients with 2 or more risk factors will be classified as
      high-risk for severe postoperative pain and the patients with less than 2 factors as low
      risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one
      of the 2 study groups on the day of the surgery:

        1. "Usual care" group A

        2. "Care pathway" group B

      If the participant is randomized to the "spine surgery analgesic pathway" group the
      participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery
      for their specific pain management needs. The participant will also get some additional
      medication for pain in preoperative and intraoperative period. Before surgery the participant
      will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is
      asleep the participant will receive an infusion of ketamine and lidocaine through the
      participant venous line. After the surgery the participant will receive pain medications as
      per current standard protocol including acetaminophen and gabapentin. Pain management team
      specialist will follow for pain control after a surgery as needed.

      If the participant is randomized to the "usual care" group the participant will be given
      placebo preoperatively; the rest of the time pain medication will be provided in a routine
      manner as per the anesthesia care team and the surgical team. Pain management team specialist
      will follow for pain control after a surgery as needed.

      The primary outcome will be assessed on post-operative day 3: The participants will complete
      a short survey about quality of recovery.
    

Intervention name(s): Spine surgery analgesic pathway; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Enhanced pain management care; Standard of pain management care
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The present study aimed to investigate the importance of gravitational induced forces that
      appear during normal ambulation for the health of muscles, bones and blood vessels. The main
      hypothesis of the present study is that gravitational loading alone, without muscle
      contractions, is insufficient to maintain bone strength.
    

Detailed description: 
      The 56day unloading intervention with HEPHAISTOS had the following key objectives:

        1. Primary objective: Assessment and evaluation of bone adaptation.

        2. Secondary objective: Assessment and evaluation of functional and structural muscular
           adaptations.

        3. Third objective: Assessment and evaluation of functional and structural vascular
           adaptations.

        4. Fourth objective: Assessment and evaluation if the present findings deviate from
           findings observed in established unloading models.
    

Intervention name(s): HEPHAISTOS
Intervention type(s): Device
Intervention description(s): HEPHAISTOS unloading orthotic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bone density; weight bearing; muscle atrophy; vascular degeneration; gravitational loading; muscular unloading
Effect of Raisins on Cognitive Function in Healthy Older Adults
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective:To assess the effect of an intervention based on including 50 g of raisins
      (sultanas) daily in the diet for 3 months on improving cognitive performance, cardiovascular
      risk factors and inflammatory markers in a population of older adults without cognitive
      impairment.

      Methodology: Randomised two parallel-group clinical trial. Population: 80 patients between 70
      and 80 years of age will be included, selected from primary care clinics in Salamanca and
      Zamora.

      Measurements and intervention: Participants included in the study will have a baseline visit
      and two evaluations visits at 3 and 6 months where cognitive performance (attention,
      executive functions, verbal memory, working memory and language) will be assessed using a
      brief neuropsychological battery; quality of life, using the WHOQol- AGE and EUROQOL-5D
      questionnaire; blood pressure; glycaemia; body composition, using an impedancemeter; and
      different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis factor alpha
      (TNF); and different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis
      factor alpha (TNF-α).

      Participants will be randomised using the Epidat 4.0 programme into 2 groups (control group
      and intervention group) with a ratio of 1:1. Both groups will be instructed to continue with
      their usual dietary pattern without changing their habits during the study period.

      Those in the control group will not receive any amount of raisins to their usual diet. The
      participants in the intervention group will receive 50 g of raisins and instructions on the
      time of day to take it (at night). The duration of this intervention will be 3 months. The
      daily nutritional intake of this amount of raisins is as follows: 146 kcal; 0.25 g of fat; 34
      g carbohydrates of which 34 g sugars; 1.3 g protein; 1 g fibre. The total polyphenol content
      of total polyphenols from 50 g of raisinas is approximately 532,5 mg (phenols explorer
      database).
    


Intervention name(s): Raisins
Intervention type(s): Dietary Supplement
Intervention description(s): Daily supplementation of 50 g of rainsins for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cognitive dysfunction; Heart Disease Risk Factors; Vitis; Polyphenols; Clinical Trial