bioihbjkbjnl/mcl2 huggingface dataset:
PHYSICAL ACTIVITY AS COPING STRATEGY FOR ACADEMIC STRESS AMONG UNDERGRADUATE FEMALE COLLEGIATE STUDENT
Condition: Physical Activity and Stress
Study type: Interventional

Summary: 
      Physical Inactivity is one of the major cause causing academic stress in students, so
      effectiveness of Light, moderate and vigorous physical activity as a baseline treatment were
      assessed through academic stress scale questionnaire, Cohen Perceived stress Scale and rapid
      assessment of physical activity (RAPA).
    

Detailed description: 
      A total of 388 students participated in first phase of study and total 60 students with
      moderate academic stress were filtered. Among those only 37 were physically inactive from
      last one month by the assessment through RAPA (Rapid assessment of physical activity). ASS
      (Academic stress scale), Cohen Perceived stress Scale and RAPA questionnaires were used to
      collect data. Three equally distributed groups were given three different modes of physical
      activities i.e light, moderate & vigorous.
    

Intervention name(s): Light physical activity; Moderate physical activity; Vigorous physical activity
Intervention type(s): Other; Other; Other
Intervention description(s): Each session started with leisure walk, duration of which was set to 35 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks); Each session started with brisk walk, duration of which was set to 30 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks); Each session started with jogging, duration of which was set to 15 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; academic stress; Light Physical activity; Moderate Physical Activity; Vigorous Physical Activity
Maintenance Intermittent Therapy for Symptomatic GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a
      maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal
      Reflux Disease (s-GERD).
    


Intervention name(s): Rabeprazole 20 mg
Intervention type(s): Drug
Intervention description(s): rabeprazole sodium tablet 20 mg once daily
Other intervention name(s): rabeprazole
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: non-erosive symptomatic GERD; GERD
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
Condition: Immune Thrombocytopenic Purpura (ITP)
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to assess the ability of eltrombopag to induce sustained
      treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or
      failed to respond to an initial treatment with steroids.
    

Detailed description: 
      Protocol Amendment 01 added a follow-up period of 12 months for patients with sustained
      response off treatment at month 12 to obtain further data on response duration.

      The starting dose was eltrombopag 50 mg daily (25 mg daily for Asian patients and 12.5 mg
      daily for Japanese patients in Japan). The starting dose for this study was consistent with
      the dosing guidelines approved for eltrombopag use in ITP. An increase of eltrombopag dose up
      to 75 mg was allowed for patients who did not respond to standard-dosage treatment and to
      reduce the risk of bleeding. The rationale for this increased dose was to use the minimal
      efficacious dosage of eltrombopag in order to achieve a platelet count ≥ 100×10^9/L and
      maintain it around 100×10^9/L (no counts below 70×10^9/L) for 2 months in order to allow
      patients to start the eltrombopag tapering and withdrawal process.

      Patients who reached a platelet count of >= 100 × 10^9/L and maintained counts around
      100×10^9/L for 2 months with no platelet count < 70 × 10^9/L were eligible for tapering-off
      and treatment discontinuation, which occurred via 25 mg reduction every 2 weeks up to 25 mg
      on alternate days for 2 weeks until treatment discontinuation.

      Patients who successfully discontinue eltrombopag and maintained platelet count >= 30 ×
      10^9/L in the absence of bleeding or use of rescue therapy were followed to month 12. If a
      relapse (defined as platelet count <30 × 10^9/L) occurred during the 12-month treatment
      period, they were offered a new course of eltrombopag treatment within this timeframe at the
      appropriate starting dose. If a patient relapsed in the post 12-month follow-up period, no
      further attempts for tapering and achieving sustained response off treatment were made.

      The taper-off scheme followed recommendations within the current established dosing regimen
      for when to consider dose adjustment.
    

Intervention name(s): eltrombopag
Intervention type(s): Drug
Intervention description(s): 12.5, 25, 50 and 75 mg tablets for oral use once daily
Other intervention name(s): ETB115
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thrombocytopenic; Immune; Platelets; Bleeding; ITP; eltrombopag; ETB115; induce sustained response off treatment; refractory or relapsed; first-line steroids
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives

      Primary Objectives:

        -  Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in
           post-stem cell transplant patients with RSV infection.

        -  Main Study: To determine the antiviral effect of oral A-60444 versus placebo in
           post-stem cell transplant patients with RSV infection and to assess the safety of oral
           A-60444 in post-stem cell transplant patients with RSV infection.

      Secondary Objectives:

        -  To study the pharmacokinetics of A-60444 in the presence of concomitant medications such
           as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV
           infection.

      Sample Size: Six patients will be included in the open, pilot phase of the study and there is
      an option to include a further 22 patients into the main, placebo-controlled study, depending
      on the pilot study findings. An independent Data Safety Monitoring Board will assess the
      findings of the pilot study.
    

Detailed description: 
      Clinical will be recorded daily. A-60444 PK will be studied pre-dose and at peak dose on the
      last day (Day 5) of dosing.
    

Intervention name(s): A-60444
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV; HSCT; HEMATOPOIETIC STEM CELL TRANSPL
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the patient satisfaction and onset of effect following treatment with
      botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
    


Intervention name(s): botulinum toxin Type A
Intervention type(s): Biological
Intervention description(s): 20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Calculated and Graphically Produced Depth of Anesthesia
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and
      postoperative complications in the patient undergoing surgery. Having a unnecessary "deep"
      anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause
      delirium and increase the mortality rate. Being too "light", on the other hand, can make the
      patient experience awareness when muscle relaxant is used. This can lead to serious
      psychological struggles.

      Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can
      be difficult because clinical signs depend on many factors. In addition to clinical
      evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice.
      Unfortunately, this method is not always accurate and has a delay.

      New devices are now developed to calculate the anesthesia level based on the drugs given. The
      level is simultaneously presented graphically on screen. The purpose of this study is to
      investigate and compare clinical parameters within patients undergoing general anesthesia,
      with and without the use of such devices. Hemodynamic stability, less use of adrenergics,
      higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate
      a more precise level of anesthesia, hence, promote patient safety.
    


Intervention name(s): Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
Intervention type(s): Device
Intervention description(s): Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Anesthesia, Methods; Anesthesia, Analysis; Patient Safety; Anesthetics/administration and dosage
A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an
      inhibitor of cytochrome P450 [CYP] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4
      and P-glycoprotein [P-gp]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of
      erdafitinib in healthy adult participants.
    


Intervention name(s): Erdafitinib; Fluconazole; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 4-mg of erdafitinib tablet will be administered on Day 1 in Treatment A and on Day 5 in Treatment B and C.; A 400-mg fluconazole orally (4*100 mg capsules) will be administered from Day 1 to Day 11.; A 200-mg itraconazole orally (2*100 mg capsules) will be administered from Day 1 to Day 11.
Other intervention name(s): G-024
Intervention MeSH terms: Itraconazole; Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Melatonin vs Pregabalin for Anxiolysis and Sedation
Condition: Anxiety
Study type: Interventional
Phase: Phase 4

Summary: 
      preoperative melatonin, pregabalin or both will be given to all patients preoperative
    

Detailed description: 
      On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure
      and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will
      be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a
      warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be
      administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the
      patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature
      hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete
      aseptic technique . The patient was returned to the supine position for 15 min then to
      lateral position with operative side up.

      HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the
      values will be recorded in the anesthesia chart only every five minutes for 2 hours then
      every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal
      injection as time zero.

      Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be
      treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If
      bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR
      (≥60 bpm).
    

Intervention name(s): Melatonin; Pregabalin; Ondansetron 4 MG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery; In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery; before spinal anaesthesia
Intervention MeSH terms: Pregabalin; Ondansetron; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: melatonin; pregabalin
Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
Condition: Covid19; Corona Virus Infection; Autoimmune Diseases; Coagulation Disorder, Blood
MeSH terms: COVID-19; Coronavirus Infections; Hemostatic Disorders; Blood Coagulation Disorders; Autoimmune Diseases
Study type: Interventional

Summary: 
      The purpose of this study to evaluate the translational application of the safe and effective
      treatment of Narrow-Band Ultraviolet light B-band (NB-UVB) to high-risk COVID-19 patients in
      an effort to improve their immune and hemostatic imbalance to increase survival and improve
      outcomes.
    

Detailed description: 
      Study Design

      This is a multi-center, double blind, randomized control trial designed to assess the safety
      and efficacy of daily NB-UVB light for patients presenting to site hospitals over the age of
      50 with a positive COVID-19 panel and at least one comorbidity.

      This trial provides adjunctive therapy and no in-hospital treatments need to be modified in
      any way. The sponsor and the centers acknowledge standards of care are actively evolving and
      this trial is not intended to interfere in any form.

      Double Blind: Patient and Health care provider will be blinded to the treatment vs. placebo
      by use of a non-NB-UVB light card. All dosing and times for treatment and placebo will be
      calculated the same methods.

      Arm A: Control: Will receive non-NB-UVB light during the Treatment Period.

      Arm B: Treatment: Will receive NB-UVB light during the Treatment Period.

      Treatment Phase (Days 1-8): Treatment Schedule will be identical for arm A and B.

      Follow Up Phase (Days 9-28 or discharge): Follow-up will be identical for arms A and B.

      Blood Draw Schedule: Blood draws are to be performed after enrollment, before the first
      treatment day 1 and on days 3, 5, 8, 14 and day of discharge (if prior to day 14 unless blood
      draw has already occurred within one day of discharge).
    

Intervention name(s): Narrow Band ultraviolet B-Band Light; non Narrow Band ultraviolet B-Band Light
Intervention type(s): Device; Device
Intervention description(s): Daily doses of NB-UVB for 8 consecutive days.; Daily doses of non-NB-UVB for 8 consecutive days.
Other intervention name(s): Phototherapy; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 Randomized Placebo Control Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Narrow Band Ultraviolet Light B-Band; NB-UVB; Immune Dysregulation; Vitamin D
Multimedia First Aid Program for Families
Condition: Injury
Study type: Interventional

Summary: 
      Unintentional injuries are the leading cause of death for children and infants under 14 years
      of age. Many of these deaths are preventable, in part by promoting injury prevention
      behaviors but also by administering effective emergency first aid techniques until advanced
      care arrives. This project created a web site program that paired video-based instruction
      with interactive skills training to teach parents of children birth to 12 years old basic
      first-aid and CPR skills, and that included the option to practice skills as needed.
    

Detailed description: 
      Program content was based on the American Heart Association's (AHA) 2010 guidelines for CPR
      and first aid training. The Online IMM course was designed to teach participants in six
      modules: Principles of care; CPR for infants; CPR for children; How to relieve infant
      choking; How to relieve child choking; and Preventing injuries. Participants were also able
      to view text articles on first aid topics, such as Wound care or Caring for burns. Although
      the users of the Online IMM training program did not have direct contact with a manikin
      during their training, there were opportunities to practice CPR skills through the use of
      interactive animations. These animations demonstrated and then encouraged users to practice
      key functions similar to actual CPR skill delivery: including the location, depth and rate of
      compressions, opening the airway and giving breaths. Participants were encouraged to view the
      entire program; however, they could navigate and review all program content as much or as
      little as desired.
    

Intervention name(s): Family First Aid Online Training; Text-only Online Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Web-based interactive multimedia program comprised of videos, interactive animations and text information designed to teach parents of children aged birth to 12 years old basic first-aid and CPR skills, including the option to practice skills as needed.; Online text created from the American Heart Association's 2010 guidelines for CPR training via a computer, depicting infant, child and adult CPR skills and choking relief.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: children; parents; internet; video; training; interactive
High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant
Condition: T-cell Lymphoma; Leukaemia
MeSH terms: Lymphoma; Leukemia; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Observational

Summary: 
      Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and
      Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than
      65 years old, an allogeneic donor is searching out. Patients included at relapse and with
      lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed
      during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria)
      receive allogeneic transplant. Patient follow-up is planned for 3 years old
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Populations of French Caribbean Islands and Guyana with ATLL-HR. .
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK
      Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
    

Detailed description: 
      Subjects can receive routine childhood vaccination according to the expanded program of
      immunisation recommendations in China.

      There will be two treatment groups (liquid human rotavirus vaccine and placebo). The study
      will also have two immunogenicity subgroups comprising of few subjects from both the
      treatment groups. The immunogenicity subgroup 1 will assess the immunogenicity of the liquid
      human rotavirus vaccine and the immunogenicity subgroup 2 will assess the immunogenicity of
      liquid human rotavirus vaccine and also the immunogenicity of oral poliovirus vaccine and
      diphtheria tetanus and acellular pertussis vaccine given concomitantly with liquid human
      rotavirus vaccine or placebo.

      This protocol posting has been updated following the Protocol Amendment 2, dated 05 August
      2011. The impacted section in the protocol posting is: Outcome Measures Section.
    

Intervention name(s): GSK Biologicals' liquid human rotavirus vaccine 444563; Placebo; Infanrix™; Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Oral administration; Oral administration; Intramuscular administration; Oral administration
Other intervention name(s): DTPa
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Liquid human retrovirus vaccine