bioihbjkbjnl/mcl2 huggingface dataset:
Boswellia Serrata Extract in Acute Diarrhea
Condition: Acute Diarrhea; Boswellia Serrata
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or
      food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to
      its an-ti-inflammatory, antispasmodic and antimicrobial activity.
    


Intervention name(s): lecithin-based delivery form of Boswellia serrata; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): 250 mg for 5 days; 250 mg for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years
Condition: Influenza; Flu, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M®
      Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with
      preservative) in volunteers aged between 18 and 60
    

Detailed description: 
      1. Assessment of the tolerability and safety of the Flu-M® inactivated split influenza
           vaccine (without preservative) and Flu-M® (with preservative).

        2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with
           preservative) and Flu-M® (without preservative).

      Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit)
      and Long-term follow-up - 180±3 days.
    

Intervention name(s): Flu-M [inactivated split influenza vaccine] without preservative; Flu-M [inactivated split influenza vaccine] with preservative
Intervention type(s): Biological; Biological
Intervention description(s): Solution for intramuscular injection, 0.5 ml; Solution for intramuscular injection, 0.5 ml
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Flu; Vaccine; FLU-M; SPbSRIVS
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to increase the fraction of patients, who become MRD-negative
      during consolidation for the non-HR ALL group through individualized intensification of the
      6MP-dosage days 30-85.
    

Detailed description: 
      20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and
      research protocol that aims to improve the overall outcome of Nordic children and adolescents
      with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

      The specific and primary objectives of the randomised study is:

      To increase the fraction of patients, who become MRD-negative during consolidation for the
      non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will
      additionally measure EFS and toxicity as secondary end points of effect.
    

Intervention name(s): 6MPindividualized; 6MPfixed
Intervention type(s): Drug; Drug
Intervention description(s): Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered; Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Other intervention name(s): PuriNethol, Puri-Nethol (6-mercaptopurine); PuriNethol, Puri-Nethol (6-mercaptopurine)
Intervention MeSH terms: Mercaptopurine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute lymphoblastic leukemia; child; 6-mercaptopurine; minimal residual disease; efficacy; childhood acute lymphoblastic leukemia
Modified HFNC Oxygen in Patients Undergoing Bronchoscopy.
Condition: Bronchoscopy,Oxygen
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the Modified High-flow nasal cannula is
      effective in the oxygen of the patients undergoing bronchoscopy.
    


Intervention name(s): Modified High-flow nasal cannula; nasal cannula
Intervention type(s): Device; Device
Intervention description(s): Modified High-flow nasal cannula; Conventional oxygen therap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Modified High-flow nasal cannula; Bronchoscopy; Oxygen therapy
Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second
      leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was
      implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are
      performed annually at Hospital Clínic de Barcelona. Adequate colon preparation (anterograde
      cleansing with laxatives) improves polyp detection, decreases examination time, and
      complications. There are both low and high volume intestinal regimens with polyethylene
      glycol (PEG) as the main active ingredient or without it.

      Hypothesis: Two low volumen regimens, 1L PEG plus ascorbate and magnesium citrate plus
      picosulphate, at starting doses have the same Adenoma Detection Rate as cleansing solutions
      in preparation for screening colonoscopy.
    

Detailed description: 
      The primary objective of the study is to compare the clinical efficacy (by comparing the
      adenoma detection rate) of 1L PEG plus ascorbate versus magnesium citrate plus picosulphate
      in subjects undergoing colonoscopy in a colorectal cancer screening programme. We also will
      compare the Lesion Detection Rate, the quality of colon cleansing (Boston classification)
      overall and by segments, the tolerability and satisfaction and the rate of adverse effects
      experienced with intake of these products.

      Methodology: A comparative, parallel, randomized, single-centre, low-intervention clinical
      trial to be conducted at the CCR screening unit of Hospital Clínic de Barcelona that will
      include 1,002 participants.

      Subjects will complete a Tolerability and Satisfaction Questionnaire after completing the
      bowel preparation. Findings (polyps, CRC, or other lesions) and quality of bowel cleansing
      will be collected from the colonoscopy report.
    

Intervention name(s): Plenvu
Intervention type(s): Drug
Intervention description(s): randomization 1:1
Other intervention name(s): citrafleet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A comparative, parallel, randomized, non-inferiority, non-blinded, single-centre and low-intervention clinical trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bowel Preparation Solutions; Screening colonoscopy; Adenoma detection rate; Tolerability; 1L PEG plus ascorbate; Magnesium citrate plus picosulphate
Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various
      stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted
      Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).

      The hormonal control of multiple follicular growth and maturation is a critical part of ART
      procedures since it maximizes the yield of embryos to be transferred, thus increasing the
      cumulative pregnancy rate.

      Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and
      highly effective treatment in order to improve oocyte quality in patients undergoing IVF.
      Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable
      predictor of oocyte quality. High MI concentration in the FF directly correlates with high
      oocyte and embryo quality.

      Another stereoisomer of Inositol was successfully used into clinical practice
      D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in
      hyperglycemic PCOS patients.

      In the present study we aim to compare MI versus DCI supplementation on oocyte quality of
      women undergoing IVF-ET
    


Intervention name(s): Myo-inositol; D-chito-Inositol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Poor oocyte quality; IVF failure
Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein
      associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline
      as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV)
      events in patient populations with chronic coronary heart disease and after an acute coronary
      syndrome.

      This study will determine the effect of repeated administration of diltiazem on the
      pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a
      moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.
    


Intervention name(s): Darapladib; Diltiazem
Intervention type(s): Drug; Drug
Intervention description(s): Enteric coated, free base (micronized) white round tablet, 160mg, Oral/repeat dose/10 days (Treatment Period 1), 14 days (Treatment Period 2); Extended release, Blue capsule imprinted with cardizem CD and 240mg on one end, 240 mg, Oral/repeat dose/17 days
Intervention MeSH terms: Diltiazem; Darapladib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYP3A4; Lp-PLA2; Atherosclerosis; healthy volunteer; Drug interaction
Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effects of an exercise program proposed by the
      CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle
      thickness of trunk muscles in patients with traumatic spinal cord injury.

      The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the
      traumatic spinal cord injury.
    

Detailed description: 
      Participants were allocated into one of two groups (rehabilitation or control).
      Rehabilitation group (8 weeks of rehabilitation; CHORDATA® Method) Control group (patients
      with up to three years of traumatic spinal cord injury): Participants maintained their
      daily-life activities routine during the same eight weeks period and were tested before and
      after this control period. At the end of the control period, patients interested at
      participating on the training program were included in the intervention group
    

Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): The CHORDATA® Method (16 sessions; 50 minutes each; twice a week) consisted of three exercises: (1) anterior pendulum, with the patient seated on a chair, upper limb suspended by springs and straps, and actively moving the trunk forward; (2) posterior pendulum exercise, on a similar position as exercise (1) but now moving the trunk backwards and recruiting the abdominal wall muscles during a posterior pelvic tilt motion; and (3) stand-up and sit-down exercise, patient with knees fixed anteriorly, initiating the standing-up movement by pulling back and down the springs, trying to maintain the standing position for as long as possible, balancing the trunk and transferring the supporting force from the upper limbs to the lower limbs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal cord; Wounds and Injuries; Rehabilitation
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of
      distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but
      without additional adjuvant chemotherapy.
    

Detailed description: 
      The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with
      concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low
      risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The
      investigators would like to know if same therapeutic effect and survival rate can be achieved
      without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)
    

Intervention name(s): Radiotherapy; Cisplatin; 5-FU
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): External beam radiotherapy with curative intent, at least 66 Gy; cisplatin IV injection over 3 hours; 5-FU IV 24 hours continuous infusion
Other intervention name(s): CDDP; 5-fluorouracil
Intervention MeSH terms: Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant chemotherapy; NPC
Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial
      oxygenation and respiratory mechanics
    

Detailed description: 
      Inverse ratio ventilation already known as effective to improve the oxygenation and
      respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway
      pressure and improve in respiratory compliance during inverse ration ventilation undergoing
      one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from
      1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients
      who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might
      compromise cerebral perfusion pressure due to an elevation in central venous pressure and
      concomitant reductions in mean arterial pressure.
    

Intervention name(s): inverse IE
Intervention type(s): Other
Intervention description(s): in only one group changes of I:E ratio would be applied
Other intervention name(s): inverse I:E
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: laparoscopy, Trendelenburg Position, ventilation
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Condition: Central Sleep Apnea; Mixed Sleep Apnea; Cheyne-Stokes Respiration; Complex Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central; Cheyne-Stokes Respiration
Study type: Observational [Patient Registry]

Summary: 
      This multi-center observational study will prospectively collect data from patients who have
      an indication for servo ventilation therapy. This registry is intended to characterize the
      patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV,
      Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will
      assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and
      mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex
      sleep-disordered breathing (SDB).
    


Intervention name(s): DreamStation BiPAP autoSV
Intervention type(s): Device
Intervention description(s): Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The registry will include adult participants with indication and prescription of PR
        DS-autoSV
Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years)
      suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the
      outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry,
      Cairo University. This clinical trial was meant to assess clinically and radiographically the
      possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft
      substitute together with open flap debridement versus open flap debridement alone in the
      treatment of periodontal intrabony defects.
    

Detailed description: 
      periodontal intrabony defects in patients with moderate or advanced chronic periodontitis
      were treated with open flap debridement only in the control group while open flap debridement
      and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention
      group. probing pocket depth, clinical attachment level, gingival index, plaque index,
      gingival recession and bone defect area were assessed at baseline and six months post
      surgically to evaluate the possible improvement in the clinical and radiographic outcomes.
    

Intervention name(s): open flap debridement; n-HA bone graft
Intervention type(s): Procedure; Procedure
Intervention description(s): open flap debridement for managing two and three walls intrabony periodontal defects; Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal intrabony defects
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, open label, non-randomized, single dose study to determine
      pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral
      administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be
      enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening
      visit within 30 days prior to the administration of study drug, a treatment visit, and a
      follow-up visit 7-14 days after the administration of study drug.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention description(s): 50mg tablet
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: GSK1349572; pharmacokinetics; Japanese; HIV
First Time in Human Study With GSK1018921
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921
      differs from other available drugs in its mode of action and it is assumed that it may have
      an effect in the treatment of so-called positive symptoms such as hallucinations and negative
      symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in
      humans until now. This is the first study where this compound is administered to humans; the
      study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in
      a separate group of healthy smoker volunteers.
    

Detailed description: 
      Single-Blind, Randomised, Placebo-Controlled First Time in Human Study to Evaluate Safety,
      Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses of
      GSK1018921 in Healthy Volunteers and to assess the effect of a single dose of GSK1018921 on
      quantitative EEG and Mismatch Negativity in a separate cohort of healthy smoker volunteers
    

Intervention name(s): GSK1018921; Nicotine Lozenges; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1018921 will be supplied as 0.5, 5, 10 and 40 milligrams coated tablets.; Nicotine Lozenges will be supplied as 4 milligrams lozenges.; Placebo tablets will be given to the subjects.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: qEEG,; GlyT-1 inhibitor,; ERP; GSK1018921,; FTIH,; schizophrenia,; single-dose,; healthy volunteers,; MMN,