bioihbjkbjnl/mcl2 huggingface dataset:
Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure
Condition: Acute Hypoxemic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Protective ventilation can be difficult to achieve during noninvasive ventilation for "de
      novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung
      disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI)
      as a possible mechanism aggravating lung damage in these patients.

      The aim of this study is evaluate the tidal volume, measured by respiratory inductance
      plethysmography, in patients receiving different non invasive respiratory support.
    


Intervention name(s): Ventimask; High Flow Nasal cannula (HFNC); Helmet CPAP; Non Invasive Ventilation (NIV)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): The patients will be asked to breathe spontaneously using their actual low oxygen flow; The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%; The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%; the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: De novo; ARF
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and
      lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of
      atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with
      other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may
      be higher than the acceptable range and could be associated with ATV related toxicity.
    

Detailed description: 
      We are interested in once daily ATV/RTV 200/100 mg OD because of the convenience, reduction
      in ATV doses which may improve adherence while reducing toxicity and cost. There are limited
      prospective studies evaluating pharmacokinetic and long term efficacy and safety of
      atazanavir/ritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients. We
      believe that the PK parameters of ATV/RTV given at 200/100mg daily in Thai patients will be
      equivalent to the ATV/RTV 300/100mg once daily dosing in Caucasian patients when combined
      with 2NRTIs, and that the once daily regimen will have better safety, tolerability profile,
      and cost saving while maintaining good CD4 and VL outcome. If, the pharmacokinetic profile of
      ATV/RTV 200/100 mg OD + 2NRTIs is in acceptable range or comparable with standard dose of
      ATV/RTV 300/100 mg OD, long term efficacy will be explored later.
    

Intervention name(s): Atazanavir
Intervention type(s): Drug
Intervention description(s): ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atazanavir/ritonavir; pharmacokinetic of ATV/r200/100 OD+2NRTIs
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Condition: Papilloma; Cervix Lesion
MeSH terms: Papilloma
Study type: Interventional

Summary: 
      To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying
      chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one
      tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50
      mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.
    


Intervention name(s): Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid
Intervention type(s): Dietary Supplement
Intervention description(s): One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Epigallocatechin gallate; Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied
      in the isolation processes of post-acute patients with mild and moderate symptoms who had
      positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and
      dynamic balance,fatigue,anxiety and depression.
    

Detailed description: 
      This study was conducted with 270 patients who were the COVID-19 test was positive and
      isolated in their homes during post-acute periods.While one of the groups (n=135) was asked
      to remain isolated at home by providing patient education,a PR program was applied for 4
      weeks in addition to the patients in the other group(n=135).PR consists of patient education,
      breathing, in-house mobilization and range of motion exercises.As the evaluation
      parameters,pre-treatment and post-treatment dyspnea levels with Borg scale,muscle pain with
      visual analog scale(VAS),functional capacities with sit-up test,chest expansions with tape
      measure,respiratory frequency,fatigue level with fatigue severity scale,and emotional status
      with hospital anxiety and depression(HAD) scale were evaluated.
    

Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pulmonary Rehabilitation; Dyspnea; Fatigue; Pain; Anxiety
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      Food effect part:

      To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety
      of RTA 402 in Japanese healthy male adults, using the capsule formulations.

      Caucasian subject part:

      To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted
      state and compare the pharmacokinetics with those observed in Japanese healthy male adults in
      the food effect part
    


Intervention name(s): Bardoxolone methyl; Bardoxolone methyl
Intervention type(s): Drug; Drug
Intervention description(s): Bardoxolone methyl 5 mg capsules; Bardoxolone methyl 5 mg capsules
Other intervention name(s): RTA 402; RTA 402
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bardoxolone Methyl; Healthy subject; Food effect
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Condition: LC Pelvic Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional

Summary: 
      Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures
      encountered. There is a substantial amount of controversy surrounding the treatment of these
      injuries and there is evidence that both operative and non-operative treatment can be
      successful.
    

Detailed description: 
      The crux of the problem is determining which of these patients would benefit from early
      surgical stabilization and which will heal uneventfully without surgery. Many authors site
      patient pain and inability to mobilize as indications for surgery, although there is
      conflicting evidence supporting this claim. The presence of chronic pain in the trauma
      population is a growing area of interest, and there is a push towards controlling pain more
      effectively in the acute setting. It remains to be proven that surgical intervention is more
      effective at decreasing acute and longer term pain.

      There is evidence in the literature to support both operative and non-operative treatment of
      patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical
      stabilization decreases acute pain and narcotic requirements, although patients are often
      counseled to that effect. The investigators propose to prospectively randomize patients with
      lateral compression type pelvic fractures to non-operative versus operative treatment and
      track which group has less pain, less need for narcotic pain medications, and who mobilizes
      with physical therapy faster.
    

Intervention name(s): LC fracture surgical fixation; LC fracture non-operative management
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Operative vs. Non-operative; LC pelvic fracture; Complications
Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients.
      The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in
      children receiving CT.
    


Intervention name(s): Hyaluronic acid; Sodium bicarbonate
Intervention type(s): Drug; Drug
Intervention description(s): The main function of HA appears to be in tissue healing, by activating and modulating inflammatory responses, stimulating cellular proliferation, migration, and angiogenesis, inducing basal keratinocyte proliferation and re-epithelization by reducing collagen deposition and scarring; sodium bicarbonate solution
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mucositis; hyaluronic acid
Alcohol and Immune Response
Condition: Alcohol Drinking; Alcohol; Harmful Use
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study investigates how alcohol affects the immune system and behavior in healthy adults.
      The study also will examine how an individual's typical drinking habits may affect the immune
      system's response to alcohol.
    


Intervention name(s): Alcohol, Ethyl; Alcohol, Ethyl - placebo
Intervention type(s): Drug; Other
Intervention description(s): Randomized within-subjects design; Randomized within-subjects design
Other intervention name(s): Alcohol; Placebo
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Marijuana Effects on Simulated Driving Performance
Condition: Cannabis; Cannabis Use; Marijuana; Marijuana Usage; Alcohol Drinking
MeSH terms: Marijuana Abuse; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effects of various strains of marijuana on simulated driving
      performance; the effects of alcohol administration will also be examined to further
      understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary
      outcomes will include physiological effects, subjective- and observer-rated outcomes, and
      psychomotor performance under the various dose conditions.
    


Intervention name(s): Marijuana; Alcohol; placebo alcohol; Inactive marijuana
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Experimental, non-therapeutic administration of active marijuana dose(s); Experimental, non-therapeutic administration of active alcohol dose(s); Experimental, non-therapeutic administration of inactive alcohol dose(s); Experimental, non-therapeutic administration of inactive marijuana dose(s)
Other intervention name(s): Active cannabis; Active alcohol; inactive cannabis
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: simulated driving, outpatient
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Bone marrow transplantation may be able to replace immune cells
      that were destroyed by chemotherapy used to kill cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous
      leukemia.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of MCE (mitoxantrone/cytarabine/etoposide) followed by
      granulocyte colony-stimulating factor to mobilize peripheral blood stem cells (PBSC) in
      patients with chronic myeloid leukemia (CML). II. Evaluate the toxicity of this regimen. III.
      Evaluate the cytoreductive effects of this regimen in CML as determined by the ability to
      mobilize Philadelphia chromosome-negative PBSC. IV. Assess the time of peak CD34+ and
      CD34+/CD38- cell concentrations in the peripheral blood of patients treated with this
      regimen.

      OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 DHAD Mitoxantrone,
      NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) HU Hydroxyurea,
      NSC-32065 MCE DHAD/ARA-C/VP-16 VP-16 Etoposide, NSC-141540 Single-Agent Cytoreduction
      followed by 3-Drug Combination Chemotherapy/Stem Cell Mobilization. HU; followed by MCE;
      G-CSF.

      PROJECTED ACCRUAL: 30 patients will be entered over 3 years.
    

Intervention name(s): filgrastim; cytarabine; etoposide; hydroxyurea; mitoxantrone hydrochloride; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone; Hydroxyurea
Primary purpose: Treatment
Keywords: relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia
Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer
Condition: Recurrent Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK)
      immunotherapy to recurrent breast cancer.
    

Detailed description: 
      By enrolling patients who have breast cancer of Her-2 positive adapted to enrolled criteria,
      this study will document for the first time the safety and the short and long term efficacy
      of the combined therapy using Trastuzumab and NK cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Trastuzumab; NK immunotherapy
Intervention type(s): Drug; Biological
Intervention description(s): Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days); For each procedure, 10 billion cells will be infused for 4 times
Other intervention name(s): Herceptin
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; Her-2 positive; Trastuzumab; NK immunotherapy
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Condition: Otitis Externa
MeSH terms: Otitis; Otitis Externa
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the efficacy and safety profiles of the test
      product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of
      hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
    

Detailed description: 
      Phase III, non inferiority, multicentric, controlled, single blind, parallel-group,
      randomized study.

      Population: 224 patients with external otitis , men and women aged between 1 - 70 years.

      Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and
      otorrhea (cure).

      Secondary endpoint: The endpoint will be the identification of the side effects of medication
      use.
    

Intervention name(s): Cipro HC; Ciprofloxacin HCl and Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Cipro HC (Ciprofloxacin HCl and Hydrocortisone); Ciprofloxacin Hydrochloride and Hydrocortisone
Other intervention name(s): Otociriax
Intervention MeSH terms: Ciprofloxacin; Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare propranolol and misoprostol versus misoprostol alone for induction of labour in
      primigravidas
    

Detailed description: 
      Candidates will be randomized into 2 groups according to a computer generated sequence. Each
      candidate will be assigned an opaque sealed envelope containing a paper with her group on it.
      Both the patient and doctor on duty will be blinded to which group the patient was assigned
      to.

      - Study procedure:

        1. Written informed consent will be obtained from all participants prior to the study.

        2. Full history taking.

        3. General examination.

      Patients will be subjected to the following:

        -  Patients attending labour room for induction of labour will be divided into two groups.

        -  Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal
           fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.

        -  In group 1, after induction is started with misoprostol placement, 30 minutes will pass
           before administration of oral Propanolol 20mg

        -  In group 2, after induction is started with misoprostol placement, 30 minutes will pass
           before administration of oral placebo in the form of sugary tablets.

        -  After induction, women will be monitored for fetal and maternal wellbeing and progress
           of labour.
    

Intervention name(s): Misoprostol; Placebo; Propranolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol; placebo; Propranolol
Intervention MeSH terms: Propranolol; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of an acute dose of BNC210 compared to
      placebo on reducing anxiety provoked by a speaking challenge and measured using the
      Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center
      study. Participants will attend a Screening Visit to confirm eligibility and then return to
      the clinic within 14 days to be randomized into the study. Randomized participants will
      receive a single dose of their allocated study intervention (225 mg BNC210, 675 mg BNC210 or
      placebo) and approximately 1 hour later participate in a speaking challenge. After 1 week, a
      safety follow-up assessment will be conducted by phone/video conference.
    

Intervention name(s): 225 mg BNC210; 675 mg BNC210; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 225 mg BNC210; 675 mg BNC210; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
Condition: Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if everolimus combined with reduced exposure CNI
      (TAC) is efficacious and safe and will support corticosteroid elimination compared to a
      standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation.
      An additional purpose of the study is to assess the effect of the combination of EVR and
      reduced exposure CNI (TAC) on renal function.

      This study is part of the requirements of the Paediatric Investigational Plan approved by
      Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and
      is intended to support the indication of everolimus in the prevention of acute rejection in
      paediatric recipients of a renal transplant.
    


Intervention name(s): RAD001; MMF
Intervention type(s): Drug; Drug
Intervention description(s): Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant; MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paediatric kidney transplantation; Early MMF to everolimus conversion; Composite efficacy (biopsy-proven acute rejection, graft loss or death); Renal function