bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache
Condition: Cluster Headache; Chronic Disease
MeSH terms: Cluster Headache; Headache; Chronic Disease
Study type: Interventional

Summary: 
      Cluster headache is also called suicide headache due to excruciating nocturnal attacks. There
      are few treatment options available. Inhalation of oxygen has shown to abort the attacks.

      Continuous positive airway pressure (CPAP) is a machine used during sleep to treat
      respiratory failure. Automatic CPAP machines adjust the air pressure through the night to
      keep the upper airways patent.

      Single reports have shown a high prevalence of obstructive sleep apnea in people suffering
      from cluster headache, and positive effects of CPAP treatment, but no randomized controlled
      trial has been conducted so far.

      If proven effective CPAP would make an affordable treatment option for many patients within
      the existing healthcare system.
    

Detailed description: 
      This is a single center study carried out in collaboration between the neurological,
      neurophysiological and thoracic departments at St. Olavs Hospital in Trondheim.

      Participants will keep sleep and headache diaries in a baseline period of 4 weeks, then
      receive treatment (CPAP or sham-CPAP at nighttime) during 8 weeks, have a 4 week wash out
      period followed by a second treatment period of 8 weeks (CPAP or sham-CPAP). Finally there
      will be follow-up during 1 month.

      Throughout the whole study (7 months) participants keep a headache diary. Participants must
      maintain current preventive and sleep medication regimens during the whole study period, and
      may use acute medication of choice (sumatriptan, oxygen or other).

      Sleep registration in all participants will be done by polysomnography(PSG). An Ultra Wide
      Band radar/movement sensor device will be used to detect sleep patterns, together with wrist
      pulse oximetry and wrist actigraphy during PSG and the last week of each treatment period.

      Neurophysiologic tests such as temperature and pressure thresholds will be measured before
      PSG and after each treatment period.
    

Intervention name(s): Continuous Positive Airway Pressure; sham Continuous Positive Airway Pressure
Intervention type(s): Device; Device
Intervention description(s): standard automatic CPAP machine set on optimal automatic pressure; CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask
Other intervention name(s): CPAP; sham-CPAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Continuous Positive Airway Pressure; Sleep Apnea, Obstructive; Polysomnography
Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
Condition: Spinal Cord Injuries; Lower Urinary Tract Symptoms; Dysuria; Incontinence
MeSH terms: Spinal Cord Injuries; Lower Urinary Tract Symptoms; Dysuria
Study type: Interventional

Summary: 
      The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent
      from late complications. The present study is to evaluate the efficacy of electrical pudendal
      nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The
      study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible
      patients will be involved and divided into EPNS or TES group according to their location of
      medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS).
      The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine
      volume.
    


Intervention name(s): Electrical pudendal nerve stimulation; Transvaginal electrical stimulation
Intervention type(s): Device; Device
Intervention description(s): Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. Needles of 0.40 Х 100 mm are inserted perpendicularly to the upper points to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The two lower points are about 1 cm bilateral to the tip of the coccyx. Needles of 0.40 Х 100 or 125 mm are inserted obliquely to the lower points towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally needles.; A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pudendal nerve modulation; transanal/transvaginal electrical stimulation
Safety and Immunogenicity of Live Attenuated Influenza H5N2
Condition: Influenza Due to Influenza A Virus Subtype H5N2
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate immune response and safety of live attenuated
      influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,
      Thailand in healthy Thais.
    

Detailed description: 
      It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as
      being tested in phase I.

      150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All
      will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch
      2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and
      13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos)

      Each batch will be admitted in the isolation ward for 5 days after each immunization mainly
      for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain
      A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 28 days apart. Total
      follow up is 60 day.
    

Intervention name(s): Avian Flu Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis
Condition: Indolent Systemic Mastocytosis
MeSH terms: Mastocytosis; Mastocytosis, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to
      placebo in patients with mastocytosis with handicap.
    

Detailed description: 
      This was a prospective, multicenter, randomized, placebo-controlled, parallel-group, phase 3
      study, conducted in 15 countries, evaluating the efficacy and safety of masitinib (6
      mg/kg/day administered orally in two daily intakes over 24-weeks with a double-blind
      extension period possible) for the treatment of indolent systemic mastocytosis, smoldering
      mastocytosis or cutaneous mastocytosis, in patients with mast cells mediator release symptoms
      that are refractory to conventional symptomatic treatment.

      A study protocol amendment restricted enrolment to patients with severe indolent and
      smoldering systemic mastocytosis. The objective of this phase 3 study was therefore to
      evaluate masitinib efficacy and safety in severe systemic mastocytosis patients, with or
      without D816V mutation of c-Kit. The primary objective of the phase 3 study was to detect a
      statistically significant difference between masitinib (plus optimal concomitant symptomatic
      treatments) and placebo (plus optimal concomitant symptomatic treatments) in cumulative
      response on four severe symptoms, referred to also as handicaps.
    

Intervention name(s): Masitinib; Placebo; Best Supportive Care
Intervention type(s): Drug; Drug; Other
Intervention description(s): Masitinib 6 mg/kg/day; Matching placebo; Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.
Other intervention name(s): AB1010
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mastocytosis with handicap; Mastocytosis; Mast cell; Mast cell infiltration; Skin; Bone marrow; Pruritus; Flushes; c-kit; c-kit mutation; Wild Type; Mutation Asp-816-Val(D816V); Indolent systemic mastocytosis; smoldering systemic mastocytosis
Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)
Condition: Insomnia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant
      (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease
      (COPD). This is a crossover study, so all participants will receive both suvorexant and
      placebo while on study. The primary hypothesis of this study is that multiple doses of
      suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2)
      during total sleep time in participants with COPD, as compared to placebo.
    


Intervention name(s): suvorexant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants <65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days; one tablet matching suvorexant, orally, once daily, for 4 consecutive days
Other intervention name(s): MK-4305; SCH 900433
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pulmonary Disease, Chronic Obstructive
Troglitazone in Treating Patients With Liposarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Liposarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm,
      open-label study with a two-stage design to evaluate troglitazone in patients with
      liposarcoma stratified by histologic subtype.
    

Detailed description: 
      OBJECTIVES:

      I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma
      stratified by histologic subtype.

      II. To perform correlative imaging, biological, and biochemical testing of patients in order
      to define the degree to which in vivo terminal differentiation may be promoted by this
      therapeutic intervention.

      III. To evaluate the tolerance and safety of troglitazone in this patient population.

      PROJECTED ACCRUAL:

      Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued.
      If 1 or more patients show evidence of biological response, an additional 16 patients of each
      subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients
      achieve biological response then troglitazone will be deemed promising in that histologic
      subtype.
    

Intervention name(s): troglitazone
Intervention type(s): Drug
Other intervention name(s): Rezulin
Intervention MeSH terms: Troglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult liposarcoma; recurrent adult soft tissue sarcoma
CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia, Adult B-Cell; Acute Lymphoblastic Leukaemia Recurrent
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      In this single-center, open-label, no control, prospective clinical trial, a total of 20
      resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be
      enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a "split dose"
      (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on
      day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19
      CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.
    

Detailed description: 
      In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a
      total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients
      will be enrolled. Patients will be diagnosed according to morphologic, immunologic,
      cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype,
      cytogenetic and molecular examination. CD19 CAR T cells transduced with a lentiviral vector
      to express anti-CD19 scFv TCRζ:4-1BB,administered by i.v. injection as a using a "split dose"
      (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on
      day 2. This protocol will be given to subjects with unmet medical needs for which there are
      no effective therapies known at this time. Side effects of CD19 CAR T cells therapy will be
      monitored. The purpose of current study is to determine the clinical efficacy and safety of
      CD19 CAR T cells therapy in patients with chemotherapy resistant or refractory CD19+ ALL.
    

Intervention name(s): CD19 CAR T cells
Intervention type(s): Biological
Intervention description(s): CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute; Leukemia; Lymphoid; CD19; Refractory
Effect of Repeated Doses of YF476, Omeprazole and Placebo on Stomach Acidity in Healthy Volunteers
Condition: Reflux Oesophagitis
MeSH terms: Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were:

      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
      their effect on basal- and food- stimulated gastric pH in healthy volunteers.

      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to
      their effect on basal and meal stimulated pH.

      To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in healthy
      volunteers.
    

Detailed description: 
      YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and
      meal-stimulated gastric acid secretion, enhance gastric emptying of a liquid meal and
      increase lower oesphageal sphincter pressure in man. Therefore YF476 might benefit patients
      with reflux oesophagitis.

      YF476 has been well tolerated in healthy volunteers at single doses up to 100mg and
      remarkably well tolerated at repeat doses in animals up to 350 times the maximum dose planned
      for the proposed study. A range of doses of YF476 (25 and 100mg twice daily) will be
      administered to steady state. 24-hour ambulatory gastric pH will be monitored via an
      intragastric pH electrode to assess the effect of YF476 on basal and meal stimulated gastric
      pH. Although there is variability between subjects with respect to the effects of food and
      drug treatment on gastric pH, the methodology for measurement of ambulatory gastric pH is
      robust.
    

Intervention name(s): YF476; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): There were 4 treatments as follows: YF476 25mg twice daily, YF476 100mg twice daily, placebo and omeprazole 20mg once daily. Each treatment was taken by mouth for 7 days. Each subject took 1 of the 4 treatments.; There were 4 treatments as follows: YF476 25mg twice daily, YF476 100mg twice daily, placebo and omeprazole 20mg once daily. Each treatment was taken by mouth for 7 days. Each subject took 1 of the 4 treatments.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; gastric pH; healthy subjects; omeprazole
The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals
Condition: Gender Dysphoria
MeSH terms: Gender Dysphoria
Study type: Observational

Summary: 
      Observational survey study of transgender individuals who have undergone cosmetic neurotoxin
      and soft tissue filler for the purpose of influencing gender perception.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        2 healthy transgender volunteers age 18-65, of any skin type, with the desire to alter
        gender perception, and are already scheduled for standard of care treatments will be
        enrolled.
Pharmacokinetics of Ghrelin
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The main purpose of this study is to determine the half life of the hormone "ghrelin" in the
      human body. Other purposes are to investigate the effect of ghrelin on appetite and
      cardiovascular function.
    

Detailed description: 
      Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine
      cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for
      the growth hormone (GH) secretagogue receptor (GHS-R).

      Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and
      pituitary levels.

      Several studies show that bolus injections of ghrelin have positive effects on cardiac
      function in healthy humans as well as in humans with cardiac disease. We investigate the
      changes in cardiac function during ghrelin infusion in healthy subjects.

      The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate
      this aspect further.

      Comparisons: In a double blind, placebo controlled, cross over study we investigate the
      effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler,
      stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life
      (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.
    

Intervention name(s): Human acylated ghrelin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
Condition: Bariatric Surgery Candidate; Nausea, Postoperative
MeSH terms: Nausea; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea
      in the bariatric surgery patient population.
    

Detailed description: 
      Healthy weight management and use of essential oils and aromatherapy as natural interventions
      to manage health-related issues are significantly growing interests. One frequent
      intervention for healthy weight management is bariatric surgery. In the post-operative period
      following bariatric surgery, nausea is a common consequence. Peppermint oil aromatherapy is
      an effective intervention for relieving nausea and other gastrointestinal symptoms in the
      bariatric and surgical population. This study has multiple aims. One is to determine
      effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the
      bariatric surgery patient population. A second aim is to establish relative
      cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug
      therapies. A third is to determine whether peppermint oil aromatherapy increases patient
      satisfaction versus anti-emetic drug therapies. This is a randomized study with control and
      experimental groups. The control group will receive no peppermint oil aromatherapy and only
      traditional anti-emetics as needed. The experimental group will receive peppermint oil
      aromatherapy and traditional anti-emetics as needed.
    

Intervention name(s): Peppermint oil aromatherapy
Intervention type(s): Other
Intervention description(s): Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized by day of week
Masking: None (Open Label)
Primary purpose: Prevention
Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens
Condition: Immediate Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional

Summary: 
      The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC
      found that prevalence of AR and asthma inThailand was in moderately high group.

      Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of
      allergen in patient. They guided the investigators for proper management as well as patient
      education. Clinician will use the result for choose allergen in case that might need
      immunotherapy.

      SPT is safe and more economic for patient. Specific IgE has an advantage in patient who
      cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT
      and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two
      tests. In Thailand, the investigators haven't had data about it yet.
    

Detailed description: 
      SPT and specific IgE for allergens is necessary for allergen avoidance and specific
      immunotherapy. To have local allergen extracts will help the patients to easier get the
      appropriate management
    

Intervention name(s): Skin prick test; specific IgE measurement
Intervention type(s): Procedure; Other
Intervention description(s): skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed; measure specific IgE of American cockroach, dog, cat, dust mite and mold
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic