bioihbjkbjnl/mcl2 huggingface dataset:
Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate whether blockade of the histamine H2 receptors in
      the brain will have any beneficial effect on the symptoms of subjects with schizophrenia.
    

Detailed description: 
      Histamine functions as a neurotransmitter in the brain. It has an important role as modulator
      of the release of other neurotransmitters, including dopamine.

      The histamine receptors are widely expressed in the brain, H1 and H2 receptors are
      post-synaptic, H3 a pre-synaptic autoreceptor. There is an abundance of neurobiologic data
      from animal and human studies supporting the role of histamine in the pathogenesis and
      treatment of psychoses.

      In 1990 a case report of a treatment resistant subject with schizophrenia whos symptoms
      improved markedly when he was prescribed a H2 antagonist because of peptic ulcer. Later, a
      open-label trial including 18 patients has been performed, reporting significant symptom
      reduction, especially on negative symptoms. Also the subjective comments both by the subjects
      and the investigators in that study were optimistic and suggested an effect primarily on
      negative symptoms.

      The present study will be the first double-blind, randomized, placebo controlled, parallel
      group study of the subject matter. The study focuses on treatment resistant schizophrenia
      cases in the stable phase.
    

Intervention name(s): famotidine; Placebo (Microcrystallized cellulose)
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.; Placebo administered in identical capsules as the experimental drug.
Other intervention name(s): Famotidin Hexal; Microcrystallized cellulose
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment resistant; Chronic
Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus
      reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with
      the frequency in women who receive placebo.
    

Detailed description: 
      Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy
      of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency
      of clinical or bacteriological cure. Secondary outcomes will be a) time to
      clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who
      receive probiotics for 12 days compared with the time in women who receive placebo; b)
      frequency of clinical/laboratory and bacteriologic relapse in women with non complicated
      acute cystitis who receive probiotics for 12 days compared with the frequency in women who
      receive placebo, at day 30 after treatment start and c) frequency of adverse related events
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with
      the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of
      Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 + cranberry extract. The
      control group will recibe Cranberry extract. The products will be taken twice per day,
      morning and evening.
    

Intervention name(s): Lactobacillus reuteri; Sachet with cranberry + placebo
Intervention type(s): Combination Product; Dietary Supplement
Intervention description(s): Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5*10^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc; Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, double blind allocation concealment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Booster Vaccination Against COVID-19
Condition: COVID-19; Sars-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have
      passed at least 90 days and at most 270 days after the second dose of the first course of
      CoronaVac vaccine.
    

Detailed description: 
      To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2
      after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2
      dose primary regimen.

      It is planned to recruit 111 subjects for 2 vaccines (Turkovac and CoronaVac). There will be
      a total of 222 subjects.
    

Intervention name(s): CoronaVac; Turkovac
Intervention type(s): Biological; Biological
Intervention description(s): One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.; One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2 (Hybrid COV-Rapel TR)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2 Vaccine; Booster; Efficacy; Immunogenicity; Safety
Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of
      QAW039 in patients with hepatic impairment compared to healthy matched control subjects.
    

Detailed description: 
      The purpose of this study is to determine if the pharmacokinetic profile of Fevipiprant is
      different in patients with hepatic impairment compared to healthy matched volunteers to an
      extent that would require an adjustment of the dosage. Data from this study will be used to
      guide enrollment criteria in future clinical trials and to support regulatory submission and
      labeling information.
    

Intervention name(s): Fevipiprant
Intervention type(s): Drug
Intervention description(s): Single 450mg dose
Other intervention name(s): QAW039
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic impairment,; Fevipiprant,; adults,; pharmacokinetics
The Effect of Yoga in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if yoga is an effective intervention in treating
      individuals with chronic low back pain (LBP).
    

Detailed description: 
      Chronic LBP is a major public health problem associated with functional and psychological
      disability. Conservative interventions are often prescribed to people suffering from chronic
      LBP, but alternative interventions like yoga are not well researched. The regulator practice
      of yoga may improve pain, disability or quality of life in people with chronic LBP.

      Study participation will last approximately 24 weeks. Yoga sessions will last 12 weeks for 2
      one hour sessions per week
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Twice weekly one hour sessions of Hatha Yoga for 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic low back pain; low back pain; yoga
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of
      multiple oral doses of PF-06835919 in healthy adult Japanese participants.

      A total of approximately 8 healthy participants will be enrolled in this study. Participants
      will be randomized to 2 groups to receive PF-06835919 or placebo treatment with a
      randomization ratio of 3:1.
    


Intervention name(s): PF-06835919; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-06835919 300 mg repeated doses; Placebo repeated doses
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase 1, randomized, double-blind, sponsor-open, placebo-controlled study in healthy adult Japanese participants.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: NASH, KHK, PF-06835919, Japanese
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
Condition: Mild Persistent Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study aims to identify markers to prove rapid improvement of lung function, airway
      inflammation and bronchodilator response after 2-week LTRA administration.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout
      period of at least one week between each study period.

      After an initial screening visit, subjects entered a screening period of one to two weeks to
      ensure clinical stability without medication, which means absence of daily asthma symptoms.
      Eligible subjects were randomized into either the treatment portion of the trial, in which
      subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized
      manner. During each treatment period, which lasted 2 weeks, the study medication was
      administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was
      permitted during the study period but was withheld 24 hours prior to bronchodilator challenge
      test.

      Inclusion criteria will be mild persistent asthma children old enough to cooperate on
      performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to
      the beginning of the study. Exclusion criteria will be the following: respiratory symptoms
      including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic
      upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation,
      etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or
      admission or visit of the emergency department during the previous 4 weeks.
    

Intervention name(s): Montelukast to placebo; Placebo to montelukast
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks; Subjects will receive matching placebo. Each treatment period consists of 2 weeks
Other intervention name(s): SINGULAIR 4mg or 5mg; SINGULAIR 4mg or 5mg matching placebo
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Leukotriene Antagonists; Bronchodilator response
Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Twenty participants with severe arthritis will be enrolled. For the first week participants
      will either be injected with dextrose or just have fluid withdrawn for testing. The remaining
      participants will be given dextrose injection at the end of the week. After one week dextrose
      injections will be given at one, two, three, four, five, and six months. Fluid will be
      withdrawn from the knee at time zero, one week, and three months. The hypothesis is that
      dextrose injection will cause a change in proteins in the knee consistent with improved
      repair signals, along with improving knee pain and function. .
    

Detailed description: 
      Participants with stage IV knee osteoarthritis will be evaluated for eligibility and
      randomized 1 to 1 using an Internet randomization method to ensure random allocation.

      At time zero all participants will receive aspiration of their knees from the suprapatellar
      pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants
      will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection
      after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48
      hours after aspiration with or without injection to gather information about the time course
      of analgesia.

      At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch
      for cytokine analysis, followed by injection of the remaining 10 participants with dextrose
      12.5%. Pain levels will be measured at the same time intervals to complete evaluation of
      dextrose analgesia.

      After two weeks injections will be open label with 10 mills of dextrose 12 and have percent
      injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of
      synovial fluid will be sent to the laboratory for cytokine analysis.
    

Intervention name(s): Dextrose 0; Aspiration 0; Dextrose 1; Aspiration 1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dextrose injection at time 0; Aspiration only at time 0; Dextrose injection at week 1; Aspiration only at week 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first two weeks of this study involve two groups with a crossover at 1 week. From two weeks on, there is a single arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cytokine
Comparative Cycle Control Europe
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new
      four-phasic oral contraceptive in comparison to a reference OC.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658K); SH D 593 B (Miranova)
Intervention type(s): Drug; Drug
Intervention description(s): 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo; 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap
Condition: Sensory Reconstruction of the Volar Aspect of the Finger; The Heterodigital Neurocutaneous Island Flap
Study type: Interventional

Summary: 
      The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because
      of its similar quality to the original. The dorsal digital island flap can be used for
      repairing the defect of adjacent finger, but the limited length of the pedicle precludes its
      use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal
      branch of the digital nerve can be used as an alternative to resolve this problem.
    

Detailed description: 
      At final follow-up, we measured the sensibility of the flaps using the Semmes-Weinstein
      monofilament test and the static 2-point discrimination test. The test points were at the
      center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or
      ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated. Each area
      was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit
      of 2PD and considered this normal.
    

Intervention name(s): the neurocutaneous island flap
Intervention type(s): Device
Intervention description(s): The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.
Other intervention name(s): dorsal digital island flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dorsal branch of the digital nerve;; dorsal digital artery;; dorsal digital island flap;; neurocutaneous island flap.
Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral
      dose in subjects with severe renal impairment and end stage renal disease not on dialysis.
    

Detailed description: 
      The main objective of this trial is to evaluate the pharmacokinetics of dabrafenib and
      metabolites after a single oral dose of dabrafenib in subjects with renal impairment as
      compared to healthy subjects with normal renal function.

      This was a single-dose, open-label, parallel group single dose study to evaluate the
      pharmacokinetics (PK) and safety of a single oral dose of dabrafenib 100 mg in subjects with
      severe RI or ESRD compared to matched healthy subjects with normal renal function (control
      group).

      The study consisted of a screening period, a treatment period and a follow-up period.

      The Screening period started up to 28 days prior to dosing. Subjects who satisfied the
      inclusion/exclusion criteria at screening were admitted for baseline evaluations, which was
      done locally by the investigator. In the treatment period, subjects received a single 100 mg
      oral dose of dabrafenib administered as two 50 mg capsules with a whole glass of
      non-carbonated water (approximately 240 mL) in the morning of Day 1 following an overnight
      fast (minimum 10 hours). Subjects were confined to the study facility from Day -1 to Day 5,
      for collection of serial blood and urine samples. Subjects were discharged on Day 5.

      In the follow-up period a telephone call was made to subjects 30 days post-dose to evaluate
      subject safety during the weeks after discharge from the facility. Adverse events occurring
      prior to Day 30 were followed until resolution or until judged to be permanent. Subjects
      returned to the clinic on Days 90 and 180 for the post-dose dermatological examination follow
      up.

      For this study, the terms "investigational drug", "study drug" or "study treatment" refer to
      dabrafenib, administered as a single dose.
    

Intervention name(s): dabrafenib
Intervention type(s): Drug
Intervention description(s): Single dose dabrafenib 100 mg
Other intervention name(s): DRB436
Intervention MeSH terms: Dabrafenib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal impairment; Healthy volunteers; Clinical pharmacology study; DRB436; dabrafenib; normal renal function; impaired renal function