bioihbjkbjnl/mcl2 huggingface dataset:
ELTGOL and Bronchiectasis. Respiratory Therapy
Condition: Respiratory; Complications, Therapy; Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.

      Primary objective:

      -To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to
      placebo.

      Secondary objectives:

        -  To evaluate the level of knowledge of airway clearance techniques and adherence to them
           in patients with bronchiectasis.

        -  To assess the side effects during the procedure: oxygen desaturation, increased dyspnea
           and hemoptysis.
    

Detailed description: 
      The incidence of bronchiectasis has increased in recent years resulting in greater costs,
      including periods of hospitalisation and the prescription of drugs.

      The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy
      has been recommended for patients with bronchiectasis and chronic productive cough and/or
      evidence of mucus plugging on HRCT.

      However, to date, there is insufficient evidence of benefits of chest physiotherapy through
      randomised controlled trials. Furthermore it rests unclear the most effective technique, the
      frequency and optimum duration of the RP and the most suitable variables to monitor.

      A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway
      clearance will fill this important "gap" in the scientific evidence.
    

Intervention name(s): Low Expiration Open glottis inferolateral (ELTGOL); Stretching
Intervention type(s): Procedure; Procedure
Intervention description(s): Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.; Patient will be instructed to do muscle stretching of the thorax
Other intervention name(s): airway clearance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bronchiectasis; respiratory therapy; airway clearance
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
Condition: Covid19
MeSH terms: COVID-19; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19
      participants who were in cytokine release syndrome and there was also a control group who
      received steroids(RECOVERY TRIAL wasn't published or available at that time) this study was
      conducted in the early days of 1st wave of COVID in our country Pakistan so it was need of
      the day to develop some national guidelines on the basis of multiple studies' results from
      Pakistan.
    

Detailed description: 
      Objectives: To analyze the effectiveness of Tocilizumab in moderate to severe Covid-19
      participants on the basis of predefined assessment criteria.

      Study Settings: Single center, Fatima Memorial Hospital, Lahore.

      Study Design: Quasi experimental.

      Duration of Study: From 12th May, 2020 to 12th July, 2020.

      Participants & Methods: Sample size and technique: Sample size was 93; 33 participants were
      kept in experimental group, given Tocilizumab, 8mg/kg intravenously or 162 mg subcutaneously
      and rest of the 60 participants were given corticosteroids, methylprednisolone 80 mg/day.
      Consecutive sampling.

      Failure of therapy was labeled when participants were intubated or died, and the endpoints
      were failure-free survival which was the primary endpoint and overall survival secondary at
      the time of discharge.
    

Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Participants received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. The response of the participants after Tocilizumab administration was recorded based on clinical parameters (Oxygen requirement, Fever, Need for invasive positive pressure ventilation), biochemical parameters (D-dimers, C-reactive protein (CRP), Ferritin, Lactate dehydrogenase (LDH) levels), Chest X-ray findings, and Repeated PCR test for COVID-19. Any side effects noted after administration of TOCILIZUMAB were recorded.
Any side effects noted after administration of TCZ/ Corticosteroid were recorded.
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tocilizumab; Covid-19; SARS-CoV-2
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre, open-label extension study in subjects who showed clinical response
      to induction therapy in the treatment of subjects with active Crohn's disease in the
      double-blind main study C87037 (NCT00291668).
    

Detailed description: 
      In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary
      outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response
      at Week 6 were eligible to enter this open-label extension study. The first visit in this
      extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were
      dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being
      assessed at Week 26. All week numbers quoted are relative to the start of the double-blind
      main study.
    

Intervention name(s): Certolizumab pegol (CZP); Certolizumab pegol (CZP); Certolizumab pegol (CZP)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 400 mg at Weeks 0, 2 and 4.
Other intervention name(s): CDP870; Cimzia; CZP; CDP870; Cimzia; CZP; CDP870; Cimzia; CZP
Intervention MeSH terms: Certolizumab Pegol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Certolizumab pegol; Cimzia; CZP
Methylphenidate in Myotonic Dystrophy Type 1
Condition: Dystrophia Myotonica 1
MeSH terms: Myotonic Dystrophy; Disorders of Excessive Somnolence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether methylphenidate is effective in the
      treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).
    

Detailed description: 
      Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by muscle weakness,
      myotonia, and the involvement of several systems. Hypersomnolence is one of the most
      frequently reported symptoms in patients with DM1 and often lead to handicap such as
      cessation of employment and withdrawal from social activities.The current investigation
      represents a prospective, double-blind, randomized, crossover, placebo-controlled study
      designed to evaluate the efficacy of methylphenidate for the treatment of excessive daytime
      sleepiness (EDS) in adults with DM1.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One Tablet of methylphenidate, 20 mg per day during 3 weeks; one tablet placebo per day during 3 weeks
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; double-blind; crossover; methylphenidate; excessive daytime sleepiness
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are:

        -  To see how the new medicine (PF-07853578) under study is tolerated. And if there are any
           important side effects. And, how people feel after taking single increasing amount of
           the medicine by mouth.

        -  To measure the amount of study medicine in your blood after the medicine is taken by
           mouth.

      This study is seeking for participants who:

        -  are females of 18 to 65 years old and are not able to give birth to a child.

        -  are males of 18 to 65 years old.

        -  have body mass index of 16 to 31 kilograms per meter squared.

        -  have a total body weight of more than 50 kilograms (110 pounds). Participants will be
           randomly selected to receive either study medicine (PF-07853578) or placebo (a pill that
           has no medicine in it). Participants may receive up to 4 amounts of study medicine and
           up to 2 amounts of placebo.
    


Intervention name(s): PF-07853578; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined.; Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Patient Expectation in Dry Needling and Analgesia
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate
      whether an additive effect occurs when DN is provided with an instructional set known to
      enhance placebo analgesia. External manipulation of patient expectation for receiving DN will
      be performed, in a similar way as has been already done in studies investigating the
      influence of expectation on spinal manipulative therapy interventions. The main purpose of
      this study will be therefore to determine, for the first time, how subjects' expectation
      about the effect of DN influences the resultant hypoalgesia. Analgesic effects of DN will be
      assessed using the conditioned pain modulation (CPM) paradigm, which has not been previously
      evaluated in relation to DN.
    

Detailed description: 
      Just before DN intervention, participants will receive a positive or a neutral expectation
      instructional set regarding effects of a DN technique on pain perception. This instructional
      set will be randomly allocated to each patient.

      Participants in the positive expectation group will be told that DN procedure: "is a very
      effective form of treatment used to treat neck-shoulder pain and it is expected to reduce
      your perception of pressure pain". Participants in the neutral expectation group will be told
      that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown
      effects on your perception of pressure pain".

      DN intervention An experienced and trained physical therapist will provide DN to all the
      subjects. This researcher will be blinded to the specific expectation instructional set the
      participant receives. Participants will receive one session of DN treatment for the active
      Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in
      a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40
      mm length will be used. The needle will be inserted into the skin over the palpated MTrP
      using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a
      twitch response is elicited.
    

Intervention name(s): Dry needling with positives expectation; Dry needling with neutral expectation
Intervention type(s): Procedure; Procedure
Intervention description(s): DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"; DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY2940680 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the
      safety and side effects of LY2940680 in healthy participants. Part A will involve two groups
      of participants, each taking up to two single doses of LY2940680 at different dose levels.
      There is a minimum 14 day washout period between each of the participant's doses. The purpose
      of Part B is to study how much of the study drug, in capsule or tablet form, gets into the
      bloodstream and how long the body takes to get rid of it. In addition, the effect of food and
      a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of
      participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a
      minimum 7 day washout period between doses. Participants may only enroll in one part.
      Screening is required within 28 days prior to the start of the study.
    


Intervention name(s): LY2940680 Capsule(s) (Reference); LY2940680 Tablet (Test); Lansoprazole; Placebo Capsule(s)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally as a capsule(s); Administered orally as a tablet; Administered orally as a capsule; Administered orally as a capsule(s)
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE
Condition: sRAGE Level; SUV and TBR Levels in FDG PET
Study type: Observational

Summary: 
      Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging
      diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And
      there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is
      correlated with metabolic risk. So the investigators will investigate association between
      sRAGE and FDG-PET uptake in large artery in healthy patient.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        type 2 DM diagnoed according to critereia of American Diabetes Asociation.
      
Keywords: sRAGE; SUV; TBR; FDG PET CT; Type 2 DM
Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones
Condition: Common Bile Duct Gall Stones; Common Bile Duct GallStones
MeSH terms: Gallstones
Study type: Observational

Summary: 
      ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However,
      4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation
      due to chronic inflammation of biliary duct is generally considered an important cause of
      CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy.
      Although it was believed that DBR was the important cause of CBDS recurrence, the direct
      evidence was still lacking. Here we conducted a case control study to investigate the DBR
      rate in patients with recurrent CBDS after ERCP.
    


Intervention name(s): standard barium meal examination
Intervention type(s): Other
Intervention description(s): All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with history of recurrent common bile duct stone (recurrent group) and
        non-recurrent common bile duct stone (control group) in Xijing Hospital of Digestive
        Diseases were invited to participate the study. All the patients underwent successful stone
        removal by ERCP previously. Patients in the control group were matched with the recurrence
        group by age and gender at 1:1 ratio.
      
Keywords: duodenal-biliary reflux
Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effect of dosing with flutucasone furoate in asthmatic
      subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over
      a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and
      serum cortisol levels.
    

Detailed description: 
      This study will investigate the effect of dosing with fluticasone furoate 100 μg (micrograms)
      in asthmatic subjects aged 5-11 years of age. Fluticasone furoate is currently under
      development as the inhaled corticosteroid component of a combination product containing an
      inhaled corticosteroid and a long-acting beta-agonist.

      The study will be a randomized two-way crossover, with a placebo control. During each
      treatment period subjects will receive a daily dose via a novel dry powder inhaler for 14
      days. Approximately 26 subjects will be recruited to this study, with the aim that 20 will
      complete the study. Safety, tolerability, pharmacokinetics and serum cortisol levels will be
      investigated.
    

Intervention name(s): Fluticasone furoate; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate.; Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: inhalation profiles; pharmacokinetics; pharyngometry; asthma; pediatric subjects; GW685698; Fluticasone furoate; safety
Immunological Changes Through Narrative Treatment of Post-Traumatic Stress Disorder (PTSD) in Torture Victims
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Posttraumatic stress disorder (PTSD) is associated with poor health, high health care
      utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune
      diseases. Research, including our own findings, indicates immunological alterations in PTSD
      patients. The aim of this study is to investigate whether alterations in the immune system of
      PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure
      Therapy).
    


Intervention name(s): NET
Intervention type(s): Behavioral
Intervention description(s): Narrative Exposure Therapy for traumatized survivors of organized violence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Narrative Exposure Therapy; torture victims; immune system
Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks
Condition: Oral Hygiene
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      The aim of this study is to investigate the stain removal efficacy of 2 experimental
      anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A
      daily use, regular fluoride dentifrice will be included as a reference dentifrice.
    

Detailed description: 
      This will be a single-center, 8-week, randomized, controlled, single-blind, three
      treatment-arm, parallel design, stratified clinical study in healthy volunteers with a
      propensity to form dental stain. It has been designed to investigate changes in tooth stain
      and color, following twice-daily use of two experimental dentifrices, after four and eight
      weeks twice daily use; a regular fluoride dentifrice will be included as reference
      dentifrice. Sufficient participants will be screened to randomize approximately 300
      participants to study treatment to ensure approximately 270 participants complete the study.
    

Intervention name(s): Experimental Dentifrice 1; Experimental Dentifrice 2; Reference Dentifrice
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).; 5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.; Regular Fluoride Dentifrice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS as Tablet in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI
      1356 BS during 4 week treatment duration
    


Intervention name(s): BI 1356 BS, low dose; BI 1356 BS, medium dose; BI 1356 BS, high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment