bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Tadalafil and Glycemic Traits
Condition: Cardiovascular Disease; Insulin Resistance; Glucose Intolerance; Obesity
MeSH terms: Cardiovascular Diseases; Insulin Resistance; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if tadalafil can help overweight and obese people
      metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day
      of tadalafil for 3 months is safe to take without causing too many side effects. The
      investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).
    

Detailed description: 
      This study is examining changes in insulin resistance and glucose tolerance following 3
      months of treatment with oral, once daily tadalafil.

      The investigators primary hypotheses are that measurable decreases in insulin resistance (as
      measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index)
      will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to
      placebo.

      The investigators secondary hypotheses are that improvements in average glycemia (as measured
      by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition
      index), and body composition (including weight, waist circumference, body mass index, and
      waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.
    

Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg Tadalafil taken once a day for 3 months; Placebo tablet taken by mouth once a day for 3 months
Other intervention name(s): Adcirca, Cialis; Sugar pill
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tadalafil; Phosphodiesterase 5 Inhibitors; Cyclic Guanylyl Monophosphate Pathway; Pharmacologic Actions; Vasodilator Agents; Cardiovascular Agents; Obesity; Glycemic Traits; Insulin Resistance; Glucose Metabolism
Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)
Condition: Stroke, Ischemic
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels
      with Recurrent Ischemic Strokes patients
    

Detailed description: 
      Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal
      medicall treatment without stenting and comparative study of primary outcome was conducted
    

Intervention name(s): Intracranial Stenting by Intracranial Stent Device; Optimum medical treatment
Intervention type(s): Device; Drug
Intervention description(s): Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted; Optimum Medical treatment
Other intervention name(s): cardiac and wingspan IC stent device; Clopidogrel 75 mg +Aspirin 161 mg
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two armed medical study
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D Metabolism and the Williams Syndrome
Condition: Williams Syndrome
MeSH terms: Williams Syndrome; Syndrome
Study type: Observational

Summary: 
      The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies,
      mental retardation and other congenital defects are sometimes associated with abnormal
      vitamin D and calcium metabolism. Whereas some patients have been reported to show increased
      sensitivity to vitamin D or an exaggerated response of serum 25-hydroxyvitamin D {25(OH)D} to
      administration of vitamin D and to have hypercalcemia caused by increased circulating
      1,25-dihydroxyvitamin D{1,25(OH)2D} in infancy and early childhood, most patients have normal
      calcium metabolism and normal values for circulating 25(OH)D and 1,25(OH)2D. We propose to
      carry out further studies of vitamin D metabolism to elucidate the mechanism(s) for abnormal
      vitamin D metabolism. We will determine the response of serum 1,25(OH)2D to administration of
      1,25(OH)2D3. Measurement of the 1,25(OH)2D in the patients compared to normal subjects will
      be the primary outcome.
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
In-vivo Efficacy and Safety of Artemether/Lumefantrine Vs Dihydroartemisinin-piperaquine for Treatment of Uncomplicated Malaria and Assessment of Parasite Genetic Factors Associated With Parasite Clearance or Treatment Failure
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Drug efficacy testing is one of the most important tasks that is routinely undertaken by the
      National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World
      health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT)
      and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently,
      Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and
      Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine
      (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is
      revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as
      an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ
      is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess
      the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the
      NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment
      guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
    

Detailed description: 
      Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of
      Health and Social Welfare and therefore testing of new ACTs such as
      dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently
      required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and
      DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However,
      efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania.
      Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide
      important data which will enable the NMCP to make informed decisions; and possibly recommend
      DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of
      uncomplicated malaria in the country.
    

Intervention name(s): Artemether-lumefantrine; Dihydroartemisinin-piperaquine
Intervention type(s): Drug; Drug
Intervention description(s): Artemether-lumefantrine; Dihydroartemisinin-piperaquine
Other intervention name(s): A; B
Intervention MeSH terms: Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parasite clearance, Treatment failure
Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma
Condition: Primary Open-angle Glaucoma (POAG); Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the
      investigational SHP639 eye drops will be evaluated in participants with high eye pressure or
      primary open-angle glaucoma.
    


Intervention name(s): SHP639 (n=60); Placebo Comparator (n=24)
Intervention type(s): Drug; Drug
Intervention description(s): Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.; Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Women's Health Habits Study
Condition: Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
MeSH terms: Osteoporosis; Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized trial is to test the effectiveness of screening and brief
      intervention for risk drinking by nonpregnant women with specific medical problems
      exacerbated by excessive alcohol consumption. The medical problems are female factor
      infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat
      and difficult to manage. Just as pregnant women are thought to be highly motivated to modify
      their alcohol consumption, so women with specific medical problems worsened by alcohol intake
      are an appropriate group to receive a brief intervention.
    


Intervention name(s): Brief Intervention; Diagnostic assessment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up; Single session diagnostic assessment with 12 month followup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Risk drinking; Women; Medical problems
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Placebo-controlled, double blind (triple-dummy technique), randomised parallel design
      comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with
      T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label
      placebo run-in period before randomisation. Background insulin therapy will be kept stable
      during the first 7 days of the treatment period and will be freely adjusted thereafter.
    


Intervention name(s): Empagliflozin medium placebo; Empagliflozin low placebo; Empagliflozin low placebo; Empagliflozin high placebo; Empagliflozin medium; Empagliflozin medium placebo; Empagliflozin high placebo; Empagliflozin high placebo; Empagliflozin medium placebo; Empagliflozin low placebo; Empagliflozin low; Empagliflozin high
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Empagliflozin medium placebo; Empagliflozin low placebo; Empagliflozin low placebo; Empagliflozin high placebo; Empagliflozin medium; Empagliflozin medium placebo; Empagliflozin high placebo; Empagliflozin high placebo; Empagliflozin medium placebo; Empagliflozin low placebo; Empagliflozin low; Empagliflozin high
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Clinical Trial on Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
Condition: Cerebral Small Vessel Disease
MeSH terms: Cerebral Small Vessel Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a
      beneficial effect on outcomes of cerebral small vessel disease (CSV).
    

Detailed description: 
      CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of
      brain. Few treatment methods are available except some beneficial effect shown with
      nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small
      vessel disease has not been investigated. The investigators designed this randomized,
      double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect
      on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive
      deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is
      sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be
      used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by
      mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
    

Intervention name(s): remote ischemic preconditioning; sham remote ischemic preconditioning
Intervention type(s): Procedure; Procedure
Intervention description(s): RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.; Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remote ischemic preconditioning; random-controlled; double blind; RIPC
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The main objective is to quantify energy expenditure when using the SmartDrive system during
      manual wheelchair propulsion in external conditions (slope, straight line). For this two
      comparisons are performed:

      Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute
      propulsion test.

      Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion
      test.
    

Detailed description: 
      Prospective study mono-centric, controlled, randomized cross over. Randomization of the
      equipment (without and with SmartDrive).

      22 SCI manual wheelchair users. 22 caregivers (healthy subjects)
    

Intervention name(s): SmartDrive assisting device; Standard manuel wheelchair
Intervention type(s): Device; Device
Intervention description(s): oxygen consumption; oxygen consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
Condition: Healthy; Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423
      when administered in different ways.
    


Intervention name(s): AZD5423; AZD5423; AZD5423; AZD5423
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423; nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423; nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423; nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Healthy male volunteers; mild asthmatics; pharmacokinetics; Bioavailability and AUC; Level of AZD5423 in your blood
Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see how the body processes and gets rid of NVA237 in people
      who have impaired kidney function compared to people whose kidney function is normal.
    


Intervention name(s): NVA237
Intervention type(s): Drug
Intervention description(s): NVA237 is administered via a BREEZHALER device
Intervention MeSH terms: Glycopyrrolate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal impairment; NVA237; Pharmacokinetics
Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Observational

Summary: 
      Evaluate the safety and general clinical response of desloratadine syrup in the relief of
      symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
    

Detailed description: 
      Children, ages 2-11, with a history of perennial allergic rhinitis
    

Intervention name(s): Desloratadine (assigned by investigator as part of normal practice)
Intervention type(s): Drug
Intervention description(s): Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits
Other intervention name(s): SCH 034117
Intervention MeSH terms: Desloratadine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children, ages 2-11, with a history of perennial allergic rhinitis
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
Condition: COPD
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      1. To determine the Effects of combined pursed lip breathing with diaphragmatic breathing
           on pulmonary functions in patient with COPD.

        2. To determine the different durations of combined pursed lip breathing with diaphragmatic
           breathing on Pulmonary functions in patient with COPD.

        3. To determine the Effects of combined pursed lip breathing with diaphragmatic breathing
           on quality of life in patient with COPD
    

Detailed description: 
      The technique of pursed lip breathing allow the patients to control the oxygenation and
      ventilation. This technique is performed by allowing the person to inspire through the nose
      exhale through the mouth at a slow controlled flow. This technique works by moving oxygen
      into your lungs and carbon dioxide out of your lungs. Pursed lip breathing (PLB) helps to
      slow down breathing rate and relieving shortness of breath by keeping the airways open
      longer. So patients can remove the air that is trapped in to the lungs.

      In a recent systematic review that is published in 2018, PLB was shown to significantly
      improve ventilation related outcomes such as respiratory rate and minute ventilation, but not
      dyspnea and exercise capacity.

      Diaphragmatic breathing (DB), that is also called deep breathing, this breathing is done by
      contracting the diaphragm, a muscle located horizontally between the thoracic cavity and
      abdominal cavity. During this type of breathing, air enters in to the lungs, the chest does
      not rise and belly expands. Diaphragmatic breathing encourages fully oxygen exchange, that is
      the beneficial trade of incoming oxygen for out going carbon dioxide.
    

Intervention name(s): Pursed Lip Breathing; Pursed Lip Breathing +DB; Conservative care
Intervention type(s): Other; Other; Other
Intervention description(s): PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.; PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.; Participants will be having different dose as per tolerance 5 times daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of POV After Paediatric Tonsillectomy
Condition: Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Tonsillectomy is one of the most frequently performed surgical procedures in children. It
      remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk
      of bleeding, and dehydration due to impaired oral intake. Current medications for POV have
      limited efficacy and may even be associated with potential side-effects. Non-pharmacological
      techniques such as acupuncture has been investigated as alternatives to antiemetics and as
      additional treatment modalities for POV.
    

Detailed description: 
      Postoperative vomiting (POV) is one of the most common complication in children undergoing
      tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given.
      Because of Limited efficacy and side effects with antiemetics, many alternative treatment had
      been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The
      objective of this study is to compare two prophylactic antiemetic treatments :

        -  Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia

        -  Acupuncture treatment (immediately after induction of anaesthesia and for approximately
           20 minutes)
    

Intervention name(s): Dexamethasone; Acupuncture
Intervention type(s): Drug; Device
Intervention description(s): Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.; Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tonsillectomy; postoperative vomiting (POV); Dexamethasone; Acupuncture