bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is
      superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms
      in children with allergic rhinitis.
    

Detailed description: 
      1. BHS is superior to NSS for improving mucociliary function that by measure saccharine
           clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.

        2. BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up

             -  at short period: compare the following results at baseline and 10 minute after
                nasal irrigation

                  1. total nasal symptom score(TNSS)

                  2. satisfaction to nasal irrigation

                  3. side effect

             -  at 2 and 4 weeks follow up : compare the following results at baseline and 10
                minute after nasal irrigation

                  1. quality of life(by specific questionnaire for Thai allergic
                     rhinoconjunctivitis patient)

                  2. medication use to relieve AR symptom(from diary record)

                  3. compliance for nasal irrigation (from diary record)

                  4. side effect (from diary record)

                  5. overall satisfaction to nasal irrigation
    

Intervention name(s): NSS nasal irrigation salt; BHS nasal irrigation salt
Intervention type(s): Drug; Drug
Intervention description(s): nasal irrigation twice daily for 4 weeks period; nasal irrigation twice daily for 4 weeks period
Other intervention name(s): NORMALINE; SEANIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nasal irrigation; allergic rhinitis; children
Evaluation of Patient Education in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      About 10% of the population in western countries suffer from abdominal pain and change of
      bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of
      life and they are often not well taken care of within the public healthcare system. They
      often feel frustrated and seek both their family doctors, specialists and alternative
      medicine for help. Many patients feel they do not know enough about their disease, and the
      uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information
      and education in these patients.
    

Detailed description: 
      The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized
      to receive intervention now (intervention group) or in 6 months (control group). The
      intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced
      gastroenterologist at the local hospital.

      Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment,
      nutritional advices.

      The patients are evaluated at time: 0 months and 6 months (intervention group and control
      group), 12 months (control group) and after 2 years (both groups).
    

Intervention name(s): patient education
Intervention type(s): Behavioral
Intervention description(s): Patient education group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Quality of life; Gastrointestinal symptoms; Health related costs
Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy
      and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes
      inadequately controlled with metformin monotherapy.
    

Detailed description: 
      This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy
      and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes
      inadequately controlled with metformin monotherapy.

      Screening will be made to select eligible participants before intervention. The trial will
      include 1-week run-in period of stable doses of metformin (1500mg) and 48-week treatment
      period. After the run-in period, patients were randomly assigned to one of two groups for
      antihyperglycaemic therapies for a total of 48-weeks: saxagliptin and glimepiride. The
      treatment of saxagliptin will be initiated and maintained at 5mg every morning until the
      completion of the study. Glimepiride will be initially treated with 1 mg every morning, and
      further titrated up at 4-week intervals until to reach the target fasting blood glucose
      (FPG).As to Glimepiride groups, if the fasting blood glucose dose not achieved the target
      after the maximal doses, maintain the maximal doses(6mg per day) until the completion of the
      study.Meanwhile, participants in both groups should take metformin 1500mg per day throughout
      the whole 48 weeks. At the end of the study, data will be collected and analyzed.
    

Intervention name(s): Saxagliptin; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg/d; 1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg
Other intervention name(s): Onglyza，Astrazeneca; Amaryl，Sanofi-Aventis
Intervention MeSH terms: Glimepiride; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: saxagliptin; glimepiride; metformin monotherapy
Guidelines for Post-exercise Dietary Intake in T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesise that manipulating the glycaemic index of the meal after
      exercise and before sleep will help prevent Type 1 diabetes individuals experiencing
      hypoglycaemia.
    


Intervention name(s): Meal composition
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: T1DM, Exercise, Hypoglycaemia
Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      The Bioequivalence studies were performed to compare the rate and extent of release of the
      drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride
      Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®
      (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,
      USA.

      Study Design:

      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose
      Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test
      formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule
      (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers
    


Intervention name(s): Venlafaxine Hydrochloride Extended-Release Capsules of Torrent Pharmaceuticals Limited
Intervention type(s): Drug
Intervention MeSH terms: Venlafaxine Hydrochloride
A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
Condition: COPD, Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID)
      and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and
      resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD)
      following chronic dosing after approximately two weeks treatment.
    


Intervention name(s): GP MDI (PT001) 14.4 μg; FF MDI (PT005) 9.6 μg
Intervention type(s): Drug; Drug
Intervention description(s): Glycopyrronium; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postoperative Analgesia After Low Frequency Electroacupuncture
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      The purpose of this study is to determine whether electroacupuncture is a effective tool to
      the postoperative analgesia
    

Detailed description: 
      The electroacupuncture is a known therapeutic modality with particular application to pain.
      In this study the investigators investigate the effect of electroacupuncture in condition of
      surgery, which is a particularly painful situation. The investigators will verify the
      postoperative analgesia, as patients will receive either electroacupuncture or placebo
      electroacupuncture.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Intervention description(s): Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly,
        Greece.
      
Biospecimen description: 
      serum, plasma
    
Keywords: electroacupuncture; acupuncture; pain management
Use Of Fragmin In Hemodialysis
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of
      patients during dialysis.
    


Intervention name(s): Fragmin
Intervention type(s): Drug
Intervention description(s): variable dosing regimen
Intervention MeSH terms: Dalteparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fragmin; dalteparin; hemodialysis; anticoagulation; Renal Failure
A Study to Assess Drug Interaction of ASP015K and Midazolam
Condition: Healthy; Pharmacokinetics of ASP015K and Midazolam
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to characterize the effect of multiple doses of ASP015K on the
      pharmacokinetics of a single dose of midazolam.
    


Intervention name(s): ASP015K; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Midazolam; Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; midazolam; healthy volunteers
Comparison of Noninvasive Hemoglobin Disposable Sensors
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the concentration of hemoglobin within the subject's blood will be reduced in
      a controlled manner by administering fluids intravenously. The accuracy of two noninvasive
      hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a
      laboratory analyzer.
    


Intervention name(s): Rainbow adhesive adult/pediatric sensor; Rainbow adhesive adult/neonatal sensor
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions
Condition: Diabetes; Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Randomized control trial studying the effect of medical assistant health coaching for
      patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care
      community clinics, Mission Neighborhood Health Center and Southeast Health Center
    


Intervention name(s): Health coaching by medical assistants in primary care
Intervention type(s): Behavioral
Intervention description(s): Patients with uncontrolled diabetes, hypertension, hyperlipidemia will receive health coaching by medical assistants working with primary care providers in the Teamlet Model [Bodenheimer 2007] for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Gastric Partitioning Procedure for the Treatment of Unresectable and Obstructive Distal Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The incidence of unresectable and obstructive gastric cancer patients ranges in the
      literature from 5 to 30 % . In such cases, gastro-entero anastomosis is traditionally
      performed and can improve the quality of life by relieving the symptoms of impaired oral
      intake without having a high surgical risk. Unfortunately, up to 25% of these patients may
      develop impaired gastric emptying syndrome. Gastric partitioning was originally described by
      Devine in 1925 as a method of antral exclusion and complete division of the stomach
      accompanied by a gastro-entero anastomosis in the proximal gastric pouch for the management
      of difficult duodenal ulcers. This procedure has been modified along the years and was
      adopted for the palliative treatment of gastric cancer. The advantages of the partitioning
      includes: better gastric emptying, avoidance of direct tumor invasion of the gastro-entero
      anastomosis, less contact between the ingested food and the tumor with less blood lost and
      improved survival. Retrospective not randomized studies have been published demonstrating the
      effectiveness of the procedure.
    

Detailed description: 
      The first group (Group A) will be considered the control group in which patients will undergo
      gastro-entero anastomosis. The anastomosis will be pre-colic, along the posterior wall of the
      stomach with the length of at least 5 cm. The first jejunal loop approximately 40 cm from the
      angle of Treitz will be used. The anastomosis can be performed manually or with staplers.

      The second group (group B) will be considered the intervention group in which patients will
      undergo gastric partitioning plus gastro-entero anastomosis. The gastric partitioning is done
      5 cm proximal to the lesion along the greater curvature towards the lesser curvature above
      the incisura using linear cutting stapler. The partitioning is performed horizontally and
      preserve a narrow tunnel along the lesser curvature that is calibrated with a orogastric tube
      gauge 32. Subsequently, a pre-colic gastro-entero anastomosis is performed in the proximal
      gastric chamber created by the partitioning. The anastomosis is done along the posterior
      wall, with at least 5 cm of length using the first jejunal loop approximately 40 cm from the
      angle of Treitz. The anastomosis can be performed manually or with staplers.
    

Intervention name(s): Gastro-entero anastomosis only; Gastric partitioning Plus Gastro-entero anastomosis
Intervention type(s): Procedure; Procedure
Intervention description(s): Gastro-entero anastomosis only; Gastric partitioning Plus Gastro-entero anastomosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to characterize and compare the pharmacokinetic profiles
      of mitapivat following a single dose administration of 100 mg mitapivat in two tablet
      formulations (50 mg and 100 mg tablet strengths) in healthy adult participants.
    


Intervention name(s): Mitapivat tablet
Intervention type(s): Drug
Intervention description(s): Oral tablets
Other intervention name(s): AG-348; AG-348 sulfate hydrate; Mitapivat sulfate
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TP0502-Pharmaco-Scintigraphic-Study and Amendment
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-site trial to evaluate the drug release, using
      scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with
      mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be
      evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1]
      radio-labelled tablet of either formulation D or formulation E, respectively.

      Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects
      and five [5] patients will be administered one [1] radio-labelled tablet of this new third
      improved formulation H.

      In order to keep the number of patients low, recruitment of patients will be stopped when
      obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will
      then be recruited to achieve a full set of participants (n=9 per Arm).
    


Intervention name(s): TP05 Coating D; TP05 Coating E; TP05 Coating H
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One radio-labelled tablet given to subjects; One radio-labelled tablet given to subjects; One radio-labelled tablet given to subjects
Other intervention name(s): Mesalazine; Mesalazine; Mesalazine
Intervention MeSH terms: Mesalamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are
      safe and tolerable in humans and to see how the immune system responds to the vaccines.

      There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS
      is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to
      prevent HIV disease is the best way to try to deal with this situation. Several vaccine
      products have been tested, but only 2 are still in trial. There is a need for a new product.
    

Detailed description: 
      Despite recent advances in the treatment and prevention of HIV disease, the epidemic is
      worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan
      Africa and the leading infectious cause of death in the world. An effective and inexpensive
      vaccine to prevent HIV disease remains as the best option to try to deal with this expanding
      epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a
      Phase III trial, underscoring the need for new vaccine strategies.

      Prior to study entry, participants have their risk status for HIV infection determined by a
      series of questions. Further eligibility is determined by results of physical exam,
      laboratory tests, and further questions. Blood is drawn on each study visit. Participants are
      assigned randomly to 1 of 4 study groups:

      Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group
      receives a different concentration of gp120.

      All immunizations are admixed with AS02A adjuvant. Vaccinations are administered
      intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and
      immunogenicity are performed at designated time points; participants have about 11 clinic
      visits.
    

Intervention name(s): Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A; NefTat; AS02A Adjuvant; gp120W61D
Intervention type(s): Biological; Biological; Drug; Biological
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; Injections, Intramuscular; HIV Antibodies; HIV-1; HIV Envelope Protein gp120; Gene Products, tat; AIDS Vaccines; Neutralization Tests; Vaccines, Combined; AIDS Seronegativity; Gene Products, nef