bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Nasal Mask Usability Study
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating
      obstructive sleep apnea (OSA) in a pediatric population.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse
      of the upper airway during sleep. Features of OSA include snoring to upper airway resistance,
      which could be mild to severe. While OSA has been studied extensively in an adult population,
      research indicates that OSA is prevalent in a pediatric population as well, though the
      options for treatment are not as varied as that for the adult population. The study seeks to
      determine if a mask made for a pediatric population effectively treats their OSA.
    

Intervention name(s): Pixi pediatric mask
Intervention type(s): Device
Intervention description(s): The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MIDCAB Versus DES in Proximal LAD Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally
      invasive bypass surgery in patients with isolated proximal left anterior descending coronary
      arteries in terms of non-inferiority of an end point combining mortality, acute myocardial
      infarction and rate of reintervention of the target vessel within one year.
    


Intervention name(s): Stenting and minimally invasive bypass surgery; PCI with DES
Intervention type(s): Procedure; Procedure
Intervention description(s): PCI with DES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stent; drug-eluting stent; Minimally invasive bypass surgery; left anterior descending
Color Synbiotics Study
Condition: Beneficial Bacteria in Gut
Study type: Interventional

Summary: 
      This study is initiated to investigate the effect of infant formula with added specific
      synbiotics mixture on proportion of beneficial bacteria.
    


Intervention name(s): Regular non-hydrolysed cow's milk I; Regular non-hydrolysed cow's milk II; Regular non-hydrolysed cow's milk - control
Intervention type(s): Other; Other; Other
Intervention description(s): Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I; Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II; Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Individually Adapted Therapy of Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to directly compare the efficacy of acamprosate, naltrexone and
      placebo for relapse prevention in alcoholics.
    

Detailed description: 
      The primary objective is to directly compare the efficacy of acamprosate, naltrexone and
      placebo for relapse prevention in alcoholics. The secondary objective is to establish an
      association between patients' motivational type and drug effects. The aim is to improve
      alcoholism treatment by identifying characteristics for response to specific pharmacological
      relapse prevention. Such items could allow for an individually adapted pharmacotherapy of
      alcoholism. Specifically, we will study the possible dependence of the efficacy of naltrexone
      and/or acamprosate on different motivational types (reward versus relief craving) and genetic
      profiles referring to glutamatergic and opioidergic candidate genes. Lastly, the longterm
      costs and cost-effectiveness of the different treatment strategies for alcoholics chosen in
      our study are established.
    

Intervention name(s): Acamprosate or Naltrexone
Intervention type(s): Drug
Intervention description(s): mg&d 90 days
Intervention MeSH terms: Naltrexone; Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholism; Drug Therapy
Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Condition: Menopause; Cardiac Function Impaired; Cardiovascular Diseases; Blood Platelet Disorders; Metabolic Diseases
MeSH terms: Cardiovascular Diseases; Blood Platelet Disorders; Metabolic Diseases
Study type: Interventional

Summary: 
      The hypothesis of the present study is that physical training can oppose detrimental changes
      in cardiovascular and metabolic health associated with estrogen loss after menopause.
    


Intervention name(s): Spinning
Intervention type(s): Behavioral
Intervention description(s): After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: premenopausal; postmenopausal; cardiovascular; exercise training; vascular function; cardiac function; cardiac morphology; health
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Fluticasone Propionate/Salmeterol (FSC) 250/50 Microgram (mcg) Through a Capsule-Based Inhaler and a Multi-Dose Inhaler Administered Twice Daily (BID) in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks
      noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg
      capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The
      primary objective of this study is to establish the non-inferiority of the efficacy of the
      FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler
      administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks),
      Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and
      Follow-up (1 week). The total duration of the study for each subject will be at least 32
      weeks.
    


Intervention name(s): FSC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods; Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: efficacy; tolerability; capsule-based inhaler; quality of life; safety; multi-dose inhaler; fluticasone propionate/salmeterol (FSC) 250/50 mcg; Chronic obstructive pulmonary disease
Hair Transplantation in Cicatricial Alopecia
Condition: Hair Transplantation; Cicatricial Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      follicular unit extraction as a method of hair transplantation in cicatricial alopecia
    

Detailed description: 
      The study will include 20 patients with cicatrical alopecia.Patients will be randomly
      assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.

      Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:

        -  Preoperative Investigations including complete blood count, coagulation profile and
           hepatitis viral markers.

           1-Group(A): will undergo (FUE)

        -  Washing the scalp with antiseptic shampoo before the procedure.

        -  Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted
           with 20 cc saline in addition to adrenaline.

        -  Creation of micropunches(0.7-1 mm) using micromotor.

        -  After removal of the punch,the follicular unit is extracted with Jweler's forceps.

        -  Extracted grafts are then placed on chilled saline gauze for maximum four hours until
           ready for transplantation.

        -  The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades
           0.9 mm.

        -  Implantation using fine tipped jweler's forceps.

        -  Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage
           is applied.

           2-Group (B): FUE+PRP

        -  The same procedure will be done but grafts will be placed in Prp solution.

        -  Prp session one week before transplantation then monthly for 3 monthes after (FUE).

        -  Preparation of PRP

        -  10 cc blood will be aspirated in test tube contained a modified solution of
           anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH
           will reached to preserve the platelet integrity.

        -  The first spin of whole blood sample will be at 2500 rpm for 4 minutes

        -  The second spin at 4000 for 20 minutes for obtained plasma.

        -  Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma
           (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The
           resulting suspension is used as PRP.

        -  Prp is injected in the recipient area. 4-Follow up:

        -  Follow up clinically by digital photographs and trichoscopy 1 week after operation,
           after 3 months and after 6 months.
    

Intervention name(s): follicular unit extarcation and platelet rich plasma
Intervention type(s): Procedure
Intervention description(s): hair transplantation procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hair loss, follicuular unit extraction, platelet rich plasma
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8
      weeks in Chinese hypertensive subjects who failed to achieve BP control with the
      starting-dose antihypertensive monotherapy.
    

Detailed description: 
      Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one-
      to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks.

      The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS
      60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the
      starting-dose antihypertensive mono-therapy.

      The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.
    

Intervention name(s): Nifedipine (Adalat GITS, BAY1040)
Intervention type(s): Drug
Intervention description(s): Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment
Intervention MeSH terms: Nifedipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare PF-00299804 given orally on continuous schedule to the approved drug,
      erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy;
      patients will be randomized to receive one of these drugs, and followed for efficacy and
      tolerance of each.
    


Intervention name(s): Erlotinib; PF-00299804
Intervention type(s): Drug; Drug
Intervention description(s): Continuous oral dosing at 150 mg daily.; Continuous oral dosing at 45mg daily
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; advanced; second or third line
Evaluating the Effect of Diabetes Control Through Intensive Lifestyle Modifications on Diabetic Peripheral Neuropathy
Condition: Diabetic Polyneuropathy; Weight Loss
MeSH terms: Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to find out the impact of improving diabetes control through
      weight reduction and lifestyle changes on a common diabetes complication called peripheral
      neuropathy.
    


Intervention name(s): Weight Achievement and Intensive Treatment (Why WAIT)
Intervention type(s): Other
Intervention description(s): Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer
      of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation
      therapy may add benefit. The purpose of this study is to determine if a treatment program of
      combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery
      will delay or eliminate recurrence of the cancer.
    


Intervention name(s): Radiation; Paclitaxel; Cisplatin; 5-Fluorouracil
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Fluorouracil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese
      participants with relapsed or refractory lymphoma.
    


Intervention name(s): duvelisib
Intervention type(s): Drug
Intervention description(s): Duvelisib will be administered orally as a fixed dose in 28-day cycles.
Other intervention name(s): IPI-145; ABBV-954
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed Lymphoma; Phosphoinositide 3-kinase (PI3K) Inhibitor; Duvelisib; Japanese; Refractory Lymphoma
Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
Condition: Respiratory Complication
Study type: Interventional

Summary: 
      Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are
      common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and
      even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its
      success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on
      patient compliance with IS effort and frequency. The investigators hypothesize that a focused
      education preoperatively on IS for POH and intensive monitoring of patient compliance with IS
      therapy in the early postoperative period shortens postoperative oxygen therapy, decreases
      POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients
      receiving standard of care.
    


Intervention name(s): Focused incentive spirometer education and monitoring
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bariatric Surgery; Spirometry Monitoring
Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study
Condition: TMJ - Oral &Maxillofacial Surgery
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of
      3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when
      performed in contrast with conventional arthrocentesis of TMJ.
    


Intervention name(s): Computer Guided Arthrocentesis; Conventional Arthrocentesis
Intervention type(s): Procedure; Procedure
Intervention description(s): patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.; patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single center, 2-treatment, 3-period, 3-sequence
      reference-replicated, crossover trial in healthy subjects to compare the PK of glepaglutide
      (ZP1848) after a single SC administration by vial/syringe and by autoinjector.
    

Detailed description: 
      A total of 72 subjects will be randomized in a 1:1:1 ratio to receive 10 mg glepaglutide SC
      via vial/syringe (Reference) twice or autoinjector (Test) in one of the 3 treatment
      sequences.
    

Intervention name(s): Glepaglutide
Intervention type(s): Drug
Intervention description(s): GLP-2
Other intervention name(s): ZP1848
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to determine the effects of nevirapine on the steady state pharmacokinetics of
      rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in
      combination with rifabutin
    


Intervention name(s): Nevirapine; Rifabutin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nevirapine; Rifabutin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thoracic Spine Manipulation for Patients With Thoracic Spine Pain
Condition: Pain
Study type: Interventional

Summary: 
      The study includes two phases. In phase one the reliability of thoracic spine mobility
      measurements are studied in subjects with thoracic spine pain. In phase two the reliable
      measurements are used to measure the effects of thoracic spine manipulation in subjects with
      thoracic spine pain. The changes in pain is measured as well.

      In second phase the control group receives TNS treatment six times at home as a placebo so
      that the power of TNS is limited to very low level. The number of treatments are controlled
      as well as the time of treatment. The treatment group receives six manipulation treatments
      within 3 week period. The effects are measured immediately after the treatment weeks, and 3
      and 8 week follow-up. Moreover the one year follow-up will be performed by mail
      questionnaire.
    

Detailed description: 
      Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility
      (measured with computer, tape measurements, inclinometer and manually).
    

Intervention name(s): Manipulation vs. TNS thoracic pain
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thoracic spine, pain, manipulation
Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like
      device to expose users to controlled fluctuations in air pressure. It is designed to promote
      quicker altitude acclimatization, thus promoting improvements in exercise capacity at
      altitude and, possibly, at sea level. However, over the past few years, anecdotal stories
      from users of the device suggest that the CVAC treatments might be causing changes beyond the
      expected endurance exercise performance benefits. Therefore, the purpose of the study is to
      obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in
      strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint
      swelling) as well as to obtain broad questionnaire data in order to identify more specific
      variables to investigate in future studies.
    


Intervention name(s): CVAC Device (Cyclic Variations in Altitude Conditioning)
Intervention type(s): Device
Intervention description(s): A hypobaric hypoxia chamber
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research