bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea Syndrome; Resistant Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure
      (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive
      patients with moderate-severe obstructive sleep apnea syndrome (OSAS).
    

Detailed description: 
      Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in
      patients with resistant hypertension (defined as uncontrolled clinic BP despite being on
      anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic).
      Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP)
      device on clinic and ambulatory BPs in patients with resistant hypertension is largely
      unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect
      of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as
      an apnea-hypopnea index [AHI] greater than 15 on a full polysomnographic examination).
      Two-hundred patients will be randomly allocated either to treatment with CPAP device plus
      their usual anti-hypertensive treatment or to continue their usual treatment alone for 6
      months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including
      microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric
      treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before
      and after the 6-month treatment, with the observers blinded to the allocation group.
    

Intervention name(s): Continuous positive airway pressure treatment
Intervention type(s): Procedure
Intervention description(s): Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Continuous positive airway pressure; Ambulatory blood pressures
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of African Sub-Saharan infants with pneumococcal
      conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell
      pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4
      months of life.
    

Detailed description: 
      Vaccination course at 6, 10, 14 weeks of age.
    

Intervention name(s): GSK Biologicals' Synflorix™; GSK Biologicals' Polio Sabin™; GSK Biologicals' Zilbrix™ Hib
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 IM doses.; 3 oral doses; 3 IM doses.
Other intervention name(s): 10Pn; OPV; DTPw-HBV/Hib vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcal conjugate vaccine; Streptococcus pneumoniae
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)
Condition: Chronic Pain; Chronic Nonmalignant Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate efficacy of chronic pain self-management program in
      community settings to adopt Integrative Yoga Therapy (IYT).
    


Intervention name(s): Integrative Yoga Therapy
Intervention type(s): Other
Intervention description(s): Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity
Condition: Obesity; Protein-energy; Imbalance; Insulin Sensitivity; Gastrointestinal Complication
MeSH terms: Insulin Resistance; Hypersensitivity; Weight Loss
Study type: Observational

Summary: 
      The purpose of the study is to determine the effect of three weight loss surgeries compared
      to a low calorie diet with regard to energy expenditure, body composition, insulin
      sensitivity, and the response of gastrointestinal peptides to a standard meal. Baseline
      assessments will be conducted in all four groups and changes will be compared six and
      fifty-two weeks post-operatively.
    

Detailed description: 
      The purpose of the study is to determine the effect of three weight loss procedures compared
      to a low calorie diet. Three different obesity surgery methods; Roux-en-Y gastric bypass
      (RYGB), gastric banding (GBa), sleeve gastrectomy (SGx), and one low calorie diet program on
      metabolism, with regard to body fat, physical activity levels, hormone changes after eating a
      meal, and changes in taste preferences.

      Participants having obesity surgery will receive laparoscopic (minimally invasive surgery
      performed by making several small incisions in the abdomen and inserting a camera called a
      laparoscope) an adjustable gastric band, a sleeve gastrectomy or roux en Y gastric bypass. In
      addition to the regular surgical procedures, the surgeons will remove laparoscopically about
      10g (1 tablespoon) of fat from within the abdomen. This fat tissue will be processed and
      stored for future study (at completion of the study) of your metabolism pre-treatment.
      Participants will complete post-operative follow-up appointments with their surgeon as
      required.

      Participants on the LCD program will experience weight loss by following a low calorie diet
      program (LCD). For this diet you will select all your own food choices and our dietitians
      will assist you to reach your daily calorie target. You will be asked to follow this balanced
      food diet for the remainder of the 12 month study.
    

Intervention name(s): Laparoscopic Roux-en-Y gastric bypass; Laparoscopic gastric banding; Laparoscopic sleeve gastrectomy; Low Calorie Diet
Intervention type(s): Procedure; Procedure; Procedure; Behavioral
Intervention description(s): Laparoscopic Roux-en-Y gastric bypass surgery; Laparoscopic gastric banding surgery; Laparoscopic sleeve gastrectomy surgery; Low Calorie Diet Program
Other intervention name(s): RYGB; GBa; SGx; LCD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Medically qualified for obesity surgery by Drs LeBlanc or Hausmann
      
Biospecimen description: 
      Blood draw, urine, stool, fat and muscle biopsies.
    
Keywords: Roux-en-Y gastric bypass surgery; Sleeve gastrectomy (SGx) surgery; Gastric banding (GBx) surgery; Low calorie diet program
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
Condition: Acute Disease; Myelodysplastic Syndromes; Leukemia, Myeloid, Chronic; Myeloproliferative Disorders; Blood and Marrow Transplant (BMT); Myelodysplastic Syndromes (MDS); Leukemia
MeSH terms: Leukemia; Preleukemia; Hematologic Neoplasms; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Myeloproliferative Disorders; Syndrome; Acute Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the tolerability and efficacy in treating patients
      aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or
      myeloproliferative disorders (MPD).
    

Detailed description: 
      To learn whether a new preparative regimen to prepare patients for bone marrow
      transplantation is useful in patients above 50 years of age and whether it is useful in
      patients with myelodysplastic syndromes.
    

Intervention name(s): ablative allogeneic hematopoietic cell transplantation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of
      LEO 138559 in healthy Japanese subjects.

      The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO
      138559 or placebo, and 8 follow-up visits to Day 85.

      A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and
      randomized to either LEO 138559 or placebo in a ratio of 6:2.
    


Intervention name(s): LEO 138559; LEO 138559 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEO 138559 is an antibody given by injection just under the skin.; LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except the medical ingredient LEO 138559.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antiviral Activity of AZD7295 in HCV Carriers
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      PK, safety study of AZD7295 in HCV carriers
    


Intervention name(s): AZD7295; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 700mg per day maximum; matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure
Condition: Lactating Women
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the transfer of fospropofol and its active metabolite,
      propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a
      needed procedure.
    

Detailed description: 
      E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic
      agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing
      diagnostic or therapeutic procedures.1 It is a water-soluble, phosphono-O-methyl prodrug of
      propofol. Upon IV injection, the inactive fospropofol undergoes metabolism, most notably by
      alkaline phosphatase enzymes, to yield the active metabolite (propofol), phosphate, and
      formaldehyde. Formaldehyde is quickly converted to formate in vivo, and formate is further
      metabolized by a folate-dependent mechanism.
    

Intervention name(s): Lusedra; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge); Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)
Intervention MeSH terms: Propofol; Fospropofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monitored anesthesia care
A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus
Condition: Metabolic Syndrome; Cardiovascular Risk Factors; Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      An increased prevalence of the metabolic syndrome has been found in patients with systemic
      lupus erythematosus in recent years.
    

Detailed description: 
      This study will investigate the prevalence of the metabolic syndrome in patients with SLE in
      Taiwan. We expect our study will provide further understanding of the association between SLE
      and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and
      mortality in SLE patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons aged 18 and above.
      
Biospecimen description: 
      Stored serum
    
Keywords: Metabolic syndrome; Systemic lupus erythematosus
Stem Cell Injection in Cancer Survivors
Condition: Cardiomyopathy Due to Anthracyclines
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to examine the safety and feasibility of delivering
      allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer
      survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced
      cardiomyopathy (AIC).

      The secondary purpose of this study is to obtain preliminary evidence for therapeutic
      efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV
      dysfunction secondary to AIC.
    

Detailed description: 
      This phase I, randomized, placebo-controlled, trial will evaluate the safety and feasibility
      of allo-MSCs administered by transendocardial injection in thirty-seven subjects with
      anthracycline-induced cardiomyopathy (AIC). The first six subjects received allo-MSC therapy
      (open label) and were assessed for safety and feasibility of the study procedures. Following
      1 month data review of each of the six subjects by the National Heart, Lung, and Blood
      Institute Gene and Cell Therapy Data Safety Monitoring Board; this was followed by a
      randomized, double-blind clinical trial enrolling thirty-one subjects. These subjects were
      randomized 1:1 to receive allo-MSCs or placebo. All subjects underwent cardiac
      catheterization and study product administration using the NOGA Myostar catheter injection
      system. Subjects are being followed at 1 day, 1 week, 1 month, 6 months, and 12 months post
      study product injection. All endpoints are assessed at the 6 and 12 month visits which will
      occur 180 ±30 days and 365 ±30 days, respectively, after the day of study product injection
      (Day 0). For the purpose of the safety evaluations and endpoint analysis, the Investigators
      will utilize an "intention-to-treat" study population. In addition, because this phase I
      study is the first cell therapy study in this population, at 12 months available
      standard-of-care medical records for cancer surveillance will be reviewed for cancer
      recurrence.
    

Intervention name(s): Allo-MSCs; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure); 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
Other intervention name(s): Allogeneic Mesenchymal Stem Cells; Buminate solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiomyopathy; AIC; Anthracyclines; Chemotherapy; Allogeneic; Mesenchymal stem cells; MSCs; Cancer survivors; Breast Cancer; Leukemia; Lymphoma; Sarcoma
Comparison of Vibration and Dry Needle in Trigger Point Therapy
Condition: Myofascial Pain Syndrome; Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of localized vibration and dry needling
      applied to the trigger point in the individuals with acute myofascial pain syndrome.Pressure
      pain threshold (PPT) was used for the primary outcome measure of the study, and pain
      intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures.
    

Detailed description: 
      The patients were divided into two groups as dry needling and localized vibration using the
      permuted block randomization method. The study was completed with 20 (17 women, 3 men) in the
      dry needling group and 20 in localized vibration (15 women, 5 men). In both applications, a
      total of 3 sessions were made to the patients at 1-day intervals.Patients' age, gender,
      duration of pain, localization, presence of additional disease, drug use were questioned and
      recorded. Pressure pain threshold (PPT) was used for the primary outcome measure of the
      study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary
      outcome measures. All evaluation criteria except SF-36 were made before, immediately after
      and 1 day after each session, 1 week after the last session. SF-36 was evaluated before the
      1st session treatment, after the 3rd session treatment and 1 week after the 3rd session
      treatment.
    

Intervention name(s): Dry needle; Localize vibration
Intervention type(s): Other; Device
Intervention description(s): Local twitch responses (LTRs) were obtained by multiple rapid insertions of the needle in and out of the point, similar to Hong's rapid-entry and rapid exit technique. Hong 1994). The needle was not removed from that site for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained.; the vibration was applied with 110 Hz and 5.57 mm amplitude.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial Pain Syndrome; Trigger Point; Dry Needling; Vibration
Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Dual combination therapy with metformin and sulphonylurea is the most commonly used
      combination regimen to treat patients with type 2 diabetes. But, treatment with the dual
      combination therapy is often unsuccessful at achieving glycaemic control in patients with
      type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.

      Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical
      practice. It is well established that DPP-IV inhibitor improve glycemic control in patients
      with type 2 diabetes.

      But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors
      (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a
      sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on
      therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering
      effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C
      and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination
      with a sulfonylurea agent and metformin in type 2 diabetic patients.
    


Intervention name(s): Vildagliptin; Sulphonylurea dose-up
Intervention type(s): Drug; Drug
Intervention description(s): Vildagliptin 50mg twice a day, orally, for 24 weeks; glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
Other intervention name(s): Galvus; Amaryl
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Vildagliptin; insulin; C-peptide
Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm
Condition: DNA Damage; Other Complications Associated With Artificial Fertilization
Study type: Observational

Summary: 
      The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic
      acid, which is the genetic material inside your cells) alterations in the sperm's head, in
      the near future leading us to choose the "good sperm" in a simplified manner. This could then
      increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm
      abnormalities.
    

Detailed description: 
      If you take part in this study,

        1. Your physician is asking you to provide a semen sample as you already would. The sample
           will be taken to the IVF lab which would occur if you were not involved in this
           research. The part that would be thrown away is then further analyzed under a polarized
           light microscope. The sample is exposed to ultraviolet (UV) light for a period of 20
           minutes after which it is analyzed under the microscope again, looking for any changes
           when compared the sample that was not exposed to UV light. The sample is then discarded.

        2. Your name will be removed from the sample after the regular semen analysis is done;
           therefore there will be no way of associating the research results with you. No
           information will be needed from you and you will not be contacted in the future
           regarding this research.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IVF patients already undergoing therapy and providing a semen sample for sperm count
      
Biospecimen description: 
      sperm
    
Keywords: IVF