bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase
      I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of
      dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy
      HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive
      2.5mL dapivirine vaginal microbicide gel at one of three concentrations.
    


Intervention name(s): dapivirine (TMC120) vaginal gel
Intervention type(s): Drug
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV-1; HIV Seronegativity
Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID
Condition: Severe Combined Immunodeficiency Due to ADA Deficiency
MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical
      study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101
      (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS (Elongation
      Factor 1α Short form) Lentiviral Vector (LV) encoding for the human ADA gene) administered to
      ADA-SCID subjects between the ages of 30 days and 17 years of age, who are not eligible for
      an Human Leukocyte Antigen (HLA) matched sibling/family donor and meeting the
      inclusion/exclusion criteria. The OTL-101 product is infused after a minimal interval of at
      least 24 hours following the completion of reduced intensity conditioning. For subjects who
      successfully receive the OTL-101 product, pegademase bovine (PEG-ADA) Enzyme Replacement
      Therapy (ERT) is discontinued at Day+30 (-3/+15) after the transplant. After their discharge
      from hospital, the subjects will be seen at regular intervals to review their history,
      perform examinations and draw blood samples to assess immunity and safety.
    


Intervention name(s): Infusion of autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101); busulfan; PEG-ADA ERT
Intervention type(s): Genetic; Drug; Drug
Intervention description(s): autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously; Busulfan is used for non-myeloablative conditioning; PEG-ADA ERT is discontinued at Day +30 (-3/+15 days) after successful engraftment
Other intervention name(s): OTL-101
Intervention MeSH terms: Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gene therapy; hematopoietic and progenitor cells; lentiviral vector; ADA-SCID
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate whether eradication treatment of
      Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the
      time to relapse in patients with gastroesophageal reflux disease (GERD).

      A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14
      days that are equal or above the critical value of 25.

      The secondary objectives are

        1. To compare the time to relapse in the two H. pylori positive study groups with the H.
           pylori negative control group

        2. To compare the pattern of inflammation and atrophy in the two H. pylori positive
           treatment groups with the naturally H. pylori negative control group at relapse.

        3. All the above objectives analyzed for the efficacy subset that is the per-protocol
           patients broken down by effective H. pylori-eradication.

      Secondary endpoints will be analyzed by the following parameters and their interactions:

        1. Treatment : Eradicated, Non-eradicated, Hp-negative control

        2. Esophagitis at study start: grades 0, A/B and C/D

        3. Gender

        4. Alcohol intake

        5. NSAID/ASA intake (for histological results)

             -  Trial with medicinal product
    


Intervention name(s): Esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: H. pylori
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
Condition: Safety Issues; Infant Nutrition Disorders
MeSH terms: Nutrition Disorders; Infant Nutrition Disorders
Study type: Interventional

Summary: 
      This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy
      full-term infants by investigating effects on growth and gastrointestinal tolerance and by
      identifying any adverse effects.
    

Detailed description: 
      Infants were randomized to receive either a standard protein formula or a low-protein
      formula. The composition of the low-protein formula vs the standard formula was: energy (65
      vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).

      To investigate the safety of the low-protein formula without any bias, a 4-month intervention
      period was selected during which the infants were fed only formula.

      Anthropometric parameters (weight, length, and head circumference) and body composition were
      assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the
      occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two
      weeks either by clinic visits or phone calls.

      The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term
      infants.
    

Intervention name(s): Low protein formula; Standard protein formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.; Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Full term healthy infants; Low protein content formula; Safety; Growth; Body composition
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Condition: Congenital Heart Defects
MeSH terms: Heart Defects, Congenital
Study type: Interventional

Summary: 
      This is a prospective, single center, safety and feasibility trial to evaluate the use of
      autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be
      identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital
      heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram.
      At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a
      sterile fashion and the umbilical vein will be dissected free and preserved until first
      clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will
      be followed until their Stage II palliative procedure.
    


Intervention name(s): Preserved umbilical vein as shunt/conduit
Intervention type(s): Procedure
Intervention description(s): All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RESPeRATE for Treatment of Hot Flashes
Condition: Menopause
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      This is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and
      effectiveness of a device called RESPeRATE that paces respiration to treat menopausal hot
      flashes in 12 peri- or postmenopausal women. Participants will practice paced respiration for
      15 minutes everyday for six weeks and attend assessment visits at weeks 3 and 6.
    

Detailed description: 
      This is an uncontrolled pilot trial of the effects of learning paced respiration using
      RESPeRATE in 12 healthy peri- or postmenopausal women between 40 and 60 years old who report
      experiencing at least 4 hot flashes per day or 30 hot flashes per week. Participants will be
      screened by telephone, then attend a clinic visit for further screening, and a baseline visit
      for final eligibility assessment and to learn how to use the RESPeRATE. Participants will
      receive information about the use of the RESPeRATE and paced respiration from a trained staff
      member and practice using the RESPeRATE during the clinic visit. Participants will also be
      instructed how to record hot flashes in a diary. The intervention will consist of using the
      RESPeRATE device for 15 minutes daily. Outcomes will be assessed in the clinic after 3 weeks
      and 6 weeks use of the device. The main efficacy outcomes are change in number of hot flashes
      per week and change in hot flash score (number of flashes x mean severity) from baseline to 3
      and 6 weeks post-training, reported on the 7-day diary. Frequency of hot flashes will also be
      measured at baseline and 6 weeks using a 24-hour ambulatory hot flash monitor. Change in
      breathing rate will be calculated from baseline to 3 and 6 weeks and changes in sleep and
      quality of life from baseline to 6 weeks as measured by validated self-administered
      questionnaires. The mechanism of response to the RESPeRATE will be explored by measuring
      blood pressure at baseline, 3 weeks and 6 weeks and, body mass index and 24-hour levels of
      urinary epinephrine, norepinephrine and cortisol at baseline and 6 weeks. We will also draw a
      fasting blood sample at baseline and 6 weeks to measure serum lipids, glucose and insulin.
    

Intervention name(s): Paced Respiration
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hot Flashes; Menopausal Symptoms; Paced respiration; RESPeRATE
Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
Study type: Interventional

Summary: 
      The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of
      life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary
      disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days)
      during the implementation of a LABD (Long-acting bronchodilator) treatment.

      The main objective is to compare the total Score of the VQ11 auto-questionnaire before and
      after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality
      of life linked to health, specifically in the COPD.
    

Detailed description: 
      Evaluation of the VQ11 auto-questionnaire of quality of life in pneumology investigation,
      during the implementation of a long-acting bronchodilator treatment of patients with COPD.

      Two visits per patient are planned:

      V1: After complete information and collection of the written consent, the pulmonologists ask
      the patients participating in the study to fill out the VQ11 questionnaire, 2 visual
      analogical scales concerning the dyspnoea and the physical activity, the short IPAQ version
      and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional
      exploration) is also realized during this medical exam.

      V2 (3 months after the treatment setup, at day90 ± 15): the pulmonologists ask the patients
      participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales and
      Likert scales concerning the dyspnoea and the physical activity, the short IPAQ version and
      the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional
      exploration) is also realized during this medical exam.

      Inclusion period : 6 months; Study participation period / patient : 3 months; Complete study
      duration : 9 months
    

Intervention name(s): VQ11 validation
Intervention type(s): Other
Intervention description(s): Two visits per patient are planned: V1 and V2.
For each visit, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, which will be correlated to the other parameters (Likert scale, IPAQ, RFE, SGRQ,...)
LABD treatment consist in β 2 agonists or anticholinergic drug.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: VQ11 questionnaire; COPD; LBD
Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)
Condition: Sleep Apnea; Cardiovascular Diseases
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the levels of 8-isoprostane and other oxidative
      stress biomarkers in plasma and condensed exhaled air between patients with SAHS and
      cardiovascular complications, patients with SAHS without cardiovascular complications and
      control subjects. To evaluate the effect of three months of treatment with CPAP on the
      oxidative stress biomarkers.
    

Detailed description: 
      Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma
      and condensed exhaled air between patients with SAHS and cardiovascular complications,
      patients with SAHS without cardiovascular complications and control subjects. To evaluate the
      effect of three months of treatment with CPAP on the oxidative stress biomarkers.

      Design: randomized, double blind, of parallel groups and controlled with placebo study.

      Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without
      cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23
      control subjects.

      Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).

      Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free
      corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure,
      endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1,
      NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in
      plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of
      catecholamines.
    

Intervention name(s): nasal CPAP; Sham CPAP
Intervention type(s): Device; Device
Intervention description(s): Nocturnal; Nocturnal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: sleep apnea; morbidity; cardiovascular; cpap; oxidative stress
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Studies of myocardial fuel selection using a novel palmitate-based PET probe
    

Detailed description: 
      A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be
      used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2
      diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting
      conditions and under insulin clamp conditions.
    

Intervention name(s): thiapalmitate tracer; Saline; Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Radiolabeled tracer infusion; occurs in all treatment arms; Saline infusion for control; Insulin infusion for insulin/glucose clamp procedure
Other intervention name(s): 16- 18-F-fluoro-4-thiapalmitate
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      18 children post acquired brain injury and 18 typically developed controls matched for age
      and gender.

      All children aged 10-18 yrs who understand simple commands.

      Tools:

        1. Heart rate monitor

        2. Six minute walk test

        3. The behavior rating inventory

      Method:

        1. At the introductory visit the child will be asked to walk for six minutes, to sit and
           perform a cognitive test and then to walk on a treadmill for 5 seconds.

        2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at
           the same time to perform the cognitive assignment; After a rest the child will be asked
           to walk on the treadmill for 5 minutes and at the end to perform the cognitive
           assignment .
    


Intervention name(s): cognitive and motor assignments
Intervention type(s): Other
Intervention description(s): walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance
Condition: Reproductive Performance Following Ovarian Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology
      centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed
      ovarian tissue, with the aim to conceive.

      Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine
      monitoring, IVF.
    

Detailed description: 
      Main Outcomes expected:

      Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue
      live-births rates following transplantation of ovarian tissue cancer disease recurrence
    

Intervention name(s): transplantation of ovarian tissue
Intervention type(s): Procedure
Intervention description(s): operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fertility preservation; ovarian tissue transplantation; ovarian endocrine function; assisted reproductive technology; pregnancy and live birth
Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess blood pressure reduction with nebivolol or placebo in patients taking
      lisinopril or losartan.
    


Intervention name(s): nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration; Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Other intervention name(s): Bystolic ™; Lisinopril-other names: Prinivil, Zestril; Losartan-other name: Cozaar
Intervention MeSH terms: Losartan; Lisinopril; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nebivolol; Bystolic ™; lisinopril; losartan; Hypertension
Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
Condition: Myocardial Ischemia; Coronary Disease; Myocardial Infarction
MeSH terms: Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Reperfusion Injury; Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size
      following balloon catheterization for acute myocardial infarction.
    


Intervention name(s): FX06; Percutaneous coronary intervention
Intervention type(s): Drug; Procedure
Intervention description(s): 400 mg as intravenous injection in two divided boluses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Revascularization