bioihbjkbjnl/mcl2 huggingface dataset:
Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is determine if the combination of zonisamide SR and bupropion SR
      are is more effective than either drug given alone or placebo in the treatment of obesity.
    


Intervention name(s): Zonisamide SR placebo/ bupropion SR placebo; Zonisamide SR placebo/ bupropion SR 360 mg/day; Zonisamide SR 120 mg/day/ bupropion SR placebo; Zonisamide SR 360 mg/day/ bupropion SR placebo; Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day; Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 placebo combination tablets twice daily for 16 weeks (maintenance period); 2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period); 2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period); 2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period); 2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period); 2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Intervention MeSH terms: Zonisamide; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; zonisamide; bupropion
A Bioequivalence Study of Levetiracetam Versus Keppra
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra
      administered under fasting conditions to healthy adult subjects.
    

Detailed description: 
      This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic
      blood samples and vital signs were obtained before and after administration at scheduled
      intervals as indicated in the study protocol.
    

Intervention name(s): Levetiracetam (Lotus Pharmaceutical Co.,Ltd.); Keppra (Levetiracetam - USB SA Pharma Sector)
Intervention type(s): Drug; Drug
Intervention description(s): Levetiracetam 500mg/tablet Oral once; Levetiracetam 500mg/tablet oral once
Other intervention name(s): The test drug Levetiracetam is no brand name.; Manufacturer:Lotus Pharmaceutical Co.,Ltd.; Keppra; Manufracturer:USB SA Pharma Sector
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: The bioequivalence of Levetiracetam vs. Keppra; volunteer
Botulinum Toxin for Stomach Cancer Treatment
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Preclinical studies at our institution, using a genetic mouse model of gastric cancer,
      strongly suggest that innervation of the stomach wall is required not only for the
      development, but also for the progression of gastric cancer, and that denervation of the
      stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall
      may represent an effective therapeutic intervention. New treatment options for inoperable
      cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to
      be an attractive possibility. In this pilot study Botox injections will be given by
      gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is
      to obtain data needed to calculate sample size in a larger controlled trial.
    


Intervention name(s): Botox
Intervention type(s): Drug
Intervention description(s): injection by gastroscopy (100 Allergen units)
Other intervention name(s): Botulinum toxin
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum Toxins; Injections; Stomach; Tomography, X-Ray Computed
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on EMA (European Medicines Agency) new guidelines on the clinical development of
      products for immunotherapy for the treatment of allergic diseases the aim of this study was
      to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations
      in patients allergic to Dermatophagoides pteronyssinus.
    


Intervention name(s): subcutaneous immunotherapy with DPT extract; Subcutaneous depot placebo
Intervention type(s): Biological; Biological
Intervention description(s): Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units); Increasing doses of subcutaneous depot placebo in three different scales
Other intervention name(s): DPT depot vaccine
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Immunotherapy; Allergic Rhinoconjunctivitis; D. pteronyssinus; house dust allergy
Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement
Condition: Total Knee Replacement
Study type: Interventional

Summary: 
      The main objective of this study is to show that postoperative Total Knee Replacement (TKR),
      an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor
      quadriceps femoral perineural catheter that (KTF) infused with even low doses of local
      anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking
      of the knee feasible at the bedside.

      Patients will be randomized in two arms:

        -  catheter in position under sartorial (experimental group)

        -  femoral catheter (control group)
    


Intervention name(s): under sartorial catheter; femoral catheter
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: total knee replacement; anesthesia; catheter
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Condition: Cardiovascular Disease; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs
      primarily used to treat hypertension or congestive heart failure) to prevent or delay
      cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining
      their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled
      study.
    

Detailed description: 
      This study will be the first to examine whether aortic stiffness is increased in elderly
      patients with CKD compared to their age-matched healthy controls and further examine whether
      ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy
      appears beneficial in preventing or delaying arterial stiffening in elderly patients with
      CKD, this work has important implications for improving the overall health of this
      population.
    

Intervention name(s): angiotensin converting enzyme inhibitor; lisinopril
Intervention type(s): Drug; Drug
Intervention description(s): Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day; 1 x 40 mg per day
Other intervention name(s): ACE-inhibitor; ace inhibitor
Intervention MeSH terms: Lisinopril; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cardiovascular disease; angiotensin converting enzyme inhibitors; chronic kidney disease; cardiovascular disease in elderly patients with CKD
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
Condition: HIV; Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      In a group of HIV-positive patients under observation since their first exposure to ART or
      monitored off of ART, BMD changes over one year will be determined. For each subject, the
      investigators will also determine associations between changes in BMD and 1) ART initiation,
      2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated
      through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a},
      high-sensitivity c-reactive protein {hsCRP}).

      Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of
      ART, after excluding those subjects treated with tenofovir.

      BMD will decrease most significantly in HIV-positive subjects with the highest levels of
      cumulative viremia.

      HIV-positive persons with highest cumulative viremia will have the highest levels of
      inflammation, as measured by pro-inflammatory cytokines.

      Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare
      sample and fracture association with the use of varying ART medications among dual-eligible
      persons in Medicare and Medicaid datasets.

      Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to
      HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest
      duration of ART exposure.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        For primary outcomes: 1917 Clinic cohort. For secondary outcomes: Medicare sample.
      
Keywords: HIV; Bone mineral density; bone turnover; fracture; inflammation
Long-term Follow up After SG vs RYGB vs OAGB
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB
      and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned
      into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones
      undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM),
      hypertension (HT) and dyslipidemia (DL) were assessed.
    

Detailed description: 
      A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB
      and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned
      into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y
      Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index
      (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and
      dyslipidemia (DL) were assessed.
    

Intervention name(s): Sleeve Gastrectomy; Roux-en-Y gastric bypass; One-Anastomosis Gastric Bypass
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patients undergo a Sleeve Gastrectomy as bariatric procedure; The patients undergo a Roux-en-Y gastric bypass as bariatric procedure; The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
Condition: Ovarian Cysts
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the impact of electrocoagulation on ovarian
      reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.
    

Detailed description: 
      Laparoscopic cystectomy is currently considered the treatment of choice in women with benign
      ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However,
      the safety of this technique in terms of ovarian damage to the operated gonad has recently
      been questioned. In the present study, with the combined use of serum hormonal evaluation and
      ultrasound examination, we planned to prospectively investigate the ovarian reserve after the
      excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a
      12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation
      or suture during ovarian cystectomy
    

Intervention name(s): Ovarian cystectomy; Ovarian cystectomy; Ovarian cystectomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Laparoscopic ovarian cystectomy using bipolar; Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation; Laparotomic ovarian cystectomy using suture
Other intervention name(s): laparoscopic ovarian cystectomy using bipolar; laparoscopic ovarian cystectomy using ultrasonic scalpel; Laparotomic ovarian cystectomy using suture
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ovarian Cysts; Electrocoagulation; Ovarian Function Tests; Laparoscopy
A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This 4-part study will assess the effect of formulation, food, and active pharmaceutical
      ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an
      open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period
      crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet
      formulation, in the fasted or fed state.
    


Intervention name(s): GDC-0032 Phase III Tablet; GDC-0032 Tablet; GDC-0032 Capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.; Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.; Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic
      Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children
      affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure
      of the glycemia is visible in real time on the pump and then the rate can be normalized. The
      study will evaluate the impact of the continuous measurement of blood glucose on insulin pump
      on child quality of life with type 1 diabetes aged 2 to 13 years old.
    

Detailed description: 
      The French High Health Authority recommends, for patient with type1 diabetes, a supervision
      of at least 4 tests a day in pre and post prandial with additional controls in circumstances
      of meal or of unusual physical activities.

      Du to age, this control need supervision of an adult, in each place of children life (school,
      nursery, out-of-school center ...), according to their autonomy.

      During several years, all the actors of educational care tried to improve the welcome of the
      children affected by handicap or by chronic disease.

      Since 10 years, the team of pediatric diabetology of Mulhouse Hospital has developed a
      partnership with the department of Education by setting up every year in September of a
      training courses for voluntary teachers and all staff nursery.

      These sessions are consisted of a formal time bringing knowledge on the disease, followed by
      exchanges and finally a practical time around manipulation of the readers of glycemia and
      pumps.

      Alerts can be scheduled to warm an increase or an important reduction of blood glucose.

      The study will evaluate the child quality of life, and also parents and staffs in preschool,
      school or in out-of-school center felt too.
    

Intervention name(s): Peds QL questionnaire and diabetes modulate; WHO-5 questionnaire; Felt questionnaire
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Peds QL questionnaire and diabetes modulate is a pediatric questionnaire about quality of life - children's version and parents version : assessed in the 1st visit (enrollment visit) and after ten months ( V6 End of study); WHO-5 questionnaire is a questionnaire about quality of life : assessed in the 1st visit (enrollment visit) and after ten months (V6 End of Study) by the children; Felt questionnaire completed by parents with regard to the welcome of their child in community and by the staffs in preschool, school or in out-of school center : assessed 2 months (V2) and ten months (V6 End of study) after enrollment visit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 diabetes children,School,Childcare facilities,Sensor
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Condition: Respiratory Syncytial Viruses
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this two-part designed study is to assess in the setting of a planned early
      interception of pediatric RSV disease, early viral and disease kinetics (observational stage)
      and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor,
      JNJ-53718678 (interventional stage). In the observational stage the infant is closely
      monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for
      diagnosis earlier than in the typical setting.
    


Intervention name(s): RSV Mobile Application; Placebo; JNJ-53718678 2.5 mg/kg; JNJ-53718678 3 mg/kg; JNJ-53718678 4.5 mg/kg
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.; Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.; JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.; JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.; JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control,
      however, its use inevitably increases the incidence of postoperative nausea and vomiting
      (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention
      and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the
      prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3
      antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study
      evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using
      IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of
      the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48
      h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all
      patients.
    


Intervention name(s): Ramosetron; Palonosetron
Intervention type(s): Drug; Drug
Intervention description(s): ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery; palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.
Intervention MeSH terms: Palonosetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
PT003 MDI Dose Confirmation Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its
      individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    


Intervention name(s): PT003; PT001; PT005
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PT003 MDI administered as two puffs BID for 7 days; PT001 MDI administered as two puffs BID for 7 days; PT005 MDI administered as two puffs BID for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD