bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers
Condition: Epilepsy; Physical Activity
MeSH terms: Epilepsy
Study type: Observational [Patient Registry]

Summary: 
      To investigate physical fitness and activity levels in children with epilepsy and compare the
      results with healthy peers.
    

Detailed description: 
      Many individuals with epilepsy are physically inactive due to the fear of seizures triggered
      by physical activity/ exercise, and the advices given by the family members and the health
      care professionals to avoid intense activity . In two studies performed about this subject,
      this is the probable reason why adult patients with epilepsy have a weaker physical fitness
      than healthy individuals in the control group. However; in a study of Drawskowski et al., the
      avoidance of activity and exercise in individuals with epilepsy was investigated, and it was
      reported that the injuries and seizure problems were rare even during very intense physical
      activity.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of children with epilepsy and their healthy peers.
      
Keywords: Childhood Epilepsy; Physical Fitness; Physical Activity; Use of Pedometer
Safety and Immune Response to a Clade C DNA HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA
      vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity to DNA-HIV-PT123 (an
      HIV clade C DNA vaccine) and to Bivalent Subtype C gp120/MF59 in healthy, HIV-uninfected
      adults.

      The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants
      will be randomly assigned to one of 6 groups. Each group will receive experimental vaccine
      and protein and/or placebo at 4 study visits. Participants in Groups 1-3 will receive all
      injections via needle and syringe. Participants in Groups 4-6 will receive the DNA vaccine
      via Biojector, and protein and/or placebo via needle and syringe.

      Participants in Groups 1 and 4 will receive the DNA vaccine at months 0, 1, 3, and 6 and the
      protein at months 3 and 6. Participants in Groups 2 and 5 will receive the DNA vaccine and
      the protein at months 0, 1, and 6 and placebo at month 3. Participants in Groups 3 and 6 will
      receive placebo at months 0, 1, 3, and 6.

      Study visits will include a physical examination, an interview and/or questionnaire, HIV
      testing and HIV risk-reduction counseling, and urine and blood collection. Participants may
      optionally choose to provide rectal fluid, cervical fluid, or semen samples.
    

Intervention name(s): DNA-HIV-PT123 vaccine; Protein/MF59 vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Contains a mixture of 3 DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C ZM96 gag, 2) clade C ZM96 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose 4 mg administered as 1 mL intramuscularly (IM); clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered as 0.5 mL IM; Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products
Other intervention name(s): Bivalent Subtype C gp120/MF59; Sodium Chloride, 0.9%
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Condition: Complications in Diagnostic Percutaneous Lung Biopsy Procedures
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the
      prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.
    


Intervention name(s): Percutaneous Lung Biopsy
Intervention type(s): Device
Intervention description(s): Patients will undergo the usual biopsy procedure with a fine needle inserted through a larger guide needle, under CT guidance; at the end of the biopsy, the MIPP-Kit will be introduced through the same guide needle. The guide needle and the MIPP Kit will be retracted together slowly, whilst injecting BioGlue in appropriate amounts along the whole track, from the lesion to the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lung Biopsy, pneumothorax, interventional radiology
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin
Condition: Bladder Transitional Cell Carcinoma Stage IV
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is assessing the combination of well known cytotoxics with a novel anti-cancer
      agent that could be administered as monotherapy without renal toxicity in patients with renal
      impairment presenting with advanced or metastatic urothelial carcinoma previously treated
      with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio
      of the two most promising associations of cytotoxics including the novel therapeutic agent,
      vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.
    

Detailed description: 
      Gemcitabine and carboplatin have been the most studied and used anticancer agents in
      cisplatin-unfit patients with advanced urothelial carcinoma. Both agents previously
      demonstrated clinical activity as single agent and/or as part of combination regimen in
      patients with advanced or metastatic disease even if clinical benefits and survival remains
      limited in this setting for this population.

      The purpose of this study is to test in a randomized trial enrolling patients with renal
      impairment or moderate congestive heart failure two combinations of a novel cytotoxic agent,
      vinflunine, one with gemcitabine and another with carboplatin in order to determine the most
      promising combination in the first line treatment of advanced/metastatic urothelial
      carcinoma.
    

Intervention name(s): Vinflunine, Gemcitabine; Vinflunine, Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
Gemcitabine 750 or 1000 mg/m2, IV administration over 30 minutes (starting dose based on baseline creatinine clearance value), Day 1 and 8 every 3 weeks up to progression or unacceptable toxicity or patient's refusal; Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
Carboplatin AUC 4.5, IV administration over 60 minutes, Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
Other intervention name(s): JAVLOR, GEMZAR; JAVLOR, CBDCA
Intervention MeSH terms: Carboplatin; Gemcitabine; Vinblastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urothelial carcinoma; bladder cancer; vinflunine; transitional cell carcinoma; advanced or metastatic; unfit; ineligible to cisplatin; renal impairment; renal insufficiency; urologic neoplasms; urogenital neoplasm; urinary neoplasms; cisplatin; tubulin inhibitors
Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Protocol to screen potential subjects for islet transplantation
    

Detailed description: 
      Subjects with Type 1 diabetes and history of severe hypoglycemia will undergo screening
      similar to the screening done for islet transplantation including: history; physical; chest X
      rays; upper GI series if history of ulcer; abdominal and pelvic ultrasound with careful
      attention to liver parenchyma and gallbladder; EKG; stress echocardiography if older than 35,
      psychological evaluation; autonomic and sensorimotor evaluation. They will also have a
      tuberculosis skin test (PPD), and pre-transplant laboratory tests, including: serology (for
      hepatitis B and C, HTLV I and II, Herpesvirus 1 and 2, CMV, EBV, Parvovirus B19, RPR and
      HIV); first morning urine (albumin, protein and creatinine), GFR; urinalysis and urine
      culture; CBC, chemistry, PT, PTT, INR, C-peptide (basal and stimulated), HbA1c, , lipid
      profile, LFTs, thyroid profile, blood typing, PRA, MHC determination, auto-antibodies (GAD65,
      IA2 and insulin), and if male, prostate specific antigen (PSA). Severity of glucose lability
      and hypoglycemia unawareness is assessed with Clarke score, Lability index, Mage and
      hypoglycemia score.

      I
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with type 1 DM
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
Condition: Labor Induction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to estimate the safety and efficacy of titrated oral
      misoprostol compared with vaginal route for labor induction at term.
    

Detailed description: 
      Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum
      concentration following oral administration of 34 minutes and a half-life of 20-40 minutes.
      Peak serum concentration for vaginal administration is 60-80 minutes, this level being
      sustained for up to four hours. Although the direct local effect of vaginal administration on
      cervical ripening may be advantageous, the shorter half-life of oral delivery may be
      beneficial in the event of uterine hyperstimulation.In order to avoid uterine
      hyperstimulation, it appears reasonable to suggest that oral misoprostol should be
      administered in small, frequent doses, titrated against the uterine response.
    

Intervention name(s): misoprostol
Intervention type(s): Drug
Intervention description(s): Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: misoprostol; labor induction
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Condition: Hemodialysis Access
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation
      of an AV graft or fistula for hemodialysis access.
    

Detailed description: 
      Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment
      vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for
      hemodialysis access.

      All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever
      is the standard of care at the research site) of the vein and artery to evaluate the optimal
      site for vascular access placement in the upper extremity.

      Patients will be examined with Doppler ultrasound or standard of care immediately after
      surgery to verify patency of the AV graft or fistula.

      During the follow-up period, each patient will undergo a physical examination and imaging of
      the vascular access at specified intervals.
    

Intervention name(s): Vascugel; Placebo Comparator
Intervention type(s): Biological; Biological
Intervention description(s): One time implant on the day of surgery; One time implant on the day of surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemodialysis access; Arteriovenous graft; Arteriovenous fistula; End stage renal disease
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Condition: Stretch Marks; Striae; Treatment
MeSH terms: Striae Distensae
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial
      dermabrasion in subjects that have recent stretch marks.
    

Detailed description: 
      Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6
      months of evolution),reddish or purple line stretch marks. The striae should be symmetrical
      and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer),
      hips, and buttocks.

      Thirty subjects will be randomly divided in two groups:

      Group 1 will receive tretinoin cream that should be applied daily in areas affected by
      stretch marks.

      Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.

      Subjects will be evaluated by pictures, measurement of width and length of stretch marks,
      using Mirror System(Canfield).

      Biopsy to quantify alterations of epidermis and dermis of treated area, will be held
      pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch
      of 3mm.

      The results will be evaluated two weeks after the conclusion of the interventions. An
      independent dermatologist, blinded for intervention, will analyse pictures pre and post
      treatment. This subjective evaluation will be performed using Global Aesthetic Improvement
      Scale.

      Safety and adverse events will be assessed each visit.
    

Intervention name(s): Tretinoin cream 0.005%; Superficial Dermabrasion
Intervention type(s): Drug; Device
Intervention description(s): Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.; Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Other intervention name(s): (Vitanol A, Stiefel)
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stretch marks; Striae; Tretinoin; Superficial dermabrasion
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
Condition: Atrial Fibrillation; Arrhythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The aim is to evaluate if internet- delivered CBT, based on behavioral activation and
      exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will
      include 30 patients with symptomatic AF despite optimal medical treatment in accordance with
      current guidelines.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat)
      affecting 3% of the population. AF is associated with poor quality of life (QoL) and large
      costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations,
      fatigue, and chest pain) are not alleviated by current medical or interventional treatments.
      Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF
      patients. Symptom preoccupation and avoidance of social and physical activities are likely to
      play important roles in the development of anxiety, depression, disability and healthcare
      utilization.

      The aim is to evaluate if CBT, based on behavioral activation and exposure principles,
      improves wellbeing and QoL in symptomatic AF patients.

      Method: Pilot study with a pre-post-design and no control group. The internet-delivered
      CBT-program will last for 10 weeks and include weekly therapist support, consisting of online
      messages and telephone calls.
    

Intervention name(s): Internet-based cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that fruitlessly aim to prevent triggering of AF episodes or to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
Condition: Surgery; Pain Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Midline laparotomy is commonly used in emergency and elective cancer surgery and patients
      need effective and safe pain treatment after this type of surgery. Nowadays modern
      anticoagulant therapy may prevent use of central regional blocks in pain management.
      Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied
      using different administration techniques. The primary aim is the efficacy of the rectus
      sheath analgesia measured with pain ratings and the amount rescue opioid used.

      Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to
      analgesia method used.
    


Intervention name(s): Levobupivacaine continuous infusion; levobupivacaine bolus dosing; single bolus of levobupivacaine; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Levobupivacaine continuous infusion to rectus sheath catheters; Levobupivacaine bolus dosing to rectus sheath catheters; Levobupivacaine single dose to rectus sheath catheters; No rectus sheath analgesia
Other intervention name(s): continuous infusion group; bolus group; single dose group; no rectus sheath catheters
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparotomy; pain; rectus sheath block
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
Condition: Melanoma; BRAF V600 Mutation; Unresectable Melanoma; Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as
      immediate release film-coated tablets for oral administration. For the treatment of adult
      patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended
      dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial
      formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new
      strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a
      result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x
      15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45
      mg tablet and three 15 mg tablets is therefore required.
    

Detailed description: 
      The reference (R) formulation is the currently commercially available tablet containing 15 mg
      of binimetinib as active substance, administered as three tablets for a total of 45 mg
      binimetinib. The Test (T) formulation is the tablet containing 45 mg of binimetinib as active
      substance in one tablet. Participants will be randomized to one of 2 treatment sequences (RT
      or TR) containing 2 treatment periods, with at least a 7-day washout between each dose.

      The study will consist of a screening period between 21 and 2 days before the first study
      treatment administration on Period (P) 1 Day (D) 1, 2 treatment periods of 5 days each, and a
      washout of at least 7 days between P1D1 and P2D1.

      Study treatments are given by the oral route in fasted condition. The end-of-study (EOS)
      visit will be performed 30 (± 3) days after the last study treatment administration or
      discontinuation.
    

Intervention name(s): Binimetinib Oral Tablet
Intervention type(s): Drug
Intervention description(s): Two-period Crossover study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to provide stronger evidence for extended-dose chloroquine
      treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP),
      Pakistan or justification for discontinuation of the policy.
    

Detailed description: 
      To determine whether extended-dose chloroquine provided better cure rates and fewer
      recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum
      patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ
      40mg/kg) treatment arms and followed for up to 60 days.
    

Intervention name(s): Chloroquine
Intervention type(s): Drug
Intervention description(s): Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
Other intervention name(s): CQ
Intervention MeSH terms: Chloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical Trial; Chloroquine; Refugees; Afghanistan; Pakistan