bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures; Epileptic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in
      children with epilepsy syndromes associated with generalized seizures. LCM will be added to
      current antiepileptic treatment.
    

Detailed description: 
      SP0966 is a Phase 2, multicenter, open-label exploratory study designed to assess the safety
      and preliminary efficacy of oral lacosamide as adjunctive therapy for epilepsy syndromes
      associated with generalized seizures in pediatric subjects ≥1 month to <18 years of age.
    

Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Oral intake twice daily of tablet (100 mg or 50 mg) or syrup formulation (10 mg/ml).
Total daily dose will be titrated over a period of 6 weeks with starting dose of 100 mg/day or 2 mg/kg/day up to doses not exceeding 600 mg/day or 12 mg/kg/day tablet or syrup, respectively. Followed by a 12 week maintenance period with stable dosing of at least 200 mg/day or 4 mg/kg/day tablet or syrup, respectively.
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide; Vimpat; Epilepsy; Children
Kinesiotape on Quadriceps and Gluteus in Counter Movement Jump and Sprint in Soccer Players
Condition: Sports Physical Therapy; Athletics; Performance
Study type: Interventional

Summary: 
      The main objective of this study is to analyse the effect of KT on countermovement jump (CMJ)
      and sprint immediately and 24 hours after its application on the quadriceps and gluteus
      maximus.
    

Detailed description: 
      Kinesiotape (KT) is a technique commonly used in sports practice. It may be beneficial in
      enhancing muscle function by additional cutaneous afferent stimulation. The objective of this
      study was to analyze the effect of KT on countermovement jump (CMJ) and 20-m sprints
      immediately and 24 hours after its application on the quadriceps and gluteus maximus. A total
      of 37 male soccer players (19.7 ± 0.9 years old) were randomly assigned to one of 3 groups:
      experimental group: KT activation (KTact), placebo group: sham tape (KTst), and control group
      (CG). Participants performed a 30-minute preliminary warm-up, after which they conducted CMJ
      and 20-m sprint tests. These tests were repeated later (with KT application or not) and after
      24 hours.
    

Intervention name(s): Kinesiotape of the physical performance
Intervention type(s): Other
Intervention description(s): It has done a countermovement vertical jump, a twenty meter sprint and a kinesio tape application technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty-seven subjects were randomly allocated to the different study groups using the software AleatorMetod.xls. Subjects were divided into three groups: 13 subjects were assigned to the experimental group with KT activation (KTact); 12 subjects, to the placebo group with a sham tape KT (KTst); and 12 subjects, to the control group (CG).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesiotape; Soccer; Sprint
Diphenhydramine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite
      the fact that data supporting this practice do not exist. The investigators propose a
      randomized double blind study to test the hypothesis that 50mg of intravenous
      diphenhydramine, when added to standard migraine therapy, will result in a greater rate of
      sustained headache relief than standard migraine therapy alone. For this study, standard
      migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is
      defined as achieving a headache level of "mild" or "none" within two hours and maintaining a
      level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency room
      (Bronx, NY) with an acute migraine will be approached for participation. They will be
      screened for medication contra-indications and non-migraine etiologies of headache. The study
      will be randomized. Assignment will be concealed. Participants and researchers will be
      blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours
      in the Emergency Department and by telephone 48 hours after medication administration. A
      sample size calculation, based on pilot data, revealed the need for 374 participants. An
      interim analysis will be performed after 200 participants have been enrolled with the goal of
      assessing for lack of conditional power.
    


Intervention name(s): metoclopramide; diphenhydramine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 milligrams, administered intravenously over 15 minutes; 50 milligrams, administered intravenously over 15 minutes
Other intervention name(s): Reglan; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; headache; metoclopramide; diphenhydramine
Turkish Version of The Lower Limb Assessment Score
Condition: Hypermobility, Joint
MeSH terms: Joint Instability
Study type: Observational

Summary: 
      Hypermobility is more than normal joint laxity, mobility, and range of motion. It is
      characterized by increased laxity and fragility of connective tissues. Symptoms from
      hypermobility can begin at any age and affect women more than men. People are at higher risk
      than other people. It is stated that hypermobility is an important factor in orthopedic
      injuries and diseases. Individuals with hypermobility have more frequent orthopedic
      complaints and the problems are usually idiopathic and chronic. Studies have reported that
      proprioception and musculoskeletal reflex function may be affected independently of symptoms
      in hypermobile individuals. Therefore, evaluating hypermobility is very important in
      preventing hypermobility-related problems and injuries and developing appropriate treatment
      methods. Although the Beighton score is the most commonly used scoring method to determine
      hypermobility, it may be insufficient to determine hypermobility of the lower extremities.
      The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate
      scoring methods for assessing lower extremity hypermobility in the literature. The aim of
      this study is to adapt LLAS to Turkish and measure its validity and reliability.
    


Intervention name(s): Turkish validity and reliability
Intervention type(s): Other
Intervention description(s): Explanation of the Turkish version of the scale.
Translating the Turkish version of the scale into English to ensure consistency with the original scale.
First application of scales to participants by two examiners separately.
Second application of the scales to the participants by one examiner.
Statistical analysis and scaling
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - The study will be carried out by young adults and adults in the Kutahya Health Science
        University
Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of
      reducing the surgical stress response and obtaining optimal recovery after surgery.
    

Detailed description: 
      There is strong evidence of the usefulness of the ERAS programs in patients undergoing
      colorectal surgery in terms of significantly reduced postoperative complications and shorter
      length of hospital stay, compared to the patients of conventional treatment.

      However, few studies exist about the implication of ERAS programs in the laparoscopic
      gastrectomy.

      The aim of this study was to compare the recovery rate, morbidity, and quality of life in the
      patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS
      protocol or conventional postoperative cares.
    

Intervention name(s): ERAS perioperative cares; Conventional perioperative cares
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient's preoperative counseling & education before surgery
No Bowel preparation
Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
Fluid restriction & Management by pulse contour analysis or transesophageal doppler
Early mobilization
Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
Epidural patient controlled analgesics (no opioids analgesics)
Postoperative Nausea Active Control
Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
Perioperative High content Oxygen therapy
No drain insertion
No Levin tube
Patients will be discharged at POD#4 if there's no problem.; No Patient's preoperative counseling & education before surgery
Bowel preparation
No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
Conventional Mobilization
Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
IV PCA
Postoperative Nausea Control if needed
No Thromboembolism prophylaxis
No or Low Content Oxygen therapy
Routine drain insertion
Levin tube insertion if needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; ERAS (early recovery after surgery); fast track; laparoscopic gastrectomy
Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study
Condition: Preterm Premature Rupture of Membranes
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Phase 3

Summary: 
      Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all
      pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide
      with increased rates of neonatal and maternal morbidity and mortality. Despite its frequency,
      very little is known about its pathophysiologic mechanisms. Mechanical strength is provided
      to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV are the main
      collagen types in these membranes. Studies have shown that total collagen content is reduced
      in the amnion of women with preterm PROM.

      Vitamin C is involved in the metabolism of collagen and has been proposed to play an
      important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin E
      may play a synergic role with vitamin C, increasing the antioxidant capacity against reactive
      oxygen. Woods et al hypothesized that an increase in dietary consumption or supplementation
      of vitamin C and E during pregnancy might reduce the risk of that portion of preterm PROM
      that may be mediated by oxidative injury to fetal membranes. Plessinger et al report that
      pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous acid-induced
      membrane damage.

      Borna et al. reported a randomized, double-blind controlled study of vitamin C and E
      supplementation, in which women with preterm rupture of membranes and singleton gestations at
      26 to 34 weeks were randomized to vitamin C and E supplementation or placebo. Supplementation
      with vitamin C and E were associated with longer latency before delivery. However, the sample
      size in this study was very small.

      The aim of this study was to evaluate the effect of supplementation with vitamins C and E
      after preterm premature rupture of membranes. We hypothesised that supplementation vitamins C
      and E may be effective in decreasing oxidative stress and increasing the latency period.
    


Intervention name(s): vitamine C and E
Intervention type(s): Drug
Intervention description(s): Eligible and consenting women were randomly assigned to capsules containing a combination of 1,000 mg vitamin C (ascorbic acid) and 400 international units of vitamin E (RRR alpha tocopherol acetate)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prevention of Type 2 Diabetes Mellitus in Children
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to examine the short-term effects of supervised exercise on metabolic
      risk factors for type 2 diabetes mellitus in children from a population that is at high risk
      for this disease. We hypothesize that exercise will significantly improve insulin sensitivity
      in all children, especially in children who are already insulin resistant, thereby lowering
      the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses
      being tested are:

        1. Insulin resistance will be most evident in overweight children while an impaired ability
           of the pancreas to release insulin will be most evident in children with a family
           history of type 2 diabetes mellitus.

        2. Exercise will significantly improve insulin resistance (as measured by the fasting
           glucose/insulin ratio) with little or no effect on insulin secretory capacity (as
           measured by circulating insulin concentration at 1, 3, and 5 minutes following an
           intravenous glucose load) in children.

        3. Participation in a school-based health, nutrition, and exercise education program will
           have long-term beneficial effects on health-related behaviors and on insulin resistance.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: diabetes; adolescent
Effectiveness of Pressure Garment Therapy After Burns
Condition: Hypertrophic Scarring After Burn Injury
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic; Burns
Study type: Interventional

Summary: 
      Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the
      prevention of hypertrophic scarring in healed burns.

      Background - Approximately one million people are burned each year in the United States. The
      most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that
      interferes with work and all other aspects of life. Pressure garment therapy is routinely
      used to minimize hypertrophic scarring even though there is no scientifically valid data that
      this therapy is efficacious. Pressure garments are extremely unattractive, expensive and
      uncomfortable and their use needs to be based upon valid data.

      Goals and Objectives - The investigators plan to determine the effectiveness of pressure
      garment therapy in the control of hypertrophic scarring in healed burns.

      Methods - The I-Scan® device was designed to measure pressure at the body/environment
      interface and allows clinicians to deal with pressure-related problems for at-risk patients.
      It has been widely used in rehabilitation medicine but not with burn survivors. The
      investigators will use this device to measure the pressure at the garment/skin interface. 2)
      Furthermore, the few studies that have been attempted to determine efficacy have used between
      subjects designs. Since burn depth is extremely variable from patient to patient and since
      hypertrophic scarring is greatly influenced by age and race/origin, the between subjects
      design requires very large numbers of subjects. The investigators will use a within wounds
      design studying forearm burns and applying pressure to half of the wound and no pressure to
      the other half. The investigators will then compare hardness, color, thickness and clinical
      appearance.
    


Intervention name(s): Custom fabricated pressure garments
Intervention type(s): Device
Intervention description(s): Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and <5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months
Other intervention name(s): Medical Z (Medical Z, San Antonio, TX)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: hypertrophic; scar; burn; cicatrix; pressure; garment
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in
      QT/QTc intervals.
    

Detailed description: 
      evaluation of effect of tigecycline on QT/QTc in healthy volunteers
    

Intervention name(s): tigecycline; tigecycline; moxifloxacin; 100 mL 0.9% Sodium Chloride intravenous; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): intravenous, 200 mg, single dose; intravenous, 50 mg, single dose; oral tablet, 400 mg, single dose; intravenous fluid, 100 mL, single dose; 0.9% Sodium Chloride intravenous 100mL, single dose
Other intervention name(s): Tygacil, GAR-936; Tygacil, GAR-936
Intervention MeSH terms: Moxifloxacin; Tigecycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Condition: Bipolar Affective Disorder
MeSH terms: Genetic Diseases, X-Linked; Mood Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      The primary objective of the clinical trial is to evaluate the data of an app for smartphones
      (BiP-App) with regard to sleep, movement, mood and communication behavior.

      The data will be compared between two groups: people with a bipolar affective disorder and
      individuals without a psychiatric disorder.

      Secondary objective of the trial is to investigate if it is possible to detect early warning
      symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.

      Furthermore it will be evaluated whether the BiP-app can find applicability in the examined
      patient group.

      Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
    


Intervention name(s): Smartphone APP
Intervention type(s): Device
Intervention description(s): Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate safety and pharmacokinetic properties of the two
      treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and
      metformin SR 750mg, in healthy volunteers.
    

Detailed description: 
      To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and
      metformin SR 750mg
    

Intervention name(s): Atorvastatin 20mg and Metformin SR 750mg; CJ-30056 20/750mg
Intervention type(s): Drug; Drug
Intervention description(s): co-administration of Atorvastatin 20mg and Metformin SR 750mg; fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg
Other intervention name(s): Atorvastatin (Lipitor) and Metformin (Glucophage SR); not yet approved
Intervention MeSH terms: Metformin; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: volunteers
An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs.
      placebo over 12 weeks of dosing.
    

Detailed description: 
      Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to
      examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity,
      plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once
      daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.
    

Intervention name(s): rilapladib; placebo; 18F Fluorodeoxylucose (FDG)-PET
Intervention type(s): Drug; Drug; Other
Intervention description(s): 250 mg oral dose once daily; placebo; FDG-PET
Other intervention name(s): SB-659032; FDG marker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rilapladib,; Lp-PLA2,; atherosclerosis; SB-659032,; FDG-PET,