bioihbjkbjnl/mcl2 huggingface dataset:
Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees
Condition: Amputee
Study type: Observational

Summary: 
      The purpose of this study is to compare the accuracies of the Patient Activity Monitor to
      that of a standard pedometer during a walking task and some day-to-day activities in a
      simulated apartment setting.
    

Detailed description: 
      The ability to accurately measure daily activity levels in lower extremity amputee patients
      is important for a better understanding of their use of prosthetic limbs. Most studies have
      shown that patients often report their activity level inaccurately. More objective data on
      activity levels will not only provide information helpful for determining the appropriate
      prosthetic components for an individual, it will also be helpful when assessing the effects
      that medical illness have on activity levels and in objectively determining the benefits of
      rehabilitation. In addition, being able to measure activity accurately will allow further
      verification of currently developed clinical surveys designed to determine amputee activity
      in a practical form.

      Until more recently a practical, accurate and affordable means of monitoring lower extremity
      amputee activity has not been available for use. Currently a monitoring device designed
      specifically for this task is available for research use. It is called the Patient Activity
      Monitor (PAM). Many different models of more generic activity monitoring devices, called
      pedometers, also exist and need to be further tested in the amputee population.

      The objective of our study was to measure and compare the step count and ambulation distance
      accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3
      Level within a simulated apartment setting and during relatively continuous gymnasium
      walking.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Ambulation; Ambulatory Monitoring; Activities of Daily Living; Pedometer; Validation Studies [PT]
The Efficacy of REHACOP Program in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to
      improve cognition, social cognition, clinical symptoms and functional outcome in patients
      with schizophrenia.
    


Intervention name(s): REHACOP; Occupational activities
Intervention type(s): Behavioral; Behavioral
Intervention description(s): REHACOP group consists of 90-minute-long sessions 3 days per week. Specifically, REHACOP group remediation consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas; Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine whether prolonged-release fampridine (10 mg twice
      daily) has a clinically meaningful effect on participant-reported walking ability over a
      24-week study period.

      The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken
      twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical
      impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period;
      to evaluate criteria for early assessment of response to fampridine that can predict
      clinically meaningful benefits in walking ability and balance; to assess the safety and
      tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment
      period.
    


Intervention name(s): fampridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Matched placebo
Other intervention name(s): dalfampridine; Ampyra; Fampyra; fampridine prolonged-release tablets; BIIB041
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fampridine
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This multi-center, open-label study will evaluate the efficacy and safety of Pegasys
      (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in
      treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys
      (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated
      time of study treatment is 48 weeks, follow-up is 24 weeks.
    


Intervention name(s): peginterferon alfa-2a; ribavirin [Copegus]
Intervention type(s): Drug; Drug
Intervention description(s): 180 mcg sc weekly, 48 weeks; 1'000 or 1'200 mg orally daily, 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of DA-9801 to Treat Diabetic Neuropathic Pain
Condition: Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in
      the treatment of pain associated with diabetic neuropathy. Subjects will receive either
      300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain
      score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and
      Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.
    


Intervention name(s): DA-9801 300mg; DA-9801 600mg; DA-9801 900mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.; 600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.; 900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.; Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Neuropathies
Tab Block and Patient Controlled Analgesia in CS
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      cesarean section rate become increasing nowadays
    

Detailed description: 
      indication of cesarean section are different from case to case and the use of pain
      controlling agents is very important to relieve post operative pain
    

Intervention name(s): tab block; PCA; women who will not receive tab block or PCA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): injection of tab block to women who are doing cs; giving women PCA; no tab block or PCA will be given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant
      vaccination schedule including kinetics of immune response in the early phases of the series.
    


Intervention name(s): MenACWY-CRM; MenACWY-CRM; Routine Vaccines
Intervention type(s): Biological; Biological; Biological
Intervention description(s): This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.; This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.; Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Infants; Persistence
Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure:
Condition: Acute Circulatory Failure
MeSH terms: Shock
Study type: Interventional

Summary: 
      The objective of the present research is a combination of a one-sided test of non-inferiority
      and a one-sided test of superiority. A stepped approach will be used to evaluate these
      hypotheses:

        1. a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt
           absolutely needed, according to consensual and predefined safety criteria) is non
           inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the
           early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).

        2. a less invasive intervention is not only non-inferior but also superior to usual care in
           terms of mortality.

      Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority
      clinical trial.
    


Intervention name(s): Non-invasive strategy; Control strategy
Intervention type(s): Procedure; Procedure
Intervention description(s): No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.
In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure).; An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Patient Controlled Tissue Expansion for Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      This study is designed to compare the performance and safety of the AirXpander tissue
      expander to standard saline expanders in patients undergoing two-stage breast reconstruction
      following mastectomy.
    

Detailed description: 
      This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical
      study designed to compare the performance and safety of the AirXpander Tissue Expander System
      to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to
      participate in the study will be enrolled and randomized to either the investigational arm
      (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1
      (AirXpander to saline) permuted block randomization stratified by investigational center and
      procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same
      type of expander will be implanted in each side. Subjects in both arms will be followed in
      the same manner until the explantation of the tissue expander(s) and exchange for permanent
      implant(s).
    

Intervention name(s): AeroForm Tissue Expansion; Saline Tissue Expansion
Intervention type(s): Device; Procedure
Intervention description(s): The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.; A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Other intervention name(s): AirXpander Tissue Expander System; Patient Activated Controlled Expansion (PACE); AeroForm Patient Activated Tissue Expander; AeroForm Tissue Expander System; AeroForm Tissue Expander; saline breast tissue expander; saline expander; breast tissue expander; tissue expander
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tissue Expansion; Tissue Expander; Breast Tissue Expansion; Breast Tissue Expander; Breast Reconstruction; Two Stage Breast Reconstruction; 2 Stage Breast Reconstruction
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
Condition: Pulmonary Neoplasm
MeSH terms: Lung Neoplasms; Pancoast Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the trimodality
      (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus
      tumors.
    

Detailed description: 
      Pre-operative radiotherapy has long been the community standard in Pancoast, or superior
      sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are
      poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial
      in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy
      thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this
      trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative,
      multi-center, prospective one to evaluate its safety and efficacy.
    

Intervention name(s): mitomycin C, vindesine, cisplatin and radiotherapy
Intervention type(s): Drug
Intervention MeSH terms: Mitomycins; Mitomycin; Vindesine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary neoplasm; preoperative chemoradiotherapy; surgical resection; superior sulcus tumor; chest wall invasion; mytomicin C; vindesine; cisplatin
Handling Medium for ICSI With Ionomycin and Latrunculin A
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium
      during the ICSI procedure has them.
    


Intervention name(s): Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A
Intervention type(s): Other
Intervention description(s): Ionomycin and Latrunculin A would activate oocyte during ICSI along with cytoskeleton stabilization for a favourable outcomes
Intervention MeSH terms: Ionomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Colony-stimulating factors such as sargramostim may increase the
      number of immune cells found in bone marrow or peripheral blood and may help a person's
      immune system recover from the side effects of chemotherapy.

      PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in
      treating patients who have advanced cancer.
    

Detailed description: 
      OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the
      percentage of progenitor cells in cycle at the time of chemotherapy administration in
      patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic
      effects of topotecan when administered with sargramostim in these patients. III. Conduct a
      preliminary assessment of the activity of this topotecan regimen in these patients.

      OUTLINE: This is a dose escalation study of topotecan. Patients receive priming with
      sargramostim (GM-CSF) on days -4 through -2. On day 0, topotecan IV is administered over 30
      minutes. Cohorts of 6 patients receive escalating doses of topotecan. The maximum tolerated
      dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience
      dose-limiting toxicity (DLT). Sargramostim resumes on day 1 following topotecan, and
      continues for 5 days or until sufficient hematologic recovery. The next course of topotecan
      is given 48 hours later. Treatment repeats every 6 weeks for 4 courses. Patients are followed
      every 3 months for the first year, then every 6 months thereafter.

      PROJECTED ACCRUAL: 15-25 patients will be accrued for the duration of 18 months.
    

Intervention name(s): sargramostim; topotecan hydrochloride
Intervention type(s): Biological; Drug
Intervention MeSH terms: Topotecan; Sargramostim
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Tobacco Use in Opioid Agonist Treated Pregnant Women
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the proposed study is to evaluate the efficacy of tobacco
      abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives
      for reducing or eliminating tobacco use during pregnancy in methadone treated women. In
      addition, the impact that this intervention has in reducing the incidence and severity of
      methadone associated neonatal abstinence syndrome will also be examined.
    


Intervention name(s): tobacco abstinent contingent; non-contingent; control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence; Participants receive vouchers regardless of tobacco use status; this group receives no vouchers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; pregnancy; neonatal abstinence syndrome
Mobile Health Sleep and Growth Study 2
Condition: Childhood Sleep Promotion
Study type: Interventional

Summary: 
      Investigators seek to determine if an online behavioral economic based intervention can be
      developed to target increases in childhood time in bed (TIB).
    

Detailed description: 
      Investigators seek to determine if an online behavioral economic based intervention can be
      developed to target increases in childhood time in bed (TIB). The primary objectives of this
      study are to determine if the behavioral economic strategy of compensatory effect leads to
      the middle time in bed (TIB) target to be most commonly selected, and if the behavioral
      economic strategies of normative feedback and loss-framed incentives lead to longer TIB and
      therefore longer total sleep time.Children aged 10-12 who sleep about 7-8 hours per night
      will wear a FitBit for 11 weeks in order to measure time in bed and total sleep time.
      Participants will have a time in bed goal to meet each night. Participants will be randomized
      to one of four study arms and receive text and/or email messaging from the study about sleep
      hygiene. Some study arms receive additional messaging. The study involves two visits to the
      Children's Hospital of Philadelphia (CHOP) Roberts Center for Pediatric Research.
    

Intervention name(s): Mobile Sleep and Growth Study
Intervention type(s): Behavioral
Intervention description(s): The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood sleep promotion; Sleep promotion; Sleep
Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors - A Study Protocol for a Double-blind, Randomised, Multi-center, Placebo-controlled Clinical Trial
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The Purpose of this trial is to investigate the efficacy and safety of GGT on Korean obese
      Women with or without metabolic syndrome Risk factors
    


Intervention name(s): GGT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other intervention name(s): Galgeun-tang
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Metabolic syndrome; Traditional Korean Medicine; Galgeun-tang
A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
Condition: Healthy Adults
Study type: Interventional

Summary: 
      A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in
      which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d
      eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish
      oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to
      compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at
      the end of the 4 week study.
    


Intervention name(s): fish oil ethyl ester; fish oil triglyceride; krill oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: bioavailability; fish oil; krill oil