bioihbjkbjnl/mcl2 huggingface dataset:
Can a 6-minute Walking or Resting Break Improve Executive Function in Gamers.
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      This study will ask ranked first person shooters in esports to participate on three separate
      days from their home computer to test executive function prior tp play and following two
      hours of play. One testing day will incorporate a 6 minute walk break, another day will
      incorporate a 6 minute rest break, and the third day will be continuous play. Executive tests
      will be administered electronically prior to game play and post game play.
    

Detailed description: 
      A ranked first person shooter player will play for two hours each session, and on separate
      days will take a 6 minute walking break or a 6 minute resting break within 2 hours of game
      play. This study is virtual and you may play from your regular home gaming computer. The
      third day will be continuous play.

      The study will take place on 3 separate days. Preferably 2 -3 days in -between testing days.

        -  Participants will sign an electronic consent form to sign and agree to participate. It
           will explain the study in detail.

        -  Participants will then be asked to take two executive function tests online. These test
           will be sent electronically through email. This is for practice. These tests take
           approximately 6-7 minutes.

        -  We will schedule one day where the participant will play a first -person shooter game.
           Prior to playing the participants will be take to take the two executive function tests.

        -  On one day the participant will be asked to stop after the first hour (they will be
           allowed to finish the test) they will either walk for 6 minutes near their computer or
           rest for 6 minutes. Participants will be contacted through cell phones or discord.

        -  Game play will resume normally for another hour. When that hour is completed the
           participant will be asked to take the two online tests again.

        -  This will be 2 days. The third day the participant will take the online tests and play
           continuous for 2 hours with no break and then repeat the online tests.
    

Intervention name(s): Walking
Intervention type(s): Behavioral
Intervention description(s): 6 minute casual walk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of SHR-1501 in Patients With Advanced Tumors
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients
      with advanced malignancies .
    


Intervention name(s): SHR-1501
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
Condition: Neoplasm Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral
      injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced,
      refractory solid tumors who have failed standard therapies or are not eligible for standard
      treatment.
    

Detailed description: 
      Intratumoral injection of alpha gal glycolipid in experimental knockout mouse model systems
      incorporates into tumor cell membranes and presents these xeno-transplantation epitopes to
      antigen presenting cells with that particular tumor's tumor associated antigens (TAA). Thus
      this maneuver converts any individual tumor into an in situ tumor vaccine without the need to
      isolate, purify or supply TAA exogenously. The effects in these model systems demonstrate
      both the upregulation of cytotoxic T cells which react against the particular tumor's TAA, as
      well as resolution of injected primary tumor and eradication and prevention of metastatic
      disease at distant sites. This current study was undertaken to investigate the safety and
      feasibility of such an approach in humans. The major toxicity concerns are acute allergic or
      complement activation reactions or development of autoimmunity. The primary treatment is a
      single intratumoral injection of alpha gal glycolipid. The study design is a standard dose
      escalation design and the primary endpoint is Dose limiting toxicity at one month after
      injection (grade 3 or 4. Subjects are followed until death utilizing standard clinical
      imaging and evaluation to judge overall tumor response.
    

Intervention name(s): Alpha-Gal Glycosphingolipid
Intervention type(s): Biological
Intervention description(s): Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cancerous solid tumors; Alpha-Gal Glycosphingolipids
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis.
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses
      (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
    

Detailed description: 
      Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive,
      estrogen-dependent disease that occurs in menstruating women of reproductive age. Although
      all major endometriosis therapies are effective for the treatment of pain, no single
      treatment is superior to others in terms of efficacy. The major drawbacks of the current
      medical therapies are severe side effects such as hot flushes and osteoporosis. The objective
      of this study is to determine if a dose-response relationship exists between asoprisnil and
      endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective
      dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with
      endometriosis. Women with surgically confirmed endometriosis will be administered asoprisnil
      0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed
      by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global
      efficacy, and quality of life questionnaires. Safety will be based on assessments of the
      endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and
      vital signs.
    

Intervention name(s): Asoprisnil; Asoprisnil; Asoprisnil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg Tablet, oral Daily for 12 weeks; 1.5 mg Tablet, oral Daily for 12 weeks; 5.0 mg Tablet, oral Daily for 12 weeks; Tablet, oral Daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic pain; Dysmenorrhea; Dyspareunia; Infertility; asoprisnil
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare efficacy and safety of different regimens of olodaterol
      administration in asthma (once daily, twice daily) with placebo in a complete cross-over
      design each within one of the two daily dose groups (medium or high daily dose).
    


Intervention name(s): Placebo twice daily; Olodaterol low daily dose twice daily; Olodaterol medium daily dose twice daily; Placebo twice daily; Olodaterol high daily dose once daily and placebo; Olodaterol medium daily dose once daily and placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Placebo of Olodaterol twice daily; Inhaled Olodaterol medium daily dose administered as low dose twice daily; Inhaled Olodaterol high daily dose administered as medium dose twice daily; Inhaled Placebo of Olodaterol twice daily; Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily; Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study
Condition: Focal Epilepsy
MeSH terms: Epilepsies, Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as
      levetiracetam are reported to have less adverse effect in children but not many studies have
      systematically reviewed the subject. This study aims to prospectively evaluate the effect of
      levetiracetam on neurocognition, behavioral issues and quality of life, as well as its
      seizure control efficacy and other adverse events in pediatric epilepsy patients, in
      comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed
      for both partial and generalized seizures, despite its well known side effects.

      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from
      age 4 to 16 woh will be randomized into two groups, which will be prescribed with
      levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and
      life evaluations of the patients will be performed at baseline period and after the 52 weeks
      of study period.
    


Intervention name(s): Levetiracetam; Carabamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Levetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion.; Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children.
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam, Carabamazepine
Interventions for Children With Attention and Reading Disorders
Condition: Attention Deficit Hyperactivity Disorder; Reading Disabilities
MeSH terms: Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this randomized clinical trial is to address unanswered questions about the
      relative effectiveness of treatments for children with both Attention Deficit Hyperactivity
      Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional
      and word reading outcomes for students with both conditions when provided with either (a)
      ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD
      treatment.
    

Detailed description: 
      The objective of this randomized clinical trial is to address unanswered questions about the
      relative effectiveness of treatments for children with both Attention Deficit Hyperactivity
      Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional
      and word reading outcomes for students with both conditions when provided with either (a)
      disorder-specific ADHD treatment (carefully managed medication + parent training), (b)
      disorder-specific RD treatment (intensive, individualized reading instruction), or (c) the
      combination of ADHD and RD treatment. The study aims to address the relative benefits of
      providing either disorder-specific ADHD or RD treatment alone and providing the combined
      treatment. The investigators hypothesize that the combined treatment approach will result in
      better outcomes in terms of both word reading/decoding and a reduction in ADHD symptoms than
      either of the disorder-specific treatments alone. Treatment will last for 16 weeks, with
      assessment prior to and following treatment and some measures collected regularly throughout
      the intervention periods.
    

Intervention name(s): Methylphenidate; Intensive reading instruction; Parent Training; Mixed Salt Amphetamine; Atomoxetine; Guanfacine
Intervention type(s): Drug; Behavioral; Behavioral; Drug; Drug; Drug
Intervention description(s): Appropriate dosage to be individually determined; daily for 16 weeks; Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.; Nine sessions on parenting a child with ADHD; Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta; Appropriate dosage to be individually determined; daily for 16 weeks; Appropriate dosage to be individually determined; daily for 16 weeks
Other intervention name(s): Concerta Extended Release; Ritalin; Adderall Extended Release (XR); Strattera; Intuniv
Intervention MeSH terms: Guanfacine; Methylphenidate; Amphetamine; Adderall; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine the safety and feasibility of delivering
      HDMTX in an outpatient setting.
    

Detailed description: 
      High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main
      toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to
      deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring
      of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required
      supportive care needs, HDMTX has historically been given as an inpatient. In some centers
      however, HDMTX is being given safely as an outpatient in order to reduce health care costs,
      improve patient quality of life and to deliver timely therapy with limited inpatient
      chemotherapy beds available.
    

Intervention name(s): High Dose Methotrexate
Intervention type(s): Drug
Intervention description(s): Methotrexate will be given by IV at a dose of 12 gram/m2/dose.
The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).
Intervention MeSH terms: Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; Osteosarcoma; Methotrexate; Outpatient
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with
      Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C
      infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid
      viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in
      the placebo group, when each is administered concomitantly with pegylated interferon
      (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated
      compared with placebo, when each is administered concomitantly with peg-IFN α-2a and
      ribavirin for 28 days.
    


Intervention name(s): Vaniprevir; Pegylated Interferon (peg-IFN); Ribavirin; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days; Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks; Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks; Placebo to vaniprevir oral capsule twice daily for 28 days
Other intervention name(s): MK7009
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Smartphone Addiction and Temporomandibular Joint Dysfunction in Individuals With Nonspecific Neck Pain
Condition: Smartphone Addiction, Temporomandibular Joint Dysfunction
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Neck Pain; Behavior, Addictive; Internet Addiction Disorder
Study type: Observational

Summary: 
      It has been reported that excessive use of smartphones increases the stress on the cervical
      spine, and changes in cervical curvature and pain in the muscles around the neck are
      associated with the increase in stress. Studies have reported that smartphone users with
      addictions have neck pain (68%), upper back pain (62%), right shoulder pain (52%), left
      shoulder pain (46%), and right hand pain (46%). As a result of our study, the frequency of
      smartphone addiction and temporomandibular joint dysfunction and related factors in
      individuals with nonspecific neck pain were examined and the results we obtained will
      contribute to the literature.
    


Intervention name(s): patient group/ healthy group
Intervention type(s): Other
Intervention description(s): Cranio- Cervical Flexion Test, cervical mobility, Pressure Pain Threshold,Functional evaluation of the temporomandibular joint,Pittsburg Sleep Quality Index
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with nonspecific neck pain, individuals who voluntarily agreed to participate
        in our study and signed the consent form
Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and Function
Condition: Exercise; Healthy Male Subjects
Study type: Interventional

Summary: 
      The aim of the study is to investigate the acute and short-term effects of collagen peptides
      (Collagen Peptan) on muscle and connective tissue during an eccentric overload training
      period. Currently, all studies investigating the effects of post-exercise collagen
      supplementation did this in the absence of whey proteins, which are part of the standard
      recommendations for post-exercise recovery. The investigators will therefore investigate
      whether the combined intake of whey proteins and collagen peptides ensures a better recovery
      of exercise performance and whether it can prevent or reduce symptoms of muscle and tendon
      overload during a three-week eccentric overload training period (n = 22).
    


Intervention name(s): whey protein; whey protein + collagen peptide
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily 45g of whey protein supplementation during a three week eccentric training period; Daily 15g of whey protein and 20g collagen peptide supplementation during a three week eccentric training period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Whey protein; Collagen peptide; Muscle and tendon overload training
Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
Condition: Cellulite; Laxity; Skin; Edematous Fibrosclerotic Panniculopathy
MeSH terms: Cellulite
Study type: Observational

Summary: 
      All participants who completed the EN3835-224 study will be invited to participate in this
      observational study to evaluate long term durability of response and safety.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Safety Population is defined as all participants who meet the inclusion/exclusion
        criteria at Day 360. All Safety analyses will be based on this population.

        The Full Analysis Set (FAS) is defined as all participants in the Safety Population who
        have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.