bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary
      objective of this study is to evaluate the safety, tolerability and feasibility of a single
      intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at
      12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who
      have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who
      have had an incomplete response to at least one TNF-alpha inhibitor.
    


Intervention name(s): Allogeneic Mesenchymal Precursor Cells; Normal Saline
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laser Therapy for Patients With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; Muscle Pain; Chewing Function
MeSH terms: Myalgia; Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental
      effects on connective tissue and other organs. The musculoskeletal system is one of the most
      affected systems in this group of patients including the temporomandibular joint. The most
      common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength
      and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for
      these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular
      joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of
      TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been
      used to evaluate this treatment modality on the chewing function and pain values of SLE
      patients with myogenic TMD.
    


Intervention name(s): GaAlAs semiconductor diode laser device
Intervention type(s): Device
Intervention description(s): low-level laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
Condition: Wegener's Granulomatosis
MeSH terms: Granulomatosis with Polyangiitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and
      necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.
      Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is
      limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible
      damage due to the disease and the consequences of prolonged drug exposure. The efficacy and
      safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with
      refractory disease. A prospective, international, nulti-centre, single limb, open label
      study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity
      Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate.
      Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to
      clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in
      six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped
      early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0
      for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle
      azathioprine was commenced and follow-up continued for a further six months.
    


Intervention name(s): Gusperimus
Intervention type(s): Drug
Intervention description(s): SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles
Intervention MeSH terms: Gusperimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wegener Granulomatosis; Vasculitis; Gusperimus; Immunosuppression
Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk
Condition: Suicidal Ideation; Suicide, Attempted
MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted
Study type: Interventional

Summary: 
      In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western
      Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical
      trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single
      and additive effects of two components of an inpatient unit intervention for suicidal
      adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety
      planning, and an emotion regulation/safety plan phone app (BRITE).
    

Detailed description: 
      The investigators aim to randomize 240 adolescents psychiatrically hospitalized for suicidal
      ideation with a plan or a suicide attempt to one of four treatment arms: (1) ASAP + BRITE +
      TAU (treatment as usual); (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU (treatment as
      usual); and (4) TAU (treatment as usual) alone. The investigators will assess suicidal
      ideation and behavior at 4, 12, and 24 weeks post-intake, in order to:

        1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation,
           non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations.

        2. Examine mediators and moderators of treatment outcome.

        3. Examine the costs and cost efficacy of ASAP and BRITE and the combination.
    

Intervention name(s): ASAP (As Safe As Possible); BRITE smart phone app; TAU (treatment as usual)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): ASAP (As Safe As Possible) is a brief intervention for adolescents hospitalized for suicide risk that focuses on the development of a safety plan, teaching emotion regulation and distress tolerance skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan and to outpatient treatment.; BRITE is a smart phone app that aims to support daily emotion regulation and a safety plan that is personalized to the needs and preferences of each adolescent.; TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Investigators will randomize 240 hospitalized suicidal adolescents with a history of a suicide attempt or ideation with plan to one of 4 conditions in a 2 by 2 design: (1) ASAP + BRITE; (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU; or (4) TAU alone to determine the single and additive effects of ASAP and BRITE on suicide attempts in the subsequent six months.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of AD128 to Treat Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea
      (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will
      randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a
      drug without pharmaceutical effect. Neither the participants, nor the investigators will know
      in which arm participants are until the end of the study. After one week of trial, an
      evaluation will be perform and will be follow by one week without any treatment. During the
      third and last week of trial, there will be a crossover of the groups, i.e. the participants
      of the first group who took the two drugs (AD128) during the first week will take a placebo
      and those who took the placebo will take the drugs combination.
    


Intervention name(s): AD128; Mannitol
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of two capsules before sleep for 7 days.; Oral administration of two capsules before sleep for 7 days.
Other intervention name(s): Placebo
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, placebo-controlled, double-blind crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; pharmacologic treatment; sleepiness; vigilance
6 Weeks Plyometric Training on Vertical Jump and Agility in Relation to Gender Among Badminton Players
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      This study exmine the effects of plyometric training on vertical jump and agility in male and
      female badminton players.The two groups will be subsequently randomly assign into the
      experimental group and control group.
    

Detailed description: 
      After approval from the graduate committee permission will be obtained from the higher
      authorities of the naval anchorage badminton club islamabad. Purpose of this study will be
      explained to the all participants written informed consent will be obtained.participants will
      recive 6 weeks intervention with a generic warm up consisting of ten body weight squats,ten
      forward lunges each side and 3 mintues of dynamic stretching of relevant lower extremity
      muscles. The agility t-test will be used to measure and seargent vertical jump test will be
      used to measure vertical jump.
    

Intervention name(s): Plyomtric training to male badmninton players; Plyomtric training to female badmninton players
Intervention type(s): Other; Other
Intervention description(s): Plyometric training has been proven to be effective and effecient in developing strength and speed.
plyometric training includes different types hops,jumping,drills.; Plyometric training has been proven to be effective and effecient in developing strength and speed.
plyometric training includes different types hops,jumping,drills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Strength Training; Plyometric training; Agility; Vertical Jump
Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9
      days, will promote sleep during the following night without significant post-dose thinking
      impairment and drowsiness in subjects with primary insomnia.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cognition; Primary Insomnia; sleep; polysomnography
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there are any difference between supervised
      exercise therapy and homebased exercise when looking at pain and function for patients with
      shoulder pain.
    

Detailed description: 
      Shoulder pain is common in the population. Various treatment modalities are used. According
      to the literature, it is equally good results for home exercises and for guided exercise
      therapy. The purpose of this study is to look at this again and determine whether there are
      any difference between supervised exercise therapy and homebased exercise when looking at
      pain and function for patients with subacromial impingement.
    

Intervention name(s): supervised exercise; homebased exercises
Intervention type(s): Other; Other
Intervention description(s): This group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises; This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain; shoulder impingement; rotatorcuff pathology; supervised exercise; homebased exercise
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
Condition: Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as
      monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with
      partial seizures.
    

Detailed description: 
      The study will consist of 2 periods. The First Period (6 weeks drug treatment) is designed to
      confirm efficacy of levetiracetam (LEV), and the Second Period is designed to evaluate the
      long-term efficacy and safety of LEV.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL)
Other intervention name(s): Keppra; E-Keppra; LEV
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Partial Seizures; Levetiracetam; Monotherapy; Adjunctive Treatment
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
Condition: Lung Cancer; Precancerous Condition
MeSH terms: Lung Neoplasms; Precancerous Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
      of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers
      with bronchial intraepithelial neoplasia.

      PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA
      works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with
           bronchial intraepithelial neoplasia.

        -  Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant
           methylation, cell cycle regulation, apoptosis, as well as phase I and II enzyme
           regulation.

        -  Establish a library of in vivo confocal microendoscopy images with corresponding
           histopathology, nuclear morphometry, and other biomarker information to assess the
           potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of
           chemoprevention agents.

      OUTLINE: Patients are stratified according to gender. Patients are randomized to 1 of 2 arms.

        -  Arm I: Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months.
           Patients achieving a partial response receive an additional 6 months of ACAPHA.

        -  Arm II: Patients receive oral placebo twice daily for 6 months. Patients achieving a
           partial response receive an additional 6 months of placebo. Patients with progressive
           disease receive ACAPHA twice daily for 6 months.

      Patients undergo sputum cytology, oral and bronchial brushings, bronchoalveolar lavage, and
      bronchial tissue biopsies at baseline and at 6 and 12 months. Samples are analyzed for
      histopathological and morphometric cell changes; MIB-1 bcl-2, and TUNEL immunostaining;
      methylation biomarkers; and gene expression analysis of RNA.

      After completion of study therapy, patients are followed at 1 and 6 months.
    

Intervention name(s): multi-herbal agent ACAPHA; Sugar Pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer; squamous lung dysplasia
NUTRITION: Natural Tocotrienol Against Ischemic Stroke Event
Condition: Ischemic Stroke; Transient Ischemic Attack (TIA)
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as
      barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and
      lowers cholesterol, which make it a potential therapy for stroke prevention, though these
      effects are less well characterized for TCT. We plan to conduct two trials (I & IIA) to
      determine the effects of orally supplemented TCT on platelet function and cholesterol.
    

Detailed description: 
      A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as
      barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and
      lowers cholesterol, which make it a potential therapy for stroke prevention, though these
      effects are less well characterized for TCT. We plan to conduct two trials (I & IIA) to
      determine the effects of orally supplemented TCT on platelet function and cholesterol. Phase
      I subjects will be healthy volunteers, recruited by an advertisement. Phase IIA subjects will
      be hyperlipidemic (having high cholesterol), and will be referred to us by their Wound Care
      Center Physicians. Patients will be randomized to receive placebo pills, (400 or 800 mg) TCT
      pills, low-dose 81 mg aspirin (commonly used for secondary prevention of stroke), or TCT and
      aspirin together. Potential subjects for Phase-I who meet study criteria and agree to
      participate will be in the study for 6 months and have the following study related
      procedures, blood draw total 4 times, tape stripping (non-invasive procedure), BMI, and blood
      pressure measurement at each visit (every month). Participants in Phase-IIA will have blood
      drawn a total of 6 times, tape stripping, BMI and blood pressure measurement and participants
      will be in the study for 13 months.
    

Intervention name(s): Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin; Placebo vehicle control
Intervention type(s): Other; Other
Intervention description(s): Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg; vehicle control compared to Vitamin E TCT pills
Other intervention name(s): placebo capsule
Intervention MeSH terms: Aspirin; Vitamin E; Tocopherols; Tocotrienols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: stroke; ischemia; TIA
Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment
Condition: Laparoscopic Hysteretctomy With Promontofixation
Study type: Interventional

Summary: 
      Use lay language.

      The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12
      mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in
      peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low
      Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum
      may be better in minimizing adverse effects on surgical peritoneal environment and improving
      clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard
      cool, dry CO2 gas.
    

Detailed description: 
      Patients undergoing laparoscopic hysterectomy with promontofixation are randomized into four
      groups: Group 1: 12mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 2:
      12mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20), Group 3: 8mmHg
      intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 4: 8mmHg intraperitoneal
      pressure with warmed, humidified CO2 gas (n=20).

      Normal peritoneum is collected from the parietal wall at the beginning of laparoscopic
      surgery and at 1 and 2 hours. Expression of genes encoding components of the fibrinolytic
      system, extracellular matrix and adhesion molecules, and inflammatory cytokine signaling
      molecules in peritoneal tissues are measured by real-time PCR.

      Quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, per
      or post operative complications and intraoperative core temperature are assessed and
      compared.
    

Intervention name(s): Fisher and Paykel Humidifier (MR860AEU)
Intervention type(s): Device
Intervention description(s): Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Carbon deoxide pneumoperitoneum; Intraperitoneal pressure; Peritoneum; Gene expression; Post-operative recovery; Laparoscopic Humidification System
The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study
Condition: Primary Dysmenorrhea,
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the effect of high frequency TENS and compare to
      the placebo effect by sham TENS in a randomized control study.
    

Detailed description: 
      Over 50% of American women suffered from dysmenorrhea and 10% of them will take sick leave
      for 1-2 days. Previous randomized control studies have demonstrated the pain relief effect of
      using high frequency TENS in dysmenorrheal pain. However, no investigation has been conducted
      to investigate the effect of high frequency TENS in female population in our country. The
      purpose of this study is to investigate the effect of high frequency TENS and compare to the
      placebo effect by sham TENS in a randomized control study.
    

Intervention name(s): Transcutaneous Electric Nerve Stimulation (TENS)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea,; Transcutaneous Electric Nerve Stimulation