bioihbjkbjnl/mcl2 huggingface dataset:
Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms; Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Exercising regularly may lower the risk of breast cancer.

      PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer
      in healthy young women.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the changes in urine levels of a stable marker of oxidative stress
           (F_2-isoprostanes) in healthy young women who undergo exercise training during 4
           menstrual cycles vs no exercise.

      Secondary

        -  Assess the changes in other metabolic factors that explain the association between
           physical activity and breast cancer, including:

      Estrogen metabolism (estrone, estradiol, estriol, 2-OHE_1, 2-OHE_2, 2-MeOHE_1, 2-MeOHE_2,
      4-OHE_1, 4-OHE_2 [as well as ratios of these metabolites], insulin-like growth factor (IGF)-1
      (as well as IGF-binding proteins-1, -2, and -3, insulin, glucose, body composition (including
      body mass index, lean mass, and body fat [DEXA scan]).

      OUTLINE: This is a randomized, controlled study. Participants are stratified according to
      baseline body fat percentage and age (18 to 24 years vs 25 to 30 years). Participants are
      randomized to 1 of 2 intervention arms.

        -  Arm I: Participants exercise for 30 minutes 5 times a week. The intensity of exercise is
           increased every 4 weeks. The exercise regimen continues for up to 4 menstrual cycles.

        -  Arm II: Participants are observed for 4 menstrual cycles. Participants in both arms
           undergo 24-hour collection of urine on days 7, 8, and 9 of menstrual cycles 1 and 6.
           F_2-isoprostanes are measured via gas chromatography-mass spectrometry (GC/MS).
           Estrogens are also measured by GC/MS and include E_1, E_2, E_3, 2-OHE_1, 2-OHE_2,
           4-OHE_1, 4-OHE_2, 2-MeE_1, 2-MeE_2, 4-MeE_1, 4-MeE_2, and 16OHE_1.

      Participants undergo blood collection, body mass measurement by dual-energy x-ray
      absorptiometry, and a fitness assessment twice during the 6-month study.

      PROJECTED ACCRUAL: A total of 400 participants will be accrued.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): 5 days per week exercise for 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; breast cancer; prevention; obesity; estrogen metabolism; oxidative stress; IGF-1
ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 1

Summary: 
      A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial
      MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory
      movement disorders, namely Essential Tremor (ET).

      This study is designed as a prospective, single site, single arm, nonrandomized study.
      Assessments will be made before and three months after MRgFUS for clinical symptom relief,
      quality of life (QoL) improvements, and safety of MRgFUS in the treatment of ET. Similarly,
      QoL measures will be obtained using Quality of Life in Essential Tremor (QUEST)
      questionnaire. Relative Safety will be evaluated using a common description of Significant
      Clinical Complications for patients treated in this study. This study will be performed on
      the 3T MR scanners.

      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI
      scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
      targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion
      created in the ventralis intermedius nucleus of the thalamus.

      The treatment begins with a series of standard diagnostic MR images to identify the location
      and shape of tumor to be treated. The ExAblate computer uses the physician's designation of
      the target volume to plan the best way to cover the target volume with small spots called
      "sonications". These treatment spots are cylinder shaped. Their size depends on sonication
      power and duration. During the treatment, a specific MR scan, which can be processed to
      identify changes in tissue temperature, provides a thermal map of the treatment volume to
      confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,
      and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.

      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing
      1000-element phased array transducer) positioned above the subject head. The ExAblate
      transcranial system also includes means to immobilize the subject head, cool the interface
      water, and software for CT analysis and phase correction computation.

      The ExAblate transcranial system is an experimental device and is being investigated in this
      study.
    


Intervention name(s): ExAblate Transcranial MRgFUS System
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nuedexta for the Treatment of Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by
      the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8
      weeks over subjects given placebo.

      Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt
      Aggression Scale (OAS).
    

Detailed description: 
      This is a randomized placebo-controlled crossover study. The parents, neuropsychologists,
      clinical research coordinator (CRC) and PI will be blinded as to whether subjects are on
      placebo or Nuedexta.

      Nuedexta will be given once daily for 7 days. If well-tolerated, it will be given every 12
      hours for the next 7 weeks. Patients may also remain on the once-daily dose if desired.

      The study will last 44 weeks. This includes 20 weeks for study enrollment, 8 weeks of
      treatment/placebo, 4 weeks for washout, and a second 8 week-period of treatment/placebo
      followed by 4 weeks of washout.

      Subjects will be randomized to 8 weeks of Nuedexta/placebo. After the 8 week follow-up visit,
      there will be a 4 week washout period. At week 12 (second baseline), the groups will
      crossover for another 8 weeks of Nuedexta/placebo. Study endpoints will be measured in the
      both groups at weeks 8, 12, and 20. A final study visit will occur at week 24.
    

Intervention name(s): Nuedexta; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.; Placebo will be given once daily for 7 days.
Other intervention name(s): Dextromethorphan hydrobromide and quinidine sulfate
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adults
Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
Condition: Inflammation
MeSH terms: Uveitis; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Intraocular delivery of ketorolac will be an effective means to treat inflammation and
      macular edema and prevent structural complications and vision loss in patients with uveitis
      who are unable to tolerate corticosteroids due to their side effects.
    

Detailed description: 
      A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and
      complications due to inflammation who have either failed medical therapy or who cannot
      tolerate corticosteroids due to side effects.

      Specific Aims

        1. Test the safety of intraocular injection of 4mg of ketorolac in patients who have
           intractable uveitis or complications of uveitis such as chronic macular edema who are
           unable to tolerate corticosteroids due to their side effects.

        2. Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural
           complications of inflammation in patients with uveitis who are unable to tolerate
           corticosteroids due to their side effects.
    

Intervention name(s): Intravitreal Ketorolac
Intervention type(s): Drug
Intervention description(s): 4mg of intravitreal ketorolac
Other intervention name(s): ketorolace, tromethamine, preservative free
Intervention MeSH terms: Ketorolac
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammation; Macular Edema
Ulnar Nerve Deep Branch Compression by a Ganglion
Condition: Guyon's Canal; Nerve Compression
Study type: Interventional

Summary: 
      Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of
      this study are to report a series of 9 patients with pure ulnar nerve deep branch compression
      by a ganglion and to evaluate the outcome following a surgical treatment. According modified
      Bishop's scoring system, the investigators would evaluate postoperative results of this
      uncommon nerve lesion.
    

Detailed description: 
      Pre- and post-operative physical examination include assessment of tenderness and strength
      (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are
      measured using the E-LINK system. According Bishop's scoring system, the investigators
      redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.
    

Intervention name(s): Decompression of the ulnar nerve
Intervention type(s): Procedure
Intervention description(s): Surgical decompression of the Guyon's canal and ganglion excision
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep branch of the ulnar nerve; Distal ulnar nerve compression
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is designed to compare the pharmacokinetic characteristics of combination
      and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also
      investigate drug interaction between separate and combination administration.

      Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day
      administration, 16 days washout after 6th day of administration.

      The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over
      design during 2 each period.

      The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a
      cross-over design during 2 each period.
    


Intervention name(s): Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
Intervention type(s): Drug
Intervention description(s): For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period.
For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Intervention MeSH terms: Telmisartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Drug interaction; Rosuvastatin; Telmisartan; Pharmacokinetic; (Pharmacokinetics and Drug Interaction)
Electronic Hookah and Endothelial Cell Function
Condition: Smoking; Endothelial Dysfunction
Study type: Interventional

Summary: 
      Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among
      adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used
      through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol,
      glycerin, and flavorings-to pass through a water-filled basin, potentially altering the
      vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is
      the belief that the flavored smoke is detoxified as it passes through the water-filled basin,
      rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored
      nicotine by creating a vapor of fine particles and volatile organic compounds that could
      induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the
      specific role of nicotine and the mechanisms by which it may impairs endothelial function
      remain understudied. The objective of this project is to investigate the specific role of
      nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.
    


Intervention name(s): Electronic hookah vaping with nicotine; Electronic hookah vaping without nicotine
Intervention type(s): Other; Other
Intervention description(s): Participants will be invited to vape a 30-minute session of e-hookah containing nicotine; Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, phase 2 study. The
      purpose of the study is to initially evaluate the safety and efficacy of SM934 combined with
      steroids compared to placebo in adult subjects with active systemic lupus erythematosus (SLE)
      over a 12-week period.
    


Intervention name(s): SM934; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.; The placebo pills are made identical to the investigating SM934 in appearance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms
Condition: Rectal Neoplasms
MeSH terms: Neoplasms; Rectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of irreversible
      electroporation (IRE) for unresectable Rectal Neoplasms.
    

Detailed description: 
      By enrolling patients with unresectable Rectal Neoplasms adapted to enrolled criteria, this
      study will document for the first time the safety and the short and long term efficacy of
      percutaneous IRE for unresectable Rectal Neoplasms.
    

Intervention name(s): Irreversible electroporation (IRE); NanoKnife
Intervention type(s): Procedure; Device
Intervention description(s): Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: irreversible electroporation; Unresectable Rectal Neoplasms
Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy
      followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC
      patients.
    

Detailed description: 
      Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1
      day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and
      28 Gy/7 fractions administered in the first and second courses, respectively, with one-month
      break. The primary end point is progression-free survival, which is the time that passes from
      the first day of radiotherapy to the date at which disease progresses. Progression-free
      survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according
      to CTCAE v. 4.0.
    

Intervention name(s): split-course radiotherapy; concurrent chemotherapy
Intervention type(s): Radiation; Drug
Intervention description(s): Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor.; Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small Cell Lung Cancer; hypofractionated radiotherapy
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to establish the equivalence of 2 formulations to the intended final
      market product. The formulations to compare are the capsule given to patients in the phase I
      and II studies and the capsule that is being administered to the patients in the phase III
      trials. Both capsules will be compared to the intended final market capsule. The comparison
      will be performed looking at the pharmacokinetic parameters that define the rate and extent
      of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing
      these parameters calculated after a single 125 mg dose of the 3 capsules identifying like
      that if there are significant differences between these 3 formulations.
    


Intervention name(s): palbociclib capsule: phase 1 and 2 studies; Palbociclib capsule: phase 3 studies; Palbociclib capsule: ICH
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies; 125 mg dose of palbociclib. Formulation used in phase 3 studies; 125 mg dose of palbociclib. Intended final market formulation
Intervention MeSH terms: Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; Cmax; AUC
EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of
      a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV)
      and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.
    

Detailed description: 
      The first phase explores single ascending doses of EDP-494 (active drug or placebo) in
      healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.

      The second phase involves multiple ascending doses (active drug or placebo) for 14 days in
      healthy subjects.

      The third, proof of concept, phase will assess two different doses for 14 days each in
      Hepatitis C patients.

      Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or
      placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist
      of 10 subjects randomised in a 4 to 1 ratio.
    

Intervention name(s): EDP-494; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10, 100 and 200 mg capsules; placebo to match EDP-494
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment