bioihbjkbjnl/mcl2 huggingface dataset:
A New Micrografting Technique for Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Dermabrasion-Micrografting; Dermabrasion
Intervention description: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).; Only dermabrasion (removal of epidermis) alone will be done at baseline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study evaluates micrografting using a harvesting and grafting process that has been
      designed by Momelan Technologies. The overall concept is to harvest several small pieces of
      skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a
      commercially available suction blister device, adhere them to a sterile elastomeric substrate
      and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the
      epidermis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 to 80 years old

          -  Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0
             or 1

          -  Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each
             measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and
             anticipated equal sun exposure.

          -  Have not used any topical therapy to patches or Ultraviolet light therapy for at least
             2 weeks (subjects may restart phototherapy at week 10 if desired)

          -  Be able to understand the requirements of the study, the risks involved, and be able
             to sign the informed consent form

          -  Agree to follow and undergo all study-related procedures

        Exclusion Criteria:

          -  Female patients who are breastfeeding, pregnant, or planning to become pregnant

          -  Patients with a history of hypertrophic scaring or keloids and psoriasis

          -  Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.

          -  Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and
             other cytotoxic reagents within 2 weeks of grafting)

          -  Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks

          -  Patients with a positive HIV status

          -  Patients withDiabetes Mellitus with a hemoglobin A1C of more than 8.

          -  Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen
             planus.

          -  Participation in another interventional study with potential exposure to an
             investigational drug within past 30 days
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Condition: Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Intervention: Lanraplenib; Filgotinib; Lanraplenib placebo; Filgotinib placebo
Intervention description: 30 mg tablets administered orally once daily with or without food; 200 mg tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus
      erythematosus (CLE).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per
             investigator evaluation, with the following:

               -  Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and
                  severity index [CLASI] activity score ≥ 10) at screening and Day 1

               -  Prior intolerance or inadequate response to at least one of the listed
                  medications for the treatment of CLE

          -  Stable dose (defined as no change in prescription for at least 28 days prior to Day 1)
             of antimalarials and/or topical or oral corticosteroids is permitted during the study.
             Individuals who are not planning to continue these medications during the study must
             have discontinued them at least 28 days prior to Day 1

        Key Exclusion Criteria:

          -  Use of prohibited concomitant medications per study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Hydroxychloroquine in Untreated B-CLL Patients
Condition: B-Cell Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Hydroxychloroquine
Intervention description: 400mg by mouth daily x 1 year
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: untreated

Summary:

      Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine
      400mg po daily for up to one year. They will be monitored for disease status as well as
      adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at
      baseline and every 6 months or sooner if the patient develops any visual disturbances.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Flow cytometry confirmed B-CLL

          -  No prior chemotherapy or immunotherapy

          -  Performance status 0-2

          -  Age > 18 years old

          -  If childbearing age, woman you must be willing to use birth control for length of
             hydroxychloroquine use

          -  Must have capacity to consent for study and sign consent form

          -  Asymptomatic CLL not requiring treatment at time of study entry

        Exclusion Criteria:

          -  Pregnancy

          -  Significant optic nerve pathology as documented by an opthalmologic exam

          -  Hypersensitivity to 4-aminoquinoline compound

          -  Patients taking cardiac glycosides and cyclosporine
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Condition: Pain, Postoperative; Mammaplasty
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone 4mg; Saline
Intervention description: The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.; The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The surgeon (investigator), patient, and anesthesiologists were not aware of which arm each participant was assigned to. Furthermore, each injected analgesic was premixed and uniformly labeled to maintain blinding.
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been
      shown to enhance pain control and prolong the time until first request for postoperative
      narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been
      investigated in any types of breast surgery. The investigators assessed if the combination of
      dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast
      reduction surgery resulted in improved pain control relative to bupivacaine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age 18-80

          -  Bilateral reduction mammaplasty

          -  American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3

          -  Must choose to receive preoperative nerve block as part of pain management strategy

        Exclusion Criteria:

          -  Allergy to dexamethasone or bupivacaine

          -  History of postoperative nausea and vomiting following anesthesia

          -  History of chronic pain conditions

          -  History of narcotic abuse or dependency

          -  History of chronic renal disease

          -  History of chronic liver disease
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Alpha, gamma, beta, and delta (mixed) tocopherols; Alpha lipoic acid; Placebo; Placebo
Intervention description: approximately 666 IU daily (1 pill) for 6 months; 600 mg daily (2 pills 300 mg each) for 6 months; placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months; placebo for alpha lipoic acid; 2 pills daily for 6 months
Intervention MeSH terms: Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Thioctic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood
      markers which their body makes in response to increased stress and injury. An increase in
      these markers have been shown to be related to cardiovascular disease and death in ESRD
      patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic
      acid) may decrease these markers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with end-stage renal disease receiving thrice weekly hemodialysis

          2. Age > 18 years

          3. Life expectancy greater than one year

          4. Ability to understand and provide informed consent for participation in the study

        Exclusion Criteria:

          1. AIDS (HIV seropositivity is not an exclusion criteria)

          2. Active malignancy excluding basal cell carcinoma of the skin

          3. Gastrointestinal dysfunction requiring parenteral nutrition

          4. History of functional kidney transplant < 6 months prior to study entry

          5. Anticipated live donor kidney transplant over study duration

          6. History of poor adherence to hemodialysis or medical regimen

          7. Prisoners, patients with significant mental illness, pregnant women, and other
             vulnerable populations

          8. Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the
             past 30 days

          9. Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past
             30 days

         10. Patients using a temporary catheter for dialysis access

         11. More than two hospitalizations within the last 90 days or one hospitalization within
             the last 30 days
Gabapentin Treatment of Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: Placebo; Gabapentin
Intervention description: Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cannabis treatment; marijuana treatment

Summary:

      This is a study to evaluate the efficacy of the medication gabapentin in treating persons
      with cannabis dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females age 18-65 with cannabis dependence

          -  Meets DSM-IV-TR criteria for Cannabis Dependence

          -  Smoked marijuana at least once a week in the 90 days prior to study participation

          -  Willing to attend 12 weekly study visits and 1 follow-up visit

        Exclusion Criteria:

          -  Currently meets DSM-IV-TR criteria for dependence on illicit substances other than
             cannabis

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation

          -  Women with childbearing potential who are pregnant, nursing, or refuse to use a
             reliable method of birth control

          -  Treatment with an investigational drug in the last month
A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients
Condition: HIV Infection; HIV; Acquired Immunodeficiency Syndrome
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: etravirine (ETR, TMC125); efavirenz (EFV)
Intervention description: 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks; 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
Intervention MeSH terms: Efavirenz; Etravirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HIV; Intelence; etravirine; ETR; TMC125; Sustiva; efavirenz; EFV; Non-nucleoside Reverse Transcriptase Inhibitor; NNRTI; treatment-naive

Summary:

      The purpose of this study is to compare the neuropsychiatric adverse event profiles of
      etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2
      N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability
      and efficacy of both treatment arms will be assessed throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV-1 infection

          -  In the judgement of the investigator, it is appropriate to initiate ARV therapy based
             on the patients medical condition and taking into account applicable guidelines for
             the treatment of HIV-1 infection

          -  Patient has access to an investigator-selected ARV regimen post-study in accordance
             with applicable guidelines for the treatment of HIV-1 infection

          -  HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)

          -  Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs
             in their background regimen at screening

        Exclusion Criteria:

          -  Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of
             NVP for the prevention of vertical HIV transmission

          -  The presence of at least one of the mutations that are specific indicators of
             transmitted (or primary) drug resistance

          -  Known infection with HIV-2 or with HIV-1 group O

          -  Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if
             not progressive

          -  Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured

          -  Specific grade 3 or 4 laboratory abnormalities
Internet-based Treatment for Chronic Insomnia
Condition: Insomnia; Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Cognitive Behavioral Therapy
Intervention description: 6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: insomnia; online systems

Summary:

      Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia,
      such treatments are underutilized. This study evaluates the impact of a 6-week, online
      treatment for insomnia.

      Design This is a randomized controlled trial with online treatment and waiting list control
      conditions.

      Participants

      Participants are adults in Manitoba Canada with chronic insomnia.

      Setting

      Participants receive online treatment from their homes. Intervention. Online treatment
      consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep
      restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help
      with medication tapering. Measurement and Results. The impact of online treatment on primary
      end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Access to high speed internet, insomnia duration > 6 months and occurring at least 4
             nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30
             minutes, and/or early morning awakening > 30 minutes before desired time, at least one
             type of daytime impairment.

        Exclusion Criteria:

          -  Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14
             drinks/week for males, > 12 drinks per week for females, current or past behavioral
             treatment for insomnia
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: indacaterol; placebo; mometasone furoate
Intervention description: indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler; placebo delivered via Concept 1 inhaler; via Twisthaler inhaler
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with
      persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who
             additionally meet the following criteria:

          -  Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks

          -  Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal
             value

          -  Patients who demonstrate an increase of >= 12% and 200 mL in FEV1

          -  ACQ-5 score ≥ 1.5

        Exclusion Criteria:

          -  Patients who are current smokers or have a smoking history of greater than 10 pack
             years (defined as the number of packs of 20 cigarettes smoked per day multiplied by
             number of years the patient smoked).

          -  Patients with chronic lung disease, including COPD, pulmonary tuberculosis,
             bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.

          -  Patients with any chronic conditions affecting the respiratory tract (e.g., chronic
             sinusitis) which in the opinion of the investigator may interfere with the study
             evaluation or optimal participation in the study.

        Other protocol-defined inclusion/exclusion criteria may apply
Cytokine Induced Killer (CIK) Cells In Leukemia Patients
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: in vitro expanded Cytokine Induced Killer (CIK) cells
Intervention description: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hematologic malignancies (excluding Chronic Myeloid Leukemia)

Summary:

      The purpose of the Phase IIA study are to:

        1. define the safety profile

        2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte
           Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular,
           cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The
           progression free survival and the overall survival after the sequential infusion of
           Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with
             a molecular, cytogenetic or haematologic relapse after allogeneic transplantation.

          -  Patients with an available donor willing to donate peripheral blood lymphocytes

          -  Immunosuppression must be withdrawn at the beginning of the cell therapy program

          -  Written informed consent prior to any study procedures being performed

        Exclusion Criteria:

          -  Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis

          -  Patients with active acute or chronic Graft versus host disease (GvHD)

          -  Patients with rapidly progressive disease or not controlled by palliative supportive
             treatments including chemotherapy and with a life expectancy less than 8 weeks

          -  Patients with severe psychiatric illness or any disorder that compromises ability to
             give truly informed consent for participation in this study