bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Intervention: ClariVein RES; Sodium Tetradecyl Sulfate 1% Injection; Sodium Tetradecyl Sulfate 3% Injection
Intervention description: ClariVein system; Sodium Tetradecyl Sulfate STS 1% Injection; Sodium Tetradecyl Sulfate 3% Injection
Intervention MeSH terms: Sodium Tetradecyl Sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      VICARES is a prospective randomized, controlled, multi-center, double blind study treating
      venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium
      Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient with incompetent saphenous vein

          2. Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound

          3. One or more of patient reported symptoms related to the target vein: i.e., heaviness,
             achiness, swelling, throbbing or itching.

          4. Candidate for endovenous procedure

        Exclusion Criteria:

          1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD)
             that would preclude the wearing of compression stockings

          2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an
             Ankle-Brachial Index (ABI) <0.6

          3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments
             (e.g., femoral and popliteal) in the ipsilateral extremity

          4. Previous surgical or endovenous procedure in the treatment section of the target vein

          5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in
             the treatment section

          6. Pregnant or breastfeeding

          7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)

          8. Known high risk of thrombosis

          9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of
             acute superficial vein thrombus, known hypercoagulable condition, post thrombotic
             syndrome

         10. Known history of anaphylaxis or presence of multiple severe allergies
Oxytocin for Couples Conflict Resolution
Condition: Substance Misuse; Interpersonal Conflict; Neuroendocrine Reactivity
Intervention: Oxytocin; Placebo
Intervention description: Placebo for Oxytocin
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Oxytocin is a promising new medication found to have positive effects on prosocial behavior,
      reduce negative affect such as fear and anxiety, and reduce stress-induced addictive
      behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal
      oxytocin improves couples' conflict resolution skills and subjective, physiological, and
      neuroendocrine responses to conflict. Conflict resolution discussions will take place in the
      laboratory and will be videotaped.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-65 years of age

          2. both partners are willing to participate, and

          3. at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for
             women, 6 or more for men) or illicit drug use during the past 60 days

        Exclusion Criteria:

          1. pregnancy for women

          2. current psychotic or bipolar disorders

          3. active suicidal or homicidal ideation and intent

          4. subjects who would present a serious suicide risk, such as those with severe
             depression, or who are likely to require hospitalization during the course of the
             study

          5. severe, unilateral intimate partner violence in the past year

          6. BMI greater than 39.
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: 25 mg Proellex
Intervention description: one 25 mg capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine fibroids

Summary:

      An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Four subjects at one site whom have completed ZPU 003 Ext 1 study

        Exclusion Criteria:

          -  All other subjects
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL/VOX; RBV
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination
      (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV)
      infection and prior treatment experience with a direct acting antiviral (DAA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with chronic HCV genotype 1 infection

          -  Documented as treatment experienced with a direct acting antiviral-containing regimen
             without achieving sustained viral response

          -  Absence of cirrhosis or presence of compensated cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Must use specific contraceptive methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol

          -  Pregnant or a nursing female

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: Synthetic Human Parathyroid Hormone 1-34; Calcitriol & Calcium
Intervention description: twice daily subcutaneous injections; Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation
Intervention MeSH terms: Vitamin D; Calcitriol; Calcium; Parathyroid Hormone; Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 17 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Hypoparathyroidism; Parathyroid Hormone; Vitamin D; Calcium Metabolism; PTH 1-34; Bone

Summary:

      This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH)
      as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with
      calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients
      who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism
      to be managed effectively with the investigational drug, PTH. The primary goals of this study
      are to (1) provide long-term PTH therapy to patients who do not respond to conventional
      therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney
      function and bone mineral density; (3) study and track linear growth and bone accrual in
      children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone
      mass and if the timing of this is comparable to normal age-matched healthy controls.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        This study will include patients (ages 17-69) with biochemically confirmed
        hypoparathyroidism.

        EXCLUSION CRITERIA

        Women who are pregnant will be excluded.
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Condition: Curvature of Spine
MeSH terms: Spinal Curvatures
Intervention: Tranexamic Acid
Intervention description: intravenous administration of bolus and infusion for duration of surgical procedure
Intervention MeSH terms: Tranexamic 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: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss
      and red blood cell transfusion during high risk spine surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age>17 years

          -  undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of
             major transfusion

        Exclusion Criteria:

          -  age < 18 years

          -  non-English speaking

          -  pregnancy

          -  emergency procedures

          -  surgery for tumor, trauma or infection

          -  severe coronary artery disease

          -  history of venous thromboembolism

          -  history of cerebral vascular accident

          -  history of renal insufficiency

          -  allergy to tranexamic acid
A Network & Dyad HIV Prevention Intervention for IDU's - 1
Condition: HIV; Hepatitis
MeSH terms: Hepatitis
Intervention: Intervention Condition; Control Condition
Intervention description: In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.; The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1024.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

Summary:

      The purpose of this study is to evaluate a peer-based HIV prevention intervention that
      targets active injection drug users and their drug and sex partners.
    

Eligibility criteria:

        Inclusion Criteria:

        (i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a
        risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

        Exclusion Criteria:

          -  Not concurrently enrolled in another HIV prevention intervention
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Condition: Common Cold
MeSH terms: Common Cold
Intervention: 3804-250A; 3804-291
Intervention description: topical product
apply 2 pumps
apply at least every 4 hours or after hand washing; topical
apply 2 pumps
apply at least every 4 hours or after hand washing
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 411.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cold, common; rhinovirus

Summary:

      The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the
      common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a
      virus that causes many common colds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy normal

          -  good general health

        Exclusion Criteria:

          -  pregnancy

          -  insulin dependent diabetes

          -  daily smoker

          -  skin disease on the hands/wrists

          -  immunological disorders

          -  occupation involving frequent handwashing

          -  common cold symptoms
Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome
Condition: Recurrent Abortion
MeSH terms: Abortion, Habitual; Antiphospholipid Syndrome; Recurrence
Intervention: enoxaparin 40mg plus low dose aspirin; Heparin calcium5,000 U twice daily plus low dose aspirin
Intervention description: Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initiated. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop enoxaparin or UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID)) is started before conception and continued until 36 weeks gestation.; Heparin Calcium 5,000 U twice daily (Cal-Heparine, Amoun Pharmaceutical Co, Egypt) by subcutaneous injection is started when the serum pregnancy test become positive. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID))is started before conception and continued until 36 weeks gestation .
Intervention MeSH terms: Aspirin; Heparin; Enoxaparin; Calcium heparin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 19 Years
Maximum age: 37 Years
Healthy volunteers: No
Keywords: Recurrent abortion; Antiphospholipid syndrome; unfractionated heparin; Low Molecular Weight Heparin

Summary:

      The aim of this study is to compare the efficacy and safety of Low molecular weight heparin
      (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with
      recurrent pregnancy loss associated with antiphospholipid syndrome (APS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a minimum of three consecutive pregnancy losses before 10 weeks
             gestation

          -  Positive lupus anticoagulant and/or anticardiolipin antibodies (IgG and IgM) on at
             least two occasions twelve weeks apart .

          -  Age between 19 - 37 years,

          -  Body mass index between 19-30

        Exclusion Criteria:

          -  Parental chromosomal abnormalities

          -  Uterine abnormalities

          -  Luteal phase defect

          -  Systemic lupus erythematosus

          -  Previous thromboembolism

          -  Sensitivity to aspirin.
Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Lenalidomide; Dexamethasone
Intervention MeSH terms: Dexamethasone; Lenalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible
      and safe.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

          -  Documented evidence of active multiple myeloma:

               -  Newly diagnosed, not candidate for transplant

               -  Relapsed/refractory who have received up to 3 prior lines of therapy

          -  Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

               -  Not refractory to prior Lenalidomide which is defined as no progression while
                  receiving Lenalidomide or within 60 days of last dose of Lenalidomide

               -  Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event
                  (AE)

        Exclusion Criteria:

          -  Target Disease Exceptions

               -  Plasma cell leukemia

               -  Monoclonal gammopathy of undetermined significance (MGUS)

               -  Smoldering Myeloma

          -  Primary amyloidosis

          -  Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes
             (POEMS) syndrome
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: RPC1063
Intervention MeSH terms: Ozanimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Crohn's disease (CD) confirmed by endoscopy and histology

          -  Active disease as evaluated by Crohn's Disease Activity Index Score and Simple
             Endoscopic Score for CD

          -  Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic
             therapy

        Key Exclusion Criteria:

          -  Diagnosis of ulcerative colitis or indeterminate colitis

          -  Known strictures/stenosis leading to symptoms of obstruction

          -  Current stoma or need for ileostomy or colostomy

          -  Clinically relevant cardiovascular conditions or other relevant diseases that could
             impact the implementation or interpretation of the trial, or put the patient at risk

          -  History of uveitis or known macular edema

          -  History of colonic dysplasia
Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: gemcitabine; cisplatin; radiation
Intervention description: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5); 80 mg/m2, IV, every 21 days x 5 cycles; 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the response rate of patients with non small lung
      cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this
      combination will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inoperable non small cell lung cancer Stage III

          -  Adequate hematological parameters

          -  Adequate Lung function reserve

        Exclusion Criteria:

          -  Previous chemotherapy and thoracic radiation for non small cell lung cancer

          -  Presence of distant metastases
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: VT-1161; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 254.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in
      vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida
      albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161
      is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect
      profile that limits the use of commonly prescribed antifungal agents for the treatment of
      recurrent yeast infections.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Clinical diagnosis of symptomatic acute VVC

        3 or more episodes of acute VVC in the past 12 months

        Positive KOH

        Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

        Composite vulvovaginal signs and symptoms score of <3 at Baseline

        Must be able to swallow tablets

        Key Exclusion Criteria:

        Evidence of major organ system disease

        Presence or a history of another vaginal or vulvar condition(s)

        History of cervical cancer

        Poorly controlled diabetes mellitus

        Pregnant

        Recent use of topical or systemic antifungal drugs

        Recent use of immunosuppressive or system corticosteroid therapies