bioihbjkbjnl/mcl2 huggingface dataset:
Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: In-Person ACT; Telehealth ACT
Intervention description: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action; 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pain; Acceptance and Commitment Therapy (ACT)

Summary:

      The purpose of the study is to test a brief, individual psychosocial in-person or telehealth
      intervention to reduce interference of pain with daily life, emotional distress, and pain
      intensity, and improve quality of life and physical activity levels in individuals with
      chronic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic non-terminal pain condition;

          -  Pain severity and interference rated > 4/10; and

          -  Pain most days (> 3/week) for at least 6 months.

        Exclusion Criteria:

          -  Current participation in group psychotherapy for pain or any type of individual
             psychotherapy;

          -  Previous treatment with ACT;

          -  Active suicide ideation or history of suicide attempt within 5 years;

          -  Serious or unstable medical or psychiatric illness or psychosocial instability that
             could compromise study participation; and

          -  The following DSM-IV diagnoses or active problems within the past 6 months noted in
             the patient's Computerized Patient Record System (CPRS) medical record or diagnosed
             during a structured psychiatric interview:

               -  schizophrenia;

               -  other psychotic disorder;

               -  bipolar disorder;

               -  organic mental disorder;

               -  borderline or antisocial personality disorder; or

               -  alcohol or substance abuse or dependence.
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
Condition: ACE Inhibitor Induced Angioedema
MeSH terms: Angioedema
Intervention: ecallantide 60 mg; ecallantide 30 mg; ecallantide 10 mg; placebo; placebo match for 30 mg ecallantide arm; placebo match for 10 mg ecallantide arm
Intervention description: Administered as two 3 mL SC injections, each containing 30 mg ecallantide; Administered as one 3 mL SC injection containing 30 mg ecallantide; Administered as one 3 mL SC injection containing 10 mg ecallantide.; Administered as two SC 3 mL injections; One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.; One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
Intervention MeSH terms: Ecallantide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A double-blind, randomized, controlled trial comparing the safety and effectiveness of
      conventional therapy with ecallantide to conventional therapy with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years of age or older

          -  Must currently be on ACE inhibitor therapy and have received a dose within 36 hours

          -  Presenting with ACEIA of the head/neck region within 12 hours after onset

          -  All females must have a negative urine pregnancy test prior to administration of the
             study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two
             years post-menopausal do not require a pregnancy test.

        Exclusion Criteria:

          -  Hypersensitivity to ecallantide

          -  Pregnancy or breast feeding

          -  Patients who have had angioedema and were not concurrently on an ACE inhibitor

          -  Patients exhibiting urticaria

          -  Patients who are intubated or who have a tracheostomy related to the current episode
             of angioedema

          -  Opinion of the investigator that the patient would not be a good candidate

          -  Participation in another investigational study within 30 days prior to enrollment
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Condition: Asthma; Allergic Sensitization
MeSH terms: Asthma
Intervention: Oral mucosal immunoprophylaxis (OMIP); Placebo
Intervention description: OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.; The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 12 Months
Maximum age: 30 Months
Healthy volunteers: No
Keywords: asthma; allergen; allergic disease; allergen immunotherapy; allergic sensitization; atopic dermatitis; eczema; food allergy; oral mucosal immunoprophylaxis (OMIP)

Summary:

      The purpose of this study is to determine whether early childhood exposure to common
      allergens (substances that can trigger allergies and asthma) can prevent the development of
      asthma in children at high risk for developing the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with eczema (atopic dermatitis)

          -  Family history of eczema, allergic rhinitis, or asthma

          -  Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean

          -  Weigh at least 9.5 kg (20.9 lbs)

          -  Parent or guardian willing to provide informed consent

        Exclusion Criteria:

          -  Allergy to house dust mite, cat, or timothy grass

          -  Born prematurely (before 36th week's gestation)

          -  Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during
             the first year of life

          -  Chronic pulmonary disease

          -  Chronic disease requiring therapy

          -  Past or current treatment with systemic immunomodulator medication

          -  Past or current treatment with allergen-specific immunotherapy

          -  Received 10 or more days of systemic steroids in the 3 months prior to study entry

          -  Orofacial abnormalities that are likely to interfere with the subject's ability to
             take study treatment

          -  Participated in another clinical study within the 3 months prior to study entry
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Condition: PPHN; Persistent Pulmonary Hypertension of the Newborn; Hypoxic Respiratory Failure
MeSH terms: Hypertension, Pulmonary; Respiratory Insufficiency; Persistent Fetal Circulation Syndrome; Hypertension
Intervention: sildanefil
Intervention description: Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 1 Hour
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: PPHN; neonates; sildanefil IV

Summary:

      Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will
      reduce the need for inhaled nitric oxide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  72 hours of age; and > or = to 34 weeks gestational age.

          -  Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure
             associated with:

               1. Idiopathic PPHN or

               2. Meconium aspiration syndrome or

               3. Sepsis or

               4. Pneumonia

          -  Oxygenation Index (OI) >15 and <60 calculated

        Exclusion Criteria:

          -  Patients already receiving inhaled nitric oxide (iNO) on referral.

          -  Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal
             Membrane Oxygenation (ECMO).

          -  Life threatening or lethal congenital anomaly.

          -  Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on
             admission to GOSH).

          -  Clinically significant active seizures as per clinical judgment.

          -  Bleeding diathesis as per clinical judgment
Teriparatide for Postsurgical Hypoparathyroidism
Condition: Hypoparathyroidism Post-surgical
MeSH terms: Hypoparathyroidism
Intervention: Teriparatide
Intervention description: The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypoparathyroidism

Summary:

      This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the
      setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that
      teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in
      patients with symptomatic hypoparathyroidism.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients post bilateral thyroid bed surgery (cancer, Graves disease, multinodular
             goiter)

          -  Symptomatic hypocalcemia

          -  Total calcium < 8 mg/dL persisting after 24 hours of therapy with calcitriol (minimum
             0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental
             calcium per day)

          -  Parathyroid hormone (PTH) level below low end of normal range

        Exclusion criteria (all subjects):

          -  Renal failure

          -  Any prior parathyroid pathology

          -  Pre-existing hypercalcemia

          -  Metabolic bone diseases other than osteoporosis

          -  Pagets disease

        Exclusion criteria (active treatment subjects only):

          -  Ongoing therapy with Forteo for osteoporosis

          -  Active non-thyroidal malignancy or suspicion of residual thyroid malignancy

          -  History of skeletal malignancies, primary or metastatic

          -  Pregnancy

          -  Active or recent urolithiasis

          -  Digitalis therapy

          -  Patients at increased baseline risk for osteosarcoma, i.e., family history of
             osteosarcoma or prior radiation therapy involving the skeleton

          -  Pediatric populations

          -  Unexplained elevations of alkaline phosphatase
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
Condition: Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Neoplasm
MeSH terms: Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Peritoneal Neoplasms; Fallopian Tube Neoplasms
Intervention: enzastaurin; carboplatin; paclitaxel; placebo
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial
      treatment. In many participants the tumor will shrink, or even disappear, after treatment
      with these drugs. But, unfortunately, the tumor will grow again in many participants. This
      trial will try to address the question: Can we delay the time till the tumor grows again by
      adding a 3rd drug to the standard therapy? To answer this question, participants will, by
      chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the
      chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not
      know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined
      time, the treatment will be uncovered, and the number of participants with tumor growth at a
      specific time point will be compared between the two treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have specific stages of disease, known as Fédération Internationale
             de Gynécologie et d'Obstétrique (FIGO) stages IIB, IIC, III or IV

          -  Organ functions (blood, renal, liver, cardiac) must meet specific requirements.

          -  Participants who could become pregnant must take care not to become pregnant during
             the study participation and for 6 months after study discontinuation

          -  Participants must give written consent for study participation.

        Exclusion Criteria:

          -  Participants received any experimental drug within the last 30 days.

          -  Participants received any prior chemotherapy or other drug therapy for the current
             disease.

          -  Participants receive any other treatment for the cancer during study participation.

          -  Participants are unable to discontinue concurrent administration of carbamazepine,
             phenobarbital, or phenytoin.

          -  Participants are pregnant, breast feeding, or not using adequate contraceptive methods
             to prevent pregnancy.
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Condition: Hookworm Infections
MeSH terms: Infections; Hookworm Infections; Ancylostomiasis
Intervention: Mebendazole
Intervention description: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mebendazole; Chewable tablet; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Acceptability

Summary:

      The rational of this study is to provide evidence on the safety and efficacy of a new
      chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged
      children infected with hookworm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children aged between 3 and 12 years;

          -  Written informed consent signed by caregiver;

          -  Was examined by a study physician before treatment;

          -  Provided two stool samples at baseline;

          -  Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one
             hookworm egg;

        Exclusion Criteria:

          -  Pregnant;

          -  Presence or history of major systemic or chronic illnesses, as assessed by a medical
             doctor, such as can upon initial clinical assessment;

          -  Suffers from severe anemia (Hb < 80 g/l);

          -  Received anthelminthic treatment or metronidazole within past four weeks.

          -  Attending other clinical trials during the study.
Safety and Efficacy of a Drug Delivery System in Glaucoma
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Intervention: High Dose Drug Device; Low Dose Drug Device; Placebo Device; bimatoprost 0.03%
Intervention description: device inserted for 4 days; device inserted for 4 days; device inserted for 4 days; one drop in each eye on one day only
Intervention MeSH terms: Bimatoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma
      or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman 21 years of age or greater

          -  Open angle glaucoma or ocular hypertension

          -  Corrected visual acuity in each eye of 20/200 or better

        Exclusion Criteria:

          -  Previous glaucoma intraocular surgery or refractive surgery

          -  Planned contact lens use during the study

          -  Clinically significant ocular or systemic disease that might interfere with the study

          -  Use of chronic corticosteroids by any route
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Condition: Solid Tumors; High Grade Gliomas; Lung Cancer; Head and Neck Cancer; Sarcoma; Renal Cell Carcinoma; Breast Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Fluciclatide Injection
Intervention description: Fluciclatide Injection (AH111585 (18F) Injection)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection.
      Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8
      days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels
      of 18F uptake on PET.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has been diagnosed with at least one solid primary or metastatic tumor
             greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM,
             melanoma, sarcoma, breast and H&N cancers.

          -  The subject has received clinical routine imaging diagnostic work-up within 8 weeks
             prior to the first [18F]AH111585 PET scan.

          -  The subject has a clinically acceptable (as judged by the investigator) physical
             examination at screening and is capable of self-care.

        Exclusion Criteria:

          -  The subject has known hyper- or hypo-coagulation syndromes.

          -  The subject has received chemotherapy within 3 weeks, or received radiotherapy,
             surgery or any other treatment against cancer within 4 weeks prior to the first
             [18F]AH111585 PET scan.

          -  The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other
             treatment against cancer between the first and second [18F]AH111585 PET scans.

          -  The subject is scheduled to undergo biopsy for the target tumour between the first and
             second [18F]AH111585 PET scans.

          -  The subject has intra-hepatic tumour(s) only.

          -  For the immuno-histochemistry group, the subject's target tumour has been biopsied
             less than or equal to 1 week prior to the first [18F]AH111585 PET scan.
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: BMS-986165; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will investigate BMS-986165 to assess its effects in participants with systemic
      lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening
             visit

          -  Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification
             criteria for SLE

          -  One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti-
             double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate
             results) or positive anti-Smith (anti-Sm) as determined by the central laboratory

          -  Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6
             points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash
             [score must be confirmed by Central Review Services (CRS)]

          -  Men and women must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus
             nephritis

          -  SLE overlap syndromes such as scleroderma and mixed connective tissue disease

          -  Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)

          -  History of any significant drug allergy

        Other protocol defined inclusion/exclusion criteria apply