bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Intranasal Ketamine; Intranasal Midazolam
Intervention description: A single dose of intranasal ketamine up to 50 mg; A single dose of intranasal Midazolam up to 4 mg
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: OCD

Summary:

      Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and
      impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are
      FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and
      even then they usually only partially reduce OCD symptoms. The present study, will test if
      intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a
      comparison medication called midazolam. Therefore, you may or may not receive ketamine as
      part of this study. Results from this study will allow doctors and researchers to better
      understand if you and others with OCD may respond to this class of medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-55

          -  Physically healthy and not currently pregnant

          -  Primary diagnosis of OCD

          -  Sufficient severity of symptoms

          -  For all patients on medications, medications dose must be stable for at least 6 weeks
             prior to enrollment. Must discuss with Dr. current medications and doses.

          -  Able to provide consent

        Exclusion Criteria:

          -  First degree relative with schizophrenia

          -  Psychiatric conditions that would make participation unsafe determined by study doctor

          -  Female patients who are either pregnant or nursing

          -  Planning to start EX/RP during the period of the study or those who have completed an
             adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks
             prior to enrollment.

          -  Nasal obstruction or history of nasal surgery

          -  Currently on psychotropic medication or other medication likely to interact with the
             glutamate system

          -  Medical conditions that make participation unsafe

          -  Allergy or intolerance to ketamine or midazolam
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Condition: Infections, Gram-Positive Bacterial; Abscess; Burns; Cellulitis; Ulcer; Wound Infections
MeSH terms: Infections; Communicable Diseases; Wound Infection; Cellulitis; Gram-Positive Bacterial Infections
Intervention: Telavancin; Vancomycin or antistaphylococcal penicillin
Intervention description: Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days; Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
Intervention MeSH terms: Vancomycin; Penicillins; Telavancin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Serious infections caused by resistant bacteria are becoming more of a medical problem
      throughout the world. One of the ways to deal with this problem is to develop new drugs that
      can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control
      infections and whether this drug can be safely given to patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of one of the following complicated skin and skin
             structure infections with either a suspected or confirmed Gram positive organism as
             the major cause of the infection:

               -  major abscess requiring surgical incision and drainage

               -  infected burn (see exclusion criteria for important qualifications)

               -  deep/extensive cellulitis

               -  infected ulcer (see exclusion criteria for important qualifications)

               -  wound infections

          -  Patients must be expected to require at least 4 days of intravenous antibiotic
             treatment

        Exclusion Criteria:

          -  Previous systemic antibacterial therapy (with the exception of aztreonam and
             metronidazole) for > 24 hours within 7 days prior to the first dose of study
             medication unless the pathogen was resistant to prior treatment or the patient was a
             treatment failure (no clinical improvement after 3 days).

          -  Burns involving > 20% of body surface area or third degree/full thickness in nature,
             diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or
             mediastinitis.
Adding Phosphorus to Osteoporosis Drug Treatment
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Calcium carbonate; Calcium Phosphate
Intervention description: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.; Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 241.0
Sex: Female
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Bone Mineral Density; Calcium

Summary:

      Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two
      minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly
      prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus
      available for bone building. Teriparatide is a drug that reduces the risk of fractures by
      increasing bone thickness and strength. Vitamin D is also necessary for strong bones and
      teeth. The purpose of this study is to evaluate the bone-building effectiveness of two
      calcium supplements, one with a source of phosphorus and one without, in combination with
      teriparatide and vitamin D in women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bone mineral density (BMD) T-score less than -1.0

          -  One or more vertebral fractures

          -  Serum creatinine less than 1.3 mg/dL

          -  Serum phosphorus less than 3.6 mg/dL

          -  Daily phosphorus intake below NHANES-III median

          -  Body mass index (BMI) less than 30 kg/m2

        Exclusion Criteria:

          -  Paget's disease or history of osteosarcoma

          -  Systemic corticosteroid therapy

          -  Hyperparathyroidism

          -  Recent history of kidney stone

          -  Anticonvulsant therapy known to alter vitamin D metabolism

          -  Radiation therapy to bone
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001+ QS21 (3mcg); ACC-001 (10 mcg) + QS-21; ACC-001+QS-21 (30mcg)
Intervention description: ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo; ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo; ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long term safety, tolerability, and immunogenicity
      of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate
      Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all
        inclusion/and none of the exclusion criteria.

        Screening brain MRI scan is consistent with the diagnosis of AD.

        Mini-Mental State Examination (MMSE) score greater than or equal to 10.

        Other criteria apply.

        Exclusion Criteria:

        Significant Neurological Disease other than Alzheimer's disease.

        Current clinically significant systemic illness.

        Other exclusion criteria apply.
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Condition: Neoplasm, Gastrointestinal
MeSH terms: Adenocarcinoma; Gastrointestinal Neoplasms; Digestive System Neoplasms
Intervention: DS-8201a; Physician's Choice
Intervention description: DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.; Either:
Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted)
Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens.
Two non-randomized exploratory arms will run with HER2 treatment-naive participants.
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Adenocarcinoma Metastatic; Adenocarcinoma of the Stomach; Adenocarcinoma of the Gastroesophageal Junction; HER2 Overexpression; Adenocarcinoma, Locally Advanced; DESTINY - Gastric 01

Summary:

      The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and
      physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal
      junction adenocarcinoma patients who have progressed on two prior treatment regimens
      including fluoropyrimidine agent, platinum agent, and trastuzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of
             gastric or gastroesophageal junction

          2. Progression on and after at least 2 prior regimens

          3. Has an adequate tumor sample

          4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST)
             version 1.1

        Exclusion Criteria:

          1. Has a medical history of myocardial infarction, symptomatic congestive heart failure
             (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia

          2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females

          3. Has a medical history of clinically significant lung disease

          4. Is suspected to have certain other protocol-defined diseases based on imaging at
             screening period

          5. Has history of any disease, metastatic condition, drug/medication use or other
             condition that might, per protocol or in the opinion of the investigator, compromise:

               1. safety or well-being of the participant or offspring

               2. safety of study staff

               3. analysis of results
CSTC1 for Diabetic Foot Ulcers Phase II Study
Condition: Diabetic Foot Ulcer; Diabetes Mellitus; Wounds
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Ulcer
Intervention: CSTC1; CSTC1 Matched vehicle
Intervention description: vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer; Diabetes Mellitus; Debridement; Standard of Care; wounds

Summary:

      The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with
      diabetic foot ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  With either gender aged at least 20 years old;

          -  With a diabetic ulcer (which is defined as the target ulcer) on the foot and not
             healing for at least 2 weeks;

          -  The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner
             system;

          -  The target ulcer should show "infection control" at investigator's discretion;

          -  Subject should be free of any necrosis or infection in soft and bone tissue;

          -  Subject has signed the written informed consent form

        Exclusion Criteria:

          -  With active osteomyelitis;

          -  With target ulcer size decreased by at least 50% after at least 2 weeks of
             standard-of-care-only period or any other recorded regular therapy before
             Randomization visit;

          -  With poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 12%),
             anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/mm3, abnormal liver function
             (AST, ALT>3 x upper limit of normal range);

          -  Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic
             agents;

          -  Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;

          -  Receiving revascularization surgery performed <8 weeks before entry in the study;

          -  With known or suspected hypersensitivity to any ingredients of study product and
             vehicle;

          -  With coronary heart disease with myocardial infarction, coronary artery bypass graft
             (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior
             to study;

          -  Pregnant or lactating or premenopausal with childbearing potential but not taking
             reliable contraceptive method(s) during the study period;

          -  Enrollment in any investigational drug trial within 4 weeks before entering this
             study;

          -  With any uncontrolled illness judged by the investigator that entering the trial may
             be detrimental to the subject.
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2% BID; Placebo ointment (vehicle)
Intervention description: Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label); Placebo ointment (vehicle) BID for 15 days (double blind)
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; topical treatment; skin diseases; phosphodiesterase-4 inhibitor; PDE-4 inhibitor; crisaborole

Summary:

      This study is being conducted to characterize the mechanism of action of crisaborole ointment
      2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD)
      lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate
      AD. Two identified AD skin lesions for each subject will be treated for the first 15 days,
      one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for
      biomarker analysis will be performed on the lesions. Following completion of the blinded
      treatment period, subjects will start the 28 day open label period during which all AD
      affected skin lesions will be treated with crisaborole ointment 2% twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history
             prior to Screening and that has been clinically stable for 1 month.

          -  Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at
             Baseline.

          -  Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at
             Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back
             of the hands, and soles.

          -  Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical
             Lesion ISGA score of greater than/equal to 3.

        Exclusion Criteria:

          -  Clinically infected AD or requires high potency topical corticosteroids or systemic
             (oral/injectable) corticosteroids to manage AD.

          -  History of angioedema or anaphylaxis to topical products or known sensitivity to
             components of crisaborole ointment 2%.

          -  History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the
             skin).

          -  Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the
             reason of lack of efficacy.
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Intervention: Abametapir Lotion 0.74% w/w; Vehicle Lotion
Intervention description: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.; control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      The purpose of the study was to evaluate ovicidal efficacy of a single application of
      abametapir lotion 0.74% w/w intended for the treatment of head lice.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female based on medical history

          2. Six months of age or older.

          3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10
             undamaged and unhatched head lice eggs in their hair.

          4. Agrees to an examination for head lice and compliance with the study procedures.

          5. All adult subjects must sign a written voluntary informed consent. For minors, the
             parent/ legal guardian agrees to the subject participating in the study as determined
             by the signing of an assent of informed consent.

        Exclusion Criteria:

          1. Has scalp disease or a history of allergies or prior reactions to any head lice
             products.

          2. Has a condition that, in the opinion of the Investigator, may interfere with the
             study.

          3. Is receiving systemic or topical medication, which in the opinion of the Investigator,
             may compromise the integrity of the safety and/or efficacy assessments.

          4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within
             14 days prior to Day 0.

          5. Has received an investigational agent within 30 days prior to Day 0.
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Condition: Gastroduodenal Ulcerations; Erosion
MeSH terms: Ulcer
Intervention: PL3100; Naproxen
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: NSAID-induced gastroduodenal ulcerations or erosion

Summary:

      The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of
      PL3100 versus Naproxen in normal healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria (Selected)

          -  Male and female healthy adult subjects

        Exclusion Criteria (Selected)

          -  Subject has protocol specified significant medical history.

          -  Subject is currently participating, or has participated within 30 days prior to study
             entry, in an investigational drug study.

          -  Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other
             NSAID.
Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: bepotastine besilate ophthalmic solution; placebo comparator ophthalmic solution
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bepotastine besilate; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the safety and efficacy of bepotastine besilate
      ophthalmic solution in allergic conjunctivitis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

        Exclusion Criteria:

          -  No active ocular or nasal infection