bioihbjkbjnl/mcl2 huggingface dataset:
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Oxytocin; Placebo
Intervention description: See arm/group descriptions for dosage amount and procedure.; See arm/group descriptions for dosage amount and procedure.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will use multiple methods (including Oxytocin intranasal inhalation,
      neuroimaging, behavioral measures, peripheral hormone measurements) to examine how
      individuals' behavior, cognition, and brain function is impacted by the neuro-hormone
      Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin
      administration on affective processing in non-trauma exposed and trauma-exposed adults (both
      with and without posttraumatic stress disorder, PTSD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults: age 18-55

          -  Be in good medical health

          -  Be cooperative with testing

          -  English is a language spoken in the family

          -  PTSD as diagnosed by a certified clinician or the research team for PTSD group.

        Exclusion Criteria:

          -  Moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes,
             epilepsy, influenza).

          -  History of hypertension with baseline blood pressure above 160 mm Hg (systolic) over
             100 mm Hg (diastolic).

          -  history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).

          -  weight >300lb

          -  The use of some psychotropic medications will not be allowed. Females taking
             contraceptive hormones will not be able to participate in the study.

          -  Currently breast feeding or pregnant

          -  For MRI ONLY: Any metal or electromagnetic implants

          -  For MRI ONLY: Significant hearing loss or other severe sensory impairment

          -  A fragile health status.

          -  For MRI ONLY: A history of seizures or current use of anticonvulsants

          -  Healthy adult controls (HC):

          -  Be free of both neurological and psychiatric disorders (current and past) on the basis
             of self-report

          -  Be free of psychiatric disorders
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
Condition: Cesarean Section
Intervention: ketorolac; Chewing Gum; Enhanced Recovery Protocol
Intervention description: Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.; Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.; enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
Intervention MeSH terms: Ketorolac
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Enhanced Recovery

Summary:

      To determine whether women randomized to an enhanced recovery program will have improved
      postoperative outcomes including improved breastfeeding initiation and continuation,
      reduction in hospital length of stay without compromising patient satisfaction in comparison
      to standard postoperative recovery interventions.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

        Exclusion Criteria:

          1. Women undergoing an urgent or emergent cesarean birth

          2. Women less than 18 years old

          3. Patients receiving general anesthesia

          4. Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss
             (Placenta accreta)

          5. Pre-existing essential hypertension or hypertensive disorders of pregnancy
             (preeclampsia, eclampsia, HELLP)

          6. Chronic or acute renal impairment

          7. Bleeding disorders or platelet dysfunction

          8. Peptic ulcer disease or gastrointestinal bleeding

          9. Known hypersensitivity to ketorolac (toradol)

         10. Active infection at the time of cesarean

         11. Cesarean birth prior to 37 weeks

         12. Women in significant pain in labor
Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
Condition: COVID-19
Intervention: Ivermectin; Placebo
Intervention description: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days; Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
Intervention MeSH terms: Ivermectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ivermectin

Summary:

      This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients
      with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus
      disease (COVID-19).

      The primary efficacy endpoint is the proportion of participants with a disease control status
      defined as no progression of severe disease Hypothesis (H0): There is no difference between
      group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the
      primary endpoint on day 14.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus
             infection defined by RT-PCR.

          -  Asymptomatic, or with mild symptoms who are taking outpatient treatment of the
             disease.

          -  Signed Informed Consent.

        Exclusion Criteria:

          1. Patients with severe disease COVID-19.

          2. Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.

          3. Recurrent urinary tract infections.

          4. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its
             normal limits.

          5. Pregnant or lactating patients

          6. Patients receiving antihypertensive medication verapamil, the immunosuppressant
             cyclosporin A and / or the antipsychotic trifluoperazine.

          7. Patients with a known allergy or hypersensitivity to dewormers.

          8. Patients who are using an antioxidant supplement.

          9. Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or
             any parasitic disease in the last twelve months.
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: senna/docusate
Intervention description: Stimulant laxative
Intervention MeSH terms: Bismuth subsalicylate; Sennosides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the
      treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce
      peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on
      the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach
      emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this
      open label study, participants will be randomized into high and low dose groups to assess for
      ideal dosing and tolerability. It is the overall goal of this study to select the most
      promising dose-strength for the treatment of mild through severe gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years, male and non-pregnant, non-lactating females

          -  Diagnosis of type 1 or type 2 diabetes mellitus

          -  Clinical diagnosis of diabetic gastroparesis

        Exclusion Criteria:

          -  Diagnosed idiopathic gastroparesis

          -  A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis

          -  A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed
             rectal bleeding

          -  Gastrointestinal cancer

          -  Any active cancer

          -  Prior gastric surgery

          -  End-stage heart disease, liver disease, lung disease

          -  Known or suspected drug abuse

          -  Any condition requiring use of daily narcotics

          -  Concurrent usage of mineral oil or products containing mineral oil

          -  Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Condition: Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery
MeSH terms: Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Drug-Related Side Effects and Adverse Reactions
Intervention: Fixed dose; Variable dose
Intervention description: Participants will receive 40 mg enoxaparin twice daily; Participants will receive 0.5mg/kg enoxaparin twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their
      operative procedures. Thus, plastic & reconstructive surgery patients are among those at
      highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study
      seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing
      aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients
      randomized to receive two different enoxaparin dose regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving plastic and reconstructive surgery under general anesthesis

          -  Expected post-operative stay of 2 days or more

        Exclusion Criteria:

          -  Contraindication to use of enoxaparin

          -  intracranial bleeding/stroke

          -  Hematoma or bleeding disorder

          -  Heparin-induced thrmbocytopenia positive

          -  Creatinine clearance less than or equal to 30 mL/min

          -  Serum creatinine greater than 1.6 mg/dL

          -  epidural anesthesia

          -  patients placed on non-enoxaparin chemoprophylaxis regimens

          -  gross weight exceeding 150kg
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Nivolumab; Ipilimumab; Relatlimab; BMS-986205; Rucaparib
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Rucaparib; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability
      of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with
      advanced gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or
             gastroesophageal junction (GEJ) carcinoma and have histologically confirmed
             predominant adenocarcinoma and/or squamous carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  At least 1 lesion with measurable disease

        Exclusion Criteria:

          -  HER2-positive tumor and previously untreated with trastuzumab

          -  Suspected, known or progressive central nervous system metastases

          -  Other active malignancy requiring concurrent intervention

          -  Active, known or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Ozanimod; Placebo
Intervention description: Ozanimod capsules by mouth daily.
Intervention MeSH terms: Ozanimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 73 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether RPC1063 is effective in the treatment of
      ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ulcerative colitis (UC) confirmed on endoscopy

          -  Moderately to severely active UC (Mayo score 6-12)

        Exclusion Criteria:

          -  Current use of anti-TNF agents
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Condition: Patent Ductus Arteriosus; Preterm Infant; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Ductus Arteriosus, Patent
Intervention: Ibuprofen and acetaminophen; Ibuprofen and placebo
Intervention description: Intravenous ibuprofen given concomitantly with oral acetaminophen; Intravenous ibuprofen given concomitantly with oral placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 5 Days
Maximum age: 21 Days
Healthy volunteers: No
Keywords: patent ductus arteriosus; acetaminophen; ibuprofen; bronchopulmonary dysplasia; mechanical ventilation

Summary:

      The purpose of the present study is to determine whether treatment of hemodynamically
      significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and
      oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard
      treatment strategy of using intravenous ibuprofen alone among preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Preterm infant ≤27 6/7

          2. Written parental consent is obtained

          3. Infant requires respiratory support

          4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at
             least two of the following:

               1. Ductus size ≥ 1.5 mm

               2. Maximum flow velocity through the ductus ≤ 2 m/s

               3. Left atrium to aorta ratio ≥ 1.4

               4. Wide pulse pressure

               5. B-type natriuretic peptide (BNP)

          5. Attending neonatologist made decision to treat patent ductus arteriosus

        Exclusion Criteria:

          1. No parental consent

          2. Infants > 21days of postnatal age

          3. Congenital anomalies such as cardiac or multiple anomalies

          4. Infection (e.g., septicemia, pneumonia)

          5. Bleeding disorder or platelet count< 50,000/ml

          6. Acute kidney injury (AKI)defined as oliguria (urine output< 0.5 ml/kg/hr for 16hrs)
             and/or serum creatinine > 1.5 mg/dl

          7. Elevated liver enzymes (>2 fold from upper normal limits)

          8. Pulmonary hypertension or right to left shunt through the ductus arteriosus

          9. Diagnosis of necrotizing enterocolitis

         10. Unable to tolerate oral medications at the time of enrollment.
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Condition: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Intervention: Meclofenamic acid; Pentosan polysulfate sodium
Intervention MeSH terms: Meclofenamic Acid; Pentosan Sulfuric Polyester
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Psychotic; Schizophrenia; Schizoaffective; Bipolar

Summary:

      This study evaluates the feasibility of administering meclofenamic acid or pentosan
      polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic
      disorder. Half of participants will receive meclofenamic acid, while the other half will
      receive polysulfate sodium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder,
             bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and
             other psychotic disorders, unspecified schizophrenia spectrum and other psychotic
             disorders

          -  Negative pregnancy test in females of childbearing age

        Exclusion Criteria:

          -  Urine drug screen positive for psychostimulants such as cocaine, amphetamines and
             ecstasy

          -  Any infection, neoplasm, autoimmune disease or other primary inflammatory condition
             (3) Previous diagnosis of intellectual disability or dementia

          -  Current treatment with heparin

          -  Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate
             sodium

          -  Current or anticipated corticosteroid use

          -  History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal
             bleeding

          -  Those on warfarin or any anticoagulant

          -  Current treatment with lithium or asthma medication

          -  Individuals with pre-existing liver, cardiac, or kidney disease
Nitric Oxide to Treat Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: Inhaled Nitric Oxide; Sham
Intervention description: Nitric Oxide + oxygen; Nitrogen + Oxygen
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary embolism clot

Summary:

      This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled
      nitric oxide or placebo (oxygen).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18

          -  Pulmonary imaging-proven PE, as interpreted by local radiologist

          -  At least one predictor of RV dysfunction:

               1. echocardiography with RV dilation or hypokinesis,

               2. estimated RVSP >40mm HG,

               3. RV>LV on CTPA,

               4. elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),

               5. screening bedside cardiac ultrasound with color flow capability that shows RV
                  dysfunction,

               6. RV strain on ECG

          -  Plan to admit to a bed with telemetry capability

        Exclusion Criteria:

          -  Vasopressor support at time of enrollment

          -  Pregnancy

          -  Plan by clinical care team to use lytic or surgical embolectomy

          -  Plan by clinical team to use platelet inhibiting drugs

          -  Contraindication to anticoagulation

          -  Altered mental status such that the patient is unable to provide informed consent

          -  Inability to use a nasal cannula or face mask

          -  Comfort care measures instituted

          -  Supplemental oxygen requirements greater than can be administered via nasal cannula in
             order to maintain Sa)2 > 80%

          -  Pneumothorax with decompression

          -  Serum MetHb > 10%

          -  Recent use of drugs known to increase cGMP

          -  Use of nitroprusside or nitroglycerin within the last 4 hours

          -  Use of any other nitrates with in the past 24 hours

          -  Use of a fibrinolytic medicine within the past 14 days