bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: CJC-1134-PC; Placebo
Intervention description: 1.5 or 2.0 mg CJC-1134-PC; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

Summary:

      This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.

      The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment
      with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin
      monotherapy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  BMI: 27 to 45 kg/m2

          -  Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator

          -  Stable life-style, i.e. diet & physical activity, as determined by the Investigator

          -  Stable metformin daily dose ≥1000 mg for at least 3 months

          -  Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Diabetes Mellitus; Nutrition Disorders
Intervention: semaglutide; liraglutide; placebo
Intervention description: Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.; Once-daily subcutaneous (s.c., under the skin) administration.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 957.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate safety and efficacy
      of once-daily semaglutide in obese subjects without diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial - Male or female, age 18 years
        or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0
        kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per
        investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or
        above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment
        with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal
        to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or
        multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) -
        Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any
        medication within 90 days before screening that based on investigator's judgement may cause
        significant weight change - Previous surgical treatment for obesity (liposuction and/or
        abdominoplasty performed 1 year before screening is allowed) - History of major depressive
        disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt -
        Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
        potential and not using an adequate contraceptive method (adequate contraceptive measures
        as required by local regulation or practice)
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Intervention: DAXI 80 U; DAXI 120 U; Placebo
Intervention description: DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group); DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group); Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blinded
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: DAXI for injection,; Plantar Fasciitis,; Heel Pain,; BotulinumtoxinA

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of
      a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection
      versus placebo for the management of Plantar Fasciitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent, including authorization to release health information.

          -  Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar
             fasciitis.

          -  Persistent heel pain.

          -  Women of child bearing potential must have a negative pregnancy test at Screening and
             Injection Visits and must use an effective method of contraception during the course
             of the study.

        Exclusion Criteria:

          -  Previous injection of botulinum toxin in the lower extremities or feet.

          -  Previously suffered a partial or full thickness tear or surgery of the plantar fascia
             within the 5 years preceding participation in the investigation.

          -  Pregnant, nursing, or planning a pregnancy during the study.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days prior to first visit.

          -  Any condition or situation which, in the Investigator's opinion, puts the subject at
             significant risk, could confound the trial results, or may interfere significantly
             with the subject's participation in the trial.
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Condition: Bronchopulmonary Dysplasia
MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia; Premature Birth
Intervention: Inhaled Nitric Oxide (iNO); Nitrogen (placebo)
Intervention description: iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).; Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 124.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Premature Newborns; Inhaled Nitric Oxide

Summary:

      Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns.
      The condition involves abnormal development of lung tissue and is characterized by
      inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce
      the incidence of BPD and another commonly associated condition called pulmonary hypertension,
      which is high blood pressure in the vessels carrying blood to the lungs.. This study will
      determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary
      hypertension, and death in premature newborns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight of 500-1250 grams and gestational age of less than 34 weeks

          -  Age at enrollment is less than 72 hours

          -  Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

        Exclusion Criteria:

          -  Presence of structural heart disease (other than patent ductus arteriosus, atrial
             septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)

          -  Presence of lethal congenital anomaly

          -  Participating in another concurrent experimental study

          -  Requires mechanical ventilation in the first 72 hours of life (patients are not
             excluded if they are intubated briefly but they must be extubated at the time of
             consent and study entry prior to 72 hours of life)
Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Intervention: Olinciguat; Matching Placebo
Intervention description: oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives of this study are as follows:

      In participants with primary Type I or II achalasia, following a single 5-mg dose of
      olinciguat (IW-1701),

        -  To assess the safety and tolerability

        -  To determine the effects on measures of esophageal function by high-resolution impedance
           manometry (HRIM)

        -  To determine the pharmacokinetic (PK) parameters
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patient has a diagnosis of primary Type I or II achalasia.

          -  Patient has no contraindications to the performance of the baseline and postdose HRIM
             procedures per Investigator discretion.

        Key Exclusion Criteria:

          -  Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment
             with sclerosing agent.

          -  More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime.

          -  Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to
             randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.

          -  Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to
             randomization or more than 2 esophageal Botox injection procedures in their lifetime.

          -  Patients with malignant or premalignant esophageal lesions.

          -  Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72
             hours before check-in through discharge from the clinic.

        Other inclusion and exclusion criteria specified in the protocol.
Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder; Schizophrenia
Intervention: Varenicline; Placebo
Intervention description: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.; Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and
      mortality. In this study, smokers with schizophrenia will complete a baseline session and
      then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication,
      participants will complete a cigarette rating task session. Participants will then undergo a
      72-hr abstinence period in which they will come to the laboratory twice per day and receive
      high-value cash reinforcement contingent upon meeting a strict breath CO abstinence
      criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of
      the abstinence period, they will repeat the cigarette rating task. Participants will return
      to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their
      CO samples for one week. Date and time of smoking relapse will be measured from these
      samples.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women

          2. Ages 18-65

          3. Have schizophrenia or schizoaffective disorder

          4. Would like to quit smoking within the next 6 months

          5. Have smoked at least 10 cigarettes per day in the past year

          6. Have breath CO level > 10 ppm

          7. Able to speak, read and comprehend English well enough to complete study procedures

        Exclusion Criteria:

          1. Pregnant, breast-feeding, or unwilling to use medically-approved contraception

          2. Currently using varenicline, bupropion or nicotine replacement therapy for smoking
             cessation

          3. Medical disease that would preclude participation

          4. Unstable psychiatric conditions

          5. Body mass index (BMI) < 15 or > 38 kg/m2

          6. Past-month suicidal intention, with or without a specific plan

          7. Positive urine drug screen or breath alcohol level > 0.01% at screening
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
Condition: Pain; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Acute Pain
Intervention: pregabalin; placebo; questionnaire administration
Intervention description: Given PO; Given PO; Ancillary studies
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in
      patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > or equal to 18 years

          -  Ability to complete questionnaires by themselves or with assistance Paclitaxel at a
             dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of
             12 weeks without any other concurrent therapy

          -  Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or
             neo-adjuvant) setting, every week for a planned course of 12 weeks without any other
             concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small
             molecule treatment is allowed, except for PARP inhibitors).

          -  Life expectancy > 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
             women of childbearing potential only (per clinician discretion)

        Exclusion Criteria:

          -  Pregnant women

          -  Nursing women

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception since this study involves agents that have known genotoxic, mutagenic
             and teratogenic effects

          -  Previous diagnosis of diabetic or other peripheral neuropathy

          -  Current, planned or previous use, within last 6 months, of gabapentin or pregabalin

          -  History of allergic or other adverse reactions to gabapentin or pregabalin

          -  Significant renal insufficiency with a history of a creatinine clearance (CrCL) <
             30ml/min

          -  Prior exposure to neurotoxic chemotherapy

          -  Seizure history

          -  Diagnosis of fibromyalgia

          -  Previous exposure to paclitaxel
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AMG 827
Intervention description: 210 mg SC or 140 mg SC
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      This study is an open-label extension of study 20090062 to evaluate extended subcutaneous
      dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was randomized into Study 20090062 and completed the week 16 evaluation.

        Exclusion Criteria:

          -  Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was
             considered possibly related to IP.

          -  Subject experienced an adverse event in Study 20090062 that, in the opinion of the
             investigator, could cause extension of treatment to be detrimental to the subject.
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Condition: Peritoneal Carcinomatosis
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma; Peritoneal Neoplasms; Hyperthermia
Intervention: Paclitaxel; Radical surgery-peritonectomy
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ovarian cancer

Summary:

      A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed
      with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical
      surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues
      (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia
      intraperitoneal intraoperative chemotherapy with paclitaxel
    

Eligibility criteria:

        Inclusion Criteria:

          1. age ranged between 18 and 75 years old;

          2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian
             cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));

          3. Karnofsky index > 70 or performance status ≤2;

          4. informed consent form filled out correctly.

        Exclusion Criteria:

          1. unfulfillment of inclusion criteria;

          2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);

          3. concomitance of another malignant neoplasm;

          4. renal, hepatic or cardiovascular dysfunction;

          5. intolerance during the treatment; - (6) refusal to participate in the study.
Impact of Duloxetine on Male Fertility
Condition: Infertility, Male; Depression
MeSH terms: Infertility; Infertility, Male
Intervention: Duloxetine; Placebo
Intervention description: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week; Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
Enrollment: 69.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are conducting a placebo-controlled, randomized control trial with
      duloxetine in healthy, fertile men not previously on any antidepressants. Participants will
      be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will
      assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes
      measured will include semen parameters (sperm concentration, motility, morphology), hormone
      levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)
      surveys.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men aged 18-65 years old;

          -  normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm
             motility > 30%, sperm morphology > 3%);

          -  willing to engage in sexual activity (alone or with a partner) at least once per week
             for the duration of the study;

          -  capable of providing semen sample.

        Exclusion Criteria:

          -  Clinically detected varicocele;

          -  oligoasthenoteratospermia or azoospermia on semen analysis;

          -  ongoing attempts to initiate pregnancy;

          -  current sexual dysfunction (classified as moderate or worse on IIEF);

          -  history of seizure disorder;

          -  history of previous chemotherapy or radiation therapy;

          -  current psychiatric history or history of bipolar disorder;

          -  family history of bipolar disorder, depression, or suicide;

          -  use of any psychotropic medications or anticonvulsants;

          -  use of sleeping pills more than once per week;

          -  use of any hormonal medications on a daily or intermittent basis during the preceding
             3 months;

          -  use of medications which may affect hormone measures and/or sexual function;

          -  inability to read, follow instructions, or complete questionnaires in English;

          -  consumption of tobacco or illicit drugs;

          -  consumption of >2oz of alcohol daily.