bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
Condition: Anesthesia, General
Intervention: Sugammadex; Neostigmine
Intervention description: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered; After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate in adult participants faster recovery from a
      neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance
      of T2 (the amplitude of the first response of second twitch to train of four (TOF)
      stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex
      (Org 25969) compared to 50 ug/kg neostigmine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is of American Society of Anesthesiologists (ASA) 1 - 4;

          -  Is above or equal to the age of 18;

          -  Scheduled for surgical procedures with a general anesthesia with the use of rocuronium
             or vecuronium for endotracheal intubation and maintenance of neuromuscular block;

          -  Scheduled for surgical procedure in supine position;

          -  Given written informed consent.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations was
             expected;

          -  Is known or suspected to have neuromuscular disorders impairing neuromuscular block
             (NMB) and/or significant renal dysfunction;

          -  Is known or suspected to have a (family) history of malignant hyperthermia;

          -  Is known or suspected to have an allergy to narcotics, muscle relaxants or other
             medication used during general anesthesia;

          -  Is receiving medication in a dose and/or at a time point known to interfere with
             neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;

          -  Participants in whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated;

          -  Had already participated in a sugammadex trial;

          -  Had participated in another clinical trial, not pre-approved by NV Organon, within 30
             days of entering into P05960.

          -  Females who are pregnant:

          -  Females of childbearing potential not using any method of birth control: condom or
             using only hormonal contraception as birth control;

          -  Females who were breast-feeding.
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Intervention: IQP-AK-102; Placebo
Intervention description: IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.; The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several
      studies demonstrating their efficacy, we are conducting this study to look into the efficacy
      and safety of this novel combination of three fibres, in appetite regulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years

          -  25≤BMI≤35

          -  Expressed desire for weight loss

          -  Accustomed to 3 main meals/day

          -  Generally in good health

          -  Consistent and stable body weight 3 months prior to study enrolment

          -  Consistent regular physical activity

          -  Commitment to avoid the use of other weight loss products during study

          -  Commitment to adhere to diet and lifestyle recommended for the study

        Exclusion Criteria:

          -  Known sensitivity to the ingredients of the device

          -  Presence of any active gastrointestinal disease

          -  Malabsorption disorders

          -  Pancreatitis

          -  Stenosis in the GI tract

          -  Bariatric surgery

          -  Any other reason deemed suitable for exclusion, per investigator's judgement
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Diclofenac Test (lower dose); Diclofenac Test (upper dose); Celecoxib; Placebo
Intervention description: Capsules; Capsules; 200 mg Capsules; Capsules
Intervention MeSH terms: Celecoxib; Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 428.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and
      effective for the treatment of bunionectomy pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 65 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Has undergone primary, unilateral, first metatarsal bunionectomy with no additional
             collateral procedures

          -  Patient must be willing to stay at the study site ≥ 72 hours

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to screening
Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Condition: Video Assisted Thoracoscopic Surgery; Pain, Postoperative; Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion); US Guided Paravertebral Catheter (0.2% ropivicaine bolus); Thoracic Epidural (0.125% bupivicaine/hydromorphone)
Intervention description: Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.; Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.; Epidural catheter will be placed in the thoracic region prior to surgery.
Intervention MeSH terms: Hydromorphone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VATS; pain

Summary:

      The purpose of this study is to compare three different pain control methods on subjects who
      are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study
      will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic
      side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pt undergoing VATS procedure at Indiana University Hospital

          -  ASA 1,2,3 or 4

          -  Age 18 or older, male or female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion Criteria:

          -  Any contraindication for Thoracic Epidural or Paravertebral block

          -  History of substance abuse in the past 6 months

          -  Patient staying intubated after surgery

          -  Known allergy or other contraindications to the study medications , which include
             dilaudid, bupivacaine, ropivacaine
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol etabonate; Vehicle of Loteprednol Etabonate
Intervention description: Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.; Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to compare the safety and efficacy of loteprednol etabonate to
      vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are at least 18 years of age.

          -  Subjects who are candidates for routine, uncomplicated cataract surgery.

        Exclusion Criteria:

          -  Subjects who have known hypersensitivity or contraindication to the study drug or
             components.

          -  Subjects with a severe/serious ocular condition, or any other unstable medical
             condition, that in the investigator's opinion may preclude study treatment or
             follow-up.

          -  Subjects with elevated intraocular pressure (>/=21mm Hg), uncontrolled glaucoma, or
             being treated for glaucoma in the study eye.

          -  Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse
             in the non-study eye.
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: Flibanserin
Intervention description: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1723.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness
      of Flibanserin in Women with HSDD that have already completed a previous study
      (511.70/71/.74/.75/.105) with Flibanserin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with a primary diagnosis of HSDD who have completed a previous study of
             Flibanserin.

          2. Patients must have used a medically acceptable method of contraception for at least 2
             months before the start of the study and continue to use that method for the duration
             of the study.

          3. Patients must be reliable, compliant, and agree to cooperate with all study
             evaluations.

          4. Patients must be able and willing to give meaningful, written informed consent prior
             to the start of the study and be willing to discuss their sexual functioning with the
             study staff.

        Exclusion Criteria:

          1. A history of Major Depressive Disorder within 6 months prior to the start of the
             study, current suicidal thoughts, or any history of a suicide attempt.

          2. Participation in another clinical trial within 1 month prior to the start of the
             study, except for Flibanserin.

          3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal
             infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant
             vaginal atrophy.

          4. Patients who are pregnant or have been pregnant within 1 month prior to study start.

          5. Patients experiencing major life stress (including loss of income, death of a family
             member, major illness, etc.) or relationship trouble that could interfere with sexual
             activity, except distress about HSDD.

          6. Clinically significant ECG or lab abnormalities at study start.

          7. Patients taking prohibited medications that were excluded in their previous trial
             which contribute to sexual dysfunction or safety-related interactions.
13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: vaccine-13vPnC; vaccine-13vPnC
Intervention description: Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1); Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prevention of pneumococcal diseases

Summary:

      The purpose of this study will be to assess the safety, tolerability, and immunogenicity of
      13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50
      years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female older than 50 years of age

          -  Eligibility must be determined by medical history, physical exam and clinical judgment

          -  Able to complete an electronic diary

          -  Available for duration of study

          -  Negative pregnancy test for subjects in group 2 age 50 to 64 years

          -  Practice abstinence or use reliable birth control if age is 50 to 64 years

        Exclusion Criteria:

          -  History of allergic reaction to any vaccine

          -  Previous vaccination with licensed or experimental pneumococcal vaccine

          -  S. pneumonia infection within past 5 years before investigational product
             administration

          -  Known or suspected immunodeficiency or received treatment including cytotoxic agents
             or systemic corticosteroids, serious chronic disorder such as malignancy cancer

          -  Receipt of plasma products or immunoglobulins within 60 days

          -  Bleeding conditions or diathesis

          -  Receipt of investigational product within 28 days before study entry

          -  Other severe acute or chronic medical or psychiatric condition
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Condition: Colonoscopy
Intervention: BLI800; Polyethylene glycol 3350 based bowel preparation
Intervention description: Solution for oral administration prior to colonoscopy; Solution for oral administration prior to colonoscopy
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colonoscopy; bowel preparation

Summary:

      To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before
      colonoscopic examination in adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication.

          2. At least 18 years of age

          3. Otherwise in good health, as determined by physical exam and medical history

          4. If female, and of child-bearing potential, is using an acceptable form of birth
             control

          5. Negative urine pregnancy test at screening, if applicable

          6. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Exclusion Criteria:

          1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

          2. Subjects who had previous gastrointestinal surgeries.

          3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia,
             hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those
             secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

          4. Subjects with clinically significant electrolyte abnormalities based on Visit 1
             laboratory results.

          5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          6. Subjects undergoing colonoscopy for foreign body removal and decompression.

          7. Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          8. Subjects of childbearing potential who refuse a pregnancy test.

          9. Subjects allergic to any preparation components

         10. Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

         11. Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Condition: Contraception
Intervention: AG200-15; Levora
Intervention description: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.; One tablet of Levora will be taken each day for a 28 day cycle.
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Hormonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive

Summary:

      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  sexually active women requesting contraception

          -  Regular menses every 24 - 35 days

          -  In good general health, confirmed by medical history, physical (including gynecologic
             examination adn screening laboratory values

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A; Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: rVIII-SingleChain
Intervention description: Recombinant single-chain coagulation factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: Male
Healthy volunteers: No

Summary:

      This multicenter, open-label, phase 3 extension study will investigate the safety and
      efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in
      at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and
      previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to
      rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no
      previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in
      this study. A substudy (open to both PTPs and PUPs) will investigate the use of
      rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to
      rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance
      induction (ITI) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        PTPs:

          -  Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII
             activity levels < 1%) and who participated in a previous CSL-sponsored clinical study
             with rVIII-SingleChain.

          -  Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A
             (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who
             are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.

        PUPs:

          -  Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A
             (FVIII activity levels < 1%)

          -  No prior exposure to any Factor VIII product (with the exception of short-term use of
             blood products).

        ITI substudy:

          -  PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of
             rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.

          -  Currently receiving a therapy not permitted during the study.

          -  Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate
             aminotransferase > 5 x upper limit of normal at Screening (if specified)

          -  Any first-order family (eg, siblings) history of FVIII inhibitors

          -  For PTPs not rolling over directly from a CSL-sponsored clinical study with
             rVIII-SingleChain: any history of or current FVIII inhibitors