bioihbjkbjnl/mcl2 huggingface dataset:
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Condition: Psychiatric Emergency; Aggression; Agitation
MeSH terms: Emergencies; Aggression
Intervention: Haloperidol + Promethazine + Chlorpromazine; Haloperidol + Promethazine
Intervention description: This is the usual treatment given by this hospital during an aggressive psychiatric episode.; This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Intervention MeSH terms: Promethazine; Diphenhydramine; Haloperidol; Chlorpromazine; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol
      + promethazine + chlorpromazine for agitated patients in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient will be eligible if (1) requiring emergency acute intramuscular sedation
             because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of
             the benefits between haloperidol plus promethazine vs haloperidol plus promethazine
             plus chlorpromazine.

          -  Gender - both male and female

          -  Age (18-64)

          -  Clinician is unaware on the effects of either treatment interventions

        Exclusion Criteria:

          -  If the clinician KNOWS one treatment has benefit over another for a particular person

          -  If the clinician is aware of a contra-indication of one of the treatments

          -  If there is an Advanced Directive expressing a wish for one or other, or another
             treatment in the emergency setting.

          -  If the clinician does not want to undertake for both personal and professional
             reasons.

          -  If the participant is known to be allergic to one or more of the interventions

          -  Already randomized

          -  Already sedated

          -  Accompanying person (Friend/Family/Police Officer) refuses patient trial entry
Neurotoxin and Physical Therapy
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botox injection; Physical Therapy; Transcranial magnetic stimulation (TMS)
Intervention description: Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms; Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.; For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cervical Dystonia; Botox

Summary:

      This study aims to compare Botox injections without Physical Therapy sessions to Botox
      injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is
      expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms
      and quality of life more than Botox alone. It is also expected that Botox combined with
      Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new
      connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox
      injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a
             movement disorders specialist

          -  Positive response to at least two prior treatments with Botox as indicated by an
             improvement in Clinical Global Improvement Scale.

          -  Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

        Exclusion Criteria:

          -  Any conditions that would contraindicate transcranial magnetic stimulation (for
             example, pregnancy or epilepsy)

          -  Any secondary, fixed, post-traumatic, or psychogenic dystonia
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole; Placebo
Intervention description: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days; Participants in this arm will receive placebo
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Bacterial Vaginoses; Cesarean delivery; Surgical site infection; Endometritis; Infection; Vaginitis

Summary:

      This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant
      women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks).
      During routine clinic visit after 34 weeks, prospective patients will be counseled about the
      study. Patients who agree to be enrolled, will sign informed consent. Following enrollment,
      patients will be screened for BV. Those patients who are BV positive by clinical diagnosis,
      will be randomized to receive either metronidazole 500 mg BID orally for 7 days or
      identically appearing placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women 18 to ≤50 years with the ability to give informed consent.

          -  Patients expected to have a vaginal delivery with no obstetric contraindication for
             vaginal delivery at time of screening.

          -  Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.

          -  Gestational age ≥ 35 weeks

        Exclusion Criteria:

          -  Plan for elective cesarean delivery

          -  Allergy or contraindications to metronidazole

          -  Receipt of metronidazole or clindamycin on admission for delivery for other
             indications.

          -  Hemodialysis

          -  Severe liver dysfunction

          -  Patient reports BV to nurse or clinician provider at current clinic visit or has been
             treated for BV within the past 3 months.
Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Intervention: Amantadine Hydrochloride
Intervention description: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
Intervention MeSH terms: Amantadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cerebral palsy; amantadine; cognitive function; gross motor skills; fine motor skills; mood

Summary:

      Cerebral palsy (CP) is a common childhood-onset disability associated with motor and
      cognitive impairments, however most research is focused on motor outcomes. The aim of this
      study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive
      function in adolescents and adults with CP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Cerebral Palsy

        Exclusion Criteria:

          -  Currently pregnant

          -  Unstable seizure condition

          -  Currently taking methadone

          -  Currently taking other dopamine agonists

          -  Currently taking anti-psychotic medication

          -  Previously taken amantadine

          -  Diagnosed with Chronic Kidney Disease (CKD)
Pain Outcomes Following Intralesional Corticosteroid Injections
Condition: Keloid; Alopecia Areata; Acne; Hypertrophic Scar; Epidermal Inclusion Cyst; Frontal Fibrosing Alopecia; Lichen Plano-Pilaris; Keratoacanthoma; Plaque Psoriasis; Lichen Simplex Chronicus; Prurigo Nodularis; Nummular Eczema; Granuloma Annulare; Morphea; Lichen Planus
MeSH terms: Epidermal Cyst; Granuloma; Alopecia; Alopecia Areata; Lichen Planus; Prurigo; Granuloma Annulare; Neurodermatitis; Keratoacanthoma; Cicatrix, Hypertrophic
Intervention: Corticosteroid with lidocaine; Corticosteroid with normal saline
Intervention description: Intralesional corticosteroid injection; Intralesional corticosteroid injection
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: corticosteroid; local anesthetic

Summary:

      Corticosteroid therapy, including intralesional and topical applications, has many
      indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However,
      these injections can be quite painful, which leads many patients to discontinue treatment.

      Often, the injection involves a mixture of local anesthetic and corticosteroids despite a
      lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine
      component of the injection can actually cause a significant burning sensation during the
      procedure. Lidocaine does not have anti-inflammatory properties and does not treat the
      underlying pathology. By including another medication, lidocaine also adds cost and risk to
      the procedure.

      The purpose of this study is to see if removing lidocaine from intralesional injections
      decreases the pain of injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >12 years old presenting with an indication for intralesional steroid injection

        Exclusion Criteria:

          -  Unconsentable

          -  Not a candidate for corticosteroid injection

          -  Contraindication to lidocaine
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Injections of tildrakizumab
Intervention description: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of
      10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40,
      Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week
      16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks,
      excluding a screening period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects are non-immunocompromised males or females 18 years of age or older.

          2. Subjects have ≥3% total body surface area plaque psoriasis.

          3. Subjects are candidates for phototherapy or systemic therapy.

          4. Subject must be diagnosed at least 6 months prior to entering the study.

          5. Females must be surgically sterile, postmenopausal for >5 years, or using a highly
             effective form of birth control (<1% failure rate), for at least 30 days prior to test
             article exposure, with a negative serum pregnancy test.

        Exclusion Criteria:

          1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

          2. Subject is younger than 18 years of age.

          3. Subjects with uncontrolled mental illness or active suicidal ideations based on
             baseline mental health questionnaire of choice.

          4. Subject is known, or suspected of being unable to comply with the study protocol, in
             the opinion of the investigator.

          5. Subject is currently enrolled in an investigational drug or device study.
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Condition: Bleeding; Blood Loss, Surgical; Cardiovascular Surgical Procedures; Prothrombin Complex Concentrates; Fresh Frozen Plasma
MeSH terms: Hemorrhage; Blood Loss, Surgical
Intervention: Prothrombin complex concentrate (Human); Fresh frozen plasma (FFP)
Intervention description: PCC (Kcentra); FFP
Intervention MeSH terms: Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be the first prospective randomized controlled clinical trial directly comparing
      Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post
      cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a
      difference in bleeding and transfusion requirements in patients received PCC versus FFP?
    

Eligibility criteria:

        Inclusion Criteria

        All subjects accepted for this study must:

          -  Be 18 years of age

          -  Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass

          -  Have evidence of excessive microvascular bleeding in the surgical field as determined
             by the surgical team in addition to a PT >16.6 sec or INR >1.6 sec.

        Exclusion Criteria

        Subjects who have one or more of the following will be excluded from the study:

          -  Are unable to grant informed consent or comply with study procedure

          -  History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency,
             Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous
             unprovoked thromboembolic complications

          -  Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin
             induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at
             the time of cardiovascular surgery

          -  Thromboembolic event within past 3 months

          -  Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within
             the past 5 days

          -  Patients taking chronic warfarin therapy who have not discontinued treatment and
             demonstrated an INR <1.3 prior to surgery

          -  Fibrinogen level <150 mg/dL on initial post cardiopulmonary bypass labs

          -  Antithrombin 3 level < 80% control (preoperative)

          -  Are undergoing emergency open heart-surgery

          -  Cardiopulmonary bypass time is expected to be < 30 minutes

          -  Age < 18 years of age

          -  Are pregnant
Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Benzoyl Peroxide; Dermotivin® Soft Liquid cleanser; Cetaphil® Dermacontrol Moisturizer SPF30
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The aim of this study is to evaluate a complete acne regimen consisting of a medication
      (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil®
      Dermacontrol Moisturizer SPF30 in patients with acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject of any ethnic background of 12 years or older.

          -  Subject with mild or moderate facial acne vulgaris defined as an Investigator Global
             Assessment (IGA) score at 2 or 3 on a 0-4 scale.

          -  Subject with any skin phototype according to T.B. Fitzpatrick skin phototype
             definitions.

        Exclusion Criteria:

          -  Subject with severe acne (IGA>3) with nodules, cysts, scars or extra-facial lesions,

          -  Female subject who is pregnant, lactating or planning a pregnancy during the study,

          -  Subject susceptible to take a corticosteroid treatment during the study except inhaled
             or topic when needed to treat a condition outside the face,
Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: empagliflozin 10mg; empagliflozin 25 mg; Placebo
Intervention description: For blinding purposes
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 65.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study
      of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus
      with insufficient glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Male and female patients on diet and exercise regimen who are pre-treated with
             Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be
             >=7.0% and <=10.0% at screening

          -  Male and female patients on diet and exercise regimen who are pre-treated with
             Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10
             weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0%
             at placebo run-in

          -  Male and female patients on diet and exercise regimen who are pre-treated with OAD
             alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both
             screening and placebo run-in

          -  Age at informed consent must be >=20 years

          -  BMI at screening must be <=40 kg/m2

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an
             overnight fast during switch/washout/placebo run-in period and confirmed by a second
             measurement

          -  Patients who are drug-naïve at screening visit or treat with any of insulin,
             thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks
             prior to informed consent.

          -  Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to
             informed consent

          -  Indication of liver disease, defined by serum levels of either alanine
             aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper
             limit of normal as determined during screening and/or switch/washout/placebo run-in
             period

          -  Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45
             mL/min/1.73m2 (Japanese equation) as determined during screening and/or
             switch/washout/placebo run-in period

          -  Further exclusion criteria apply
Paracervical Block Versus No Paracervical Block During IUD Insertion
Condition: Analgesia; IUD Insertion
Intervention: Lidocaine; No analgesia; Intrauterine device (IUD)
Intervention description: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.; IUD placement without analgesia.; IUD placement with or without paracervical block with 1% lidocaine.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 52 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the pain level and level of discomfort with
      paracervical block versus no analgesia in women who present to the University of Texas (UT)
      Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and
      the UT Physicians Women's Center- Bellaire for IUD insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women of reproductive age who present for an IUD insertion procedure at the University
             of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians
             Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

        Exclusion Criteria:

          -  Women with current pelvic inflammatory disease (PID)

          -  Women who are not good candidates for an IUD

          -  Patients who have a Lidocaine allergy
Preoperative Pain Control in Gastric Bypass Surgery Patients
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Pregabalin; Placebo (for Pregabalin)
Intervention description: One 300 mg oral dose of Pregabalin given before surgery.; One oral dose of placebo given before surgery.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will
      alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly
      obese patients undergoing laparoscopic gastric bypass surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

        Exclusion Criteria:

        -