bioihbjkbjnl/mcl2 huggingface dataset:
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Condition: Pregnant Women
Intervention: HB Prilocaine 2% (varying dose); HB Prilocaine 2%; Sufentanil; Morphine
Intervention description: Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; 2.5µg sufentanyl; 100 µg Morphine
Intervention MeSH terms: Sufentanil; Morphine; Prilocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: scheduled cesarean delivery; spinal anesthesia; local anesthesia

Summary:

      Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly
      used for spinal injection in cesarean section. Nevertheless, its use often results in a long
      duration of motor nerve block and a haemodynamical instability. Recently developped, the
      Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for
      hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for
      intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the
      effect of the local anesthetics while decreasing their dose-related side effects, the aim of
      this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled
      cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical status (ASA) < III

          -  Age 18-40 year

          -  Body Weight <100 kg

          -  Height between 155 and 175 cm

          -  Gestational age>37 SA

          -  Elective cesarean delivery

          -  Singleton pregnancy

          -  Non complicated pregnancy

          -  Signed informed consent obtained prior to any study specific assessments and
             procedures

        Exclusion Criteria:

          -  Twin pregnancy

          -  History of 2 cesarean section or more

          -  Diabetes and gestational diabetes

          -  Placenta praevia

          -  Congenital foetal abnormality

          -  Patient in labour

          -  Membrane rupture

          -  Known allergy to local anaesthetics

          -  Disagreement of the patient

          -  Pregnancy-induced hypertension

          -  Pre eclampsia and eclampsia
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines
Intervention: DaxibotulinumtoxinA for injection
Intervention description: Intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lateral canthal wrinkle; Crow's feet lines; LCL

Summary:

      A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of
      Moderate or Severe Lateral Canthal Lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent consistent with International Conference on
             Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including
             authorization to release health information, signed prior to any study procedures
             being performed

          -  Be outpatient, male or female subjects, in good general health, 18-65 years old

          -  Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by
             the IGA-LCWS

          -  Able to understand the requirements of the study and be willing and able to follow all
             study procedures, attend all scheduled visits, and successfully complete the study.

        Exclusion Criteria:

          -  Active skin disease, infections, or inflammation at the injection sites

          -  History of clinically significant bleeding disorders

          -  Clinically significant laboratory values at screening that may interfere with a
             subject's ability to complete the study, as determined by the investigator

          -  Planned or anticipated need for surgery or hospitalization through the end of the
             study

          -  Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child
             Bearing Potential (WOCBP) but is not willing to use an effective method of
             contraception

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days prior to screening through the end of the study
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: ACT-541468; Placebo
Intervention description: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg; Capsules for oral administration matching the ACT-541468 capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; elderly; Polysomnography

Summary:

      This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset
      (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure.

          -  Male or female aged ≥ 65 years.

          -  Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0

          -  Insomnia disorder according to DSM-5 criteria.

          -  Self-reported history of insufficient sleep quantity.

          -  Insufficient sleep quantity as collected subjectively in the sleep diary and validated
             objectively by polysomnography.

          -  Insomnia Severity Index score ≥ 15.

        Exclusion Criteria:

          -  Any current history of sleep disorder other than insomnia, or any lifetime history of
             related breathing disorder, periodic limb movement disorder, restless legs syndrome,
             circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.

          -  Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.

          -  Caffeine consumption ≥ 600 mg per day.

          -  Shift work within 2 weeks prior to the screening visit, or planned shift work during
             study.

          -  Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel ≥
             3 time zones during study.

          -  Hematology or biochemistry test results deviating from the normal range to a
             clinically relevant extent as per judgment of the Investigator.

          -  AST and/or ALT > 2 × ULN and/or bilirubin > 1.5 × ULN (except known history of
             Gilbert's syndrome);

          -  Severe renal impairment (known or defined as estimated creatinine clearance < 30
             mL/min);

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.
Atrasentan Spermatogenesis and Testicular Function
Condition: Nephropathy; Diabetes
MeSH terms: Kidney Diseases
Intervention: Atrasentan
Intervention description: Atrasentan
Intervention MeSH terms: Atrasentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetic Nephropathies; Kidney Diseases; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Summary:

      This study is being conducted to evaluate the effects of Atrasentan on sperm production and
      testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.

      This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an
      Observational Period (up to an additional 52 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 30 to 75 years of age

          -  Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic
             medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor
             blockers (ARB) (renin-angiotensin system [RAS] inhibitor)

          -  Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min/1.73
             m^2 with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and
             Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than
             5,000 mg/g creatinine.

          -  Able to provide a semen specimen at the required intervals.

          -  Baseline sperm concentration equal to or greater than 30 million per mL.

        Exclusion Criteria:

          -  Treatment with hormone suppressive agents or cancer chemotherapy within the 6 months
             prior to the initial screening visit or planned during the study.

          -  History of severe peripheral edema or facial edema unrelated to trauma or history of
             myxedema in the prior 4 weeks prior to screening.

          -  History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring
             oxygen therapy.

          -  Documented diagnosis of heart failure, previous hospitalization for heart failure or
             current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea,
             paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not
             explained by other causes, and for which there was a change in medication or other
             management directed at heart failure.

          -  Currently receiving or has received hormone replacement therapy within 6 months prior
             to screening.
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: CFZ533 active - Cohort 1; CFZ533 placebo- Cohort 1; CFZ533 active - Cohort 2; CFZ533 placebo - Cohort 2; CFZ533 active -Cohort 3; CFZ533 active - Cohort 3
Intervention description: multiple doses of CFZ533 s.c. injection; multiple doses of placebo s.c. injection; multiple doses of CFZ533 intravenous infusion; multiple doses of placebo intravenous infusion; multiple doses of CFZ533 s.c. injection; Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Sjögren's syndrome, CFZ533, ESSDAI

Summary:

      This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of
      multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary
      Sjögren's syndrome(pSS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary Sjögren's syndrome

          -  ESSDAI score ≥ 6

        Exclusion Criteria:

          -  Secondary Sjögren's syndrome

          -  Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab,
             belimunab, other immunosuppressives.

          -  At significant risk for thromboembolic event

          -  Clinically significant systemic infection

          -  Significant elevated risk for infection
Darbepoetin Administration to Preterm Infants
Condition: Infant, Newborn
Intervention: Darbepoetin Alfa Injection; erythropoietin alfa injection; sham injection
Intervention description: darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks; Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation; sham injection other names: not applicable
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 1 Hour
Maximum age: 49 Hours
Healthy volunteers: No
Keywords: erythropoietin; darbepoetin; transfusions; neonates; outcomes; neurodevelopment

Summary:

      Infants born prematurely do not increase production of the primary red cell growth factor,
      erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The
      anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of
      Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is
      successful in treating the anemia of prematurity. A slightly modified, long-acting version of
      rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in
      increasing hematocrit (red blood cell levels) in adults. In addition to its red cell
      stimulating properties, recent evidence has shown that rHuEpo is protective in the developing
      or injured brain. We have designed a randomized, masked, placebo-controlled study to
      determine the safety and short and long term efficacy of darbepoetin. At this time,
      darbepoetin has been studied primarily in adults and pediatric patients, but there is
      evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well.
      It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize
      that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight
      will result in increased reticulocyte counts and decreased transfusions compared to placebo;
      and 2. The administration of darbepoetin will be associated with an increased mental
      developmental index at 18-22 months compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  500-1250 grams birth weight

          -  less than or equal to 32 weeks gestation

          -  less than 2 days of age

        Exclusion Criteria:

          -  severe hemorrhagic disease

          -  severe hemolytic disease

          -  DIC

          -  seizures

          -  hypertension

          -  thromboses

          -  receiving erythropoietin
Calcium for Out-of-Hospital Cardiac Arrest
Condition: Heart Arrest, Out-Of-Hospital
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Intervention: Calcium Chloride; Sodium chloride 0.9%
Intervention description: Calcium chloride 5 mmol; Placebo
Intervention MeSH terms: Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel
      group, double-blind, superiority trial of calcium during adult out-of-hospital cardiac
      arrest. 430 adult patients with out-of-hospital cardiac arrest receiving at least one dose of
      adrenaline will be enrolled. The primary outcome is sustained return of spontaneous
      circulation and key secondary outcomes include survival at 30 days and survival at 30 days
      with a favorable neurological outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Out-of-hospital cardiac arrest

          -  Age ≥ 18 years

          -  Received at least one dose of adrenaline

        Exclusion Criteria:

          -  Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging,
             strangulation, or foreign object airway obstruction)

          -  Known or strongly suspected pregnancy

          -  Prior enrollment in the trial

          -  Received adrenaline during cardiac arrest before arrival of prehospital personnel with
             the study drug

          -  Clinical indication for calcium administration during the cardiac arrest
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Inflammation
Intervention: alpha-lipoic acid and acetyl-L-carnitine; Control
Intervention description: none to report; none to report
Intervention MeSH terms: Thioctic Acid; Acetylcarnitine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Antioxidant; Inflammation; Sickle Cell Disease; Oxidative Stress; Cytokines; anti-inflammatory; Acetylcarnitine

Summary:

      The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine
      will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative
      stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and
      improve their quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta
             zero thalassemia genotype

          -  Age at entry at least 14 years. Younger children will not be included since the
             combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a
             smaller dose at this time.

        Exclusion Criteria:

          -  More than 3 packed red blood transfusions in the past 12 months

          -  Coexisting illness that could contribute to inflammation. These include chronic
             hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and
             other similar conditions.

          -  Acute sickle cell disease related symptoms requiring a hospital visit in the past 4
             weeks

          -  Women who are pregnant, attempting to get pregnant, or breast feeding

          -  Active participation in other investigational drug or device studies

          -  Participants who start hydroxyurea or regular transfusion therapy during the course of
             the study on the recommendation of their primary hematologist will be ineligible for
             further participation.
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Mavrilimumab 100 mg
Intervention description: Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Intervention MeSH terms: Mavrilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 409.0
Sex: All
Minimum age: 19 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A clinical study to investigate the safety of mavrilimumab, an antibody being developed for
      the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that
      affects the joints.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the treatment period of the qualifying study or will have
             failed to respond adequately to investigational product at a predefined time point in
             the qualifying study regardless of their initial randomization.

          -  No evidence of clinically uncontrolled respiratory disease to be confirmed by a local
             pulmonologist

        Exclusion Criteria:

          -  Subjects who have been permanently discontinued from investigational product in
             previous qualifying study.

          -  Any new conditions or worsening of any pre-existing conditions as defined in the
             protocol.