bioihbjkbjnl/mcl2 huggingface dataset:
Progesterone Treatment in Female Smokers - 12
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate progesterone effects in female smokers
    

Detailed description: 
      Limited research has been done on the effects of gender and menstrual cycle in response to
      drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and
      tolerability of progesterone treatment in female nicotine users. In addition, plasma
      progesterone levels reached with a single 200 mg dose of progesterone treatment will be
      measured. The study will be a double-blind placebo controlled, crossover trial in which 12
      female smokers who are in the early follicular phase of their menstrual cycle will be
      enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of
      micronized progesterone or placebo and multiple blood samples will be obtained to measure the
      plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment,
      subjects will have a self-administration period that will last around 2.5 hours. We
      hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone
      concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.
    

Intervention name(s): Micronized Progesterone
Intervention type(s): Drug
Intervention MeSH terms: Progesterone
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA
Condition: MPS IV A
MeSH terms: Mucopolysaccharidoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This multicenter, open-label study is designed to assess safety, dose-response using
      pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in
      subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).
    


Intervention name(s): BMN 110
Intervention type(s): Drug
Intervention description(s): Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:
Weeks 1-12: 0.1 mg/kg/week
Weeks 13-24: 1.0 mg/kg/week
Weeks 25-36: 2.0 mg/kg/week
Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mucopolysaccharidosis IV type A; MPS IV Type A; Mucopolysaccharidosis IVA; MPS IVA; Morquio A Syndrome; Lysosomal Storage Disorder; LSD; N-acetylgalactosamine-6-sulfatase; N-acetylgalactosamine-6-sulfate sulfatase; galactose-6-sulfatase; GALNS; enzyme replacement therapy; ERT
Immune Modulation by Parenteral Lipids
Condition: Infections; Total Parenteral Nutrition
MeSH terms: Infections
Study type: Interventional

Summary: 
      Immune modulating properties of parenteral lipid emulsions seem to contribute to the
      increased risk for infections which remains associated with the use of total parenteral
      nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used
      lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty
      acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs,
      has been approved for parenteral nutrition in many countries. Mainly retrospective studies on
      clinical outcomes in septic and postoperative patients have suggested clinical benefits with
      the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the
      beneficial immunological effects of parenteral FO have, however, not yet been elucidated.

      Objective:

      To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based
      emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and
      functions and on the susceptibility to oxidative stress.

      Study design:

      Randomized placebo controlled cross-over pilot study with healthy volunteers.
    


Intervention name(s): Parenteral lipid emulsion (Omegaven); Parenteral lipid emulsion (Intralipid); Parental lipid emulsion (Saline 0.9%)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days; Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days; Placebo (Saline 0.9%), same volume/hr as lipid emulsions
Other intervention name(s): Omegaven 10%, Fresenius Kabi, Bad Homburg Germany; Intralipid 10%, Fresenius Kabi, Bad Homburg Germany; lipid free control
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total parenteral nutrition; infections; Infectious complications related to parenteral nutrition
A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as
      compared to placebo in pediatric patients with T2DM.

      Secondary Objectives:

        -  To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending
           doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric
           patients with T2DM.

        -  To evaluate the change from baseline in fasting and post-prandial plasma glucose
           concentrations during a standardized meal test after 3 ascending repeated doses of
           lixisenatide in comparison to placebo.
    

Detailed description: 
      The total study duration will be up to 10 weeks that includes a 6-week treatment period with
      dose escalation every 2 weeks.
    

Intervention name(s): Lixisenatide (AVE0010); Placebo; Basal Insulin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Metformin; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Use of the Modified Atkins Diet in Infantile Spasms
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young
      children. The ketogenic diet has been shown to be very effective in these children. The
      modified Atkins diet is a less restrictive option than the ketogenic diet, which has been
      effective in preliminary studies on refractory epilepsy in children, adolescents and adults.
      Modified Atkins diet may be of special importance in infants, as proteins are not restricted,
      hence no problems with growth are expected. Hence this pilot study has been planned to
      evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms
      refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).
    


Intervention name(s): modified Atkins diet; modified Atkins diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Modified Atkins Diet administration
Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
Fats (e.g. cream, butter, oils, ghee) encouraged.
Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
Clear carbohydrate-fluids not restricted.
Calcium and multivitamin supplementation will be provided.; Modified Atkins Diet administration
Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
Fats (e.g. cream, butter, oils, ghee) encouraged.
Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
Clear carbohydrate-fluids not restricted.
Calcium and multivitamin supplementation will be provided.
Other intervention name(s): Dietary treatment; Dietary treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: West syndrome; Hypsarrhythmia
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50
      mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week
      double-blind phase and a 52-week open-label phase.
    


Intervention name(s): agomelatine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: agomelatine, major depressive disorder, MDD, depression
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure
Condition: Patient Satisfaction
Study type: Interventional

Summary: 
      This study aim to examine the safety and feasibility of unsedated colonoscopy in patients
      with high risk for sedation (ASA score≥3).
    

Detailed description: 
      This was a two-part study: Part 1 was a retrospective study of patients with ASA score≥3 that
      underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center, who
      were contacted up to one year after the procedure and were asked to assess their satisfaction
      and pain level on a standard Likert score from 1-5. Part 2 was a prospective study which
      included high risk patients who were scheduled for an anesthesiologist-assisted
      sedated-colonoscopy and who consented to undergo an unsedated procedure. The primary outcome
      was patients' satisfaction during and up to one week after the procedure. Pain level, adverse
      events and hemodynamic parameters during the procedure were secondary outcomes. Baseline
      State-Trait Anxiety Inventory (STAI) questionnaire were also administered and results
      examined vis-à-vis satisfaction scores
    

Intervention name(s): un-sedated colonoscopies
Intervention type(s): Procedure
Intervention description(s): un-sedated colonoscopies in high risk patients with ASA>=3
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Family Lifestyle Overweight Prevention Program-Physical Activity Only
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This randomized control trial evaluates the physical activity component of the Family
      Lifestyle Overweight Prevention Program compared to physical education class as usual among
      Hispanic middle school students.
    

Detailed description: 
      Family Lifestyle Overweight Prevention Program (FLOW) is an intensive, multi-component
      obesity intervention designed to take place during physical education class. This
      intervention has established efficacy at improving standardized BMI among low income,
      Hispanic middle school students with overweight classification or obesity. However, the
      efficacy of individual components of the intervention have not been investigated. The purpose
      of this study was to compare only the physical activity component of FLOW to a physical
      education class as usual. The primary outcome of the study is time spent in moderate-vigorous
      physical activity. Secondarily the study evaluated the impact of the intervention on
      standardized BMI.
    

Intervention name(s): FLOW-PA; PE class as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Classes were designed to provide the opportunity to be physically activity at a moderate-vigorous level. Each station included exercise options to accommodate varying fitness levels and offer students choice. Heart rate monitors provided consistent biofeedback to students throughout the intervention. Participants were evaluated based on the number of minutes they spent each class between 60-80% of their maximal heart rate. Games were intermixed either as a station or as a break in the circuit (e.g. short game of tag half-way through the workout) to make physical activity enjoyable and engaging.; PE teachers were instructed to teach class as usual. Research staff were not involved in class activities or instruction. In this school district PE class as usual includes sports-based instruction in which students learn the rules to games and then practice playing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Is it Necessary to Set External PEEP in AECOPD Patients
Condition: Acute Exacerbation Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive
      end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of
      breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level
      compared with pressure-support ventilation (PSV)
    

Detailed description: 
      All patients randomly underwent a 30 mins PSV and NAVA crossover ventilation (15 mins each)
      at progressive PEEPe levels. Progressive levels of PEEPe were applied stepwise in increments
      of 40% of baseline static PEEPi, every 30 mins, from zero to 160% of baseline static PEEPi
      during the protocol (0, 40%, 80%, 120% and 160% of static PEEPi, respectively). During PSV,
      pressure support level was set to meet a Vt 6ml/kg, I/E cycling was 30% of the maximum
      inspiratory peak flow, flow trigger was 1L/min, and inspired fraction of oxygen (FiO2) was
      set to the similar level before the study protocol. During NAVA, NAVA Level was set at 15
      cmH2O / µV and a peak airway pressure limit was set in order to apply the same inspiratory
      pressure support at each PEEPe level during PSV. The new setting of NAVA was defined as
      NAVA15. Moreover the trigger was set at 0.5 µV and the I/E cycling fixed at 70% of the peak
      of EAdi. During the entire protocol, FiO2 and peak air way pressure were maintained the same
      levels at each PEEPe level between PSV and NAVA. Arterial blood gases were measured at the
      end of PSV or NAVA15 ventilation at each PEEPe level.
    

Intervention name(s): PEEP titration
Intervention type(s): Other
Intervention description(s): In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AECOPD; work of breathing; patient-ventilator synchrony
A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if ensifentrine is safe and effective for the
      treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): Ensifentrine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage Formulation:
Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks; Dosage Formulation:
Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric
      intraocular lens in the bag in high myopic subjects.
    

Detailed description: 
      According to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (D)
      of refractive astigmatism. New toric IOL designs (Acrysof © toric IOL; Alcon), approved by
      the US Food and Drug Administration (FDA) at the end of 2005, have been found to be more
      stable and safety in the capsular bag in subjects with normal axis length of eye. Then,this
      study aims at the confirmation of the stability of The AcrySof Toric intraocular lens in the
      bag in high myopic subjects.Then we may find a more effective treatment for the high myopic
      patients with complicated cataract and sever cornea astigmatism .
    

Intervention name(s): Cataract Surgery
Intervention type(s): Procedure
Intervention description(s): Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.
Other intervention name(s): refractive lens exchange surgery
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cataract
A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an escalating dose study in subjects with T2DM, which will consist of four
      overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and
      pharmacodynamics.
    


Intervention name(s): SB756050
Intervention type(s): Drug
Intervention description(s): doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; pharmacodynamics; safety; pharmacokinetics
Effect of Contrast Medium on Optic Nerve Sheath Diameter
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      One method of indirect measurement of intracranial pressure is using optic nerve sheath
      diameter. There is no study whether equal volume of contrast medium injection has any
      increasing effect of optic nerve sheath diameter.

      This study is designed to measure the changes of optic nerve sheath diameter and cerebral
      oxygenation when equal volume of contrast medium or normal saline was injected in epidural
      space.
    

Detailed description: 
      Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during
      caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high
      volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and
      oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of
      visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve
      sheath diameter. This study was designed to examine the changes of optic nerve sheath
      diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was
      injected in epidural space.
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Other
Intervention description(s): thoracic epidural catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: optic nerve sheath diameter
Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine
Condition: Enteric Fever
MeSH terms: Typhoid Fever; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy
      participants aged 18 to 45 years inclusive.
    

Detailed description: 
      This is a Phase I, randomised, double-blind, placebo-controlled, parallel group,
      single-centre study involving 45 healthy participants. The aim is to evaluate the safety and
      immunogenicity of Entervax, a combination vaccine against enteric fever comprising Typhi ZH9
      (hereafter ZH9) plus an engineered derivative that will provide an immune response to the key
      antigens (LPS 0:2 and H:a flagella) from S. Paratyphi A (hereafter ZH9PA). ZH9PA has not
      previously been tested in humans therefore the first two cohorts comprise a dose escalation
      of ZH9PA and the final cohort comprises a single dose level of the combination of ZH9PA and
      ZH9.
    

Intervention name(s): ZH9PA and ZH9; Placebo; ZH9PA
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 150mL vaccine for oral administration; 150mL vaccine for oral administration; 150mL vaccine for oral administration
Other intervention name(s): Entervax
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort 1 will consist of 9 participants, who will receive 3 doses of 1x10^9 Colony Forming Units (CFU) of ZH9PA (6 participants) or placebo (3 participants).
Cohort 2 will consist of 18 participants, who will receive 3 doses of 1x10^10 CFU of ZH9PA (12 participants) or placebo (6 participants).
Cohort 3 will consist of 18 participants, who will receive 3 doses of 1x10^10 CFU of ZH9PA and 1x10^10 CFU of ZH9 (12 participants) or placebo (6 participants).
Masking: Double (Participant, Investigator)
Primary purpose: Prevention