bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev®
      lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home
      setting to support product and system labeling.
    

Detailed description: 
      This study is a multi-center, single arm study in insulin-requiring adult and pediatric
      subjects with type 1 diabetes on the MiniMed™ 780G system using Lyumjev® insulin lispro-aabc
      and Medtronic Extended infusion set and reservoir. The run-in period and study period will be
      approximately 120 days long.

      A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be
      enrolled at up to 25 investigational centers across the United States in order to have at
      least 200 subjects enter the study period. Up to 125 subjects will be enrolled in the
      pediatric age group (7-17 years of age) and up to 125 in the adult age group (18 years or
      older).
    

Intervention name(s): MiniMed 780G System
Intervention type(s): Device
Intervention description(s): MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety and Tolerability of BMN 111 Administered to Healthy Adult Volunteers
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the study drug gets into the blood-
      stream and how long it takes the body to get rid of it when given as a single dose.
      Information about any side effects that may occur will also be collected.
    


Intervention name(s): BMN 111; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): SC injection, Part 1 single dose and Part 2 multiple dose.; SC injection, Part 1 single dose and Part 2 multiple dose
Other intervention name(s): Modified C-Natriuretic Peptide, ProCNP38
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Achondroplasia
Blood Donor Recruitment During Epidemic of COVID-19
Condition: Blood Donation
Study type: Interventional

Summary: 
      In December 2019, an unknown pneumonia rapidly spread in Wuhan, China, a new coronavirus,
      2019 novel coronavirus (2019-nCoV), aroused the attention of the entire world. On January 31,
      2020, World Health Organization (WHO) announced the outbreak of Coronavirus Disease 2019
      (COVID-19) in China as a Public Health Emergency of International Concern. The number of
      volunteer non-remunerated blood donors decreased because of quarantine, caring for relatives,
      and fear of exposure to COVID-19. Due to the blood shortage, patient blood management and
      cessation of elective surgery are contributing to decreased demand, but sepsis may increase
      requirements and significant reductions will not be possible in areas such as trauma, cancer
      patients, hereditary haemolytic anaemias and childbirth. Therefore, recruiting enough blood
      donors during the epidemic is vital for public health in China, and also worldwide. In order
      to assess the effects of a questionnaire on blood donor recruitment, the investigators
      designed two kinds of self-administered, standardized and structured questionnaires. In
      addition of the basic socio-demographic characteristics, one questionnaire includes the
      information of precautions of blood donation during epidemic, and the other dose not. The
      questionnaires were randomly sent to ever blood donors, and the same number of ever blood
      donors are coded as control.
    

Detailed description: 
      In order to assess the effects of a questionnaire on blood donor recruitment, the
      investigators designed two kinds of self-administered, standardized and structured
      questionnaires. In addition of the basic socio-demographic characteristics, one questionnaire
      includes the information of precautions of blood donation during epidemic, and the other dose
      not.

      Information of precautions of blood donation during epidemic included taking donor's
      temperature and enhancing hand disinfection before donation etc.

      The questionnaires were randomly sent to ever blood donors, and at the same day, equal number
      of ever blood donors as the ones who filled the questionnaire are coded as control.
    

Intervention name(s): Questionnaire with precaution information; Experimental: Questionnaire without precaution information
Intervention type(s): Other; Other
Intervention description(s): Ever blood donors in this group would receive a questionnaire which includes some information about how donors can donate safely and how blood center will protect the blood donors during the epidemic of COVID-19.; Ever blood donors in this group would receive a questionnaire which dose not include the information above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
    

Detailed description: 
      The primary goal of this Phase III study is to compare three lots for consistency of
      manufacture.
    

Intervention name(s): PXVX0200 Lot A; PXVX0200 Lot B; PXVX0200 Lot C; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Lot P700-1CA03; Lot P700-3CA03; Lot P700-6BA03; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29
      participants with moderate to severe Parkinson's Disease.
    

Detailed description: 
      Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by
      SAGE-217 for 4 days.

      Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an
      adjunct to antiparkinsonian agent(s).

      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Levodopa; Antiparkinsonian Agent(s)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).; Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
Intervention MeSH terms: Levodopa; Antiparkinson Agents
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 3-arm study to compare tolerability of three different titration and
      dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.

      Following a screening of up to 28 days, eligible participants will be initially randomised to
      one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all
      subsequent participants allocated to Arm 3.
    


Intervention name(s): AC-OLE-01-VA
Intervention type(s): Drug
Intervention description(s): formulation of tricaprilin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males
Condition: Dysglycemia
Study type: Interventional

Summary: 
      Maize Cob Extract (MCE) is intended to be used as a bulking agent in food. The purpose of
      this study is to determine the glycaemic and insulinemic response of MCE consumed in
      isolation compared to glucose; the glycaemic and insulinemic response will also be determined
      for MCE alone and in combination with glucose. This is a randomised, double-blind,
      single-centre trial in 10 healthy male participants.
    


Intervention name(s): MCE; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of 15g MCE in water after min 10 hours of fasting; Ingestion of 15g glucose in water after min 10 hours of fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Molecular Pathology and Neuronal Networks in LRRK2 Parkinson's Disease
Condition: Parkinson Disease, PARK8; Parkinson Disease; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's Disease (PD) is a progressive neurodegenerative disease characterized clinically
      by bradykinesia, resting tremor, rigidity, and postural instability. Little is known about
      the mechanisms underlying neuronal degeneration in PD and currently, no treatment is
      available to halt disease progression in PD.

      The pathophysiological characterisation of phenomena occurring in the time window between the
      pathological start of the disease and the onset of motor symptoms is crucial to develop
      potential neuroprotective agents.

      Several genes have been discovered providing important insights on the pathogenesis of PD.
      Mutations of Leucine-rich repeat kinase 2 (LRRK2) are associated with 2-5% of all PD cases in
      North American Caucasians. LRRK2 is an enzyme that in humans is encoded by the autosomal
      dominant Parkinson's disease-8 (PARK8) gene, which is associated with an increased risk of
      PD.

      Clinical and digital biomarkers, blood and cerebrospinal fluid (CSF) biomarkers and molecular
      positron emission tomography (PET) imaging, with specific radioligands, provide invaluable
      insights to help understand and characterise disease pathophysiology.

      The investigators aim to characterize molecular phenomena underlying LRRK2 PD with the hope
      of providing further insights into possible mechanisms taking place in PD and to help
      identify targets for disease-modifying therapeutics.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        LRRK2 PD patients, idiopathic PD patients and healthy controls.
      
Keywords: Parkinson Disease; LRRK2
A Study of IMR-687 in Healthy Adult Volunteers
Condition: Sickle Cell Disease; Sickle-Cell; Hb-SC; Sickle Beta 0 Thalassemia
MeSH terms: Anemia, Sickle Cell; Thalassemia; Hemoglobin SC Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled
      study is to evaluate the safety, tolerability, PK and PD profile of the orally administered
      IMR-687 in healthy adult subjects.
    


Intervention name(s): IMR-687; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): 1 of 6 possible single doses administered orally following overnight fast; Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other intervention name(s): Microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; Sickle Beta 0 Thalassemia
Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with
      diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and
      a half to recieve the placebo (LED).
    

Detailed description: 
      Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with
      diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by
      medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT
      shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to
      see whether LLLT shoe helps with healing compare with placebo (LED shoe).
    

Intervention name(s): Control LED shoe arm; Laser Shoe arm
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients with DFU will wear LED shoe 30 minutes once daily; Patients with DFU will wear Laser shoe 30 minutes once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The randomised clinical trial with participants randomised1:1 to either
Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily
Laser group : Patients will wear Laser shoe 30 minutes once daily
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer; Low Level Laser Therapy
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is

        1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal
           hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia

        2. To test whether non-fixation of mesh leads to less pain compared to the repair when the
           mesh is fixed.
    

Detailed description: 
      Hernia repair is one of the most common surgery performed all over the world. The same is
      true about India. With more than a billion population, the number of hernia patients in India
      perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India.

      Decreased post operative pain and lesser morbidity are the main advantages of Total Extra
      Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now
      recommended as the method of choice for bilateral and recurrent inguinal hernias. The
      disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma
      formation and difficult learning curve. Fixation of mesh with metal staples, apart from
      increasing the cost, may lead to new post operative groin pain which even becomes chronic in
      small percentage of patients. This had led to various studies showing that the non-fixation
      of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared
      to the conventional open hernia repair. Requirement of GA for TEP repair also had several
      disadvantages compared to regional anesthesia such as significant hemodynamic changes,
      delayed recovery, post operative nausea and vomiting, increased cost and inability to give
      anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have
      demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We
      earlier reported that TEP repair could be done without fixation of the mesh under regional
      anesthesia.

      This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of
      mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal
      anesthesia. The end points measured would be the recurrence of the hernia and pain in the
      post operative period.
    

Intervention name(s): Mesh Fixation
Intervention type(s): Procedure
Intervention description(s): Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Other intervention name(s): Mesh fixation by Tacker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hernia, laparoscopic, recurrence, pain, inguinal
Treatment of Diabetes After Gastric Bypass With Sitagliptin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe
      and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.
    

Detailed description: 
      Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type
      2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in
      increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases
      post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1
      levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose
      control in patients who have elevated incretin levels post Gastric Bypass. The study will
      also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after
      Gastric Bypass.

      Recruitment and data collection for this study was started at St. Luke's Hospital in New
      York, NY and later moved to Columbia University Medical Center in New York, NY.
    

Intervention name(s): Sitagliptin phosphate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 100 mg/day orally; 1 Placebo Pill per day
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Januvia; Sitagliptin; Diabetes; Gastric-Bypass
A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how the body processes oral contraceptive (OC), using
      Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female
      participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body.
      Information about any side effects that may occur will also be collected.
    


Intervention name(s): Ortho-Cyclen; Dulaglutide
Intervention type(s): Drug; Biological
Intervention description(s): Administered orally; Administered subcutaneously
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS)
      treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The
      secondary hypothesis is that the efficacy outcomes in UnCLOS group would be superior to those
      in historical UnCLOS group from prospective stroke registries.
    

Detailed description: 
      1. Study design: A prospective multicenter trial

        2. Study centers: 6 participating medical centers in South Korea

        3. Participants: Consecutive patients with acute ischemic stroke visiting the emergency
           room within 6 hours of the detection of stroke symptoms

        4. Methods

             -  3 thrombolysis protocols applicable to UnCLOS patients

                  1. IV tissue plasminogen activator (tPA) : Conventional intravenous tPA (0.9
                     mg/kg, 10% of the dose as a bolus and the remainder over 60 minutes) will be
                     administered to patients within 3 hours of first found abnormal time who had
                     no arterial occlusion or catheter-inaccessible occlusion.

                  2. IV tPA + IA urokinase protocol : Combined intravenous tPA (0.6 mg/kg, 10% of
                     the dose as a bolus and the remainder over 30 minutes) with intra-arterial
                     urokinase will be administered to those within 3 hours from first found
                     abnormal time who had catheter-accessible arterial occlusion.

                  3. IA UK protocol : Intra-arterial urokinase will be given to those between 3 and
                     6 hours after first found abnormal time who had catheter-accessible arterial
                     occlusion.

        5. Outcome variables

             -  Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from
                thrombolytic therapy.

             -  Efficacy outcomes

                  1. Long-term clinical outcomes (modified Rankin Scale) at 3 months

                  2. Secondary efficacy outcomes : Good vs. Poor outcomes according to mRS
                     responder analysis, Early neurological improvement, Immediate and 5-day
                     recanalization on MRA or CTA
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with acute ischemic stroke visiting the ER within 6 hours of the
        detection of stroke symptoms will be screened for this study.
      
Keywords: Acute ischemic stroke with unclear onset time
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's
      disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in
      both healthy volunteers and Parkinson's disease patients and to determine if there is a
      difference in the way that the body deals with Cogane (pharmacokinetics) between these two
      groups.

      It is expected that the study will prove that Cogane™ is safe and well tolerated and will
      provide us with a pharmacokinetic profile for both subject groups.
    


Intervention name(s): Cogane™ (PYM50028)
Intervention type(s): Drug
Intervention description(s): Orally active neurotrophic factor inducer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Phase I