bioihbjkbjnl/mcl2 huggingface dataset:
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes Mellitus; Type 1 Diabetes; Diabetes Mellitus, Insulin-Dependent; Juvenile Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the safety and efficacy of multiple administrations
      of PROCHYMAL® in participants recently diagnosed with type 1 diabetes mellitus.
    

Detailed description: 
      Diabetes mellitus refers to disorders in which the body has trouble controlling its blood
      glucose levels. There are two main types of diabetes: type 1 and type 2. Type 1 diabetes
      mellitus (T1DM), which is being studied in this trial, is an autoimmune disorder in which the
      body's own immune system attacks and destroys the cells that make insulin. These cells are
      called beta cells. As beta cells are destroyed, less insulin can be made. This causes blood
      sugar levels to increase above normal and can cause life-threatening hypo- and hyper-glycemic
      reactions. For this reason, people with type 1 diabetes must take insulin to help control
      their blood sugar levels. Over time, poorly controlled diabetes can lead to a variety of
      serious health conditions, including heart disease, stroke, blindness, amputations, kidney
      disease, and nerve damage. Insulin is the primary method of controlling diabetes by
      regulating blood glucose levels, but it may not reverse or prevent disease progression. The
      active ingredient in PROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been
      shown to interact with the immune cells in the body, reducing inflammation and assisting in
      tissue repair. This study will help determine whether MSCs can protect normal pancreatic
      tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in
      insulin production and decrease in circulating blood glucose. The characteristics and
      biologic activity of PROCHYMAL®, along with a good safety profile in human trials to date,
      suggest that PROCHYMAL® may be a good candidate for addressing Type 1 Diabetes.
    

Intervention name(s): PROCHYMAL®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells; Intravenous infusion of excipients of PROCHYMAL®
Other intervention name(s): ex vivo cultured adult human mesenchymal stem cells; Prochymal
Intervention MeSH terms: Remestemcel-l
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T1DM; Type 1 Diabetes Mellitus; Type 1 Diabetes; Diabetes Mellitus, Insulin-Dependent; Juvenile Diabetes; Adult Human Stem Cells; Mesenchymal Stem Cells; MSCs; Insulin; Osiris; Prochymal
Lantus in the Treatment of Type 1 Diabetes Children
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, we plan to examine the difference in effect on blood glucose control in
      patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice
      daily, injected separately) or on intensive insulin management (IIM-several shots of short
      acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the
      short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be
      used to monitor blood glucose control over a 6 month period. Twice during the course of the
      study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records
      blood sugar readings every 5 minutes) will be used to record all the changes in the blood
      glucose levels occurring over a 72-hour period.
    

Detailed description: 
      The landmark report of the diabetes control and complications trial (DCCT) trial has shown
      that intensive management delays and/or prevents complications in small vessels associated
      with Type 1 diabetes (T1DM). To achieve the goals of the DCCT, a number of new insulin
      analogs( man-made insulins ) are now being incorporated into the management of patients with
      T1DM.

      These insulin analogs are gaining importance with their ability to overcome the major
      obstacle to intensive insulin therapy, namely low blood glucose. In particular, insulin
      Glargine, considered a basal insulin, is being extensively used for management as an
      alternative to continuous insulin therapy injected into the tissue just below the skin. The
      major drawback to using insulin Glargine is that it has to be given as a separate injection
      and cannot be mixed with other insulins. This results in the undesirable administration of
      multiple insulin injections to a child with diabetes making the therapeutic plan more complex
      and adhering to the treatment plan more difficult.

      In a previous study, (now accepted for publication in a leading diabetes journal, Diabetes
      Care), we have demonstrated, using continuous glucose monitoring system, that there is no
      significant difference in glucose concentrations (ie. high and low blood glucose episodes)
      when insulin Glargine is administered either mixed with a short-acting insulin analog or when
      giving it as a separate injection.
    

Intervention name(s): Lantus and short acting analogs Vs NPH and short acting analogs
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Lantus
A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, three part study to evaluate the effect of BCX7353 on drug
      transporters as well as the effect of an inhibitor of drug transport on BCX7353.
    

Detailed description: 
      This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the
      effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP
      substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the
      pharmacokinetics of BCX7353.

      It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1
      will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of
      digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the
      pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of
      cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any
      order.
    

Intervention name(s): BCX7353; Digoxin; BCX7353 + digoxin; Rosuvastatin; rosuvastatin + BCX7353; Cyclosporine + BCX7353
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3; Day 1 of Cohort 1; Day 19 of Cohort 1; Day 1 of Cohort 2; Day 15 of Cohort 1; Day 14 of Cohort 3
Intervention MeSH terms: Cyclosporine; Digoxin; Rosuvastatin Calcium; Cyclosporins; Berotralstat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 parallel treatment assessments
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Hyperglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if a low glycemic index diet will reduce blood sugar
      levels in pregnant women with high blood sugar levels.
    

Detailed description: 
      Women with gestational hyperglycemia, including women with gestational diabetes and impaired
      glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience
      better blood glucose control thereby decreasing the risk associated complication(s).
    

Intervention name(s): Control diet; Low GI diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block
Condition: Orthopedic Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Recent evidence suggests that injection pressure monitoring may be able to predict needle
      nerve contact in the brachial plexus nerve block model, but little is known about
      multifascicular nerves. The investigators hypothesize that injection pressure monitoring can
      reliably predict needle-nerve contact during femoral nerve block.
    

Detailed description: 
      Single center, observational study. Patients scheduled for elective lower limb surgery with
      femoral nerve block will be recruited. Femoral nerve will be identified using a linear
      ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward
      and advanced to the following conditions:

        1. Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve

        2. Needle tip advanced through fascia iliaca

        3. Needle tip slightly indenting the anterior surface of the femoral nerve

        4. Needle tip withdrawn 1 mm from nerve.

      At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump
      at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded
      observer will measure opening injection pressure using both an electronic and a mechanical
      transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In
      addition, minimum threshold current required to elicit a motor response will be recorded for
      conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.
    

Intervention name(s): Apposition of needle bevel against femoral nerve
Intervention type(s): Procedure
Intervention description(s): Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: opening injection pressure; femoral nerve block; fascia iliaca; ultrasound guided nerve block
Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that
      are too small and are too sick for standard techniques. But they may benefit from a new
      technique called transcaval TAVR. For this technique, doctors make a hole between the largest
      vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they
      replace the valve through a tube they put in the groin vein. Then they close the hole between
      the vein and the artery using a device designed to close holes in the heart. This study tests
      the device for this new, off-label use.

      Objective:

      - To further study the safety and effectiveness of transcaval TAVR.

      Eligibility:

      - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are
      not suitable.

      Design:

        -  Participants will be selected by a team of heart specialists and others.

        -  Participants will have a computed tomography (CT) scan with or without contrast dye.

        -  Participants will have blood tests.

        -  Participants will have transcaval TAVR.

        -  Participants will receive the same standard care as for all patients with TAVR.

        -  Participants will also have another CT scan, or an MRI or ultrasound, before they leave
           the hospital, and again after about 30 days and after about 12 months.

        -  Participants will be contacted 1 and 6 months afterwards and will have another visit 1
           year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a
           physical exam.
    

Detailed description: 
      Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has
      enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have
      no good options for standard percutaneous femoral access or for standard surgical access to
      the cardiac apex or to the ascending aorta. In this prospective registry we will collect data
      from multiple medical centers as they offer transcaval TAVR to patients with extreme or
      prohibitive risk of conventional TAVR.
    

Intervention name(s): CA-TAVR; Amplatzer Duct Occluder
Intervention type(s): Procedure; Device
Intervention description(s): Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcaval; TAVR; AMPLATZER(R) Occluder
Arginase Inhibition in Humans With Obesity
Condition: Obese; Endothelial Function
MeSH terms: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the efficacy of arginase inhibition on endothelial function in humans with
      obesity.
    

Detailed description: 
      The study is performed on one group of subjects with body mass index >35 and the absence of
      type 2 diabetes.

      Inclusion criteria:

      Body mass index >35 kg/m2.

      Exclusion criteria:

      Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L
      following 2h of oral glycemic load.

      Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral
      anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral
      vasculopathies, arterial shunting or other vascular surgery of the study arm.

      Any concomitant disease or condition that may interfere with the possibility for the patient
      to comply with or complete the study protocol.

      Participant in an ongoing study. Unwillingness to participate following oral and written
      information.

      Forearm blood flow is determined by venous occlusion plethysmography. Endothelium-dependent
      vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and
      210 ng/min). Endothelium-independent vasodilatation is determined by infusion of sodium
      nitroprusside (SNP; 1, 3 and 10 µg/min). Each dose is given for 2 min at a rate of 2.5
      ml/min. Data are expressed as percentage change in forearm blood from baseline flow.

      Fifteen subjects are included. On the day of the study the subject arrives to the laboratory
      after having a light breakfast. Forearm vessels of the non-dominant arm are cannulated and
      forearm blood flow is determined as described above. Baseline endothelium-dependent and
      endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin
      and SNP, respectively. Thereafter an intra-arterial infusion of the arginase inhibitor
      N-omega-hydroxy-nor-l-arginine (nor-NOHA) is administered as an intra-arterial infusion at a
      rate of 0.1 mg/min and is maintained for 120 min. The dose is based on a previous study by
      our group demonstrating improved endothelial function. Endothelium-dependent and -independent
      vasodilatation is reassessed at 120 min of infusion.
    

Intervention name(s): Nω-hydroxy-nor-arginine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
W-SUDs for COVID-19
Condition: Substance Use Disorders; Alcohol Use Disorder
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the efficacy of a substance use disorder intervention
      delivered via a mobile application in an adult population during the COVID-19 pandemic.

      This study that will test the comparative efficacy of the mobile-app based substance use
      disorder program to reduce substance use relative to a wait list control condition, and
      explore between group differences on quality of life indices as well as retention and
      engagement during COVID-19.
    


Intervention name(s): Woebot Substance Use Disorder
Intervention type(s): Other
Intervention description(s): Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
SLE Therapy Changes in Pregnancy and Relation to Pregnancy Outcome
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Observational

Summary: 
      to review the changes to SLE medications during pregnancy including adherence and
      non-adherence to the medications and correlate these to the pregnancy outcome and post-partum
      course of the disease.
    

Detailed description: 
      This was a retrospective study of pregnancies in SLE patients. These patients had confirmed
      SLE diagnosis according to the American College of Rheumatology (ACR) criteria (5). The
      diagnosis of SLE was confirmed by consultant rheumatologist. These patients were followed up
      by consultant rheumatologist and obstetrician. The pregnancies' data were curated using the
      patients' medical files and notes, both paper-based and electronic, antenatal records,
      rheumatology and hematology clinic notes in addition to delivery and postpartum records.
      These data were collected including ID numbers, ages, duration of the SLE, their SLE
      medications before the pregnancy (names, doses and frequency) and whether the SLE was active
      or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease
      activity index (SLEDAI) score. the investigators studied Hydroxychloroquine (HCQ),
      prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and
      low molecular weight heparins (LMWH) Enoxaparin 40 mg subcutaneously once daily) as these
      were the most commonly used medications. The use of these medications in the different
      pregnancy periods were noted and analyzed (BPG, before pregnancy; DPG, during pregnancy; PG,
      pregnancy; PP, post-partum). Changes in these medications were also recorded. The data was
      then analyzed to find out the rates of changes and discontinuation. The postpartum period was
      also studied similarly. The investigators correlated these alterations to the following
      feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction
      (IUGR) and intra-uterine fetal death (IUFD). The 6 months-pre-conceptual SLEDAI score was
      recorded and investigated in relation to the above mentioned feto-maternal outcomes and
      postpartum relapse. We divided the pregnancies into 2 groups; Group A, inactive SLE and
      SLEDAI score of 0-3; Group b, active SLE and SLEDAI score of 4-24.
    

Intervention name(s): Naser Al-Husban
Intervention type(s): Other
Intervention description(s): observation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with SLE
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine functional target engagement of SAGE-904
      using electrophysiological paradigms before and after ketamine administration.
    


Intervention name(s): SAGE-904; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SAGE-904 oral solution.; Placebo oral solution.; Ketamine intravenous (IV) infusion.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteer; SAGE-904; Ketamine
MTPr With Shockwave on Pain & Function of SHS in Stroke
Condition: Stroke
MeSH terms: Stroke; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Background: shoulder-hand syndrome is considered a significant reason for the reduction of
      upper limb functions after stroke. Purpose: To investigate the influence of Myofascial
      Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper
      extremity in stroke patients with diabetic neuropathy.
    

Detailed description: 
      Methods: two equal groups of thirty stroke patients, divided into, study group: which treated
      with MTrPs release combined with shockwave therapy and conventional program, while control
      group: treated with a conventional selected exercise program.
    

Intervention name(s): Myofascial trigger points pressure (MTrP) release; Shockwave therapy application; conventional therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Myofascial trigger points pressure (MTrP) release technique, the initial step was to recognize and find the trigger points (TP) , and The second step after TP palpation was the MTrP release technique, as follow, by one or both hands, the thumbs or four fingers of the therapist applied a maintained pressure, pushing internal toward the middle; The JEST-2000 (JOEUN Medical, Dae-Jeon, South Korea) was used for the ESWT. The application of pressure pulses of ESWT was centered around the flexor muscles with hypertonia; Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Diabetic Neuropathy; Shoulder hand syndrome