bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
Condition: Glomerulosclerosis, Focal Segmental
MeSH terms: Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in
      participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis
      (FSGS).
    


Intervention name(s): VX-147
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration.
Other intervention name(s): IXP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single
      dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed
      conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence,single dose,
      crossover, oral bioequivalence study of Eszopiclone tablets 3 mg of Dr. Reddy's Laboratories
      limited, and 'LUNESTA' tablets 3 mg Mfg for Sepracor Inc. USA in healthy adult human subjects
      under fed conditions.
    

Intervention name(s): Eszopiclone Tablets 3 mg
Intervention type(s): Drug
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of
      palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.
    


Intervention name(s): Palbociclib
Intervention type(s): Drug
Intervention description(s): Palbociclib 125mg/d
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with breast cancer with confirmed metastasis, regardless of being de
        novo diagnosed or progressed from a non-metastatic stage.
Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires
Condition: Humeral Fractures
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      Completely displaced (Type III) supracondylar fractures of the humerus are treated in the
      operating room and are held together with pins stuck into the bone. There are two ways of
      inserting the pins: crossed and laterally. The crossed method is often used because it is
      thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It
      is not known which method is more stable. Our hypothesis is that loss of reduction will be
      equivalent between the two pinning methods.
    

Detailed description: 
      Children with type III supracondylar fractures of humerus who meet the study inclusion
      criteria will be invited to participate in the study by the on call orthopaedic surgeon. All
      patients will be required to provide informed consent. Patients will then be randomized
      through a random number software package and will commence immediately after confirmation of
      inclusion into the study. The fracture is reduced and fixed percutaneously either with
      crossed or lateral K wires, according to which group the subject was randomized to. Post
      reduction antero-posterior and lateral radiographs of the elbow are done in the operating
      room. Above elbow cast is applied. Radiographs are taken at follow-up visits to the clinic.
      The radiographs are measured to determine loss of reduction between immediate post-op films
      and films taken immediately prior to pin removal.
    

Intervention name(s): Crossed K-wiring of supracondylar fracture of the humerus; Lateral K-wiring of supracondylar fracture of the humerus
Intervention type(s): Procedure; Procedure
Intervention description(s): Closed reduction of the fracture followed by crossed K wire percutaneous pinning.; Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Supracondylar fracture; humerus; ulnar nerve injury; Baumann's angle; Supracondylar fracture of the humerus
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
Condition: CDKL5 Deficiency Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in children and young adults with
      genetically confirmed CDKL5 gene mutation.
    

Detailed description: 
      The Marigold Study is a global, double-blind, placebo-controlled, Phase 3 clinical trial that
      will enroll approximately 70 patients between the ages of 2 and 21 with a confirmed
      disease-related CDKL5 gene variant. Patients will undergo a baseline period before being
      randomized to receive, in addition to their existing anti-seizure treatment, either
      ganaxolone or placebo for 17 weeks. Following the treatment period, all patients that meet
      certain eligibility requirements will have the opportunity to receive ganaxolone in the open
      label phase of the study. The study's primary efficacy endpoint is percent reduction in
      seizures. Secondary outcome measures will include non-seizure-related endpoints to capture
      certain behavioral and sleep disturbances that have been seen in previous clinical studies
      with ganaxolone.
    

Intervention name(s): ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): active drug; inactive
Other intervention name(s): Placebo (for ganaxolone)
Intervention MeSH terms: Pregnanolone; Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: refractory seizures; genetic pediatric encephalopathies; epilepsy in children; seizure disorder
Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
Condition: Cholesterol Metabolism; Ketone Metabolism
Study type: Interventional

Summary: 
      The purpose of this study is to understand how the reduction in dietary carbohydrates in a
      very-low carbohydrate ketogenic diet impacts the synthesis of cholesterol, fatty acid, and
      ketones, and the turnover rate of VLDL and chylomicron particles.
    

Detailed description: 
      Participants will consume a standard American diet for one week followed by a very-low
      carbohydrate ketogenic diet (VLCKD, <50 grams carbohydrate/day) for two weeks. Participants
      will undergo an oral stable isotope tracer study during each diet to measure de novo
      synthesis of fatty acid, cholesterol, ketone bodies, and for measurement of apolipoprotein B
      and triglyceride kinetics.
    

Intervention name(s): Standard American diet; Very low carbohydrate diet
Intervention type(s): Other; Other
Intervention description(s): Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.; Ketogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ketogenic diet; LDL cholesterol; carbohydrate
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
Condition: Obstetric Pain; Postpartum Depression; Breastfeeding; Pain, Acute; Pain, Chronic; Obstetric Anesthesia Problems; Drug Effect; Opioid Use
MeSH terms: Depression, Postpartum; Acute Pain; Chronic Pain; Labor Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1)
      and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine
      bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid
      requirements.

      In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk
      transfer of ketamine and its metabolites will be assessed. Additionally calculated
      estimations for neonatal and infant exposure will be assessed.

      In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include
      postpartum pain, depression scores, central sensitization measures, patient-reported
      postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute
      post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.
    

Detailed description: 
      Postpartum pain management strategies currently permit opioids for breakthrough pain, but
      strategies focused on minimizing or eliminating opioids are lacking. In the non-obstetric
      surgical population, modalities such as intravenous ketamine are well-recognized as effective
      adjuncts in opioid-reduction strategies for postoperative pain. Although there have been some
      studies of ketamine exposure in postpartum women without deleterious outcomes noted, these
      studies in pregnant and lactating women are limited by a lack of information on maternal
      pharmacokinetics, breastmilk secretion, and clinical effectiveness when used with standard
      multimodal analgesic approaches. There is also a lack of information on intermediate and
      long-term outcomes in this setting. This two-part trial will address these knowledge gap by
      advancing understanding of the safety and efficacy of ketamine and its metabolites in
      peripartum populations.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Subjects in the intervention arm will receive infusion dosing as noted in arm/group descriptions at the time of cord clamping. Duration of infusion will be 12 hours. Concentrations of ketamine and ketamine metabolites (nor-ketamine, NKET; and dehydro-nor-ketamine, DHNK) are measured in maternal plasma and urine as well as breastmilk. Maternal side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and over 15 hours after infusion discontinuation.
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Intervention model description: Prospective observational open-label trial (Part 1)
Masking: None (Open Label)
Primary purpose: Prevention
The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study
Condition: Myelodysplastic Syndromes (MDS)
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      The purpose of this observational study is to compare overall survival in older adults with
      myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem
      cell transplant (RIC HSCT) versus those who do not receive HSCT.
    

Detailed description: 
      MDS is a hematologic malignancy characterized by cytopenias, bone marrow failure, and a risk
      of transformation to acute myeloid leukemia (AML). HSCT is the only curative therapy for MDS.
      Despite its increasing use among older patients (age greater than 60), more data are needed
      to assess outcomes of HSCT in older adults compared to other therapies.

      In this observational study, patients with MDS presenting at the study institutions are
      screened for disease characteristics that indicate that they are potentially appropriate for
      HSCT (both high-risk disease and fit for the procedure). Patients who meet inclusion and
      exclusion criteria and agree to participate in the study are entered into a clinical database
      and followed for overall survival. Patients also complete quality of life (QoL) assessments
      at enrollment and two years afterward, with the goal of investigating potential relationships
      between QoL and MDS treatment (HSCT vs. non-HSCT strategies).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients will be 60 to 75 years old with a diagnosis of MDS or related disorder
        (eg, MDS/MPD or CMML) who have disease that is advanced enough to warrant RIC HSCT (defined
        by high-risk cytogenetics OR int-2 or high-risk on IPSS OR transfusion dependence as
        defined by WPSS) and who are physically fit enough to undergo RIC HSCT as assessed by
        pre-determined measures of organ function. Patients whose baseline donor status is known
        will be excluded; however, knowledge of HLA status is allowed as long as a donor search has
        not been performed.
      
Keywords: Myelodysplastic syndromes (MDS)
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      Collection of venous blood samples in male T1D patients to evaluate the behavior of different
      biomarkers (beta-hydroxybutyrate, lactate, glucose) during and after morning Aerobic (60% of
      VO2 max) and Symptom Limited Maximal Exercise Test.
    

Detailed description: 
      Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate)
      before, during and after morning aerobic and symptom limited maximal exercise (cycling) to
      predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in
      order to create treatment algorithms to prevent these events.

      Endpoint:

      • Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and
      after morning exercise in venous blood.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult male participants, aged 18-40 years, with Type 1 Diabetes (T1D) treated with Multiple
        Daily Insulin injections (MDI) and Continuous Subcutaneous Insulin Injections (CSII)
      
Biospecimen description: 
      Venous blood samples were analysed for glucose, lactate and ketone values with YSI technology
    
Keywords: exercise; biomarker; glucose; lactate; ketones; continuous glucose monitoring
Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human study of single and multiple ascending doses and food effect of
      ASC42.

      This study consists of 8 cohorts and is divided as follows:

      Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design
      of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study
      including cohorts 6 to 8.
    


Intervention name(s): ASC42; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi
      Syndrome (PWS).

      This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned
      to include around 24 PWS patients aged 2-17 years and 5 months.
    


Intervention name(s): Oxytocin nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study treatment will be administered intranasally daily for 12 weeks. The daily dose of OT will be adapted according to age at the beginning of the study; Study treatment will be administered intranasally daily for 12 weeks.
Other intervention name(s): oxytocin; placebo nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Prader-Willi syndrome; Oxytocin
Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)
Condition: Hypertension; Stroke
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      One of the most powerful predictors of stroke is hypertension, with estimates of
      approximately 33% of adults in the United States experiencing this condition. Hypertension is
      significantly more prevalent in African Americans compared to European Americans.
      Importantly, hypertension is a modifiable stroke risk factor.

      This proposal will use a community-based participatory research approach to perform a
      randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure
      in an urban African American community in Flint, Michigan.
    

Detailed description: 
      This is a randomized controlled trial of text messaging and blood pressure self-monitoring to
      reduce blood pressure.
    

Intervention name(s): Text Messaging
Intervention type(s): Behavioral
Intervention description(s): hypertensive participants will be randomized to receive tailored, motivational text messages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hypertension treatment; stroke prevention
Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
Condition: Postprandial Glycemia; Resistant Starch
Study type: Interventional

Summary: 
      Resistant starch partially resists hydrolyzation by digestive enzymes in humans.
      Consequently, it is not absorbed in the small intestine and goes directly to the large
      intestine, where it is fermented by the intestinal microbiota, acting as a prebiotic and
      stimulating the growth of beneficial bacteria in the colon. In addition, the effect of
      resistant starch on postprandial glucose metabolism is studying. Thus, the present research
      on healthy subjects has been proposed.

      The main objective is to assess the effect on postprandial glycemia of eating a pasta dish
      made with resistant starch versus its original version.

      For this purpose, a randomized, double blind crossover study has been designed.

      Target sample size is 18 subjects.
    

Detailed description: 
      The arms of the study are two:

        -  Experimental group (pasta dish made with resistant starch).

        -  Control group (original pasta dish).

      Volunteers who wish to participate in the study will be interviewed by phone to verify that
      they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will
      be invited to an information and screening visit to resolve any doubts. Volunteers who agree
      to participate in the study will sign the informed consent and will be randomly assigned to
      one of the two arms of the study.

      The two visits (clinical investigation days) of the study will take place with the volunteers
      in a fasting state of 4 hours and separated by at least 1 week washout period. The day before
      the visit, volunteers won't be able to drink alcohol, drink and eat excessively, and/or sleep
      few hours. Both visits will consist of eating a pasta dish in a maximum of 15 minutes. Blood
      samples will be taken before eating and during the 2.5 hours after (30, 60, 90, 120 and 150
      minutes), in order to analyze the evolution of blood glucose and insulin levels.
    

Intervention name(s): Pasta dish with resistant starch; Original version of pasta dish
Intervention type(s): Other; Other
Intervention description(s): Pasta dish with 20-22% of resistant starch; Original pasta dish, not reinforced with resistant starch
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, double blind crossover intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resistant starch; Postprandial glycemia; Postprandial insulinemia; Pasta
Dietary Analysis for Caries Prevention in Children Using a Computer Software
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Children will be recruited from the pediatric dentistry clinic of Marquette University at
      their first or recall appointment and will be asked to fill a questionnaire regarding their
      dietary habits. Afterwards a dietary analysis will be performed using a computer software,
      developed for this study and dietary instructions will be given to the children.
    


Intervention name(s): Software instruction
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients
Condition: Adenovirus Infections, Human
MeSH terms: Infections; Communicable Diseases; Adenoviridae Infections; Adenovirus Infections, Human
Study type: Observational

Summary: 
      To depict the incidence, outcomes and standards of care (SoC) of adenovirus (AdV) infections
      and associated practice patterns in allogeneic hematopoietic cell transplant recipients. It
      is expected that participating centers will be in the United Kingdom, France, Spain, Germany,
      and Italy.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        compromised of all allo-HCT recipients at participating centers during the pre-specified
        study period
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Condition: Strabismus
MeSH terms: Strabismus; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to determine if local anesthetic, either a subtenons injection
      (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel
      (applied directly on the surface of the eye) given at the end of strabismus surgery reduces
      postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic
      for pain at the end of strabismus surgery.
    


Intervention name(s): subtenons anesthetic - preservative-free bupivacaine 0.75%; topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel; topical control - 0.5 cc of Hypromellose 0.3% gel; subtenons control - 0.5 cc of Normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lidocaine; Bupivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science