bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Embryo Cryopreservation on Birth Weight
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo
      replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo
      cohort. The aim of this study was to determine whether the freezing-thawing procedure is
      involved in such difference.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        sibling pairs where fresh embryo replacement resulting in a singleton live birth was
        followed by transfer of one or two frozen embryos from the same cohort that resulted in a
        singleton live birth, between May 2007 and June 2015.

        Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was
        unknown, the pair was not included in the study
      
Keywords: ART; Birthweight; Siblings; Cryopreservation; Epigenetic; Medical assistance to procreation
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, single dose study in approximately 5 healthy male and female (of non
      childbearing potential only) participants has been designed to characterize mass balance and
      further the understanding of human pharmacokinetics, metabolism, and excretion of PF 07304814
      administered at a dose of 500 mg [14C] PF-07304814 containing approximately 420 nCi [14C]
      PF-07304814 as a constant-rate, continuous IV infusion over 24 hours
    


Intervention name(s): PF-07304814
Intervention type(s): Drug
Intervention description(s): PF-07304814 is an anti-viral, formulated for intravenous delivery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; SARS-COV-2; Viral Disease
Interventional Effects on Myocardial Revascularization Post-surgical Patients
Condition: Myocardial Revascularization
Study type: Interventional

Summary: 
      The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine
      with CPAP in the postoperative period after myocardial revascularization
    

Detailed description: 
      Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation
      of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease
      the length of stay in the ICU, and help maintain functional capacity
    

Intervention name(s): Conventional Therapy; Cycle ergometer combine with CPAP
Intervention type(s): Other; Other
Intervention description(s): Subjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.; Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dental Status of Patients With Severe Mental Illness
Condition: Schizophrenia; Bipolar Disorder; PTSD; Depression
MeSH terms: Depression; Schizophrenia; Bipolar Disorder
Study type: Observational

Summary: 
      The investigators aim to assess the dental status of psychiatric patients suffering from
      severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).
    

Detailed description: 
      PATIENTS WILL BE ASSESSED USING THE

      1. DMFT (Decayed/Missing/Filled teeth)

      AN EPIDEMILOGICAL ASSESSMENT TOOL THAT ASSESSES:

        1. THE NUMBER OF TEETH WITH CURRENT DECAY

        2. THE NUMBER OF TEETH MISSING

        3. THE NUMBER OF TEATH TREATED IN THE PAST (FILLED)

      2. CPI - Community Periodontal Index AN ASSESSMENT OF THE GUMS

      3. OHIP-Oral Health Impact Profile A SELF-RATING FORM TO ASSESS THE SOCIAL AND FUNCTIONAL
      AFECTS OF THIER DENTAL STATUS
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        THE SEVERE MENTAL ILL IN THE PSYCHIATRIC POPULATION OF THE HADASSAH MEDICAL ORGINIZATION
        -PSYCHIATRIC OUTPATIENT CLINIC
      
Keywords: Severe mental illness; Dental measures; Resistant depression
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants
      will receive an investigational product or placebo for 28 days.
    


Intervention name(s): Placebo; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, 0 mg, twice daily, 28 days; Tablet, 15 mg twice daily, 28 days; Tablet, 50 mg twice daily, 28 days; Tablet, 150 mg twice daily, 28 days; Tablet, 300 mg twice daily, 28 days; Tablet, dose TBD, twice daily, Cohort 5, 28 days; Tablet, dose TBD, twice daily, Cohort 6, 28 days; Tablet, dose TBD, twice daily, Cohort 7, 28 days; Tablet, dose TBD, twice daily, Cohort 8, 28 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 diabetes mellitus
Effect of Peer Support Intervention on Early Recovery Outcomes Post Coronary Artery Bypass Graft Surgery
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving
      physical recuperation and psychological adjustment. The high prevalence of postoperative
      depression in this population may threaten optimal recovery. Peer support over the recovery
      period has promise to mitigate this threat. The purpose of this study was to examine the
      effect of a professionally-guided telephone peer support intervention on recovery outcomes
      including depression, social support and health care resource utilization.

      In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an
      intervention (n=61) or usual care (n=124) group. Participants in the intervention group
      received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At
      hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck
      Depression Scale-II, social support was measured using the Shortened Social Support Scale and
      health care resource utilization was measured using items in the Postoperative Self Report of
      Recovery Questionnaire. Participants in the intervention group were also asked questions
      about their perceptions regarding peer support using the Peer Support Evaluation Inventory.
    


Intervention name(s): Peer Support
Intervention type(s): Behavioral
Intervention description(s): Support (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery.
Other intervention name(s): Social Support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Depression, peer support, recovery, health services
A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to establish the prevalence of comorbidities in Italian patients
      with chronic bronchitis with at least 2 exacerbations per year, and to document the
      appropriateness of instrumental diagnostic tests, such as spirometry of these patients.
    

Detailed description: 
      This is an observational study so participants will only take medication that is presently
      prescribed by their regular healthcare provider. No additional study medication will be
      administered. This study will enroll patients who have been previously diagnosed with COPD.
      This study will look at the medical history and other diseases that have been diagnosed in
      people who also have COPD.

      The study will enroll approximately 3000 patients.

      This multi-centre trial will be conducted in Italy. The overall time to participate in this
      study is at a single, regularly scheduled visit at the pulmonologists office. There will not
      be any follow up assessments.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.
      
Keywords: Drug Therapy
Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes
Condition: Type 2 Diabetes; African American; Cholesterol; Lipoprotein; Apolipoprotein
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Compared to other races, African-Americans with type 2 diabetes have different cholesterol
      levels, specifically triglycerides and low density lipoprotein. Recent data has shown the not
      only are cholesterol levels important in determining the risk for cardiovascular disease, but
      the size of the cholesterol particles and surface proteins on the cholesterol particles are
      also important. The objective of this study is to determine if African-American males with
      diabetes have different particle size, surface proteins, and cholesterol genetic links than
      African-American male without diabetes and Caucasian-American males with and without
      diabetes.

      African-American males with type 2 diabetes and not taking lipid-lowering medications are the
      current target population.

      After obtaining an informed consent, a complete medical history will be obtained and subjects
      will be examined, noninvasively, for physical signs of elevated cholesterol levels.
      Afterwards, blood samples [one venous puncture, 6 tubes (21 mL total)] will be obtained.
      Blood samples will be coded, sent to Berkeley Heart Lab and/or Clinical Laboratory Services,
      and undergo genetic testing at Mercer University College of Pharmacy and Health Sciences.

      Confidentiality of the subjects will be explained in the consenting process to the subjects.
      All subject samples and information will be coded. Each subject will be given a subject
      number upon consenting and this will be used throughout the study. All pertinent information
      of the subjects will be listed under the designated number, but will not be associated with
      that patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is a cross-sectional epidemiologic study in which the lipoprotein subclasses,
        apolipoprotein levels, and genetic polymorphisms of African-American men with type 2
        diabetes will be compared to African-American men without diabetes.
      
Biospecimen description: 
      We will retain a sample of serum, plasma and whole blood.
    
Keywords: Type 2 diabetes; African American; cholesterol; lipoprotein; apolipoprotein
Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy
Condition: Nasopharyngeal Carcinoma; Radiation-induced Xerostomia
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Xerostomia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective phase II clinical randomized controlled study, the purpose of this
      study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy
      (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC
      patients.
    


Intervention name(s): superficial parotid lobe-sparing intensity-modulated radiotherapy
Intervention type(s): Radiation
Intervention description(s): The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety of N1539 in subjects with acute
      moderate to severe pain following unilateral bunionectomy.
    


Intervention name(s): N1539; Intravenous Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Intravenous meloxicam
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bunion; Bunionectomy; Pain; Analgesia; N1539
An Efficacy and Safety Study of Sodium Oligo-mannurarate (GV-971) Capsule for the Treatment of Alzheimer's Disease
Condition: Mild to Moderate Alzheimer Disease; Cognitive Impairment
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine the efficacy and safety of Sodium
      Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.
    


Intervention name(s): Sodium oligo-mannurarate 900mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks; simulant of sodium oligo-mannurarate capsule
Other intervention name(s): GV-971
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer.

      PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples
      from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on
           glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell
           precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.

        -  Identify differences in gene expression and GR occupancy of response elements in HR
           BCP-ALL patients > 10 years old in response to both Dex and Pred.

      OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of
      glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene
      expression and ChiPseq data sets are compared by luciferase reporter assay.
    

Intervention name(s): DNA analysis; RNA analysis; gene expression analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
      
Keywords: B-cell childhood acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia
Dietary Intake of Salmon and Bone Health
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The aims of this study were to investigate how intake of tailor-made salmon affected bone
      biomarkers, nutritional status, as well as body composition and bone mineral density. The 122
      healthy postmenopausal women included in this 12 weeks intervention study were randomized
      into four groups: three salmon groups (with three different vitamin D3/vitamin K1
      combinations) and one tablet group (vitamin D and Calcium).
    

Detailed description: 
      Suboptimal vitamin D status is common among humans, and might have a negative impact on bone
      health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source.
      However, due to a considerable change in fish feed composition, the contribution of vitamin D
      from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made
      salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body
      composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55
      years) included in this 12 weeks intervention study were randomized into four groups: three
      salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg
      Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had
      three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or
      high D3 + low K1.
    

Intervention name(s): Tailor-made salmon with high levels of vitamin D3 and K1; Tailor-made salmon with low levels of vitamin D3 and high K1; Tailor-made salmon with high levels of vitamin D3 and low K1; Supplement with vitamin D and Calcium
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.; The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.; The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.; The aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section
Condition: Attempted Vaginal Delivery After a Cesarean Section
Study type: Interventional

Summary: 
      The main objective is to evaluate a specific cervicograph (the graph describing the cervical
      dilation, included in the partograph) for pregnant women with an history of cesarean section,
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women
      will be randomly assigned to this specific cervicograph (including an action line 2 hours
      after the alert line), or to the normal cervicograph (no lines). The primary outcome is
      appropriate detection of dystocia.
    

Detailed description: 
      Appropriate management of labor is essential to minimize the risk of uterine rupture in case
      of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk
      factor for uterine rupture during labor in women with previous cesarean section. Some studies
      have shown that this risk increases after 2 hours at the same cervical dilation during labor.
      The cervicograph is an important tool to detect dystocia during labor. There is currently no
      specific cervicograph for pregnant women with a history of cesarean section, and no study
      evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.

      The main objective is to evaluate a specific cervicograph (the graph describing the cervical
      dilation, included in the partograph) for pregnant women with an history of cesarean section,
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women
      will be randomly assigned to a specific cervicograph (including an action line 2 hours after
      the alert line), or to the normal cervicograph (no lines).

      The outcomes of this randomized trial are: appropriate detection and management of dystocia;
      uterine rupture; and success of VBAC.
    

Intervention name(s): specific cervicograph
Intervention type(s): Diagnostic Test
Other intervention name(s): usual cervicograph
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Metabolic Response to Fat and Glucose
Condition: Obesity; Insulin Resistance; Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral
      load according to lifestyle factors.
    

Detailed description: 
      The metabolic response in plasma and urine, pre- and post-load tests in people with specific
      dietary lifestyles will be tested. This project will focus on fat and glucose induced changes
      of targeted metabolic pathways that have been related to diabetes and obesity risk.
    

Intervention name(s): Glucose tolerance test; Fat tolerance test
Intervention type(s): Other; Other
Intervention description(s): Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load; Oral fat tolerance will be provided to fasting participants and blood samples will be collected before and 4 hrs after the fat load.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic