bioihbjkbjnl/mcl2 huggingface dataset:
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
Condition: Artery Stenosis, Carotid; Artery Stenosis; Occlusion of Artery; Stroke
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using
      POLYPATCH® when exposed to a larger and more varied population.

      All data will be retrieved from medical charts for each patient from time of surgery
      (considered as baseline of study) until a maximum of 3 years after surgery.

      A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different
      sites. At least 100 subjects will be evaluated in carotid location and at least 100 in
      femoral location.
    


Intervention name(s): Endarterectomy
Intervention type(s): Device
Intervention description(s): Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.
Other intervention name(s): Carotid Endarterectomy; Femoral Endarterectomy; Patch Angioplasty
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will screen all potential subjects and will select those who are
        appropriate for study inclusion, i.e. adult subjects implanted with POLYPATCH® for at least
        one year.

        All data will be retrieved from medical charts for each patient from time of surgery
        (considered as baseline of study) until a maximum of 3 years after surgery.

        A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different
        sites. At least 100 subjects will be evaluated in carotid location and at least 100 in
        femoral location.
      
Keywords: vascular patch; Polypatch; femoral endarterectomy; carotid endarterectomy; Thrombosis
Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome
Condition: Postural Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have
      different levels of certain chemicals in their blood than people who don't have POTS. This
      study will test whether the blood vessels of people with POTS will react differently to
      certain tests than people without POTS.

      The hypothesis of the study is:

      Patients with POTS will have vascular endothelial dysfunction compared with control subjects.
    


Intervention name(s): Blood Pressure and Blood Flow
Intervention type(s): Device
Intervention description(s): A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The probes also measure blood pressure. After 10 minutes, the arm blood pressure cuff will be inflated. The cuff will stay inflated for 5 minutes, then the air will be let out. A cuff will be place above the left calf and the left knee. The subject will lie quietly for 9 minutes, then blood pressure and calf blood flow will be measured for one minute. the lower leg cuff will be inflated after 1 minute, then the cuff will be deflated. The blood pressure and forearm blood flow will be recorded. Next, the cuff on the upper leg will be inflated for 5 minutes then, it will be released and the measurements of blood pressure and calf blood flow will be repeated.
The study lasts about 2 hours.
Other intervention name(s): Pulsitile Arterial Tonometry Protocol (PAT)
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with Postural Tachycardia Syndrome

        Controls will be age & sex matched to the patients with POTS
      
Keywords: POTS; Vascular Endothelial Function
A Study of VI-0521 on Ambulatory Blood Pressure in Overweight or Obese Subjects
Condition: Blood Pressure
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as
      measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an
      active control (phentermine 30 mg).
    


Intervention name(s): VI-0521; Phentermine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phentermine/Topiramate Top Dose 15 mg/92 mg capsule; Phentermine 30 mg capsule; Inactive oral capsule
Other intervention name(s): Qsymia; Phentermine and topiramate
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Qsymia; ABPM
uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node
      metastases in breast cancer.
    

Detailed description: 
      The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be
      tested by observer-blinded readings (two separate teams) and compared to diagnostic
      performance of conventional preoperative diagnostic workup procedures. The reference test
      will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND).
      Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.
    

Intervention name(s): 68Ga-NOTA-AE105; Positron Emission Tomography PET/CT
Intervention type(s): Other; Device
Intervention description(s): One injection of 68Ga-NOTA-AE105; Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of
      HSK16149 in subjects with mild, moderate and severe renal impairment compared to the matched
      control subjects with normal renal function.
    


Intervention name(s): HSK16149
Intervention type(s): Drug
Intervention description(s): single oral adminiatration, 20mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Role of Lung Ultrasonography for Detection of Atlelectasis in Robot Assisted Laproscopic Pelvic Sugeries
Condition: to Detect the Incidence of Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Observational [Patient Registry]

Summary: 
      Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound
      with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest
      auscultation and ultrasound to see atelectasis
    

Detailed description: 
      Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound
      with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest
      auscultation and ultrasound to see atelectasis inclusion criteria: age 18 to 70 yrs age ASA I
      and II robot assisted pelvic surgeries in steep trendelenburg position

      exclusion criteria: cardiac disese severe obstructive and restrictive disease upper airways
      infection ASAIII and IV
    

Intervention name(s): lung ultrasound
Intervention type(s): Other
Intervention description(s): lung ultrasound and blood gas
Other intervention name(s): blood gas analysis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA Iand II age 18-70 yrs
The Effects of a Nutrition Supplement on Health Related Quality of Life
Condition: Sleep; Stress; Health, Subjective; Inflammation; Cognitive Symptom
MeSH terms: Neurobehavioral Manifestations; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the health related benefits of a superfoods
      nutrition supplement on health related quality of life.
    

Detailed description: 
      After being informed about the study, participants will provide informed consent and be
      randomized to one of two groups: intervention or control. Those in the intervention group
      will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be
      assessed at baseline, on day 30 and on day 60.
    

Intervention name(s): Supplement Drink
Intervention type(s): Dietary Supplement
Intervention description(s): Superfoods based nutritional supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: immune health; prevention; phytonutrients; superfoods; antioxidant; essential oils
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      IBI306 is a fully human monoclonal antibody that binds proprotein convertase
      substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein
      cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density
      lipoprotein cholesterol（LDL-C）uptake. This is a randomized, double-blind,
      placebo-controlled,single ascending dose study to evaluate the safety, tolerability,
      pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
    

Detailed description: 
      Ascending dose design includes 6 dose levels （25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600
      mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous
      cohort will be reviewed before proceeding to the next dose. Total duration of the study per
      subject is 12 weeks.
    

Intervention name(s): IBI306; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.; Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Patients suffering from Cervicogenic headache have restricted range of motion and pain which
      in turn causes functional disability and reduced quality of life. The aim of this research
      was to determine the effects of Graston technique to improve range of motion, function, and
      reduction of pain and in patients having Cervicogenic headache
    

Detailed description: 
      A randomized controlled trial in which Graston Technique and Neuromuscular Re-education
      technique would be applied on patients presenting with cervicogenic headaches by using
      different tools and the changes would be examined pre and post intervention. The participants
      fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received
      different protocols and will be assessed on data collection tool on their first and last
      visit using Goniometer, Headache Disability Index (HDI), Neck pain Disability Index (NDI) and
      Numeric Pain Rating Scale (NPRS). Participants of both groups will be pre-tested before the
      application of interventional techniques and post-tested after the application of respective
      intervention.
    

Intervention name(s): Garston tool; Neuromuscular Re-education
Intervention type(s): Device; Procedure
Intervention description(s): GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. Using the Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes were given over the painful area. Baseline values were recorded for demographics evaluation and episodes of pain onsets. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.; General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.
Other intervention name(s): Neuromuscular Re-education
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy
Condition: Hypertrophic Cardiomyopathy; Genetic Disease; Gene Product Sequence Variation
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Genetic Diseases, Inborn; Hypertrophy
Study type: Observational

Summary: 
      Investigators aim to use comparative exome and/or genome sequencing to discover causative
      molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this
      study, investigators have targeted hypertrophic cardiomyopathy.
    

Detailed description: 
      The hypothesis is that sporadic or simplex occurrences of what are typically autosomal
      dominantly inherited diseases can instead be caused my mosaic mutations, specifically,
      mutations in the heart itself.

      This hypothesis mandates that investigators sequence both affected and unaffected tissues,
      which in this case, investigators will construe to be peripheral blood DNA and discarded
      myocardium from cardiac procedures.

      Eligible individuals will first undergo informed consent to be part of the study prior to
      their scheduled myomectomy. The study participants will also have phlebotomy for research
      samples.

      The NIH Intramural Sequencing Center (NISC) will perform paired exome or genome sequencing
      and we will first screen for germline mutations in known cardiomyopathy genes that meet ACMG
      standards of likely pathogenic or pathogenic.

      Then, if this is negative, investigators will screen for sequence variants that are present
      in cardiac tissue but absent in the blood DNA. Investigators will also screen blood DNA for
      secondary findings in genes recommended for annotation and results return by the ACMG and
      sequence variants deemed clinically relevant in this gene set will be validated in a
      CLIA-certified laboratory and the results returned to that participant.
    

Intervention name(s): Genomic sequencing
Intervention type(s): Genetic
Intervention description(s): Genomic sequencing of DNA in Blood sample and myectomy tissue
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18 years and older, scheduled for septal myectomy and no family history of HCM
      
Biospecimen description: 
      leftover of myectomy tissue and peripheral blood
A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
Condition: Sepsis
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids
      are broken down in the body by the liver. This study is designed to see whether the effect of
      the drug in people with poorly functioning livers is any different to the effect on healthy
      adults.
    


Intervention name(s): Intravenous GR270773 - Phospholipid emulsion
Intervention type(s): Drug
Intervention description(s): GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; GR270773; Emulsion
Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR
      after single and multiple doses of the PR-formulation. It will also investigate the safety
      and tolerability of ropinirole PR after single and multiple doses of PR-formulation.
    


Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention description(s): Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning.
Single and repeat dose treatment periods will be separated by 7 days of washout period.
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome
Condition: Small-For-Size Liver Syndrome; Ligation; Liver Regeneration; Splenic Artery; Portal Vein; Ischemia; Reperfusion Injury; Hepatectomy
MeSH terms: Reperfusion Injury; Syndrome; Ischemia
Study type: Observational

Summary: 
      Our study aimed at assessing the changes of portal vein pressure, portal vein flow and
      hepatic arterial flow (HAF) in liver remnants ≤ 30% of the standard liver volume by reducing
      portal vein overflow via ligation of the splenic artery.
    

Detailed description: 
      It has been reported that prevention of acute portal overpressure in small-for-size liver
      grafts leads to better postoperative outcomes. Accordingly, we aimed to investigate the
      feasibility of the technique of splenic artery ligation in a case series of patients
      subjected to major liver resections with evidence of small-for-size syndrome and whether the
      maneuver results in reduction of portal venous pressure and flow.
    

Intervention name(s): splenic artery ligation
Intervention type(s): Procedure
Intervention description(s): We identified portal hyperperfusion as a cause of potential small-for-size liver remnant dysfunction and we applied splenic artery ligation as a technically simple procedure to manage the situation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective analysis of an internal hepatectomy database
      
Keywords: small-for-size liver syndrome; ligation; splenic artery; hepatectomy; liver regeneration
Bone Mineral Markers in Hypogonadism
Condition: Hypogonadotropic Hypogonadism; Endothelial Dysfunction; Insulin Resistance
MeSH terms: Insulin Resistance; Hypogonadism
Study type: Observational

Summary: 
      The aim of this study is to investigate the markers of bone mineral metabolism in an
      unconfounded group of patients with hypogonadism and to search for a relationship between
      endothelial dysfunction and insulin resistance.
    

Detailed description: 
      Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial
      dysfunction and insulin resistance are used in determining cardiovascular risk. The role of
      markers of bone mineral metabolism in hypogonadism is not clearly presented.

      49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy
      male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23),
      vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin
      sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR)
      formula.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study group was selected from the male subjects with hypogonadotropic hypogonadism who
        were not previously given testosterone or human chorionic gonadotropin therapy. The
        patients did not have any chronic metabolic disorders or organ dysfunction. Forty three age
        and BMI matched male volunteers were enrolled as control subjects.
      
Biospecimen description: 
      Serum and plasma samples
    
Keywords: Hypogonadism; Asymmetric Dimethyl Arginine; Osteoprotegerin; Fibroblast Growth Factor; Vitamin D
Citicoline Treatment of Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if citicoline (a nutritional supplement) is
      effective in helping people reduce their dependence on methamphetamine. The investigators
      will use neuroimaging to look at the structure and chemical make up of the brain at the start
      of the study and after 8-9 weeks of treatment of citicoline or placebo.
    

Detailed description: 
      This is a prospective, randomized, double-blind, placebo-controlled study, in which we will
      systematically evaluate the therapeutic effects of citicoline, which may both increase
      dopamine and normalize cognitive and structural deficits in the brains of methamphetamine
      dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat
      cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional
      supplement. We will also evaluate the chemical and structural changes in brain regions
      identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and
      cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline
      treatment. Specific brain regions of interest include the prefrontal cortices, temporal
      cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology
      of methamphetamine dependence.
    

Intervention name(s): Citicoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.; Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
Other intervention name(s): CDP-Choline
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: methamphetamine; Citicoline; CDP-Choline; Neuroimaging; MRI; Brain; MRS; DTI