bioihbjkbjnl/mcl2 huggingface dataset:
Laser-assisted ICSI Versus Conventional ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI
      can serve to decrease this degeneration rate.
    


Intervention name(s): Laser-assisted ICSI
Intervention type(s): Other
Intervention description(s): Laser opening of the zona pellucida.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Flapless Emdogain in the Treatment of Periodontal Residual Pockets
Condition: Chronic Periodontitis, Generalized
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      48 adult patients participated in a single-centre randomized clinical trial with split- mouth
      design. They had presented at re-evaluation after initial non-surgical periodontal therapy
      (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth
      with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two
      teeth with similar PPD were randomized to receive re-instrumentation either with (test) or
      without (control) adjunctive flapless administration of EMD. Differences in the changes of
      PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket
      closure (PPD ≤4 mm and no BOP) will be compared
    


Intervention name(s): Re-instrumentation with flapless Emdogain application; Re-instrumentation with placebo application
Intervention type(s): Procedure; Procedure
Intervention description(s): Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD; Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus
Condition: COVID-19 Virus Infection
MeSH terms: Infections; COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess safety and efficacy of Carnipure tartrate (L-Carnitine
      and L-tartaric acid - LCLT) supplementation for SARS-Cov-2 infection
    

Detailed description: 
      After being informed about the study and potential risks, all patients given written informed
      consent will be divided em two cohorts according to inclusion criteria.One group with
      patients with diagnosed mild SARS-Cov-2 infection and another with healthy contacts of
      patients with diagnosed mild SARS-Cov-2.

      Both groups will be randomized to receive either LCLT supplementation or placebo during 21
      days. After this period primary endpoints of efficacy will be assessed.

      Clinical follow up evaluations will be monitored (Cohort 1 and 2), and chest tomography will
      be monitored in cohort 2 as well. Subjects will be followed for safety through 8 weeks
      (cohort 1) and 6 weeks (cohort 2) after being included into the study.
    

Intervention name(s): LCLT : 68% elemental L-carnitine and 32 % Tartric acid; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 3 g orally capsules; orally capsules
Other intervention name(s): Carnipure™ Tartrate (LCLT) formulation
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A total of 274 subjects, will be prospectively enrolled into a pilot randomized, placebo controlled study in the two cohorts: Cohort 1: 220 healthy, SARS-CoV-2 negative, individuals (55 to 85 years old) with close contact (cohabit) to a person with newly acquired SARS-CoV-2 infection based on PCR detection and absence of antibody response; and, Cohort 2: 54 asymptomatic ( 18 to 85 years old) or symptomatic patients with mild COVID-19 that tested positive for COVID-19 by RT-PCR within the last 24 hours prior to the enrolment in the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assess the Penumbra System in the Treatment of Acute Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as
      an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator
      (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV
      rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not
      work very well in cases where the stroke is caused by a large vessel occlusion. The
      hypothesis being tested is to determine if the addition of a treatment by a mechanical
      thrombectomy device like the Penumbra System can improve the clinical outcome of the patient
      over just using IV rtPA alone.
    

Detailed description: 
      Current therapies for acute stroke are limited to the intravenous administration of a
      intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of
      the affected cerebral arteries within 3-4.5 hours from symptom onset, and the use of
      intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus,
      all of which have limitations as mono therapies. For example, IV rtPA may not be very
      efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy
      devices on patient functional outcome is unknown. This is a randomized, concurrent controlled
      study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to
      IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms
      of acute ischemic stroke who have evidence of a large clot burden (clot length > 8mm) in the
      anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum
      of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial
      (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and
      assessed for 3 months after enrollment.
    

Intervention name(s): intravenous (IV) recombinant human tissue plasminogen activator (rtPA); Penumbra System
Intervention type(s): Drug; Device
Intervention description(s): 0.9mg/kg to a maximum of 90mg; The Penumbra System is an aspiration based mechanical thrombectomy device
Other intervention name(s): recombinant tissue plasminogen activator, Alteplase
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic stroke; acute intervention; thrombolysis; rtPA; internal carotid artery; middle cerebral artery; mechanical thrombectomy; Penumbra System; clot length; mRS; NIHSS
Reliability and Validity of Urdu Version of Mini-BESTest in Persons With Parkinson's Disease
Condition: Balance
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Various clinical scales are available to investigate balance impairment, Mini-BESTest is one
      of them. Thus, this study aims to translate the Mini-BESTest into Urdu and investigate its
      psychometric properties in the Pakistani Parkinson's population with dynamic balance
      impairment.
    

Detailed description: 
      The aim of study is to translate and culturally adapt Mini-BESTest into Urdu language and
      secondly to investigate the reliability and validity of Urdu Version of Mini-BEStest in
      Parkinson's Pakistani population. This study will be cross sectional survey study in which
      convenience sampling technique will be used.

      The results of study will help to know the validity and reliability of Mini-BESTest in Urdu
      version with dynamic balance impairments in Parkinson's population. The reliability of the
      scale will be checked through internal consistency and test-retest methods. Internal
      consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be
      assessed using an intraclass correlation coefficient with 80 patients.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The incidence of Parkinson disease increases by age especially after the age of 60 As we
        know equilibrium and postural control are essential for everyday work so postural
        instability, freezing of gait, impaired anticipatory and reactive balance, impaired
        cognition ,reduced leg muscle strength, reduced proprioception, and frontal lobe impairment
        are major cause of balance impairment and falls in persons with Parkinson disease and
        falling puts persons with Parkinson disease at a higher risk of fractures, soft tissue
        injury, immobilization, depression, daily activity restriction, and mortality
      
Keywords: Balance; Mini-BESTest; Parkinson's ; reliability; validity
PREPARE (A5361s) Substudy of REPRIEVE (A5332)
Condition: HIV-1 Infection
Study type: Observational

Summary: 
      Aging with HIV may be related to an earlier development of frailty (weakness) or disability,
      including difficulties in tests of strength or walking speed. Few treatments have been shown
      to prevent or slow these impairments in people with or without HIV. Some studies have
      suggested that the class of drugs called statins (for example, pitavastatin) might be helpful
      in slowing frailty or disability. This might happen by decreasing fat within the muscle or by
      decreasing inflammation markers (substances in the blood that determine how the body reacts
      to infection or irritation) in the blood. Other studies have shown that statins increase the
      risk of muscle aches and pains. This substudy is being done to determine the impact of the
      drug pitavastatin on muscle.
    

Detailed description: 
      A5361s is a prospective study to determine the effects of pitavastatin on physical function.
      The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic
      sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to
      REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to
      randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study.

      Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after
      REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function,
      frailty and self-reported physical activity and sedentary time. In addition, demographic and
      clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE
      (A5332) or its mechanistic sub-study A5333s will be used.
    

Intervention name(s): Pitavastatin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): One tablet (4 mg) taken once daily, orally with or without food; One tablet taken once daily, orally with or without food
Intervention MeSH terms: Pitavastatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        It is desired that a substantial proportion of participants are enrolled in A5333s.
Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy
Condition: Adrenal Disease
MeSH terms: Adrenal Gland Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare two surgical methods of adrenalectomy. One is called
      PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at
      patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through
      patient's abdominal cavity after making 3 or 4 holes in the abdomen.
    

Detailed description: 
      Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of
      adrenalectomy. This traditional method has been used widely because this procedure provides
      wide view of the whole abdomen which is familiar to surgeons. But due to its unique location
      at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal
      approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal
      adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach
      to kidney and adrenal gland, and so operative time can be shortened. But there has been no
      randomized controlled trial between these two methods.

      Therefore, as experienced surgeons in both methods, we want to practice this study.
    

Intervention name(s): PRA; LA
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pheochromocytoma; aldosteronism; cushing's syndrome; adrenal incidentaloma; Conn's syndrome
Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder
Condition: Attention Deficit Hyperactivity Disorder; Substance Abuse
MeSH terms: Hyperkinesis; Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether atomoxetine (also called Strattera) helps
      teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol
      problems.
    

Detailed description: 
      Evidence-based psychosocial treatments have recently been developed. However, very little
      data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One
      promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common
      co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD).
      Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential
      are now available. However, all controlled studies of atomoxetine have specifically excluded
      teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in
      this population. This research project will address the important research gap with the
      specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in
      teens with SUD.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder; Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adolescent; ADHD; SUD
Evaluation of the Efficacy and Safety of LevoCept
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to
      support commencing a Phase III Clinical Study
    

Detailed description: 
      Study Design:

      Prospective, multi-center, single-arm, open-label, Phase II clinical study

      Approximately 250 subjects will be enrolled at about 14 centers in the US.

      Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are
      interested in using only this intrauterine contraceptive for birth control will be eligible
      for this study. Subjects must provide written informed consent and meet the study subject
      selection criteria without any exclusions as outlined in the Clinical Investigation Plan
      (CIP).

      Primary Effectiveness Outcome:

      The primary outcome measure is effectiveness, evaluated as the absence of pregnancy during
      LevoCept use.

      Safety and other outcome measures include:

      Study Device Placement:

        -  Ease of placement

        -  Placement success

      Safety:

        -  Serious Adverse Events

        -  Adverse Events

      Tolerability:

        -  Bleeding and spotting patterns

        -  Discontinuation rate and reasons for discontinuation
    

Intervention name(s): LevoCept
Intervention type(s): Drug
Intervention description(s): placement of LevoCept IUD
Other intervention name(s): Levonorgestrel-Releasing Intrauterine System
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
Condition: Obesity; Type2 Diabetes; Bariatric Surgery Candidate
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The objective of the analysis was to evaluate the relationship between bariatric surgery and
      cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective
      matched cohort study of patients with diabetes that underwent bariatric surgery at the
      Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical
      control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic
      Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates
      for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10.
      Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as
      a completing risk.
    


Intervention name(s): Bariatric Surgery
Intervention type(s): Procedure
Intervention description(s): Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Type 2 diabetes patients with obesity (BMI>=30) between 18-80 years old.
Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Condition: Genetic Risk for Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examines the sensitivity of functional MRI to detect brain changes caused by
      donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for
      Alzheimer's Disease.
    

Detailed description: 
      This 24-week study will examine the sensitivity of functional MRI to detect brain changes
      caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk
      for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be
      eligible for this study. Participants without a family history of AD will also be enrolled to
      serve as a control group.
    

Intervention name(s): donepezil HCL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
Condition: Reconstruction of the Breast Nipple and Areola Complex
Study type: Interventional

Summary: 
      A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety
      and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
    

Detailed description: 
      This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients
      with a history of breast cancer following breast conservation surgery or mastectomy with
      breast reconstruction, seeking reconstruction of the breast nipple and areola complex.

      The study is designed to evaluate the long-term safety and performance of the FixNip NRI in
      patients undergoing nipple reconstruction procedure.
    

Intervention name(s): FixNip™ NRI
Intervention type(s): Device
Intervention description(s): The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition
Intervention model: Single Group Assignment
Intervention model description: The sample size will be 10 female subjects undergoing reconstruction of the nipple, S/P breast reconstruction surgery as a result of breast cancer.
Masking: None (Open Label)
Primary purpose: Other
Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.
Condition: Diabetic Nephropathy Type 2; Albuminuria; Type2 Diabetes Mellitus; Glucose Metabolism Disorders; Microalbuminuria; Diabetic Nephropathies; Diabetic Complications Renal; Diabetes Mellitus; Kidney Diseases; South Asian
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Complications
Study type: Interventional

Summary: 
      Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular
      health and urinary heparanase levels in South Asian type 2 diabetic patients with
      albuminuria.
    


Intervention name(s): Fasting mimicking diet Prolon; Food supplement Endocalyx; Placebo
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): 5-day fasting mimicking diet; Food supplement; Placebo
Other intervention name(s): FMD; Prolon; L-Nutra; Endocalyx; Q-prime
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized into the diet group, food supplement group or placebo group. The placebo and foodsupplement groups are double blinded.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
Condition: Massage; Anaerobic Exercise; Aerobic Exercise
Study type: Interventional

Summary: 
      Foot reflexology treatment provides acute and chronic effects on cardiovascular and
      hemodynamic functions. However, no information is available to us in regarding the treatment
      effect of foot reflexology after exercise. This study investigated the acute effect of foot
      reflexology treatment on heart rate variability after anaerobic-based and aerobic-based
      intermittent exercises.
    

Detailed description: 
      The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be
      immediately modulated by foot reflexology massage. The acute benefits of foot reflexology
      intervention on cardiac sympathovagal balance can be considered as exercise recovery
      strategies in sports.
    

Intervention name(s): Foot reflexology massage
Intervention type(s): Other
Intervention description(s): Foot reflexology technique of Father Josef was used as massage intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heart rate variability; Arterial pulse waveform