bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
Condition: Pain; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The rationale of this study was to compare the efficacy of peri-tract bupivacaine
      infiltration with intravenous post-operative analgesia following PCNL in reference to the
      context with the previous studies so that we can adopt the better technique to curtail the
      post-operative pain.
    

Detailed description: 
      The rationale of this study was to compare the efficacy of peri-tract bupivacaine
      infiltration with intravenous postoperative analgesia following PCNL in reference to the
      context with the previous studies so that we can adopt the better technique to curtail the
      post-operative pain.
    

Intervention name(s): Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
Intervention type(s): Drug; Drug
Intervention description(s): Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.; Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required
Other intervention name(s): Local Anesthesia; Intravenous analgesic
Intervention MeSH terms: Acetaminophen; Tramadol; Analgesics; Orphenadrine; Dimenhydrinate; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Local anesthesia, Percutaneous nephrolithotomy.
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether afamelanotide and narrow band UVB are
      effective in the treatment of non-segmental vitiligo (NSV).
    

Detailed description: 
      The investigational product, afamelanotide, is a synthetic analogue of the human alpha
      melanocyte stimulating hormone (alpha-MSH). The earliest described function of alpha-MSH is
      its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation.
      Vitiligo is the most common depigmentation disorder. Interventions in the treatment of
      vitiligo include phototherapy with narrow-band (NB) ultraviolet B (UVB) irradiation (NB-UVB).

      The purpose of this study is to look at the efficacy of afamelanotide, when combined with
      narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.
      Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to
      reducing frequency and doses of NB-UVB.
    

Intervention name(s): Afamelanotide; NB-UVB
Intervention type(s): Drug; Device
Intervention description(s): NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation; NB-UVB light therapy 3-times per week, for total of 72 treatments
Other intervention name(s): CUV1647
Intervention MeSH terms: Afamelanotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitiligo; depigmentation; phototherapy; non-segmental vitiligo
Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether soy isoflavone supplementation is safe and
      effective to prevent bone loss in postmenopausal women.
    

Detailed description: 
      Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal
      women. However, there is no documented scientific evidence of its long-term safety and
      efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy,
      and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women.
      The multi-state, multi-institutional design ensures that the study results are representative
      of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy
      isoflavones could translate into reduced healthcare costs related to osteoporosis.
    

Intervention name(s): Placebo; Soy isoflavones; Soy isoflavones
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Three pills per day for two years; Three pills that delivered 80 mg of aglycone isoflavones per day for two years; Three pills that delivered 120 mg aglycone isoflavones per day for two years
Other intervention name(s): Soy germ isoflavones; Soy germ isoflavones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Osteoporosis; Soy isoflavones; Postmenopausal women; Safety; Efficacy; Effective dosage
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      As per request by the Heath Authorities, the present clinical study will assess the
      immunogenicity and safety
    


Intervention name(s): Hepatitis A vaccine AVAXIM 80U; Hepatitis A vaccine (HAVRIX 720)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): AVAXIM 80U Pediatric vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A
Human Epilepsy Project 2: Resistant Focal Seizures Study
Condition: Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Biomarkers
MeSH terms: Epilepsy; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases
Study type: Observational [Patient Registry]

Summary: 
      The HEP2 study is designed to better understand the challenges of living with focal seizures
      that do not respond to medication, by following 205 people with medication-resistant focal
      epilepsy over two years to measure changes in health status, healthcare costs, quality of
      life, and biomarkers of epilepsy severity and treatment response.
    

Detailed description: 
      The Epilepsy Foundation is launching a partnership, called the Human Epilepsy Project, in
      collaboration with the Epilepsy Study Consortium. This study (which is called HEP2 for short)
      is designed to better understand the challenges of living with focal seizures that do not
      respond to medication. The HEP2 study will follow 200 people with medication-resistant focal
      epilepsy (with seizures that occur at least 2 times per month) over two years to measure
      changes in their seizure frequency, treatments used, adverse events experienced, presence of
      co-morbidities like depression and anxiety, healthcare costs, and quality of life. Blood
      samples will also be collected in order to look for biomarkers of epilepsy severity and
      treatment response.

      Participants can join the HEP2 study at any one of nine recruiting study centers. These study
      centers were selected because they are epilepsy centers with track records of conducting
      high-quality research in epilepsy and efficiently recruiting participants into studies. The
      designated sites for the HEP2 study are located in New York, California, Minnesota,
      Connecticut, Pennsylvania, and Tennessee. A participant may enroll in the HEP2 study but
      continue to receive their standard epilepsy care with their current physician, as long as the
      participant is willing to share his or her medical records, and travel to the study center
      for two or three in person visits at the beginning of the study, after the first year, and a
      final visit after the second year.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include a cohort of 205 individuals with focal epilepsy who meet
        the ILAE definition of treatment resistance.
      
Biospecimen description: 
      Blood samples will be collected at the first visit and the final visit. A third sample may be
      collected from those participants who experience a seizure-free period of three months or
      more during the study period. All blood samples will be retained indefinitely, for use in
      future research. The specific details of future studies are unknown at this time, but will
      include genomic, proteomic, metabolomic and transcriptome analyses.
    
Keywords: focal; partial
Detection of COVID-19 Using Breath Analysis - Validation Study.
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation
      study.
    

Detailed description: 
      A diagnostic prospective single-site study, with no anticipated risks or constraints.

      Primary objective- To validate the value of a set of breath VOC biomarkers that enable the
      investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison
      to the gold-standard testing methodology.
    

Intervention name(s): VOX
Intervention type(s): Diagnostic Test
Intervention description(s): Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared
      to giving bevacizumab at the same time as chemotherapy improves patient overall response to
      treatment.
    

Detailed description: 
      OBELICS is a two-arm phase 3 trial comparing in mCRC patients (1:1): concurrent
      administration of bevacizumab in combination with modified FOLFOX-6 regimen (mFOLFOX-6) or
      modified OXXEL regimen (mOXXEL), in which bevacizumab is administered the same day as
      oxaliplatin, (standard arm); and sequential administration of bevacizumab with the same
      chemotherapeutic regimens, in which bevacizumab is administered 4 days before oxaliplatin at
      each cycle (experimental arm) Oxaliplatin regimen (mFOLFOX/mOXXEL) is chosen according to
      local clinical practice at the beginning of the study.
    

Intervention name(s): Bevacizumab; Oxaliplatin; levo-folinic acid; 5-fluorouracil; Capecitabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.; 85mg/m2 IV every 2 weeks for up to 24 weeks; 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks; 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule); 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
Other intervention name(s): Avastin; Eloxatin; Lederfolin; Fluorouracil; Xeloda
Intervention MeSH terms: Leucovorin; Folic Acid; Bevacizumab; Capecitabine; Fluorouracil; Oxaliplatin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic; stage IV
The WISE Trial - Walking Improvement for SCI With Exoskeleton
Condition: Injuries, Spinal Cord
MeSH terms: Spinal Cord Injuries; Spinal Injuries
Study type: Interventional

Summary: 
      A randomized, controlled trial comparing exoskeleton gait training with standard gait
      training or no gait training in community-dwelling participants with chronic incomplete
      spinal cord injury
    

Detailed description: 
      Community dwelling iSCI participants may improve clinical gait function by engaging in a gait
      training regimen, where robotic exoskeletons can readily deliver a precise dose and
      simultaneously reduce the physical stress imposed on therapists using conventional manually
      assisted stepping practice. Exoskeleton training is predicted to improve function in
      participants receiving usual care, but not superior to intensity-matched manual training. The
      rationale to implement exoskeleton robotics as preference in gait training is based on
      precision dosing, over-ground training, and reduced therapist burden for high repetition
      training.

      The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve
      gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The
      objectives of this study are the following:

      A. Primary Objective:

      To demonstrate that a 12 week robotic gait training regimen can lead to a clinically
      meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in
      community dwelling participants with chronic iSCI.

      B. Secondary Objectives:

        1. To examine the economic factors such as number of physical therapists/staff required
           during training.

        2. To analyze the physical burden on therapists assisting and supervising during training.

        3. To study the influence of factors that may modify the gait recovery in the chronic
           incomplete SCI population (demographic, clinical, functional, psychological, balance,
           etc.).
    

Intervention name(s): Ekso GT Rehabilitation Therapy; Body Weight Supported (BWS) Treadmill Training
Intervention type(s): Device; Device
Intervention description(s): Walking Improvement for Spinal Cord Injuries with Exoskeleton; Standard gait training using BWS PT and overground training
Other intervention name(s): Exoskeleton; Conventional Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Cord; Injury; Exoskeleton; Ekso; Rehabilitation
Assessing Repeat Fit Testing for CRC
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will randomly assign 220 men and women to either a social media intervention or a
      standard reminder system to have a repeat screening test for colo-rectal cancer.
    

Detailed description: 
      Only persons initially screening by FIT (through a Rural Cancer Prevention Center service
      program) will be eligible for study participation. The objective is to test a social
      media-based intervention designed to promote annual repeat colo-rectal cancer screening using
      the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220
      men and women (50 to 75 years of age) will be recruited and randomly assigned to either the
      intervention condition (monthly social media contact) or a control condition (standard of
      care reminder for repeat testing one month before the annual test is due). The dependent
      variable will be whether volunteers requested and retuned a FIT kit with 60 days of the
      annual due date (one year from their initial screening).
    

Intervention name(s): Now I'm Telling You
Intervention type(s): Behavioral
Intervention description(s): Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males
Condition: Obesity Adult Onset
Study type: Interventional

Summary: 
      It was demonstrated that acute dietary supplementation with GSE reduced arterial blood
      pressure via reduction in Q in obese individuals. However, no studies have investigated the
      chronic effects of dietary GSE supplementation on hemodynamic responses during exercise.
      Given the fact that obesity is associated with an impaired function of eNOS, the effect of
      chronic dietary GSE supplementation on abnormal blood pressure response to exercise and
      aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases
      systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),
      Q, and aortic stiffness at rest and during exercise. This study would determine that this
      supplementation may be used as a non-pharmacological intervention to prevent incident
      hypertension and cardiovascular events during exercise via enhanced endothelial function.
    

Detailed description: 
      We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in
      obese and overweight males (N=10) are reduced following chronic GSE supplementation during
      exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial
      pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular
      conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were
      compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period.
      Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60%
      workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no
      significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that
      chronic supplementation with GSE reduces arterial pressure at rest and during exercise
      primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to
      treat augmented blood pressure responses in obese and overweight males at rest and during
      exercise.
    

Intervention name(s): Grape Seed Extract
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore whether patients with restless legs syndrome (RLS)
      differ from healthy subjects in daytime and night time autonomic function and cardiovascular
      risk markers and whether 4 week treatment with pramipexole affects autonomic function and
      cardiovascular risk markers in patients with RLS.
    


Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Restless legs syndrome
Health Needs of Patients With Kallmann Syndrome
Condition: Kallmann Syndrome; Congenital Hypogonadotropic Hypogonadism; Idiopathic Hypogonadotropic Hypogonadism
MeSH terms: Kallmann Syndrome; Hypogonadism; Syndrome
Study type: Observational

Summary: 
      Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a
      rare endocrine disorder that is characterized by failure to undergo puberty combined with
      infertility. KS/CHH patients face a number of psychosocial burdens related to delays in
      diagnosis, inadequate access to expert care, and lack of information about the condition. As
      such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This
      study aims to identify the needs of patients and understand the issues that must be overcome
      to achieve improved health and quality of life.
    

Detailed description: 
      This study aims to examine the experiences of patients diagnosed with Kallmann syndrome
      (KS)/congenital hypogonadotropic hypogonadism (CHH).

      The study includes two parts:

        -  online survey (less than 30 minutes to complete)

        -  focus groups with KS/CHH patients

      The aim of this project is to better understand what health needs are not presently being met
      for these patients and to identify targets for improving the care of patients diagnosed with
      KS/CHH
    

Intervention name(s): online questionairres
Intervention type(s): Other
Intervention description(s): see group descriptions
Other intervention name(s): patient focus groups
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults diagnosed with congenital hypogonadotropic hypogonadism/Kallmann syndrome will be
        recuited internationally.
      
Keywords: rare disease; community-based participatory research; health promotion; quantitative research; qualitative research; focus group
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is
      to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will
      be treated for at least 6 weeks.
    


Intervention name(s): CSF-1; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): One drop bilaterally twice daily for approximately 6 weeks; One drop bilaterally twice daily for approximately 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
Condition: Affective Psychosis, Bipolar; Depression, Bipolar; Manic-Depressive Psychosis; Psychoses, Manic-Depressive
MeSH terms: Mania; Depression; Depressive Disorder; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Affective Disorders, Psychotic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of sustained-release
      quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression
      for 8 weeks.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate (Seroquel) SR
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder; Bipolar Depression,; Manic Depression; Seroquel; Seroquel SR; quetiapine fumarate