bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
Condition: Chronic Spontaneous Urticaria; Angioedema
MeSH terms: Angioedema; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the impact of omalizumab on the quality of life improvement when added
      to the standard therapy in refractory patients suffering from chronic spontaneous urticaria
      and angioedema.
    

Detailed description: 
      This study will be conducted using a double-blind, placebo-controlled, randomized,
      multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in
      Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or
      inhibiting the occurrence, time-course and severity of angioedema episodes.

      Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current
      approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed
      by an 8-week follow-up. The study aims to enroll approximately 70 patients.

      The study is divided into a 2-week screening period, a 28-week double-blind treatment phase
      with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Humanized monoclonal antibody against human IgE; Placebo to omalizumab
Other intervention name(s): IGE025; Placebo for Omalizumab
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic spontanous urticaria, refractory CSU, Angioedema
A Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Participants With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the psychometric properties of a Self-administered
      Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal
      Learning Test (RAVLT) in normal control (NC) participants and participants with Mild
      Cognitive Impairment (MCI) against a standard version of the RAVLT test, administered by an
      examiner under the same conditions.
    

Detailed description: 
      This is a single-center (when only one hospital or medical school team work on a medical
      research study), randomized (participants are assigned to treatment by a chance), crossover
      (participants may receive different treatments sequentially during the trial) study. The
      study consists of a Screening Phase (Day -3 up to and including Day 1), Test Phase (Test Day
      1 and Test Day 2 [within 7 to 14 days following Test Day 1]) and an optional follow-up visit
      within 7 days after the last study-related activity for participants who experienced an
      adverse event that had not resolved by the end of the last test visit.The NC and MCI
      participants will initially either undergo a standard version of the RAVLT test or the
      SAMSTAR version of the RAVLT test on Test Day 1 or on the same day as screening, with
      follow-up testing using the other test using a crossover design to be conducted within 1 to 2
      weeks at the same venue (Test Day 2). There will be a 7-to 14-day memory washout period
      between the test periods. No investigational medicinal product will be administered. The
      maximum study duration for a participant will not exceed 3 weeks.
    

Intervention name(s): SAMSTAR; RAVLT
Intervention type(s): Other; Other
Intervention description(s): This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.; This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female adult normal control (NC) participants and participants with Mild Cognitive
        Impairment (MCI), aged 55 to 84 years receiving healthcare in primary care and/or neurology
        practice settings.
      
Keywords: Mild Cognitive Impairment; Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR); Rey Auditory Verbal Learning Test (RAVLT); Word List Recall (WLR)
Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for
      rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.

      The investigators have conceived this study to test whether TCEMS is feasible and tolerated
      by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.
    


Intervention name(s): Transcutaneous electrical muscle stimulation
Intervention type(s): Device
Intervention description(s): On the first hospitalization day patients received lower extremity TCEMS. We used GymnaUniphy device (GymnaUniphy N.V., 2004, 3740 Bilzen, Belgium) with four surface patch electrodes applied over each lower extremity quadriceps muscle. Patients were in the supine position and were advised to relax during sessions. A prespecified program for lower extremity strength training in sessions of 25 minutes, twice a day (first training in the morning, second in the afternoon, with minimal time difference of 6 hours) was performed six days per week during the hospitalization.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic obstructive pulmonary disease
Modafinil to Prevent Postoperative Cognitive Decline
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of
      the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil
      as shown by neurocognitive testing.The treatment effects will be evaluated compared to
      placebo as well as a non-surgical group.
    


Intervention name(s): Preoperative modafinil + postoperative placebo; Preoperative modafinil + postoperative modafinil; Preoperative placebo + postoperative placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg modafinil pre-operatively and placebo immediately post-operatively.; 200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.; Placebo pre-operatively and placebo immediately post-operatively.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
Condition: Post Thrombotic Syndrome; Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Syndrome
Study type: Interventional

Summary: 
      'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential
      effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen
      following an initial acute DVT in children.
    

Detailed description: 
      The feasibility of an innovative intervention of a validated fitness tracker, the Fitbit, to
      improve adherence to a 12-week activity regimen in a pilot randomized controlled trial (RCT)
      will be tested in 44 subjects with first, acute, proximal lower extremity deep vein
      thrombosis (DVT).

      The primary outcomes will consist of a) feasibility indicators determined a priori
      (eligibility, consent, adherence, retention) and b) estimates of effect size associated with
      the prescribed activity regimen, by describing within-subject change in QoL and potential
      biomarkers of postthrombotic syndrome (PTS) pre and post intervention in each group.
    

Intervention name(s): Fitbit; 30-minute education session
Intervention type(s): Device; Behavioral
Intervention description(s): The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
Other intervention name(s): Activity tracker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Venous thromboembolism; Deep Vein Thrombosis; Lower Extremity; Blood clot; Anticoagulation; Physical Activity; Fitbit; Post-thrombotic syndrome; Post-phlebitic syndrome; Thrombosis
Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate antihypertensive activity and safety profile of Tarka in Russian
      hypertension patients by ambulatory blood pressure measurement (ABPM)
    


Intervention name(s): trandolapril/verapamil
Intervention type(s): Drug
Intervention description(s): 180/2 mg QD
Other intervention name(s): ABT-TARKA; Tarka
Intervention MeSH terms: Verapamil; Trandolapril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Tarka
Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions
Condition: Diagnostic Self Evaluation
Study type: Observational

Summary: 
      This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking
      Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic
      tasks in an experimental model.
    

Detailed description: 
      7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4
      point lickert scale) were evaluated for this study. Totally twenty-four participants (8
      experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks
      (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the
      suture, move the needle from one instrument to another instrument, pick-and-place, cutting,
      three different suturing) in term of total task time and error number. Statistical Package
      Program was used to perform statistical analyses. The data were presented as arithmetic means
      and standard deviations were calculated in each group. A P value of <0.05 was considered to
      be statistically significant.
    

Intervention name(s): Laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Two methods will be compare
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Medical doctors
      
Keywords: laparoscopy, accuracy, duration
Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
Condition: Overactive Bladder; Urinary Incontinence; Children
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the
      antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic
      overactive bladder and urinary incontinence.
    

Detailed description: 
      This clinical trial showed superior efficacy of propiverine over placebo and convincing
      tolerability for the treatment of children suffering from OAB and urinary incontinence.
    

Intervention name(s): Mictonetten 5 mg, coated tablet; placebo
Intervention type(s): Drug; Drug
Intervention description(s): propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW); placebo corresponding to body weight
Other intervention name(s): Mictonetten
Intervention MeSH terms: Propiverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: antimuscarinics; children; overactive bladder; propiverine; urinary incontinence; urotherapy
Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
Condition: Recurrent Pregnancy Loss; Early Pregnancy Failure
MeSH terms: Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk
      sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in
      predicting early pregnancy failure in patients with recurrent pregnancy loss
    

Detailed description: 
      1. Mean gestational sac diameter (MSD) is determined by measuring the mean of 3 diameters
           (longitudinal, antero-posterior and transverse) which are measured from inside of the
           sac excluding the decidual reaction from the measurement. It is normally eccentric in
           location embedded in endometrium, and has a smooth; round or oval shape.

        2. Yolk sac is measured by placing calipers on the inner limits of the longer diameter. It
           usually appears at the periphery of the gestational sac and should not be floating
           within the sac. Size of the sac, shape, echogenicity of the rim and center of sac, its
           number and degenerative changes such as calcification will be evaluated. YS having
           diameter between 3-7mm, rounded shape, absence of degenerative changes, presence of
           echogenic rim and hypoechoic center are considered normal. Any deviation from above
           parameters is considered abnormal.

        3. Crown-rump length (CRL) is the length of the embryo from the top of its head to bottom
           of torso excluding the yolk sac and the extremities, to be measured in sagittal plane of
           the embryo and recorded as an average of three measurements.

        4. The MGSD-CRL ratio was calculated as the difference between the MGSD and the CRL if less
           than 5 mm are prone to first trimester miscarriage.

        5. Embryonic heart rate by M-mode calculated as beat per minute using software of
           ultrasound machine after measuring by electronic calibers of distance between 2 heart
           waves on frozen M-mode image.

        6. Uterine artery Doppler with measurement of systolic/diastolic (S/D) ratio, resistance
           index (RI) and pulsatility index (PI) of uterine arteries.
    

Intervention name(s): ultrasound parameters
Intervention type(s): Diagnostic Test
Intervention description(s): ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        90 pregnant females with history of recurrent pregnancy loss
Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)
Condition: Effect of PGD on Implantation Rates in IVF Cycles
Study type: Observational

Summary: 
      The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis
      (PGD) increases implantation and delivery rates in couples attempting to conceive through in
      vitro fertilization (IVF).
    

Detailed description: 
      FISH based PGD techniques have provided little improvement in implantation and delivery
      rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will
      show a benefit to patients. This study is a randomized clinical trial that seeks to validate
      24 chromosome PGD.

      Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In
      order to be randomized, the patient must have blastulated embryos suitable for biopsy on day
      5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos
      transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos
      will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9
      weeks gestation and buccal swabs collected from the infant(s).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        500 patients attempting conception through IVF who have a maximum of one prior failed IVF
        cycle.
      
Biospecimen description: 
      Blood samples from the male and female partners. Buccal swabs from infants.
    
Keywords: PGD; IVF
Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)
Condition: Esophageal Cancer; Surgery; Jejunostomy; Complications; Nutrition Related Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      Comparison of nutritional and early surgical outcome between early and delayed oral feeding
      after esophagectomy for esophageal cancer
    

Detailed description: 
      Esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and
      is associated with a poor prognosis. The 5-year overall survival rate is 40.0 % and the
      30-day mortality rate is 1.7 %. Surgical resection is the most effective treatment for
      localized esophageal cancer; however, esophagectomy is extremely invasive and is associated
      with high morbidity and mortality rates.

      Nutrition is one of the most important factors to consider after esophagectomy in order to
      reduce surgical mortality. The European Society for Parenteral and Enteral Nutrition
      guidelines recommend early tube feeding after major gastrointestinal surgery for cancer.
      Several studies have shown that enteral nutrition is more effective than parenteral nutrition
      in reducing postoperative complications in postesophagectomy patients. It has been reported
      that 5 to 7 days are required for anastomosis site healing. Therefore, many centers start
      oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation,
      and enteral feeding via jejunostomy are maintained for nutritional support. However, the
      optimal timing for oral feeding after esophagectomy is still under debate.

      In our center, the investigators routinely place jejunostomy tube for sufficient enteral
      feeding after esophagectomy. Before 2014, the investigators started oral feeding 5 to 7 days
      after esophagectomy and patients were discharged with soft blended diet. After 2014, the
      investigators changed our postoperative management protocols: 1) the investigators started
      only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until
      the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube.
      However, no studies have been conducted showing the optimal timing for oral feeding for
      esophagectomy patients for nutritional support and postoperative care.

      The investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy
      feeding is superior to conventional oral feeding for nutritional support and early clinical
      outcome.
    

Intervention name(s): Jejunostomy feeding
Intervention type(s): Dietary Supplement
Intervention description(s): Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophagectomy; esophageal cancer; nutritional support; jejunostomy
Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
Condition: Pain
Study type: Interventional

Summary: 
      The aim of this study is to use a brain stimulation tool called transcranial direct current
      stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of
      lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin
      cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily
      influence the way the stimulated part of the brain functions. With this method, the
      involvement of specific parts of the brain can be investigated in the working of the brain as
      a whole.
    


Intervention name(s): transcranial direct current stimulation (tDCS); Lidocaine cream; Capsaicin cream; Control cream
Intervention type(s): Device; Other; Other; Other
Intervention description(s): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.; Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).; Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).; A neutral cream will be applied on the arm as a control.
Intervention MeSH terms: Lidocaine; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
GLP-1 Receptor Targeting in Diabetic and Healthy Individuals
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of the study is to determine whether there are differences in pancreatic uptake
      of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D
      patients have a markedly reduced uptake, the compound may be suitable for estimation of
      pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.
    


Intervention name(s): radiolabeled Exendin
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 Diabetes patients and healthy volunteers responding to advertisment
      
Biospecimen description: 
      blood samples
    
Keywords: Diabetes