bioihbjkbjnl/mcl2 huggingface dataset:
Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism
Condition: Hypersplenism
MeSH terms: Hypersplenism
Study type: Interventional

Summary: 
      The present study aimes at comparing the transradial and transfemoral approaches for partial
      splenic embolization in patients with hypersplenism.
    

Detailed description: 
      Since its development in 1979, partial splenic embolization (PSE) has been universally
      accepted to treat patients with hypersplenism in preference to surgical splenectomy. The
      spleen is the primary source of antibodies, lymphocyte production, and responsible for
      phagocytosis of white cells. Additionally, it plays an essential role in the immune system.
      Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function
      and was thought to be an effective alternative to treat thrombocytopenia and leukopenia
      resulted from hypersplenism with fewer complications.

      PSE is usually performed using a femoral artery approach that requires bed rest for a few
      hours. Recently, the transradial approach, with less obvious need for bed rest, has been more
      widely applied for cardiovascular intervention.
    

Intervention name(s): partial splenic artery embolization
Intervention type(s): Procedure
Intervention description(s): embolization of the splenic artery for the treatment of hypersplenism
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AZD7325 Multiple Ascending Dose Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate safety, tolerability, PK and PD effects of orally administered
      AZD7325 after single and repeated ascending doses.
    


Intervention name(s): AZD7325
Intervention type(s): Drug
Intervention description(s): Oral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase I; Pharmacokinetics
MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Condition: End-Stage Renal Disease; Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      MK-2060 is being developed for prevention of thrombotic complications in end-stage renal
      disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the
      safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12
      receptor inhibitor, clopidogrel, in ESRD patients.
    


Intervention name(s): MK-2060
Intervention type(s): Drug
Intervention description(s): MK-2060 administered via IV infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and
      effective long-term treatment regimen. Unfortunately, there are still no disease-specific
      treatment for ADPKD approved in the US. A rational step towards identifying such agents is to
      test therapies that have a proven safety profile with mechanisms of action that can counter
      the disease progression.

      The purpose of this study is to investigate whether drinking increased amounts of water
      (water loading) might slow down polycystic kidney growth or kidney function decline. Water
      loading can cause the suppression of a pathway that causes fluid buildup and cyst growth.
      High water intake has been safely used in the clinical setting, such as in the case of kidney
      stone therapy. New York State tap water is widely available and safe, making it highly
      cost-effective as well.
    

Detailed description: 
      The study will involve 11 visits to the study site over 19 months. Participants will need to
      follow specific dietary and fluid recommendations. There will be physical examinations and
      medical history assessments at each visit. Testing will include undergoing magnetic resonance
      imaging (MRI), blood and urine tests. Study participants will be compensated for their time.
      Detailed study procedures will be reviewed upon contact with the study team.
    

Intervention name(s): High Water Intake
Intervention type(s): Other
Intervention description(s): After 6 months of usual, unchanged diet and fluid intake, participants will be asked to increase the daily fluid intake based on the principal investigator's prescription. The actual amount of extra water prescribed will depend on the results of the participant's 24 hour urine test.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire
Condition: Dizziness
MeSH terms: Vestibular Diseases; Dizziness
Study type: Observational

Summary: 
      There is currently no score in French for evaluating disorders of the child's balance. Only
      one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular
      Symptom Questionnaire ". The objective of the research is to validate the French translation
      of this questionnaire.
    

Detailed description: 
      Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7
      to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child,
      post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are
      the most common causes. However, these disorders are often undiagnosed in children as many
      doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably
      because of the difficulty children may have in expressing or describing their dizziness
      symptoms without specific questioning, but also because of the tendency of children to accept
      the terminology that an adult offers them or even tend to cling to their parents when they
      experience a balance disorder or vertigo. Vestibular disorders can also have secondary
      psychological symptoms with an impact on school learning and quality of life. A precise
      interrogation to check the symptoms, to look for the triggers and to trace the installation
      of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very
      important to help the child express his or her feelings by proposing different descriptions
      and formulations to determine the etiology and diagnosis. While a number of international
      questionnaires validated and translated into French exist in the adult to assess the
      presence, severity and impact of vestibular symptoms, there is currently no score in French
      for evaluating disorders of the child's balance. Only one questionnaire was validated in the
      child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective
      of the research is to validate the French translation of this questionnaire.
    

Intervention name(s): Pediatric Vestibular Symptom Questionnaire
Intervention type(s): Other
Intervention description(s): Subjects respond to the translated questionnaire twice with 15 days interval
Other intervention name(s): Patient questionnaire
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients followed by the department of otolaryngology and cervico-facial surgery of
        Necker-Enfants Malades hospital and siblings for the control subjects.
      
Keywords: Pediatric vestibular symptom; Pediatric vestibular symptom questionnaire in french
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese
      populations. Approximately 144 participants will be enrolled and equally stratified into
      three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages
      6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted
      sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then
      participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator
      and the Ethics Review Committee will review blinded safety data and make decision based on
      their best clinical judgment to move study forward between cohorts. Duration for the entire
      study will be approximately 6-9 months.
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo; Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.
The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.; Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.; Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.; Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
Other intervention name(s): V260, RotaTeq™; V260, RotaTeq™.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Emotional Brain Processes in Recreational Cannabis Users
Condition: Recreational Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      This fMRI study investigates neural correlates of emotion regulation, emotion processing and
      craving in recreational cannabis users.
    


Intervention name(s): fMRI
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Recreational male cannabis users
      
Keywords: cannabis; fMRI; emotion
Effects of Beer (Alcohol) on Social Cognition
Condition: Healthy
Study type: Interventional

Summary: 
      The present study aims to evaluate effects of beer (alcohol) on social cognition.
    

Detailed description: 
      Alcohol is one of the most widely used recreational drugs and it is often used in social
      settings to enhance sociability. There are few data showing that acute alcohol consumption
      affects facial emotion recognition. However the acute effects of alcohol in social drinkers
      on different aspects of social cognition are largely unknown. In the present study, we will
      therefore evaluate effects of beer (alcohol) on social cognition. The study will include 60
      subjects (30 male, 30 female) and use a placebo-controlled, crossover design with the two
      experimental conditions alcoholic beer (individually calculated amount aiming to achieve a
      blood-alcohol concentration of 0.4g/kg), and non-alcoholic beer (placebo). We primarily aim
      to evaluate whether beer (alcohol) affects the ability to correctly decode emotions in facial
      expressions using different facial emotion recognition Tasks. Additionally, appraisal of
      visual erotic stimuli following alcohol consumption will be evaluated. Subjective social and
      mood effects will be assessed using validated questionnaires. Blood samples will be collected
      to assess plasma levels of the "social hormone" oxytocin as well as blood alcohol levels to
      test possible associations with effects on emotional processing.
    

Intervention name(s): Beer (alcoholic); Placebo (non-alcoholic beer)
Intervention type(s): Other; Other
Intervention description(s): Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg); Non-alcoholic beer serves as Placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: social neuroscience; emotion; face recognition; empathy; beer; alcohol; social cognition
Acute Lymphoblastic Leukemia Relapse in Sweden 2003-2007
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The
      aim of this population-based study was to assess the results of reinduction treatment and
      allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden
      2003-2007.
    

Detailed description: 
      This is a national, multicenter, prospective, population-based study of outcome among adult
      patients aged 19 to 65 years with ALL relapse diagnosed during 2003-2007 in Sweden. Most of
      the patients had primary treatment according to National guidelines for ALL as recommended by
      The Swedish Adult ALL Group (SVALL). The guidelines suggest two different treatment protocols
      for early relapses, and retreatment according to the initial therapy for late relapses, with
      the intention to proceed to allogeneic SCT in CR2 for eligible patients. The aim of the
      current study was to assess outcome among adult patients after first ALL relapse, and the
      utilization and efficacy of recommended protocols and of allogeneic SCT in this setting.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adults with relapsed ALL
      
Keywords: acute lymphoblastic leukemia; relapse; salvage; prognostic
Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 1

Summary: 
      Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and
      soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There
      are treatments available to help manage these symptoms like weight loss, and analgesics.
      Surgery is the appropriate treatment in patients who have failed these conservative
      treatments. The aim of this clinical study is to assess safety of autologous cultured
      chondrocyte intra-articular injection and obtain its clinical results in patients with severe
      hip osteoarthritis.
    

Detailed description: 
      In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited.
      All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing
      zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive
      chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post
      injection for 6 months at time intervals. Parameters considered being evaluated are, adverse
      effects, pain intensity and joint physical function and cartilage repair. These effects are
      measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.
    

Intervention name(s): cell injection
Intervention type(s): Biological
Intervention description(s): Intra articular injection of chondrocyte
Other intervention name(s): chondrocyte transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chondrocyte hip osteoarthritis intra articular injection
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated
      by the body and to evaluate whether it is safe and well tolerated.
    


Intervention name(s): TD-1211 Dose 1; TD-1211 Dose 2
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid induced constipation; Constipation
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
Condition: Gastric Subepithelial Tumors
Study type: Observational

Summary: 
      The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound is
      currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic
      technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography
      (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and
      subcellular levels. This study aimed to describe nCLE interpretation criteria for the
      characterization of gastric subepithelial tumors, with histopathological correlation, and to
      perform the validation of these criteria.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients undergoing EUS for the diagnosis of gastric subepithelial tumors will be
        recruited in this study at Qilu Hospital, Shandong University.
Lactocare Baby Drops in Infants Colic
Condition: Infant Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      The objective of this study is to determine an efficacy of the combination of L. rhamnosus
      19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in
      infants aged 4 through 12 weeks with IC. The active group of infants will receive
      lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as
      oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at
      the end of intervention to define a difference between the groups
    

Detailed description: 
      There is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant
      colic, the condition that affects around 1 of 4-5 infants. The interest for dietary
      supplementation has been evoked by a line of earlier studies, indicating that infants with
      colic had an increased number of gas-forming E.coli in the intestines and potential
      interference between lactobacilli and E.coli. Systematic review of evidence, based on the 6
      randomized controlled dietary studies, conducted in Italy, Poland, Australia, Canada, and
      Finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day
      after the 3 weeks dietary course with lactobacilli . In the mentioned studies most commonly
      used lactobacilli were L. reuteri, however, the effect of combination of L. reuteri with
      other lactobacilli remains unknown.
    

Intervention name(s): Drops with lactobacilli and vitamin D3; Drops with vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oil suspension with lactobacilli and vitamin D3; Oil suspension with vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Yliver as a Test to Early Diagnose HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about
      750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer
      increases the available treatment options, the methods currently used for screening are not
      sufficiently sensitive for this purpose.

      The investigators provide a high-performance and highly reliable in vitro platform that
      allows the identification and quantification of autoantibodies in serum for use as biomarkers
      of liver cancer, using an ELISA test (Yliver).

      The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for
      the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients
      diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with
      chronic liver disease without cirrhosis.
    


Intervention name(s): Test Yliver
Intervention type(s): Diagnostic Test
Intervention description(s): Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic
        liver disease: patients with chronic liver diasease without cirrhosis Control: normal human
        serum from donors without liver disease
      
Biospecimen description: 
      Serum
    
Keywords: Hepatocellular carcinoma; Tumor associated antigen; Early diagnosis; Autoantibodies; Alpha fetoprotein
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to assess safety and impact of a non-antibiotic therapy
      approach with Canephron® N in the management strategy of uncomplicated lower urinary tract
      infections (UTIs).
    

Detailed description: 
      250 patients total 7-day treatment period with Canephron® N (2 tablets three times a day) and
      a follow-up period until Day 37. A total of three visits are planned on Day 0 (screening,
      start of study treatment), Day 7 (end of study treatment) and Day 37 (end of study visit).

      Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by
      the investigator. In case the patients experience consistent or worsening of symptoms they
      may be offered antibiotic therapy at the discretion of the investigator at any time. In this
      case Canephron® N intake will be stopped.

      At least 50% of the patients, i.e. 125 subjects, should have received a 7-day treatment with
      Canephron® N. If less subjects are available recruitment of subjects will be continued until
      the required number of 125 subjects is reached.

      Due to withdrawal of study in Russia total study population was reduced to 125 patients.
    

Intervention name(s): Canephron® N
Intervention type(s): Drug
Intervention description(s): 3x 2 coated tablets/day for 7 days p.o.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment