bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the TruMatch® System in Knee Prosthetic Surgery
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Patient specific instrumentation is an alternative to conventional intra- and extra-medullary
      guides to perform the femoral and tibial cuts in total knee replacement (TKR).

      This instrumentation could provide a better alignment of a TKR, reduce blood losses and
      operative time, and improve clinical outcomes.

      The primary goal of this study is to compare the femorotibial mismatch angle of two groups of
      patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional
      Attune® instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient undergoing
      TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.
    

Detailed description: 
      Good alignment after a TKR leads to faster rehabilitation, better clinical outcomes and lower
      revision rate. A correct rotational (axial) alignment reduces patellofemoral complications,
      polyethylene wear and unexplained knee pain.

      A randomized controlled study is conducted to test if to use the TruMatch® (DePuy Johnson &
      Johnson, Warsaw, Indiana) patient specific instrumentation reduces the number of patients
      presenting femorotibial mismatch.

      Secondary goals are to compare:

        -  alignment in the coronal, sagittal and axial plane of the femoral component;

        -  alignment in the coronal and sagittal plane of the tibial component;

        -  number of recuts during surgery and surgeon's adherence to planning;

        -  blood loss;

        -  clinical outcome after two months using the Oxford Knee Score (OKS).

      After having signed informed consent, patients will be randomized in 2 groups preoperatively.
      A long-leg CT scan, according to manufacturer's instructions, will be performed on patients
      randomized to the TruMatch® group.

      Haemoglobin and haematocrit will be recorded pre- and postoperatively.

      Two months after surgery a knee CT-scan, anteroposterior and laterolateral scanograms will be
      performed on all patients, and OKS will be recorded.
    

Intervention name(s): TruMatch® patient specific cutting guide
Intervention type(s): Device
Other intervention name(s): TruMatch® Personalized Solutions (DePuy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Knee Replacement; Patient specific instrumentation
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Condition: Epilepsy; Generalized Tonic-clonic Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or
      3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years
      with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2
      Anti-Epileptic Drugs (AEDs).
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
Other intervention name(s): Keppra; E Keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Epilepsy; Generalized tonic-clonic seizures
Eating Behaviors Among Weight-Discordant Siblings
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to compare weight-discordant siblings in eating in the absence
      of hunger, caloric compensation, and the quality of their habitual diet. The investigator
      hypothesized that, within families and controlling for age differences, overweight and obese
      siblings would show greater eating in the absence of hunger, poorer caloric compensation, and
      poorer diet quality (e.g., increased percent of energy from fat and caloric beverages)
      compared to normal-weight siblings.
    

Detailed description: 
      The study used a discordant sibling design to compare putative obesity-promoting eating
      traits among siblings, 5-12 years, who were raised in the same household, but were discordant
      for weight status (normal-weight: BMI-for-age between 5 and less than the 85th percentile;
      overweight/obese: BMI-for-age greater or equal to the 85th percentile). Forty-seven pairs of
      same-sex siblings (boys and girls) were recruited from the greater Philadelphia area to
      participate in a 4-week study during which their eating behaviors and body composition were
      assessed. The study tested the hypotheses that overweight/obese, compared to normal-weight,
      siblings exhibit 1) a weaker ability to compensate for calories, 2) a greater susceptibility
      towards eating in the absence of hunger, and 3) habitual dietary intakes that favor increased
      dietary energy density (kcal/g) and increased %energy derived from fat and caloric beverages.
      The use of a behavioral genetics design to study eating phenotypes among siblings is a unique
      approach to elucidate shared and non-shared environmental influences that can contribute to
      variations in weight status during childhood.
    

Intervention name(s): Feeding study
Intervention type(s): Other
Intervention description(s): In a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Comparison of Two Gelatine Solutions
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.
      during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital
      functions. To achieve this, different plasma substitutes are available: Albumin, dextran,
      hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base
      alterations during elective abdominal surgery can be reduced by the use of a new gelatine
      solution.
    


Intervention name(s): Gelofusine balanced; Gelofusine 4%
Intervention type(s): Drug; Drug
Intervention description(s): Gelofusine balanced combined with Sterofundin ISO; Gelofusine 4% combined with NaCl 0.9%
Intervention MeSH terms: Polygeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
Condition: Fetal Losses
Study type: Observational

Summary: 
      The aim of the study is to assess the role of complement dysregulation and its impact on
      antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.
    

Detailed description: 
      Females with medical history of repeated foetal losses will have blood sampling to perform
      analyses. If pregnant, blood sampling will be performed at different times throughout the
      pregnancy.

      Controls will be females without medical history of repeated foetal losses. They will also
      have blood sampling to perform analyses. If pregnant, blood sampling will be performed at
      different times throughout the pregnancy.

      Blood analyses will focus on :

        -  mutations in genes coding for molecules that modulate complement activity

        -  serum levels of sFlt1 and endoglin and their link to complement activation
    

Intervention name(s): blood sample
Intervention type(s): Other
Intervention description(s): blood sampling at inclusion and throughout pregnancy when pregnant
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females with medical history of repeated foetal losses and females without medical history
        of repeated foetal losses as controls.
      
Biospecimen description: 
      blood samples
    
Keywords: Foetal loss; complement; antiangiogenic factors; Repeated fetal losses
Statin Immune Study
Condition: Drug Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe
      drugs. However, up to one third of statin users can experience muscle symptoms, which are
      most commonly mild without any conventional laboratory signs of muscle damage. However, these
      muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy,
      reducing its effectiveness. Recent data has highlighted the potential role of immune system
      in development of statin-induced muscle pain. Variation in the LILRB5 gene has been
      associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic
      variability in tolerability and immune response to atorvastatin in healthy volunteers.

      The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in
      Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE
      study. The participants will be healthy, and recruited according to their genotype of LILRB5
      (information available from GoSHARE). The volunteers will then enter a randomised cross-over
      study with two treatment periods. During treatment period one, all participants will be
      commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment
      period, blood and urine samples will be taken and a muscle symptoms questionnaire will be
      completed to assess the tolerability and immune response to the study drug exposure. After
      four weeks, the study drug is stopped for a washout period of three weeks before cross-over
      commences. Thereafter, during treatment period two, the alternate study drug will be started,
      and tolerability will be assessed similar to that in period one. The study will last
      approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.
    


Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 80 mg once daily for 28 days.; Placebo once daily for 28 days.
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Atorvastatin; LILRB5; Statin intolerance
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
Condition: Respiratory Disorders; Asthma and Rhinitis
MeSH terms: Rhinitis; Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to determine whether the test product (GW483100 10 mg containing
      montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference
      montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under
      fasting conditions. This is an open-label, balanced, randomized, single dose, two-way
      crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete
      the study. Each subject enrolled will participate in two treatment periods separated by a
      washout period of at least 7 days and no more than 14 days between dosing occasions. Total
      duration in the study for each subject will be approximately 7 weeks from screening to the
      subject's last visit.
    


Intervention name(s): Test Montelukast; Reference Montelukast
Intervention type(s): Drug; Drug
Intervention description(s): Test Montelukast (GW483100) is available as round, biconvex, pink 10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water.; Reference Montelukast (innovator product) is available as pale beige, rounded square shaped,10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water. Singular is the innovator product used for this study, which is a trade name owned by Merck Sharp and Dohme Corporation.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Condition: Locally Advanced and Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the recommended dose of NC-6004 according to the
      dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy,
      safety and tolerability.
    


Intervention name(s): Nanoplatin (NC-6004) and Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer; Gemcitabine
Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Up to 1/3 of all patients infected with COVID-19 can develop complications that require
      hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS)
      is the most threatening and feared complication of COVID-19 infection, with mortality rates
      close to 50% in some groups.

      Autopsies between these severe cases reveal severe capillary involvement, with signs of
      intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal
      tissue repair. The available evidence suggests that abnormal activation or imbalance in the
      counter-regulation of the kallikrein-kinin system may play a central role in a positive
      feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the
      kallikrein-kinin system can therefore prevent deterioration of lung function by reducing
      inflammation, edema and microthrombosis.

      The objective of this phase IIb study is to assess the preliminary effects on the oxygenation
      parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients
      with moderate to severe COVID-19.
    

Detailed description: 
      The objective of this phase IIb study is to assess the preliminary effects on the oxygenation
      parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients
      with moderate to severe COVID-19.

      This is a blind randomized pilot clinical study which aims to include 110 patients (55 per
      arm).
    

Intervention name(s): ISIS 721744; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 1.2 mL of ISIS 721744 subcutaneous once after randomization; 1.2 mL subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antisense; kallikrein-kinin
Vilazodone Treatment for Marijuana Dependence
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated
      pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of
      vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management
      intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage
      study engagement and retention, and genomic DNA will be extracted to characterize subjects
      according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is
      hypothesized that vilazodone combined with MET and CM will reduce the percent of
      marijuana-positive urine drug screen results in marijuana-dependent individuals as compared
      to a placebo treatment combined with MET and CM.
    

Detailed description: 
      The purpose of this study is to determine if the medication vilazodone is effective in
      helping frequent marijuana smokers cut down or stop using marijuana. Vilazodone is FDA
      approved for the treatment of depression- in this study, vilazodone's effect on marijuana
      dependence is being investigated.

      Participation in the study takes 10 visits over a period of approximately two to three
      months. The first visit is a screening visit to determine if participants are eligible to
      participate. After the initial assessment visit, the weekly visits take about 30 minutes,
      with the exception of three therapy sessions which take approximately 60-90 minutes. The
      three therapy sessions will focus on participant's marijuana use and reasons they may have
      for stopping or cutting down on use. After completing an initial therapy session,
      participants will be randomly selected to receive the study medication, either vilazodone or
      placebo (a capsule that does not contain any active medication). Participants will have
      weekly study visits with a clinician. At each study visit, they will be asked to fill out
      forms and answer specific questions concerning their substance use, anxiety symptoms, and
      feelings in general. They will be providing urine samples to check for illegal drugs of abuse
      including marijuana and other drugs. They will also have blood samples drawn during to
      determine if you are taking the medication as directed.
    

Intervention name(s): Vilazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to 40 mg capsule daily; up to 40 mg capsule daily
Other intervention name(s): Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Marijuana; Vilazodone; Contingency management; Motivational enhancement therapy
Asian Youth and Tobacco Control Survey
Condition: Tobacco Use; Smoking
Study type: Observational

Summary: 
      The overall goal of this study is to identify and understand the environmental
      characteristics associated with tobacco use and tobacco initiation among Asian American youth
      from primarily two communities: Chinese and Vietnamese. The specific aims of this study are
      twofold:

        -  To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston
           area compared with non-Asian American communities.

        -  To study the relationship between environmental characteristics (both pro- and
           anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth.

        -  To explore if degree of acculturation is related to tobacco initiation and use among
           Chinese and Vietnamese youth.
    

Detailed description: 
      This is a survey about health-related behaviors, risks, attitudes and acculturation. It
      includes questions about use of alcohol, tobacco, and other drugs; safety and violence; diet
      and physical activity; and youth programs and resources in your community. Your answers are
      completely anonymous, and your name will not appear anywhere on this survey or as part of
      this survey. Your parents will not see your responses.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Questionnaire about tobacco and alcohol use, acculturation, and other related topics.
Other intervention name(s): Survey
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants self-identified as having Chinese or Vietnamese descent.
      
Keywords: Healthy Control; Tobacco Use; Tobacco Initiation; Smoking; Questionnaire; Survey
D-serine for Posttraumatic Stress Disorder Treatment
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to asses the effects of the NMDA receptor full agonist D-serine
      while used as adjuvant treatment for individuals suffering from chronic posttraumatic stress
      disorder (PTSD). Dysfunction of neurotransmission mediated at NMDA receptor plays a cardinal
      role in the pathophysiology of PTSD and PTSD patients typically suffer from cognitive
      dysfunctions and avoidance& depressive symptomatology that may be mediated by NMDA receptor
      function deficits.

      Thus, enhancement of NMDA activity by using D-serine may be beneficial in the treatment of
      PTSD. The study design involves two 6 week periods during which the participants will be
      randomly assigned to receive treatment with D-serine (~2g /dy)and placebo. This design allows
      each participant the opportunity to respond to the experimental treatment.
    


Intervention name(s): D-serine (~2g /day)
Intervention type(s): Drug
Intervention description(s): Two 6 weeks treatment arms under a cross over design. In one arm adjuvant treatment with experimental medication (D-serine ~2g /day), in the second arm adjuvant treatment with placebo (~2g /day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment