bioihbjkbjnl/mcl2 huggingface dataset:
Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia
Condition: Healthy Volunteers
MeSH terms: Hyperemia
Study type: Interventional

Summary: 
      The objective of this proof of concept study is to assess the involvement of
      epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia
      responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods
      for the study of functional microcirculation.
    

Detailed description: 
      The EETY study is a single-center proof of concept study in healthy volunteers. The main
      objective is to study the involvement of epoxy-eicosatrienoic acids (EETs) in the reactivity
      of cutaneous microcirculation during post-occlusive hyperemia and thermal hyperemia, by
      studying the response to microdialysis of fluconazole (an inhibitor of EETs) versus control,
      on the forearm.

      Response is measured by the amplitude of the post-occlusive hyperemia and thermal hyperemia
      peaks (maximum amplitude as a percentage of maximal vasodilation and areas under the curve:
      AUC) during the injection of fluconazole compared to an intradermal injection of solvent
      (NaCl 9 ‰).

      The subjects are healthy volunteers of both sexes, aged between 18 and 35, non-smokers and in
      good health. Over two years, 30 subjects will be included in the study for 6 to 13 weeks.
    

Intervention name(s): Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)
Intervention type(s): Drug
Intervention description(s): At the first three visits, volunteers will receive fluconazole (650µmol/L and 6.5mmol/L) and vehicle (NaCl 0.9%), and at the fourth, these plus L-NMMA (10mmol/L), delivered by microdialysis in the forearm, with or without anesthesia. Then post-occlusive hyperemia and thermal hyperemia are performed.
Intervention MeSH terms: Fluconazole; NG-Nitroarginine Methyl Ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: epoxy-eicosatrienoic acid; Laser Doppler; Endothelium derived hyperpolarizing factor; cutaneous microcirculation; post-occlusive hyperaemia; thermal hyperemia; intradermal microdialysis; fluconazole
Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Customized cutting block and conventional cutting guide are both effective in improving
      accuracy and function of OA knee patients.
    

Detailed description: 
      Customized cutting block and conventional cutting guide are both effective in improving
      accuracy and function of osteoarthritic knee patients.
    

Intervention name(s): Patient specific cutting guides; Standard knee cutting guides
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.; Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Total Knee Arthroplasty; Customized Cutting Block; Conventional Intramedullary Cutting Guide
Extended Release Naltrexone for Opioid-Dependent Youth
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old
      opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual
      (TAU).
    

Detailed description: 
      This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for
      340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor
      Treatment Center, a community drug treatment program in Baltimore. TAU will consist of
      buprenorphine treatment of opioid withdrawal followed by counseling with or without continued
      buprenorphine.
    

Intervention name(s): Extended Release Naltrexone; Psychosocial Treatment; Buprenorphine
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): naltrexone for extended release injectable suspension; Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.; Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
Other intervention name(s): Vivitrol; Suboxone; Subutex
Intervention MeSH terms: Naltrexone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence
Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
Condition: Early Puberty
MeSH terms: Puberty, Precocious
Study type: Observational

Summary: 
      GnRH agonists are used in the treatment of precocious puberty in order to improve adult
      height.However,the psychosocial impact of precocious puberty is often used by the clinician
      at diagnosis to justify treatment, but can not yet be properly assessed. It can not be
      considered as a rational neither for the indication to treatment, nor to assess its potential
      efficacy.

      The overall objective of this work is to improve the conditions leading to the therapeutic
      decision and the procedures for monitoring girls with idiopathic central precocious puberty.
    

Detailed description: 
      During the day hospital, the diagnostic workup for precocious puberty will be performed and
      include:

        -  A clinical examination with pubertal stage assessment.

        -  A GnRH test

        -  A Pelvic ultrasound

        -  An MRI will be performed later after the results of GnRH test confirming precocious
           central puberty.

      These reviews are conducted as part of usual care and are required to validate the inclusion
      criteria of patients.

      The CBCL questionnaire will be completed by patient's parents and the first semi-structured
      interview will be conducted by a sociologist assisted by the psychologist, dedicated to the
      study.

      Patient's follow-up will be planned 6 months after inclusion, including similar
      investigations (except MRI).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be offered to all children and families who visit in a day hospital in the
        pediatric endocrinology department of Robert Debré Hospital for further assessment of early
        puberty.
      
Keywords: Early puberty; Psychosocial impact; Qualitative assessment
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      It is the primary purpose of this pilot study to investigate if physical therapy with
      strength training is better at improving muscle and gait function after anti-spastic
      treatment with Botulinum toxin compared to physical therapy without strength training in
      children with cerebral palsy. The investigators hypothesize that it is.
    


Intervention name(s): Physical therapy with strength training; Physical therapy without strength training
Intervention type(s): Other; Other
Intervention description(s): 12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.; 12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motor control; Spasticity
Listening to Mom in the NICU: Neural, Clinical and Language Outcomes
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether playing recordings of a mother's voice to her
      infant while in the hospital nursery is an effective treatment for promoting healthy brain
      and language development in infants born preterm.
    

Detailed description: 
      Children born preterm are at-risk for developmental language delays. Language problems in
      preterm children are thought to be related to neurobiological factors, including injuries to
      white matter structures of the brain and environmental factors, including decreased exposure
      to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech
      input may be important for promoting healthy brain and language development.

      Participants will be randomly assigned to one of two study groups. Each infant has a 50%
      chance of being assigned to the group that will listen to a recording of his/her mother's
      voice and a 50% chance of being assigned to the group that will not be played a voice
      recording. Mother's of participating infants will have her voice recorded as she reads a
      common children's storybook. Recordings will be played to infants each day until s/he is
      discharged from the hospital. Participation in this study requires that all infants receive
      up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic
      resonance imaging (MRI).
    

Intervention name(s): Language Treatment; Control Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Recording of a mother's voice reading a children's storybook.; Standard of Care
Other intervention name(s): Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
Condition: Drug Interactions; Pharmacokinetics
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to understand how an antibiotic, rifampin, may change the blood
      levels of another antibiotic, daptomycin, in the body. In addition, the effect of
      polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the
      body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin
      will decrease the blood levels of daptomycin and that the effect will be greater for certain
      P-glycoprotein polymorphisms.
    

Detailed description: 
      This will be an open-label, sequential pharmacokinetic study in 12 healthy volunteers. After
      providing informed consent, participants meeting inclusion criteria will be administered
      daptomycin 6 mg/kg over 2 minutes and blood and urine samples will be collected over a 24
      hour period after infusion. Following this, participants will be given a 13 day supply of
      rifampin 600 mg/day to be taken at home. After completion of the rifampin course, a second
      pharmacokinetic sampling will be performed (day 15 overall). Participants will be
      administered a dose of rifampin 600 mg then once again be administered daptomycin 6 mg/kg
      over 2 minutes and blood and urine samples will be collected over a second 24 hour period. A
      blood sample will be obtained at the first study visit for determination of each
      participant's P-glycoprotein genotype.
    

Intervention name(s): Daptomycin; Rifampin
Intervention type(s): Drug; Drug
Other intervention name(s): Cubicin; Rifadin
Intervention MeSH terms: Rifampin; Daptomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Daptomycin; Rifampin; P-glycoprotein; Pharmacokinetic
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate if the combination therapy consisting of
      anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive
      Bladder (OAB).
    

Detailed description: 
      Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge
      incontinence, usually with frequency and nocturia.

      The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous
      system, that act via muscarinic and adrenergic receptors, respectively.

      Antimuscarinics are mainly used for the treatment of patients with OAB, especially women.
      Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be
      useful in treating DO caused by neurological diseases.
    

Intervention name(s): Solifenacin; Solifenacin plus Tamsulosin
Intervention type(s): Drug; Drug
Intervention description(s): Solifenacin (5mg, qd, oral); Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Other intervention name(s): Vesicare; Vesicare; Harnal
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive bladder; Solifenacin succinate; Tamsulosin
Long-term Effects of Combined Balance and Brisk Walking in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is a progressive neurodegenerative disease characterized with both
      clinical motor and non-motor features, as well as decrease in balance performance and walking
      endurance. The non-motor symptoms such as depression, anxiety, sleep disturbance and fatigue
      wound impose negative impacts on the quality of life of the individuals with PD. Aerobic
      endurance training can improve physical capacity and reduce those non-motor symptoms such as
      mood and sleep disorders. Based on the results of our recent pilot study, brisk walking is a
      safe and moderate-level aerobic walking exercise for improving walking capacity in the PD
      population up to 6 week after treatment ended. Community-based balance training could also
      enhance balance performance and dual-task gait performance up to 12-month follow-up for
      people with PD. The primary purpose of this proposed study is to investigate the short- and
      long-term effects of a 6-month balance and brisk walking programme in alleviating non-motor
      and motor symptoms in people with PD. The secondary objective is to examine the short- and
      long-term effects of a 6-month balance and brisk walking program on enhancing walking
      capacity, balance performance, and quality of life.
    


Intervention name(s): Combined balance and brisk walking training; Flexibility and strengthening exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6-months of combined balance and brisk walking training; 6-months of flexibility and strengthening exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; aerobic exercise; postural balance
Determination of Lysine Requirements in Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      Amino acids are building blocks of protein in our body. It is important that pregnant women
      eat adequate amount of protein/amino acids to ensure healthy growth and development of the
      fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and
      not much in plant foods such as wheat. Currently , it is not known how much lysine is needed
      to eat during pregnancy.

      Current Dietary Reference Intake recommendations for amino acid requirements are based on
      non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators
      knowledge, there is no scientific information regarding the amount of lysine needed at
      different stages of pregnancy.

      The investigators hypothesize that current recommendations for lysine intake in pregnant
      women are underestimated. The investigators also hypothesize that the lysine requirements
      will be greater during the later stages of pregnancy, compared to early stages.

      The purpose of this study is to determine lysine requirements in healthy pregnant women
      19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator
      amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks
      last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.
    


Intervention name(s): Lysine intake
Intervention type(s): Dietary Supplement
Intervention description(s): Oral consumption of Eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Indicator Amino acid technique; Lysine requirements; Pregnancy; Dietary protein
Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of
      6-week acute treatment and 52-week maintenance treatment showed positive results in patients
      with schizophrenia and its clinical improvement may start at Day 4. Some second-generation
      antipsychotics have been found that using the first 2 weeks' treatment results to predict the
      fourth or sixth week's treatment response is acceptable.

      The primary aim of this study is to investigate:

        1. . whether the early prediction model used in other atypicals could also be applied in
           paliperidone ER.

        2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER
           treatment in this study
    

Detailed description: 
      Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the
      6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of
      paliperidone could be adjusted two weeks later according to clinical judgement. They will be
      followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles,
      glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): 9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically
Other intervention name(s): 9-hydroxyrisperidone
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone; Treatment response; Schizophrenia; Early prediction; Pharmacokinetics
TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer
Condition: Oropharynx Cancer; Squamous Cell Carcinoma of the Oral Cavity
MeSH terms: Oropharyngeal Neoplasms; Mouth Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in
      patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the
      compatibility of the TPF-induction without decreasing the efficacy the dose will be given on
      day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.

      In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will
      be defined.

      In the phase II-part the progression-free survival after 2 years will be assessed in patients
      treated with the optimal therapeutic dose.
    

Detailed description: 
      Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a
      combination of surgery and/or radiation and /or chemotherapy.

      Despite of therapy improvement there are only little advances in progression-free survival
      and overall survival.

      Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the
      possibility of tumor response assessment during chemotherapy and may present a selection
      criterion for organ preservation.

      In order to minimize the time between chemotherapy and surgery it is important to have an
      early answer for the tumor response. In this study response will be assessed after the first
      cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other
      patients will receive further cycles of chemotherapy.

      Toxicity of the induction chemotherapy have to be moderate because surgery should not be
      delayed.

      To improve the tolerance of induction therapy the medication dose isn't given on day 1 every
      3 weeks, but is dispersed on day 1 and day 8, q3weeks.
    

Intervention name(s): Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Intervention type(s): Drug
Intervention description(s): Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.
Other intervention name(s): Docetaxel
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RN1001(Avotermin) in Scar Improvement Following Breast Augmentation
Condition: Mammaplasty; Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multi-centre, double-blind, within-subject, placebo controlled randomised
      trial in female subjects. All subjects will undergo bilateral breast augmentation surgery.
      Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of
      RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl
      of placebo solution per linear centimetre intradermally into both margins of their other
      breast wound. The allocation of treatment to wound (left or right) will be randomised and
      double blind.
    


Intervention name(s): Avotermin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention