bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the French Version of the Pain Sensitivity Questionnaire
Condition: Scheduled Surgery; Healthy Volunteers
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in
      Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple
      questions. These questions simulate daily life situations likely to induce pain of various
      intensities. The internal validity of the tool had been demonstrated both for the original
      version in German, and then for its English version. The external validity had also been
      demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers
      (German version), and to patients before surgery (English version). A French validation of
      the questionnaire is needed, in order to integrate it in pain research programs in
      French-speaking countries.
    

Detailed description: 
      The aim is to validate the French version of the PSQ in a 2-step plan : (i) validity of
      internal structure, convergent validity and reproducibility, in a sample of patients before
      scheduled surgery, and (ii) structure and convergent validity against external criterion, in
      healthy volunteers. A secondary objective is to study the relationship of scores of the PSQ
      with a scale assessing sensitivity to natural smells, noise and light sensitivity.
    

Intervention name(s): Psychophysical exploration
Intervention type(s): Behavioral
Intervention description(s): Psychophysical exploration (multimodal sensitivity, including pain sensitivity) Electronic von Frey applied on forearm; thermal heat applied on forearm; foot immersion in 2°C cold water; exposure to a one-frequency noise up to uncomfortable loudness ; exposure to a halogen-lamp-generated light up to uncomfortable brightness.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pain; psychophysics; Nociception; Sensitivity; Senses; Phenotyping; Questionnaire; Anxiety; Depression; Catastrophizing
Morning Versus Evening Exercise for Adults With Overweight and Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine the feasibility and acceptability of
      randomizing adults with overweight and obesity to an exercise intervention of either
      prescribed morning aerobic exercise (AM-EX) or prescribed evening aerobic exercise (PM-EX)
      progressing to 2000 kcal/wk.
    

Detailed description: 
      The purpose of this pilot study is to determine the feasibility and acceptability of
      randomizing adults with overweight and obesity to an exercise intervention of either
      prescribed morning aerobic exercise (AM-EX) or prescribed evening aerobic exercise (PM-EX)
      progressing to 2000 kcal/wk. Specifically, the purpose of this study is to assess
      recruitment, retention, and adherence to the exercise interventions.
    

Intervention name(s): AM-EX; PM-EX
Intervention type(s): Behavioral; Behavioral
Intervention description(s): AM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM.; PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: exercise; physical activity; weight loss
Proprioceptive Training vs. Hip Abductor With External Rotator Strengthening in Patients With Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder characterized by an
      insidious onset of pain in the knee's anterior /retro-patellar / peripatellar region. Even
      though various rehabilitation approaches, including hip strengthening and proprioceptive
      training, are being considered for managing PFPS, the most appropriate treatment from these
      two is still unclear. Therefore, this study aimed to compare the program consisting of hip
      abductors and external rotators strengthening exercises vs. the program consisting of
      proprioceptive training of the knee to identify the most effective rehabilitation approach
      for patients suffering from PFPS.
    


Intervention name(s): Hip strengthening exercises; Proprioceptive training; Conventional physical therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Hip abductor and external rotator strengthening exercises were performed for 4 weeks.; Proprioceptive training consisted of eight exercises was performed for 4 weeks.; Conventional physical therapy included interferential therapy and two types of knee-strengthening exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip muscles strengthening; Rehabilitation; Proprioceptive training; Exercises
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence of the metformin component of the
      Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet
      co-administered with canagliflozin in healthy fed and fasted participants.
    


Intervention name(s): Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Canagliflozin 50 mg; Canagliflozin 100 mg; Metformin Extended Release (XR)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 50 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.; Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare retrospective hospitalization rates of schizophrenic
      patients treated with oral antipsychotics to prospective hospitalization rates of these
      patients treated with IM depot aripiprazole.
    

Detailed description: 
      Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients
      with schizophrenia, increasing hospitalization rates, hospitalization days, and
      hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly
      diagnosed illness and has the seventh longest mean duration of hospital stay in the US.
      Frequent relapses and hospitalization can affect quality of life in these patients.
      Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment
      adherence and increased quality of life for patients with schizophrenia.
    

Intervention name(s): Aripiprazole (Abilify®) IM Depot Injection
Intervention type(s): Drug
Intervention description(s): 400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.
Other intervention name(s): ABILIFY®
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Effectiveness of Health Literacy Education
Condition: Health Literacy Level
Study type: Interventional

Summary: 
      To determine the effect of health literacy education given to nursing students. The study was
      conducted at two university nursing departments in Turkey between December 2018 and March
      2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group,
      were included in the study. Health literacy education, consisting of four sessions, was given
      to the intervention group.
    


Intervention name(s): Health Literacy Education
Intervention type(s): Other
Intervention description(s): Health literacy education, consisting of four sessions, was given to the intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: health literacy; nursing education; undergraduate student; education
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
Condition: Thyroid Goiter; Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases; Goiter
Study type: Interventional
Phase: Phase 2

Summary: 
      Thyroidectomy is considered a common operation with moderate to severe postoperative pain in
      some patients. Patients are divided into two groups. Bupivacaine group received bilateral
      superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of
      normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of
      bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.
    


Intervention name(s): Bupivacain; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): analgesic; analgesia
Intervention MeSH terms: Ketorolac; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: ketorolac, superficial cervical plexus block, thyroidectomy
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of an investigational drug
      in patients with type 2 diabetes mellitus.
    


Intervention name(s): Sitagliptin (MK0431); Placebo/Glipizide 5 mg; Metformin; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104; Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104); Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104); Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other intervention name(s): MK0431; sitagliptin phosphate; Januvia; ACTOS
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus
Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm Birth is the number one cause of infant morbidity and mortality worldwide and
      represents an important health disparity in the United States, particularly across the state
      of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal
      ultrasound (TVU). This study will attempt to identify and rectify provider and patient
      related barriers to TVU screening implementation.
    

Detailed description: 
      Preterm birth is the number one cause of infant morbidity and mortality worldwide and
      represents an important health disparity in the United States, and especially across the
      state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal
      ultrasound (TVU) measurement of cervical length. However, several unique provider and patient
      related barriers for implementation of this screening limit the widespread uptake of this
      evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination
      and implementation science approach using the Consolidated Framework for Implementation
      Research (CFIR) as the guiding framework for identification of key areas of knowledge
      deficits as well as attitudes, practices and perceived barriers among prenatal care providers
      and patients in eastern KY towards TVU cervical length screening using a mixed - methods
      design. This will be utilized to develop a multifaceted implementation strategy best suited
      for addressing and overcoming barriers identified by the target population in eastern KY. The
      investigators anticipate that such an implementation strategy will likely include an
      educational component targeting obstetric care providers and patients in addition to hands-on
      TVU cervical length evaluation as well as telemedicine support and surveillance. Three
      community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation
      of this multi-component pilot program focused on community engagement and outreach targeting
      obstetric providers and their patients. At the end of the pilot implementation phase,
      acceptability of the study intervention and feasibility of implementation will be evaluated
      along with a preliminary assessment of effectiveness of implementation.
    

Intervention name(s): Participant Barriers to TVU Screening; Provider Barriers to TVU Screening
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.; Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Transvaginal Ultrasound; Telemedicine
Curcumin and Function in Older Adults
Condition: Older Adults; Physical Function; Cognitive Function
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This placebo-controlled RCT tests whether dietary supplementation with curcumin maintains or
      improves cognitive and physical function in older adults who are at high risk of functional
      decline due existing (mild) functional impairments and elevated biomarkers of inflammation
      and explore the association between functional changes and changes in biological indicators
      of active inflammation.
    


Intervention name(s): Curcumin; microcrystalline cellulose
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.; Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.
Other intervention name(s): Turmeric; C3 Complex; placebo
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo-controlled design.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Curcumin, physical function, cognitive function
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Condition: Intervertebral Disc Disease; Lumbar Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in
      patients with lumbar disc herniation.
    


Intervention name(s): Condoliase
Intervention type(s): Drug
Intervention description(s): 1.25 U, intradiscal injection, one time
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mitochondrial Energy Production in ART (Assisted Reproductive Technology )
Condition: Female Infertility Due to Advanced Maternal Age
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the
      synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg
      quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo
      maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so
      that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the
      oocyte. The goal of this work is to analyze the mitochondrial function and energy production
      in oocyte donors compared with a group of women of advanced maternal age subject to a same
      ovarian stimulation Protocol
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Controls: Young women between 18-35 years old with good reproductive prognostic undergoing
        COS (controlled ovarian stimulation) for IVF-ICSI

        Cases: Infertile Women > 38 years old undergoing COS (controlled ovarian stimulation) for
        IVF-ICSI
      
Biospecimen description: 
      serum, follicular fluid and granulosa cells
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Condition: Asphyxia Neonatorum
MeSH terms: Asphyxia Neonatorum; Asphyxia
Study type: Observational [Patient Registry]

Summary: 
      Verification of biomarkers in a human population for their ability to diagnose the severity
      of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal
      studies.
    

Detailed description: 
      The aim of the study is to verify the application of combinations of several laboratory
      parameters in early postnatal blood samples, for identification of infants, who will suffer
      from early abnormal neonatal neurological outcome, in a population at risk.

      The population at risk is defined as term and late preterm (>36 weeks of gestation) human
      infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.
    

Intervention name(s): blood sampling
Intervention type(s): Other
Intervention description(s): small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants at risk for perinatal hypoxic-ischemic brain injury
      
Biospecimen description: 
      blood plasma
    
Keywords: biomarkers
The Efficacy and Safety of Dexibuprofen Syrup
Condition: Fever; Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and
      ibuprofen syrup in patients with fever due to common cold.
    


Intervention name(s): Dexibuprofen; Dexibuprofen; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one dose of Dexibuprofen 2.5 or 5 mg/kg; one dose of Dexibuprofen 3.5 or 7 mg/kg; one dose of Ibuprofen 5 or 10 mg/kg
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fever due to acute upper respiratory tract infection
Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
Condition: Chronic Renal Failure; Kidney Transplantation; Weight Gain; Insulin Resistance; Diabetes
MeSH terms: Kidney Failure, Chronic; Insulin Resistance; Weight Gain
Study type: Interventional

Summary: 
      Weight gain is a common complication after transplantation. It has adverse effects such as
      hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the
      increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved
      by a suitable dietary intervention in these patients transplanted kidney can correct lipid
      disorders and facilitate balance blood pressure. The identification of mechanisms responsible
      for weight gain would suggest prevention strategies and allow to align the caloric energy
      needs of renal transplant patients.
    

Detailed description: 
      Weight gain is a common complication after transplantation. It has adverse effects such as
      hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the
      increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved
      by a suitable dietary intervention in these patients transplanted kidney can correct lipid
      disorders and facilitate balance blood pressure. The identification of mechanisms responsible
      for weight gain would suggest prevention strategies and allow to align the caloric energy
      needs of renal transplant patients.
    

Intervention name(s): Energy expenditure evaluation in calorimetric chamber
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Kidney transplantation; Energy expenditure; Weight gain; Insulin resistance