bioihbjkbjnl/mcl2 huggingface dataset:
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions
Condition: Precancerous Conditions; Oral Cancer
MeSH terms: Mouth Neoplasms; Precancerous Conditions
Study type: Observational

Summary: 
      45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15
      patients with oral malignant lesions and 15 control individuals. Levels of chemerin and MMP-9
      were evaluated in serum and saliva of these subjects utilizing the ELISA technique.
    

Detailed description: 
      45 individuals were subdivided into 3 groups, 15 patients suffering from oral premalignant
      lesions, 15 patients suffering from oral malignant lesions and 15 individuals having age,
      gender and periodontal status matched with both patients groups acting as a control group.
      Serum and whole unstimulated saliva samples were collected from all the included groups in
      order to determine chemerin and MMP-9 in serum and saliva utilizing the ELISA technique.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        45 individuals were subdivided into 3 groups, 15 patients suffering from oral squamous cell
        carcinoma lesions, 15 patients suffering from oral premalignant lesions (OPL) and 15
        individuals having age, gender and periodontal status matched with both patients groups
        acting as a control group.
      
Biospecimen description: 
      serum and whole unstimulated saliva
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic, Healthy Volunteer
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part, randomized, double-blind, placebo-controlled study will assess the safety,
      pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with
      hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending
      doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).
    


Intervention name(s): RO5428029; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses; multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic
Condition: Stress - Prevention of Sleep Disorders, PTSD and Depression
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      Some preliminary epidemiological research conduct in China in health workers involved in the
      care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety
      disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their
      well-being as well as their ability to work effectively . These rates were observed during
      the epidemic peak, but they can also have a long-term mental health effect, both
      individually, but also in a systemic manner , similar to what has been reported relative to
      the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment
      for stress-reduction, as well as for the prevention of multiple mental health problems in
      at-risk individuals . Moreover, CBT has been found to be effective in brief online formats ,
      which could make it feasible during the current Covid-19 epidemic. To our knowledge, there
      are no online CBT programmes targeting stress problems in health workers involved in the care
      of patients during the current epidemic context. The aim of our study is to evaluate the
      efficacy of the online CBT programme we have developped to specifically address immediate
      perceived stress in health workers, as well as the prevention of mental health problems at 3-
      and 6-months follow-up
    


Intervention name(s): Online cognitive behavioral therapy (CBT); Online bibliotherapy programme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline; online bibliotherapy programme on the Ma Santé website Also with explanatory sheets and tools to improve stress management and the possibility of contacting the Psychological Hotline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma
Condition: Kidney Cancer; Melanoma (Skin)
MeSH terms: Melanoma; Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at biomarkers that predict response to high-dose
      aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the relationship of peripheral blood lymphocyte phenotype pattern in patients
           with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose
           aldesleukin (IL-2).

        -  Determine the relationship of peripheral blood mononuclear cells gene microarray
           patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to
           response to high-dose IL-2.

        -  Determine the frequency of mutations on genes encoding for IL-2 receptor A and B.

      OUTLINE: Patients receive high-dose aldesleukin (IL-2) as part of standard treatment on days
      1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
      toxicity.

      Patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after
      the completion of course 2. Samples are analyzed using peripheral blood cytometry, gene
      microarray analysis, and IL-2 receptor single-nucleotide polymorphism techniques.
    

Intervention name(s): aldesleukin; gene expression analysis; mutation analysis; flow cytometry
Intervention type(s): Biological; Genetic; Genetic; Other
Intervention MeSH terms: Aldesleukin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be receiving HD IL-2.
      
Biospecimen description: 
      Blood samples will be collected prior to, at mid-course and at the end of the course of IL-2
      therapy.
    
Keywords: stage IV renal cell cancer; stage IV melanoma
Clinical Trials to Compare Mosapride Bioavailability Between DWJ1252 and Mosapride Medicine
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and explore bioavailability of mosapride, the main
      component of DWJ1252(Test drug) and mosapride medicine(Reference drug).
    


Intervention name(s): DWJ1252
Intervention type(s): Drug
Intervention description(s): tablet(oral) administration following the schedule of each arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Cheese Intake and Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study the investigators aimed at verifying whether consumption of a sheep cheese,
      naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic
      acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild
      hypercholesterolemic subjects.
    


Intervention name(s): CLA enriched cheese
Intervention type(s): Dietary Supplement
Intervention description(s): This study was a 3-week, randomized, single blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Endocannabinoids
Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis
Condition: Primary Myelofibrosis (PMF); Post-polycythemia Vera Myelofibrosis(Post-PV MF); Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral
      Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis and
      Previously Treated With Ruxolitinib. The experiment is divided into two parts: dose
      exploration and extended research.
    

Detailed description: 
      dose exploration: It is planned to enroll about 6 subjects. According to the baseline value
      of platelet count at the time of enrollment, different doses (100mg Qd or 150mg Qd or 200mg
      Qd or 100mg Bid) of Jaktinib Hydrochloride Tablets will be Treated. The trial is in progress
      Adjust the dose according to relevant laboratory indicators. When at least one subject has a
      spleen volume reduction of ≥35% from the baseline, the sponsor and the investigator will
      jointly decide whether to enter the extended study part.

      Extended research: It is planned to enroll about 43 subjects, and the initial dosage of
      Jaktinib Hydrochloride Tablets is planned to be 100mg Bid.
    

Intervention name(s): Jaktinib hydrochloride tablets
Intervention type(s): Drug
Intervention description(s): Jaktinib hydrochloride tablets 100mg twice dose group，Jaktinib hydrochloride tablets 150mg qd dose group, Jaktinib hydrochloride tablets 200mg qd dose group and Jaktinib hydrochloride tablets 100mg qd dose group
Other intervention name(s): Jaktinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dynamic Respiratory Muscle Function in Late-Onset Pompe Disease
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Study type: Observational

Summary: 
      This study intends to evaluate dynamic respiratory motor performance as a valuable measure of
      pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a
      strategy that includes comprehensive evaluations of respiratory volume, flow, and timing
      parameters during resting and loaded breathing. These evaluations will then be associated to
      the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle
      function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic
      descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease
      will be contrasted to the function of age- and gender-matched control subjects. This approach
      will enable the investigators to evaluate the relationship between dynamic diaphragmatic
      function and respiratory motor function.
    

Detailed description: 
      The following tests will be completed over a two-day period: Respiratory pressure tests,
      breathing test, magnetic resonance imaging and magnetic resonance spectroscopy (MRI and MRS).
    

Intervention name(s): Thoracic MRI; Spirometry; Inspiratory Load Compensation; Maximal Inspiratory Pressure; Resting Breathing Pattern; Respiratory Muscle Endurance Test
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Imaging of the diaphragm will be completed during resting breathing, and then during a maximal voluntary ventilation maneuver.; Upright forced vital capacity (FVC); A spring-loaded pressure device will resist inspiration. The patient must generate the threshold inspiratory pressure to receive airflow. The changes in breathing timing, flow and volume will be recorded.; Measure the maximal airflow on inhalation; The breathing pattern will be assessed when the subject is seated and in a relaxed state.; Evaluates the time limit that a participant can maintain ventilation while breathing with a submaximal inspiratory threshold load.
Other intervention name(s): MIP
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with late-onset Pompe disease, age 20-60 years, and age and gender-matched
        unaffected control subjects
      
Keywords: respiratory test; respiratory muscle endurance; spirometry
TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial
Condition: Down Syndrome
MeSH terms: Cerebral Palsy; Down Syndrome
Study type: Interventional

Summary: 
      Children with diplegic cerebral palsy exhibit postural restrictions as a result of both
      primary and secondary brain damage impairments. One of the main goals of cerebral palsy
      rehabilitation is to improve balance and stability. As a result, the purpose of this study is
      to compare the effects of TheraTogs and reciprocal electrical stimulation on postural
      stability in children with diplegic CP.
    


Intervention name(s): 1- Reciprocal electrical stimulation; TheraTogs orthotic treatment; traditional physical therapy program
Intervention type(s): Device; Device; Procedure
Intervention description(s): A specialized programmable electrical stimulation device was used (Uniphy is the manufacturer of Phyaction787; Uniphy, Eindhoven, the Netherlands). The device has two channels that can alternatively stimulate two opposing groups of muscles (reciprocate).; A sleeveless top vest and two pairs of shorts with two thigh cuffs and limb cuffs each make up the TheraTogs strapping system which is applied to the children in the TheraTogs group. The TheraTogs suit is providing breathable, comfortable- Latex over the torso and thigh, as well as free toileting. For infection control and size fitting problems, participants are not allowed to share their TheraTogs with other patients. TheraTog's orthotic undergarment and strapping system were worn under their regular clothes, so it was neither distracting nor irritating.; Facilitation of balance and gait training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to evaluate the efficacy and safety of two different treatment
      regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care
      (SOC) with PegIFN/RBV alone.
    


Intervention name(s): BI201335; PegIFN/RBV; BI201335; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): QD BI 201335; QD (once daily) BI 201335
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Impact of Spices and Herbs on Endothelial Function
Condition: Endothelial Function
Study type: Interventional

Summary: 
      The general objective of the study is to investigate the effects of the daily consumption of
      spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular
      risk factors of men and postmenopausal women.
    

Detailed description: 
      The purpose is to assess whether the polyphenol/antioxidant content of different spices will
      affect endothelial function and other cardiovascular risk factors.
    

Intervention name(s): Cinnamon; Oregano; Ginger; Rosemary; Black pepper; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.8g/day of cinnamon in capsules during 4 weeks.; 2.8g/day of oregano in capsules during 4 weeks.; 2.8g/day of ginger in capsules during 4 weeks.; 2.8g/day of rosemary in capsules during 4 weeks.; 2.8g/day of black pepper in capsules for 4 weeks.; 2.8 g/day of placebo in capsules (corn starch) during 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Endothelial function; Cardiovascular risk factors; Spices; Herbs; Antioxidant
Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in
      COPD patients as measured by inspiratory capacity (IC).
    


Intervention name(s): Tiotropium inhalation powder capsules; Placebo inhalation powder capsules
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Role of Personal Identity in Psychotic Symptoms: a Study With the Repertory Grid Technique
Condition: Schizophrenia; Psychotic Disorders; Self
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      Personal identity is being recently recognized as a core element for mental health disorders,
      with relevant clinical implications. However, scarcity of data exists on its role in
      schizophrenia and related disorders. The repertory grid (RGT), a technique derived from
      personal construct theory, has been used in different clinical and non-clinical contexts for
      the study of the construction perception of self and others, to appreciate aspects of
      interpersonal construing such as polarization and differentiation (unidimensional thinking)
      or self-construction.and Our study aims to explore the potential influence of the structure
      of personal identity and of other relevant cognitive factors (social cognition,
      metacognition, neurocognition) in positive and negative symptoms in people suffering
      schizophrenia and related disorders.
    

Detailed description: 
      Over recent years, the importance of the sense of self and personal identity in
      psychopathology and its treatment has been highlighted. Several studies inspired in the
      Personal Construct Psychology framework have found a variety of identity characteristics in
      clinical conditions such as depression or eating disorders, but the evidence in schizophrenia
      and other psychotic related disorders is scarce.

      In addition, current psychological models of positive and negative symptoms highlight the
      influence of neurocognition, social cognition and self-concepts in the development and
      maintenance of psychotic experiences. Despite the recognized need of person-centered
      approaches to understand psychopathology processes in psychosis, psychological models for
      explaining psychotic symptoms have not explored sufficiently the role of this kind of
      person-centered measures.

      Aim

      1. To examine the influence of the structure of personal identity and other relevant
      cognitive factors in positive and negative symptoms

      Hypotheses

        1. Positive symptoms will be influenced by dichotomous thinking style and construction of
           self as measured with the RGT.

        2. Negative symptoms will be affected by the richness of the construct system as measured
           with the RGT.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients recruited from the community, suffering schizophrenia and related disorder
      
Keywords: personal identity; personal constructs
The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Bone Diseases, Metabolic; Rett Syndrome; Syndrome
Study type: Interventional

Summary: 
      Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls
      and women with Rett syndrome
    

Detailed description: 
      Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial
      to determine the safety and efficacy of oral calcium supplementation for the treatment of
      bone mineral deficits in individuals with Rett syndrome (RTT).

      Methods: The investigators measured total body bone mineral content (BMC) and bone mineral
      density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical
      laboratory techniques before and one year after oral calcium or placebo supplementation in 32
      pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated
      to provide a twofold increase in the recommended dietary allowance of calcium for age.
    

Intervention name(s): calcium; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): calcium carbonate; sodium bicarbonate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double blind
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low bone mass
Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively
Condition: Blood Pressure
Study type: Observational

Summary: 
      Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse
      pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med
      2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz
      technique, a non-invasive measurement device is now available commercially. In this study,
      the reference technique based on arterial measurement and a respiratory variation monitor
      (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a
      clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure
      and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1:
      307-10)
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective abdominal or urological surgery