bioihbjkbjnl/mcl2 huggingface dataset:
Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main objective of the present project is to evaluate the relevance of reticulum stress in
      the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying
      mechanisms of insulin resistance, which is the origin of metabolic comorbidities.
      Furthermore, the investigators will assess the potential of insulin sensitizers as a
      treatment to control endoplasmic reticulum stress markers in PCOS patients.
    

Detailed description: 
      To do this, the investigators will evaluate anthropometric, biochemical and hormone
      parameters, lipid profile and cardiovascular risk markers (using enzymatic and biochemical
      techniques, nephelometry, enzyme-linked immunosorbent assay, radioimmunoassay), and markers
      of endoplasmic reticulum stress and the insulin pathway and inflammatory and apoptotic
      parameters (by means of Western blot, Real Time- Polymerase Chain Reaction (RT-PCR), Luminex®
      xMAP® Technology ) in patients with and without PCOS. The investigators' second objective is
      to evaluate (using the abovementioned methodology) the efficacy of different insulin
      sensitizers (myoinositol and metformin) administered to PCOS patients during a 3-month period
      after which the investigators will analyze different parameters of oxidative stress and
      mitochondrial function (using Clark electrode and fluorometric techniques).
    

Intervention name(s): Metformin; Myo-inositol + folic acid
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Dose: metformin (1700 mg / day) for 12 weeks; Dose: Ovusitol® (4 g myo-inositol plus 400 micrograms of folic acid/day) for 12 weeks
Intervention MeSH terms: Folic Acid; Inositol; Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reticulum endoplasmic stress; Polycystic Ovary Syndrome; mitochondrial function; insulin resistance; inflammation; myoinositol; metformin; oxidative stress
Oxidative Balance in Opioid Therapy
Condition: Pain; Opioids
Study type: Interventional

Summary: 
      The oxidative - antioxidative balance is the crucial mechanism of opioid-induced
      immunomodulation. Additionally, impairement of cognitive function during opioid therapy is
      another important side- effect. This phenomenon was clearly described in opioids abuse. This
      is interesting to evaluate the importance of this subjects in chronic pain patients. The aim
      of the study was to investigate the oxidative - antioxidative homeostasis and cognitive
      functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC)
      tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain
      treated with opioids.
    

Detailed description: 
      The project was approved in Ethical Committee and supported by Medical University of
      Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50
      adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids
      pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group
      anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form
      of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx,
      PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.
    

Intervention name(s): biochemical measurements
Intervention type(s): Diagnostic Test
Intervention description(s): TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The serum measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. I
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: neurological condition; opioids; oxidative balance; pain
Drug-drug Interaction (DDI) Rifabutin
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to provide dosing recommendations for the coadministration of
      BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for
      prescribing information purposes
    


Intervention name(s): BMS-663068; Rifabutin; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BMS-663068; Rifabutin; Ritonavir
Intervention MeSH terms: Ritonavir; Fostemsavir; Rifabutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pushing Spatiotemporal Limits for 4D Flow MRI and Dynamic MRA in the Brain at Ultra-High Field
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study aims at investigating the blood hemodynamics with high spatiotemporal resolution
      in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as
      peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D
      flow MRI data acquired at ultra-high field strength (7 Tesla).
    

Detailed description: 
      The hemodynamic factors responsible for hemorrhagic stroke, resulting in wide variations in
      the clinical management of underlying vascular lesions, especially when they are found in
      asymptomatic individuals or individuals with symptoms not related to the disease. Therefore,
      there is an urgent need for the development of reliable biomarkers based on hemodynamic
      parameters, which can then enable improvements in risk assessment in patients presenting with
      these lesions. This need can be met by non-invasive Magnetic Resonance Imaging (MRI)
      techniques that provide information on high resolution vascular anatomy, visualization of
      cerebral hemodynamics and quantitative information about blood velocity. However, such
      techniques as presently employed at 1.5 or 3 Tesla are limited by spatial resolution and
      prolonged data acquisition times.

      The primary goal of this proposal is to overcome these current limitations by exploiting
      Ultra-High Fields (UHF, i.e. ≥ 7 Tesla (7T)) to attain significantly higher spatial
      resolution, faster acquisitions and increased lesion conspicuity utilizing

        -  Qualitative exploration of intracranial blood hemodynamics,

        -  Quantitative imaging of the spatiotemporally resolved blood velocity vector,

        -  Derivation of hemodynamic parameters.
    

Intervention name(s): 7 Tesla MRI
Intervention type(s): Device
Intervention description(s): MR imaging using a 7 Tesla MR system.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, age 18-75 years;

          -  Patients with previously un-ruptured AVMs, who have had a catheter-guided DSA for
             evaluation of the AVM; any Spetzler-Martin grade; patients with one or more
             un-ruptured AVMs regardless of symptoms

          -  Patients with non-symptomatic patients; one or more un-ruptured conservatively managed
             aneurysms, all aneurysm sizes and shapes (fusiform, saccular, sessile).

        Subjects:

        - healthy subjects between 18 and 75 years.
      
Keywords: Stroke; AVM; Aneurysm
Remote Wheelchair Skills Training Efficacy
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the effectiveness of remote training to teach
      clinicians how to train others in wheelchair skills.
    


Intervention name(s): Wheelchair Skills Training - Remote; Wheelchair Skills Training - In Person
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will receive wheelchair skills training remotely. They will be provided with the Wheelchair Skills Training Program to review (http://www.wheelchairskillsprogram.ca/eng/index.php), and then will be directed to use this information to perform the wheelchair skills. They will video the attempts, and will receive feedback on methods to improve their techniques.; Individuals will receive wheelchair skills training in one-on-one sessions, taught by those who received the wheelchair skills training remotely.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Quality of life; Participation; Training
A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to compare the
      exposure and effect of NN1250 (insulin degludec) after different routes of injection in
      healthy subjects.
    


Intervention name(s): insulin degludec
Intervention type(s): Drug
Intervention description(s): Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
Condition: Hepatocellular Carcinoma Non-resectable; Metastatic Colorectal Cancer; Liver Cancer
MeSH terms: Carcinoma; Colorectal Neoplasms; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in
      patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer
      (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an
      abnormally large number of blood vessels attached to them. Eye90 is internal radiation
      brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses
      microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation.
      The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill
      cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they
      can be seen during imaging procedures. The visibility of the microspheres allows the study
      doctor to confirm the microspheres have been delivered in the tumor; this may help to improve
      the outcome of treatment.
    


Intervention name(s): Eye90 Microspheres
Intervention type(s): Device
Intervention description(s): Y90 glass microspheres
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Metastatic Colorectal Cancer; Liver Neoplasms; Liver Diseases; Internal radiation brachytherapy; Radioembolization; Y90; Yttrium-90; Eye90 microspheres
Comparing Various Treatments for Achieving and Maintaining Remission of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of five combinations of drug therapy and
      psychotherapy in maintaining remission of depression symptoms in people with recurrent major
      depression.
    

Detailed description: 
      Depression is a serious illness that can interfere with a person's ability to work, study,
      sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several
      symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of
      hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left
      untreated, depression symptoms can last for years, and may worsen as time goes on. Even with
      treatment, however, it is possible for depression to recur. Remission is a main goal in the
      treatment of depression and it may be accomplished through various strategies. This study
      will evaluate the effectiveness of five combinations of treatments, including medication
      therapy and psychotherapy, in maintaining remission of depression symptoms.

      All participants in this study will first be treated with imipramine for 7 to 11 months. Once
      remission of depression symptoms has been achieved and maintained for 20 weeks, participants
      will be randomly assigned to one of the following five maintenance treatments for 36 months:
      psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication
      clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments
      will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes
      for depression symptoms to recur, as well as scores on depression and mania severity scales.
    

Intervention name(s): Imipramine; Interpersonal Psychotherapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depression
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
Condition: IUCD Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the
      levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions,
      insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
    

Detailed description: 
      Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
    

Intervention name(s): INH; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.; 3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      A single intravenous drip of voriconazole for injection developed by Qilu Pharmaceutical
      (Hainan) Co., Ltd. and the original product "vfend" was given to healthy subjects ， The
      pharmacokinetic differences and tolerance of the two preparations were evaluated at the doses
      of 4mg / kg and 6mg / kg.
    

Detailed description: 
      Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip
      Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per
      cycle. The dosage was 4 mg / kg for 80 min;After a 7-day cleaning period, the second cycle of
      cross administration.

      High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip
      Voriconazole (T) for injection or reference preparation vfend ® (R) in fasting state per
      cycle. The dosage was 6 mg / kg for 120 min;After a 7-day cleaning period, the second cycle
      of cross administration.
    

Intervention name(s): 4 mg/kg Voriconazole; 6 mg/kg Voriconazole
Intervention type(s): Drug; Drug
Intervention description(s): Low dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 4 mg / kg for 80 min.; High dose group: 24 healthy adult subjects are planned to be enrolled. Intravenous drip Voriconazole for injection in fasting state per cycle. The dosage was 6 mg / kg for 120 min.
Intervention MeSH terms: Voriconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A total of 48 healthy adult subjects were enrolled; Intravenous drip Voriconazole (T) for injection or reference preparation vfend ® （R）in fasting state per cycle； After a 7-day cleaning period, the second cycle of cross administration.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Voriconazole; Pharmacokinetics; Tolerance
Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
Condition: Graves Ophthalmopathy; Graves Disease; Autoimmune Thyroiditis
MeSH terms: Graves Disease; Eye Diseases; Graves Ophthalmopathy; Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease
Study type: Observational

Summary: 
      The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without
      GO, compared with healthy subjects and patients with autoimmune thyroiditis in a
      cross-sectional investigation.
    


Intervention name(s): Serum antibodies against the IGF-1R
Intervention type(s): Diagnostic Test
Intervention description(s): Measurement of antibodies against the IGF-1R in serum samples by ELISA
Intervention MeSH terms: Antibodies
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. Patients with Graves' disease, with or without GO. The presence of GO will be
             established in any patient who had at least one of the following eye features: a)
             exophthalmometry ≥17 mm in women and ≥19 mm in men, based on measurements conducted
             for the normal population; b) eyelid aperture ≥9 mm; c) clinical activity score ≥1/7;
             iv) presence of diplopia; v) presence of corneal alterations; vi) presence of
             GO-related alterations of the fundi; and vii) reduction in visual acuity that could be
             attributed to GO.

          2. Patients with autoimmune thyroiditis

          3. healthy subjects
      
Biospecimen description: 
      Serum samples
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Condition: Esophageal Neoplasms
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      Lugol's solution staining was regarded as a gold standard to detect early superficial lesion
      during esophageal cancer screening using endoscopy. However, the sensitivity and specificity
      were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was
      previously shown to improve the visibility of gastrointestinal tract. It's unknown if the
      pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A
      randomized double-blind clinical trial was designed to investigate whether or not pronase
      might improve detection rate of early esophageal lesion, especially high grade dysplasia and
      early cancer by improving the esophageal visibility.
    


Intervention name(s): Pronase; Control
Intervention type(s): Drug; Drug
Intervention description(s): use pronase to improve visibility during endoscopical iodine staining; No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Esophageal Neoplasms; Lugol's solution; Pronase; Endoscopy, Digestive System; Pretreatment method
Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in
      many ways: by infusion or intravenous boluses and with self-administration device
      (patient-controlled sedation; PCS). It is not clear which method of propofol administration
      would be preferable. The main objective of the trial is to compare 2 different methods of
      propofol administration during ERCP: patient-controlled administration(PCS) and
      target-controlled infusion (TCI).
    

Detailed description: 
      80 patients of age 18-75 undergoing elective ERCP will be included to the randomized
      non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol,
      dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure
      or lung disease, drug addiction. The endpoints are: ease of procedures performance,
      complications, degree of sedation, recovery time, propofol and opioid consumption. During the
      procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .
    

Intervention name(s): Patient-controlled sedation; Target-controlled infusion
Intervention type(s): Device; Device
Intervention description(s): Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.; Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol
Other intervention name(s): Arcomed/Syramed AG infusion pump designed for self administration of medicines; Arcomed/Syramed AG target-controlled infusion device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERCP; patient-controlled sedation; target-controlled infusion; propofol; Sedation with propofol for ERCP; Endoscopic Retrograde Cholangiopancreatography
Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      The purpose of the study is to determine the applicability and utility of Gerd Q in the
      diagnosis of GERD and in the assessment of treatment response.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Gerd Questionnaire