bioihbjkbjnl/mcl2 huggingface dataset:
PET/CT in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      When patients with psoriasis develop joint pain, it is often hard to decide whether or not
      the pain is due to psoriatic arthritis (PsA). At this time, doctors use information from the
      history and physical exam to determine the diagnosis. X-rays, magnetic resonance imaging
      (MRI) and ultrasound have been used to help with the diagnosis but all three have
      limitations. A newer imaging technique, whole body Positron Emission Tomography/Computed
      Tomography (PET/CT) uses the idea that inflammatory cells take up sugar to locate
      inflammation in the body. Because patients with PsA have inflammatory cells in their joints
      and tendons, this type of scan allows the physician to take a picture of the whole body and
      locate inflammation. The investigators have found that some patients with psoriasis (but
      without arthritis) have inflammation in joints and tendons even before the patient has
      symptoms. In this study, the investigators will explore how well PET/CT works for assessing
      inflammation in patients with PsA. This would be a very exciting tool that could be used to
      find and treat inflammation before it causes damage or pain.
    


Intervention name(s): FDG-PET/CT scan
Intervention type(s): Radiation
Intervention description(s): FDG-PET/CT is a type of imaging used currently to look for cancer. We are using it to look at inflammation within the joints.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with psoriatic arthritis defined by CASPAR criteria and active joint disease.
      
Biospecimen description: 
      Plasma, Serum, and Plasma Cells
Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes
Condition: In Vitro Fertilization; Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      observation of females condition will getting pregnant by undergoing assisted reproductive
      technologies, the most important of which is the in vitro fertilization (IVF), where blood
      and follicular fluid samples are collected from them at the same stage of in vitro
      fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on
      blood tests. The levels of interested markers in blood and follicular fluid samples of the
      study individuals are assayed in order to compare these levels with the egg criteria such as
      egg number and maturation rate and finally compare the results with occurrence or absence of
      pregnancy.
    

Detailed description: 
      Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and
      follicular fluid samples of study subjects for women undergoing in vitro fertilization after
      monitoring their health for two to three months before beginning the first stage of in vitro
      fertilization. Once start the ovulation induction protocol, which is the first stage of in
      vitro fertilization, we will monitor all the results from the number of eggs and follicles,
      their diameter, the thickness of the endometrium, the number of mature eggs, the egg
      maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not
      later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the
      embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete
      or not. On the other hand, we will later compare the levels of studied parameters with the
      aforementioned egg quality criteria and with the clinical pregnancy rate of the study group
      in order to understand the relationship between these studied parameters and the occurrence
      of pregnancy.
    

Intervention name(s): human chorionic gonadotropin
Intervention type(s): Drug
Intervention description(s): 10000 IU when at least three follicles become more than 16 mm
Other intervention name(s): Chorex
Intervention MeSH terms: Chorionic Gonadotropin
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Females attending Orient Fertility and Genetics Hospital for infertility treatment or
        pregnancy assistance
      
Keywords: Vitamin D; Vitamin E; Zinc; Glutathione peroxidase
Riluzole Orodispersible Film Replicate Bioavailability
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the pharmacokinetic profile of riluzole after
      replicate single dose of the novel orodispersible film test formulation and of the marketed
      reference Rilutek® tablets and to evaluate their bioequivalence.

      The subjects will receive single oral doses of 50 mg of riluzole, as test orodispersible film
      and reference film-coated tablets under fasting conditions, in each of 4 subsequent periods
      separated by wash-out intervals of at least 7 days between consecutive administrations,
      according to a 2-treatment, 4-period, replicate cross-over design.
    


Intervention name(s): Riluzole 50 mg Oral Film; Rilutek 50Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Before each administration, the subjects will drink 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy will take the orodispersible film (32.0x22.0 mm) out of the provided pouch and place the product directly on the top surface (dorsal aspect) of the subjects' tongue.; One film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water.
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was designed in agreement with the EMA guideline "Guidance on the investigation of bioequivalence", CPMP/EWP/QWP/1401/98 Rev. 1 January 2010 (9).
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or
      24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in
      chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
    


Intervention name(s): BI 201335; Pegylated Interferon-alpha (IFN); Ribavirin (RBV); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 201335 once a day (QD) for 24 weeks; Pegylated Interferon-alpha for 48 weeks; Ribavirin (RBV) for 24 or 48 weeks; Placebo to BI201335 for 24 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography
Condition: CT; Coronary Angiography
Study type: Observational

Summary: 
      The purpose of this study is to investigate the effects of heart rates (including maximum
      heart rate, average heart rate and minimum heart rate) and variability of heart rate on image
      quality of DSCT coronary angiography without control of heart rate experienced in our
      department.
    

Detailed description: 
      The dual-source CT (DSCT) equipped with two X-ray tubes at 90 degree offset in the gantry can
      provide temporal resolution 83ms using mono-segmental reconstruction technique. The recent
      studies about the effect of heart rate on IQ of DSCT coronary angiography which concluded in
      adequate diagnostic IQ of dual-source CTCA without immediate pre-scanning heart rate control
      included chronic users of β-blocker focused on the influences of average heart rate, heart
      rate variability and coronary arterial calcifications on IQ. The effect of blooming artifact
      of calcification on IQ by far cannot be eliminated. Here, we investigate the effects of
      maximum heart rate, average heart rate, minimum heart rate and heart rate variability on the
      motion-related IQ of DSCT coronary angiography in patients without both pre-scanning heart
      rate control and chronic use of β-blocker agent, compared with that in chronic users of
      β-blocker agents.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients or examined persons from Taiwan.
      
Biospecimen description: 
      No biospecimens
    
Keywords: Image quality; Dual-source CT; Coronary angiography; Heart rate
Hydroxyurea Treatment for Adult Sickle Cell Anemia Patients in Kinshasa
Condition: Sickle-Cell Anaemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the efficacy of hydroxyurea (HU) in improving
      disease severity in adult patients with sickle cell anemia in Kinshasa (Democratic Republic
      of Congo). This study aims to:

        -  assess the safety and efficacy of HU treatment in the Congolese environment;

        -  assess the reversibility of chronic cardiac lesions. Participants will take hydroxyurea
           for two years. The effects of the treatment will be evaluated periodically by clinical
           evaluation, biological tests, and echocardiographic exploration.
    

Detailed description: 
      Sickle cell disease is common in sub-Saharan Africa, particularly in the Democratic Republic
      of the Congo (DRC). It is characterized by chronic hemolytic anemia with the need for
      transfusions, painful osteoarticular crises, and chronic organ damage, including the heart.

      Hydroxyurea (HU) is a drug widely used in sickle cell patients in wealthy countries, while it
      is little used in poor countries with a high incidence of the disease.

      This prospective study will focus on homozygous sickle cell participants, naïve to HU
      treatment. Participants will take HU in gradually increasing doses. They will be monitored
      for the possible occurrence of side effects. The effectiveness of the treatment will be
      evaluated according to the reduction in painful crises, and the need for blood transfusion;
      as well as based on biological changes and the reversibility or stabilization of
      cardiovascular complications.
    

Intervention name(s): Hydroxyurea
Intervention type(s): Drug
Intervention description(s): The treatment started with a dose of 15mg/kg/day of HU. This initial dose was increased in steps of 5mg/kg/day every three months up to 35mg/kg/day or a maximal tolerated dose.
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Intervention model description: all eligible patients received during the study period were included and received treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sickle cell anemia; hydroxyurea; adult patients; kinshasa
Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)
Condition: Motor Activity; Motor Neuroplasticity
Study type: Interventional

Summary: 
      Investigating modulation of motor cortex excitability by transcranial magnetic stimulation
      and transcranial direct current stimulation.
    

Detailed description: 
      Purpose of this pilot study is to modulate the motor cortex excitability by transcranial
      magnetic stimulation and transcranial direct current stimulation. Electromyography will be
      recorded on right abductor digiti minimi muscle to find the motor threshold and measure motor
      evoked potentials for each healthy participant. In addition, electroencephalography (EEG)
      data will be collected on the scalp with a high-density EEG net. Eighteen healthy
      participants will be in this study. Each participant will be seated in a reclining chair and
      applied non-invasive magnetic and electrical stimulations on the scalp. At baseline, the
      participant's resting motor threshold (RMT) will be estimated by adjusting the intensity of
      TMS applied on the left motor cortex to achieve motor-evoked potentials of about 50 uV with
      10 TMS pulses at a rate of 0.25 Hz. Then a 3-condition, 3-session, 6-sequence randomized
      crossover experiment will be used to characterize and compare three versions of tDCS
      stimulation: anode, cathode, sham. Before and after a 10-min tDCS condition is applied, TMS
      pulses at 120% of RMT intensity will be applied for 10 minutes and TMS-evoked potential and
      motor-evoked potential amplitudes will be measured. Each session has at least 1-day gap to
      remove outlasting effects. We will also be collecting structural magnetic resonance imaging
      (sMRI) to target primary motor cortex precisely.
    

Intervention name(s): anodal tDCS; cathodal tDCS; sham tDCS
Intervention type(s): Device; Device; Device
Intervention description(s): The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.; The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.; The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will be assigned to 2 active and sham conditions on a different day.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: transcranial magnetic stimulation (TMS); transcranial direct current stimulation (tDCS); electroencephalography (EEG)
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is
      negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly
      reduce quality of life for individuals with TBI as functioning in this domain has been
      closely linked with successful independent living and community re-integration.
      Problematically, there are currently no empirically validated treatment options that address
      metacognitive deficits after TBI. Recent research in healthy samples demonstrates that
      specific listening interventions may alter neural activation in brain works associated with
      metacognition and can improve metacognitive functioning; however, it remains unknown if these
      effects generalize to individuals with TBI. Thus, the objective of the proposed study is to
      use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of
      applying a specific listening intervention to improve metacognition after TBI and to employ
      functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the
      intervention operates.
    


Intervention name(s): Listening-based intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will listen to pre-specified material on a CD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).
Condition: Cancer Cervix
Study type: Observational

Summary: 
      Despite the existence of an effective screening test (pap smear), cervical cancer is, every
      year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in
      10 women are not screened or not often enough (nearly 7 millions women). It is therefore
      necessary to develop new strategies to reach these women. The etiological factor of this
      cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV).
      Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with
      HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal
      self-sampling with HPV test is a powerful means to increase the participation rate in
      cervical cancer screening. The investigators hypothesize that it is possible to optimize
      participation rate by improving the communication media associated to the vaginal
      self-sampling kit. This is why the accompanying letter and the leaflet explaining how to
      perform the vaginal self-sampling will be submit to women opinion by using the Focus Group
      method. The objective is to identify improvement ideas of these two communication media.
    


Intervention name(s): Focus Group
Intervention type(s): Other
Intervention description(s): Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty women living near the city of Tours not screened by pap smear (ideally since at
        least 3 years). Women who could be interested by the vaginal self-sampling screening
        alternative.
      
Keywords: Cervical cancer screening; vaginal self-sampling; Focus group; communication
Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery
Condition: Surgical Complications From General Anesthesia; Cerebral Ischemia; Anesthesia; Reaction
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      Subsequent and non-randomised patients, adult patients qualified for major abdominal
      surgeries were enrolled
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred and one (101) subsequent and non-randomised patients, age between 35 and 84
        years (mean 64±10) hospitalised at the 1st Department of General, Oncologic and
        Gastroenterologic Surgery of the UJ CM in Krakow, qualified for abdominal surgeries were
        enrolled.
      
Keywords: cerebral saturation; epidural anaesthesia; Near Infrared Spectroscopy (NIRS); Regional cerebral oxygen saturation
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
Condition: Obstructive Sleep Apnea; Hypopnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether treatment with Armodafinil
      (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness
      associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep
      latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps
      at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings
      (as related to general condition) at week 12, or last post-baseline visit.
    


Intervention name(s): Armodafinil 250 mg/day; Armodafinil 150 mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Armodafinil 250 mg once daily in the morning; Armodafinil 150 mg once daily in the morning; Matching placebo tablets once daily in the morning
Other intervention name(s): NUVIGIL; CEP-10953; NUVIGIL; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Excessive Sleepiness; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Cephalon; Cephalon, Inc; NUVIGIL
Survival Analysis: TACE vs. Combination Therapy in HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This retrospective observational study aimed to assess potential improvements associated with
      systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially
      unresectable HCC.
    

Detailed description: 
      Standard treatments provide limited benefits for patients with intermediate or advanced
      hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens
      for patients with locally advanced HCC have attracted much attention. Therefore, this
      retrospective research was designed to evaluate the clinical outcomes of TACE alone or in
      combination with immune and targeted therapy in the primary treatment for patients with
      intermediate to advanced stage HCC.
    

Intervention name(s): Transarterial chemoembolization; Systemic treatment
Intervention type(s): Drug; Other
Intervention description(s): A 5-French RH catheter was then introduced to the celiac artery, superior mesenteric and artery common hepatic artery for angiography to determine tumor location, quantity, size, and vascularity. After confirmation by C-arm cone-beam computed tomography (CBCT), chemoembolization was administered by superselective catheterization of the branches of the tumor-feeding arteries using a 2.8-French coaxial microcatheter. For cTACE, oxaliplatin, raltitrexed and an emulsion containing idarubicin and ethiodized oil were infused for over 20 minutes, followed by combined embolization with blank embolic microspheres. For DEB-TACE, DC/LC Beads® (Biocompatibles, Farnham, Surrey, UK), as drug carriers and embolic materials, were loaded with doxorubicin hydrochloride and mixed with nonionic contrast medium. Real-time assessment of embolization was performed with the assistance of CBCT.; sorafenib (Bayer HealthCare, Berlin, Germany), lenvatinib (Eisai, Tokyo, Japan), apatinib (Hengrui Pharmaceuticals, Lianyungang, China) and donafenib (Zelgen Biopharmaceuticals, Suzhou, China), while a minority of patients received bevacizumab (Innovent Biologics, Suzhou, China).
sintilimab (Innovent Biologics, Suzhou, China), toripalimab (Junshi Biosciences, Suzhou, China), camrelizumab (Hengrui Pharmaceuticals, Lianyungang, China), tislelizumab (BeiGene, Shanghai, China), pembrolizumab (Merck Sharp & Dohme, NewJersey, USA), nivolumab (Bristol Myers Squibb, New York, USA), atezolizumab (Roche, Basel, Switzerland) and envafolimab (Alphamab Biopharmaceuticals, Suzhou, China).
Other intervention name(s): TACE
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with treatment-naive intermediate or advanced HCC who received with TACE alone or
        the combination therapy (TACE plus antiangiogenic agents with or without ICIs) at our
        institution
      
Keywords: Hepatocellular Carcinoma; Transarterial chemoembolization; Combination therapy; Survival