cyrilzakka/clinical-trials huggingface dataset:
Effects of Transcranial Direct Current Stimulation (tDCS) and Visual Illusion on Chronic Pain Due to Spinal Cord Injury

The purpose of this study is to investigate the effects of Transcranial Direct Current Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with spinal cord injury when compared to sham stimulation. The investigators will also measure changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.


Eligibility Criteria:
STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. With traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
4. Stable chronic pain for at least the three preceding months (for spinal cord injury only)
5. Score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment (for spinal cord injury only)
6. Refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
7. Pain is not attributable to other causes, such as peripheral inflammation

Exclusion Criteria:

1. Clinically significant or unstable medical or psychiatric disorder
2. History of substance abuse
3. Neuropsychiatric comorbidities, including: Documented traumatic brain injury (TBI), defined as damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia (PTA), or skull fracture, or objective neurological findings that can be reasonably attributed to TBI as assessed by the study PI
4. Implanted devices for pain control, such as vagal or deep brain stimulators
5. Contraindications to tDCS:

   * metal in the head
   * implanted brain medical devices
6. Pregnancy
7. Use of ventilators or ventilation support
8. Complete tetraplegic lesion (no motor function in the arms) (C3 to C8) as we will be measuring the motor evoked potential in the FDI (upper limbs); only tetraplegic patients with incomplete functional status and also as defined by the ability to elicit MEP in the FDI will be able to participate in this study
A Single and Multiple Ascending Dose Study of LY3876602 in Healthy Participants

The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.

Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
* Male or female participants of nonchildbearing potential

Exclusion Criteria:

* Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
* Have allergies to diphenhydramine, epinephrine, or methylprednisolone
* Have serious or unstable medical conditions,
* History of skin wounding within 14 days of screening or current skin infection
* Are unwilling to stop alcohol consumption 48 hours prior to each dosing
* Have active or latent tuberculosis
* Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics
Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.

Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir.

If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).

The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.


Eligibility Criteria:
Inclusion Criteria:

* After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
* Aged over 18 years.
* Chronic HIV infection
* Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
* Undetectable viral load determined by ultrasensitive techniques (\<50 copies HIV RNA/mL) for at least 2 years.
* CD4+ T lymphocyte count above 350 cells/mm3.
* Demonstration of R5 viral tropism (use of CCR5 coreceptors) by phenotyping in plasma samples stored before antiretroviral therapy is started.
* Understand the objective of the study and be available to make frequent visits to the hospital.

Exclusion Criteria:

* Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (\<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
* Proven resistance against the antiretroviral drugs under study.
* Planned interruption of antiretroviral therapy.
* Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
* Taking a fusion inhibitor (enfuvirtide).
* Pregnancy or intention to become pregnant during the study.
Heparinization vs Salinization of the Peripheral Venous Catheter

Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil
* Patients with at least one peripheral venous line for discontinuous treatment, which has not been channeled in a medical emergency situation.
* Written informed consent

Exclusion Criteria:

* Allergy to heparin
* Patients treated with unfractionated sodium heparin.
* Patients in dialysis
* Patients with a venous catheter indicated for diagnosis tests.
* Patients with a venous catheter indicated for blood transfusion
* Severe heparin-induced thrombocytopenia in recent months
* Active uncontrollable bleeding during admission
* Brain aneurysm or dissecting aorta, except in association with corrective surgery.
* Confirmed / suspected cerebrovascular hemorrhage
* Severe uncontrolled hypertension
* Severe alterations in platelet coagulation \<30,000, TP\> 1.7 APTT ratio\> 1.7 ratio.
* Patient included in another clinical trial with drugs or procedures that may affect the patency of venous catheters.
10-years Nationwide Alpine Accidents in Austria

This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider...).

The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime...) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.

Eligibility Criteria:
Inclusion Criteria:

* Person suffering the injury searched for;

Exclusion Criteria:

-
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.

Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.

Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Participant meets the following disease activity criteria:

  1. Moderate to severe CD as assessed by CDAI
  2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
* Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Exclusion Criteria:

* Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Participants with prior exposure to p19 inhibitors.
* Participants with complications of Crohn's disease.
* Participants having an ostomy or ileoanal pouch.
Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in MS

This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab.

This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. The study will be conducted on Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department.

The decision to treat with ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study and in line with the Summary of Product Characteristics (SmPC) approved by the Turkish Ministry of Health.

Data will be recorded at screening visit, baseline visit (month 0), second visit on 6th month, third visit on 12th month and last visit (end of the study \[EOS\]) on 24th month according to local clinic practice. Optional ad hoc visits could be conducted if relapse of MS or infection after vaccination occurs during ocrelizumab treatment.

The duration of the study for each patient will be 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old) with a diagnosis of relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the 2017 revised McDonald criteria.
* Previous MS treatment with at least one of other DMT(\*). The patients can be without treatment before switching until the end of wash-out period of previous DMT(s) or until lymphocytes parameter is in normal range.
* Previous treatment change with the reasons inefficacy, safety related issues or lack of compliance.
* Decision to initiate ocrelizumab therapy (in accordance with the product characteristics approved in Turkey) has already been taken for the treatment of MS patient as part of routine clinical practice. The decision to treat with Ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study.
* Agreed and signed informed consent.

(\*) A DMT is defined as any of the following drugs: Teriflunomide, Interferon beta 1a, Interferon beta 1b, Peginterferon beta 1a, Glatiramer acetate, Fingolimod, Daclizumab, Alemtuzumab, Cladribine, Dimethyl fumarate, and Natalizumab.

Exclusion Criteria:

* Previously treated with anti-CD20 therapy (rituximab, atacicept, belimumab or ofatumumab).
* Medical history of a malignancy, active infection (including Hepatitis B virus) or chronic inflammatory disease.
* Medical history or use of any medication other than a DMT as defined above which may affect immunophenotypes of the participants.
Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening

It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.

It concerns a study with a mixed method approach to evaluate the usability of a prototype of HIV self-test among lay users. Data collection techniques were performed through observation through videos of lay users conducting self-testing without supervision, a qualitative checklist by participant observation, pre-test and post-test interviews, and closure form. There was no randomization in this study.

The study was conducted by four clinical research sites, distributed in four different states of Brazil in other to obtain a geographic representation: Unidade de Ensaios Clínicos para Imunobiológicos (UECI) at Rio de Janeiro; Centro de Ciências da Saúde da Universidade Federal da Paraíba (UFPB) at Paraíba, Faculdade de Medicina de Botucatu (UNESP) at São Paulo and Centro de Ciências Biológicas e da Saúde da Universidade Estadual do Pará (UEPA) at Pará.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the ICF;
* Individuals who authorized filming during the test.

Exclusion Criteria:

* Illiterates;
* Participants who have already performed any other HIV self-test;
* Health professionals with complete higher education;
* Colorblind individuals.
Validation of a Test for Fetal Malformations

The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. The study aims at determining the performance parameters (specificity, sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the test and its applicability. To do this, the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international study conducted between years 2004-2008.

The test has been developed in a case-control study. In this clinical trial the investigators will test it in a large cohort that is likely to resemble a real population. The purpose of validation is to see if the test is able to recognize the few malformed fetuses in the entire population and especially its specificity in real conditions. In addition, the investigators will check whether particular maternal conditions (such as preeclampsia, gestational diabetes, etc.) or fetal conditions (Small for gestational age, Large for gestational age, etc.) affect the test results.

Eligibility Criteria:
Inclusion criteria were the ones designed by SCOPE Study:

- Nulliparous women, with a singleton pregnancy, between 14wks, 0 days and 16wks, 6 days gestation who give informed consent to participate in SCOPE.

Exclusion criteria were the ones designed by SCOPE Study:

* Unsure of last menstrual period (LMP)
* Unwilling to have ultrasound scan at ≤20 weeks
* ≥3 miscarriages
* ≥3 terminations
* Essential hypertension treated pre-pregnancy
* Moderate-severe hypertension at booking ≥160/100 mmHg
* Diabetes
* Renal disease
* Systemic lupus erythematosus
* Anti-phospholipid syndrome
* Sickle cell disease
* HIV positive
* Major uterine anomaly
* Cervical suture
* Knife cone biopsy
* Ruptured membranes now
* Long term steroids
* Treatment low-dose aspirin
* Treatment calcium (\>1g/24h)
* Treatment eicosapentanoic acid (fish oil)
* Treatment vitamin C ≥1000 mg \& Vit E ≥400 iu
* Treatment heparin/low molecular weight heparin
The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.

The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. More than 18 years of age
3. Requiring DLT for thoracic surgery

Exclusion Criteria:

1. risk of regurgitation and pulmonary aspiration
2. history of gastroesophageal reflux, pregnancy
3. scheduled tracheostomy and postoperative prolonged ventilation in ICU
4. patients with limited neck extension (\< 35°)
5. a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
6. a sternomental distance of less than 12.5 cm with the head fully extended
7. mouth can not open
Tranexamic Acid as an Intervention in Abruptio Placenta

Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality

Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.

Eligibility Criteria:
Inclusion Criteria:

* 24 weeks gestation and more
* Stable hemodynamically
* Accepted to participate

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Defective color vision
* History of venous thromboembolism
* Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
* Smoker
* Refused to participate in the trial
Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)

The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.

The total duration of the study is approximately 21 months, which includes a 6 months enrolment period. The number of patient visits depends on the number of Monofer® treatment courses needed during the study period. Each patient can receive one or more treatment courses during 12 months after informed consent. The last blood test will be taken after the last Monofer® treatment course which might occur 13-15 months after Informed consent. Patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. Study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last Monofer® treated patient in the study. Each treatment course can consist of one or more Monofer® administrations. For each administration of Monofer® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the Monofer® treatment course.

DATA COLLECTION:

* Clinical data management will be performed in accordance with applicable standards and data cleaning procedures.
* The collected data will systematically be entered into an eCRF (MyEDC, Biostata). The source of information is the relevant laboratory results obtained from the patient record.
* The data will be evaluated by the Pharmacosmos A/S Medical Affairs team.

Laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. The protocol does not accept any additional samples outside current local standard practice to be taken.

Eligibility Criteria:
Inclusion Criteria:

Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice

Exclusion Criteria:

None