cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease

The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, 18 to 65 years of age at Screening
* Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination
* Colonoscopy performed prior to first study medication administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed)
* Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/ parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide)

Exclusion Criteria:

* Subject has a diagnosis of Ulcerative Colitis or Indeterminant Colitis as determined by the investigator
* Subject has obstructive strictures with clinical evidence of partial or complete obstruction
* Subject has an active fistula (fistula secreting spontaneously or by gentle pressure)
* Subject has a history of diverticulitis or symptomatic diverticulosis
* Subject has any prior exposure to anti-IL-6 agents (eg, Tocilizumab)
* Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the study drug
* Subject has a high risk of infection (eg, subjects with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
* Subject has a concurrent malignancy or a history of malignancy. Subjects who have been successfully treated and who have remained malignancy-free for at least 5 years prior to Screening may be included
Stroke Prevention in Sickle Cell Anemia (STOP 1)

To reduce episodes of first time stroke by 75 percent in children with sickle cell anemia by the administration of prophylactic transfusion therapy.

BACKGROUND:

Stroke, occurring in about 10 percent of pediatric patients with sickle cell disease, is one of the most devastating complications, with a high recurrence rate after the first episode. Several non-randomized studies have shown reduction in stroke recurrence when periodic blood transfusions are administered to maintain hemoglobin S under 30 percent. Periodic blood transfusions are associated with significant risks of iron overload and other complications and must be accompanied by parenteral iron chelation therapy. However, this has become a standard of care for prevention of recurrent stroke in SS children. Thus, a randomized trial of blood transfusion for secondary prevention would not be feasible because it would be considered unethical. Based on various studies, the recurrence rate is reduced from 46 to 67 percent to approximately 7 percent on transfusion therapy. Because most stroke patients are left with some neurological deficit, and face a lifetime of disability, primary prevention would have a significant impact on the management of patients. However, because of complications of blood transfusions, the hypothesis should be proven by a randomized clinical trial.

A primary prevention trial had not been possible because an acceptable means of detecting those children at risk of stroke was not available. The advent of TCD to identify arterial abnormalities for the prediction of stroke has provided a means of detection. TCD abnormalities have a high specificity (100 percent) and high sensitivity (90 percent) for detecting angiographically proven narrowing of arterial diameter. Thus, TCD examination of the basal cerebral arteries is predictive of who will develop a stroke.

DESIGN NARRATIVE:

Randomized, Phase III, multicenter. Approximately 3,000 children from 12 clinics were screened with transcranial Doppler (TCD). A total of 130 were randomized to receive either standard supportive care or periodic blood transfusions if they were found to be at high risk of stroke on the basis of elevated cerebral blood flow as measured by TCD screening tests. Primary endpoints included clinically evident symptoms of cerebral infarction with consistent findings on magnetic resonance imaging (MRI), and/or symptomatic intracranial hemorrhage. Secondary endpoints included asymptomatic brain lesions detected by MRI in brain areas not involved in primary endpoints. Hematologic characteristics of the high risk group were analyzed and serum and DNA samples frozen for future analysis. Recruitment ended in October 1997 with the accrual of 130 subjects. The clinical phase ended in 1999.

Eligibility Criteria:
Pediatric patients, ages 24 months to 16 years, with sickle cell anemia or S-beta zero thalassemia.
Contrast-Enhanced US of Spleen, Liver and Kidney

To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Three cohortes will be studied: cohorte 1 infection at Plasmodium falciparum (24 patients), cohorte 3 infection at Plasmodium vivax, ovale or malariae (5 patients) and cohorte 2 other infectious diseases such as acute pyelonephritis (24 patients).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

Eligibility Criteria:
Inclusion Criteria:

* Social security number
* Age over 18
* acute malaria infection or other infectious diseases
* Inpatients
* Signed informed consent form

Exclusion Criteria:

* Pregnancy
* Criteria of bad tolerance of infection
* Treatment started for more than 8 hours
* Lack of cooperation
* History of splenectomy, hematological disease, cirrhosis with portal hypertension, splenomegaly
* Medical treatment with beta blocker, diuretic, immunodepression drugs
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.


Eligibility Criteria:
Inclusion criteria:

* Adult patients, ≥ 18 years of age
* Active rheumatoid arthritis
* Inadequate treatment with any DMARD other than methotrexate

Exclusion criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Concurrent treatment with any DMARD other than methotrexate
* Previous treatment with any cell-depleting therapies
* Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
Glucocorticoids in COVID-19 (CORTIVID)

Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
* Length of symptoms consistent with COVID-19 ≥7 days.
* Hospital admission.
* At least one of the following: CRP \>60 mg/L, IL-6 \>40 pg/mL, ferritin \>1000 μg/L.
* Acceptation of informed consent

Exclusion Criteria:

* Allergy or contraindication to any of the drugs under study.
* SpO2 \<90% (in air ambient) or PaO2 \<60 mmHg (in ambient air) or PaO2/FiO2 \<300 mmHg.
* Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
* Decompensated diabetes mellitus.
* Uncontrolled hypertension.
* Psychotic or manic disorder.
* Active cancer.
* Pregnancy or lactation.
* Clinical or biochemical suspicion (procalcitonin \>0.5 ng/mL) of active infection other than SARS-CoV-2.
* Out-of-hospital management patient.
* Conservative or palliative management patient.
* Participation in another clinical trial.
* Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Implementation Research of New Dengue Vector Control Tools

This project will provide new insights concerning how to reduce dengue transmission by means of cost-effective and sustainable implementation strategies of vector control methods.

The research will assess key strategies which deliver new vector control tools with respect to their cost-effectiveness, acceptability and sustainability in contrasting environments.


Eligibility Criteria:
Inclusion Criteria:

* No patients, but communities were included, with as inclusion criteria: neighborhoods of Lam Chabang, Thailand and Valera and San Rafael de Carvajal, Venezuela after obtaining community approval

Exclusion Criteria:

* Neighborhoods without community approval
Effect of Dexmedetomidine Upon Sleep Postoperatively

The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine administered to surgical patients intra-operatively will improve the characteristics of sleep post-operatively.

Physiological similarities exist between the anesthetized state and sleep. Pathways within the brain controlling sleep and wakefulness are also affected by anesthesia. One significant difference between the states of anesthesia and sleep is the ability to respond whenever a relatively mild stimulus is applied, e.g. verbal command or gently shaking. Interestingly, this feature of arousability is seen when dexmedetomidine is used for sedation but is absent when alternative intravenous anesthetic agents, e.g. propofol, are used to provide similar degree of sedation. Recent studies have shown that dexmedetomidine acts on receptors located within the locus ceruleus, which are responsible for both sleep and anesthesia.

During a recent study volunteers received an infusion of dexmedetomidine during the afternoon prior to remaining under study conditions for the duration of the night. The study was not designed to measure sleep but anecdotal reporting from the participants suggested that they were able to resume their normal day's activities whilst the subject receiving placebo felt extremely fatigued from lack of sleep. This prompted the establishment of a pilot study to determine if dexmedetomidine could provide restorative sleep to people under disturbed sleep conditions i.e. postoperative patients.

Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo elective lower extremity orthopaedic surgery (free vascular fibular graft)
* ASA 1 or 2
* Body Mass Index 20 - 30
* Procedure to be done under combined epidural and general anesthesia

Exclusion Criteria:

* Sleep disturbance
* Insomnia
* Sleep apnea
* Female (pregnant)
* Contra-indication to placement of epidural anesthesia
DisCoVisc Comparative Evaluation

A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral operable cataracts

Exclusion Criteria:

* Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
* Intraocular Pressure (IOP) \> 21
* History of ocular inflammation
* Systemic or ocular diseases affecting corneal endothelium
Comparison Of Suture Materials on Sectio Scars (COSMOSS)

This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 yrs women
* Primary elective cesarean section
* First delivery
* Without any systemic diseases

Exclusion Criteria:

* emergent delivery
* previous c-section history
* congenital uterine abnormality
Assessment of the TGF-beta Pathway and Micro-RNA in Pediatric Pulmonary Arterial Hypertension

This is a prospective pilot study to assess the plasma levels of particular proteins involved in the transforming growth factor beta (TGF-β) pathway and its down stream regulators, CHIP, as well as micro RNA molecules in subjects with pulmonary arterial hypertension (PAH) and compare them to control subjects without PAH to see if they can be used as a diagnostic or prognostic marker of PAH and how this compares to other diagnostic biomarkers N-terminal pro-natriuretic peptide (NT Pro-BNP) and C-reactive protein (CRP).

Aim 1: This study will correlate proteins in the TGF- β signaling pathway and micro RNA levels with invasive (catheterization) and non-invasive (echocardiography) measurements of pulmonary artery pressures to assess for the presence and severity of PAH and compare these measurements to the established biomarkers of NT Pro BNP and CRP levels.

Hypothesis 1: Plasma levels of proteins of the TGF-β pathway; bone morphogenic protein (BMP) 2, 4, 6, 7, 9 and 10 along with activin A and TGF-β1 protein as well as CHIP (carboxyl-terminus of Hsp70-intracting protein), an enzyme that regulates the activations and exports of TGF- β to the nucleus will be significantly different in subjects with PH over control subjects.

Hypothesis 2: Plasma levels of proteins in the TGF- β pathway; BMP 2, 4, 6, 7, 9 and 10 along with activin A and TGF-β1 protein as well as CHIP will show better correlation with the presence of PAH and its severity than NT-Pro BNP and CRP levels.

Hypothesis 3: The micro-RNA profiles in plasma will be significantly different in subjects with PAHPH over control subjects.

Aim 2: To correlate protein/micro-RNA levels with clinical status in PAH subjects as assessed by functional status, exercise testing, and PAH drug regimen to determine if they can correlate with disease severity.

Hypothesis 1: Clinical findings in PAH patients will correlate with disease severity and study proteins and micro-RNA levels better than established biomarkers.

Aim 3: To correlate evidence of genetic abnormalities through whole exome sequencing especially in regions known or suspected to cause PAH (e.g. BMPR2, ENG, and ALK1 mutations), within the TGF-β pathway or lung development with the tested protein/micro-RNA levels.

Hypothesis 1: Genetic evaluation of patients with PAH will show abnormalities within the TGF-β pathway or lung development.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects ages 2-17 years
* Subjects undergoing a clinically indicated cardiac catheterization.
* Subjects with proven or being evaluated for pulmonary hypertension in WHO classification group 1 or 3†
* Subjects will be categorized as PAH subjects if they meet the hemodynamic criteria: pulmonary artery pressure \>20mmHg, pulmonary vascular resistance index \>3 Woods units\*m2, and wedge pressures \<15mmHg.
* Subjects can be categorized as control subjects if they do not have PH on catheterization and do not meet any exclusion criteria.

Exclusion Criteria:

-
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration


Eligibility Criteria:
Inclusion Criteria:

* patients have an oral mucosal ulcer

Exclusion Criteria:

* patients allergic to any component of the diclofenac formulation and other NSAIDs
Donor Lymphocyte Infusion After Alternative Donor Transplantation

The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI) given with methotrexate to hasten immune recovery without causing severe graft-versus-host disease (GVHD) in recipients who have had a T-cell depleted transplant.

Studies have shown that giving donor T cells after a mismatched T cell-depleted stem cell transplant can speed up recovery of T cells in the patient. This approach can cause severe graft versus host disease (GVHD). The purpose of this study is to determine whether giving a donor lymphocyte infusion (DLI) with methotrexate can accelerate immune recovery in recipients of T cell-depleted stem cell transplants. Thirty days after a T-cell depleted transplant, patients will be given a DLI. They will be monitored for immune recovery as measured by CD4 count and for GVHD toxicity.

Patients will be separated into six cohorts based on dose of DLI received: 3 x 10\^4, 4 x 10\^4, 5 x 10\^4, 6 X 10\^4, 8 x 10\^4, and 10 X10\^4 cells/ kg of body weight. A minimum of 3 patients will be tested at each dose starting with the lowest dose. Dose escalation will continue until the dose associated with CD4 count \>100 at Day +120 after transplant without significant GVHD is determined. All patients will receive thirteen doses of methotrexate after the DLI to prevent GVHD. Patients will be followed for 2 years for outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been treated on the LCH BMT 09-01 protocol
* Signed informed consent by patient or legal guardian

Exclusion Criteria:

* Active GVHD at the time when DLI are due
* History of acute GVHD \> grade I prior to DLI
* Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)
* Uncontrolled bacterial or fungal infection
* O2 saturation by pulse oximetry \< 95%
* Bilirubin \> 3mg/dL or ALT \> 5 x upper limit of normal
* Creatinine \> 3x baseline (at transplant)
* ANC (WBC x % neutrophils + bands) \< 500/ul
* Significant effusions (eg. pleural or pericardial) or ascites
* EBV-related PTLD
* Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol
Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.

Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Previous studies carried out by this research group and in the scientific literature have shown that "Pain Neuroscience Education" (PNE) and Therapeutic Exercise (TE) constitute an effective care strategy in the treatment of persistent pain. Therefore, with this research we will try to respond with a treatment proposal from Primary Care (PC).

Objective: to determine whether an PNE and TE program is effective in patients presenting Long Covid Pain (LCP).

Method: Randomized clinical trial. A sample of 80 subjects will be recruited. The intervention group will receive a program of TE and PNE, of 12 weeks duration: 5 weeks of PNE, of 1 weekly session of 90 minutes, and 7 weeks of TE, with a total of 19 sessions of 60 minutes duration. The control group will receive the usual treatment. An assessment will be made at the beginning and after the end of the intervention, where the following variables will be measured: quality of life, intensity, distribution and expansion of pain, healthy physical condition and blood test values. These will be evaluated by means of physical examination, questionnaires and laboratory tests.

Applicability of the expected results: The proposed intervention is simple and reproducible. It requires few resources, and can produce changes in pain perception, functionality and quality of life in patients with LCP.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had Covid-19, with a confirmatory PCR+ test or positive antigen test and recorded in their primary care medical record.
* Subjects between 18-70 years old.
* Musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection.
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* History of chronic musculoskeletal pain of more than 12 weeks of evolution prior to Covid-19.
* History of diagnosed major depression.
* Having a diagnosis of fibromyalgia prior to Covid-19 infection.
* Pregnancy.
* Pain of oncologic origin.
* Fracture or surgical intervention on the spine in the last year.
* Cognitive neurological impairment that prevents understanding of PNE contents (in case of doubt, assessment with Minimental state examination).
* Bladder or bowel incontinence.
* Saddle anesthesia.
* Patients with other clinical conditions that may aggravate chronic spine pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome).
* Patients with associated pathologies that make it impossible for them to perform TE.
* Patients undergoing treatment with alternative therapies.