cyrilzakka/clinical-trials huggingface dataset:
CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room

A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast identification of CVA is crucial in order to refer the patient to an appropriate medical center as well as to direct him/her to a suitable treatment upon arrival to the Medical Center, in order to minimize the permanent damage to the brain. In this study, we are evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using innovative algorithm. The system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed based on the synchronization of the front and back hemispheres. During CVA, specific hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is to develop a tool for identifying CVA in patients who have no clear CVA related signs.


Eligibility Criteria:
Inclusion Criteria:

Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness

Exclusion Criteria:

Pregnant women
Analysis of Respiratory Variations of the Right Internal Jugular Vein as a Predictor of Fluid Responsiveness During Mechanical Ventilation

The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* Mechanical Ventilation

Exclusion Criteria:

* no exclusion Criteria
Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.

The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration \< 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).

Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
* Fagotti score by laparoscopic exploration \< 6
* Residual tumor \< 1cm after completion of cytoreductive surgery
* 18 \< Age \< 70 year old
* Expected survival \> 3 months
* Performance status: ECOG 0-1
* Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
* Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
* Voluntary participation after getting written informed consent.

Exclusion Criteria:

* Fagotti score by laparoscopic exploration \>= 6
* Suboptimal debulking (residual tumor \> 1cm)
* Extensive adhesion in peritoneal cavity
* Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
* Receiving other chemotherapy, radiotherapy or immunotherapy
* Patients who are unsuitable candidates by doctor's decision
* Without given written informed consent
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.


Eligibility Criteria:
Inclusion Criteria:

* Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.
* Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.
* Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Has at least one measurable lesion per Lugano 2014 classification.
* Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.
* Has adequate organ function.
* Has life expectancy of greater than 3 months.

Exclusion Criteria:

* Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.
* Has known additional malignancy within 5 years prior to randomization.
* Has an active autoimmune disease or has had an autoimmune disease that may relapse.
* Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.
* Has active tuberculosis infection.
* Has a known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome (AIDS).
* Has a known active Hepatitis B or C virus infection.
* Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer).
* Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment.
* Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment.
* Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways.
* Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment.
* Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment.
* Has a known severe hypersensitivity to sugemalimab, its active substance and/or any of its excipients, or to other monoclonal antibodies.
* Female participants who are pregnant or breastfeeding.
* Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.
Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
2. 2 \~ 6 weeks after operation; the surgical incision healed well;
3. Presence of lesions evaluable according to Rano criteria;
4. Aged 18-70 years;
5. Karnofsky performance status (KPS) ≥ 60;
6. The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
7. No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
8. Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
9. Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
10. Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
11. Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
12. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
13. Patient is sufficiently compliant with study and follow-up procedures;
14. Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.

Exclusion Criteria:

1. Secondary glioblastoma;
2. Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
3. Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
4. Pregnant or lactating women;
5. Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
6. Evidence of hereditary bleeding constitution or coagulation disorders;
7. Patients requiring anticoagulant therapy due to other diseases;
An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence

The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.

The impact of alcoholism can be reduced through effective treatments, which may include medical, psychological, and social interventions. The main goals of alcohol-dependence treatment are to assist patients in avoiding alcohol, developing better strategies for managing stress, and improving self-esteem and quality of life. Studies have demonstrated that treatments for alcohol use disorders can be effective, but their effectiveness is often limited. Although the optimal goal of treatment should be total abstinence, even patients who are unable to achieve this goal may still benefit from treatments leading to a reduction in drinking. Medications are commonly used in other addictive disorders, such as nicotine and opioid dependence, suggesting that this intervention could be useful in the treatment of alcohol dependence. This is a randomized, double-blind, flexible dose study to determine if topiramate, a prescription medication approved by the Food \& Drug Administration for the treatment of epilepsy and the prevention of migraine, administered at a dose of 300mg per day or the subject's maximum tolerated dose, is safe and effective compared with placebo in patients with alcohol dependence. The study hypothesis is that topiramate will be more effective than placebo in reducing the percentage of heavy drinking days (5 or more standard drinks per day for men and 4 or more standard drinks per day for women) in patients with alcohol dependence. The patients will receive topiramate tablets (25mg and/or 100mg) or matching placebo. Study medication is taken in increasing doses starting at 25 mg/day up to 300 mg per day (or maximum tolerated dose) during the first 6 weeks and the achieved dose is maintained for an additional 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have a current diagnosis of alcohol dependence
* drink an average of 28 or more standard drinking units/week for women or 35 or more standard drinking units/week for men
* have a desire to stop drinking completely or to reduce alcohol consumption with the possible long-term goal of abstinence
* have a body mass index of 18 or more
* sexually active women capable of having children must be using an acceptable method of birth control
* must be in generally good health.

Exclusion Criteria:

* No current or recent (within 6 months) diagnosis of other substance abuse or dependence
* no inpatient or outpatient counseling for alcohol dependence other than Alcoholics Anonymous within 4 weeks
* not more than 4 past failed inpatient treatments attempts for alcohol dependence
* no other psychiatric disorder that requires treatment with medication or therapy
* no current probation or parole requirement or legally mandated requirement to participate in an alcohol treatment program.
Early Laser Treatment for Diabetic Eye Disease in China : A Pilot Randomized Trial

To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in China.

Interview data from some patients and survey data from ophthalmologists in the study hospitals will help determine acceptability of early treatment, and how to overcome barriers to increased use of this option.

China now has the world's largest number of diabetic persons. Population studies show that only 10% of Chinese rural-dwellers with DR receive therapy. The current standard approach to treatment of DR often requires patients to return for multiple examinations over years, before they reach trial-proven criteria for treatment. This long process is ill-suited to support good compliance with care in low-resource settings. Our recent published review suggests that earlier PRP treatment, which could reduce the burden of compliance, may be clinically effective and cost effective, but the current evidence base is insufficient to make a firm recommendation.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>= 18 years with untreated DR at severe or very severe NPDR stage in either one or both eyes, according to the clinical opinion of the investigator.
* Sufficiently clear ocular media to allow visualization of the retina and retinal photography in either eye.
* Capable of giving informed consent.

Exclusion Criteria:

* DR at later stage of retinopathy than severe or very severe (eg, two or more of the 4-2-1 criteria are met) NPDR in either eye, but a patient may be enrolled if one eye has severe or very severe NPDR and the fellow eye has PRP-treated PDR and has been stable after treatment.
* Clinically significant macular edema in either eye.
* Dense cataracts or other media opacity preventing visualization of the retina in the eye.
* History of previous surgical or laser treatment for DR or other retinal conditions in a study eye, including history of anti-VEGF or corticosteroid injection or focal laser for DME within 6 months, or any history of scleral buckle, vitrectomy or other retinal detachment repair.
* History of other retinal vascular disorders including CRVO, CRAO, BRVO, BRAO in the study eye.
* Previous cataract or glaucoma surgery is specifically allowed if performed ≥ 6 weeks prior to enrollment.
* Pregnancy.
* Severe renal insufficiency treated with hemodialysis treatment, kidney transplant, pancreatic transplant, and intensive insulin therapy initiated within 4 months.
* Nystagmus, unable to cooperate with laser treatment.
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease from Organoids

This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).


Eligibility Criteria:
Inclusion criteria:

- Group 1: active IBD

* 18 years old or older
* Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
* Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
* Indication to perform a coloscopy
* Written consent for study participation obtained

Or

- Group 2: inactive IBD

* 18 years old or older
* Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
* Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
* Indication to perform a coloscopy
* Written consent for study participation obtained

Or

- Group 3: Control

* 18 years old or older
* Indication to perform a coloscopy to detect polyp
* No known bowel disease
* Written consent for study participation obtained

Exclusion Criteria:

* Inability to understand, read, sign informed consent and/or express consent
* Person subject to legal protection (curator, guardianship or safeguard of justice),
* Deprivation of liberty by judicial or administrative decision,
* Non-affiliation to a social security scheme or non-beneficiary of such a scheme
* Pregnant, parturient, breastfeeding women
* Contraindication to performing biopsies
* Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
* Anticoagulant treatment or bleeding disorder
* Person subject to a judicial safeguard measure
* People hospitalized without consent
Meditation to Reduce Firefighter Distress

The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).

The goal of this study is to test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) versus an active attention control (i.e., 10-day health education intervention with 10 individual prerecorded audio units delivered by smartphone app) to reduce psychological distress among N=160 career firefighters (to address possible attrition, N=192 firefighters will be consented and enrolled). The following specific aims will guide the research:

Aim 1. Examine whether firefighters' psychological distress (i.e., features of anxiety \[primary outcome\], depression) is reduced at 10 days, 30 days, and 3 months after the meditation intervention versus an active attention control. Features of anxiety, features of depression will be assessed at baseline (T1), after the 10-day intervention (T2), 30 days later (T3), and 3 months later (T4).

Aim 2: Explore the extent to which reductions in psychological distress from the meditation intervention are mediated by mindfulness and perceived social connection.

Eligibility Criteria:
Inclusion criteria: 1) currently employed as a career firefighter, 2) 18 or older, 3) speak and understand English, and 4) own a smartphone (iPhone or Android) able to download and run the intervention apps.

Exclusionary factors: 1) diagnosis of an illness requiring use of corticosteroids (e.g., asthma), and 2) have ongoing or past regular meditation experience in the last 4 years (i.e. more than two meditation session \[completed or attempted\] per year either with a group or individually), as determined by the PI.
The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter

The project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. Research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. Unfortunately, around 70% of AWS who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. The aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rTMS) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.


Eligibility Criteria:
Inclusion Criteria:

- adults who stutter without any other speech, language or cognitive problems

Exclusion Criteria:

* have any history of neurological and other speech and language problems
* condition that are violating the safety criteria for TMS
* any history of epilepsy, and brain damage,
* having any metal plant or cardiac pace-maker in the body,
* current pregnancy
Frequency and Risk Factors for Autoimmune Disorders and Rheumatic Manifestations in Egyptian Patients With IBD

To examine the prevelance of autoimmune disorders and rheumatic manifestations in egyptian patients with inflammatory bowel diseases,and asses the relation between prevelance of autoimmune disorders ,rheumatic manifestations and disease activity of IBD


Eligibility Criteria:
Inclusion Criteria:

* 1-adult patients with adiagnosis of IBD according to the validated criteria. 2-patients\>18 years without aprevious diagnosis of SPA or other rheumatological manifestations.

Exclusion Criteria:

* 1- patients with active cancer or lymphoproliferative disease. 2-patients with uncontrolled diabetes. 3-patients with unstable ischeamic heart disease or congestive heart failure. 4-patients with acute renal failure. 5-patients already diagnosed with inflammatory or crystal induced arthropathies (including gout and calcium pyrophosphate dehydrate deposition disease) or other autoimmune diseases.