cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Infectious Mononucleosis Trial

The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

This study examines the feasibility of treating adolescents and young adults diagnosed with infectious mononucleosis with acupuncture. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Eligibility Criteria:
Inclusion Criteria:

* mono diagnosis confirmed by lab test
* 21 days or less between start of symptoms and diagnostic test
* presence of fatigue of at least 4/11 (by Chalder Fatigue Questionnaire)
* no other illnesses present
* meets residency requirement

Exclusion Criteria:

* insufficient communication in English
* unable to begin acupuncture within 21 days of diagnostic test
* acupuncture use currently or in the preceding 3 months
* currently under the care of a TCM practitioner
* unwilling to be randomized
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors \[Lev-Sagie, Nature Medicine 2019\]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission.

The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50
* Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year.
* Patients are otherwise healthy.
* Contraception use

Exclusion Criteria:

* Pregnancy or a planned pregnancy in the upcoming year
* Infection with HIV.
* Immunodeficiency status.
Non-Pharmacological Treatment of Psychosis

The objectives of the project are to investigate feasibility, safety, and health-related outcomes in patients with psychosis who choose not to use antipsychotic drugs (APs). The instruction from the Ministry of Health and Care Services to establish "Medication Free" (non-pharmacological (NonPharm)) treatment services, which has received substantial critique for being given without support in scientific evidence, provides a window of opportunity for research in an under-investigated field. The study will prospectively follow a cohort over 1 year who seeks NonPharm treatment, with repeated measurements of symptoms, functional outcomes, quality of life, adverse events, as well as biological parameters including genetics and brain imaging, and environmental factors, and compare the findings to a control group of users of antipsychotic drugs, matched for age, gender and diagnosis. Current unanswered questions in the treatment of psychosis include which patients can successfully and safely discontinue antipsychotic medication; and what are the long-term symptomatic, biological and functional outcomes after use or non-use of APs, respectively. Taken together there is a fundamental lack of high-quality evidence to guide the treatment options in people who cannot or do not want to use APs in psychosis. This is also a major challenge in the study, as a more rigorous design that could directly compare different treatment options is not feasible, because no alternatives to APs have proven to be sufficiently effective and safe in controlled trials. The study is accordingly expected to provide new exploratory information that could be the basis of intervention studies which in its turn could provide important information for consumers and the mental health services regarding treatment options in psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of diagnostic criteria for schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10)
* The clinician responsible for the treatment must consider nonpharmacological treatment to be professionally justifiable in the patient in question
* Patient being able/ capable of providing informed consent
* Patient receiving active treatment including different psychosocial treatments
* Patient having a treatment plan and a crisis resolution plan.

Exclusion Criteria Not fullfilling inclusion criteria
Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes

This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports

This study delves into the intricate relationship between the history of concussions, sleep quality, and physical performance among athletes participating in contact sports. Concussions, often occurring due to the high-impact nature of these sports, have raised concerns regarding their potential long-term effects on athletes' health and performance. This research aims to elucidate whether a history of concussions influences athletes' sleep patterns and subsequently affects their physical performance.

The study employs a comprehensive approach, utilizing both subjective and objective measures to assess sleep quality, such as self-reported sleep disturbances and objective sleep monitoring techniques. Furthermore, various metrics are employed to evaluate physical performance, including agility, strength, speed, and endurance tests tailored to the specific demands of contact sports.

By analyzing the data collected from athletes with and without a history of concussions, the study aims to identify potential correlations between concussion history, sleep disturbances, and diminished physical performance. Additionally, the research seeks to uncover any potential mediating factors, such as psychological distress or neurocognitive deficits, which may contribute to these associations.

The findings of this study hold significant implications for athlete well-being and sports medicine practices. Understanding the impact of concussions on sleep quality and physical performance can inform tailored interventions and rehabilitation strategies to mitigate the adverse effects of concussions on athletes' health and optimize their performance outcomes in contact sports. Moreover, these insights may contribute to the development of preventive measures and policies aimed at reducing the incidence and severity of concussions in sports settings.

Eligibility Criteria:
Inclusion Criteria:

Participants falling in this category would be recruited into the study.

* Active Male Combat sports player.
* Age between 18-25 years.
* Athletes who had a hit on jaw, neck, head and had symptom of concussion discussed under heading of Introduction.
* Athlete who had history of concussion between 3-30 days.
* Mild concussion according to CANTU NO LOC PTA

Exclusion Criteria:

Participants fall in this category would be excluded of the study.

* Concussion other than sports.
* History of metabolic diseases.
* History of recent fractures
Live Lung Donor Retrospective Study

The use of live donors for solid organ transplantation has increased the number of available organs for those waiting for a transplant. Donation of an organ may have significant effects on a donor's health. This study will determine the baseline characteristics, early postoperative morbidity, and long-term survival for participants who underwent donor lobectomy between 1993 and 2006.

As the number of patients requiring organ transplants continues to increase, the number of organs available from deceased donors cannot meet demands. Beginning in the early 1990s, organs from living donors became a widely-available option, increasing the number of available organs for transplant. However, because organ donation has the potential to adversely affect a living donor's health, long-term studies to determine the effect of donation on these donors are needed. The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study will have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis.

There will be no study visits for retrospective cohort study. Investigators will collect data from existing medical records and databases.

Eligibility Criteria:
Inclusion Criteria:

* Had living donor lobectomy at one of the two participating study centers, the University of Southern California and the Washington University Medical Center between 1993 and 2006 (inclusive)
Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

There is a toxicity linked to the chronic use of nitrous oxide, leading to neurological disorders such as combined sclerosis of the spinal cord. One thus frequently observes patients presenting disorders of walking or paresthesias, of more or less resolving evolution being able to go until the need for using a wheelchair and more recently cases of thrombosis were reported Serum or urine N2O assays are rarely performed routinely, because they do not allow to ensure a real exposure due to the very short half-life of this gas in the body. Thus, other biological monitoring markers are mentioned in the literature, such as vitamin B12 or homocysteine. Unfortunately, there are still no recommendations for biological monitoring of nitrous oxide consumption. Moreover, underlying mechanisms leading to clinical outcomes remains misunderstood.


Eligibility Criteria:
Inclusion Criteria:

* A current or former recreational nitrous oxide user defined
* With associated clinical signs (group 1)
* Without associated clinical signs (group 2)
* With or without clinico-biological sequelae associated with use
* Consenting to the conduct of the study
* Socially insured

Exclusion Criteria:

* Pregnant or breastfeeding women
* Never used nitrous oxide or stopped using it more than 6 months ago
* Lack of social security coverage
* Not willing to participate in the entire study
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery

This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.

Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:

* First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
* Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.

IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.

IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.

Eligibility Criteria:
Inclusion Criteria:

* Children younger than 13 years of age.
* Children who underwent bilateral recession strabismus surgeries.
* Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
* The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
* Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.

Exclusion Criteria:

* Patients that are 13 years of age or older.
* Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
* Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
* Family history of glaucoma or high myopia.
* A history of steroid usage in the past year.
* Failure to comply with IOP measurements or the follow-up schedule.
Impact of New Immunological Diagnosis Tests of Latent Tuberculosis Before Anti TNF Therapy

Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are now available.

The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

Detailed description :

Principal outcome: Therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

Secondary outcomes :

* medico-economic impact of replacement of TST by QFTB-G and T-SPOT.TB tests in LTBI screening in patients before anti TNF therapy.
* concordance of QFTB-G and T-SPOT.TB tests results with TST
* Concordance between QFTB-G and T-SPOT.TB tests and evaluation of indetermined tests.
* concordance of QFTB-G and T-SPOT.TB tests results with patient disease.
* concordance of QFTB-G and T-SPOT.TB tests results with TST in patients with LTBI determinated by clinical or radiological observation
* Impact of geographical, disease and treatment in patients with LTBI determinated by clinical or radiological observation
* Identify the original characteristic and maximal impact therapeutic of QFTB-G and T-SPOT.TB test

Analysed criteria :

* therapeutic impact
* Patients percentage with different therapeutic outcome based on usual recommendations medico-economic
* Medico-economic impact :impact of both tests as early and late cost - efficacy

Statistic :

* Primary criteria : Percentage of patients for whom therapeutic would have been changed by QFTB-G and T-SPOT.TB tests results compared to usual diagnosis strategy.
* Secondary criteria : Concordance of QFTB-G and T-SPOT.TB tests with TST Concordance between both QFTB-G and T-SPOT.TB tests .

  400 patients Timing : inclusions : 1 years

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Patient with rheumatoid arthritis or Ankylosing spondylitis or Crohn's disease
* Patient without Anti TNF treatment and who need one by infliximab, adalimumab or etanercept
* Consent signed
* Patient with social right
* Patient who have been examined

Exclusion Criteria:

* Pregnancy and breast feeding
Assessment of Methotreaxate-induced Liver Fibrosis by Transient Elastography and Serological Markers

Methotrexate (MTX), a folic acid analogue, inhibits the synthesis of purines and pyrimidines and is widely used in the treatment of chronic inflammatory diseases, particularly Rheumatoid arthritis (RA). It is typically the first-line drug for RA management. However, prolonged MTX use is associated with hepatotoxicity, including liver fibrosis (LF), which necessitates regular monitoring, especially of liver function tests MTX-induced liver injury has been recognized since the early 1970and numerous studies have shown an increased risk of liver fibrosis, which is estimated to occur in approximately 5% of patients, with a potential relationship to the cumulative dose of MTX Despite intensive monitoring strategies and the recommendation for liver biopsies, liver biopsy carry significant risk, including bleeding and sampling variability .

the aim of the study to Estimate the frequency and stage of liver fibrosis in patients with Rheumatological or Dermatological diseases receiving Methotrexate in Assuit University Hospitals in comparison to a control group with the same diseases not receiving Methotrexate.

Evaluate the diagnostic performance of FIB-4 , APRI and FIB-5 scores as non invasive fibrosis markers in comparison to Transient Elastography in these patients.

Identify the predictors of liver fibrosis in these patients. As such, there is increasing interest in non-invasive methods for monitoring liver fibrosis, such as liver stiffness measurement by FibroScan (FS), APRI score , FIB-4 score and FIB-5 score . These methods offer advantages over liver biopsy, including being non-invasive, rapid, reproducible, and able to assess disease progression over time. However, the prevalence of hepatic fibrosis in MTX-treated patients, particularly in Egypt, remains under-researched.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) prescribed Methotrexate therapy for Rheumatological disease (such as Systemic Lupus Erythematosus , Rheumatoid arthritis and Ankylosing spondylitis)or Dermatological diseases (such as Psoriasis and Behcets disease).

Exclusion Criteria:

* Patients with metabolic associated fatty liver disease (MAFLD). Patients with chronic liver diseases (HBV, HCV, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease).

History of chronic heart failure or renal failure.c.
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN) 21, which serves rural areas in Northern California

More that 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication.

This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 24 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients must have chronic heart failure, systolic left ventricular dysfunction (ejection fraction less than or equal to 45%), not be receiving beta-blockers, and not have contraindications to beta-blockers.

Exclusion Criteria:
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?

This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome

This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.

All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .

Exclusion Criteria:

* Patients with gestational age ≥ 9 weeks
* patients with diagnosed other auto-immune disorder
* patients with chronic hypertension, diabetes mellitus, thyroid disorders,
* patient with renal diseases
* patients who requested to withdraw from the study at any point .
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects ≥18 years of age
2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
4. Willing to provide signed informed consent

Exclusion Criteria:

1. Treatment naïve or treatment-withdrawn acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6. Known history of HIV, hepatitis B, or active hepatitis C
7. History of alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
10. Subjects with symptomatic cholelithiasis
11. Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
12. Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)