cyrilzakka/clinical-trials huggingface dataset:
Immunopathology of Autoimmune Hemolytic Anemia

Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
* Secondary AHAI (infections, hematological diseases, systemic diseases)
* Naive of treatment for hemolytic anemia or in relapse
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent
* INCLUSION CRITERIA for CONTROLS
* Persons without auto-immune disease, cancer or active infection.
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent

Exclusion Criteria:

* Cold agglutinin disease
* Pregnancy
* Persons without national health insurance

Exclusion Criteria for Controls:

* Subjects treated with corticosteroids or immunosuppressants
* Pregnancy
* Persons without national health insurance
Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.

OBJECTIVES:

* Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma.
* Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients.

OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod.

* Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1.

A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine.

* Step 2: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod on day 1.

Cohorts of 3-6 patients receive escalating doses of resiquimod until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).

* Step 3: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod at the step 2 dose as in step 2.

Cohorts of 3-6 patients receive resiquimod to increasing amounts of surface area until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.

Blood is drawn at baseline and periodically during study treatment and observation. Samples are analyzed by flow cytometry, monoclonal antibody staining, ELISPOT, and ELISA.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior diagnosis of melanoma meeting the following criteria:

  * Stage II-IV disease
  * Complete resection of disease
  * No current evidence of disease
* HLA-A2 positive
* No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 75,000/mm³
* AST ≤ 3 times upper limit of normal
* No uncontrolled or current infection
* No known allergy to vaccine or adjuvant components
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known immune deficiency

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior biologic therapy
* No concurrent immunosuppressive therapy
XprESS Eustachian Tube Dilation Study

Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
* Have an overall ETDQ-7 score ≥3.0
* Have record of failed medical management for Eustachian tube dysfunction

Exclusion Criteria:

* Require concomitant procedures at the time of the study enrollment or procedure
* Have patulous Eustachian tube
* Have ear tubes in place or perforation of the tympanic membrane
* Have evidence of internal carotid artery dehiscence
* Be pregnant at the time of enrollment
* Be currently participating in other drug or device studies
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction

Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.


Eligibility Criteria:
Inclusion Criteria:

* Age - 40-65 years
* BMI equal to or over 30

Exclusion Criteria:

* A known cardiorespiratory, liver or kidney disease
* Treatment with nitrates or alfa blockers
* Performed polysomnography in the past
Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)

Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia (2), and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .

Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .

* Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
* Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.

The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).

• This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .

Group A : hydrogen peroxide group (n=42)

Group B : control group (normal Saline solution) (n=42) .

Eligibility Criteria:
Inclusion Criteria:

* Age from 18-40 years
* BMI \< 35 kg/m2
* Pregnant patients with placenta previa .
* Placenta accrete FIGO grade 1 .
* Vitally stable .
* Candidate for conservative management.
* No major intra-operative bleeding.

Exclusion Criteria:

* Vitally unstable .
* Massive pre- or intra-operative bleeding.
* Medical disorders ( e.g. : hypertension , cardiac .... )
* Placenta accrete , FIGO grades 2 or 3 .
* Not indicated for conservative management.
Effect of Healing on Rheumatoid Arthritis

The hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. This is tested in a three group design with a control group and two groups receiving healing with or without a healer present. The study is randomized and double blind.

The central claim of healers is that this process facilitates self-healing in the patient. Spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to God, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. The highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent

Exclusion Criteria:

* Not able to arrange own transport, language problems
Effect of Breakfast or Omission of Breakfast in T2D

The investigators will explore the effect of omission of breakfast on postprandial hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic patients

In obesity and in type 2 diabetes eating behavior especially the lack of breakfast promote weight gain, increase hunger and carbohydrate craving.

The present study is designed to address whether in T2D, a change in meal timing; specifically, by adding calories, protein and carbohydrates to the breakfast vs.the omission of breakfast will influence the postprandial elevation of glucose, insulin, intact GLP-1, glucagon and free fatty acids (FFA) after subsequent meals at lunch and dinner.

The investigators expect that compared to the day with breakfast condition the day when the breakfast will be omitted the postprandial glucose , free fattly acids, and glucagon response after lunch and dinner will be significative higher while insulin and intact GLP-1 response after lunch and dinner will be reduced

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetics for \< 10yr
2. HbA1C: 7-9 %
3. BMI: 22 to 35 kg/m2)
4. Age: ≥30 and ≤70 years of age
5. Habitually eat breakfast
6. Naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication
7. Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
8. Usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:00.
9. Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 6 months
10. Stable physical activity pattern during the three months immediately preceding study initiation
11. Normal liver and kidney function 12 No metabolic disease other then diabetes

13. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.

15. Normal TSH and FT4 levels 16. Acceptable health based on interview, medical history, physical examination, and laboratory tests 17. Those who provide signed informed consent

Exclusion Criteria:

1. Type 1 diabetes
2. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
3. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
4. Anemia (Hg \> 10g/dL)
5. Serum creatinine level \> 1.5 mg/dl
6. Pregnant or lactating
7. Participating in another dietary program or use of weight-loss medications
8. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
9. Use of psychotropic or anoretic medication during the month immediately prior to study onset

13.Work shifts within the last 5 years and did not cross time zones within the last month of the study.
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed glioblastoma multiforme
* Ages 18-65
* Karnofsky Performance Scale (KPS) equal to or less than 70
* Minimal neurological deficit
* Eligible for concurrent temozolomide chemotherapy

Exclusion Criteria:

* Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer
A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers

A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.

This was a randomized, single center, vehicle controlled, within-subject comparison study of diacerein 1% ointment and vehicle ointment applied under fully occlusive patch conditions on the infrascapular region of each subject's back to induce a photoallergic skin reaction following Ultraviolet (UV) irradiation. This was repeated twice each week during the 3-week Induction Phase, once during rest week 4 as applicable and once at Challenge Phase.

Eligibility Criteria:
Key Inclusion Criteria:

* Is a healthy male or female (to be confirmed by medical history);
* Is 18 years of age or older;
* In the case of a female of childbearing potential, is using an acceptable form of birth control;
* In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) at Day 1 and are willing to submit to a UPT at the end of study (EOS);
* Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
* Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key Exclusion Criteria:

* Has a history of photosensitivity or photoallergy;
* Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
* Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
* Are taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs \[NSAIDS\]);
* Is using medication which, in the opinion of the Investigator, will interfere with the study results;
* Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
* Has psoriasis and/or active atopic dermatitis/eczema;
* Had a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
* Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
* Has received treatment for any type of internal cancer within 5 years prior to study entry;
* Has any known sensitivity to adhesives; and/or
* Has received any investigational drugs(s) with 4 weeks prior to study entry
Effect of L-Citrulline on Vascular Function

The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.

This project employed a placebo controlled, double-blind, crossover trial. Participants were randomized to oral L-citrulline (6 g/day) or placebo (maltodextrin) for 14 days, and switched to the other treatment for another 14 days after washout. Peripheral vascular function was assessed under conditions of rest, leg exercise, and cognitive engagement. Gait performance was assessed using clinical walking tests.

Eligibility Criteria:
Inclusion Criteria:

* older adults
* women and men
* aged 60-79 yrs
* must be able to swallow capsules
* fully mobile without assistive walking devices

Exclusion Criteria:

* have physician diagnosed cardiovascular, pulmonary, or metabolic disease
* are current smokers
* currently taking medications affecting cardiovascular function
* have high blood pressure (\>159/99 mmHG)
* have high fasting blood glucose (\>110 mg/dL)
* are considered obese (body mass index ≥ 30 kg/m2)
* have orthopaedic limitations that limit walking ability
* have pacemaker or other metal objects in their body
Long COVID-19 Fatigue and Obstructive Sleep Apnea

Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease

The presence of fatigue symptoms up to 6-7 months after acute COVID-19 disease, similar to myalgic encephalomyelitis/chronic fatigue syndrome, also observed after other viral infections, have been reported as the most frequent post-COVID-19 symptom (Townsend et al., 2020).

There is a physiological plausibility for OSA being a causal factor to COVID-19 morbidity and fatigue symptoms by nocturnal hypoxemia, exacerbating or causing endothelial dysfunction, inflammation, oxidative stress, microaspiration and cardiac dysfunction. OSA activates the renin-angiotensin-aldosterone system (RAAS) and angiotensin-converting enzyme-2 (ACE2), which is the SARS-CoV-2 entry receptor in the cells (Miller et al., 2021).

In this study we will identify the prevalence of OSA and it's relation with post-COVID-19 fatigue that remains for at least six month after the acute disease, in patients that attend the post-COVID-19 Out Patients Hospital Clinics. It will be studied also the relation between fatigue and vaccination status, nocturnal hypoxemia, day time sleepness and the acute COVID-19 severity.

Data collection will be performed by a questionnaire administered by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation).

Demographic, clinical data and clinical research forms will be collected between 6-7th month after the diagnosis of COVID-19 (t1) and 9 months later (t2).

Fatigue will be assessed using the Chalder fatigue scale - CFQ-11 (Chalter et al., 1993).

The evaluation of OSA related daytime sleepiness will be measured using the Epworth Sleepiness Scale - ESS (Johns, 1991). The OSA diagnosis will be performed using portable monitoring device type III (in-home polygraphy), between 6-7th month after the diagnosis of COVID-19 (t1).

Eligibility Criteria:
Inclusion Criteria:

(1) ≥18 years; (2) previous COVID-19 at least six months before the initial study protocol evaluation; (3) persistent symptoms after cure criteria defined by WHO; (4) patients who attend the post-COVID-19 follow-up consultation of the study centers. (5) SARS-CoV-2 infection confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab (6) patients who agree to sign the Written informed consent (following the ethics committee protocol).

Exclusion Criteria:

(1) patients who had a concomitant neurological disorder that could increase OSA risk (such as stroke, Parkinson disease, or amyotrophic lateral sclerosis); (2) patients who were on invasive mechanical ventilation. (3) patients with persistent fatigue symptoms,6 months before SARS-CoV-2 infection (4) patients without SARS-CoV-2 positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab
Healthy Lifestyles After Stroke - Stroke Coach

The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.

Participants recruited in this study will be randomly assigned to either the Healthy Lifestyle Training Program, or Attention Control Memory Training Program.

Individuals in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. Individuals in the Memory Training Program will each receive 7 memory coaching telephone sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100 evaluable subjects will be recruited (124 to accommodate for 20% dropout).

Eligibility Criteria:
Inclusion Criteria:

* Has experienced a stroke in the last 12 months
* 50 years of age or older
* Living in the community with phone access
* Mild to moderate stroke severity (i.e., modified Rankin Scale score ranging from 1 to 4)
* Able to communicate in English

Exclusion Criteria:

* Stroke of non-vascular origin
* Actively engaged in formal stroke rehabilitation services
* Uncontrolled arrhythmias
* Significant musculoskeletal or other neurological condition
* Severe aphasia or dysarthria
* Not medically stable
* Pain or co-morbidities which would preclude activity
* Living in long-term residential care
* Cognitive impairment, dependent in activities of daily living, and no caregiver participation