cyrilzakka/clinical-trials huggingface dataset:
Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic

This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.

Study Procedures:

On admission or during the outpatient visit:

1. Obtaining an informed consent .
2. Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.
3. A thorough physical examination will be performed.
4. Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.
5. Laboratory to perform the following tests:

Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase Chain Reaction (RT-PCR) test by nasopharyngeal swab.

During admission:

Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19 suspected to have the following to be performed:

1. Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected
2. Chest X-ray or CT chest will be recorded.
3. Laboratory to perform the following tests:

Complete blood count with differential counts,

COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:

C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures will be recorded

On discharge:

* Date of discharge
* Period of admission
* Period of fever
* A thorough physical examination will be performed
* Record the outcome

Eligibility Criteria:
Inclusion Criteria:

1. Children below 18 years with malignancy either hematological or solid tumors or
2. Children below 18 years with hematological condition

Exclusion Criteria:

1. Patients or care-givers refusal to be enrolled in the study
Supporting Self-employment in Young Adults with Stroke

This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors.

A 2-arm randomised controlled trial will be conducted. Individuals aged 18-65 years old, with a first-ever/recurrent ischaemic/haemorrhagic stroke, and unemployed for at least 6 months will be recruited. Eligible participants will be randomly assigned to receive usual care or a new intervention with usual care. The intervention is aimed at assisting survivors in becoming self-employed by developing entrepreneurial skills. Outcomes including self-employment rate, self-efficacy, life satisfaction, emotional well-being, and community reintegration at baseline, immediately and 3 months after completing the intervention. Semi-structured interviews will be conducted with participants to elicit feedback on SSI.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old at the time of recruitment
* been clinically diagnosed with a first-ever/recurrent ischaemic/haemorrhagic stroke
* a Montreal Cognitive Assessment score (MoCA) \>2nd percentile
* a paid job (full-time/part-time) at the recent onset of stroke
* been unemployed (not in paid, full-time/part-time job) for ≥6 months at the time of recruitment
* able to communicate in Cantonese and read Traditional Chinese.

Exclusion Criteria:

* diagnosed with transient ischaemic attack
* cerebrovascular events due to tumour
* diagnosed with a mental condition for example depression or schizophrenia
* incomprehensible speech
* receiving or awaiting to receive vocational programmes
* self-employed at the time of recruitment or planning to retire
The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution

Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed following exposure to diesel exhaust.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Regular medication use (except oral contraceptive pill)
* Current smokers
* Significant occupational exposure to air pollution
* Intercurrent illness
Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Continue to Benefit From the Treatment as Judged by the Investigator

The study allowed continued use of single agent panobinostat in patients who were on single agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and were benefiting from the treatment as judged by the investigator.

This was a multi-center open label study to provide continued use of single agent oral panobinostat to patients treated in a Novartis-sponsored study (parent study) which had met its endpoint and were benefiting from continuation of the treatment with single-agent panobinostat as judged by the investigator. Patients from multiple parent studies were transferred over to this protocol and continued to receive single agent panobinostat at the last assigned dose and regimen of the parent protocol. There was no screening period, and patients had to visit the study center at least on a quarterly basis. During these visits limited information on study treatment and occurrence of SAEs was collected for the clinical database. SAEs were only reported to the Novartis safety database. Other assessments and possibly more frequent visits occurred as per standard of care at the site. Patients continued treatment until they were no longer benefiting from panobinostat treatment, developed unacceptable toxicities, withdrew consent, were non-compliant with the protocol, the investigator believed it was no longer in the best interest to continue, the patient died, or for other administrative reasons. An end of treatment visit and a safety follow-up for 30 days after the last dose was performed. The study was expected to remain open for 5 years or until such time that enrolled patients no longer needed treatment with panobinostat, whichever came earlier.

Eligibility Criteria:
Inclusion Criteria:

* patient had been enrolled in a Novartis-sponsored, Oncology OGD\&GMA study receiving s.a. oral panobinostat and had fulfilled all their requirements in the parent study
* patient had been benefiting from the treatment with s.a. oral panobinostat as determined by the guidelines of the parent protocol and according to the Investigator's clinical judgment
* patient had demonstated compliance
* patient had given written informed consent.

Exclusion Criteria:

* patient had been permanently discontinued from s.a. oral panobinostat study treatment in the parent study due to unacceptable toxicity, withdrawal of consent, non-compliance to study procedures or any other reason (including progression of disease).
* patient had participated in a Novartis sponsored combincation trial where panobinostat was dispensed in combination with another study medication and was still receiving combination therapy
* patient was pregnant or nursing at the time of entry
* women of child-bearing potential and male patients with sexual partners of child-bearing potential who were unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy

To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).


Eligibility Criteria:
Inclusion Criteria:

* Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
* Uncorrected Visual Acuity of 20/40 or worse;
* Best-Corrected Visual Acuity of 20/60 or better.

Exclusion Criteria:

* Systemic or ocular conditions that could bias results
* Previous photorefractive surgery
Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.

This is an in vivo study using serial IM testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee replacement, ACL reconstruction/revision, meniscal allograft transplantation and articular cartilage paste grafting. The design is a randomized, controlled, double blind, longitudinal study of intra-muscular injections of testosterone versus saline control. Pre-operative and post-operative assessments will include: serial MRIs and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS. Blood analysis will be performed for therapeutic assessment and safety. The participant will receive two testosterone undeconate injections, once during their pre-operative visit and once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental group at all time points may identify differences in participant response to testosterone injections.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18-65.
* Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.

Exclusion Criteria:

* Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
* Men with BMI \> 30 and Type I or II diabetes diagnosis
* Men prone to deep vein thrombosis or sleep apnea.
* Men with pre-existing hematocrit abnormalities.
* Men with pre-existing cardiac, renal, hepatic disease.
* Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.
* Men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate).
* Subject's unable or unwilling to comply with the protocol.
* Subject's unable to provide informed consent.
* Subject's unable to understand verbal and/or written English.
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.

A multicenter, randomized, double-blind, parallel group, placebo controlled study to investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of subjects with chronic obstructive pulmonary disease over 3 years of treatment.

Eligibility Criteria:
Inclusion criteria:

* Patients with COPD and FEV1 \<60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio \<70%.
* Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion criteria:

* Diagnosis of other respiratory disorders (including asthma).
* Requirement for long term oxygen therapy.
Biofeedback in Pediatric Inflammatory Bowel Disease

This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.

The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.

Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for Phase 1 are:

1. Age 8-17 years
2. Referred for a diagnostic colonoscopy with strong clinical concern for IBD
3. Live within a 2 hour drive of NCH

There is one additional inclusion criterion for Phase 2:

1. Patients have been diagnosed with IBD

Exclusion Criteria:

1. Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.
2. Age and language are limited by the demands of the study (questionnaire completion)
Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis

Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of 5 in 10,000 pregnancies. This rare condition is associated with placental inflammatory lesions leading to severe and recurrent obstetrical complications: intrauterine growth retardation (IUGR), fetal death in utero and miscarriage. The pathophysiological mechanisms of CHI are poorly understood, while the empirical treatments prescribed to prevent recurrence are cumbersome and of poor efficacy.

Recent findings suggest that an alloimmune response may play a role. In a recent work, the investigators have demonstrated the role of maternal alloantibodies directed against fetal HLA antigens in two patients followed for recurrent IUGR associated with CHI. Their work suggests that a humoral alloimmune response directed against fetal HLA antigens mimics an allograft rejection process.

The investigators propose to extend the preliminary results obtained in these patients to provide new insights into the pathophysiological mechanisms of CHI, and eventually to predict the risks of fetal loss.


Eligibility Criteria:
Family Inclusion Criteria:

* Mother and father ≥ 18 years old
* For mothers in the CHI group :

  * History of a normal pregnancy (full term, alive child) or IUGR/MFIU or miscarriage(s) or abortion followed by at least 1 obstetrical complication such as IUGR, MFIU, miscarriage
  * Diagnosis of chronic histiocytic intervillitis made by placental anatomopathological examination with CD68+ marking
* For the mothers of the antiphospholipid syndrom group

  * History of miscarriage(s)
  * Having an anti-phospholipid syndrome
* For mothers in the normal pregnancy group:

  * Third consecutive pregnancy of normal course, at term (≥ 36 weeks of amenorrhea) with eutrophic child

For the mother and father:

o Consent to participate in the study and for the participation in the study of at least one child and/or the use of existing samples (placenta / fetal DNA) from at least one previous pregnancy with CHI for the CHI group or at least one previous miscarriage for the APS group

For the father:

o Father of the last pregnancy and of the child(ren) participating in the study

Exlusion criteria :

* For mothers in the normal pregnancy group:

  o Suspected or confirmed intra-amniotic infection
* For all the mothers:

  * History of blood transfusion
  * History of allogeneic organ transplantation
* For the mother and the father:

  * Person under legal protection (guardianship, curatorship)
Prevention of Delirium With Light in the Intensive Care Unit

The purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients.

Patients, who are randomly assigned to the "Lightening arm" will have the circadian light for the whole ICU stay. Light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age 18 years and above
* Intensive Care Unit stay ≥ 48 hours
* Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure \>6hours/day and highflow \>30 litres) on the day of Intensive Care Unit admission

Exclusion Criteria:

* Patients with a history Intensive Care Unit stay during the actual hospital stay
* Patients with delirium on the day of Intensive Care Unit admission
* Patients with psychiatric diseases
* Patients with a history of stroke and known cognitive dysfunctions
* Participation in other clinical studies 10 days before study inclusion and during the study period
* Psychiatric disease
* History of stroke with known residual cognitive deficits
* History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay
* Analphabetism
* Unability of German language use
* Anacusis or Hypoacusis with hearing aid device, Amaurosis
* Allergies to any ingredient of the electrode fixing material
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
* Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Vitamin D and Type 2 Diabetes Risk in UK Adults

This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.

The aim of this study is to assess the link between vitamin D status and glucose homeostasis in a population of normal weight and overweight individuals (BMI\> 18.5 Kg/m2).

Eligibility Criteria:
Inclusion Criteria:

* Normal weight and overweight and obese adults (BMI\>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status.
* Males and females
* 18-50 years

Exclusion Criteria:

* Patients diagnosed with diabetes type 2, myocardial infarction or coronary heart disease.
* HbA1c \> 6.4%
* Pregnancy
* Diagnosis of liver disease (including liver enzymes \> 3 times above normal values)
* Diagnosis of renal disease (creatinine of \> 150 mmol/l)
* Post-menopausal women
Breast Lesion in CT Chest

The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.

Enhanced chest CT examination reports containing the key word 'breast' well be reviewed retrospectively. Patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included. Finally, 100 patients well be enrolled. Two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement. The correlations between the CT features and pathologies well be evaluated and the diagnostic accuracy of CT features in various combinations well be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest CT and were referred to a specialized breast unit for assessment and then underwent pathological confirmation.

Exclusion Criteria:

* -Patients with known breast dis ease.
* Previous history of breast cancer or breast surgery.
* Patients who had undergone only non-enhanced CT examination.