cyrilzakka/clinical-trials huggingface dataset:
Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation

The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

Medical Oncology:

* Information and collection of consent,
* Imaging staging,
* Inclusion
* Physical examination
* Contraception advise given

Reproductive medicine center:

* Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound.
* Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men.
* Infertility risk and fertility preservation techniques information.
* In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy
* Fertility preservation (COH stimulation, triggering and oocyte retrieval)

Adjuvant chemotherapy:

* The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval.
* Usual adjuvant chemotherapy is not changed

During chemotherapy:

* Clinical exam before each cycle of chemotherapy
* AMH, AFC at cycle 6

After chemotherapy:

* Usual patient monitoring in expert center :

physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual

* AMH at Month 3 (M3), M6 M9 M12 M18 and M24
* AFC at Month 12 (M12) and M24

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically proven breast cancer
* Aged 18 to 38 years old
* Planned adjuvant chemotherapy
* No prior chemotherapy
* Affiliated to a public health insurance program
* Informed consent signed by the patient

Exclusion Criteria:

* Metastatic breast cancer
* Planned neo-adjuvant chemotherapy
* Hysterectomy
* Exclusive adjuvant hormonotherapy
* Positive serology for syphilis, hepatitis B or C, or VIH
* Contraindication related to use of r-FSH
* Pregnant or breastfeeding patients
Comparison Between Main Branch and Side Branch Vessels

The purpose of this trial is

1. to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
2. to develop a new scoring system to predict the clinical significance of a side branch

1. Clinical significance EKG change, pain score during 1 min balloon occlusion
2. Different characteristics between ST segment elevation vs non-elevation side branches
3. Comparison of coronary wedge pressure
4. Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Significant stenosis at bifurcation lesion (\>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
* Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
* Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch

Exclusion Criteria:

* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Patients refuse to give informed consent
* Patients with left main coronary artery stenosis
* Patients with total occlusion of the bifurcation lesion
* Patients with infarct-related artery at the lesion of interest
* Patients with left ventricular ejection fraction\<40%
* Patients with primary cardiomyopathy
* Patients with chronic kidney disease defined as serum Cr\>2.0
* Patients who have severe side effects or contraindication to adenosine
Prevalence of Undernutrition in Assiut University Children Hospital

To describe the prevalence of undernutrition in infants and children admitted to Assiut university children hospital and to describe risk group and decrease length of stay in hospital.

Malnutrition is defined as a state in which a deficiency (or excess) of energy, protein, and other nutrition causes measurable adverse effects on the body and on growth (in children), and may impact clinical outcome. Recent studies in developed countries have estimated the prevalence of malnutrition in hospitalized children as 12% to 24%. Causes of malnutrition: There are many types of malnutrition, and they have different causes. Some causes include: Poor diet, Starvation due to food not being available , Eating disorders, Problems with digesting food or absorbing nutrients from food , Certain medical conditions that make a person unable to eat Malnourished children were classified according to the type of malnutrition into: Acute malnutrition (wasting) , Chronic malnutrition (stunting) , Micronutrient malnutrition. Malnourished children experience more complications, such as infections after surgery, than well-nourished children, also leading to increased length of stay. In infants, early malnutrition is associated with delayed physical as well as intellectual development.

Eligibility Criteria:
Inclusion Criteria:

* All infants and children from 2 months to 6 years admitted to Assiut university children hospital .

Exclusion Criteria:

* Infants less than month ,Children over the age of 6 years .
A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke

This clinical study is organized for people with stroke often experience difficulties with their sensation in their upper limb. New technologies may be able to help these important problems. However, there is currently not enough knowledge about how the brain recovers in people with sensory impairments in their arm and hand. Using a non-invasive technique of recording brain activity, known as electroencephalography (EEG), brain activity in combination with somatosensation of the hand will be measured. Therefore, the purpose of this study will be to analyse brain activity in relation to somatosensory impairments after stroke during the first two weeks after stroke.


Eligibility Criteria:
Participants will be recruited during the first 2-3 days post-stroke. They should have:

1. a first-ever unilateral, supra-tentorial stroke, as defined by Wold Health Organisation;
2. admission to the acute hospital,
3. deficit in distal pinprick somatosensory measured by Rivermead assessment of somatosensory performance (score of ≤4) and/or motor impairment measured by Fugl Meyer Assessment (score of ≤12 out of 14),
4. the age of \> 18 years and
5. the ability to provide informed consent.

Healthy adults will also be recruited and they should have:

1. no history of sensory impairments in their hands
2. the age of \> 18 years and
3. the ability to provide informed consent.
Knee Function in Patients With Two or More Episodes of Patella Dislocations

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

Introduction:

Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.

Aim:

The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.

Materials and methods:

Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.

Eligibility Criteria:
Inclusion Criteria:

* More than one luxation
* Norwegian citizens
* Unilateral problems
* Age range 12-30 years

Exclusion Criteria:

-Generalized degenerative changes
Mindfulness in Medical Training

Headspace, a smartphone application that provides guided meditation, mindfulness and sleep exercises, will be used as the intervention in improving sleep, anxiety, depression and burnout in all participating individuals selected from the University of Arizona College of Medicine-Tucson residents and fellows.

The intervention of of daily meditation with the Headspace application will be used to determine if this is a possible effective intervention for decreasing the feeling of burnout. It is being proposed that it could improve the subjects' well-being both in the short-term and long term. The primary outcomes will be burnout, anxiety, depression and sleep. This study will use the Maslach Burnout Inventory to assess baseline burnout, as well as at 30 and 90 days post-intervention period. Sleep and anxiety and depression will be assessed using the Epworth Sleepiness Scale and Hospital Anxiety and Depression Scale (HADS) scores at the same intervals.

Eligibility Criteria:
Inclusion Criteria:

* University of Arizona resident or fellow

Exclusion Criteria:

* none
The Correlation Between Fasicitis Plantaris and Hallux Rigidus

Comparison between 3 groups:

* group I has hallux rigidus. Is fasicitis plantaris present?
* group II has fasicitis plantaris. Does the hallux have limited mobility?
* group III does not have hallux rigidus or fasicitis plantaris


Eligibility Criteria:
Inclusion Criteria:

* Hallux rigidus or fasicitis plantaris or healthy volunteer

Exclusion Criteria:

-
Dexmedetomidine and Adenosine: Therapeutic Use for SVT

The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).

In 2006 the investigator found that dexmedetomidine, an alpha-2 adrenergic agonist with primarily sedative properties, possesses additional anti-arrhythmic properties. So far the investigator has found that dexmedetomidine has the ability to prevent or terminate arrhythmias like atrial ectopic tachycardia (85% success) and junctional ectopic tachycardia (75% success). The most dramatic effect however was observed in the acute termination of reentrant SVT with a success rate of \> 96%. More importantly we found that dexmedetomidine terminates SVT without causing any sinus pause or asystole (frequently seen with adenosine) and thus avoiding the feeling of "impending doom". In this study adenosine is being compared head to head with dexmedetomidine in a cross over study, for both safety and efficacy when given for the termination of SVT in the electrophysiology (EP) lab. Additional EP parameters will be measured to elucidate the exact site of dexmedetomidine's mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 5 - 30 years old, who are scheduled for cardiac electrophysiology study for evaluation of reentrant SVT

Exclusion Criteria:

* Severe Heart Failure
* Presence of of any other antiarrhythmic medication within 24 hours of enrollment
* Third degree heart block
* Sick Sinus Syndrome
Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease

The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* Hyperlipidemia
* Urinary protein

Exclusion Criteria:

* Previous rosuvastatin treatment \< 6 months prior to Visit 1
* Statin intolerance
* Severe hypertension
* Diabetes
Respiratory COVID-19: A Randomized, Sham-Controlled Study

A study of intubated critically ill patients infected with SARS-COV-2 to evaluate the safety and treatment effects of ultraviolet-A (UVA) light administered by a novel device via endotracheal tube in a first-in-human study. Study hypothesis was that respiratory SARS-CoV-2 viral burden would significantly decrease following five (5) days of UVA therapy.

The UV Respiratory Tract Light Therapy Device is intended to emit energy in the UVA region of the spectrum in intubated patients to reduce the viral burden of SARS-CoV-2 (human pathogenic coronavirus (COVID-19)) in intubated patients. The System is to be used in conjunction with the current standard of care measures.

The UV Respiratory Tract Light Therapy Device is intended to be used for 20 minutes per 24-hour period for the endotracheal application for 5 days, in combination with pharmacological and/or physical measures to optimize the therapeutic outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. Confirmed positive test result for SARS-CoV-2 within 14d
3. Mechanically ventilated (first intubation since positive SARS-CoV-2 test)
4. Endotracheal tube inner diameter at least 7.5 mm

Exclusion Criteria:

1. Unable to provide informed consent (or surrogate)
2. Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.
3. Pregnant women. While not an exclusion criterion, special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.
Efficacy and Safety of Diosmin 600mg Versus Placebo on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs

Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility.

Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).

The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient, man or woman, aged 18 and over,
2. Patient presenting a C1s or C2s venous disease grade of the lower limbs
3. Patient presenting a painful venous symptomatology in the lower limbs for at least 15 days.
4. Patient suffering from venous symptomatology in one leg with a painful symptom intensity higher or equal to 30 mm (VAS= 100mm)

Exclusion Criteria:

1. Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion,
2. Patients who started treatments such as calcium inhibitors, beta-blockers, angiotensin converting enzyme inhibitors and/or vasodilators and/or vasoconstrictors within 28 days prior inclusion (for patients already taking this type of treatments, dosage should not have been changed in the 28 days prior inclusion and should not be planned to change in the course of the study),
3. Patient treated by any analgesic within 7 days prior inclusion,
4. Patient treated by an anti-inflammatory treatment within 7 days prior inclusion,
5. Patient using elastic venous compression
6. Patient presenting permanent oedema,
7. Patients presenting venous skin changes,
8. Patient whose activity in the 4 following weeks (that is to say during the study) would be different from his/her usual activities (before the study),
9. Patient suffering from a pathology generating other pains than venous pains in the lower limbs,
10. Patient with a history of lower limbs trauma responsible for sequel pains,
11. Patient with a known deep venous reflux,
12. Patient with a history of venous thromboses or thrombo-embolic diseases within the last 6 months before inclusion,
13. Patient treated with analgesics or anti-inflammatory treatments used as analgesics within 4 weeks prior inclusion
14. Patient having a known hypersensitivity to diosmin or one of the excipients
15. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption ),
Prospective Observational Pilot-study for the Evaluation of the Nephro- an Neurotoxicity in the Anti-infectious Therapy With Inhalative Colistin Therapy for Patients With Ventilator-associated Pneumonia (VAP)

Multi-Drug resistant pathogens (MDR) are reported worldwide with increasing incidence, especially in intensive care settings.

One of the drugs which are effective against MDRs, is colistin (polymyxin E). This agent has been reintroduced in response to the increase of MDR pathogens and might be used more often in the future. Data on safety regarding the most important side effects are not sufficiently available. l This study evaluates the toxicity in patients who receive aerosolized colistin.

There is growing evidence that patients in the ICU setting have a special risk profile for consecutive colonization and possible infection due to MDR pathogens.

One therapy option is the use of inhalative colistin, as this agent has been demonstrated to be effective against these pathogens. Data on pharmacodynamics or - kinetics are transferred from older studies or from other patient populations. For patients with pulmonary colonization or infection due to an MDR pathogen the systemic resorption of the drug is not known, consequently systemic side effects including kidney or neural damage are not predictable.

This study focus on patients with inhalative colistin therapy and uses therapeutic drug monitoring to determine the rate of systemic resorption of colistin. For the evaluation of neurotoxicity function of peripheral nerves (neve conduction velocity) and of the eighth cranial nerve is monitored. Nephrotoxicity is estimated by creatinine level (-clearance) and the RIFLE criteria.

Eligibility Criteria:
Inclusion criteria:

* invasive ventilated patients (male and female) with assumed or assured bacteria with an elevated resistance pattern found in a tracheal or bronchial secretion with or without clinical signs of infection
* indicated colistin co-therapy or eradication-attempt with inhalative colistin (β-Lactam) therapy according to the standard operation procedure (SOP) of the hospital

Exclusion criteria:

* Consent of the patient or of the patient´s legal representative can´t be obtained soon
* Age \< 18 years
* Included within another, prospective clinical antibiotics-study
* Hypersensitivity to colistin or polymyxin B
* Patients with cystic fibrosis
* Present letter of attorney or patient´s provision, which precludes a priori the participation in studies
* Missing consent for storage of pseudonymised data in context of the study
* The patient is in an institution due to a court injunction or administrative order
Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts

With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.


Eligibility Criteria:
Inclusion Criteria:

* ▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:
* living in the same household as an mpox patient
* having had sexual contact or intercourse with an mpox patient
* sleeping in the same room as an mpox patient
* sharing a meal with an mpox patient
* children: having played together

  * Last exposure to the mpox index case of less than 14 days ago
  * Patients of any age and gender (children aged \< 10 years are excluded from venous blood sampling)
  * Patient or culturally acceptable representative is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Having previously been diagnosed with mpox in the last 3 months
* Inability or unwillingness to comply with the proposed follow-up schedule
Assessment of Safety of Air Travel in Patients With Pulmonary Langerhans Cell Histiocytosis

The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association website. Patients will have access to the questionnaire via REDCap (an online data management system) and each patient will be provided with a link to complete the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the purpose of this study. Secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.

The study will enroll participants through the clinic network at the Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association websites. Participants will have access to the questionnaire via REDCap (an online data management system) and each participant will be provided a link to complete the survey. In case of lack of internet access or inability to complete the online questionnaire, a paper survey will be mailed out with a pre-paid envelope to return the survey.

Primary Study Objective(s):

To define the risk of pneumothorax associated with air travel in patients with PLCH.

Secondary Study Objective(s):

To establish a contact registry for patients with PLCH to facilitate future trials To assess the rate of pneumothorax recurrence in patients with PLCH To assess the efficacy of pleurodesis in preventing recurrent pneumothoraces among patients with PLCH

Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 or older
* English literate
* Signed, dated informed consent; either given electronically or via paper form
* Confirmed diagnosis of PLCH based either on characteristic radiologic findings, or histopathological confirmation

Exclusion Criteria:

* Inability, or refusal, to sign informed consent.