cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18-75
* Glasgow Coma Scale (GCS) 13 or greater
* Hunt and Hess grade I, II conditions
* Admitted within 2 days of initial SAH event \>6/10 pain on presentation

Exclusion Criteria:

* Aphasia
* Head trauma within the past 30 days
* Need for craniotomy
* h/o obstructive sleep apnea or respiratory disease
* h/o opioid tolerance
* evidence of vasospasm
* h/o liver disease
Cardiopulmonary Rehabilitation In Heart Valve Surgery

The aim of this study was to investigate the effects of postoperative early mobilization and Bottle-P.E.P. application on respiratory parameters and functional capacity in patients undergoing heart valve surgery.

After all patients were informed about the study and potential risks, patients who gave informed consent will be evaluated preoperatively and 5-7 days after surgery by the same investigator. Patients will be randomly divided into 3 groups: Group I (n=20, control) - conventional cardiopulmonary rehabilitation, Group II (n=20), conventional cardiopulmonary rehabilitation and Bottle P.E.P. application, Group III (n=20) will be included in the study as conventional cardiopulmonary rehabilitation and early mobilization group. The respiratory parameters of the patients will be determined by a pulmonary function test and their functional capacities will be determined by a 6-minute walk test. The preoperative and postoperative periods will be compared with statistical methods in the light of these evaluations on days 5-7.

Eligibility Criteria:
Inclusion Criteria:

* After heart valve surgery: Patients undergoing valvular surgery via sternotomy
* Same surgical technique (from med-sternum)
* Age group (25-75 Y)
* Stable hemodynamic values (stable vital signs, normal temperature, etc.)
* Full awareness of time and space

Exclusion Criteria:

* Ejection Fraction 35 %
* Any Male/female patient \&lt;25 or \&gt;75
* Body Mass Index (BMI) ≥ 38 kg/m2
* Intubation time \&gt;6 hours after surgery
* Uncontrolled arrhythmias
* Rheumatoid arthritis, other inflammatory and autoimmune diseases
* Active malignancy
* Cardiac pacemaker or defibrillator
* Mental health disorders
* Any postoperative complication (general muscle weakness, wound infection of the sternum or leg, stroke.)
* Refusal to assist in data collection
Upper Limit of Leucine Intake in Adults

When dietary amino acid supplements are consumed by humans they are normally in addition to their normal daily requirements. The investigators' laboratory played a leading role in defining the estimated average requirement (EAR) and the recommended dietary intake for the "essential" amino acids (Dietary Reference Intakes 2005). The other important but less well studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of intake? The investigators now propose to determine the safe upper limits of the dietary essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population.' As intake increases above the UL, the potential risk of adverse effects may increase'. In this proposal, the investigators define a novel method to define the safe upper limit where the 'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose the amino acid. Intakes of amino acid above this level will increase the potential for adverse effects to appear.

The objective of the study will be to determine the 'metabolic limit' of leucine oxidation in healthy young men by:

A) Measuring leucine oxidation in response to short term (8 hr) graded excess leucine intake B) Correlating changes in leucine oxidation with changes in plasma concentrations of keto-isocaproic acid (KIC, the first breakdown product of leucine metabolism), other essential amino acids, ammonia, urea, creatinine, glucose, insulin, and electrolytes (sodium, potassium, chloride) to identify potential biomarkers C) Correlating changes in leucine oxidation with changes in urinary excretion of leucine and ketoisocaproic acid (KIC), urea and creatinine to identify potential biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-35 years old

Exclusion Criteria:

* Report a recent history of sudden weight loss
* Have unusual dietary habits such as chronic consumption of caffeinated beverages or alcohol
* Have any endocrine disorders
* Are currently using any prescribed medications
Depression, Anxiety, and Stress in a Sample of Resident Doctors in Upper Egypt

To assess the prevalence and severity of symptoms related to depression, anxiety, and stress, among population of resident doctors in Upper Egypt in Assiut University Hospitals and other hospitals in upper Egypt

Many resident doctors during their training experience different levels of stress and this continuous pressure can cause feelings of discouragement and dissatisfaction, which might lead to the desire of leaving a training program.

This pressure could be accompanied by anxiety and depression and have negative effects on clinical performance and even increase the risk of burnout. Adjusting to these hectic job burdens affects individual emotional and intellectual contingency, and the capacity to create a healthy home-work balance. Burnout in residents can have serious effects not only on personal well-being, interpersonal relationships as well as on career but also may have negative effects on patient care .

The prevalence and impact of mental health issues among resident doctors have garnered increasing attention in recent years. Studies suggest that residency training can exacerbate existing vulnerabilities and contribute to the development of mental health disorders. The implications of these conditions are profound, affecting not only the personal well-being of the doctors but also their professional performance, patient care quality, and overall healthcare system efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Resident doctors undergoing post-graduation training in Hospital.
* Resident in hospitals in Upper Egypt

Exclusion Criteria:

* Resident doctors who were already under treatment for any psychiatric disorder and chronic medical illnesses.
Clinical Trial to Study the Safety and Tolerability of Memantin Mepha® in Sickle Cell Disease Patients

Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary hemolytic anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are hallmarks of this disease and are causative for an important socio-economic burden worldwide, especially in Africa.

Aside from allogenic stem cell transplantation, which is rarely available and very expensive, at present there is no curative treatment for patients with sickle cell disease (SCD). The current standard of care includes treatment with hydroxycarbamide and symptomatic care such as transfusions, antibiotic/analgesic treatment.

This study has the aim to study the safety and tolerability of Memantin in patients with sickle cell disease.

During the study participants will be asked if medical occurrences (AEs) happened and laboratory analysis (haematology, coagulation, chemistry) and urine samples will be taken. In addition at each visit a physical examination and measurement of vital signs will be performed.

In addition the number of hospital days and emergency consultations, the impact on working ability (the number of days with inability to work, changes in iv%), the amount and type of analgesic medication, the amount of RBC transfusions, the number of days that antibiotics prescribed and haematology (at local and external laboratory) and chemistry laboratory parameters will be assessed. For the impact on work and social life a questionnaire of quality of life will be filled out monthly by the patient.

At screening and at the end of the study SCD specific assessments will be performed, which include cardiologic examination (ECG, ECHO), abdominal sonography, ophthalmological examination, lung function testing and neuroangiologic examination.

Eligibility Criteria:
Inclusion Criteria:

* Documented symptomatic sickle cell disease (HbSS or HbS/beta thalassemia)

  * Age 18 years or older
  * Able and willing to provide written informed consent and to comply with the study protocol procedures
  * Willing to use two effective methods of contraception during study treatment until 6 months after stop of study treatment. Effective contraception methods are considered oral, injectable, implantative contraceptives or intrauterine contraceptive devices combined with the use of condom.

Exclusion Criteria:

* History of transfusion during last three months before Screening

  * Patients with active bacterial, viral or fungal infection requiring systemic treatment
  * Patients with known infection with human immunodeficiency virus (HIV) of human T cell leukaemia virus 1 (HTLV-1)
  * Inadequate renal function: creatinine clearance \< 30ml/min
  * Inadequate liver function: NCICTC Grade 3 liver function tests (AST, ALT \> 5x upper limit of normal (ULN))
  * History of malignancy
  * Women who are pregnant or breast feeding
  * Previous known mental disorder or known family history of psychiatric diseases
  * Known epileptic disease
  * The receipt of any investigational product within 30 days prior to this trial
Computer-Assisted Hair Restoration Study Using ARTAS System

Prospective, multi-center, up to 4 investigational centers evaluating the performance of the ARTAS System in Hair Restoration Procedures.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of III-VI
* Subject is 20 to 70 years old
* Subject agrees to cut hair short (\< 1 mm) on the scalp in the designated study areas for harvesting and implantation
* Subject is able to understand and provide written consent
* Subject consents to post-operative follow-up per protocol

Exclusion Criteria:

* Subject has prior history of scalp reduction surgery(s) in the past six months
* Subject has bleeding diathesis
* Subject has active use of anti-coagulation medication
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
Evaluation of the Efficacy of Systemic Treatments for Alopecia (ESTAA)

The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.


Eligibility Criteria:
Inclusion Criteria:

* Patient with severe alopecia
* Has received at least one systemic treatment for at least 3 months (among methotrexate, intravenous or oral corticosteroid therapy, Ciclosporin, UVA/UVB phototherapy)
* Patient affiliated to a social security scheme
* Age greater than or equal to 18 years

Exclusion Criteria:

* Patients under legal protection (guardianship, curatorship, etc.)
* Refusal to participate
* Other cause of alopecia
* Follow-up less than 3 months
* Age under 18 years
Viagra for the Treatment of IUGR

It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels' ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.

Each participant will receive, after informed consent a 25 mg tablet of Viagra \[sildenafil citrate \]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.

Eligibility Criteria:
Inclusion Criteria:

* IUGR/PET/Pregnancy weeks 24-33.
* Informed consent.

Exclusion Criteria:

* Maternal cardiovascular morbidity.
* Usage of any vasodilator medication
* Smoking
* Diabetes
DRug Use & Infections in ViEtnam: TuBerculosis Control

The overarching purpose of the proposed research is to demonstrate that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.

Vietnam has a strong National TB Program (NTP), but it belongs to the 20 countries with the highest TB burden in the world. A TB prevalence study among people who inject drugs (PWID) was conducted as part of the Drug use \& Infections in ViEtnam (DRIVE) program, in collaboration with a local screening initiative (Zero TB Vietnam, national TB program - NTP) in 2018 in Hai Phong. While the annual TB rate in the general population of Vietnam is 0.13%, this study found an alarming prevalence of confirmed TB cases from 1.8% to 5.6% among PWID. Some populations, such as people who inject drugs (PWID), combine a very high risk of TB and low access to TB care. Based on the investigators experience in operational research among PWID and their expertise in TB, they designed an intervention to end TB among a highly vulnerable population such as PWID, through significant community involvement.

They hypothesize that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.

The DRIVE-TB intervention will use four repeated large-scale randomized driven sampling surveys (RDSS) to identify TB-infected PWID in the community. During RDSS 1 and 4 all participants will undergo a questionnaire on TB symptoms, and have CRP, chest X-ray, and sputum collection for Xpert MTB-RIF®. In RDSS 2 and 3, participants will be screened through the best screening algorithm (elaborated in RDSS1). Participants from all RDSS will also be screened for LTBI through Tuberculin Skin Test (TST). Moreover the 3HP ancillary study, a therapeutic cohort will assess the acceptability, safety, adherence, and cost of a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) to prevent TB disease among RDSS 2 participants with a positive QuantiFERON test result will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Self-declaring injecting heroin or any other drug
* Positive urine test for heroin or methamphetamine
* Presence of recent injection site marks

Exclusion Criteria:

* Unable to understand or refused to sign informed consent
* Patients currently under treatment for active TB
* Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study, including very severe clinical condition
* Person deprived of freedom by a judicial or administrative decision
Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.

The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.

Here, investigators use the World Health Organization (WHO) and the French database of individual safety case reports, to identify cases of MDS/AML related to PARPi.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO, also called VigiBase) or French database of individual safety case reports at the time of the extraction,
* Patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none).

Exclusion Criteria:

* Chronology not compatible between the PARPi and adverse event (MDS/AML)
Assessment of Contact Lens Wettability Using Wavefront Aberrometry

This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females that are at least 18 to no more than 40 years of age.
2. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
6. The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
7. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
8. The subject must have corrected visual acuity of 20/20 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
5. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Current wearers of rigid or hybrid contact lenses.
7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
8. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
9. History of binocular vision abnormality or strabismus.
10. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
11. Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
12. Strabismus, suppression or amblyopia.
13. Any ocular infection.
International EXPAND Lung Pivotal Trial

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:

* Donor PaO2/FiO2 ≤ 300 mmHg; or
* Expected ischemic time \> 6 hours; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥55 years old

Eligibility Criteria:
Inclusion Criteria:

* At least one of the following:

  * Donor PaO2/FiO2 ≤ 300 mmHg; or
  * Expected ischemic time \> 6 hours; or
  * Donor after Cardiac Death (DCD donor); or
  * Donor age ≥55 years old

Exclusion Criteria:

* • Presence of moderate to severe traumatic lung injury with air and/or blood leak

  * Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
  * Previous history of pulmonary disease
  * Multiple transfusions of \>10 pRBCs units
  * ABO incompatibility
  * Tobacco history of \>20 pack years
A-LiNK: Improving Outcomes in Autoimmune Liver Disease

The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).

This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.

Pediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.

The aims of A-LiNK are to:

1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autoimmune hepatitis (AIH)
* Clinical diagnosis of primary sclerosing cholangitis (PSC)
* Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)

Exclusion Criteria:

• History of liver transplant