cyrilzakka/clinical-trials huggingface dataset:
Prediction of the Risks of Cardiovascular Mortality

Monitoring risks of cardiovascular diseases in working population (18 - 65 years old) by monitoring their BMI, ankle-brachial index with pulse wave velocity, cholesterol and glycemia.

Monitoring working population in their workplace by measuring their ankle-brachial index with pulse wave velocity, BMI, glycemia and cholesterol. Putting acquired data in correlation to their work habits, type of employment, work demands, job type, activity levels. Trying to find common predictors of cardiovascular disease. All assessed subjects must understand written and spoken Czech, must be employed in a company that consents with our data collections, must be older than 18 year old, doesn't have any bleeding disorder, doesn't have deep vein thrombosis (as it produces inaccurate data with ankle brachial index). Study will be conducted in Ustecky Region in the Czech Republic on approximately 200 subjects.

Eligibility Criteria:
Inclusion Criteria:

* employed in Ustecky Region Czech Republic
* adult
* understands spoken and written Czech
* consents with assessment
* works in a company that consents to assessments of their employees

Exclusion Criteria:

* deep vein thrombosis
* not currently employed
* on sick leave
* bleeding disorder
Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer

This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.

The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and function.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed renal cell carcinoma with metastasis.
* Must have measurable disease.
* No prior cytokine, chemotherapy, hormonal, or other immuno-based therapies (including vaccine or cellular based) for their renal cancer is allowed. No prior use of bisphosphonates will be allowed. One prior experimental therapy will be permitted as long as \> 4 weeks have passed since last drug administration.
* ECOG performance status 0 or 1
* Adequate cardiac function by history.
* Pulse-oximetry \> 92% on room air.

Exclusion Criteria:

* Radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Known brain metastases
* Any history of an autoimmune disease (ie. psoriasis, inflammatory bowel disease, etc) must receive clearance by the investigator before being permitted on study due to the potential worsening of those disorders from IL-
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
* History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment.
* History of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent and disease free for \> 5 years.
* Any history of seizures given increased seizure risk with IL-2.
* Organ allograft (transplant) recipients will be excluded given absolute contraindication with IL-2 therapy.
* Pregnant women are excluded
* Patients on systemic steroids (oral or IV) will not be eligible for the study.
Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours

Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.

In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. patients with lower urinary tract symptoms (LUTS )
2. IPSS≥ 15 despite medical treatment \> 1 month if monotherapy or \> 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin
3. prostate volume \> 30 cc by transrectal ultrasonography ;
4. IPSS Qol ≥ 3 has at inclusion ;
5. PSA ≤ 4 ng / ml ;
6. if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP \<6 months .
7. Accommodation \<50 km;
8. company available for the return at home and monitoring first post- operative night .
9. patient sign the informed consent
10. patient covered by social security or other health insurance

Exclusion criteria

1. post- voiding residue \> 250 cc by suprapubic ultrasound not older than \< 45 days
2. prostate volume \> 100 cc by transrectal ultrasound not older than 45 days
3. urological antecedents : o urethral stenosis or cervical disease

   * UTI in progress
   * SAD patient or self-catheterization
   * obstructive hydronephrosis + / - renal failure
   * vesical calculi
   * cancer of the prostate treated or untreated
   * bladder tumor associated
   * Interstitial cystitis ( symptom or biopsy)
4. antecedent of the prostate surgery
5. neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome )
6. criteria related concomitant medications that can not be stopped at least \< 48 hours before PVP with GL XPS 180 W
7. contra indication for outpatient care for medical reason
8. contra indication of a product analgesic according to protocol
9. patient inability to understand and sign the informed consent as well as completing the questionnaires
10. ASA Score \> 3 .
Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

This multicentric prospective clinical practice study aims at evaluating risk factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma and ICU length of stay in patients with elevated initial mean airway pressure based on a remote ventilation monitoring system which records venlitor input and output data (including waveforms).

Brief Background:

Evidence has accumulated that protective lung ventilation and the patient-ventilator interaction are related to the outcome of patients with lung injury. While most current studies focus on the static parameters and their association with outcomes, dynamic ventilation parameters may provide a more comprehensive assessment than static ones. Time-varying features of ventilator parameters should be paid more attention. Recently, we have developed a remote mechanical ventilation visualization network system (RemoteVentilateView) and, simultaneously, a related automatic recognition algorithm for different types of patient-ventilator asynchrony. This system enables ventilation data fully used. Our main focus is on patients who have an average airway pressure no less than 10 cmH2O upon admission to the ICU. This population has a higher ventilation intensity and may be more at risk of ventilator-induce lung injury than the average ICU patients. We aims to identify risks factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma in this specific population.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving invasive mechanical ventilation, an average mean airway pressure ≥10 cmH2O for 6 consecutive hours within the first 24 hours of ICU admission.

Exclusion Criteria:

* Currently receiving or expected to receive ECMO treatment within 24 hours;
* Glasgow Coma Scale (GCS) score less than 8 due to cardiac arrest, traumatic brain injury, or acute stroke;
* Requiring invasive mechanical ventilation due to neuromuscular diseases;
* Exceeding 24 hours from ICU admission to connection to the remote monitoring system.
New Technique For Laparoscopic Appendicectomy

Introduction: Appendectomy is one of the most frequent emergency surgical procedures, currently with a preference for laparoscopic management worldwide. Objective: To report a new laparoscopic appendectomy technique and its results. Material and methods: study of patients with a diagnosis of appendicitis who are managed laparoscopically. In a total 1063 patients, 148 were operated on with the Zaragoza technique during the period from January 2002 to December 2018. The technique consists of making a window in the appendicular base between the meso and the appendicular wall, two prolene or silk sutures are placed, and the cecal appendix is cut between the two sutures, finally the mesoappendix is sectioned with a harmonic scalpel or bipolar clamp.

this is a retrospective study based on files

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of appendicitis who are managed laparoscopically.

Exclusion Criteria:

* Less than 18 year old
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
* Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg
* Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles by a designated central laboratory
* Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory.
* Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
* Performance status: dependent on age - Lansky \> 60, Karnofsky \> 60, Eastern
* Cooperative Oncology Group 0-1.
* Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis.
* At time of treatment, participant has measurable disease according to RECIST v1.1.
* Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
* Consultation for prior history per protocol specifications.

Exclusion Criteria:

* Central nervous system metastases.
* Any other prior malignancy that is not in complete remission.
* Clinically significant systemic illness (.(Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications)
* Prior or active demyelinating disease.
* History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
* Previous treatment with genetically engineered NY-ESO-1-specific T cells.
* Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
* Prior gene therapy using an integrating vector.
* Previous allogeneic hematopoietic stem cell transplant.
* Washout periods for prior radiotherapy and systemic chemotherapy must be followed.
* Participant had major surgery in less than or equal to 28 days of first dose of study intervention.
* Prior radiation exceeds protocol specified limits.
Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery

The purpose of this study is to determine whether a custom-made forced-air warming mattress can prevent heat loss in patients undergoing vascular surgery better than a circulating-water mattress

A reusable, custom-made forced-air warming mattress was made of a light to medium weight water resistant canvas, sewn like mattress with 2 arms placed underneath the patient. An open hole at proximal part of one arm was designed to attach with a hose of warm air delivery device. Small holes (2-3 mm2), 5 inches apart were punched on the upper surface of this mattress around the patient except for the area underneath the patient that the holes were 9 inches apart. The weight of the patient will obstruct the air flow and prevent direct blowing of warm air onto the underside of patients. There is a special appendage connected to the upper part of mattress which can connect warm air to cover the patient's chest. There is a special appendage connected to the upper part of mattress which can convect warm air to cover the patient's chest. The mattress is 97 inches x 97 inches, with 2 arms of 25 inches x 16 inches and a special appendage of 45 inches x 12 inches for covering the chest with warm air delivery. This size is proper for patient of 170 cm. height. In order to reuse it, the mattress can be washed, dried and sterilized by gas or autoclaved for more than 50 times. A sterile sheet well enhance the sterile environment of the operating field.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.

Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.

Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has end-stage renal disease.
2. Subject has been on regular dialysis treatment for at least 6 months.
3. Subject has autologous vascular access.
4. Subject is offered thrice weekly hemodialysis.
5. Subject is offered 4 hours duration hemodialysis.

Exclusion Criteria:

1. Infectious disease
2. Poor echocardiographic window that was unsuitable for interpretation
The Burden of Primary Caregivers of Spinal Muscular Atrophy Patients and Their Needs

The purpose of this study is to assess carer burden, needs, and expectations of Spinal Muscular Atrophy Parents

Spinal muscular atrophy (SMA) is a group of neuromuscular diseases involving the spinal cord anterior horn cells and brain stem motor nuclei. It is followed by programmed cell death. It progresses with symmetrical weakness and atrophy of voluntary muscles throughout the body. It leads to a decrease in mobility with progressive loss of power, and pulmonary function impairment with the involvement of the respiratory muscles.

Families who are confronted with these problems that arise after the birth of the baby or shortly after birth have a serious adaptation problem. When the course of the disease and its incurability are explained, patients and their families are under severe stress. Physical and emotional health is worse than normal healthy growing children's parents.

They need information, psychological and social support. The role of the family is very important in the life of children with disabilities. Family-oriented care; has been developed to facilitate the care process of children with special needs and to help their families. The main characteristics of the family-oriented approach are that families know their children in the best way, that each family is unique and different, and that family and community support is provided for the child's functionality. The assessment of family function helps the planning and management of treatment according to the concerns of the family. The education of the family, the socio-cultural structure and the psychological approach of the parents play an important role in the development of the child with SMA.

The aim of this study was to evaluate the care burden, needs and expectations of SMA parents and to reveal the problems clearly; so that this information can be used in rehabilitation planning and interpretation of results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with spinal muscular atrophy at between the ages of 0-18
2. Agree to participate in the study

Exclusion Criteria:

1-Refuse to participate in the study
Hip Arthroscopy Improves Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome

To explore the changes of the muscles around the hip joint after hip arthroscopy for patients with femoral acetabular impingement syndrome.

Retrospectively investigate the influence of hip arthroscopy on the muscle volume around the hip joint, and to provide important information for clinicians to make diagnosis and treatment plan of hip joint disease.

Eligibility Criteria:
Inclusion Criteria: (1) Age 18-50 years old; (2) Diagnosed femoroacetabular impingement syndrome; (3) Conservative treatment ineffective; (4) complete preoperative and postoperative MRI images; -

Exclusion Criteria: (1) bilateral; (2) revision; (3) osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease or surgery; (6) femoral head necrosis; (7) sacroiliac joint disease.

-
Competence Ability Study in People With Schizophrenia

The goal of this research is to understand whether schizophrenic patients are capable of comprehending clinical trial consent form or influenced by disease, also after intensified educational illustration for "understanding of consent form", their comprehension increased or not, in order to protect patient's right.

The goal of this research is to understand whether schizophrenic patients are capable of comprehending clinical trial consent form or influenced by disease, also after intensified educational illustration for "understanding of consent form", their comprehension will increase or not, in order to protect patient's right. First week, inform the patient a putative goal and method of clinical trial medicine research, then using Macarthur comprehension evaluation tool-clinical research Ed., evaluate the understanding of all patients for this putative clinical trial research consent form. For experimental group schizophrenic patients, using PANSS score evaluate seriousness of their symptom. 2 weeks later, randomly stratify schizophrenic patients into 2 groups, one give educational intervention for consent form, the other does not, then evaluate again with Macarthur comprehension evaluation tool-clinical research Ed. and PANSS score.

Eligibility Criteria:
Inclusion Criteria:

Experimental group

1. Age between 20 to 60, all genders.
2. Psychiatry doctor diagnosed who met DSMIV-TR criteria schizophrenia.
3. Participants require adequate ability to have a interview about 60-70min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

Control group

1. Age between 20 to 60, all genders.
2. Psychiatry doctor diagnosed who exclude DSMIV-TR axis. I and II.
3. Participants require adequate ability to have a interview about 30min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

Exclusion Criteria:

Experimental group and control group

Participants have no adequate ability to have a interview about 60-70min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).
Management of Pain Associated With Failed Back Surgery Syndrome

Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.

our study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them


Eligibility Criteria:
Inclusion Criteria:

* Patients with Previous spine surgery and subsequent chronic back pain

Exclusion Criteria:

* Patients with connective tissue diseases
* Patients with psychiatric illnesses
Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.

Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.

In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.

All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
* Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)

Exclusion Criteria:

* Preoperative corneal astigmatism less than 0.75D
* Patients who do not provide informed consent
* Patients who do not understand the study procedure.
* Previous corneal surgery or trauma.
* Irregular cornea (e.g. keratoconus).
* Microphthalmos.
* Severe corneal dystrophy.
* Pregnant or breastfeeding'.
* Rubella
* Mature/dense cataract making eye bottom preoperative examination difficult.
* Previous retinal detachment.
* Concurrent participation in other research with drugs or clinical devices.
* Expect to require another eye surgery during the study period.