cyrilzakka/clinical-trials huggingface dataset:
Effect of Training on the Use of Physical Restraints

Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Physical restraint is a practice performed by using patient aids to protect the individual or other patients around him, to ensure his safety and to control his behavior. Although physical detection seems to be a useful and simple method, it brings with it various physical, psychological, ethical, legal and moral problems. Nurses should use alternative strategies to prevent and reduce the use of restraint, and to avoid the negative consequences that may be caused by restraint by performing restraint appropriately and effectively, and thus ensure the safety of the patient. Evaluating nurses' knowledge on this subject, identifying deficiencies and providing training is important in terms of improving the quality of care and ensuring patient safety.


Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse in an adult intensive care unit
* Fill out the form completely
* Volunteering to participate in the study
* No vision or language problems to fill out the form

Exclusion Criteria:

* Filling the form incompletely
* Coming to the intensive care unit on rotation
* Not attending training
* No vision or language problems to fill out the form
* Having previously received training on physical detection
Approach to Hiatal Hernia Repair Based on Collagen Study

Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques.

Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery.

Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 20 years
* Initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity)
* Performance of laparoscopic hiatal hernia repair
* Informed Consent as documented by signature

Exclusion Criteria:

* Cases of conversion to open surgery
* Age \< 20 years and \> 80 years
* History of oesophageal/gastric/duodenal surgery including vagotomy
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.

Eligibility Criteria:
Inclusion Criteria Cohort A

1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

   Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and
6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Participants also receive a brain scan before and after stimulation. Our aim is to determine if tDCS can improve mental abilities in individuals with schizophrenia.

Participants enrolled into this study may be asked to do the following:

Grant permission for the researchers to view medical records associated with their language/cognitive difficulties

Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.

Complete several tasks (e.g., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.

Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.

Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.

The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.

Have a Magnetic Resonance Imaging (MRI) brain scan.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia
* English as a native language

Exclusion Criteria:

* appreciable deficits in hearing or vision
* appreciable accent
* any implanted metal device or pacemaker
* Dementia or Mini Mental Exam below 24
* History of Seizures
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis

Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.

The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female ≥ 18 years (18th birthday completed)
* Affiliation to a social welfare system
* Signed informed consent form
* More than 12 natural teeth suitable for evaluation
* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria

Exclusion Criteria:

* Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)
* Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)
* Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
* Current use of sonic toothbrush and/or dental water flosser
* Severe manual handicap preventing the patient from holding a toothbrush with a large handle
* Oral antiseptics (e.g. chlorhexidin mouthwashes)
* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
* Smoking (≥ 10 cigarettes per day)
* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
* Individual under guardianship, curatorship or judicial protection
Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations

The purpose of this research registry is to understand the real-world use of Illuccix PET/CT in prostate cancer, and how results from this testing impact patient's treatment and prostate cancer journey over time. It will follow subjects and the diagnostic testing and therapy they receive for their prostate cancer.

This is an observational research registry. Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.


Eligibility Criteria:
Inclusion Criteria:

Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.

1. Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
2. Have undergone a 68Ga-PSMA-11 (Illuccix or Gozellix) PET/CT imaging evaluation within 60 days before enrolling in the study. (Prior imaging with alternate radioactive imaging agents are allowed, but enrollment imaging must be with 68Ga-PSMA-11(Illuccix or Gozellix).
3. Have histopathologically confirmed prostate adenocarcinoma.
4. Have a life expectancy of ≥ 6 months as determined by the investigator.
5. Participants intended for enrollment in Cohort 1: Patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation to evaluate potential spread of the disease.
6. Participants intended for enrollment in Cohort 2: Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11 PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels). Participants intended for enrollment in Cohort 3: Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.
7. Be willing and able to provide informed consent and comply with the protocol requirements.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply. All participants must NOT:

1. Have any medical condition or other circumstances that, in the opinion of the Investigator, compromises the safety of the participant, the ability of the participant to comply with protocol requirements, the ability of the participant to complete the study, or confound study outcomes by being unable to produce reliable data over the course of the study.
Preventing Mid- and Later-Life Work Limitations

The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.

National demographic, economic and cultural trends are creating a need for hiring and retaining older workers. However, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. This study will conduct a randomized controlled trial (RCT) of the Work and Health Initiative (WHI). The WHI is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. This study will focus on workers 50 years of age and older. This study will test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression. Study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 45 years
* working ≥ 15 hours/week
* DSM-IV current major depression and/or dysthymia
* Work limitations: at-work productivity loss score ≥ 5%

Exclusion Criteria:

* severe physical health deficits
* non-English speaking or reading
* positive current alcoholism screening
* psychosis
* mania
Implementation of a Return Home With a Hospitalization at Home or With a Home Health Care Provider From the Services of Oncopneumology, Oncology and Hematology of University Hospital of Strasbourg

Hospitalization at home is booming. It is designed to meet the demands of patients and their families to continue care at home. It partially solves the problem of the lack of places in the "long-term care" structures and allows to respond to a desire of the health policy to reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in the management of chronic patients. Nevertheless, at the moment a certain number of requests for hospitalization at home remain unsuccessful or their implementation is complicated. In addition, the number of home health care provider has increased significantly in recent years. According to the federation of home health care provider, the number of beneficiaries increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients per year.

The objective of the study is to analyze the factors participating in Implementation of a return home with a Hospitalization at home or a home health care provider during a return home project constructed with the patient and his / her relatives from the services of Oncology, oncology, hematology of the University Hospital of Strasbourg.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient for whom an application for Hospitalization at home or with a home health provider is initiated by the Oncology, Oncology or Hematology Department of the University Hospital of Strasbourg.

Exclusion Criteria:

* Refusal to participate in the study
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients age 18 years of age or greater who are capable of giving consent
* Undergoing surgical procedures of expected length 6 \</= hours requiring NMB

Exclusion Criteria:

* Pregnancy
* History of documented anaphylaxis or contraindication to any of the study medications
* Active coronary disease with a positive cardiac stress test
* History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \< 50% of predicted
* Serum Creatinine \>/= 2.0 mg/dL
* Severe hepatic dysfunction accompanied by coagulopathy

  * Definition:
  * Known liver Disease AND
  * INR \> 1.5 (except for patients on anticoagulants) AND
  * Platelet count \<100,00/ul without other obvious cause
* Chronic sustained release opioid for \> 2 weeks duration pre op (in the 30 days prior to surgery)
* Use of toremifene
* Significant cognitive impairment or documented psychologic impairment
* Myasthenia gravis or other neuromuscular disease
* Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation.
* American Society of Anesthesiologists (ASA) Status \> 3
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

This is an single dose,two-way, crossover, oral bioequivalence study.

The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females at least 18 years of age inclusive
2. Informed of the nature of the study and given written informed consent
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

1. Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion
3. Recent history of mental illness, drug addition,drug abuse or alcoholism
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
7. Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
8. If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18 to 40 years
* With a hint of Bodymass index (BMI) between 17 and 30 kg.m - 2
* healthy subject determined by a clinical examination, a psychological interview, a blood test, a urine analysis
* Subject with a score\<6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")
* Subject agreeing to maintain a regular sleep/wake rhythm during the study
* Subject agreeing to refrain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, during the study
* Signed informed consent
* Subjectaffiliated to a social protection scheme

Exclusion Criteria:

* somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
* immune system diseases
* kidneys and urinary tract diseases
* endocrine and metabolic diseases
* neurological diseases
* infectious diseases
* thrombocytopenia or other malfunction of blood platelets
* Subject with risk of thrombosis, including subject with a history of phlebitis, smoker under oral contraceptive...
* Subject with an addiction to caffeine, nicotine, alcohol, psychotropic drugs, cannabis, or any other drug
* Subject treatment contraindicated or inadvisable in combination with heparin
* blood donation in the previous 3 months before the inclusion
* Participation in other clinical trials
* Work by shifts in the year preceding the inclusion
* Trans-meridian travel (\> 2 time zones) in the month previous the inclusion
* Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)
* Subject under safeguard of justice
* Subject under tutorship or curatorship
* Pregnancy (women of childbearing age)
* Breastfeeding
* Diet incompatible with the study's snack choices
A Study in People With High Cholesterol

The purposes of this study are to determine:

* The safety of the study medication and any side effects that might be associated with it
* Whether the study medication can help patients with high levels of "bad" cholesterol (low-density lipoprotein-cholesterol \[LDL-C\]), alone or in combination with additional study medication


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 80 years of age
* People with abnormal cholesterol levels

Exclusion Criteria:

* People with diabetes
* People whose blood pressure \>160/95 mm Hg, on or off blood pressure medicine
* People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure including stent placement, within the past 3 months
Activation of Alternative Cellular Energy (ACE) Pathway in the Therapy of Herpes Virus Infections

The research question to be addressed is whether indirect phototherapy based activation of the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly inhibit both latent HSV infections and residual HZV infections.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active, latent or residual HSV or HZV infection

Exclusion Criteria:

* Unwilling or unable to provide Informed Consent
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate persistent asthma
* Uncontrolled symptoms (C-ACT≤ 19)
* Treated for at least 3 months
* FEV1 between 60% and 90% of predicted value

Exclusion Criteria:

* Symptoms of acute respiratory infection
* Immunological or metabolic systemic disease
* Major malformations of the upper airways
* Active smoker