cyrilzakka/clinical-trials huggingface dataset:
Tobacco Intensive Motivational and Estimate Risk

Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test\< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40 and 70
* Confirmed diagnosis of Bipolar Disorder or Schizophrenia according to Diagnostic and Statistical Manual of Mental Disorder IV (DSM-IV-TR)
* Active smokers who currently consume at least 10 cigarettes a day, with a cumulative consumption of 10 packets/year or more.

Exclusion Criteria:

* Previous respiratory diagnosis of: asthma, cystic fibrosis, tuberculosis, simple chronic bronchitis, restrictive pulmonary disease or bronchiectasis
* Acute respiratory symptoms
* Heart disease or advanced oncological processes
* Existence of a pathology which makes it advisable not to perform spirometry (recent pneumothorax, recent thoracic or abdominal surgery, aortic aneurysm, unstable angulation, retinal detachment, facial hemiparesis or oral/dental problems)
* Patients who, due to their intellectual disability or mental pathology, do not understand or cannot be forced to perform spirometry
* Clinical instability with results of over 14 points on the Hamilton Depression Rating Scale (HDRS), a Young Mania Rating Scale (YMRS) of over 6 or a Positive and Negative Syndrome Scale (PANSS) of over 70
ACL Reconstruction: Clinical Outcome

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the clinical outcomes remains largely debated. The study aims to offer new elements to analyze this treatment and potentially identify the factors responsible for the outcomes and the factors useful to optimize the clinical outcome in the future. In fact, in addition to collect patient data in terms of features and clinical-functional status, objective data will be documented and correlated. In particular the quantification of knee laxity will be performed using an innovative device based on the use of inertial sensors (a methodology recently developed and already validated at the Istituto Ortopedico Rizzoli). The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1, 2 and 5 years after surgery during a clinical visit or a telephone interview. Such evaluations will include the submission of questionnaires to determine the patient's functional symptoms and also knee joint assessment during a medical examination to quantify the knee joint stability.

Moreover, the following clinical scores will be adopted: IKDC-subjective, IKDC-objective, SF12, Marxs, Koos, Tegner, VAS for pain assessment, EQ-VAS for overall health status assessment. Also it will be recorded the lapse of time for returning to work and sports, the degree of patient satisfaction,the adverse events, the failures and any new treatments on the same site.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have provided informed written written consent;
2. Patients aged between 18 and 60;
3. Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

Exclusion Criteria:

1. Patients unable to understand and to want;
2. Patients who have not signed informed consent;
Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia

A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.

After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.

Eligibility Criteria:
Inclusion Criteria:

* Single patient
* 7-year-old male
* Congenital arhinia
* No history of previous treatment

Exclusion Criteria:

-
The Effect of Kinesio Taping on Mobility, Pain, Balance and Daily Activities in Total Knee Replacement Patients

Total knee arthroplasty (TKA) is a surgical procedure performed to relieve pain and functional limitations caused by advanced gonarthrosis that cannot be managed with conservative methods. It is known that the postoperative rehabilitation program plays a crucial role in functionality and mobility in the postoperative period. Pain and swelling are the most commonly reported minor complications that lead to functional limitations, often associated with decreased muscle strength. After TKA, various current methods such as compression therapy and electrotherapy are employed to treat postoperative edema. Typically, patients are discharged with a home exercise program once they are ambulatory. However, the return to daily living activities varies among patients, and some may experience prolonged recovery times. In our country and hospital, there is no standardized algorithm for postoperative care following TKA. Patients are often referred to rehabilitation clinics only when complications arise.

Due to issues with patient ambulation, there may be a need for inpatient care following TKA. While traditional rehabilitation programs are used, alternative methods to facilitate early ambulation have emerged in recent years, one of which is kinesiology taping (KT). Developed by Kenso Kase in the 1970s, KT is an elastic, wave-textured, waterproof, breathable cotton tape applied directly to the skin. When applied with various techniques, it helps alleviate pain, reduce edema, and provides mechanical support and joint protection. KT does not restrict movement; instead, its elastic structure opens the space between the dermis and fascia, aiding lymphatic and blood flow, thereby reducing swelling in the extremities. There are studies on the use of KT in postoperative patients beyond musculoskeletal pain conditions, particularly regarding its effectiveness in managing pain, swelling, and joint range of motion after shoulder and anterior cruciate ligament surgeries.

Although recent studies in the literature have explored the use of KT after TKA, there is still no consensus on its efficacy and application methods. This study aims to investigate the potential effects or complications of KT treatment on balance, pain, mobility, and quality of life in patients undergoing rehabilitation after TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-75 who have undergone total knee arthroplasty (TKA)
* Patients able to mobilize independently
* Patients willing to participate in the treatment program
* Patients without any secondary conditions that could cause immobilization

Exclusion Criteria:

* Patients who have undergone surgery due to cancer
* Renal insufficiency (GFR \&lt;30)
* Patients with local infection in the kinesiology taping application area
* Heart failure (Stage III-IV)
* BMI \&gt;35
* Cognitive impairment
* COPD (GOLD Stage III-IV)
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cementless primary total hip replacement
* Receiving acetabular cup of 52mm or greater
* Preoperative level of function and pain same as for conventional hip replacement
* Likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health
* Willing to return for follow-up evaluations
* X-ray evaluation confirming the presence of NIDJD
* Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

Exclusion Criteria:

* Age less than 40 years or greater than 80 years at time of surgery
* Patients templated to receive an acetabular component smaller than 52mm in diameter
* Presence of a previous prosthetic hip replacement device in the hip joint to be operated
* Previous girdlestone procedure or surgical fusion of the hip to be operated
* Acute femoral neck fracture
* Above knee amputation of the contralateral and/or ipsilateral leg
* Patients with a diagnosis of inflammatory degenerative arthritis
* Skeletally immature
* Evidence of active infections that may spread to other areas of the body
* The presence of a highly communicable disease that may limit follow-up
* Presence of known active metastatic or neoplastic disease
* Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
* Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
* Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
* Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
* Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
* Any steroid therapy, local or systemic, within three months prior to surgery
* Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
* Patient has known allergies to metal, e.g., jewelry
* Any patient not meeting all radiographic and clinical parameters for inclusion
Autonomic Dysfunction in Resistant Hypertension

The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.

All patients were submitted to office blood pressure measurement, Ambulatory blood pressure monitoring and 24-hour Holter monitoring.

Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity (PRA) were collected at 08:00 after overnight fasting.

Eligibility Criteria:
Inclusion Criteria:

* resistant hypertensive patients

Exclusion Criteria:

* White-coat hypertension
* obstructive sleep apnea
Activation of the Endocannabinoid System and Cognition

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* PTSD criteria fullfilled (patients only)

Exclusion Criteria:

* All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded.
* Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded.
* psychiatric disorder according to DSM-5 (healthy controls only)
An Algorithmic Approach to Ventilator Withdrawal at the End of Life

The proposed study is an important, under-investigated area of ICU care for terminally ill patients undergoing terminal ventilator withdrawal. The proposed research has relevance to public health because an algorithmic approach to the ventilator withdrawal process will enhance clinicians' ability to conduct the process while assuring patient comfort, using opioids and/or benzodiazepines effectively.

Terminal ventilator withdrawal is a process that entails the cessation of mechanical ventilatory support with patients who are unable to sustain spontaneous breathing and is commonly performed in the ICU. Ventilator withdrawal is undertaken to allow a natural death. Opioids and/or benzodiazepines are administered before, during, and after as an integral component of the ventilator withdrawal process to prevent or relieve respiratory distress, but there are few guidelines to determine how much to administer or when. Insufficient opioid and/or benzodiazepine administration places the patient at risk for unrelieved respiratory distress and preventable suffering. Conversely, excessive medication administration may hasten death, an unintended consequence, and one that concerns clinicians. The effective doses of medications given during ventilator withdrawal are unknown. The investigators hypothesize that an algorithmic approach to ventilator withdrawal, relying on a biobehavioral instrument to measure and trend distress, will ensure patient comfort, and guide effective opioid and/or benzodiazepine administration. The investigators plan to use a stepped wedge cluster randomized controlled trial with all clusters providing unstructured usual care until each cluster is randomized to implement the algorithmic approach (intervention). The proposed study is innovative because there is no standardized, evidence-based approach guided by an objective measure of respiratory distress to this common ICU procedure. The study has broad clinical significance to provide knowledge that can potentially reduce patient suffering.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ventilator withdrawal

Exclusion Criteria:

* Patients who are conscious and cognitively intact
* Patients who will undergo organ donation after ventilator withdrawal
* Patients who are brain dead
* Patients with bulbar amyotrophic lateral sclerosis
* Patients with C-1 to C-4 quadriplegia
* Patients with locked-in syndrome
Treatment of Orthostatic Hypotension

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.

We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
* non-smokers
* drug-free
* able to give informed consent
* free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion Criteria:

* medications affecting the autonomic nervous system
* any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
* anemia (Hct \< 30)
* women of childbearing age who are pregnant or nursing
* smokers
Exercise Program for Deaf Seniors to Increase Their Balance and Fitness

Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework.

Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked.


Eligibility Criteria:
Inclusion Criteria:

* Deaf
* Uses American Sign Language (ASL) fluently
* Community-dwelling
* Able to walk independently for at least 20 ft
* Willing to attend classes twice a week at Gallaudet University

Exclusion Criteria:

* Blindness
* Dementia
* Neurological conditions
DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis

The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% \[2-4\].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis.

The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown.

Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.


Eligibility Criteria:
Inclusion Criteria:

* dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria:

* missing informed consent or unable to consent
* age \< 18 years
* pregnancy
Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM)

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.

To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).

Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.