cyrilzakka/clinical-trials huggingface dataset:
Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients

This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.

The objective is to assess whether telerehabilitation can provide comparable or significantly better outcomes in terms of functional recovery, pain management, improved range of motion, and patient satisfaction for Total Knee Replacement (TKR) patients. If telehealth interventions prove successful, they can be implemented to increase access to high-quality rehabilitation treatments and enhance healthcare delivery. Evidence-based findings from this study can help healthcare providers make educated decisions about incorporating telerehabilitation into post-operative rehabilitation protocols, thereby enhancing patient care and optimizing resource utilization in orthopedic settings.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed with TKR
* Older Age above 65
* Patient communicates with medical staff
* Patient with cemented TKA
* Patients who underwent TKA owing to degenerative arthritis

Exclusion Criteria:

* Older patients aged \>75 years
* Patient with a history of knee joint surgery before TKA
* Patient who possibly had a systematic inflammatory disease such as rheumatoid arthritis.
* Patients with difficulty in seeing, hearing, and walking independently
* Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
* Patient history of severe mobility disorder
* Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.

The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices.

Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler.

Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed for non-valvular atrial fibrillation with elevated CHADSVASC and HASBLED scores, meeting commercial LAAO criteria indications, who underwent appropriate pre-procedural imaging with Computed tomography or transesophageal echocardiography.
2. Patients with increased risk of stroke with elevated CHA2DS2-VASc score.
3. Patients who cannot be on oral anticoagulants or can't tolerate these medications.
4. Patient should be able to comply with the protocol.
5. Provide written informed consent before study participation.
6. Ages 18 and above

Exclusion Criteria

1. Presence of an intracardiac thrombus on the preprocedural TEE or CT.
2. History of previously implanted device for atrial septal defect or patent foramen ovale.
3. Severe left ventricle dysfunction- Left ventricular ejection fraction (LVEF \< 40%) or greater than moderate valvular heart disease.
4. Enrollment in another study that competes or interferes with this study.
5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
6. Subject with planned complex PCI or procedure necessitating multiple intervention.
7. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
8. Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure
9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.
Intraperitoneal Local Anesthetic Infiltration Versus Erector Spinae Block in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Both Erector Spinae Plane Block and Intraperitoneal Local Anesthetic Infiltration method are methods used to reduce postoperative pain. However, there is no study in the literature comparing these 2 methods in terms of postoperative recovery quality. In this study, patients will receive Erector Spinae Plane Block or Intraperitoneal Local Anesthetic Infiltration at the end of surgery, and both techniques will be compared using the preoperative and postoperative quality of recovery 40 survey.

The Preoperative Quality of Recovery 40 questionnaire will be administered to patients scheduled for laparoscopic cholecystectomy who consent to participate in the study. Following the surgical procedure, patients will receive either intraperitoneal local anesthetic infiltration or bilateral erector spinae plane block for postoperative analgesia. These interventions will be examined in an observational study comprising two distinct groups. At the 24-hour mark postoperatively, the Quality of Recovery 40 (QoR 40) survey will be readministered to the patients, and the outcomes will be subjected to comparative analysis. Throughout the postoperative period, patients in both cohorts will be closely monitored. Pain scores and opioid-associated adverse effects (such as nausea, vomiting, and pruritus) will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th hours. Subsequent to the surgical procedure, patients in both groups will be provided with morphine via patient-controlled analgesia, and the extent of opioid consumption within the first 24 hours postoperatively will be compared.

Primary purpose: To compare the effects of Erector Spina Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy.

Secondary objectives: To compare the effects of ESP block and intraperitoneal local anesthetic infiltration on postoperative pain scores at rest and with movement, total opioid consumption, and incidence of opioid-related side effects in patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Will undergo laparoscopic cholecystectomy operation,
* Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.

Exclusion Criteria:

* Patients who do not give consent
* Those who are allergic to the drugs used in the research
* Those with coagulation disorders
* Having a history of alcohol and substance use
* Having a history of serious psychiatric and neurological diseases
* Having chronic pain syndrome
* Those with local infection in the area to be blocked
* Patients with sepsis and undergoing emergency surgery
Biomarkers in Schizophrenia

N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. Further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. The study will assess effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a mechanism for developing appropriate outcome batteries for future trials of novel compounds.

16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent negative symptoms will be recruited for this study. This study will consist of a randomized trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline lead-in, and two 6-week intervention arms separated by a two week, placebo controlled washout period. Biomarkers will be assessed at baseline for each treatment arm, acutely (day 7) following treatment initiation, and following 6 weeks of treatment (6 biomarker sessions total). Primary biomarker outcome measures will include 1) amplitude of the mismatch negativity (MMN) waveform and 2) amplitude of the visual P1 potential. Symptomatic outcome measures will include PANSS and composite score of the MATRICS neuropsychological battery. The study will be supported from ongoing NIMH-funded Cooperative Drug Development Grant (CDDG) to the PI.

Eligibility Criteria:
Inclusion criteria:

* Age 18-64
* SCID diagnosis of Schizophrenia or Schizoaffective Disorder.
* PANSS 3 factor negative symptom (screening and baseline visit 1 and visit 3) score of \>20 and PANSS total score between 60-110. Any degree of positive symptoms is acceptable but the total PANSS score must not exceed 110.
* SAS total score less than or equal to 12 and a Calgary Depression Inventory total score less than or equal to 10 and suicide (item 8) less than moderate (\<2).
* Two consecutive CGI ratings at screening and baseline (visit 1 and 3) with no change in score.
* Estimated Glomerular Filtration Rate (GFR)(a measure of renal function) greater than or equal to 60.

Exclusion criteria:

* Organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia or significantly increase the risk associated with any of the proposed treatments
* Current DSM-IV diagnosis of drug/alcohol abuse in last month and current DSM-IV diagnosis of drug/alcohol dependence in last 6 months
* Pregnant female patients
* Impaired renal function
* Significant extrapyramidal symptoms (as reflected by a total score of 10 or above on the SAS scale), and depressive symptoms (as reflected by a score of 10 or above on the Calgary Depression Scale for Schizophrenia)
* Patients who are unable to or unwilling to participate in the Cognitive assessment (MATRICS) and the electrophysiology tasks .
* Patients on clozapine
TSH Suppression During Radiotherapy on Thyroid Site to Prevent Iatrogenic Hypothyroidism in Pediatric Cancer Patients

To offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism. Thyroid dysfunction may develop from a few months to several years after patients have completed their radiation treatment. In children with chronic diseases, or given lengthy anti-neoplastic treatments, recurrent or persistent endocrine disorders may have a negative effect on growth and development into adulthood.

Patients will undergo basal thyroid ultrasound and FT3, FT4, TSH assay. Simulations with computed tomography, and computer assisted three-dimensional treatment planning with a dose volume histogram will be used to identify thyroid volumes and corresponding RT isodose distributions.

The enrolled patients will be randomly assigned (1:1) to TSH suppression group (experimental group) or non-TSH suppression group (control group). Random allocation will be managed centrally by Clinical epidemiology and Trial organization of the Fondazione IRCCS Istituto Nazionale dei Tumori. The randomization list will be generated by SAS software. Investigators and patients will not be masked to treatment allocation.

From 14 days beforehand and throughout their RT, patients in the experimental arm will receive L-thyroxine in the morning on an empty stomach (half an hour before breakfast), starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure TSH \< 0.3 μIU/mL before RT beginning. The 0.3 μIU/mL threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" TSH suppression. Based on hormone status, L-thyroxine doses will be gradually increased to patients' individual minimum TSH-suppressive dose before starting RT, maintained throughout the treatment, then rapidly tapered off (half dose the next day after RT, 25% the following day and stop).

Eligibility Criteria:
Inclusion Criteria:

1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma before radiotherapy (RT) planning including thyroid parenchyma without previous primary or secondary hypothyroidism;
2. Written informed consent prior to any study-specific analysis and/or data collection.

Exclusion Criteria:

1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;
2. Not signed consent.
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.

The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. The aim is to determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older.

Exclusion Criteria:

* Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
* Patients who are unable to express consent and who do not have a caregiver who can give it for them.
Kinesio Tape Effects on Ankle Proprioception

The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy volunteers immediately after its application and 48 hours later.

The investigators assessed Joint Position Sense (JPS) through the difference of error (DoE) and the deviation of the target angle (DTA). JPS was assessed before the Kinesio Tape (KT) was placed, immediately after and 48 hours later.

Eligibility Criteria:
Inclusion Criteria:

* Must be signed the informed consent
* Aged between 18 and 35 years
* Did not suffered from ankle or foot skin diseases
* Active dorsal/plantarflexion ARoM equal to or above 15º and inversion/eversion
* ARoM equal to or above 5º.

Exclusion Criteria:

* Traumatic, neurological or circulatory diseases diagnosed
* Joint laxity
* More than three ankle sprains in their lives or one in the last 12 months that required treatment and ankle or foot pain at the time of study enrolment in the non-dominant lower limb.
Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).

The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.

Eligibility Criteria:
Inclusion Criteria (Patient characteristics required for surrogate inclusion)

* age ≥18
* ≥10 days of mechanical ventilation interrupted by \<96 continuous hours of unassisted breathing (including invasive and non-invasive ventilation)
* no anticipation of imminent (24 hours) death or extubation by the attending.

Exclusion Criteria (Patient characteristics that will exclude surrogates from study enrollment):

* possession of decisional capacity
* no identifiable surrogate, surrogate is unavailable for study procedures such as interviews
* imminent organ transplantation
* chronic neuromuscular disease
* physician refuses permission to approach family and/or patient for consent
* admission for severe burns
* admission for high cervical spine injury
* ventilation for \>21 days.

Inclusion criteria for surrogate decision makers:

* age ≥18
* self-identified as participating directly in health care decision making for the incapable patient under relevant state law

Exclusion criteria for surrogate decision makers:

* do not personally know the patient
* need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)
* history of clinically important neurological disorder (e.g., dementia)
* patient dies after meeting inclusion criteria but before surrogates provide consent

Physician and nurse inclusion criteria:

* ICU attending or fellow (physicians) at the time of surrogate enrollment
* bedside ICU nurse present at the time of surrogate enrollment
Out-of-Hospital Resuscitation in Winterthur - an Outcome Study

The investigators will retrospectively examine all patients with out-of-hospital resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the year 2013 with a two year follow-up and a structured interview about Quality of life. Furthermore, the costs generated by the local health system are analysed.

The Primary objective of this study is to evaluate the Quality of out-of-Hospital resuscitation by the ambulance Service from the Kantonsspital Winterthur including a 2-year follow-up of the survivors. In this follow-up we evaluate the Quality of life by a validated questionnaire.

The following endpoints will be retrospectively analysed:

time-to-Response Interval; Initial cardiac rhythm; medications given; number of Defibrillations; return of spontaneous circulation, Overall costs for the local health System

Furthermore length of hospital-stay, survival until Hospital discharge, one-year survival, Quality of life two years after resuscitation and total costs will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with out-of-hospital resuscitation in Winterthur in the year 2013 and treatment by the emergency medical team from the Kantonsspital Winterthur
* Written informed consent of patients for structured interview

Exclusion Criteria:

* Patients with resuscitation but death on Scene
* no written informed consent from patients for structured interview
Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults

This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult 18-40 years of age
* In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
* RSV 'sero-low' from a pre-vaccination serum sample
* Signed informed consent form

Exclusion Criteria:

* Occupational or household exposure to children \< 5 years of age, or to immunocompromised individuals
* Prior receipt of an investigational RSV vaccine
* Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
* Any other reason the Investigator considers exclusionary
Increased Access to Emergency Contraceptive Pills

This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).

ECPs are a back-up contraceptive method indicated for prevention of pregnancy after sexual intercourse if a primary contraceptive method fails or is not used. This trial will determine how increased access to ECPs affects the probability of pregnancy and three STIs. The STIs tested in the study are chlamydia, gonorrhea, and trichomonas. The trial will also evaluate how ready access to ECPs influences contraceptive or STI-prevention behaviors, particularly use of ECPs themselves, use of condoms, and use of other contraceptive methods.

The trial will be conducted among about 1,490 young women in the United States at high risk for pregnancy and STIs. Sexually active women aged 14 to 24 years who use barrier methods of contraception, oral contraceptive pills, or no contraception will be enrolled. Each woman will be randomly assigned to either an Advance Provision group or a Standard Care group. In the Advance Provision group, women will be given a supply of ECPs free of charge to keep at home in case of need. In the Standard Care group, women will be counseled about ECPs and invited to come to the clinic to obtain them at usual clinic charges when necessary.

Participants will be seen for follow-up at Months 6 and 12. At each visit, participants will be asked about pregnancies, STIs, sexual activity, self-assessed STI and pregnancy risk, and use of ECPs and other contraceptive methods. A specimen will be obtained for chlamydia, gonorrhea, and trichomonas testing.

Eligibility Criteria:
Inclusion Criteria

* Sexual intercourse with a male partner at least twice in the month prior to study entry
* Does not desire pregnancy within 1 year of study entry
* 6 weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy
* Literate in English or Spanish

Exclusion Criteria

* Surgically sterilized or intends to become sterilized within 1 year of study entry
* Intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry
* Received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry
* Intends to use Lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry
* Intends to use partners' vasectomy as her method of contraception within 1 year of study entry
* Pregnant or breastfeeding
* Known or suspected infertility
* Previously participated in this study
* Planning to move out of the study area within 1 year of study entry
* Currently participating in another research study that would interfere with the conduct of this study