cyrilzakka/clinical-trials huggingface dataset:
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy:

The purpose of this randomized trial is to investigate the effect of the complete removal of pharmacological treatment in patients responding to cardiac resynchronization therapy with recuperated LVEF in terms of imaging parameters (changes in LVEF and LV volume), as well as, clinical parameters that translate into worsening of heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with a CRT device for at least one year due to the presence of LBBB and LVEF \<40% of non-ischemic origin
2. Current LVEF ≥50% and normal volumes in two consecutive echocardiographic studies, separated at least 3 months, and the last one performed in the previous 6 months.
3. Normally functioning CRT device with stimulation\> 95%.
4. NYHA functional class I-II.
5. Absence of admissions for HF in the last year.
6. NT-proBNP \<450pg/ml in sinus rhythm and \<900pg/ml in patients with atrial fibrillation, in the previous 6 months.
7. Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
8. Older than 18 years.
9. Patients who have given their informed consent in writing.

Exclusion Criteria:

1. Previous episode of sustained ventricular tachycardia/recovered sudden death/appropriate shock (in the case of a patient with an implantable cardioverter-defibrillator associated with CRT).
2. Uncontrolled arterial hypertension (figures\> 140/90 mmHg).
3. Need to use beta-blockers at the medical discretion for other indications such as heart rate (HR) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias.
4. Severe valve disease.
5. Diabetic or hypertensive with microalbuminuria or proteinuria.
6. Renal failure with creatinine clearance \<30ml/min/1.73m2.
7. Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
8. Patients are currently participating in a clinical trial or have participated in the past 30 days.
Efficacy of Myofascial Trigger Point Pressure Release on Tinnitus Patients

The objective of this study is to evaluate the efficacy of myofascial trigger (MTP) point deactivation for tinnitus control in a population with tinnitus and myofascial pain.

A double blind placebo control randomized clinical trial was made to verify the efficacy of the treatment by deactivation of MTP, after 10 sessions, in tinnitus patients by means of comparison with a placebo treatment in a control group. Patients with tinnitus and frequent regional pain for at least 3 months in the head, neck and shoulder girdle were investigated in the Tinnitus Research Group of University of São Paulo Medical School. All of them underwent an interview with the otolaryngologist ("physician researcher"), an audiologist evaluation ("blind researcher"), another blind researcher evaluation for tinnitus and pain and a physiotherapist evaluation and randomization. Both blind researchers evaluated tinnitus and pain in the first, fifth and tenth session. The real treatment was made by a gradual and persistent digital pressure in each MTP previously diagnosed by the blind researcher (8 possible muscles) and some home orientations that included stretch, superficial heat in each treated muscle and watch the correct postures during daily activities and sleeping. In the control group physiotherapist researcher pressed in an adjacent non-tender muscle fibers of the same muscle that have MTP. No other complementary orientation was done.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects of any gender, age and race with presence of uni or bilateral tinnitus for at least 3 months;
2. Presence of pain complaint for at least 3 months in head, neck and shoulder girdle areas
3. Presence of at least one myofascial trigger point (MTP) related with the patient's pain complaint (active MTP).

Exclusion Criteria:

1. Pain complaint involving three or more quadrants of the body, regardless of its cause
2. Infiltration and/or specific treatment for deactivation of MTP in the last 6 months;
3. Use of medications or other techniques to treat tinnitus, pain or muscle disorders during the previous last month;
4. Impossibility of understanding the orientation and/or giving information during MTP evaluation (neurological or psychiatric diseases, bilateral severe or profound hearing loss, etc);
5. Absence of tinnitus perception during evaluation;
6. Pulsatile tinnitus or myoclonus (middle ear muscles or palatal myoclonus).
7. Tinnitus due to certain etiologies that require other specific types of treatment, determined according to the medical evaluation.
Feasibility and Effects of a Pickleball Program for People With Parkinson Disease

Pickleball is a fast-growing sport that has been shown to improve social integration, life satisfaction, function, and cognitive function in older adults. Parkinson disease is a neurodegenerative disorder characterized by bradykinesia, rigidity, tremors, and postural instability. Exercise has been shown to improve physical and cognitive function in people with Parkinson disease (PD). The purpose of this study is to assess if a community pickleball program can be a feasible and effective for people living with PD.The primary aim of this study is to assess the feasibility of a group pickleball program for people with PD. Secondary aims is to assess the effects of a 6-week pickleball exercise program on balance, gait, cognition, upper extremity function, pain, and quality of life in people with PD. This will be a pre-test, post-test single-group, prospective, mixed-methods study with 1- month follow-up. Sixteen participants will be enrolled in a 6-week pickleball program, at a frequency of twice a week for one hour each session. Feasibility will be assessed by retention rates, adherence rates, resources, and number of adverse events. Quantitative data to be collected will include the Mini-BESTest, gait and body posture variables, Parkinson's Disease Questionnaire-8, the Shirt-Buttoning Task, 9 Hole Peg Test, grip strength, PD-Pain Classification System, and the National Institutes of Health Toolbox Cognition Battery. Additionally, participants will be scheduled for small semi-structured focus group interviews to gain qualitative data about their experiences of the program. It is hypothesized that a pickleball program for people living with PD will be a feasible activity and will result in improvements in balance, gait, cognition, upper extremity function, and quality of life. Additionally, it is hypothesized that participants will have a favorable opinion on the activity.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of idiopathic Parkinson disease, able to walk without an assistive device, and able to tolerate 45 minutes of activity with occasional seated rest.

Exclusion Criteria:

Diagnosis of any other neurologic disorder, any current illness, injury, or cognitive function that would prevent ability to perform the study tasks, and not regularly participating in pickleball (less than 3 times a month).
Real World Use of Emicizumab in Infants and Children Ages 0-3 Years With Hemophilia A

We have developed a questionnaire to elucidate the dosing, frequency and indication for the use of emicizumab in patients with Hemophilia A (mild, moderate or severe) ages 0-3 years. We are also collecting data on any pre-, peri and post surgical practices while on emicizumab. More importantly, we are asking if pediatricians are planning to introduce factor 8 to children who are already on emicizumab for primary prophylaxis as well as how and when they are planning to do so. We hope that this data will help inform understanding of current use of emicizumab in infants and young children as a form of primary prophylaxis, especially when venous access has historically been a limiting factor.

This will be a multi-institutional, retrospective review of pediatric patients ages 0 to 36 months of age who are currently receiving and/or have received emicizumab-kxwh as part of their treatment for hemophilia A with or without inhibitors. Participating sites are part of the New England Region (plus New Jersey and New York-Region II) of hemophilia treatment centers. Each institution will be contributing subjects who have been treated or who are currently being treated with emicizumab, from October 4th, 2018 up to the point of IRB approval. Additionally, each institution will determine the best way to identify eligible patients and keep track of patients enrolled in the study. The Children's Hospital at Montefiore will be the coordinating center.

Eligibility Criteria:
Inclusion Criteria: Patients must meet the following criteria for study entry:

* Patients who have been prescribed Emicizumab
* Patients who are 0-36 months of age at the time of starting treatment with Emicizumab
* Diagnosis of congenital mild, moderate or severe hemophilia with or without an inhibitor

Exclusion Criteria:

* Patients with acquired Hemophilia A
* Patients with Hemophilia A and another congenital or acquired bleeding disorder.
An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)

The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.


Eligibility Criteria:
Any patient who has used Raptiva within 6 weeks prior to conception or during her pregnancy may be included in the Registry. Enrollment is based on Raptiva exposure, whether inadvertent or deliberate, in relation to pregnancy. Enrollment should occur as early as possible during the pregnancy and must occur prior to knowledge of pregnancy outcome.
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma(NHL).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL
* Relapsed/refractory solid tumor or relapsed/refractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.
* At least one evaluable or measurable lesion (as defined in the protocol).
* ECOG Performance Status 0 or 1.
* Life expectancy ≥12 weeks.
* Adequate organ function (as defined in the protocol).
* Reproductive criteria (as defined in the protocol).

Exclusion Criteria:

* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.
* Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.
* Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).
* Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.
* History of a second malignancy within 2 years (as defined in the protocol).
* Active uncontrolled or symptomatic lung disease (as defined in the protocol).
* Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.
* Known or suspected hypersensitivity to study medications.
* Known active uncontrolled or symptomatic CNS metastases.
* The investigator determined that the patient should not participate in the study.
* Known mental illness or substance abuse that may disrupt therapy.
* Clinically significant cardiac abnormalities (as defined in the protocol).
* Gestating or Lactating women.
* Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose.
* The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.
The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease

The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life.

Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities

Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days

Eligibility Criteria:
Inclusion Criteria:

* aged over 65 years
* can walk independent

Exclusion Criteria:

* can't see
* have done any exercise in the last 6 months
* have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
* having non Alzheimer's disease dementia
Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I- II Patients
* Unilateral Inguinal Hernia Repair Surgery
* Elective Operations

Exclusion Criteria:

* Patients with a history of chronic pain
* Evidence of infection in the intervention area
* Allergy to local anesthetics
* Coagulopathy
* Body-mass index (BMI) ≥ 30
* Body weight ≤ 50 kg
* Patients who do not agree to participate in the study
A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway

The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2
* Age 18-75 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35
Efficacy and Safety of Purified Starch for Adhesion Prevention in Colorectal Surgery

Intra-abdominal adhesion occurs in up to 90% of patients after abdominal surgery. Many patient will undergo a second surgery for temporary stoma closure, therefore these ostomy closure operations can give an opportunity to evaluate adhesion caused by previous operations. This study was conducted to use second surgery to investigate the anti-adhesion effect of purified starch among patients who underwent colorectal surgery.

Data was analyzed from the medical records of patients who underwent a second surgery after colectomy between January 2020 and April 2022. Patient were allocated to either the purified starch group and control group. Since January 2020, adhesion scores have been registered in operation note when patients undergo a second colorectal surgery. The primary outcomes in this study were adhesion severity and adhesion area. The secondary outcomes were operation time, blood loss, and postopera-tive complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a second surgery after colorectal resection between January 2020 and April 2022 were enrolled into this study.

Exclusion Criteria:

* Patients who underwent a second surgery less than 1 month after the first colorectal resection or who developed peritoneum carcinomatosis in the second surgery and patients younger than 20 years were excluded.
Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.

This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma.
* Planned prostatectomy with lymph node dissection.
* Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors).
* Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
* Age \> 18.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
* Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
* Including focal ablation techniques (HiFu).
* Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities

To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

Current studies on seroconversion and the time course of immunity following exposure to SARS-CoV-2 do not document: i) Seroconversion in populations in repeated and frequent contact with patients; ii) The temporal dynamics of seroconversion at medium term. These two elements are however fundamental in the comprehension and management of this epidemic or of its potential resurgence in the following months and years.

Objective: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

Secondary objectives:

1. Determine the kinetics of the protective response over 12 months (4 times).
2. Compare immunization profiles according to: gender, age, lockdown, blood type, occupational class, exposure, asymptomatic/symptomatic.
3. Compare immunization kinetics between exposed and low-exposure hospital workers.
4. To determine the characteristics of the ELISA test in comparison with the reference test (seroneutralization).

Perspectives

* To provide a reliable, affordable and faster serological test.
* Understanding of the natural evolution of seroprotection in a population over time.
* Sensitization to plasma donation for seropositive patients.

Eligibility Criteria:
Inclusion Criteria:

Cohort of exposed hospital workers

- Hospital caregiver or non-clinician agreeing to participate in the study defined as: Healthcare personnel (physician, nurse, orderly, physical therapist, midwives) who have worked for a minimum of 2 weeks since March 1, 2020 in a care unit dedicated to the management of patients confirmed or suspected of COVID-19 infection, in the participating centers: intensive care units, emergency rooms, COVID-19 units;

* Staff (physician, technician) who have worked for a minimum of 2 weeks since March 1, 2020 in the AP-HM laboratories handling samples from patients confirmed or suspected of having COVID-19 infection
* Person affiliated to a social security system

Cohort of 'unexposed' hospital workers

* Hospital care worker (physician, nurse, orderly) willing to participate in the study who has not worked since March 1, 2020 in an intensive care unit or emergency department or other department dedicated to the management of patients confirmed or suspected of having COVID-19 infection.
* Person affiliated with a social security system

Exclusion Criteria:

* Hospital worker declining to participate If the hospital worker changes assignment after the first collection, he/she remains in the exposed cohort.
* Protected adult
* Person under legal guardianship or curatorship