cyrilzakka/clinical-trials huggingface dataset:
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure

Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.

This is a prospective cohort study of 400 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic HF patients initiated on sacubitril/valsartan (N=200) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=200) but with background ACE/ARB therapy and (2) evaluate baseline and follow-up PROs via an electronic patient reported outcomes (ePRO) form in the eCOS database for 12 weeks.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of chronic systolic HF
* Active care by a provider in a healthcare system connected to a PCORnet data partner
* Ability to speak and read English (given the use of the English ePRO technology)
* Newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose)
* At least a 25% change ACE/ARB dose (including increase and decrease; or initiation or medication switching to another ACEI/ARB) in the last 6 months (comparator group only)
* Reliable access to the internet

Exclusion criteria:

* Inability to provide informed consent
* Life expectancy \< 6 months
* For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks

Other protocol inclusion/exclusion criteria may apply
PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia

The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* patients undergo hip surgery
* patients with contraindications at spinal anesthesia

Exclusion Criteria:

* allergy at local anesthetic
* age under 18 or weight under 30
Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).


Eligibility Criteria:
Inclusion Criteria:

* 18-70 year
* american society of anesthesiologist status 1-2
* elective general anesthesia

Exclusion Criteria:

* known or predicted difficult airway
* recent sore throat
* mouth opening less than 2.5 cm
* at risk of aspiration
The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane

The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.

It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.

The aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.

The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.

It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.

The aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.

The suggested study is a randomized controlled study. 500 patients older then 65 years undergoing elective non-cardiac major surgeries will be studied.

On the day prior to surgery the patient will take a series computerized cognitive tests (Mindstream® cognitive health assessment, neurotrax®, Modiin, Israel). At the holding area before entering the operating room (OR) the patients will be randomly assigned to one of two study groups.

Group 1 -IA: anesthesia will be maintained using Isoflurane carried by O2/air. Group 2 - TIVA : anesthesia will be maintained with propofol. The patients will be followed for 3 months post-operatively. Cognitive function will be assessed 7 days and 3 months postoperatively using computerized tests and telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Patients that refuse or unable to sign an informed consent

Exclusion Criteria:

* Patients with any unstable disease
* Patients treated with medication affecting the nervous system
* Patients with earring difficulty
* Patients that will not be able to participate in the study due to language barrier
HIV Education Kit for Adolescents (Pencegahan HIV di Kalangan Remaja), PREM-Kit

The goal of this community trial is to provide HIV education based on the newly developed HIV education kit (PREM-Kit) and evaluate the knowledge, attitude and practices related to HIV prevention among the late adolescents (aged 18 to 19 years old) in Malaysia. The main question it aims to answer is does the PREM-Kit improve the knowledge, attitude and practices related to HIV prevention among the adolescent?

Participants will be asked to:

* answer a questionnaire as a baseline screening to determine their knowledge, attitude and practices related to HIV prevention.
* Using PREM-Kit, they will participate in a series of health education sessions. There will be three sessions in total which will be delivered two weekly apart. Each of the sessions will take approximately 20 minutes duration.
* Following the last session (third session), participants will have to answer the same questionnaire ; once immediately after the last session, once at 3-months post-intervention, and lastly, at 4-months post-intervention.

Researchers will compare participants who received the existing Basic Science and Biology module to see if there is any improvement in the knowledge, attitude and practices related to HIV prevention.


Eligibility Criteria:
Inclusion Criteria:

* late adolescents aged 18 - 19 years
* student who attends Health Science Diploma course in the year 2023
* Malaysian citizen

Exclusion Criteria:

* student who refused to participate in the study
* student who is absent on the first session of the intervention
* student who does not understand the Malay language
Predict MDE Outcomes After MST

This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for major depressive episode. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).

Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).

Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 diagnosis of major depressive episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the HAMD-17 ≥ 24;
4. informed consent in written form.

Exclusion Criteria:

1. primary diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. Unremovable metal implants.
7. other conditions that investigators consider to be inappropriate to participate in this trial.
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.


Eligibility Criteria:
Inclusion Criteria:

* Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
* Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
* Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
* Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
* Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
* Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
* Patients with a known PALB2 mutation with one affected family member should be considered for screening.
* Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.

Exclusion Criteria:

* Not candidates for surgery
A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease

The investigational product is a specially formulated TCM and administered in the form of a capsule.

Basic pre-clinical studies have suggested that it may have good immunomodulating functions, increases the activities of T-cells, B-cells and NK cells, enhances mitochondrial antioxidant status on various tissues including brain tissues. Therefore, this formulation may have special values in improving symptoms in Parkinson's disease patients.

The purpose of the study is to determine the efficacy and safety of ViNeuro in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* A subject will be eligible for study participation if he/she meets all the following criteria:

  1. Age of at least 30 years
  2. Diagnosis of symptomatic, idiopathic Parkinson' disease using The United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria (Appendix 3 in the protocol)
  3. Stage 1-4 on the modified Hoehn and Yahr scale (Appendix 4 in the protocol)
  4. Possesses three of the four cardinal signs of Parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism
  5. If receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry
  6. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.

Exclusion Criteria:

* A subject will be excluded from the study if he/she meets any of the following criteria:

  1. Presence of atypical parkinsonian syndromes
  2. Dementia as defined by the Mini-Mental State Examination score (Appendix 5 in the protocol) of 22 or less
  3. Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
  4. Used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
  5. Used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-A inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
  6. Has history of receiving any neuroleptics
  7. Used alpha-methyldopa or flunarizine within 6 months of study entry
  8. Females who are pregnant or breastfeeding.
  9. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (Visit 1).
  10. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to screening of this study (Visit 1).
  11. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.


Eligibility Criteria:
Key Inclusion Criteria:

* Before Surgery:

  * Participant scheduled to undergo an abdominoplasty without collateral procedures
* After Surgery:

  * Participant is lucid and able to follow commands
  * All analgesic guidelines were followed during and after the abdominoplasty
  * Abdominoplasty procedure duration \<=3 hours without collateral procedures (for example., liposuction)

Key Exclusion Criteria

* Before Surgery:

  * Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
  * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug
* After Surgery:

  * Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
  * Participant had collateral procedures during the abdominoplasty

Other protocol defined Inclusion/Exclusion criteria may apply.
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.

Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade 3 or 4 shivering at the time of delivery then they will be enrolled in the study. Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine.

Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales.

* Grade 0: no shivering;
* Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group;
* Grade 3: visible muscle activity in more than one muscle group;
* Grade 4: gross muscle activity involving the whole body

Eligibility Criteria:
Inclusion Criteria:

* Women presenting for planned cesarean delivery.
* American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
* Singleton gestation in the 3rd trimester (28-42 weeks gestation).
* Spinal anesthesia technique Women presenting for planned cesarean delivery.
* American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
* Singleton gestation in the 3rd trimester (28-42 weeks gestation).
* Spinal anesthesia technique.

Exclusion Criteria:

* Any contraindication to spinal anesthesia technique.
* Allergy or intolerance to dexmedetomidine or clonidine.
* Oral temperature \< 36° Celsius prior to procedure.
* Unable to give personal consent.
* PPROM or concern for infection (e.g., chorioamnionitis).
* Conversion to General Anesthesia prior to randomization.
* Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.
Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent

ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium.

The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis.

The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis.

The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines.

In this study, the management and follow-up of patients :

* Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
* Are not modified in comparison with the usual follow-up, except for the performance of :

  * Collection of saliva
  * Completion of a self-questionnaire on symptom and quality-of-life.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 10 and 19 years,
* Patient over 18 or legal representatives of patient under 18 who has dated and signed the consent form,
* Patient with pelvic MRI available and conduct within 12 months prior to inclusion,
* Patient from one of the 3 study populations:

  * A formal endometriosis diagnosed by clinical examination and imaging or
  * With prescription for coelioscopy because of a discrepancy between clinical and radiological findings or
  * A surgical indication for a pathology of the small pelvis other than endometriosis, in adolescents with suspected endometriosis faced with symptoms suggestive (dysmenorrhea, chronic or cyclic pelvic pain, urinary disorders cycle-dependent)
* Patient affiliated to the healthcare system.

Exclusion Criteria:

* Known pregnancy in progress,
* Known infection with the human immunodeficiency virus (HIV),
* Personal history of cancer,
* Adolescent subject to a protective measure or placed adolescent,
* Adolescent or her legal representatives presenting important difficulties in reading French language,
* Patient or her legal representatives who have objected to the collection of her data,
* Patient participating in an interventional study with drug or medical device or in the exclusion period of an interventional study
* Patient who has participated or is participating in another study evaluating miRNA in endometriosis.
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

Neoadjuvant chemotherapy (NACT) in breast cancer is considered the \&#34;gold standard\&#34; for the treatment of locally advanced and inoperable malignancies.

In recent years, in view of the evidence gathered, it has also become a conventional treatment alternative for patients with operable disease who are possible candidates for adjuvant chemotherapy. NACT thus aims to reduce mortality and increase surgical options, while at the same time allowing in vivo chemosensitivity testing. In view of this, NACT represents the ideal setting for clinical and translational research, which nowadays also has to address the question of future treatment options.

It is indeed a source of lively debate whether chemotherapy should be considered the only possible treatment option for the patient.

This study falls into this context, the innovative aim of which is to demonstrate histologically with the use of VABB, the complete pathological response (pCR) and to avoid surgery.

The main aim of this study is to show that a non-surgical, radiotherapy-only treatment and follow-up approach is not inferior to a surgical approach for patients who have shown complete pathological response (pCR) following neoadjuvant chemotherapy (NACT), as confirmed through histological analysis of imaging-guided sampling.

Histology will be performed by sampling 4 grams of tissue by vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) by ultrasound guidance (on breast marker).

The hypothesis of the study is that the VAE/VABB will be used in patients with pCR at post-NACT imaging to demonstrate the absence of disease in the previous tumour bed and, accordingly, that the use of VAE/VABB with negative histology would lead to a gold standard of treatment without surgical overtreatment.

Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
* single lesion
* neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
* conservative surgery proposal
* M0
* tumour bed identified by breast markers placed in pre NACT by radiologist

Exclusion Criteria:

* Bilateral or multicentric tumour
* Presence of microcalcifications visualised on mammography
* Presence of associated DCIS
* Positive history of previous breast cancer
* Positive history of medical or psychiatric conditions preventing adherence to the protocol
* High risk patient