cyrilzakka/clinical-trials huggingface dataset:
Duloxetine for Major Depression in Peri-/Postmenopausal Women

The main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Women approaching menopause and during the post-menopausal years appear to be at greater risk for developing major depressive episodes. Moreover, this period in life has been associated with significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. In light of recent controversies involving the use of hormone therapies, most physicians and patients are seeking nonhormonal strategies to alleviate menopause-related physical and emotional complaints. Duloxetine has been shown to improve major depressive disorder (MDD) and menopause-related symptoms. To date, the effects of this agent on brain structure and functioning in midlife women with MDD have not been explored. The present study aims to investigate the effects of duloxetine on brain structure and functioning when used for the treatment of a major depressive episode in menopausal women using anatomical magnetic resonance imaging (MRI) and functional MRI (fMRI). In addition, the investigators will examine whether the impact of treatment with duloxetine on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.

Eligibility Criteria:
Inclusion Criteria:

* peri-/postmenopausal women, aged 40-60 year
* moderate to severe major depressive episode

Exclusion Criteria:

* DSM-IV Axis I diagnosis other than MDD
* contraindications to magnetic resonance imaging
* treatment-resistent
* previous failed treatment with duloxetine
* history of substance abuse or dependence in past year
* serious suicidal risk
* use of other psychotropic medications
* electroconvulsive therapy or transmagnetic stimulation in past year
* history of allergic reactions to duloxetine
* significant laboratory abnormalities at baseline
* severe hepatic impairment
* end stage renal disease and undergoing dialysis
* uncontrolled narrow-angle glaucoma
* uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration
ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

The study consisted of a 4-week Screening Period and a 26-week Randomized Treatment Period (Primary Evaluation Period). After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 4 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Treated with eculizumab for PNH for at least 6 months prior to Day 1.
3. Lactate dehydrogenase level ≤1.5 times the upper limit of normal (ULN) at screening.
4. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
5. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
6. Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
7. Willing and able to give written informed consent and comply with study visit schedule.

Exclusion Criteria:

1. History of bone marrow transplantation.
2. Body weight \<40 kilograms at screening.
3. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
4. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleeding, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, or coexisting chronic anemia unrelated to PNH).
5. Female participants who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1.
6. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study treatment on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E\*).
2. Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.

Exclusion Criteria:

1. Congenital brain anomaly identified on MRI.
2. History of systemic coagulopathy.
3. Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement

Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found a benefit from the ATO on postoperative rehabilitation and reduced length of hospitalization.

Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA during the PTH.

PTH remains a painful procedure and the occurrence of morphinic-related side effects in sometimes elderly patients is often observed.

The main objective of this study is to assess the feasibility of ATO in anterior hip replacement under general anesthesia with the primary endpoint of morphine consumption measured 24 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and 85
* ASA (American Society of Anesthesiology) I-III
* Total Hip Prosthesis programmed anteriorly
* Prior obtaining free and informed written consent .Affiliation or beneficiary of a social security scheme. Patients affiliated with or beneficiaries of a social security plan and not included in another trial.

Exclusion Criteria:

* Pregnant women or breastfeeding Spinal anesthesia Patient on long-term opiate Body Mass Index (BMI) - 20 or 45kg/m2 Incomprehension of the ENS scale Unaccompanied cardiac conduction disorder, Adam-Stokes syndrome Preoperative Spontaneous Cardiac Frequency - 40 beats/min Left ventricle ejection fraction - 40% Unpaired sleep apnea syndrome (OSA) Adult incompetent, adults under guardianship or curatorial or deprived of liberty Allergy to one of the protocol products or their excipients: levobupivacaine, paracetamol, pregabalin, ketoprofen, dexmedetomidine Paracetamol-specific contraindication: hepatocellular deficiency Ketoprofen-specific contraindications: creatinine clearance - 60ml/min, ATCD of perforated peptic ulcer, heart failure, progressive hemorrhage, asthma associated with ketoprofen use Contraindications to nefopam: symptomatic prostate disorders, angle-closing glaucoma, epilepsy Participation in another clinical study
Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.

To try to answer these many questions, the approach will be twofold: clinical and genetic.

* Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
* Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
* 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.

A blood sample (15 ml) will be performed at inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
* Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
* Late potentials ventricular analyzable.
* For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
* For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.

Exclusion Criteria:

* Impossibility to receive clear information (patient's intellectual default).
* Refusal to sign the informed consent for participation.
* Under protective measure of justice.
Effect of 8 Week Plyometric Training on Injury Prevention in Domestic Cricket Players

The study aims to find the effectiveness of plyometric training on injury prevention of domestic cricket players. Players will be taken from Chakwal and a well designed plyometric plan will be implied on them for 8 weeks. After that the results will be compared with the other group who did not get any plyometric training to see the effectiveness of the treatment plan.


Eligibility Criteria:
Inclusion Criteria:

* domestic cricket players between 18-25 years.
* actively engaged for more than 1 year

Exclusion Criteria:

* history of trauma/injury in last month
Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity

Exclusion Criteria:

* Children of less than 5 years old or more than 18 years
* Children for whom a draining renal biopsy is not or more indicated by néphrologues
* Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information
* Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.

The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in:

A-shortened duration of oxygen-dependence.

B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation \<90% during the nebulisation sessions.

C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents).

D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% during sleep.

Eligibility Criteria:
Inclusion Criteria:

* The parent or legal representative must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria:
* requires oxygen: SpO2 \<92% on room air (if CAS ≤ 4/10)

  * And / or CAS\> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care).

Exclusion Criteria:

* The patient is participating in another study
* The patients has already been included in this study a previous time
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The parent or legal representative refuses to sign the consent
* It is impossible to correctly inform the parent or legal representative
* The patient has a contra indication for a treatement used in this study
* Patient was born at \< 34 weeks of pregnancy or bronchdysplasic
* First or second episode of bronchiolitis
* Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive.
* Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV
* Patient with known congenital heart disease
* Patient with chronic respiratory disease other than asthma
* Patient with encephalopathy
* Patient with known immune deficiency
* CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% when asleep for at least 12h
Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.

A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* (1)Age from over 19 to under 74 years
* (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications
* (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs
* (5)American Society of Anesthesiology (ASA) score class I, II, or III
* (6)Written informed consent

Exclusion Criteria:

* (1)Women during pregnancy or breast-feeding
* (2)Severe mental disorder
* (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
* (5)History of unstable angina or myocardial infarction within the past six months
* (6)History of cerebrovascular accident within the past six months
* (7)History of continuous systematic administration of corticosteroids within one month
* (8)History of previous neoadjuvant chemotherapy or radiotherapy
* (9)T4b tumors
* (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
* (11)FEV1(Forced expiratory volume in one second)\<50% of predicted values
mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study

The aim of the study is to evaluate the effectiveness and implementation of the mobile health (mHealth)-assisted, person-centred care (PCC) self-care support programme for homebound older adults. The researcher will compare PCC approach to a conventional care provider-led model. Participants (n = 130) will receive the intervention of six bi-weekly WhatsApp video call sessions over three months with nurse case managers (NCMs).

This hybrid effectiveness-implementation, cluster-randomized controlled trial evaluates a mHealth-assisted, PCC self-care support programme for homebound older adults in Hong Kong. Participants (n = 130) receive six bi-weekly WhatsApp video call sessions with NCMs over three months. The study compares a PCC-based approach with a conventional provider-led model. Effectiveness outcomes include self-efficacy, functional independence, and psychosocial well-being. Implementation is assessed using the RE-AIM framework. Findings will inform scalable, digital health interventions for aging populations, improving functional independence, self-care engagement, and healthcare accessibility for homebound older adults.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older;
* Unable to leave home more than twice per week due to physical or functional health problems;
* Own and have basic proficiency in using a smartphone;
* Speak Cantonese;
* Indicate sufficient cognitive ability; and
* Be moderately frail or below.

Exclusion Criteria:

* Unable to hear, see, or communicate effectively;
* Be completely bed-bound; or
* Reside in an area without stable internet coverage.
A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults

The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.


Eligibility Criteria:
Inclusion Criteria:

* adults in the age of 21-50

Exclusion Criteria:

1. People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.
2. People for whom there is a contra-indication for consuming Ritalin.
3. Pregnant women and nursing women;
Clinical Utility Study for MyProstateScore+

This is a national-level research study of urologists. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive education materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility Criteria:
Inclusion Criteria:

* Board-certified urologists for at least two years
* Averaging at least 20 hours per week of clinical and patient care duties over the last six months
* Routinely evaluate patients at risk for prostate cancer in their practice
* Practicing in the U.S.
* English speaking
* Access to the internet
* Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

* Non-English speaking
* Unable to access the internet
* Not practicing in the U.S.
* Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
* Previous exposure to the MyProstateScore test
* Do not voluntarily consent to be in the study
Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer

This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.

Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.

After completion of treatment procedure, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven invasive breast cancer;
* received complete neoadjuvant chemotherapy and no treatment has been done before;
* surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
* pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.

Exclusion Criteria:

* not completing neoadjuvant chemoradiotherapy;
* not undergoing surgery at our hospital, or pCR was not assessed;
* lack of T2WI, or DWI or DCE-MRI data;
* insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
* had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.