cyrilzakka/clinical-trials huggingface dataset:
EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning

The objective of this protocol is to obtain on Parkinson's disease more accessible therapeutic targets than deep brain stimulation (HFS-STN), the neurosurgical treatment for this pathology. This study will pave the way for new forms of adaptive processing for the HFS-STN. It could become functionally coupled to a minimalist EEG centred on the motor cortex and to software for decoding, live or slightly delayed, classes of movements performed. On the one hand, this device could be used as a sensor of the quality of the information transmitted by the cortical network, thus allowing the selection of the optimal parameters of the HFS-STN on the basis of the movement decoding score. On the other hand, this device could lead to adapting the HFS-STN treatment over time by regularly calculating the recognition scores of the different movements performed and comparing them to the initial scores.

One of the therapies for Parkinson's disease, a condition affecting nearly 150,000 patients in France, is the invasive neurosurgical implantation of high-frequency deep brain stimulation of the subthalamic nuclei (HFS-STN). Although HFS-STN is very effective, the underlying mechanisms are still relatively poorly understood, particularly at the cortical level, a region that could become an alternative therapeutic target because it is easier to access. This study aims to measure the changes induced by the antiparkinsonian drug treatment and the HFS-STN on the encoding and transmission of motor information at the level of the motor cortex, thanks to the recording of the electroencephalogram of patients. These recordings, made during the performance of certain movements, will be subjected to an analysis using "machine learning" methods that will make it possible to decode the identity of the movement performed more or less efficiently.

Eligibility Criteria:
Inclusion Criteria:

Patients :

1. Patient over 18 years of age
2. Patient meeting the clinical diagnostic criteria for Parkinson's disease (Postuma et al, Mov Dis, 2015)
3. Signed consent to participate in the study
4. Absence of cognitive impairment (MoCA\>24)
5. Affiliation to a French social security scheme

Healthy volunteer :

1. Healthy volunteer over 18 years of age
2. Signed consent to participate in the study
3. Absence of cognitive disorders (MoCA\>24)
4. Affiliation to a French social security system

Exclusion Criteria:

Patients :

1. Patient refusal to participate
2. Pregnancy or breastfeeding in progress
3. Participation in another therapeutic interventional study
4. Patient under guardianship or curatorship
5. Person subject to a legal protection measure

Healthy volunteers :

1. Refusal of the healthy volunteer to participate
2. Pregnancy or breastfeeding in progress
3. Participation in another therapeutic interventional study.
4. Patient under guardianship or curatorship
5. Person subject to a legal protection measure
A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer.

This study has two (2) major parts:

Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51.

Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.

Former Sponsor 2seventy bio

Eligibility Criteria:
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
4. Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
5. Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
6. Expected survival ≥ 3 months

Key Exclusion Criteria:

1. Inadequate cardiovascular, renal and hepatic function, as described in the protocol
2. Absolute lymphocyte count (ALC) \< 100 cells/μL at time of leukapheresis
3. History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
4. Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
5. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
6. Treatment with any cellular or gene therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply
Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders

This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.

500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone （LH）level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.

The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)

Exclusion Criteria:

* a. History of repeated IVF failure (previous IVF cycle \>2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

A study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with Duspatalin® or Dicetel® in IBS patients.


Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)

Exclusion Criteria:

* Pregnancy and lactation
* Specific contraindications to mebeverine hydrochloride or pinaverium bromide
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who receive oral azacitidine according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea
* Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety
Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women

The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Purpose The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA) using VARIMAX rotation was conducted for all questionnaire items. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α). Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland), as well as open source R software (version 3.4.4).

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* patients with symptoms of urinary incontinence
* age 18-82 years

Exclusion Criteria:

* lack of consent
* inability to understand the study protocol
Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
* Body weight of 100-250 lbs
* Male or females
* 18-55 years of age

Exclusion Criteria:

* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide
Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery

Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Prucalopride, a selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing for preventing POI remains unclear. Higher doses may provide more potent prokinetic effects in the postoperative setting. his study investigates if higher doses of prucalopride (4 mg) improve bowel function return and hospital stay in elective colorectal surgery patients compared to standard doses and placebo.

Postoperative ileus (POI) is a common complication after abdominal surgery, particularly colorectal procedures, which can delay recovery and prolong hospital stay. POI is characterized by a transient cessation of coordinated bowel motility, leading to symptoms such as nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Effective management of POI remains challenging, with limited pharmacological options available. Prucalopride, a highly selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing of prucalopride for preventing POI remains unclear. Studies have shown dose-dependent improvements in outcomes with doses up to 4 mg daily. Higher doses may provide more potent prokinetic effects in the postoperative setting, but no studies have examined doses above 2 mg for prevention of POI in colorectal surgery. The purpose of this study is to determine if higher doses of prucalopride (4 mg) result in faster return of bowel function and shorter hospital stay compared to the standard dose (2 mg) and placebo in patients undergoing elective colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.

Exclusion Criteria:

* Emergency surgery
* Total colectomy
* Creation of a stoma
* Pre-existing gastrointestinal disorders
* Severe renal or hepatic impairment
* Known hypersensitivity to prucalopride.
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer

Retrospective cohort study used to analyze trends in minimally invasive versus open surgery in colorectal surgery, over time, in outcome in the laparoscopic, robotic and open surgery groups in patients receiving colorectal resections. Analysis will be performed using data collected through the American College of Surgeons (ACS) National Surgical Quality Improvement Project (NSQIP) database, a national database with deidentified data entered by trained nurse data reviewers.

Perioperative outcomes in patients undergoing laparoscopic compared to open surgery have been improving, and adoption of these procedures has rapidly escalated. Despite this, minimally invasive surgery in rectal cancer is more controversial now than ever before. While laparoscopy was initially limited to non-oncologic operations, it has been shown to produce equivalent oncologic outcomes as open surgery and is now a preferred technique for colon cancer resection. However, laparoscopy is technically challenging in the deep pelvis, and there is concern for adequate resection of rectal cancers.

Multiple clinical trials are ongoing to assess long-term oncologic outcomes in patients with laparoscopically-resected rectal cancers (ACOSOG, ALaCaRT, COLOR II, COREAN)1-4; yet, current data examining perioperative outcomes in these patients is limited.5,6 As there are conflicting conclusions between ongoing randomized control trials about the appropriateness of laparoscopic surgery for rectal cancers, knowledge about perioperative outcomes and trends in these outcomes over time may give surgeons more information to make clinical decisions. To address this gap, the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database was examined to determine the prevalence of laparoscopic surgery and 30-day outcomes over a ten-year period in patients undergoing open and laparoscopic surgery for rectal cancer.

Using the ACS-NSQIP database from 2005-2016, resections for rectal cancer will be studied. The proportion of laparoscopic versus open surgeries performed will be determined by year, and 16 30-day outcomes will be studied in each group. Outcomes include: death, cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism, venous thromboembolism, pneumonia, prolonged ventilation, superficial or deep incisional surgical site infection, organ space infection, renal insufficiency, acute renal failure, urinary tract infection, length of hospital stay, and operating room time. Multiple logistic regression will be utilized to determine the association between laparoscopic and open technique as well as odds of outcome over time.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Rectal Cancer

Exclusion Criteria:

* Emergency Surgery
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.

The study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (IPF).

Subjects will participate in one of two cohorts (Cohort 1 and Cohort 2). Cohort 1 will evaluate a 30 mg orvepitant dose and Cohort 2 the 10 mg dose. Within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (Treatment Period A) followed by the alternate treatment in Treatment Period B. There will be a wash-out period of 3 weeks between the two treatment periods. Subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort.

Subjects will enter a screening period of between 14 and 28 days to determine eligibility. Eligible subjects will be randomised at the Baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. There will be a total of 8 visits including the Screening, Baseline and final Follow-up visits.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
* FEV1/FVC ratio ≥0.65 at the screening visit
* Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit
* Arterial oxygen saturation on room air or oxygen ≥90% at Screening
* Life expectancy of at least 12 months
* Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening
* Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second week of the baseline assessment period

Key Exclusion Criteria:

* Recent respiratory tract infection (\<8 weeks prior to Screening)
* Recent acute exacerbation of IPF (\<8 weeks prior to Screening)
* Current smokers or ex-smokers with \<6 months' abstinence prior to Screening
* Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan
* Mean early morning cough scale score ≥5 and rest of the day cough scale score \<5 (after rounding) during the second week of the baseline assessment period (assessed at Visit 2)
* Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
Jump Start Plus COVID-19 Support

The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.


Eligibility Criteria:
Center Inclusion Criteria:

1. Have greater than 30 children ages 2- to 5-years old
2. Serve low-income families
3. Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White

Child Inclusion Criteria:

1. Child ages 2-5 years old
2. Child enrolled in a childcare center

Exclusion Criteria:

* Children with feeding tubes or those that bring their own meals.
Music Interventions for Patients Undergoing Hemodialysis

Fatigue is found to be one of the most persistent problems among patients in treatment with hemodialysis, and associated with impaired health-related quality of life. A few, non-randomized controlled trials have found positive effects on fatigue by offering pre-recorded music intra-dialytic, however, without conclusive results. So far, no studies have investigated the feasibility of integrating person-tailored live music interventions performed by professional musicians into a hemodialysis setting. This leaves a deficit in knowledge for intervention planning, understanding and effectiveness of live music on fatigue, wellbeing and feelings of meaningfulness in this group of patients.

Methods: A pilot randomized controlled trial combined with qualitative methods. The data collection will involve recruitment of 24 patients from an outpatient clinic over a six-week period. The patients will be randomized into either an intervention group or a control group. Patients in the intervention group will be offered a 30-minute session of patient-tailored live music intervention per week for six consecutive weeks. Patients in the control group will receive standard care.

Quantitative analysis on immediate post-dialysis fatigue (VAS), and long-term fatigue (MFI-20), anxiety, depression (HADS) and treatment satisfaction (VAS) will show the potential effectiveness of intervention. Qualitative analysis of informal-interviews (patients/staff), observational data (patients) and focus group interviews (staff/musicians) will explore an in-depth understanding of whether music will improve wellbeing and create feelings of meaningfulness among this group of patients as well as to assess feasibility acceptability among patients, musicians and staff.

Perspectives: This trial will ensure a firm methodological approach for the development of a future definitive randomized controlled trial of music intervention for fatigue reduction and wellbeing among hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Scheduled to receive hemodialysis treatment
* Able to understand written and spoken Danish

Exclusion Criteria:

* Deafness
* Severe mental illness
The Effects of Nutritional Intervention in Participants With Eating Disorders.

The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.

Analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) of participants with BED. This quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with Obesity and BED. The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (Body Image Scale - BSQ; Binge Eating Scale - BES; Quality of Life Scale - WHOQOL BREF). The meetings occurred from October to November 2023.

Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with BED who are available to participate

Exclusion Criteria:

* individuals without a diagnosis of BED who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires