cyrilzakka/clinical-trials huggingface dataset:
Study of Physiological Signals During and After COPD Exacerbations

Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.

Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.

Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged.

Setting : 4 investigative centers across Brittany

Patients : 50 patients will be enrolled in the study


Eligibility Criteria:
Inclusion Criteria:

* patient known or suspected to suffer from COPD
* patient admitted in pulmonology unit for COPD exacerbation
* patient accepting to use BORA Band during and after hospitalization
* patient accepting to be followed by the partner health care provider for this study (Air de Bretagne)
* patient able to understand French and express their informed consent
* patient affiliated to social security

Exclusion Criteria:

* patient is intubated
* patient already followed by a health care provider other than Air de Bretagne
* investigator assesses that the patient will have difficulties following the protocol
* patient already enrolled in another interventional study
Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma.

The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).


Eligibility Criteria:
Key Inclusion Criteria:

* Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
* Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate organ and bone marrow function

Key Exclusion Criteria:

* Prior treatment with any LAG-3 targeting biologic or small molecule
* Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
* Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease
* Corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
* Myocardial infarction within 6 months

Note: Other protocol defined Inclusion / Exclusion criteria apply
Locally Advanced Rectal Cancer - Exfoliated Peritoneal Tumor Cells

During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the time of surgery might therefore be of value for prediction of disease recurrence with subsequent prognostic implications for these patients. In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.

The investigators recently published a study investigating the incidence of exfoliated cancer cells in peritoneal lavage fluid after resection of locally advanced rectal cancer (LARC). DNA isolated from cells obtained by peritoneal lavage was analyzed by denaturing capillary electrophoresis with respect to mutations in hotspots of the K-RAS gene. This gene is mutated in 30% of rectal tumors. Exfoliated tumor cells (as assessed by the presence of mutated DNA) were found in lavage fluid from 19/237 of the patients, and the presence of tumor cells was associated with poor overall survival. Based on these encouraging results the investigators have designed a more comprehensive prospective study, using a novel, validated set of cancer specific DNA methylation - based biomarkers present in the vast majority of all colorectal tumors (sensitivity 94%, specificity 98%).Using these tumor cell associated biomarkers, the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC. Lavage will be performed prior to and after manipulation of the tumor to provide data regarding both spontaneous and iatrogenic tumor cell exfoliation and their respective contribution to patient outcome. If detection of exfoliated tumor cells is predictive of tumor recurrence, this would support an active approach to postoperative chemotherapy, possibly in the form of intraperitoneal chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Norwegian Radium Hospital.
* age \> 18 years
* written informed consent

Exclusion criteria:

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Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter.

This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 - 65 years of age;
2. First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
3. Requiring at least 3 months dialysis catheter usage
4. No clinical or radiographic evidence of superior vena cava (SVC) narrowing
5. Patent right internal or external jugular vein
6. Willing to provide the dialysis center information for F/U
7. No known diagnosis of hypercoagulopathy

Exclusion Criteria:

1. Short term catheter usage plan (\< 1 months)
2. No right jugular venous access
3. Catheter use for bone marrow transplant or plasmapheresis
A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma

The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18-70 years (inclusive);
2. Histologically confirmed peripheral T-cell lymphoma;
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1;
4. Life expectancy ≥ 12 weeks;
5. Have measurable lesions ;
6. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures.

Exclusion Criteria:

1. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug;
2. Known active HBV or HCV infection;
3. History of clinically significant cardiovascular disease;
4. History of other malignancies within 5 years;
5. Pregnant or lactating women;
6. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination.
Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment

This study evaluated the effectiveness of an online psycho-education program offered in addition to routine care for individuals attending a smoking cessation clinic. Conducted as a randomized controlled trial, the study assigned 103 participants to the intervention group and 105 to the control group. Based on follow-up data, analyses were carried out with 37 participants from the intervention group and 24 from the control group. Primary Hypotheses

Among individuals who applied to the Smoking Cessation Outpatient Clinic at the Institute on Drug Abuse, Toxicology, and Pharmaceutical Science, Ege University, those who receive additional online psychoeducational support integrated into the outpatient service are expected to:

H1: Be more successful in quitting smoking compared to those who do not receive this support.

H2: Be more successful in reducing the number of cigarettes smoked per day. H3: Show a significant change in their level of nicotine dependence.

Secondary Hypotheses H4: Show significant progress in the stages of change regarding smoking behavior.

H5: Show significant improvement in their mental well-being.

Abstract Determination of Effectiveness of Online Psycho-education Embedded in Routine Service Delivery for Smoking Cessation: a Randomized Controlled Trial Objective: This study aims to evaluate the effectiveness of online psychoeducation provided in addition to routine treatment in a smoking cessation clinic compared to routine treatment alone.

Method: The study is a single-center, single-blind, randomized controlled experimental trial conducted between May 2024 and January 2025 at the Smoking Cessation Clinic of the Ege University Institute on Substance Abuse, Toxicology, and Pharmaceutical Sciences. Participants were randomly assigned to the intervention (n=103) and control (n=105) groups in a 1:1 ratio. During the study, the Warwick-Edinburgh Mental Well-being Scale Short Form (WEMWBS-SF), the Fagerström Nicotine Dependence Test (FNBT), and a case information form including HAPA stages of change were administered. The primary outcomes of this study are cigarette consumption, FNBT score, and smoking cessation success. The secondary outcomes include the HAPA stage of change and mental well-being score. Confounding variables considered in the study include education level, age, gender, employment status, mental health issues, marital status, and smoking cessation attempt. Based on follow-up data, analyses were conducted using data from 37 participants in the intervention group and 24 in the control group. Data analysis included paired and independent samples t-tests, chi-square analysis, one-way ANOVA, and linear and logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* using internet
* being a volunteer

Exclusion Criteria:

* not using internet
* not being a volunteer
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing their first kidney transplant
* Male or female age 18 to 65 years

Exclusion Criteria:

* Patients in need of second kidney transplant or multi-organ transplants.
Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

This is a study that aims to demonstrate the non-inferiority of minimally invasive surgery versus open surgery, as an approach for patients with advanced ovarian cancer who received neoadjuvant chemotherapy, giving them the benefits of laparoscopic surgery. This way they can continue with their complementary treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epithelial ovarian cancer (all subtypes of epithelial ovarian cancer) in stage III-IV
* Partial and complete response to treatment with QTNA after 3-4 cycles, evaluated by PET-CT imaging study, patients that the functional unit decides to incorporate into the project.
* Ca 125 which will have to be less than 200
* ECOG 0 to 2 without medical contraindication to perform surgery (≤ ASA 2 or ≤ Goldman 2).

Exclusion Criteria:

* Partial response with persistence of ascites or pleural effusion.
* With unresectability criteria (multiple intrahepatic liver metastases, retroperitoneal lymph node conglomerates \>2cm above the renal lymph nodes, metastatic disease above the diaphragm, multiple intestinal involvement and mesentery retraction).
Turkish of the Acupuncture Readiness Attitude Scale

Objectives: Acupuncture is often used to promote health and well-being, relieve pain, and treat a variety of medical conditions. Acupuncture is believed to work by stimulating the body's natural healing processes, and it is important that individuals are prepared to receive acupuncture. The study aims to examine the Turkish validity and reliability of the Acupuncture Readiness Attitude Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.

Design: The study was methodological type. Methods: The study conducted between Aug 9 and December 30, 2024, with 510 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Acupuncture Readiness Attitude Scale.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are over the age of 18,
* Live in Turkey,
* Use social media, and agree to participate in the study will be included in the study.

Exclusion Criteria:

* Women who do not know how to read or write Turkish,
* Have hearing or vision problems or mental disabilities,
* Do not have social media,
* Do not volunteer to participate in the study will not be included in the study.
Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors

This study aims to work out the effectiveness (effect size) of the musical training intervention in reducing depressive symptoms, improving self-esteem and quality of life among childhood brain tumour survivors and to examine the feasibility, appropriateness, and acceptability of implementing musical training intervention in clinical practice. Subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), while those in the control group will receive usual care.

Musical training has been increasingly implemented to promote one's psychological well-being and cognitive functioning. For instance, to reduce depression, anxiety in psychiatric patients, to improve self-esteem and mood recognition in hospitalized adolescent patients diagnosed with "adjustment reaction to adolescence", to improve social skills of children with autism, to enhance reading skills and academic achievement in young poor readers, and to facilitate children's cognitive development. Nevertheless, the effectiveness of musical training in promoting psychological well-being, particularly to reduce their depressive symptoms and enhance self-esteem, and enhancing quality of life among the childhood brain tumour survivors is remain underexplored. It is of paramount importance to examine the effectiveness of musical training so as to ameliorate adverse disease- and treatment-related late effects, such as depression and low self-esteem, hence enhancing childhood brain tumour survivors' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese children surviving from brain tumours with the Modified Mini-Mental Scale (MMSE) score of 18 or above
* be aged between 7 and 16 years
* able to speak Cantonese and read Chinese
* have completed treatment for at least two months
* have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)

Exclusion Criteria:

* children who have undertaken any musical training following their cancer diagnosis
* survivors with evidence of recurrence or second malignancies
* survivors receiving palliative care
Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients

Painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.The diagnosis and treatment time of endoscopic examination is short, and the transport is fast. Anesthesia related wind such as deep breathing depression and hypoxemia will occurRisks.Eeg depth monitoring can assist anesthesiologists to evaluate the depth of anesthesia and reduce the risk. Artificial intelligence is adopted.There are few reports on the evaluation of anesthesia depth and drug dosage by electroencephalogram (EEG) monitoring in outpatient patients with painless gastroenteroscopy.

1.examination, and establish brainClassification model of electrogram and sedation depth;2. The EEG characteristics, basic information and propofol were administered to all patients.The dose model of propofol painless gastroenteroscopy was established by machine learning to guide anesthesia Drug use;3. Evaluate the time and space complexity of the model, build the model, and assist the anesthesiologist to individualize the patient Chemical, safe and comfortable management.

Eligibility Criteria:
Inclusion Criteria:

1. Painless gastroenteroscopy patients
2. ASA classification is Ⅰ-Ⅱ
3. Patients who are willing to cooperate
4. No schizophrenia,epilepsy and other neurological diseases

Exclusion Criteria:

1. allergic to propofol
2. Patients who are unwilling to cooperate
3. Patients with psychiatric disorders
4. Patients using sedative drugs for a long time
5. Patients with neuropsychiatric disorders
6. Patients with severe heart, liver, kidney and respiratory diseases
An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
* Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Exclusion Criteria:

* Severe hypertension
* History of angioedema, drug-related or otherwise, as reported by the patient.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
* History or evidence of a secondary form of hypertension.
* Other protocol-defined inclusion/exclusion criteria may apply
Pilot Pharmacokinetic Study of a Prolonged-release Formulation of St. John's Wort Extract Ze 117

A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male volunteers
* Physically and mentally healthy as judged by means of a medical and standard laboratory examination
* BMI of between 19 and 29 kg/m2, inclusively
* Weight not exceeding 90 kg
* Non-smokers (confirmed by urine cotinine test)
* Informed cConsent as documented by signature

Exclusion Criteria:

* Known or suspected hypersensitivity to any ingredient of the investigational medicinal product
* Any clinically significant illnesses or clinically significant surgery within 1 year prior to the administration of the study medication
* Any surgical or medical condition which might interfere with absorption, distribution, metabolism or excretion of the drug
* Any clinically significant abnormality or abnormal laboratory test results, as judged by the investigator found during the medical screening
* Positive test of hepatitis B, hepatitis C or HIV screening (HIV antibody, Hepatitis B (HBsAg), Hepatitis C (HCV)
* ECG abnormalities (clinical significant) or vital signs abnormalities (systolic blood pressure lower than 90 or over 145 mmHg, diastolic blood pressure lower than 60 or over 95 mmHg, or heart rate less than 45 or over 100bpm) at screening
* History of asthma or obstructive pulmonary disease (e.g.COPD)
* Known photohypersensitivity.
* Presents or history of alcohol dependence within the last year (\> 40 g ethanol/d or more than 10 units per weeks (1unit=150 ml of wine or 360 ml of beer or 45 ml alcohol 45%))
* History of drug dependence or positive results of drug screen
* Concomitant participation in another clinical trial within the 4 weeks prior to the planned first drug administration.
* Donation of blood or blood products within 30 days prior to the planned first drug administration.
* Treatment with any medication or topical drugs with systemic action used in the past 4 weeks, prior to the planned first drug administration ,or 6 times the half-life of the respective drug, whatever is longer (excluding single use of paracetamol or ibuprofen up to 24 hours prior to the planned first drug administration).
* Suspected inability, e.g. language problems, or known or suspected non-compliance, e.g. non-willingness to fulfil the dietary restrictions
* Difficulty to swallow study medication
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Any reason which, in the opinion of the Investigator, would prevent the subject from participating the study
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids

This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.

The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population


Eligibility Criteria:
Inclusion Criteria:

- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.

Exclusion Criteria:

* Patient is pregnant or plans to become pregnant in the next 3 months,
* Patient is breastfeeding,
* Patient has genital bleeding of unknown etiology or not due to uterine fibroids,
* Patient has been diagnosed with uterine, cervical, ovarian or breast cancer,
* Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment,
* Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients