cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Ultrasound in Bowel Deep Endometriosis

This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).

Bowel DIE is a severe form of endometriosis that often infiltrates the rectum and the sigmoid colon, requiring precise surgical techniques to achieve complete excision while minimizing unnecessary resections of healthy tissues and organs. Current preoperative imaging techniques, such as transvaginal ultrasound and magnetic resonance imaging, are often limited in their ability to assess lesion depth and extent in cases of severe pelvic anatomical distortion. Intraoperative ultrasound offers a real-time evaluation after rectal mobilization, allowing for a more accurate assessment of lesion location, depth, and bowel wall infiltration. The primary objectives are to evaluate the feasibility and accuracy of intraoperative ultrasound in detecting rectal and RSJ DIE nodules and to guide surgical decision-making. Secondary objectives include determining the impact of these techniques on surgical outcomes, postoperative pain management, and quality of life. The goal is to enhance surgical decision-making by accurately assessing lesion depth and location, potentially reducing unnecessary colorectal resections or avoiding inadvertent retention of endometrial nodules. Participants will complete health and pain questionnaires preoperatively and at 3, 6, and 12 months postoperatively, evaluating dysmenorrhea, dyspareunia, dyschezia, and quality of life using validated tools. The study will also document intraoperative findings, surgical decisions, complications, and postoperative outcomes. By combining IOTVUS and IOERUS with existing surgical approaches, this study seeks to establish these techniques as standard tools for improving surgical precision in bowel DIE cases. Results could provide valuable insights for tailoring interventions to patient-specific disease presentations, enhancing long-term management strategies.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, rectum, and/or sigmoid colon).
* Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).
* Planned postoperative follow-up for at least 12 months.
* Written informed consent provided before surgery.

Exclusion Criteria:

* Planned surgery for diagnostic purposes only.
* Pregnancy at the time of enrollment.
* Poor understanding of Spanish or English.
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.


Eligibility Criteria:
Inclusion Criteria:

* english speaking
* candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
* scheduled for surgery at Texas Sinus Institute

Exclusion Criteria:

* allergy to either NSAIDs or opioids
* contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
* surgical plan exceeding basic endoscopic sinus surgery
* use of anticoagulation
* the presence of any pain disorder
* the current usage of any analgesic medication
* history of opioid addiction
* pregnancy
* history of chronic pain or fibromyalgia
* current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer

This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed HER2-positive breast cancer
* Eligible to receive Herceptin as per Summary of Product Characteristics

Exclusion Criteria:

* Contra-indications according to Summary of Product Characteristics
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial

The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited.

The proposed research will systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services. The main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must speak and understand English.
* Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).
* Must not have a total smoking ban in their home.

Exclusion Criteria:

* Participants who are in immediate crisis
* Participants who are calling to be transferred to the TIERS program
* Participants who are homeless or facing homelessness
A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401

The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects.

This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged 18 to 65 years

Exclusion Criteria:

* Subjects with a clinically relevant medical history
CD19-CAR-T Cells in Patients With R/R B-ALL

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Primary objective:

To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.

Secondary objective:

To Assess the patient's quality of life after receiving the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
2. Age 3-70 years old;
3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
4. B cells are positive for CD19 expression;
5. Peripheral blood tumor cell load \<50%; 6. KPS score \>50 points;

7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

Exclusion Criteria:

1. Patients with non-B cell acute leukemia;
2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
3. Active infection;
4. Human immunodeficiency virus (HIV) positive;
5. Acute and chronic graft-versus-host disease (GVHD)\> Level 1；
6. Pregnant or lactating women;
7. Patients do not agree to use effective contraception during the treatment period and following 3 months;
8. Patients who participated in other clinical studies at the same time;
9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
10. Long-term use greater doses of hormones than physiological doses.
Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy

Although it is known that the functions of pulmonary and upper limb is affected in late stage of Duchenne Muscular Dystrophy (DMD) negatively, the investigators do not have clear information about its early stage. The aim of this study was to investigate the differences in pulmonary and upper limb functions between children with DMD in early stage and healthy peers.


Eligibility Criteria:
Inclusion Criteria:

children with DMD was;

* age between 5-10 years
* being on treatment with corticosteroids for more than 6 months
* being at Level I according to Brooke Upper and Lower Extremity Classification Systems

Healthy peers;

* age between 5-10 years
* not having any diagnosed disease

Exclusion Criteria:

• Children has undergo surgery and disease affect upper extremity or pulmonary function in last six months.
Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.

Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years.
* Diagnosis of resectable colon cancer with elective surgery.
* Participants have at least 2 weeks to their operation date.
* Agree to collaborate in the study and sign the informed consent

Exclusion Criteria:

* Diagnosis of unresectable colon cancer.
* Inability to follow the prehabilitation programme.
* Participants be able to understand written and spoken Spanish.
* Subjects with previous nutritional supplements.
* Pre-anesthetic evaluation with results, according to the classification of the American Society of Anesthesiologists (ASA) IV or V.
Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

In order to determine norm values for skeleton muscle disassembly due to physical exertion in healthy and trained population, and developing a prediction test for approval for rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of different physical tests.

50 healthy civilians volunteers will be recruited for this study. Each subject will undergo the physical tests: anthropometric measurements, wingate test, VO2max test, step test and running on the anaerobic threshold, on separate days. Blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test.

Eligibility Criteria:
Inclusion Criteria:

* healthy civilians ages 18-30.
* above average aerobic and anaerobic fitness.
* Without heart, cardiovascular, metabolic or respiratory illnesses.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* existence of any of undesired conditions detailed in the inclusion criteria.
* the physician decision.
Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)

This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years and above;
2. Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant non-small cell lung cancer and breast cancer patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
3. ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
4. Life expectancy greater than 3 months;
5. T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\*ULN, or AST and ALT≤5\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\*ULN#
6. Signed informed consent form# -

Exclusion Criteria:

1. Current pregnancy or lactation# 2. History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous system diseases or mental illness; 4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosis infection; 10. Other disorders with clinical significance according to the researcher's judgment.

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Relapse Prevention Study in Newly Abstinent Smokers

The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.

The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* has smoked at least 10 cigarettes a day for at least 2 years
* has had multiple previous attempts to quit smoking and relapsed to smoking.
* generally healthy

Exclusion Criteria:

* cannot be using smokeless tobacco of any type or has tried to quit with medicine.
* does not abuse alcohol or drugs
* certain emotional problems being treated with medications
* pregnant or breast feeding female
OptiVol® Care Pathway

Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States. The purpose of this clinical trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass Trends with OptiVol will shorten time to clinical action as compared to quarterly review.


Eligibility Criteria:
Inclusion Criteria:

* Subject (or subject's legally authorized representative) is willing and able to sign and date written consent form and Authorization for Access to and Use of Health Information
* Subject is at least 18 years of age
* Subject is willing and able to comply with Clinical Investigation Plan
* Subject is willing and able to transmit data using Medtronic CareLink® Network
* Subject has market released right atrial (RA) (if applicable), right ventricular (RV), and left ventricular (LV) (if applicable) leads and one of the following generators implanted: Concerto® CRT-D - Model C154DWK, Virtuoso® DR ICD - Model D154AWG, Virtuoso® VR ICD - Model D154VWC, Consulta™ CRT-D - Model D224TRK, Secura™ DR ICD - Model D224DRG, Secura™ VR ICD - Model D224VRC, or any future market released Medtronic generator with wireless telemetry, Cardiac Compass with OptiVol Fluid Status Monitoring, and that is supported by the Medtronic CareLink Network

Exclusion Criteria:

* Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
* Subject has life expectancy of less than 1 year
Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection

The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.


Eligibility Criteria:
Inclusion Criteria:

* patients having a mandibular osteomylelitis due to DENOSUMAB

Exclusion Criteria:

* none
Determination of the Nature of the Endogenous Ligand of TREM-1 and Its Use as a New Diagnostic Biomarker in Sepsis

Step 1: Identification and characterisation of the TREM1L protein from samples already available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalised in a Medical Intensive Care unit whatever the reason
* written informed consent obtained

Exclusion Criteria:

* patients less than 18 years old or under guardianship, persons without national health insurance.
Dose Tolerance Study in Healthy Male Volunteers After Intranasal Application of Epinastine Nasal

Safety, tolerability and pharmacokinetics


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca -Index)
* Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
* In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance
Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality

The aim of this study is to evaluate the effects of ergonomics training with exercises applied on factory workers with low back pain on pain, functionality, sleep and fatigue.

The study was planned as a randomized controlled trial. Workers between the ages of 18 and 60 working in a plastic casting factory in Gebze/Kocaeli with back and low back pain will be included in the study. Participants will be divided into two groups using a simple randomization method. Ergonomics training will be given to the first group together with core stabilization exercises; The second group will be given only ergonomics training. The exercises they will do will be explained to the participants individually and will be supported by an exercise brochure. Participants will be asked to do the given exercises 3 days a week and continue for 8 weeks. Follow-up of the given exercises will be done with the exercise follow-up chart. Persons with psychological or physical disabilities who can exercise regularly will not be included in the study. In order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill in this form. In order to collect data from the participants; "McGill Pain Questionnaire (Short)" and "Visual Analog Scale" to collect information on pain; "Fatigue Severity Scale" will be used to determine fatigue levels, "Pittsburgh Sleep Quality Questionnaire" will be used to determine sleep quality, and "Oswestry Low Back Pain Scale" will be used to evaluate functionality. The questionnaires will be repeated before and after the study. The data before and after the intervention will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18-65,
* Having low back pain in the last 3 months
* Visual Pain Scale (VAS) \>4
* No surgical intervention in the last 6 months,

Exclusion Criteria:

* Not being cooperative desk work
* Presence of psychological problems,
* Using sleeping pills
* Presence of neurological and orthopedic disease.