cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

The purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma.

The issue of elective lymph node dissection (LND) in the management of melanoma patients with clinically negative nodes remains controversial. The concept of elective LND is attractive because it provides the opportunity to detect and remove occult micrometastases before they become clinically apparent. Numerous retrospective analyses have consistently shown a 15-20% long term survival advantage in patients undergoing elective LND who are found to have positive nodes, compared to those undergoing therapeutic LND for clinically positive nodes. The majority of patients undergoing elective LND however, do not have lymph node involvement, and the impact of removal of these negative nodes on the survival of these patients is unknown. The substantial morbidity of these procedures has led to the conduct of a number of important prospective randomized trials designed to define the impact of elective LND on the survival of patients with clinically node negative melanoma. In 1982, the World Health Organization reported on the end results of 553

The primary objective of this protocol is to establish the feasibility of lymph node mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to detect the sentinel node in patients at risk for regional lymph node metastasis from their primary melanoma.

Eligibility Criteria:
Inclusion Criteria:

* primary melanomas Clark III and Breslow thickness \> 1 mm, or Clark IV-V and any Breslow thickness
* clinically negative regional nodes

Exclusion Criteria:

* previous definitive wide local excision of the primary melanoma with skin graft
* an inflammatory lesion in the area of the primary melanoma that is likely to drain to the same nodal basin
* pregnancy
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

* Chinese women
* Age between 20 and 40 years.
* Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):

  1. Oligo- or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)
* At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.
* Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.

Exclusion Criteria:

* Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.
* Patients with known sever organ dysfunction or mental illness.
* Pregnancy, post-abortion or postpartum within the past 6 weeks.
* Breastfeeding within the last 6 months.
* Not willing to give written consent to the study.
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery

Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Females aged 18 years or older but not exceeding 80 years;
2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
5. ECOG Performance Status (PS) - 0 or 1;
6. Subjects voluntarily join this study and sign the informed consent form.

Exclusion Criteria:

a.Tumor-related symptoms and treatments

1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.

We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.

Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.

We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.

Eligibility Criteria:
Inclusion Criteria:

* hip fracture patient \> 50 years of age
* able to give consent (or proxy consent available)
* lives within health region
* no contraindications to bisphosphonate therapy

Exclusion Criteria:

* refuses to participate or consent
* dementia or delirium without a proxy consent available
* nursing home or longterm care
* pathologic fracture
* chronic glucocorticoid use
* already receiving prescription osteoporosis treatment (calcium and vitamin D do not preclude inclusion)
Screening for Frailty at Home

"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home.

It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "

Many tools to evaluate frailty have been developed. However, most are designed for use in the hospital setting, with the resultant drawback that they are not suitable for routine use in the community setting. A few tools have been developed for use in community-dwelling subjects, such as the Cardiovascular Health Study (CHS) developed by Fried from a cohort of subjects aged 65 and older; the Study of Osteoporotic Fractures (SOF); or the SHARE frailty instrument, developed in a cohort of the same name comprising subjects aged 50 years and older living at home. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home. It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument.

Eligibility Criteria:
Inclusion Criteria:

* Age: 65 years or more
* Living at home
* Able to read and understand French
* With a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale

Exclusion Criteria:

-
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old.
2. Histopathological diagnosis as FL Grade1, 2 or 3a
3. The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
4. Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements \> 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm.
5. Life expectancy ≥12 weeks.

Exclusion criteria:

1. Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
2. A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
3. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
4. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
5. pregnant or lactating women.
Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.

Functional electrical stimulation (FES) has been used for decades in rehabilitation centers. Having demonstrated efficacy for prevention of muscle atrophy following spinal cord injury (SCI), FES can also be considered for functional restoration of hand movements in the patients with complete tetraplegia belonging to group 0 or 1 of the classification of Giens. However, the majority of the systems using the FES directly stimulates the muscles (surface electrodes, intramuscular or epimysial), which increases the number of components and requires more electrical energy for the muscle activation. Nerve stimulation would activate more muscles through a reduced number of electrodes, limiting the number of internal components, reduces the risk of spreading infections and require less electrical energy for its operation.


Eligibility Criteria:
Inclusion Criteria:

1. Neurological level ≥ C7
2. 18 years old min and max 65 years old,
3. Complete traumatic injury: defined by A or B score on the AIS scale.
4. patient belonging to group 0 or 1 of the Giens classification.
5. neurological stability (no change in muscle testing)\> 6 months,
6. post-injury duration\> 6 months
7. Patients undergoing surgery to restore elbow extension.
8. threshold of stimulation and diffusion of the studied muscles below 50 mA of intensity for a pulse width of 300 μs and a frequency of 25 Hz.
9. positive electrical mapping of muscles with a minimum score of 4 MRC for at least one of the extensors (triceps, ECRL, ECRB, EDC, EPL) and / or flexor (FPL, FDS, FDP).

Exclusion Criteria:

* 1. strong spasticity and contractures in flexion or extension of the upper limbs.

  2. Unstable epilepsy. 3. Unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure etc.).

  4. wearing a pacemaker. 5. Dermatological problems contraindicate the application of surface electrodes.

  6. body weight\> 100kg
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)

The aim of Alizé is to describe a population of premature babies (gestational age (GA) \< 32 weeks) in real life situation and the management of RDS.

Description includes gestational age, birth clinical characteristics in particular the respiratory function, evaluation of the mother prenatal corticosteroids treatment in prophylaxis of RDS, mother medical and obstetric history, premature babies care in the delivery room with a special focus on the Curosurf use: prophylactic or curative use / other surfactant / no surfactant. A special focus is on the Prophylactic use.

Eligibility Criteria:
Inclusion Criteria:

* during the study, each neonatologist will have to include all the babies born with a gestational age \< 32 GA

Exclusion Criteria:

* gestational age \> 32 GA
* No consent to the data collection by one of the parents
Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best

Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.

A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.


Eligibility Criteria:
Inclusion Criteria:

* Type 1A endoleak after EVAR

Exclusion Criteria:

* no
Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.

Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

1. Single spinal cord injury lesion caused by trauma
2. Affected cord segments between C1 and T1, confirmed by magnetic resonance
3. Incomplete lesion (ASIA B, C or D)
4. Chronic disease state (between 1 and 5 years after the injury)
5. Patients from 18 to 70 years of age, both sexes
6. Life expectancy \> 2 years
7. Residence near the center during study participation and confidence that the patient will attend the follow-up visits
8. Given informed consent in writing
9. Patient is able to understand the study and its procedures

Exclusion Criteria:

1. Mechanic ventilation
2. Penetrating trauma affecting the spinal cord
3. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
4. Planned spinal surgery within subsequent 12 month after entering the trial
5. Neurodegenerative diseases
6. Significant abnormal laboratory tests that contraindicates patient's participation in the study
7. Neoplasia within the previous 5 years, or without complete remission
8. Patient with communication difficulties
9. Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
10. Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
11. Contraindication for lumbar punction
12. Contraindication or inability to follow a rehabilitation program
13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers

Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. Therefore, the resilience of family caregivers decreases and they feel burden.


Eligibility Criteria:
Inclusion Criteria:

* A family member who has been a primary caregiver for at least one year
* Literate
* Willingness to participate in the study

Exclusion Criteria:

* Have any communication disability
* Have any diagnosed physical or psychological disorder
* Receiving any supportive care
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability

The purpose of this research is to address the comparative effectiveness and harm of the therapeutics frequently given to pregnant women and their young infants including antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and steroids.

Our overall hypothesis is that the use of an existing electronic medical record with additional resources for precise data collection and 18 month follow up will successfully address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm.

We will use an existing electronic medical record into which detailed healthcare information is entered for over 100,000 newborns each year. These infants will comprise the "Source Cohort". Nested within that database, we will prospectively enroll 10% of the population (10,000 newborns) as the Follow-Up Cohort.

The current electronic medical record for the Source Cohort does not capture therapeutic dosing with sufficient precision to conduct comparative effectiveness research sufficient to change medical practice. The proposed research will: 1) ensure accurate data collection through electronic monitoring and real-time quality assurance evaluation in the Source Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and disability using an interactive web-based system, mail, telephone follow up, and in-person examination.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the a Pediatrix Medical Group NICU
* \<=5 days of life
* likely to follow-up at 18 months adjusted age

Exclusion Criteria:

* failure to consent
Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce

The purpose of this study is to investigate the effects of three different exercise programs (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on health-related physical fitness, biochemical variables and general health outcomes in high-risk employees, with about 2000 volunteers will participate in the randomized and repeated-measure study.

Exercise programs (e.g. low-intensity, medium-intensity, high-intensity) consist of aerobic workout, strength training and flexibility exercise, with different program has different intensity, volume, frequency and duration of exercise.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age

Exclusion Criteria:

* no diseases of musculoskeletal system
Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT

The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.

There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.


Eligibility Criteria:
IInclusion criteria:

1. Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
2. Adults \>18 years.
3. Systemically healthy.

Exclusion criteria:

1. Patients not indicated for orthognathic surgery.
2. Severe systemic disease.
3. Have a medical condition associated with systemic neuropathy (e.g. diabetes)
4. Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)
5. Are unwilling to sign informed consent.