cyrilzakka/clinical-trials huggingface dataset:
Oncological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.

The primary purpose of this study is to compare the differences of oncological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effect of two different surgical methods on prognosis.

Transanal total mesorectal excision (taTME) is a new surgical procedure for total mesorectal excision (TME) by dissociating the mesorectum from the bottom through transanal endoscopic. The characteristics of TaTME are mainly summarized as transanal reverse operation, no auxiliary abdominal incision, complete mesorectal excision and specimen removal through the anus. So taTME is a natural orifice specimen extraction procedure (NOSES). However, similar to NOSES, the specific surgical approach to taTME surgery may raise oncological safety concerns. Due to the premature contact with the tumor, the squeezing of the tumor cannot be avoided during the operation. The tumor may also be squeezed when the specimen is removed through the anus, putting the tumor cells at risk of shedding into the abdominal and pelvic cavity.

Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to oncological in NOSES surgery, but there is a lack of prospective clinical studies on the issue of oncological diffusion during taTME surgery. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for oncological examination, to clarify the influence of the two different surgical methods on the intraoperative oncological diffusion. The purpose of this study was to clarify the effect of two different surgical methods on intraoperative tumor cell proliferation, and to compare the long-term oncological outcomes of the two surgical methods, so as to provide more evidence-based medical evidence for the safety of taTME surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primary rectal carcinoma
* Single lesion
* No metastasis

Exclusion Criteria:

* History of malignant tumors
* Acute bowel obstruction, bleeding or perforation
* Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
* Severe other contradictions of surgery
* Pregnant women will be excluded
Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

The purpose of the study is to evaluate whether it is advantageous for adolescents who have recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on the treatment a further 6 months or is it just as helpful to stop the medication after recovery.

The hypothesis is that adolescents with major depression who recover from the 6 to 12 week trial of citalopram will be less likely to have a recurrence of depression over a 6 month period if continued on the citalopram as compared to those who discontinue the medication.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major Depression.
* Age 13-18.
* A score of \> 16 on the 17 item Hamilton Depression Scale or a score of \> 12 on the 17 items plus a score of \>7 on the atypical items.
* Males and females.
* Outpatient at initiation of double blind treatment phase.
* Ability to give informed consent.

Exclusion Criteria:

* Past or current hypomanic or manic episode.
* Currently meets criteria for a Conduct Disorder.
* Current psychotic symptoms.
* Substance dependence in the last 3 months.
* Significant medical condition that would contraindicate the use of an antidepressant.
* Pregnancy
* Past treatment with Citalopram for major depression
Gene Transfer Clinical Trial for Krabbe Disease

This is a nonblinded, non-randomized dose escalation study of intravenous AAVrh10 after hematopoietic stem cell transplantation (HSCT) in which subjects will receive standard of care hematopoietic cell transplantation for Krabbe disease, followed by a single infusion of an adeno-associated virus gene therapy product. Extensive natural history subjects will be used to compare as control group.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of infantile Krabbe disease, characterized by the following criteria outlined below:

   * Galactocerebrosidase (GALC) activity levels in leukocytes compatible with the diagnosis of Krabbe disease; AND AT LEAST ONE OF THE FOLLOWING:
   * Elevated psychosine levels predictive of infantile disease onset by DBS; OR
   * Imaging or neurophysiological findings consistent with Krabbe disease (CSF, MRI, NCV, ABR); OR
   * Two GALC mutations predictive to result in infantile onset phenotype.
2. Age at the time of screening: 1 day to 12 months
3. Participant has been deemed eligible for treatment with HSCT (standard of care) and a fully myeloablative reduced intensity/toxicity conditioning regimen (RIC/RTC) is/has been used
4. Participant's parents or legal guardian consents to participate in the study and provides informed consent according to IRB guidelines prior to any study procedures being performed
5. Parent(s) and/or legal guardian able to comply with the clinical protocol
6. Participant must have adequate organ function at time of screening as measured by:

   * Creatinine ≤ 1.5x upper limit of age appropriate normal and creatinine clearance ≥ 60 mL/min/1.73 m2
   * Hepatic transaminases (ALT/AST) ≤ 2x age related upper limit of normal
   * Ejection fraction of \> 50% by echocardiogram or other appropriate study without evidence of pulmonary hypertension
   * Pulmonary evaluation testing demonstrating resting pulse oximeter \> 95% on room air
   * Coagulation tests within 110% of normal ranges for age. (PT/INR and PTT)

Exclusion Criteria:

1. History of prior treatment with a gene therapy product
2. Presence of major congenital anomaly or any other condition that affects neurodevelopmental function
3. Presence of any neurocognitive deficit or brain damage not attributable to Krabbe disease
4. Active aspiration
5. Signs of active infection or disease from cytomegalovirus, adenovirus or other viruses
6. HIV positive
7. Uncontrolled and progressive bacterial or fungal infection
8. Presence of any contraindication for MRI
9. Use of any investigational product prior to study enrollment or current enrollment in another study that involves clinical interventions
10. Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the PI, would preclude participation in the study
11. Ongoing veno-occlusive disease (VOD) as determined by liver ultrasound (moderate ascites and static or retrograde portal vein flow) the day before FBX-101 infusion.
Analysis of Hospitalizations One Year After Acts of CAG and PCI in the Aquitaine région - ACIRA Register Data Analysis

Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The aim of this study is to quantify the frequency and analyse the types of rehospitalizations and repeat revascularizations during one year after a PCI or a CAG. This information is needed to organize the health care pathway and to identify preventable rehospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in ACIRA Registry : All volunteer adults (≥ 18 years) and French resident patients who underwent PCI and CAG in the interventional cardiology hospitals in the Aquitaine region (France),
* Initial PCI or CAG performed from January 1, 2012 to December 31, 2013,
* Initial PCI or CAG performed in nine interventional cardiology hospitals in the Aquitaine region (France).

Exclusion Criteria:

* Patients who declined to take part of ACIRA Registry,
* Patients resident outside the Aquitaine region (France),
* Patients who died during the initial hospital stay,
* Patients hospitalized for a PCI or a CAG the month preceding the initial procedure including in the ACIRA-Rehosp study.
Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia

The aim of the study is to evaluate the use of Granulocyte Colony Stimulating Factor (GCSF) on the clinical and biochemical outcome of type 3 biliary atresia post kasai.

Biliary atresia (BA) is a devastating disease manifest early in infancy characterized by bile duct injury and extrahepatic biliary obstruction, leading to cirrhosis in the majority of infants.

Although BA is a rare disease, occurring in \~1 in 5600 to 1 in 18,000 infants worldwide, it is considered the most common indication for liver transplantation in children.

However, despite a 50-60% rate of initial jaundice clearance, liver transplantation by 2 years of age is necessary for long term survival in many of the post-Kasai patients.

GCSF cytokine that stimulates neutrophil and hematopoietic stem cell (HSC) production and mobilization from the bone marrow, and has served as a complementary agent to bone marrow stem cell therapy for patients with congenital or acquired diseases of bone marrow suppression.

Granulocyte colony-stimulating factor (G-CSF) mobilizes CD34+(cluster of differentiation34) cells, these CD34+ cells increase hepatocyte growth factor inducing the proliferation of hepatic progenitor cells within 7 days.

In experimental liver diseases of toxin-induced or bile duct ligation-induced liver injury, GCSF-based stem cell therapy has the same effects as direct HSC transplantation on improving liver regeneration and suppressing the inflammatory and fibrotic responses to hepatic injury. The cellular and molecular mechanisms are unknown but are postulated to be derived from the many paracrine actions of GCSF.

Eligibility Criteria:
Inclusion Criteria:

* Infants with initial diagnosis of biliary atresia with biliary atresia score \> 23.927 will be allocated for Kasai porto-enterostomy with intra-operative cholangiogram reaching type 3 biliary atresia anatomy as a final diagnosis.

Exclusion Criteria:

* Major cardiac, renal, pulmonary, neurological malformations or illnesses.
* Hemoglobinopathies, such as sickle cell anemia
* Active systemic infection.
* White blood cell count \> 20,000 cells/mm3.
* Platelet count \< 40,000 cells/mm3 or ≥ 800,000 cells/mm3.
* Purpura fulminans or unexplained vascular thrombotic conditions.
Is There Hearing Loss After Acute Mastoiditis

Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* History of acute mastoiditis 4 years and older

Exclusion Criteria:

* Younger than 4 years old Not cooperative for hearing test Active ear disease Major medical illness
Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children

This retrospective study investigated the influence of prior pulse dye laser (PDL) treatment on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.

The study population included patients without a history of PDL treatment and patients with a history of PDL treatment.

Background Hemoporfin-mediated photodynamic therapy (Hemoporfin-PDT) is considered a safe and effective treatment for port-wine stains (PWS). This study aims to investigate the influence of prior pulse dye laser (PDL) treatments history on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.

Methods Data was gathered for individuals with PWS aged 1-3 years who received two or more Hemoporfin-PDT treatments. The study population was stratified into two groups: Cohort 1 (No PDL) comprised patients without a history of PDL treatment, while Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment. An analysis was conducted to investigate the relationship between treatment efficacy and variables including gender, age, location, and type of PWS.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with PWS (Port Wine Stain) who were between 1 and 3 years old at the time of their first HMME-PDT treatment.

  * Patients who, after evaluation by a clinician, are deemed eligible for HMME-PDT treatment and whose guardians have signed an informed consent form.

    * Patients who have undergone two or more HMME-PDT treatments.

      ④ Patients with complete basic information and treatment-related information.

Exclusion Criteria:

* Exclusion of patients with syndromes associated with PWS.

  * Exclusion of patients with a history of treatments for PWS other than PDL treatment.

    * Patients with other vascular malformations. ④ Exclusion of patients who have received any other PWS treatment within 2 months prior to HMME-PDT treatment.
A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC

Low intensity, intermediate frequency (100-300 kHz) alternating electric fields, also known as Tumor Treating Fields (TTFields) were found to have a profound inhibitory effect on the growth rate of a variety of human cancer cells. Previous study showed anti-tumor activity in respect of melanoma, glioblastoma (GBM), breast carcinoma and NSCLC cell lines. This study aims to assess the impact of TTFields on NSCLC though the understanding of tumor evolution and peripheral lymphocytes activity and proliferation.

Concomitant to drug therapy, patients will receive treatment with Tumor Treating Fields (TTFields), generated by the medical device NovoTTF-200T with a recommended duration of minimum 18 h a day. TTFields administered using insulated transducer arrays applied to the skin surrounding the region of a malignant tumor.

50 patients will be recruited according to the study design in two cohorts and will receive TTFields therapy: Cohort A: Adult NSCLC EGFR positive mutation. Cohort B: Adult NSCLC patients to be treated with PD-1 inhibitors. The cohort A will focus on the clonal evolution in EGFR mutated lung cancer patients by using circulating tumor DNA (ctDNA) analysis of paired baseline and end-of-treatment (EOT) plasma samples. The cohort B will study the impact of TTField on the profile, activity, and proliferation of peripheral lymphocytes. Lymphocytes will be purified from whole blood samples for the profile, proliferation, and activity analyzed by FACS.

Treatment with TTFields will be administered until progressive disease, unacceptable toxicity1, withdrawal of consent or death. After the end of treatment, the patients will be followed until data cutoff date or 2 years after the last patient had entered the study.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years of age and older.
2. Have histologically or cytologically confirmed lung cancer.
3. Documented next generation sequencing assay performed on tumor sample in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory.
4. Have at least 1 measurable lesion per RECIST v1.1
5. Have life expectancy ≥3 months.
6. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Must provide a signed and dated informed consent indicating that the participants have been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
8. Have the willingness and ability to comply with scheduled visits and study procedures.
9. Cohort A, confirmed EGFR mutation.

Exclusion Criteria:

1. Implanted electronic devices (e.g. pacemaker) in the upper torso.
2. Have been diagnosed with another primary malignancy within the past 3 years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ or prostate cancer, which are allowed within 3 years).
3. Have any condition or illness that, in the opinion of the investigator, would compromise participants' safety or interfere with the evaluation.
4. Be pregnant or breastfeeding.
The Role of SCUBE-1 in Ischemia-reperfusion Injury

One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury. Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4 hours.

SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells, including endothelium and platelets. Immunohistochemical demonstration of subendothelial matrix deposition in atherosclerosis in humans. We did not find any study that showed the post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic events in the literature.

in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced by tourniquet application in knee prosthesis attempts in our aimed patients and compare this with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters

After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.

In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* knee replacement surgery
* using a pneumatic tourniquet

Exclusion Criteria:

* coronary artery disease
* renal disorders
* cognitive disorders
* bleeding diathesis
* who have passed general anesthesia
* anti-inflammatory drugs treatment
* abnormal HbA1c values
Allo-HSCT as First-line Consolidation in High-risk PTCL

Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.

After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI\>=0
* age \<= 60 years
* KPS\>=70

Exclusion Criteria:

* stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma
* HIV positivity
* major organ dysfunction
* pregnancy
* patient unable to give informed consent
A Biomarker Stress Test for Detection of Early Osteoarthritis

Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is common among Veterans and is a leading cause of disability. The earliest stages of OA development, where the joint cartilage wears away, is usually painless. By the time Veterans experience symptoms, the OA is typically advanced and there is nothing that can be done except palliation until the joint is replaced with metal and plastic. If there was a blood test to provide early warning of cartilage wear and joint deterioration, Veterans could potentially be treated early enough to slow down or even prevent OA. So far, development of such a blood test has proved elusive. The investigators propose a new method to amplify the signs of cartilage wear in the blood by challenging the affected joint with a walking task. Similar to a cardiac stress test, this walking challenge may help to separate joints at risk from healthy joints. The investigators will also see if this 'OA stress test' can show if a simple and inexpensive load-modifying shoe can improve joint health in Veterans with early knee OA.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* symptomatic medial compartment knee OA (KL grades 0-2)
* full weight-bearing status
* able to walk for 30 minutes or longer
* able to undergo MRI scan
* agreement and ability to use provided shoe as primary walking shoe (4 or more hours a day) during the 6 month study period

Exclusion Criteria:

* inflammatory arthritis, gout or recurrent pseudogout
* patellofemoral or lateral compartment disease that is equal to or more extensive than medial disease
* symptomatic OA of other lower extremity joints
* BMI \>35 kg/m2
* prior structural surgery of the knee except for medial meniscectomy performed \> 6 months prior
* use of shoe insert or hinged knee brace
* pes planus, and/or unusual foot size or shape