cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Perfusion of Microvascular Free Flaps

The perfusion of microvascular free flaps is inevitable for completion of reconstruction in the head and neck area. In some patients microvascular anastomosis is impossible because of arteriosclerotic changes, different oncological interventions, and consecutive vessel depletion at the neck. The aim of the project is to establish an innovative system for extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is required for free flaps to survive and provide functional and aesthetic reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Vessel depleted neck
* defect in the head and neck area

Exclusion Criteria:

* active oncological disease
* vessels suitable for microvascular anastomosis and reconstruction
Clinical and MRI Finding of The Temporomandibular Joint Stuck Disk

the study aimed to evaluate the clinical and MRI finding of TMJ with stuck disk with predication of the risk factors

the study aimed to evaluate the clinical and MRI finding of TMJ with stuck disk with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility Criteria:
Inclusion Criteria:

* patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.

Exclusion Criteria:

* Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older.
* Ulcerative colitis described according to usual criteria.
* Refractoriness Ulcerative colitis or unefficient by using other therapy
* Signed informed consent form.

Exclusion Criteria:

* History of neoplasm or hematological disease
* Uncontrolled high blood pressure (\>180/110)
* Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
* Malignant ventricular arrythmia
* Deep venous thrombosis during the last 3 months
* Active bacterial infection
* Body mass index \> 35 Kg/m2
* Stroke or myocardial infarction during the last 3 months
Exploratory Study of Pagoclone in Men With Premature Ejaculation.

The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.

Eligibility Criteria:
Inclusion Criteria:

* A male regularly experiencing premature ejaculation
* 18 to 55 yrs old
* In a Stable relationship with one woman for at least 6 months
Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection

Intimate protections, designed to absorb menstrual flow during menstruation, are classified into two categories: internal intimate protections (tampon, menstrual cup) and external intimate protections (disposable or washable sanitary pads, panty liner, menstrual panty).

Recently, women's expectations have changed with a demand for transparency regarding intimate protection's composition and potential health risks.

The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. The cost of intimate protectioncould influence patient choice, as disposable sanitary pads are often less expensive.

The primary objective is to describe medical students 's intimate protection practices.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Medical student
* Aged more than 18
* Presenting menstrual cycles
* Agreeing to participate in the study

Exclusion Criteria:

- Aged less than 18
A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer

This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. Be able to provide fresh or archived tumour tissue.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. At least one measurable lesion according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
4. Subjects with active hepatitis B or active hepatitis C;
5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Investigation of Genetic Risk of Atrial Fibrillation

The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is responsible for substantial morbidity and mortality independent of associated heart disease or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains significantly associated with excess mortality rates. The current unsatisfactory treatment for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation. Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study. Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart failure were excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atrial fibirillation

Exclusion Criteria:

* coronary artery disease
* severe valvular heart disease
* cardiomyopathy
* heart failure
Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.

Patients with pelvic pain (VAS score≥4) and ultrasound diagnosis of endometrioma \> 4cm candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will undergo laparoscopical stripping technique; the other one will undergo laparoscopic aspiration and sclerotherapy using 95% ethanol.

The women will be introduced with both operative options and they will be informed about the randomization . After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), symptoms related to endometriosis (through VAS score), fertility history including any fertility treatment in the past and planned pregnancy after the operation.

The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a Nelathon catheter. Ethanol will be left in the cyst for 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.

The women will be followed at 1 , 3 , 6 and 12 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18-35 years old
* Women with ultrasound diagnosis of ovarian endometrioma ≥4cm (with or without deep infiltrating endometriosis)
* History of dysmenorrhea and/or chronic pelvic pain
* candidates for elective laparoscopy due to endometriosis.

Exclusion Criteria:

* - Previous surgery for ovarian endometriosis
* Evidence of premature ovarian failure (follicle stimulating hormone ≥40 international units/L)
* Endocrinal disorders that might affect ovarian function (e.g., polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia)
* Ultrasound suspicious of ovarian malignant disease according IOTA criteria
* endometrial cyst \< 4 cm. • ethanol sensitivity.
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE) satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria (Appendix B)
* Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis

Exclusion Criteria:

* Estimated glomerular filtration rate (GFR) less than or equal to (\<=) 30 milliliter per minute (mL/min) per 1.73 square meter (m\^2)
* Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment
* Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept.
* Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.
Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

Basilea provided expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib was ongoing.


Eligibility Criteria:
The following inclusion criteria were applied:

* all other treatment options had been exhausted
* patient was ineligible for any ongoing trials or was geographically inaccessible to trials including a trial with derazantinib
* there was a reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
* patient was willing and able to provide written informed consent
* if applicable, regulatory approval by the appropriate jurisdiction was obtained
Investigating How Childhood Tumours and Congenital Disease Develop

Every cell and every organ in the human body derives from a fertilised egg. As the fertilised egg divides, a human being develops and grows. The process of how the fertilised egg divides and forms a human being is very sophisticated and is directed by the genetic information, the DNA, that is present in every cell.

When errors, mutations, in the DNA code arise, the orderly process of human development can be disrupted. This can lead to the development of tumours during childhood and congenital diseases (that is, abnormalities that children are born with).

The aim of this study is to define exactly which DNA errors underpin childhood tumours and congenital diseases.

Cancers and some congenital anomalies are caused by changes (mutations) in the genetic code (DNA) of cells. The use of Next Generation Sequencing (NGS) has enabled the study of the genetic changes that underpin these diseases, genome wide and at base pair resolution.

A key question about the molecular pathogenesis of a range of childhood tumours and congenital anomalies that remains unanswered is the order in which the different mutations arise. To define the order in which mutations arise, the investigators will need to reconstruct the life history of individual tumours / anomalies. This can be achieved by segregating the major clone ('ancestral' cell) from sub-clones or by studying multiple areas from the same lesion. Although this approach allows timing of mutations to some degree, in childhood tumours and congenital lesions this approach is fundamentally limited by the inability to define embryonic mutations. The basis of the limitation is that the lesions in question is conventionally compared to the patient's germline (the genetic information they have from birth). In such a comparison embryonic mutations will be misclassified as either germline or somatic (acquired).

To overcome this limitation one would have to compare the lesion to the parental germline.

Thus, here this study proposes to perform the first NGS study of childhood tumours and congenital anomalies, focusing on defining the embryonic pathogenesis. A unique feature of this study will be that lesions will be compared to the parental germline to define embryonic mutations. A focus of the analysis will be to define order in which mutations arise.

Eligibility Criteria:
Inclusion Criteria:

* Presence of childhood tumour / congenital disease, or relative of participant with childhood tumour / congenital disease
* Sufficient \&#39;surplus to diagnostic/clinical use\&#39; tissue is available
* Child assent and parental/guardian consent obtained where applicable

Exclusion Criteria:

* Insufficient surplus tissue is available
Calgary Registry for Advanced and Therapeutic Endoscopy

The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multi-centre registry. The study population consists of consecutive adult ERCP patients from September 2018 to August 2022. Informed consent is acquired for each patient. All relevant pre-procedural, procedural, peri-procedural and post-procedural data are captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes are ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. This registry also serves as a secure data collection platform for several currently recruiting prospective studies and randomized trials.


Eligibility Criteria:
Inclusion Criteria:

* any standard indication for ERCP, in the absence of standard contraindications;
* age 18 years or over;
* ability and willingness to give informed consent to be included in the registry and/or to involvement in one (or more) prospective sub-studies, or accompaniment by a surrogate who is willing and able to provide consent.

Exclusion Criteria:

-none other than inverses of above.
Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound

The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt

Congenital Hydrocephalus is a very common congenital anomalie known as the abnormal accumulation of csf in the ventricles and subarachnoid spaces under high tension due to imbalance between synthesis and absorption of csf , The incidence of congenital hydrocephalus is higher in low income country than in high income countries Treatment options for hydrocephalus are multiple but the most common treatment option world wide is VP Shunt . Although, VP Shunt still has a high rate of failure as revisions are required in 30% - 40% of cases In Vp shunt insertion , the placement of ventricular catheter is done mainly by free hand technique but recently The trans fontanelle ultrasound guided placement of ventricular catheter become a standard technique in multiple centers The free hand technique has low accuracy rate in proper intraventricular placement of the proximal catheter than the ultrasound guided technique . On the other hand , the use of intra operative ultrasound can visualize the anatomy of lateral ventricles and choroid plexus which makes the placement of ventricular catheter more accurate than the blind free hand technique So we are aiming in this study to highlight the efficacy of ultrasound guided placement of ventricular catheter of the frontal shunt in decreasing the rate of proximal catheter obstruction and we choose the frontal shunt because it has an advantage over the occipital in rate of revisions as it has a lower rate

Eligibility Criteria:
Inclusion Criteria:

* patients who are diagnosed with congenital Hydrocephalus
* age of patients : \< 2 years with patent Anterior Fontanelle
* Not operated with frontal shunt before

Exclusion Criteria:

* patients who are diagnosed with congenital Hydrocephalus
* age of patients : \< 2 years with patent Anterior Fontanelle
* Not operated with frontal shunt before
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in 652 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants were randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib was open label.

Eligibility Criteria:
Key Inclusion Criteria

1. Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
2. CLL/SLL requiring treatment per 2008 IWCLL criteria
3. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
4. Measurable disease by computerized tomography (CT)/magnetic resonance imaging (MRI)
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
6. Life expectancy ≥ 6 months
7. Adequate bone marrow function
8. Adequate renal and hepatic function

Key Exclusion Criteria

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Clinically significant cardiovascular disease.
3. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast
4. History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
6. Severe or debilitating pulmonary disease
7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
8. Known central nervous system involvement by leukemia or lymphoma
9. Known infection with HIV or active viral hepatitis B or C infection
10. Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
11. Major surgery within 4 weeks of the first dose of study drug
12. Prior treatment with a (Burton's Kinase) BTK inhibitor
13. Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
14. Pregnant or lactating women
15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
16. Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
17. Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.