cyrilzakka/clinical-trials huggingface dataset:
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.

Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.

Study design :

* Prospective, randomized, multi-center study
* A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.
* Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.
* Patients will be followed clinically for 1 year after the procedure.
* Angiographic or CT follow-up will be performed at 1 year.


Eligibility Criteria:
Inclusion Criteria:

Clinical criteria:

1. Age 20 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4 or 5)
3. Patients with signed informed consent

Anatomical criteria:

1. Target lesion length ≥80 mm by angiographic estimation
2. Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria:

Clinical criteria

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Major bleeding history within prior 2 months
4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
5. Age \> 85 years
6. Severe hepatic dysfunction (\> 3 times normal reference values)
7. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity

Angiographic criteria

1. Previous bypass surgery or stenting of the superficial femoral artery
2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
Human Chorionic Gonadotrophin & Trigger

In women being treated with medicines to help eggs to grow (called ovulation induction), The investigators wish to know whether adding medicines (called ovulation triggers) that help to release the egg (ovulation) would lead to more women having babies without causing harm compared with not giving them ovulation triggers.

Women will be treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the investigators tried to determine the benefits and harms of administering an ovulation trigger to anovulatory women receiving treatment with ovulation-inducing agents in comparison with spontaneous ovulation following ovulation induction. so we will have comparison between 2 groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.

Eligibility Criteria:
Inclusion Criteria:

1. Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )
2. Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6 months) or amenorrhea (bleeding interval more than 6 months)
3. Age 18-40 years
4. Duration of primary infertility more than2 years
5. No history of ovulation induction treatment
6. No history of thyroid disease
7. Normal results on hysterosalpingogram
8. Husband with normal semen analysis

   -

Exclusion Criteria:

1. Ovarian cyst
2. Endometrioma
3. Liver disease
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia

This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over,
* With isolated high-grade vulvar intraepithelial neoplasia OR associated with invasive cancer proven histologically by biopsy
* Naive of any vulvovaginal treatment (surgery or radiotherapy)
* No metastases
* WHO \<or equal to 3
* Contraception method for women of childbearing potential
* Patient affiliated to the social security scheme
* Patient who understood, signed and dated the information note and the
* consent form,
* Patient able and willing to follow all study procedures in accordance with the protocol.

Exclusion Criteria:

* History of hypersensitivity to the active substance methyl aminolevulinate or to any of the components of the drug (including peanut oil and refined almond oil), soybean or peanut
* Ulceration or hyperpigmented lesions of the vulva
* Patient with porphyria
* Any previous vulvovaginal treatment (surgery or radiotherapy)
* Metastatic disease
* Patient undergoing treatment for any other invasive cancer
* Pregnant, likely to be or breastfeeding patient
* Patient deprived of liberty or under guardianship (including guardianship)
* Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons.
* Patient already included in another therapeutic trial with an experimental molecule,
* Associated pathology that may prevent the patient from receiving METVIXIA application and light exposure.
Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.

This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.

Patients will be randomized 1:1 in two groups:

1. Study group: bipolar coagulation technique
2. Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women.

Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.

The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \>18 years
* Genital prolapse \> II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
* Understanding and signing of informed consent for surgical procedure

Exclusion Criteria:

* Need for simultaneous bilateral adnexectomy
* Previous cesarian section
* Patients with abdominal laparoscopic or laparotomy history
* Patients with malignant pathology and/or adnexal pathology
* Confirmed or presumed pregnancy
A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a protein made in the body to response to a foreign substance) response following tetanus, diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant, and this determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin G \[IgG\]). If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant agrees not to donate bone marrow, blood, and blood products from the study intervention administration until 3 months after receiving it
* Body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg)
* must be a nonsmoker (not smoked for at least 3 months prior to screening) and has not used nicotine-containing products (example, nicotine patch and vaping) for at least 3 months prior to screening
* Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbance
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study
* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
* Known allergies, hypersensitivity, or intolerance to pneumococcal polysaccharide vaccine (PPSV23) and tetanus, diphtheria, pertussis (Tdap) vaccines, nipocalimab, or any of their excipients
* Has a serum albumin level less than (\<) 30 grams per liter (g/L) at screening or Day -1
* Has a total IgG less than or equal to (\<=) 6 g/L at screening.
* Has received a tetanus (example, Tdap, Td) vaccine in the past \<= 5 years
Head to Head Comparison of Two Needles EUS Guided FNB

The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.

EUS guided core biopsy using various needle designs and sizes, seems to be a promising technique to procure tissue in solid pancreatic masses for making an accurate histological diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic EUS-FNA samples and institutions where they do not have on-site cytopathology available for prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in planning appropriate treatment but also may decrease morbidity/mortality from unnecessary surgeries.

Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25 gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound biopsy needle.

This is a non- inferior paired, prospective, single-blind study design in which patients undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic needles of interest in this study will be used in random order. The biopsy needle passed first will be randomized, after which the two needles will be alternated for each of the remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they record the needle visibility on ultrasound. The biopsy site will be examined for evidence of bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded containers, where pathologist determine the number of adequate biopsies out of two passes of each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of material in a blinded fashion. Post procedure care will including a letter to referring physician with recommendations for treatment and follow up.

This study include 30 patients referred to Hershey Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic mass.
* Voluntary enrollment
* Ability to give written informed consent
* Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound or at the time of EUS.

Exclusion Criteria:

* Patients with coagulopathy with an elevated INR\>2
* Any individual who cannot provide one's voluntary informed written consent.
* Any pre-existing or discovered medical condition that may at the discretion of investigator interfere with the completion of and/ or participation in existing protocol.
* Pregnancy
* Less than 18 years old
Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital

The main objectives of this observational study are:

1. Provide reliable data on the prevalence of pericardial diseases, pericardial effusion, constrictive pericarditis and its predisposing factors among ESRD patients, undergoing long-term dialysis.
2. Detect the predisposing factors that could contribute to pericardial effusion amount and severity.

Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whatever feasible and possible.

* Inclusion Criteria: Patients with ESRD with a GFR \<10 cc/min admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
* Exclusion Criteria: Patients presented with non-uremic pericarditis such as intra-thoracic malignancy, injury (thoracic, oesophageal, and iatrogenic trauma), pulmonary TB, autoimmune diseases, history suggestive of recent viral infection, myxedema, and severe HF.
* Study tools:

  1. Demographic data (age, sex, and comorbidities).
  2. Clinical data including (The etiology of ESRD). (History of stitching anterior chest pain worse on inspiration, audible friction rub, and raised JVP).

     (Muffled heart sounds, ascites, and lower limb edema).
  3. ECG for signs of pericarditis, such as concave ST segment elevation in all leads, and signs of tamponade, such as low-voltage complexes with electrical alternates.
  4. Doppler echocardiography by Phillips HD 11: for detection of amount and severity of pericardial effusion. The severity was defined as Small (10 \< mm echo-free space behind the left ventricle). Moderate (10-20 mm, echo-free space behind the left ventricle and in front of the right ventricle in less than 1 cm).

     Large (\>20 mm which was the mentioned finding in addition to a right-sided atrial collapse).
  5. Echocardiography in constrictive pericarditis shows the presence of small left ventricular dimensions with preserved systolic function, impaired diastolic function, dilated atria, abrupt termination of diastolic filling, interventricular septal bounce expiratory diastolic flow reversal in hepatic veins and tissue doppler of the medial mitral annulus is more than lateral.
  6. Serum calcium and phosphorus concentrations and creatinine levels in both serum and urine were elevated. Serum lipid profile, serum albumin, hormone tests such as thyroid and parathyroid along with complete blood count.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ESRD with a GFR \<10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.

Exclusion Criteria:

* Patients presented with non-uremic pericarditis such as intra-thoracic malignancy, injury (thoracic, oesophageal, and iatrogenic trauma), pulmonary TB, autoimmune diseases, history suggestive of recent viral infection, myxedema, and severe HF.
A Study of Oral Clofarabine in Adult Patients With Myelodysplastic Syndromes (MDS)

This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed, written informed consent.
* Be at least 18 years old.
* Have a pathologically confirmed MDS and score according to the IPSS at study entry. Pathologic confirmation is the responsibility of the investigator.
* Have been treated previously for MDS as follow: a.Patients must have had at least 1, but no more than 2, prior treatment regimens; b.Patients must not have refractory (i.e., disease progression or no evidence of response while on treatment) to more than 1 prior treatment regimen.
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Be able to comply with study procedures and follow-up examinations.
* Have adequate hepatic and renal function.
* Be non-fertile or agree to use birth control during the study through the end of the last treatment visit and at least 90 days after.

Exclusion Criteria:

* Have had a readjustment of dose and/or schedule of erythropoietin, granulocyte colony stimulating factor(G-CSF) or other growth factors within 8 weeks prior to the first dose of oral clofarabine.
* Have had any other chemotherapy or any investigational therapy for MDS within 4 weeks of the first dose of oral clofarabine.
* Have not recovered to ≤ Grade 2 in severity of any drug-related non-hematologic toxicity prior to the first dose of oral clofarabine.
* Have an uncontrolled systemic fungal, bacterial, viral or other infection. Have a history of serious disease involving the heart.
* Have a clinically significant cardiac assessment at screening or a known family history QT prolongation.
* Currently uses a medication known to prolong the QT interval.
* Have had any prior treatment with clofarabine (IV or oral).
* Have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years after completing curative intent therapy except for the following: a. Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment or the condition has been completed. b. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
* Have prior positive test for the human immunodeficiency virus (HIV).
* Have gastrointestinal disease or prior surgery, which may affect the ability of the patient to absorb oral clofarabine.
* Is currently participating in another concurrent investigational protocol that is not restricted to data and/or sample collection for patient demographic and/or disease purposes.
Triathlon PKR Study in Japan

The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee Replacement (PKR) with the Japanese population. It is expected that patients who receive the Triathlon PKR will achieve excellent clinical results without adverse effects and that the device fits well with Japanese morphology.


Eligibility Criteria:
Inclusion Criteria:

1. Patient requires a primary unicompartmental knee replacement.
2. Patient is between 20 years old to 80 years old.
3. Patient is diagnosed as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis.
4. Patient can walk independently at least 10m.
5. Patient has signed the Institutional Review Board (IRB) approved, study specific informed patient consent form.
6. Patient is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient requires a revision.
2. Patient is pregnant.
3. Patient has lateral osteoarthritis.
4. Patient has less than 10°of flexion contracture and greater than 90°of flexion.
5. Patient's preoperative mechanical alignment is less than 10° of varus and 15° of valgus.
6. Patient has had high tibial osteotomy, femoral osteotomy and/or joint fusion.
7. Patient has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
8. Patient has a systemic or metabolic disorder leading to progressive bone deterioration.
9. Patient is immunologically suppressed or receiving steroids (\>30 days) in excess of normal physiological requirements.
10. Patient has a deformity which will require the use of wedges or augments.
11. Patient has an active or suspected latent infection in or about the knee joint.
12. Patient who is inappropriate for participating in the study by the judgment of the investigator.
Nurse-Led Rapid Access Chest Pain Clinic

This study aims to ascertain the lived experiences of 6 patients attending a nurse-led chest pain clinic via an interview, and to understand the demographics of referred patients.

A qualitative analysis of a nurse-led chest pain clinic will be undertaken to improve understanding of patient experience. Patients who have used this service will be invited to take part in an interview. Patients will be split in to two groups: those reassured and discharged after first attendance, and those who went on to have further diagnostic testing. The aim is to interview three patients from each group to compare experiences and perceptions of a service which previously would have been undertaken by physicians, but is now completely nurse-led.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have attended the chest pain clinic in the last four month months
* Eighteen years-of-age and older
* Able to give valid consent
* English speaking

Exclusion Criteria:

* Non-English speaking patients
* Patients under 18 years of age
* Patients with any cognitive impairment.
* Any vulnerable patients (defined by the mental health act 2005 as anyone lacking capacity to make decisions, ie, someone with severe impairment in the functioning of the brain).
* Offenders in the care of prison services (for logistical reasons)