cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Transperineal US in Stress Incontinence

Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified risk factors are aging, obesity and repeated pregnancies and deliveries.

Urodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound appears to have a good role in diagnosing stress incontinence

A comparative observational cross sectional study will be conducted .

The symptom, or "subjective indicator of disease," of SUI is described as "the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing." 1 Stress urinary incontinence (SUI) has an observed prevalence of between 4% and 35%.

It's a social problem that causes hygienic problem that s distressing for females.

Urodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it's not done routinely in all cases of urinary incontinence according to the NICE guidelines 2 Translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.

Eligibility Criteria:
Inclusion Criteria:

females between 20-75 years old

* -Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic.

Exclusion Criteria:

* -Known to be Diabetic
* Urge incontinence or mixed type
* Voiding dysfunction
* Neurological problems
* open suprapubic wound
* Previous surgery for POP(pelvic organ prolapse) or incontinence
* suspicion of pelvic malignancy
Molar Potency Study of HM12460A in Healthy Subjects

This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Females must be non-pregnant and non-lactating
* Males must be surgically sterile or using an acceptable contraceptive method

Exclusion Criteria:

* History of any major surgery within 6 months prior to screening
* Use of any new prescription or non-prescription drug in the last 30 days
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-85 years
* Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
* On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6

Exclusion Criteria:

* Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
* Receipt of atrial septostomy within the 6 months preceding Screening
* History of left-sided heart disease
* Clinically relevant obstructive lung disease
* Chronic renal or liver disease
* Uncontrolled systemic hypertension or hypotension
* Cerebrovascular event within the 6 months preceding Screening
The Efficacy of Intraoperative Pulmonary Nodules Localization Guided by Virtual Reality Technology

As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients

This is a prospective, mulitiple-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 90 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.

Eligibility Criteria:
Inclusion Criteria:

• diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. • commit to follow the research procedures and cooperate with the implementation of the whole process research • 1 / 3 of pulmonary nodules are located in the periphery of the lung • signed informed consent with date

Exclusion Criteria:

• the target lesion is close to the hilar or large blood vessels • subjects with FEV1 less than 1.2 in lung function • subjects with cardiac function III and cardiac function IV (NYHA, New York) • subjects with uncontrollable acute pleura infection • patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side • Other factors that investigators disagree enrollment.
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

1. Participants scheduled to change the type and dosage regimen of low-dose aspirin
2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. Participants with a previous or current history of aspirin-induced asthma
Effect of AVACEN 100 on Brachial Artery Blood Flow and Heart Rate Variability

Determine effect of AVACEN 100 on brachial artery blood flow and heart rate variability

Blood flow measured via ultrasound doppler. Heart rate variability measured via polar chest strap

Eligibility Criteria:
Inclusion Criteria:

* anyone within specified age

Exclusion Criteria:

* anyone outside specified age
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients

The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.

The primary objective of this study is as follows:

* To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.

The secondary objectives of this study are as follows:

* To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.
* To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients.
* To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in the study.

* HIV-1 infection
* Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening.
* No active opportunistic infection within 45 days prior to baseline.
* Able to understand and sign the informed consent form and comply with the study.
* Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method).

Exclusion Criteria:

Patients who meet any of the following are not to be enrolled in this study.

* Women who are pregnant or breastfeeding
* Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder.
* Women of childbearing potential who are unwilling to use an effective contraceptive method during the study
* Contraindications to tenofovir DF, emtricitabine or efavirenz
* Undergoing treatment for tuberculosis
* Using atazanavir
* Prior history of mutation M184V, K65R or T69 insertion
* Z-score on pre-baseline DEXA scan less than -2.5
* The following laboratory values within 30 days prior to study entry: \*absolute neutrophil count (ANC) less than 750/mm3, \*hemoglobin less than 9.0 g/dL, \*platelet count less than 50,000/mm3, \*AST (SGOT) or ALT (SGPT) less than 5 x ULN and \*CD4 cell count less than 100/mm3.
* Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential
* Clinically significant cardiac, pulmonary or gastrointestinal disorder
* Alcohol or drug abuse that could hinder compliance with the study
Mechanisms of Treatment Effects Using Cultured, Allogeneic Mesenchymal Stromal Stem Cells (MSCs) in Knee Osteoarthritis

The goal of this clinical trial is to pharmacologically evaluate the effects of culturued allogeneic umbilical cord blood-derived mesenchymal stromal stem cell (UCB-MSCs) in the treatment of end-stage knee osteoarthritis (Kellgren-Lawrence grade 4) with the analysis of soluble biomarkers and expression of key genes, as well as the evaluation of clinical outcomes with patient-reported outcome measures (PROMs) and recording of potential complications.

Patients will be randomized in the intervention and control groups. In both groups, the knee aspiration will be performed 4-6 weeks prior to the knee arthroplasty to analyse baseline synovial fluid characteristics. The intervention group will receive the injection of UCB-MSCs. All patients will complete PROMs questionnaires and maintain a pain diary on visual analogue scale (VAS) at home until the surgery. On the day of admission to hospital for knee arthroplasty, the same questionnaires will be administered again. During the operative procedures, the samples of synovial fluid, synovial membrane and resected cartilage will be obtained and analysed afterwards.

It is anticipated that the study results will contribute to elucidate the mechanisms of action of MSCs in the treatment of knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage (Kellgren-Lawrence) knee osteoarthritis scheduled for knee arthroplasty
* Osteoarthritis of primary or post-traumatic etiology

Exclusion Criteria:

* Secondary arthritis of other etiology
* Rheumatic diseases
* Uncontrolled metabolic disorders
* Crystalopathies
* Coagulopathy
* Anticoagulant therapy
* Heart failure
* Renal failure
* Other conditions that may affect immune response or pose additional risk during cell application
Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year.

Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2. Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED.

This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information.

The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.

This study will test the capacity of a gastrointestinal tract cryobiopsy probe that Tearney Lab investigators have designed to obtain biopsies from the upper GI tract.

A total of twenty (20) subjects, adults 18 years of age and older, scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study.

A maximum of 3 cryobiopsies per subject will be collected. After each cryobiopsy is complete, the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed. A maximum of 3 standard forceps biopsies for research purposes only will be taken. Biopsy collection will be performed at the discretion of the endoscopist. The standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure. The total experimental procedure time will not exceed 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an elective esophagogastroduodenoscopy with biopsy.
* 18 years of age or older.
* Able to provide informed consent.

Exclusion Criteria:

* According to standard of care.
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Histologically confirmed B-cell lymphoma of the following subtypes:

   * LBCDL
   * Grade 3b follicular lymphoma
   * Mantle-cell lymphoma
   * Transformed B-cell lymphoma
   * Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
3. High-risk B-cell CD20+ lymphoma defined by

   * Having attained less than PR after two chemotherapy lines
   * Post-transplantation relapse
   * Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation
   * Inability to collect enough stem cells for autologous transplantation
4. Stable disease at the time of transplantation
5. Age between 18 and 65
6. Performance status (ECOG) ≤ 2
7. Normal and suitable pulmonary function (DLCO ≥ 30%)
8. Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
9. Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)

Exclusion Criteria:

1. Prior treatment with radiopharmaceutical agents
2. HIV-associated lymphoma
3. Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
4. Patient's inability to follow the protocol
5. Hypersensitivity to 90Y-itritumomab tiuxetan
6. Presence of severe pathologies that preclude chemotherapeutic treatment
7. Pregnant women or pregnancy risk due to inappropriate contraceptive measures
8. Breastfeeding women
FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions

The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent organs, with the aim of establishing for which lesions and from which location the capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS

Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of potentially expanding the therapeutic applications of EUS. This prototype is a modification of the CLA scope and it is characterized primarily by a shifting of the orientation of the endoscopic and US views from oblique to forward. The US transducer is located adjacent to the working channel, at the endoscope tip, to display a forward-viewing image along to a scanning plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm working channel without elevator, which allows exit of the FNA needle or any other accessory used parallel to the longitudinal axis of the scope.

Preliminary experiences with this scope have reported potential advantages over the conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary strictures. Moreover, a large experience still unpublished from the Catholic University, Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI tract has shown the FV-EUS to be highly effective with a performance that seems at least comparable to that of the CLA-EUS. To date, however, no data comparing the performance of both scopes for FNA of target lesions are available to better clarify the advantages and disadvantages of one scope over the other.

We designed a randomized comparative trial in which patients will be randomized to undergo examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the presumed lesion; (ii) failure in performing the FNA with the scope used based on randomization, a second attempt will be made using the other scope.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of a solid lesion in the GI tract or in one of the adjacent organs identified at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because unresectable or because tissue characterization is needed to decide further treatment modalities
2. Age greater than 18.
3. Absence of histological or cytological confirmation of malignancy.
4. Informed consent obtained.

Exclusion Criteria:

1. Patients with active coagulopathy that cannot be corrected after administration of plasma.
2. Resectable lesions that does not need tissue characterization to decide treatment modalities.
3. Pregnancy.
4. Patients who cannot give inform consent.
Maternal Oral Therapy to Reduce Obstetric Risk Kids

The principal objective was to conduct a 5 year; multi-center, observational follow-up study enrolling infants born to mothers who participated in the MOTOR clinical trial to determine the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and mortality and whether this will result in lower incidence of functional neurological impairment.

A total of 525 infants where planned to be enrolled at the 3 performance sites. The number of infants enrolled at each site depended on past Motor recruitment rates, and the observed delivery rate of high risk babies at that site. Infants were enrolled from both the high risk and low risk groups. The intended sample size was fixed, over sampling among the low risk group and was used to assure the sample size.

The Data Coordinating Center (DCC) identified and provided each clinical site with participant listings of all MOTOR high risk births and a randomly ordered sample of low risk births for enrollment into the study.

Mothers where approached by MOTOR or MOTORkids personnel to ascertain participant interest in enrolling their infant. Once consent was obtained, infants were followed and tracked until scheduled for the follow-up exams at age 24 months +/- 2 months adjusted age.

Eligibility Criteria:
Inclusion Criteria:

* All infants born to mothers enrolled to MOTOR study prior to 35 weeks gestational age,
* All small for gestational age (SGA) infants and all infants born after 37 weeks gestation and who were appropriate for gestational age are eligible for enrollment.
* All infants born \< 34 weeks gestation and all SGA infants will be considered a high risk infant and will be recruited for enrollment.
* Appropriate weight for gestational age infants born after 37 weeks will be considered low risk infants and a random sample of these infants will be recruited for enrollment.

Exclusion Criteria:

* Only a random sample of the low risk group will be recruited.