cyrilzakka/clinical-trials huggingface dataset:
Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.


Eligibility Criteria:
Inclusion Criteria:

* Every patient above 18 years of age with an echocardiographic established moderate to severe AS
* A guideline indication for aortic valve replacement therapy

Exclusion Criteria:

* Unable to perform exercise testing
* Previous aortic valve intervention
* More than moderate other valvular disease
* Patients refusing participation or unwilling to sign the informed consent
Physical Therapy Prior to Total Knee Replacement

In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.


Eligibility Criteria:
Inclusion Criteria:

1. Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
2. Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
3. Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

1. Anyone who received physical therapy in the last 6 months
2. Inability to walk unaided for \>1 block
3. Currently engaged in regular PT or a regular home exercise program
4. Prior knee arthroplasty
5. Prior knee surgery for trauma, tumor and osteotomy
6. Injection given within 6 weeks of starting therapy
7. Patients using daily narcotic medications within prior 6 weeks
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been informed about the study
* The patient is at least 18 years old
* Patient suffering from moderate stress incontinence (pure or predominant) following radical prostatectomy surgery, for at least 12 months, unresolved after of pelvic floor reeducation
* Patient scheduled for REMEEX® implant

Exclusion Criteria:

* It proves impossible to give the patient clear information
* Patient refuses to participate
* Life expectancy of the patient estimated to be less than the 5 year follow-up
* Impossible to contact patient after hospitalization
* Radiotherapy of less than 6 month
* Patient unable to fill in questionnaire
* Incapably of performing pad test at 24 hours
* Recurrent symptomatic prostate cancer
* Mixed incontinence with urgency incontinence
* Bladder outlet obstruction: stenosis of the vesico-urethral anastomosis or untreated urethral stricture.
* Post void residual \>100ml
* Other cancer under treatment or progressing
* Kidney injury, hepatocellular insufficiency
* Auto-immune disease
* Neurological-origin urinary incontinence (stroke, MS, Parkinson's)
* Incontinence arising from surgery other than prostatectomy
* recurrent gross hematuria
* Recurrent urinary infection
* Bladder stones
Osseointegrated Transdermal Femoral Amputation Prostheses

Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom pain or lack of stabilization between the prosthesis and the residual limb. Many have a low score on "health-related quality of life" questionnaires (HRQL).

Some femur amputated patients may be a candidate to osseointegrated prosthesis. Osseointegrated prosthesis is an implant, where the fixture is inserted into the femur canal and an abutment screw, on which the leg-prostheses is inserted, protrudes the skin. By this procedure the patient have a high score on HRQL and experience fewer problems. They have improved gait, reduced discomfort when sitting, increased prosthetic use, and experience fewer skin and pain problems.

Femur amputee patients formerly mobilized on socket prosthesis have a reduced bone mineral density in the affected femur and pelvis.

The Phd-theses compromise of three studies. The aim of the first study is to follow patients with oosseointegrated prosthesis before and after surgery with DXA-scans to monitor the BMD. In the second study patients will be randomised to receive medical treatment with an RANKL-inhibitor, approved for treatment of osteoporosis, and monitored with DXA, microdialysis and radiostereometry. Depending on the DXA-results patients in the third study may receive fast track rehabilitation.

The hypothesis is that patients with osseointegrated prosthesis will have an increased BMD after surgery, 2 years follow up. Patients receiving RANKL inhibitor will have increased BMD, stability of the prosthesis, and some receive fast-track rehabilitation due to high BMD.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years
* Scheduled for OI-implant surgery
* Body mass index \<30
* Female patients of childbearing age must produce a negative pregnancy test and use effective contraception
* informed consent

Exclusion Criteria:

* Diabetes with complication
* Atherosclerosis
* Smoking
* Drug abuse
* Treatment with NSAID or cytostatic
* Active cancer
* Liver or kidney insufficiency
* Dementia
* Hip flexion contracture on the affected side \>10 degrees
* Body weight \>100 kg
* Hypocalcaemia
* Contraindications to denosumab
Water Exercise and Vascular Function in Elderly

Objectives:

The purpose of this research was to assess modifications caused by a concurrent water exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the elderly and analyze the correlations between these variables after intervention.

Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to determine the resistivity index and Cholesterol was determined using the colorimetric enzymatic method and test kit. Intervention with water exercise program consisted of three weekly sessions for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* older than 60 and lass than 80 years age;
* the elderly should be independent in their ADLs;
* be considered able for medical evaluation to participate in the intervention and testing protocols;
* still not be participating in regular systematized physical activity for at least six months.

Exclusion Criteria:

* subjects with any form of transmittable or uncontrolled disease or insulin-dependent hypertensive;
* unable to perform functional autonomy tests;
* women undergo hormonal replacement therapy
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Psoriasis for 6 MO
* BSA 10%
* PASI 12 or above
* PGA 3 or above

Exclusion Criteria:

* Previous exposure to either etanercept or ABT-874
GNRI and Influence of Nutrition on the Mortality of Trauma Patients

The geriatric nutritional risk index (GNRI) is a simple and efficient tool to assess the nutritional status of patients with malignancies or after surgery. Because trauma patients constitute a specific population that generally acquires accidental and acute injury, this study aimed to identify the association between the GNRI at admission and mortality outcomes of older trauma patients in the intensive care unit (ICU).

The nutritional risk index (NRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. However, even under professional care, the usual body weight is often not documented for older patients. To determine the usual body weight of older patients, the geriatric nutritional risk index (GNRI) was introduced in 2005 by Bouillanne et al - the formula included a combination of serum albumin levels and the ratio of body weight to ideal body weight. The GNRI formula replaces the usual body weight in the NRI formula with the ideal body weight, calculated using the Lorentz formula. Although the GNRI was developed using the data of patients who were admitted to a geriatric rehabilitation care unit, it was found to be a strong prognostic factor for certain malignancies and a simple, objective, and quick method to determine the nutritional status of patients and long-term postoperative outcomes and the correlation between these elements. Using this simple calculation, it is possible to evaluate the nutritional status of critically ill patients with acute respiratory distress syndrome in the intensive care unit (ICU). Considering that trauma patients constitute a specific population, as injuries generally occur accidentally and acutely, it is important to determine whether the GNRI can be used to link nutritional status and outcomes in trauma patients. Therefore, this study aimed to identify the association between GNRI at admission and mortality outcomes of older trauma patients in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* trauma from different injuries
* hospitalized for treatment
* admitted to the ICU

Exclusion Criteria:

* albumin data were not available
* patients with incomplete data
Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh

The purpose of this study is to assess whether a mobile phone intervention can be effectively used to improve post menstrual regulation contraceptive uptake and continuation in Bangladesh.

The study will consist of two phases: Phase I: A formative phase to understand barriers to post-abortion contraceptive uptake and continuation and the content and modality of messages most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test the effectiveness of the mHealth intervention developed during the formative phase on contraceptive use.

The proposed study aims to develop and evaluate a mHealth intervention to promote post-abortion contraceptive uptake and continuation among menstrual regulation clients in the Sylhet, Chittagong and Dhaka regions of Bangladesh.

The aim of the formative phase of the study is to develop an interactive two-way messaging service for post-MR clients. The messaging service will deliver information relating to the women's contraceptive method of choice as well as information about other modern contraceptive methods. This part of the study will focus on determining the modality, content, timing, language and acceptability of messaging services for post menstrual regulation clients.

The aim of the RCT phase is to measure the effect of mHealth on uptake or switching to long-acting reversible contraceptives at the 4 month and 12 month follow ups. The investigators expect mHealth to have a positive effect on uptake and a negative effect on discontinuation rates of contraceptive users.

Eligibility Criteria:
Inclusion Criteria:

* Received menstrual regulation services using Manual Vacuum Aspiration (MVA) or Medical Abortion (MA)
* Have a personal mobile telephone
* Agree to receive messages on mobile about family planning
* Provide informed consent for participation

Exclusion Criteria:

* Received anaesthesia for their MVA procedure
* Intend to become pregnant within the next six months
* Intend to use, or for partner to use, a permanent method of contraception (i.e. sterilisation) within the next six months
Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty

The goal of this study is to teach emergency medicine resident physicians to communicate more effectively with patients at the time of emergency department discharge in the setting of diagnostic uncertainty (i.e. no definitive cause identified for the patient's symptoms). All residents will complete baseline and follow up assessments by completing in-person simulated patient discharged. After the baseline assessment, they will complete an online educational curriculum that has been developed by the study team, and will participate in video-based simulation deliberate practice (DP) and feedback sessions using a simulation-based mastery learning (SBML) approach. They will be assessed with the Uncertainty Communication Checklist (UCC), a tool already developed by the study team, that has a minimum passing standard (MPS) that was established through engagement of both patients and physicians. The investigators will perform a 2-arm wait-list randomized control trial with resident physicians to test the efficacy of the SBML curriculum in training residents to have a discharge discussion with patients discharged from the emergency department with diagnostic uncertainty.


Eligibility Criteria:
Inclusion Criteria:

-Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University.

Exclusion Criteria:

-None
Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.


Eligibility Criteria:
* Moderate to severe active ulcerative colitis diagnosed for at least 4 months.
* Mayo score of 5-10 (inclusive)
* Not used any investigational therapy for 30 days prior to screening
* No treatment with monoclonal antibody therapy within 12 weeks of screening
* No prior treatment with daclizumab
Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection

Background. Peritoneal carcinomatosis is a frequent and deadly localization of gastric cancer. Available imaging techniques have a low accuracy in detecting small peritoneal nodules, and direct laparoscopic visualization may fail too. A more accurate staging technique would be advantageous for individualization of therapeutic path. Indocyanine Green (ICG) fluorescence imaging has been reported as a tool for visualizing small peritoneal seedings due to the "enhanced permeability and retention" (EPR) effect of cancer nodules.

Aim. To explore the feasibility and effectiveness of fluorescence-enhanced peritoneal carcinomatosis detection in patients with gastric cancer undergoing staging laparoscopy.

Methods. This prospective, multicentric, single arm study will include patients with gastric cancer, without a radiological suspicion of peritoneal carcinomatosis, undergoing staging laparoscopy. An intravenous injection of ICG is given at different dosage and at different timepoints before the intervention. During the staging laparoscopy, the abdominal cavity exploration is performed using standard white-light, and subsequently using fluorescence imaging. Suspicious nodules are harvested, until a maximum of 5 per patient, and sent for definitive histological examination. Peritoneal washing is also harvested for cytologic assessment in all cases. The eventual benefit of fluorescence imaging in terms of additional peritoneal lesions that were not detected during standard white-light imaging is evaluated.

Discussion. This study will establish if fluorescence imaging increases sensitivity and/or specificity of staging laparoscopy in detecting peritoneal carcinomatosis from gastric cancer. Improved accuracy may translate in better care path selection.


Eligibility Criteria:
Inclusion Criteria:

1. Age of ≥18years
2. Ability to provide written informed consent
3. Histologically confirmed gastric adenocarcinoma or oesophago-gastric junction adenocarcinoma Siewert 2 and 3
4. cT\>1
5. cM0 (clinical staging: no metastases)
6. Staging laparoscopy is indicated by the internal work-up protocol
7. Staging laparoscopy is in accordance with NCCN (National Comprehensive Cancer Network) guidelines

Exclusion Criteria:

1. Pregnancy
2. Iodine allergy/sensibility
3. Clinical P1 (defined as high probability of peritoneal carcinomatosis at imaging)
4. Investigator judgement that the patient should not participate for any reason
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast carcinoma.
* Early stage breast cancer (stage 1, 2, 3).
* No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
* 18 years of age or older.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

* Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
* Major surgery within 28 days of study entry.
* Evidence of central nervous system (CNS) metastases.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)

The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Furthermore, while clinics are the typical sites for treating each of these health problems, this proposal will examine a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention will encourage mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman and their children
* Age 18 or older
* Informed consent

Exclusion Criteria:

* Psychosis, neurological damage, inability to communicate with interviewer
* Inability to give consent
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.

OUTLINE:

Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects age \>= 18 years (yr)
* Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery
* Able to provide written informed consent
* If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential
* Available for all study visits and able to comply with all study requirements

Exclusion Criteria:

* Known or suspected sensitivity to indocyanine green
* In the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results
* Any current medications with the potential to generate fluorescence or photochemical reaction
* Enrolled in any other ongoing study
* Currently lactating or breastfeeding
* Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide
* Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data
* Creatinine clearance \< 60 mL/min
* Aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 1.5 x ULN
* Bilirubin \> 1.5 x ULN