cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension

This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients who undergo liver biopsy or hepatic venous pressure gradient test

Exclusion Criteria:

* decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy);
* alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 × upper limit of normal (ULN);
* any malignant tumor;
* any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases;
* severe neurological or psychological disease;
* pregnant or lactating women.
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and volunteer women \>18 years old
* Primiparous
* With a singleton pregnancy
* No objection from the subject and the spouse to participate in the study

Exclusion Criteria:

* History of prior delivery or c-section
* History of perineal troubles
* BMI \> à 35 mg/m²
* History of chronic muscular disease or connective tissue pathology
* Psychiatric pathology requiring hospitalization
* Patients who do not understand the French language
* Legal incapacity or limited legal capacity
* Patients unlikely to cooperate
Ovarian Function Following Intraovarian Injection of PRP

Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).

As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.

Eligibility Criteria:
Inclusion Criteria:

* fewer than 6 oocytes in response to past ovulation induction
* desire to establish a pregnancy using IVF
* Age 44 years and under.
* FSH \> 12
* AMH \< 1.0
* No Aspirin or Motrin for one week before treatment

Exclusion Criteria:

* Age \> 45 years
* Marked thrombocytopenia
* Blood diseases
* Hypofibrinogenemia
* Hemodynamic instability
* Anticoagulant or antiaggregant treatment
* Oncological diseases (specially, skeletal system and blood)
* Sepsis
* Acute and chronic infectious diseases
* Autoimmune diseases, for example, lupus erythematosus, etc.
4P Study: Predictive Quality With Painfree Therapies

The aim of the study is to characterize and quantify the relative effectiveness and contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes under the conditions of daily practice.

Swiss, multicenter, prospective, observational study.

The main role of ICD's is to stop potentially lethal ventricular tachyarrhythmias through overdrive pacing or shock, reducing the risk of sudden cardiac death. The device is programmed to detect episodes of arrhythmias, classify them according to the threat to patient, and deliver therapies to stop the arrhythmias.

The actual focus of ICD programming has been the application of fast-pacing therapies (ATP or antitachy pacing) as first therapy before applying a shock as last resort to terminate an episode. Some studies have shown the high success rate of this method in decreasing the number of shock delivered to patients. Furthermore significant improvement has been done to improve the sensitivity and specificity of the detection and discrimination algorithm.

This study will focus on the latest generation of device and their performance will be reviewed and analyzed by an Adjudication Board.

Eligibility Criteria:
Inclusion Criteria:

* Patients having an indication for a Protecta ICD or CRT-D device, or later market released ICD (first implant, replacement, or upgrade)
* Patients monitored with the Carelink monitoring system
* Patients having signed the patient informed consent form
* Patients older than 18 years

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients with a life expectancy of less than 24 months
* Females, pregnant and of child bearing potential
* Patients participation to another concomitant trial
* Patients unable or not willing to provide a signed patient informed consent
Intensive Prevention Program After Myocardial Infarction

It is unknown, if a modern prevention program, including intense nurse-coordinated education sessions, regular telephone contacts and a telephone hotline for 12 months, significantly reduces cardiovascular risk factors, clinical events and quality of life in myocardial infarction patients compared to usual care. Furthermore, actually no data on the additional effects and the feasibility of longterm telemetric care of cardiovascular risk factors exist.

The primary hypothesis to be tested is that an intensive longterm prevention program compared to the standard of medical care, will achieve better risk factor control and consecutively less clinical adverse events in patients after myocardial infarctions. The study endpoints will be evaluated after 12 months and during long-term course (after 24 months = one year after termination of the prevention program).

In a substudy the effects of short reinterventions ("Prevention Boosts") during long-term course are tested (IPP Prevention Boost Study). Patients with at least one insufficiently controlled risk factor at 24-months visit are randomly assigned to a short (2-month) reintervention vs. no reintervention. The effects of the reinterventions on risk factor control are evaluated after 36 months.

A further substudy focusing on young patients \<= 45 years of age at time of MI (IPP-Y = IPP in the Young) was added after completion of the pilot IPP study. In this study we focus on the prevention program in young MI-patients. A retrospective analysis of individual genetic risk (assessed by genetic risk scores) in the young patients is included in this substudy.


Eligibility Criteria:
Inclusion Criteria:

Hospitalisation due to myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction)

Exclusion Criteria:

i) Hemodynamically significant valvular heart disease (\> NYHA class II) or inborn cardiac malformations.

ii) Cardiomyopathy associated with hemodynamic obstruction, pregnancy or myocarditis.

iii) Exercise limitations due to clinical conditions not related to CAD. iv) Any major non-cardiac condition that would adversely effect survival during the duration of the study.

v) Patients unlikely to comply to the study treatment and the follow-up visits. vi) Pregnancy (all pre-menopausal females should have a negative serum pregnancy test).

vii) Inability of cooperation with the protocol, including longterm follow-up. viii) Patient refusal or inability to give informed consent. ix) Refusal of the patient's physician regarding trial participation of the patient.

x) Chronic drug or alcohol abuse.
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery.

One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups:

1. Lidocaine group (short-acting medication).
2. Liposomal bupivacaine group (long-acting medication)

Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia.

Secondary outcomes include:

1. post-operative opioid medication use
2. return to baseline pain status
3. post-operative time to first bowel movement
4. post-operative antiemetic use (nausea medication)
5. results of voiding trial after surgery
6. patient satisfaction with pain control


Eligibility Criteria:
Inclusion Criteria:

1. Female gender
2. Age ≥ 18 years, ≤95 years
3. Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
4. Able to give informed consent to participate

Exclusion Criteria:

1. Male
2. Age \<18 years, \> 95 years
3. Unable or unwilling to give informed consent to participate
4. Pregnancy
5. History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
6. Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
7. Known renal or hepatic insufficiency
8. Planned hysterectomy at the time of prolapse repair
9. Planned transobturator mid urethral sling at the time of prolapse repair
Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.


Eligibility Criteria:
Inclusion Criteria:

* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20
* Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4.

Exclusion Criteria:

* Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores.
* Past treatment with desvenlafaxine succinate sustained release.
* Other eligibility criteria also apply.
Active Communities - Adherence to Physical Activity

The primary aim of this study is to investigate whether a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities (e.g. local sports and exercise associations) can support persons with type 2 diabetes, cardiovascular disease and/or obesity in maintain physical activity levels.

This study is an evaluation of a number of co-created bridge-building activities between municipality-based lifestyle programs and community-based physical activities. Persons with type 2 diabetes, cardiovascular disease and/or obesity initiating a lifestyle program (8-12 weeks duration) in the municipality of Odsherred, Denmark, will be included in the study. We will include sixty (n=60) persons or the number of persons recruited at the end of the recruitment period, December 1, 2022 - whichever is reached first. Participants will undergo objective measurement of physical activity level, test of standing balance, 6-minute walk test, measurement of body composition, and answer questionnaires related to their background (education, job situation, civil status), health, lifestyle and well-being. Measurements will be performed before and after participants undergo a lifestyle program, and 3 and 6 months after termination of the lifestyle program.

Eligibility Criteria:
Inclusion Criteria:

* Citizens in the municipality of Odsherred undergoing a municipality-based lifestyle program
* Obese, or diagnosed with type 2 diabetes or cardiovascular disease

Exclusion Criteria:

* reliant on a wheelchair
Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.

Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been informed, the affirmative agreement has been obtained and inclusion and exclusion criteria verified the patients are randomized to 30% or 60% oxygen concentration. In the operating room while placing the intravenous line, a sample blood is obtained. General anesthesia is induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in order to provide the oxygen concentration according to the randomization. One hour later a second venous sample is obtained. Samples are stored in cold conditions until their analysis in the laboratories of the biology faculty - Barcelona University.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery, under general anesthesia.
* ASA 1 - 2
* Orl surgery, reconstructive surgery, neck surgery, abdominal wall surgery.

Exclusion Criteria:

* Smoking Habit
* Pregnancy
* No compensated disease.
* ASA 3 or Higher.
Repair of Thumb Defect by Using the Toe Nail Flap

The thumb accounts for 50% of the total hand function. This study reports the functional outcomes and complications of people with traumatic thumb amputations who underwent toe-to-thumb reconstruction.From 2013-01 to 2018-01, 29 patients with second-degree thumb defect underwent thumb reconstruction with distal phalangeal braided toenail flap. The footscan foot pressure gait analysis system was used to measure the index changes of the same foot before and after one, three and six months. The contact area, peak pressure, impulse value, contact time of each gait phase, centre of gravity coordinate and foot balance were analysed statistically. Twenty-nine cases of thumb reconstruction recovered well. After following up for 6-15 months, the appearance of the reconstructed thumb was close to normal, and the sensation was restored to S3+. The two-point discrimination was 6-8 mm, and the function of the thumb was good. The function of the donor foot was well restored, and no skin ulceration, pain and claudication were noted during walking. Compared with that before operation, the biomechanical indices of the donor foot were basically restored to normal six months after operation. Only the stress and impulse values of the third metatarsal head were significantly increased, forming a stress concentration area centred on the third metatarsal head.This study confirmed that the toe nail flap with distal phalangeal bone restored the second-degree thumb defect without destroying the main functional structure of the sole. The biomechanical indices of the donor foot were basically restored to normal six months after operation. Only the stress concentration area centred on the third metatarsal head, and the pain on the forefoot was induced after the operation. Discomfort, callus formation, metatarsal fasciitis, etc. can lead to fatigue fracture of the third metatarsal bone in severe cases, which requires further follow-up and observation.


Eligibility Criteria:
Inclusion Criteria:

1. patients with second-degree thumb defect；
2. without any foot disease or deformity before injury；
3. Written informed consent to undergo the surgical procedure；

Exclusion Criteria:

1. Concomitant phalanx fractures or other injuries needing immobilization；
2. Loss of skin substance requiring grafts or flaps
3. Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders
4. Smokers
Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?

The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

Lithiasis disease represents a real public health problem. Indeed, 10% of the general population is asymptomatic carrier of gallbladder stones and among them, 35% will present a symptomatic form which will cause the indication of cholecystectomy. As a result, around 120,000 cholecystectomies are performed per year in France, and around 750,000 in the United States for this indication. Cholecystectomy is therefore the most widely performed procedure in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and to be treated. Different strategies are proposed: a treatment called "all surgical" or an endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy. The investigators defined two groups of patients: one group with success of fully laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common bile duct at the same time), and one group treated by laparoscopic cholecystectomy and management of the common bile duct stone(s) by an ERCP performed intra, per ou postoperatively. The primary outcome was the failure of surgical management, defined as the requirement of ERCP for extraction of common bile duct stones, which permit us to identify risk factors of failure in the fullfil surgical treatment process. The secondary outcome was to study the morbimortality in each group, and length of stay.

Eligibility Criteria:
Inclusion criteria:

* More than 18 years old
* Between 2007 and 2019
* Montpellier University Hospital
* Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones
* Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography
* Common bile duct stones treated during the same hospital stay surgically or endocopically

Exclusion criteria:

* Laparotomy
* Previous ERCP
* Less than 18 years old
* Lost to follow up
* Lack of data \> 10%
* Other surgical procedure associated at the same time
* Previous cholecystectomy
* Caroli's disease
* Severe cholangitis or acute pancreatitis
* Pigmentary or hydatic lithiasis
* Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis
Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with newly diagnosed Ewing's sarcoma.

OBJECTIVES:

Primary

* Assess the responsiveness of single-agent irinotecan hydrochloride in a patient population with newly diagnosed high-risk Ewing's sarcoma.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan hydrochloride IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses. After completion of 2 courses of therapy, patients may receive additional treatment at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Ewing's tumor

  * Ewing's sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue
  * High-risk disease (R3), defined as metastases at extrapulmonary/pleural sites
* Newly diagnosed disease
* Measurable primary and/or metastatic disease

  * At least one bidimensionally measurable lesion
* Concurrent enrollment on EURO-Ewing99 clinical trial required

PATIENT CHARACTERISTICS:

* No abnormal cardiac function, including any of the following:

  * Fractional shortening \< 29%
  * Ejection fraction \< 40%
* Glomerular filtration rate ≥ 60mL/min
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No prior or current history of chronic diarrhea, bowel obstruction, sub obstruction, Crohn's disease, or ulcerative colitis
* No other medical, psychiatric, or social condition incompatible with the study treatment

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No more than 45 days since prior definitive biopsy