cyrilzakka/clinical-trials huggingface dataset:
Tranexamic Acid in Nasal Mohs Reconstruction

This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

Tranexamic acid (TXA) is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA has been extensively described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding and epistaxis. Studies have suggested administration of TXA may improve outcomes in aesthetic surgery as well, specifically regarding intraoperative bleeding and postoperative ecchymosis and hematoma formation. TXA may be administered systemically, via IV or PO routes, or locally, via topical application or subcutaneous injection. Local administration allows for similar benefits with minimal risk of systemic effects.

Following facial Mohs reconstruction patients often experience surgical site ecchymosis and swelling, which may be distressing, painful, prolong healing, and result in increased healthcare utilization. Other complications include hematoma, wound dehiscence, and suboptimal scarring. Given the growing body of literature demonstrating the benefits of TXA in surgical bleeding outcomes, TXA may also be beneficial in improving postoperative Mohs complications and patient satisfaction.

To date, no studies have investigated the use of perioperative TXA specifically in nasal Mohs reconstruction. This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

Eligibility Criteria:
Inclusion Criteria:

1. Adults at least 18 years of age undergoing local flap reconstruction (bilobe flap, note flap dorsal nasal flap, advancement flap) of a nasal defect following Mohs micrographic surgery. Reconstructive procedures will be performed by Drs. Yang or Patel in the division of Facial Plastic Surgery in the Department of Otolaryngology, Head and Neck Surgery at Vanderbilt University Medical Center.
2. No other facial plastic procedure or sinus surgery performed simultaneously.
3. Lack of all the below exclusion criteria.

Exclusion Criteria:

1. Known allergy to TXA
2. Intracranial bleeding
3. Known defective color vision
4. History of venous or arterial thromboembolism
5. History of coagulation disorder
6. Active thromboembolic disease
7. Severe renal impairment (diagnosis of chronic kidney disease)
8. History of acute myocardial infarction
9. History of stroke
10. History of seizure
11. History of liver failure
12. Preoperative lab results indicating thrombocytopenia (platelets \<150,000), increased bleeding risk (PT over 45, INR over 1.2).
Improving Perinatal Outcomes Using Conditional and Targeted Transfers

It has been estimated that increasing the use of skilled care during childbirth could prevent up to 1.5 million maternal and newborn deaths and stillbirths by 2025. Conditional cash transfer programs, in which women receive cash payments conditioned on the use of maternal health services, are increasingly being used as a mechanism to increase uptake. In this study, the investigators randomly assign households to receive varying cash amounts conditioned on uptake of recommended pregnancy and delivery care. The investigators crosscut this with an intervention in which pregnant women receive information about their risk type. This randomized trial will provide new evidence about the potential efficacy of targeting cash transfers by pregnancy risk. This study will take place in 288 primary health service areas (HSAs) in Nigeria.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 15-49 who reside in the participating health service areas

Exclusion Criteria:

* none
Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)

Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.

A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.

We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.


Eligibility Criteria:
Inclusion Criteria:

* patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. Fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects such as maternal acidosis.

The objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary outcome was maternal arterial pH at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years
* Single fetus pregnancy
* Fetus with myelomeningocele
* Gestational age from 19 to 26
* Fetus with normal karyotype

Exclusion Criteria:

* Multiple pregnancy
* Fetal abnormality not related to myelomeningocele
* Kyphosis greater than or equal to 30 degrees
* Placenta previa
* Maternal disease that increases the risk of pregnancy (insulin-dependent DM, hypertension poorly controlled)
* History of incompetent cervix
* Carrier of HIV, hepatitis B or hepatitis C
* Maternal-fetal isoimmunization
* Uterine Alteration
* Obesity (IMC greater than 30)
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes

The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.


Eligibility Criteria:
Key Inclusion Criteria:

* Completed study drug treatment in parent study (VX19-445-116, NCT04353817), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study

Key Exclusion Criteria:

* History of study drug intolerance in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply
ONO-4538 Phase II Rollover Study (ONO-4538-98)

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit

Exclusion Criteria:

1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia
2. Participant judged by the investigator to be inappropriate as participants of this study
White Matter Integrity According to BDNF Genotype After Stroke

The aim of this study was to investigate differential plastic changes of fractional anisotropy (FA) in the corticospinal tract (CST), the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (M1PMv) and the corpus callosum (CC) from 2 weeks to 3 months after stroke according to BDNF genotype.

The aims of this study were to investigate plastic changes in the fractional anisotropy (FA) of three motor-related white matter fibers according to the BDNF genotype from 2 weeks to 3 months after stroke onset; one is a the majority of fibers from M1 to medullary oblongata (CST), another is the intrahemispheric connection from M1 to ventral premotor cortex (M1PMv), and the other is the interhemispheric connection between bilateral M1s (CC). There were also to investigate the relationships between motor impairment and tract-related FA of white matter tracts in each BDNF genotype

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with first-ever hemispheric ischemic infarction with damage to the supratentorial area confirmed by brain MRI within 2 weeks after stroke onset

Exclusion Criteria:

* any clinically significant or unstable medical disorder or neuropsychiatric comorbidity
Diazoxide In the Management Of Hypoglycemic Neonates

Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the causes of hypoglycemia in infants of diabetic mothers occurs due to a transient hyperinsulinemic state postnatally. The investigators have clinical experience and success using diazoxide in their unit for patients with hypoglycemia not adequately managed with intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study the investigators expect that by using diazoxide as the initial treatment for infants of diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the investigators will be able to decrease the number of infants requiring an intravenous by at least thirty percent.


Eligibility Criteria:
Inclusion Criteria:

* Infants of diabetic mothers (IDMs) or infants weighing \>90%
* Hypoglycemia: two consecutive blood glucose measurements \<2.6mol/L and \>1.9mmol/L in the first twelve hours of life
* \> 36 weeks gestational age

Exclusion Criteria:

* Infants with symptomatic hypoglycemia (regardless of value
* Infants who meet criteria for intravenous dextrose according to the Canadian Pediatric Society (CPS) position statement
* Infants with contraindications for enteral feeds and/or medications
Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Each of the Two Laparoscopic Routes (Conventional and Robot-assisted).

Benign total hysterectomy is one of the most commonly performed gynecological surgery.

Conventionally performed by a classical surgical approach, it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy.

A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access, using a vaginal trans-laparoscopic technique, defined by the name V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery).

These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters (signing, surgical trauma, pain and post-operative ileus, recovery of autonomy) and consider possible management in the outpatient sector.

This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled.

The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 years old and over
* Participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled
* Participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, V-Notes, robot-assisted laparoscopy)
* Patient eligible for outpatient treatment
* Participant affiliated or beneficiary of a social security regimen
* Participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research)

Exclusion Criteria:

* Participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure)
* Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study
* Participant in another research
* Participant in a period of exclusion from another research still in progress at the time of inclusion
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent
PROFILE-MI - The FAPI Fibrosis Study

The investigators here propose to investigate the timing and pattern of myocardial fibrosis activity following acute myocardial infarction using hybrid 68Ga-FAPI positron emission tomography and cardiovascular magnetic resonance. The investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling. Simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will be assessed enabling the exploration of the presence of unstable atheroma.

Fibrosis is a fundamental process underlying almost all cardiomyopathic conditions. Established fibrosis can be detected by existing imaging techniques including cardiovascular magnetic resonance. However, these techniques are not specific for fibrosis and do not directly measure fibrosis activity or matrix remodelling. This limits the ability to detect early disease and differentiate active from end-stage phenotypes. Fibroblast activation protein is a key factor in fibrogenesis that is expressed in the myocardium following myocardial infarction and in thin-capped fibroatheroma. Radiolabelled fibroblast activation protein inhibitor (68Ga-FAPI) measures in vivo fibrosis activity and matrix remodelling, as supported by preliminary pilot studies. The timing and pattern of myocardial fibrosis activity following acute myocardial infarction will be investigated using hybrid 68Ga-FAPI positron emission tomography. The investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling. Simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will also be assessed allowing exploration of the presence of unstable atheroma. This project will enhance understanding of fibrosis activity and matrix remodelling in myocardial infarction and unstable atherosclerotic plaque with potential future application to a broad range of cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* specific to cohort;
* aged 50 years or older

Exclusion Criteria:

* Claustrophobia
* Inability to undergo MRI
* eGFR \<30ml/min/1.73\^m2
Electrical Nerve Block for Amputation Pain

The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.

The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 21 years old
* Unilateral amputated leg ≥ 12 months
* Chronic post amputation pain ≥ 6 months
* Pain episodes typically lasting ≥ 60 minutes
* Stable drug regimen ≥ 4 weeks
* No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

* Implanted with an active implantable medical device (i.e. pacemaker)
* Confounding source of pain that interferes with reporting of limb pain
* Uncontrolled diabetes
* Spasticity preventing full range of motion of involved side
* Extremely short stump; sits on end
* Untreated psychological condition (i.e. borderline personality)
* Condition requiring MRI studies or diathermy after device implant
* Life expectancy of less than 24 months
* Progressive neurological disease (i.e. multiple sclerosis)
* Subjects with active local or systemic infection or immunocompromised
Non-invasive Tools for PSVD Diagnosis

Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.

PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.

Eligibility Criteria:
Inclusion Criteria:

1. Received platinum chemotherapy for organ tumors;
2. Ages 18-80;
3. sign the informed consent voluntarily.

Exclusion Criteria:

1. Liver pathology suggested cirrhosis;
2. Underwent liver transplantation;
3. Combined with hepatocellular carcinoma exceeding Milan criteria;
4. Complicated with severe heart, kidney, or lung failure;
5. Pregnant or lactating women;
6. Data is seriously missing;
7. Patients were judged not suitable for participation in this study by the researchers.
Safety and Performance of POLYTHESE® Vascular Prosthesis

POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.

PMCF Study.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:

- Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

- none
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or above
2. Patients with advanced gastric cancer or locally advanced gastric cancer
3. Have not received any previous anti-tumor therapy
4. Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Adequate organ function

Exclusion Criteria:

1. Patients with contraindications to immunotherapy
2. Have received anti-tumor treatments such as immunotherapy and chemotherapy
3. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
4. Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
5. History of allogeneic stem cell transplantation or organ transplantation
Minimally Invasive Benign Hysterectomy

A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.

Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
* size of uterus and vagina allows for retrieval by the vaginal route
* maximum uterine size equivalent to 16 weeks of pregnancy
* informed consent

Exclusion Criteria:

* malignant disease
* known extensive intra-abdominal adhesions
* anaesthesiological contraindications to laparoscopic surgery
* women with pacemaker or other implants where electrosurgery is to be avoided
* immunoincompetent women
* simultaneous need for prolapse surgery
* women with known defects of the hemostasis
* allergies towards metronidazole and doxycycline
* inability to understand patient information