cyrilzakka/clinical-trials huggingface dataset:
Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection

The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism
* Bleeding portal hypertension
* INo evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
* Informed consent to participate in the study

Exclusion Criteria:

* Hepatocellular carcinoma or any other malignancy
* Hypercoagulable state other than the liver disease related
* DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs
* Base line INR \>2
* Child-Pugh grade C
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy
* Uncontrolled Hypertension
* Age\>75 yrs
* Human immunodeficiency virus (HIV) infection
Cellular Immune Augmentation in Colon and Rectal Cancer

While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
* Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
* Patient must be able to be taught to administer GM-CSF subcutaneously

Exclusion criteria:

* Known allergic or other adverse reaction to GM-CSF
* Chemotherapy administration more frequently than bi-weekly
* Pregnant or lactating women
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis

This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 65 years old, having signed the informed consent;
* fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
* BASDAI score more than 4;
* stop taking DMARDs for at least 4 weeks;
* NSAIDs dosage has been stable for at least 4 weeks;

Exclusion Criteria:

* Intra-articular injection of cortisone within 3 months.
* History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
* Accompanied by fibromyalgia or other rheumatic diseases;
* Female of pregnancy or breast feeding;
* History of mental disease and poor compliance.
* History of drug abuse or alcoholism.
SV2A in Older Adults

The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using \[11C\]UCB-J PET imaging.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Male or female, aged ≥50 years
* No history of significant medical or neurological disease
* BMI ≤ 50
* If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans

Exclusion Criteria:

* Women with a positive pregnancy test or women who are lactating
* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
* History of a bleeding disorder or are currently taking anticoagulants
* Subjects who have donated blood within 8 weeks of the present study
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine

To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.

Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with

1. Caudal end of the instrumentation at S1
2. Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

Stratification of both groups by:

* Number of instrumented levels
* Sagittal balance (Roussouly type 1+2 vs. 3+4)

Prospective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
* Lumbar or thoracolumbar Instrumentation
* Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
* Age ≥ 18 years

Exclusion Criteria:

* Scoliosis \>20°
* Chronic steroid usage
* Significant co-morbidity influencing the surgical success:

  * Osteoporosis
  * Rheumatoid arthritis
  * Mental illness/dementia
Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block In Shoulder Arthroplasty Surgery

The suprascapular nerve, originating from the C5 trunk, provides innervation to the acromioclavicular and glenohumeral joints. The supraclavicular nerve, a branch of the cervical plexus, contributes to the sensory innervation of the upper deltoid region. Cervical and brachial plexus blocks can cause diaphragm paralysis. This study examined the effects of low-volume combined anterior suprascapular nerve block and superficial cervical plexus block on pain and phrenic nerve in participants underwent reverse shoulder arthroplasty surgery.

A retrospective analysis was performed on data obtained from eight participants who underwent reverse shoulder arthroplasty surgery. Anterior suprascapular nerve block and superficial cervical plexus block were applied to these participants. Anterior suprascapular nerve block was performed using 5 ml and superficial cervical plexus block was performed using 3 ml of %0,5 bupivacaine. Ultrasound was used to measure the diaphragm thickness at the end of inspiration and expiration, and to calculate the diaphragm thickness fraction. Postoperative pain management included patient-controlled analgesia with morphine, opioid consumption and VAS score recorded by pain observation forms.

Data will be collected by examining these pain observation forms and diaphragm thickness measurements.

Eligibility Criteria:
Inclusion Criteria:

* Population is defined by database within a given time frame
* Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
* Participants aged 18-80
* ASA I-II-III

Exclusion Criteria:

* ASA score \> III
* Pediatric individuals under 18 years of age
* Individuals who are pregnant
* Known diaphragmatic paralysis
* Had an allergy or toxicity to local anesthetic agents
* Have an opioid drug allergy
Detecting Transitional Cell Carcinoma From Haematuria

To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.

The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC early is crucial to increase the chances of a cure. Cystoscopy, which is currently the standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive procedure but, while several potential markers in urine have been studied with the goal of replacing cystoscopy, no urinary marker alone or in combination with others has shown sufficient accuracy.

In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine samples collected from patients referred to the haematuria clinic with visible or microscopic haematuria. These values will be linked to the subsequent diagnosis of each patient, and used to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving written informed consent
* Age ≥18 years
* Referral to haematuria clinic (gross or microscopic haematuria)

Exclusion Criteria:

* Inability to provide written informed consent
* Previous radiotherapy to the bladder (e.g. prostate cancer)
* Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
* Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
* Other known malignant condition, either active or in complete remission ≤5 years
* HIV, hepatitis C, or any other known communicable disease
Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

Social-emotional difficulties and unhealthy lifestyle behaviors are prevalent among children in the U.S. and are associated with negative health outcomes. These challenges are even more pronounced among families who deal with major stressors, such as parental trauma history and mental health difficulties, parental chronic illness (e.g., HIV), parental substance use, economic disadvantage, and racial discrimination. The purpose of this study is to assess the feasibility, acceptability, and preliminary efficacy of a parent-based preventive intervention targeting parental self-regulation, stress reduction, and positive parenting, to promote child social-emotional and lifestyle behavior health, among families where the parents (a) have a child aged 3 to 9 years old, (b) have concerns about their child's behavior, mood, and/or lifestyle health, and (c) are experiencing major stressors. The intervention to be tested is based on Family Life Skills Triple P.

Eligibility Criteria:
Inclusion Criteria:

1. Child between the ages of 3-9 years
2. Parent/caregiver willing to engage in the intervention who

   * is at least 18 years of age
   * is primary caregiver or guardian for the participating child
   * has concerns about the child's mood, behavior, and/or lifestyle health
   * is experiencing two or more major stressors of the following: trauma history, mental health difficulties, living with HIV, racial discrimination, substance misuse, and/or financial strain
   * is English speaking.

Exclusion Criteria:

a. Parent or child has

* a significant cognitive disability, developmental delay, or pervasive developmental disorder
* active suicidal or homicidal ideation
* psychotic symptoms (active hallucinations, delusions, or impaired thought processes)
* ongoing family violence occurring within the home and/or active involvement of child protect services related to child maltreatment allegations.
The Effect of Anesthesia Type on RIRS

Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing.

The purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.

RIRS with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia.

Anesthesia type is decided in the basis of medical condition of a patient and patient's preference.

This study is a prospective observational study. During operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10).

According to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group.

Investigators will compare the scale for visual stability of surgical field during RIRS.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring RIRS because of renal stone.

Exclusion Criteria:

* disagreement for the trial.
Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration.

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
* AGE\>15 years
* ASA II status
* No history of hypertension, preeclampsia or cardiopathy
* BMI\<40

Exclusion Criteria:

* cesarean section under genearl anesthesia or epidural analgesia during labor
International PPB/DICER1 Registry

Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the discretion of the treating institution. This study builds off of the 2009 study and will also seek to enroll individuals with DICER1-associated conditions, some of whom may present only with the DICER1 gene mutation, which will help the Registry understand how these tumors and conditions develop, their clinical course and the most effective treatments.

PPB is a rare cancer of the lung presenting in early childhood, mostly commonly from birth to age \~72 months. PPB occurs within the lung or between the lung and the chest wall. There are three primary forms of PPB called Types I, II, and III PPB. PPB is related to an underlying change/mutation in a gene called DICER1 which impacts gene expression and cell growth. DICER1 mutations may also lead to the development of other tumors in children and adults.

The International PPB/DICER1 Registry offers information based on previous data from Registry participants and the medical literature and collaborative efforts with international rare tumor groups.

Retrospective and real-time central pathology review is encouraged. Therapy decisions remain at the discretion of the treating institution.

Children with Type I PPB require surgery and sometimes chemotherapy. Therapy decisions are the responsibility of the treating institution. Surgical guidelines are presented. It is unknown whether adjuvant chemotherapy improves cure rates for Type I PPB patients. Chemotherapy options include a 22-week regimen: 4 courses of vincristine, actinomycin D and cyclophosphamide (VAC) followed by 3 courses of vincristine and actinomycin D (VA).

Children with Types II and III PPB, require surgery, chemotherapy and sometimes radiation therapy. Many children with Types II or III PPB receive a single-arm multi-agent chemotherapy neo-adjuvant/adjuvant regimen of IVADo (ifosfamide, vincristine, actinomycin, doxorubicin) for 36 weeks. Second and possible 3rd look surgery may be considered for local control. Radiation therapy may be considered.

Eligibility Criteria:
Inclusion Criteria:

1. Known or suspected PPB or related thoracic tumor
2. Known or suspected sex-cord stromal tumor including Sertoli-Leydig cell tumor and gynandroblastoma (males or females)
3. Other known or suspected DICER1-related condition including ovarian sarcoma, cystic nephroma, renal sarcoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, ciliary body medulloepithelioma and others
4. Individuals with known or suspected DICER1 pathogenic variation regardless of whether they have an established DICER1-associated condition
5. Informed consent by patient/ or parent/guardian (also, where appropriate: assent and HIPAA consent)

Exclusion criteria:

Absence of appropriate consent for Registry participation
Nutrition and Exercise Program for Elderly Colorectal Cancer Patients

The goal of this interventional study is to evaluate the effect of mobile health intervention on frailty, physical fitness, physical activity, and nutritional status of elderly patients with colorectal cancer. The main questions it aim to answer are: 1. Does the mobile health intervention reduce frailty in elderly colorectal cancer patients compared to standard care? 2. Does the mobile health intervention improve physical fitness, physical activity, and nutritional status in elderly colorectal cancer patients compared to standard care? Participants will receive the Mobile Health Management Frailty Care Program.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with colorectal cancer confirmed by a physician.
* Aged 60 and above.
* Have communication skills, able to read and write or converse in Mandarin and Taiwanese.
* Clear consciousness and no mental or cognitive impairment.
* Physical activities are accessible.
* Those who have a smartphone and have experience using smartphones.

Exclusion Criteria:

* People who have difficulty walking or standing.
* The wrist is not suitable for those wearing sports bracelets.
* People in infectious or protective isolation.
* Those who live alone or in institutions.
Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)

Aim of the study is an examination whether a modified perioperative pain management system, that integrates the 2017 European Society of Anaesthesiology (ESA) guidelines for treatment of postoperative Delirium, can improve patient's wellbeing in comparison to the current certified standard management.

Aim of the study is to evaluate whether the integration of the 2017 ESA guidelines for treatment of postoperative Delirium in a pain management, can improve patient's wellbeing in comparison to the current certified standard management. Adherence to the modified management includes minimizing nil per os time, renouncing benzodiazepines, 1.8 ltr crystalloid infusion per day, simplified standard medication option and postoperative 12µg/h Fentanyl TTS for 72h (for wound pain).

Eligibility Criteria:
Inclusion Criteria:

* adult patients with hip fractures that have to be operated (ICD S72.01-S72.2)

Exclusion Criteria:

* severe liver damage
* ongoing dialysis therapy
* Monoamine oxidase inhibitor intake
* inability to give consent to trial participation
Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy

We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy, thereby hastening electrosurgical transection, reducing activation time and reduce lateral thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished, due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.


Eligibility Criteria:
Inclusion Criteria:

* All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign disorder will be asked to participate and included after written informed consent.

Exclusion Criteria:

* pregnancy
* malignancy
* if uterine size exceeds 20 weeks of gestation
* or if the uterus could be removed by a vaginal approach