cyrilzakka/clinical-trials huggingface dataset:
Promoting Asylum-seeking and Refugee Children's Coping With Trauma

A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children.

The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.

Teaching Recovery Techniques (TRT) was developed by Children and War Foundation (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental reactions to being exposed to war and catastrophes. TRT has proven to be effective in reducing trauma-related mental health symptoms in such contexts. However, it has never been used with children experiencing all the uncertainties and stress of an asylum-seeking context, or with refugee children in high-income countries. The main aim of the present study is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in the context of four different care conditions: 1)asylum-seeking children who arrived accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and older living in asylum centers regulated by the Directorate of Immigration 4) Former unaccompanied asylum-seeking children who have been granted residence (refugees) and are resettled in a municipality in Norway.

Based on Power analyses, the target group is 40 children in each care condition (total n = 160) \> 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.

The study employs a randomized clustered experimental design that includes a waiting list control group, which will receive the TRT when the intervention group has completed the program.

Eligibility Criteria:
Inclusion Criteria:

* Accompanied asylum-seeking children living in reception centers,
* Unaccompanied asylum-seeking children living in reception centers
* Unaccompanied refugee minors who have been granted residence

Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items

-

Exclusion Criteria:

* Psychosis,
* Mental disabilities
Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth

The purpose of this project is to compare "usual care" for chronic low back disorders in a rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy (PT) into a rural health care team:

1. in-person PT assessment, where the PT travels from an urban center
2. interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth.

The project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. The hypothesis is that an interprofessional Telehealth assessment with be as effective as an in-person PT assessment, but more effective than usual care.

The study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the intervention, the NP involved in the telehealth-based intervention group may alter their "usual care" practice; therefore, the control group participants will be drawn from the practices of 2 NPs not involved in the Telehealth intervention providing services out of a different clinic. Each PT and the NP alone will complete a standardized online diagnostic classification tool.Participants will be randomly assigned to one of the three groups.

Eligibility Criteria:
Inclusion Criteria:

* adult 18-80
* low back pain and/or related leg pain affecting function, \>3 months duration

Exclusion Criteria:

* clients within a third party payer insurance coverage system
* clients with primarily neck or thoracic pain
* clients with language or comprehension difficulties that would limit completion of paperwork
Circadian Rhythm of Melatonin in Burns

Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* 5-18 years old

Exclusion Criteria:

* anoxic brain injury
* preexisting neurological disorder
* pre-existing sleep disorder
* no informed consent or HIPAA release
Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.

Amanita toxin-associated acute liver failure is a life-threatening condition that can often lead to the need for an emergency liver transplantation. The disease may also be fatal, particularly in patients who are not eligible for a liver transplant due to advanced age or corresponding comorbidities.

Therapeutic plasma exchange treatment has been shown to significantly improve patient survival in other cases of acute liver failure and has since become standard treatment for acute liver failure in many, but not all, liver transplant centers. However, no patients with Amanita toxin-associated acute liver failure were included in these cohorts.

The hypothesis of the planned study is that an additive therapeutic plasma exchange treatment (PEX) can improve liver transplantation-free survival in these patients compared to standard medical therapy (SMT) alone. Since the therapy procedure in different transplant centers in differs with regard to the use of therapeutic plasma exchange, we are therefore planning a multicenter retrospective comparison of PEX with SMT with regard to transplant-free survival and other clinical endpoints. For this very small cohort of patients with acute liver failure, which also varies in frequency depending on the season and weather conditions, there will certainly never be a sufficiently powered randomized and controlled study. This analysis may change the standard procedure for patients with Amanita toxin-associated acute liver failure.

Eligibility Criteria:
Inclusion Criteria:

* Acute liver failure (presence of hepatic encephalopathy of grade I or higher and a coagulopathy with an INR \> 1.5)
* Amanita Toxin related acute liver failure

Exclusion Criteria:

* Acute liver failure of other reason than Amanita Toxin
* Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure
Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer

In this study, we will investigate the diagnostic efficacy and safety of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.

  (3) Written informed consent signed by the subject or his/her legal guardian or caregiver.

  (4) Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.

(4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.
Meditation and Student Empathy

Physician empathy and reducing stress are major factors in attaining positive clinical outcomes for patients. Fostering empathy in medical students is particularly important as they are the future of the healthcare workforce and a trend of declining empathy during medical education may lead to decreased health care quality outcomes. Meditation may be an avenue to promote positive student attitudes including empathy, though very few studies have examined this idea through empirical research. Using validated measures, the Jefferson scale of empathy and the perceived stress scale, we seek to investigate whether use of a meditation app will be associated with higher levels of self-rated empathy and lower self-rated stress.


Eligibility Criteria:
Inclusion Criteria:

-Medical students from New York Institute of Technology

Exclusion Criteria:

-Not a medical student
Dopamine Reuptake Inhibitors of Cocaine Abuse - 1

The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Correlation of Measurements From Mespere Venus 1000 System & Echocardiography to Estimate Right Atrial Pressure

The purpose of this clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.

The non-invasive assessment of the pressure on the right side of your heart using an imaging machine called a Doppler echocardiography machine (also known as an ECHO machine) is a widely accepted technique and is used as a screening tool for pulmonary hypertension and heart failure. The pressure on this side of your heart reflects the pressure of the blood in your veins returning to your heart and the effectiveness of your heart to pump that blood to your lungs. The accuracy of this technique depends on making an accurate estimate of the pressure in the upper chamber (atrium) of the right side of your heart, known as your right atrial pressure (RAP). Right atrium pressure can be measured non-invasively by imaging of your heart using an echocardiography (aka ECHO) machine. But the technique depends on the skills of the sonographer (the person who operates the ECHO machine) and can take considerable time to complete.

In view of this limitation, a non-invasive technique that could be used to make the RAP measurements may be more reliable and/or faster than the current technique.

Mespere Lifesciences Inc. has developed a new non-invasive device that is expected to allow for a simple, rapid and reliable measurement of RAP. The device consists of a set of light sensors on a patch that is placed onto the surface of the patient's right side of the neck.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patient referred to St. Michael's Hospital Echocardiography Lab
* Signed written and informed consent

Exclusion Criteria:

* Lack of patient consent
* Presence of known AV dialysis fistula
* Allergy to adhesive tape from Mespere Venus 1000 system
* Known central vein stenosis
* Unable to identify right external jugular vein
* Ongoing photodynamic therapy
* Assisted ventilation
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection

Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that \~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected \>T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.


Eligibility Criteria:
Inclusion Criteria:

* Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction);
* Cancer stage pT1N+M0 or pT2-3N0M0;
* Radical R0 resection;
* Retrieved lymph node number ≥15;
* Without hepatic, peritoneal, or other distant metastasis;
* Aged 18-70 years;
* No other cancer-directed therapy except primary cancer resection;
* Good tissue and organ function: white blood cell count ≥4000/mm3; neutrophil count ≥1500/mm3; platelet count ≥100000/mm3; total bilirubin ≤25.7 μmol/L or within 1.5 times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate \>60 mL/min;
* No serious cardiovascular or cerebrovascular disease;
* No concomitant or previous malignancies;
* Enrolled within 6 weeks after resection;
* Eastern Cooperative Oncology Group (ECOG) score ≤2;
* Clavien-Dindo morbidity score 0-2;
* Patient informed consent.

Exclusion Criteria:

* The need to take phenytoin or coumarin anti-coagulates;
* Allergic to capecitabine or fluorouracil;
* Known DPD activity deficiency (DPYD gene mutation);
* Pregnant or breeding women;
* All others contradictory to the items listed in the Inclusion Criteria.
Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

This is a prospective clinical study aiming to tests the safety and efficacy of lenvatinib in combination with gefitinib in people with lenvatinib resistant hepatocellular carcinoma. This study will help find out if lenvatinib and gefitinib is a safe and useful combination for treating patients with lenvatinib resistant hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the Study of Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) clinical diagnostic criteria of hepatocellular carcinoma; (3) Barcelona Clinic Liver Cancer (BCLC) Stage B or C, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) progressing after standard treatment; (5) Unresponsive or resistant to Lenvatinib; (6) Child-Pugh A or scored 7 B; (7) Eastern Cooperative Oncology Group performance status score \<= 1; (8) Platelet count \>= 60x10\^9/L, Prothrombin time prolonged \<= 6 seconds.

Exclusion Criteria:

(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients need long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) Patients with unstable or active ulcer or gastrointestinal bleeding; (4) Heart disease requiring treatment or not well controlled high blood pressure; (5) Patients with interstitial pneumonia; (6) Hepatic encephalopathy or refractory ascites requiring treatment; (7) There is a clear active infection; (8) Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (9) Severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (10) Other accompanying anti-tumor treatments; (11) The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight

Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females between 18 and 70 years
* Obese (BMI \> 30 kg/m2 and 55 kg/m2)
* Non-smokers or smoking cessation \> 6 months
* \< 14 alcoholic beverages per week
* Willing and able to give informed consent

Exclusion Criteria:

* Active participation in any weight loss program within previous 3 months
* Weight changes of \> 5% body weight within previous 3 months
* Participated in an Optifast program within prior 5 years
* Prior bariatric surgery or liposuction
* Use of any medication prescribed for weight loss in the past 3 months
* Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis)
* Type 1 DM
* Current ESRD
* Current COPD
* Any major or active hepatic disease requiring inpatient or outpatient treatment
* History of acute pancreatitis in the past year
* Active cancer treatment in the past 2 years other than non-malignant skin cancers
* Uncontrolled hypertension (Blood pressure 160/100 or greater)
* Hemoglobin A1c \> 10%
* Recent CV event in past 6 months
* Pregnancy, childbirth, or nursing within prior 6 months
* Eating Attitudes Test (EAT-26) \> 30
* Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score \> 16
* Schizophrenia, history of bipolar disorder
* Recent hospitalization for psychiatric illness in past 6 months
* Dependence on alcohol or sedative-hypnotic drugs
* Intolerance or allergy to Optifast product
* Unable to read/speak English
* Orthopedic limitation preventing participation in regular physical activity
* Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism
* Major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way
* Inability to complete the 7-day run-in satisfactorily
SodiUm Restriction by Behavioral Intervention

The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.

Patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. Sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. The test persons with sodium excretion higher than 90mmol/24h will receive intensive education. Test persons in the control group receive standard care. After 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. Within 3 months of total study duration, data collection and measurements take place at the end of every month.

At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients\>14 years of age and \<70 years of age
* Diagnosed immunoglobulin A nephropathy with biopsy;
* eGFR\>30ml/min per 1.73m2 using Chronic Kidney Disease Epidemiology Collaboration formula
* Proteinuria \>1 g per day
* urinary sodium excretion \>200 mmol per day within one month
* systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg, or a well-controlled blood pressure by treatment with antihypertensives including renin-angiotensin-aldosterone system-blockade (ACE-inhibitor or ARB)
* Written informed consent

Exclusion Criteria:

* Be treated with diuretics
* Blood pressure \> 180 mmHg systolic or \> 125 mmHg diastolic without medical treatment
* Have undergone renal transplantation
* With acute kidney injury (RIFLE criteria) \< 6 months ago
* Cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) \< 6 months ago
* With progressive malignancy or pregnancy
* With contraindications of RAAS blockers
* unwilling or unable to meet the requirements of the protocol
GnRH Agonist and Antagonists in an Oocyte Donation Program

The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.

The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).

Eligibility Criteria:
Inclusion Criteria:

* oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;

Exclusion Criteria:

* PCO
Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia

Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years

Eligibility Criteria:
Inclusion Criteria:

* primary idiopathic trigeminal neuralgia

Exclusion Criteria:

* secondary trigeminal neuralgia
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

The aim of this study was to analyze the safety, pulmonary function, and imaging changes of patients with silicosis treated with autologous bone marrow stromal cells with modification by hepatocyte growth factor.


Eligibility Criteria:
Inclusion Criteria:

- age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 \<60% and \> 40%, FVC \> 60% and SaO2 \>90%

Exclusion Criteria:

- smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy