cyrilzakka/clinical-trials huggingface dataset:
The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)

The goal of this exploratory validation study is to compare levels of expertise (or non-expertise) between GI fellows and experts with the varix trainer. The main question it aim to answer is:

Can the varix trainer distinguish levels of expertise (or non-expertise) between novices and experts for specific skills (torque, small wheel and retroflexion techniques)? Does the training with the varix trainer improves these specific skills of GI fellows? Participants will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.


Eligibility Criteria:
Inclusion Criteria:

* We enrolled participants from Ramathibodi hospital King Chulalongkorn Memorial hospital Siriraj hospital Rajavithi hospital Vajira hospital Nanthana-Kriangkrai Chotiwattanaphan Institute of Gastroenterology and Hepatology Srinagarind Hospital

  1. Expert (\> 1,500 EGD)
  2. Trainees (First and second year fellow)

Exclusion Criteria:

* Deny to participate in our study
The Genetics of Chiari Type I Malformation

Duke University Medical Center is investigating the hereditary basis of Chiari type I malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if CM1/S is indeed caused by factors inherited through the family and, if so, which genes are involved.


Eligibility Criteria:
The study is not currently enrolling new participants.
Research in Autism: Parent Intervention

The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autistic Disorder or At Risk of Autistic Disorder
* Age 2-0 to 3-11 years of age
* Use of fewer than 10 functional words at intake

Exclusion Criteria:

* Primary diagnosis of mental retardation
* Neurologic pathology (e.g., PKU, encephalitis, brain trauma)
* Major sensory impairment
Lutein and Alzheimer's Disease Study

Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants may suppress this free radical damage associated with AD. Carotenoids are a family of naturally occurring antioxidants that have important functions for human health. Carotenoids are known to reduce oxidative damage, but their effects have not been studied in AD patients.

The objective of the study is to examine whether lutein supplementation helps to reduce oxidative damage from free radicals in AD patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderately severe Alzheimer's disease
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.


Eligibility Criteria:
Inclusion Criteria:

* uterine myoma
* be planning to laparoscopic myomectomy
* images ; the number of myoma \<4
* images ; the diameter of the largest myoma \<9cm

Exclusion Criteria:

* be planning other surgery in addition to laparoscopy
* clinically significant coagulation abnormality
Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites

The low sodium intake is important for ascites control in liver cirrhosis patients. Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients or the general population in practice. For this reason, it has been suggested that a spot urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However, the evidence is not sufficient for that. The investigators will evaluate the usefulness of spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K, Creatinine (Cr).

● Detailed Description:

1. Measurements: they should be performed for 2 days (the urine collected within 24 hrs)

   * 24-hour urine Na, K and Creatinine (patients were instructed to collect all subsequent urine voids over the next 24-hour period including the ﬁrst void of the following day.)
   * Spot urine Na, K, Creatinine with the same urine sample in some containers provided to patients. (every urination)
2. Calculation

   * Na/K Ratio with spot urine Na, K
   * Estimating 24-hour urine Na with spot urine Na, K, Cr by using some formulas.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhotic patients with ascites diagnosed by imaging study, biopsy or clinically, regardless of taking diuretics.

Exclusion Criteria:

* Uncontrolled sepsis or systemic infection.
* Serum Creatinine \>1.5 mg/dL.
* Patients who are being treated for cancers except hepatocellular carcinoma.
* Patients who refuse the examine or are not cooperative.
Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

OBJECTIVES:

* Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer.
* Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients.

OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed lung cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* May have received prior EGFR inhibitors
SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project

This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old).
* Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
* Availability of a 18F-FDG PET/CT scan or a full dose CT scan (without contrast media) pre-treatment with CART
* Written informed consent voluntarily provided

Exclusion Criteria:

* Patients not fulfilling the eligibility criteria
Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

This study evaluates a culturally-modified version of Thrive, a computerized Cognitive Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural Montanans. Study participants will be randomized to either a wait-list treatment as usual or the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary assessment measure is the Patient Health Questionnaire-9.

Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression.

Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.

The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Baseline PHQ-9 score of 5 or greater
* Montana resident
* Regular access to broadband internet (streaming capability)

Exclusion Criteria:

* No broadband internet access
* Aged 17 years or younger
* Does not have Montana residency
* Baseline PHQ-9 score of \< 5
The Experiences of People Who Live With Glanzmanns Thrombasthenia.

To understand the lived experiences of people with Glanzmanns Thrombasthenia

A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia

Exclusion Criteria:

Acquired Glanzmanns Thrombasthenia
Orexin-A Levels in Insomnia Patients

In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. In the literature, investigators could not attain any studies about the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide on the emergence process from anesthesia was investigated by comparing plasma OXA levels before and after anesthesia in insomnia patients.

ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent elective laparoscopic cholecystectomy were included in the study. Patients were evaluated with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative examination and were divided into insomnia and control groups. Blood samples were obtained for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation. The times from stopping anesthesia to eyes opening and extubation and end-tidal sevoflurane concentrations at these time points were recorded.

Eligibility Criteria:
Inclusion Criteria:

* male patients undergo elective laparoscopic cholecystectomy under general anesthesia
* Between 18-65 age
* ASA I-II

Exclusion Criteria:

* ASA≥III
* Patients with obstructive sleep apnea syndrome
* Bleeding over 500 ml
* Allergic to anesthetic agents
* Patients with a BMI \> 30 kg/m2
To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors

The overall goals of this study are to demonstrate the change in renal tubular function in living donors pre and post nephrectomy at 6 months.

The physiologic sequelae of living kidney donation are still poorly understood. Uni-nephrectomy from donation results in decreased number of glomeruli and research has shown that there is glomerular hyperfiltration and glomerular hypertrophy. Uni-nephrectomy also results in a decreased number of tubules, but there is not much data about possible tubular injury post donation and its long term effects on donors.

Our overall hypothesis is that post uni-nephrectomy tubular function, measured by maximum urine concentration capacity, will be decreased and may be a more sensitive marker of kidney damage than standard tests, such as urine albumin, serum creatinine, estimated glomerular filtration rate (eGFR), or measured urine creatinine clearance (CrCl). The goal of this study is to evaluate the effect of uni-nephrectomy on renal tubular function and its potential in being an early and more sensitive marker in kidney injury when compared to standard tests.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years of age, who has been evaluated and approved as a potential living donor by the multi-disciplinary committee. All donors undergo a standard medical, social, and psychological pre- donation assessment
* Only patients who are able to sign their own consent form may be included in this study.
* Subjects must be able and willing, in the investigator's opinion, to complete all study requirements.

Exclusion Criteria:

* Subjects denied for donation for any medical, social or surgical reason to be living donor.
* Patients who are contraindicated or relatively contraindicated for DDAVP: a. patients with von Willebrand disease; b. Patients with habitual or psychogenic polydipsia; c. Patients with coronary artery insufficiency and/or hypertensive cardiovascular disease; d. Patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, and renal disorders; e. Patients predisposed to thrombus formation
Tight Glycaemic Control During Cardiac Surgery

To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.

Eligibility Criteria:
Inclusion Criteria:

* age \> 15 years
* cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* active infection
* insulin allergy
* off-pump cardiopulmonary bypass procedures
The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.

To evaluate the safety and efficacy of hair products containing probiotics

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers between the ages of 20-70.

Exclusion Criteria:

* Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
* Subjects with cosmetics allergy.
* Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
* Subjects with pregnancy or breast-feeding.
Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery disease and peripheral arterial disease. This auto-antibodies could activate endothelial cells leading to the expression of leukocyte adhesion molecules and increasing the release of pro-inflammatory cytokines.

On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary pathogenic event, as it occur before structural changes are evident on angiogram or ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local coagulation alterations and an increase arterial wall proliferation. This situation s been attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free radical formation in the context of the pro-inflammatory status found in atherosclerosis.

Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Peripheral arterial disease diagnosis
* Intermittent claudication.
* Hemodynamic confirmation of the disease through non-invasive vascular studies.

Exclusion Criteria:

* Autoimmune disease
* Previous revascularization of the ischemic limb.
* Ischemic ulcers
* Previous history of organ transplants.
* Treatment with immunosuppressors
Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome

The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score\>8\[10\], and an apnea/hypopnea index (AHI\>15/h) before and after catheter-based radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should be stable during the whole study time. Primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.


Eligibility Criteria:
Inclusion criteria: We plan to include male or female subjects, age 18-80 with a diagnosis of medium-severe sleep apnea syndrome (defined by symptoms, a complaint of excessive daytime sleepiness, an Epworth sleepiness score \>8, and an apnea / hypopnea index \>15/h) and a resistant hypertension (systolic blood pressure \>140 mmHg or \>130 mmHg in patients with type II diabetes or chronic kidney disease, under treatment with three antihypertensive drugs including a diuretic).

If the selected patients are treated with CPAP, this therapy should be stable during the whole study time.

Every patient will be asked for a written informed consent.

Exclusion criteria: - Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).

* Long acting nitrates, or PDE-5-Hemmer
* Alcohol or drug abuse,
* Malignancy (unless healed or remission \> 5 years)
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Pulmonary Hypertension (PAP\>50 mmHg)
* Pregnancy
* Anatomical contraindication to renal denervation
* Know allergy to contrast
* Participation in another study within the last month
Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
* All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
* Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
* Reports from pre and post treatment imaging will be required at time of registration to document response.
* Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
* Patients may have received previous adjuvant or neoadjuvant therapy.
* No prior antiangiogenic therapy for this stage of the disease.

Exclusion Criteria:

* Major surgery within 4 weeks of starting the study treatment.
* NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
* History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
* Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
* Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Patients with history of or who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA(obtained within one month of registration or the next business day if falls on a weekend or holiday).
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \> 2.
* Unresolved bacterial infection.
* Uncontrolled hypertension.
* Pre-existing thyroid abnormality that can not be controlled medically.
* Concurrent treatment on another clinical trial.
* Pregnant or breast-feeding
Change in Taste Sensation After Orthognathic Surgery

Orthognathic surgery refers to jaw operations that can be performed on the upper jaws (Le Fort I osteotomy) and lower jaws (Sagittal Split Ramus osteotomy). In orthognathic surgery practice, taste perception could be affected by potential damage to peripheral nerves that conduct chemosensory information regarding gustation from the palate and tongue. This study aimed to evaluate the changes in the sense of taste after Le Fort I osteotomy, Sagittal Split Ramus osteotomy, and bimaxillary surgery.

The subjects were orthognathic surgery patients with facial skeletal deformities who applied to the Department of Oral and Maxillofacial Surgery. Thirty-five patients, aged 17-42 years, gustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. In the tests, solutions containing sucrose for a sweet taste, sodium chloride for a salty taste, citric acid for a sour taste, and quinine hydrochloride for a bitter taste were used. Patients were compared between the operation group they were in and between operation groups.

Eligibility Criteria:
Inclusion Criteria:

* dentofacial deformity
* American Society of Anesthesiologists category 1 or 2

Exclusion Criteria:

* zinc, iron, and/or vitamin deficiencies
* oncological, neurological, endocrinological, and rheumatological diseases
* chronic drug use due to systemic disease
* smokers
* history of chemotherapy and radiotherapy to the head and neck region, orthognathic surgery, maxillofacial trauma, and damage to the nerves related to the taste sensation