cyrilzakka/clinical-trials huggingface dataset:
Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial

The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

Background: The use of laparoscopic surgery in the management of advanced gastric cancer (AGC) has not yet met with widespread acceptance and remains limited to only a few centers.

Intervention: According to tumor pathological stage (JGCA, 2nd English ed), location of tumor, and patient clinical condition, a laparoscopy-assisted radical gastrectomy and open gastrectomy were performed. Laparoscopy-assisted radical gastrectomy consisted of the following procedures: 1) laparoscopic dissection of the lesser and greater omentum, ligation and division of the main vessels to mobilize the stomach under pneumoperitoneum, 2) laparoscopic D2 lymph node dissection, based on the Guidelines of the Japan Gastric Cancer Association and 3) resection of the distal two thirds (LADG), proximal third (LAPG), or total stomach (LATG), depending on the location of the tumor, followed by reconstruction by the Billroth I, Billroth Ⅱ, esophagogastrostomy, or Roux-en-Y method through a 3 to 5-cm-long minilaparotomy incision.

Follow-up schedule: All patients were monitored postoperatively by physical examination, and blood tests including a test for serum carcinoembryonic antigen (CEA) at least every three months for the ﬁrst year, every six months for the next two years, and every year for the fourth and fifth year, and thereafter by abdominal ultrasonography, CT, chest radiography, and gastroscopy at least once each year.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven gastric adenocarcinoma
2. Age:older than 18 years old,younger than 80 years old
3. Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0,cT3N2M0
4. ASA score:≤3
5. Patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded
6. No history of other cancer
7. No history of chemotherapy or radiotherapy
8. Written informed consent

Exclusion Criteria:

1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
4. ASA score:\>3
5. Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
6. Complicated case needed to get emergency operation
7. Any accompanying surgical condition needed to be performed in same time
Mutation Analysis of 17βhydroxysteroid Dehydrogenase 3 Deficiency

To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

17βhydroxysteroid dehydrogenase 3 (17βHSD3) deficiency is a rare cause of male pseudohermaphroditism. The incidence is reported to be 1: 147,000 in the Netherlands. Fewer than one hundred affected 46, XY males were reported in the literature, and no such case has been reported in Taiwan before. The 46, XY patients have ambiguious or complete female external genitalia. They are mostly unrecognized at birth and reared as female. They often draw medical attention when they receive operation for inguinal hernia or during puberty, clitoromegaly and musculization were noticed. However, the homozygous or compound heterozygous genetic females are asymptomatic. The 17βHSD3 catalyze the conversion of androstenedione to testosterone, the last step in the synthesis of testosterone. Therefore, the serum levels of androstenedione are elevated and testosterone or dihydrotestosterone are in the low range in these affected 46, XY individuals. The clinical diagnosis is made by HCG stimulation test, because androstenedione-to-testosterone ratio is abnormally elevated in these patients. But the molecular basis of 17βHSD3 deficiency was not determined till recent decade.

The HSD17B3 gene was elucidated in 1994, and composed of 11 exons. Several missence mutation and splice mutation were identified. But the precise action and tissue distribution of 17βHSD3 still need to be clarified. The Wölffian ducts virilze normally in the embryonic stage and the serum concentration of testosterone achieve to the normal range in the pubertal stage. The exact mechanism is not understood clearly and peripheral conversion under other isozymes was suggested in some studies.

The purpose of this study is to disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 17β-hydroxysteroid dehydrogenase 3 deficiency and their family
Exercise in Patients With Glioblastoma

Patients with newly-diagnosed GBM will be given personalized exercise regimes during concurrent chemo-radiation and up to 3 months later. Study aims are to investigate the feasibility and preliminary efficacy of the exercise program on progression free survival. Secondary outcomes of interest include cognition, fatigue, and quality of life.

Background: Glioblastoma (GBM) is the most common malignant glioma in adults, with a very poor prognosis, limited new treatment options, and neurological sequelae, including physical and cognitive decline that adversely affect quality of life (QOL). Physical activity may be an intervention that attenuates the cognitive and physical decline associated with GBM. However, few studies examine physical activity in brain tumor patients, perhaps due to challenges in trial design, measuring outcomes, and complexity of care. Aims of this work are to develop and implement an individualized exercise intervention for GBM patients to support functional independence, and to delay tumor progression and cognitive decline. Methods: GBM patients scheduled to be treated with concurrent radiation and chemotherapy will be recruited from the neuro-oncology clinic at the Princess Margaret Cancer Centre. Participants will receive an individualized, home-based exercise program that includes aerobic and resistance training, tailored to prior level of fitness, current physical status, and individual interests. They will undergo 1-hr standardized, validated assessments of physical and neurocognitive functions, mood, fatigue, and QOL, prior to radiation, and then 3, 6, 12, and 18 months later. Significance: Identifying interventions that preserve or improve mobility and cognitive function will enhance QOL and may lengthen progression-free survival in brain tumor patients. Moreover, finding ways to help patients maintain self-care will lessen the strain on the health care system (e.g., fewer hospitalizations, delayed utilization of palliative care hospice).

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed glioblastoma
* fluent in English
* scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)

Exclusion Criteria:

* brain metastases secondary to non-central nervous system cancer
* less than 18 years old
* receiving treatment at a location other than the Princess Margaret Cancer Centre
* deemed unfit to exercise by a study oncologist
* lack of fluency in English
* psychiatric or neurological disorders that could interfere with participation
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

In patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (IPAA) surgery\* a short interval to loop ileostomy reversal will result in differences in complications and quality of life compared to a long interval to loop ileostomy reversal.

Aim #1: To compare the Comprehensive Complication Index (CCI), the incidence of postoperative complications, including total number of complications per patient, percent of patients with complications, and total number of ostomy-related complications per patient among IPAA patients who have their ileostomy reversed after a short interval compared to a long interval.

Aim #2: To compare the short vs. long interval groups on measures of health-related quality of life (PROMIS) and IPAA functional outcomes

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consents.
* Man or woman between 18 and 64 years of age.
* Ulcerative colitis (UC) or indeterminate colitis (IC) diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria.
* Patient will be scheduled for non-emergent proctocolectomy or completion proctectomy with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).
* Clinical assessment of patient after IPAA surgery indicates that patient is suitable for early ileostomy reversal

Exclusion Criteria:

* Age \< 18 or \> 64 years
* Colon or rectal cancer
* Crohn's disease or suspected Crohn's disease
* Prednisone dose \> 20 mg per day (or equivalent other steroid dose) within 4 weeks of scheduled IPAA
* Body mass index (BMI) equal to or greater than 40 kg/m2
* Hemodynamic instability (persistent pulse rate \< 50 or \> 120 bpm, systolic blood pressure \< 90 or \> 160 mm Hg, uncontrolled cardiac arrhythmia, or active vasopressor drug use)
* Organ transplant recipient (e.g. Liver, Kidney, Pancreas)
* Immunosuppression due to chemotherapy drug use or systemic disease.
* Sepsis
* Renal insufficiency (i.e. serum creatinine ? 2 mg/dl or need for dialysis)
* Therapeutic anticoagulation (e.g. venous thromboembolic disease, prosthetic heart valve)
* Blood Hemoglobin \< 8 g/dl
* Serum Albumin \< 2.5 g/dl
* Individualized decision by the surgeon to exclude the patient based on sound surgical judgment
* Pregnant patients and female patients who do not satisfy the standard of care requirements of participating centers for an elective surgical procedure.
* Clinical assessment of patient after IPAA surgery indicates that patient is not suitable for early ileostomy reversal
* Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial
* Well-founded doubt about the patient's cooperation.
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older
2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:

   1. Morning stiffness in and around the joints lasting at least 1 hour;
   2. Arthritis of 3 or more joint areas;
   3. Arthritis of hand joints;
   4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
   5. Rheumatoid nodules;
   6. Serum Rheumatoid Factor (RF)
   7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
4. Patients naive to anti-TNF drugs
5. Outpatients

Exclusion Criteria:

Patients involved in controlled or interventional trials in the 12 previous months
Diet and Omega-3 Intervention Trial on Atherosclerosis

The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice.

The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.

The basis for recruitment was a follow up of subjects participating in the Oslo Diet and Anti Smoking Study (1972-1977) characterised as hypercholesterolemic in 1972.

Measurements of the outcome variables were performed at baseline and after 36 m; blood sampling also after 6 and 18 m.

In addition to the main outcome variables, a biobank was established for future analyses.

Clinical events were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Elderly men with long standing hypercholesterolemia (cholesterol \> 6.45 mmol/L and \< 8.00 mmol/L) with or without coronary heart disease.

Exclusion Criteria:

* Cholesterol \> 8.00 mmol/L, blood pressure \> 170/100
* Uncontrolled hypertension
* Socially or otherwise unsuitable subjects
* Anticipated non compliance
* Other major non cardiac illness expected to reduce life expectancy or interfere with study participation.
Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction

To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the association.

To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then use HPLC-MS/MS to measaure the plasma levels of methionine metabolites, such as SAH, SAM, and use methylated specifical PCR to detect the promoter DNA methylation of p66shc, and use ELISA kits to measure the plasma ROS levels of CVD patients, such as MDA, 8-iso-prostaglandin F2a, and finally analyze the association between SAH, ROS levels, promoter DNA methylation of p66shc, and flow-mediated dilation.

Eligibility Criteria:
Inclusion Criteria:

* patients who have stable clinical conditions, except for acute coronary syndromes, and the availability of measurement of flow-mediated dilation, or have more than three cardiovascular traditional risk factors, such as smoking, alcohol use, obesity, hypertesion, diabetes, family history, and so on.

Exclusion Criteria:

* critical illness or hemodynamic instability other than acute coronary syndromes, surgery, or trauma within the previous month, known cancer, hepatic failure or hepatitis, or the use of drugs, such as anticancer agents, which would affect plasma tHcy concen-trations.
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)

The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.

The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.


Eligibility Criteria:
Stent underexpansion as stent expansion of \<80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).
A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765

This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30 Non-smoker for at least 4 weeks

Exclusion Criteria:

* Any clinically relevant acute or chronic disease
* History of substance abuse Hypersensitivity to ketamine
The Effect of Pramlintide on Meal Time Insulin Bolus

The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

Pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. As such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. Current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. By using continuous glucose monitoring(CGM) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. We anticipate that the reduction in bolus dosage will be about 25%. In addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age: \>17
* Type I diabetes
* Onset of diabetes \>3 months
* Use of insulin pump \>3 months
* Hb A1C \<8.9%
* Demonstrated compliance to clinic visits
* Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter
* Monitor blood glucose \>4/day

Exclusion Criteria:

* Pregnancy or nursing
* Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.
* Renal failure (creatinine \>1.5 mg/dl
* Symptomatic gastroparesis
* Using a medication that would interfere with insulin sensitivity
* Treatment with extenatide or DPP IV inhibitor within the last 4 weeks
* HbA1C change \>0.9 % within the last 3 months
* Significant change in eating or activity pattern
* Weight change of \>1.9 kg within the last 3 months
* ALT \>3 times upper limits of normal
Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive)
* Current smoker of \< or = 10 cigarettes/day
* Fagerström score \< or = 5
* Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Current or recurrent buccal lesions
Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)

Study Phase: phase 1 and phase 2

Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in patients with relapsed multiple myeloma previously treated with lenalidomide

Study design: prospective, multicenter, non-randomized

The REPEAT-study is a prospective, multicenter, non-randomized phase 1 and phase 2 study in which we evaluate the effect of lenalidomide, cyclophosphamide and prednisone (REP-therapy) in patients with relapsed multiple myeloma, previously treated with lenalidomide and refractory to lenalidomide monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* salmon \& Durie stage II/III A or B
* previous lenalidomide refractory disease
* patient commits to pregnancy prevention programme

Exclusion Criteria:

* non-secretory myeloma
* known hypersensitivity to lenalidomide
* inadequate marrow reserve
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to give written informed consent
2. Completion of the study 6002-009

Exclusion Criteria:

1. Mini-mental status examination score of 23 or less
2. Less than 70% of compliance in the study 6002-009
3. Emergency deviation in the study 6002-009
4. Pregnant females
Digital Techniques

The present study is performed to evaluate clinical performance and patient satisfaction of innovative digital techniques for fabrication of monolithic ceramic crowns

Digital dentistry has progressed rapidly in the last few years, primarily to improve and enhance the practice of dentistry through the advancement in digital tools and techniques, providing improved accuracy and precision, enhancing patient experience, increasing efficiency and productivity, thereby resulting in better treatment outcomes, whilst also improving clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with posterior molars indicated for full coverage restorations.
* Patient able to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:

* Patient in the growth stage with partially erupted teeth.
* Patient with poor oral hygiene and motivation.
* Patients with parafunctional habits.