cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer

The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).

The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 and \<75 years old;
2. The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma \[pap\], tubular adenocarcinoma \[tub\], mucinous adenocarcinoma \[muc\], signet ring cell carcinoma \[sig\], and poorly differentiated adenocarcinoma \[por\]);
3. Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM);
4. It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors)
5. Preoperative ECOG status score of 0/1;
6. Preoperative ASA (American society of anesthesiology) class of I -III;
7. Patients signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Serious mental illness;
3. History of abdominal surgery (except for laparoscopic cholecystectomy);
4. History of gastric surgery (including ESD/EMR for gastric cancer);
5. Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm)
6. Other malignant disease history within five (5) years;
7. Patients who received or were recommended a new adjuvant therapy;
8. History of unstable angina or myocardial infarction within six (6) months;
9. History of cerebral infarction or cerebral hemorrhage within six (6) months;
10. History of sustained systemic corticosteroid therapy within one (1) month;
11. Patients requiring simultaneous surgical treatment of other diseases;
12. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;
13. Pulmonary function test with FEV1 \<50% of the expected value.
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older

The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female participants ≥1 years old at Visit 1.
* Participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-diary for 7 days for participants after each of 3 vaccinations.
* Participants and/or a legally acceptable representative/parent/legal guardian must be able to be contacted by telephone during study participation.
* Participants and/or a legally acceptable representative/parent/legal guardian are capable of giving signed informed consent.

Exclusion Criteria:

* Major known congenital malformation or serious chronic disorder.
* Known history of TBEV infection.
* Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West Nile virus).
* Known history of infection with HIV, HCV, or HBV.
* Immunocompromised participants with known or suspected immunodeficiency.
* History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
* Previous vaccination with any licensed or investigational TBE vaccine, or planned receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue fever) during the study. Administration of JEV vaccine is prohibited during participation.
Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.

There are 2 sections of this trial. Step1: the patients will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study. Step2: Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). After 6 cycles of induction therapy, all patients were followed for survival data every 12 week until disease progression, disease recurrence, death, or study termination. Patients with progression were also followed up for survival data as above. Overall survival will be followed up to 3 years after the last subject entered the study. Establishing the feasibility of chemo-free treatment in primary central nervous system lymphoma will provide the foundation for a larger study of efficacy and long-term outcomes of chemo-free therapy for patients with PCNSL.

Eligibility Criteria:
Inclusion Criteria:

* • Newly diagnosed primary central nervous system lymphoma

  * Pathological type is B cell lymphoma
  * Age 18-70 years
  * Demonstrate adequate marrow hemopoietic function as defined below:WBC\>3.0×109/L,ANC\>1.5×109/L,HGB\>90g/L,PLT\>80×109/L
  * Demonstrate adequate organ function as defined below: cardiac function grade 0-2（NYHA）；SpO2\>88%( natural state)；ALT\<3UNL，TBil\<2ULN; SCr\>60ml/min/m2
  * Having at least one measurable lesions
  * Sign the Informed consent

Exclusion Criteria:

* • The pathological diagnosis was T-cell lymphoma.

  * systemic lymphoma involved CNS
  * Pre-existing uncontrolled active infection
  * Acute myocardial infarction or unstable angina within 6 months; Uncontrolled hypertension and arrhythmia
  * Active bleeding
  * Allergic to any component of the investigational product.
  * Subjects who are suspected to be unable to comply with the study protocol
  * Pregnancy or active lactation
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference

In this observaltional study, 240 patients aged \>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be included.We aim to compare patients' adherence to Mediterranean diet (MD) before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics, as well as anthropometric measurements, BMI, body composition, lipid levels, blood pressure and gut microbioma. Moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.

This observational study will include 240 participants (80 participants per country) from IGI region (Italy, Greece and Israel), children adolescents and young adults (12\> years old) with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system. After a 7-day run-in period, participants will be evaluated with food intake log and adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. One hour session on MD and healthy impact on Diabetes will be provided to all participants and will be assigned to initiate MiniMed 780G and followed for 12 weeks. HbA1c, CGM and Insulin Metrics, anthropometric measurements, body composition, blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks, after MiniMed 780G initiation. A 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study. At baseline, at 6 and at 12 months, markers of endothelial and cardiovascular function will also be assessed. An extension phase will include additional 3 and 6, which concludes one year of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c \< 12.5%
3. Age \>7years at the initiation of the system
4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
5. Clinically able to start the AHCL system
6. History of 3 clinic visits in the last year

Exclusion Criteria:

1. Diabetic Ketoacidosis in the 6 months prior to screening visits

-
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)

The study uses a multi-site, cluster design to determine the effectiveness of an intervention based on a Trauma Collaborative Care (TCC) model in improving patient outcomes for persons with severe orthopedic trauma and enhancing both patient and provider satisfaction with overall care. The study will also determine the cost and cost-effectiveness of the intervention.

Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus standard treatment will result in lower rates of the composite outcome (i.e. positive for poor function, depression, and/or PTSD).

Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus standard treatment will result in lower levels of pain and higher rates of return to usual major activity and higher levels of health related quality of life. In addition, both primary and secondary outcomes will correlate strongly with the intermediate outcome of self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated surgically for one or more orthopaedic injuries with initial admission to the trauma service of the participating hospital
2. Ages 18-60 yrs inclusive
3. Length of Stay (LOS) \>=5 days or \>= 3 days with planned readmission for additional procedures
4. At least one orthopaedic injury of AIS 3 or greater (determination based on information available at the time of enrollment) resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, high fall). Injuries can include those to the upper or lower extremities, pelvis/acetabulum or spine.
5. Traumatic amputations of the upper or lower extremities (excluding amputations to fingers or toes)

Exclusion Criteria:

1. Initial admission to non-trauma service.
2. Peri-prosthetic fractures of the femur, regardless of etiology
3. Patient eligible for the METRC OUTLET Study, i.e. patient with:

   1. Gustilo type III distal tibia and/or foot or type III B or C ankle fractures with fracture pattern consistent with one of OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C, 81B2-B3, 82B, and 82C;
   2. Open or closed industrial foot crush injuries;
   3. Open or closed foot blast injuries.
4. Patient requiring a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
5. Patient non-ambulatory due to an associated spinal cord injury
6. Patient non-ambulatory pre-injury
7. Non-English speaking
8. Patient diagnosed with a severe psychosis
9. Patient lives outside the hospital's catchment area and/or follow-up is planned at another medical center
10. Severe problems with maintaining follow-up expected (e.g. patients who are prisoners or homeless at the time of injury or those who are severely intellectually challenged).
The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients

The purpose of this study is to determine the effects of music therapy-based relaxation stress/reduction strategies on the frequency/severity of toxic side-effects of marrow ablative chemotherapy and the timing of immune reconstitution in patients undergoing bone marrow/stem cell transplantation.

The regimen-related toxicities associated with bone marrow transplantation (BMT) can be severe and even life threatening. The overall goal of this randomized controlled pilot study in BMT patients is to determine the effect of relaxation/stress reduction strategies on: (1) the frequency/severity of toxic side effects of marrow ablative chemotherapy, and (2) the timing of immune reconstitution. Substantial literature indicates that music therapy-based interventions are effective in inducing relaxation and also affect immune function by modulating circulating and salivary levels of such agents as cortisol, immunoglobulin A, interleukin-1, natural killer cells, and a variety of other immune system-related substances. Over the past two years, we have provided music therapy-based stress reduction/relaxation interventions to a convenience sample of patients undergoing BMT. Preliminary findings from this pilot feasibility study demonstrate that patients report significantly decreased pain (p\< .004) and sense of nausea (p \< .001) following an intervention. Average time-to-engraftment was 13.5 (+/- 2.85) days as compared to 15.5 (+/- 4.40) days (p \< .O1) for a group of historical controls matched on diagnosis, type of transplant, conditioning regimen, date of transplant, age, and gender. Although highly promising, our data are limited by lack of randomization, an appropriate control condition, measurement of psychologic factors known to influence outcome in BMT, and systematic monitoring of early phase markers of immune reconstitution that could help explain the phenomena we have observed. This proposal corrects these shortcomings and especially highlights the potential mediational effect of cytokine release on regimen-related toxicities and the timing of immune reconstitution.

Eligibility Criteria:
Inclusion:

Recipient of bone marrow/stem cell transplant

Exclusion:

None
Genetic Testing for Type 2 Diabetes

In this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. We hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.

In this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for type 2 diabetes on psychological, health behavior, and clinical outcomes. Eligibility criteria included age 21 to 65 years, overweight or obese (body mass index \[BMI\] \>27 kg/m2), and no prior diagnosis of type 2 diabetes. At baseline, participants (N=601) had conventional risk factors assessed, including demographics, fasting plasma glucose (FPG), and family history. They also provided blood samples for genetic testing of TCF7L2, PPARG, and KCNJ11, three genes that confer elevated risk for development of type 2 diabetes. Participants were then randomized to receive conventional counseling plus control eye disease counseling (CR+EYE) or conventional counseling plus genetic test results (CR+G). Two to four weeks following the baseline visit, when the genetic test results were available, participants returned for a visit with a genetic counselor. All participants received conventional risk counseling based on their lifetime population risk, FPG results, and family history. Next, participants were informed of their randomization assignments; CR+EYE participants received counseling on eye diseases, whereas CR+G participants received genetic counseling. Then perceived risk, affect, self-efficacy, and readiness to change were assessed. All other outcomes were also assessed at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* body mass index \>27 kg/m2
* baseline fasting plasma glucose \<=125 mg/dL

Exclusion Criteria:

* prior diagnosis of type 2 diabetes
* fasting plasma glucose \>125 mg/dL on more than one occasion
* HbA1c \> 7%
* taking diabetes medication
* actively losing weight
* enrolled in research study focusing on lifestyle changes
* unable to provide informed consent or answer survey questions unassisted
* residing in nursing home or receiving home health care
* active diagnosis of psychosis or dementia
* at least one error on 6-item cognitive screener
Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis

The aim of this study is to verify the ability of transglutaminase type 2 to predict rejection or chronic allograft nephropathy of renal allograft. On the basis of biomolecular mechanisms aggravating chronic allograft nephropathy, we eventually expect to develop the remedy to prevent chronic allograft nephropathy after kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* kidney transplant recipients from cadaveric or living donors
* kidney transplant recipients who take immunosuppressants regularly
* kidney transplant recipients who voluntarily agree to participate in this trial

Exclusion Criteria:

* multiorgan transplant recipients
* kidney transplant recipients with active infection
* kidney transplant recipients with alcohol or drug addiction
Using Deep Learning Methods to Analyze Automated Breast Ultrasound and Hand-held Ultrasound Images, to Establish a Diagnosis, Therapy Assessment and Prognosis Prediction Model of Breast Cancer.

The purpose of this study is using a deep learning method to analyze the automated breast ultrasound (ABUS) and hand-held ultrasound(HHUS) images, establish and evaluate a diagnosis, therapy assessment and prognosis prediction model of breast cancer. The model would provide important references for further early prevention, early diagnosis and personalized treatment.

1. Establishing a database By collecting ABUS, HHUS and comprehensive breast images data, essential information, clinical treatment information, prognosis, and curative effect information, a complete breast image database is constructed.
2. Marking ABUS images Three doctors use a semi-automatic method to frame the lesions on the image.
3. Building the model Using the deep learning method to preprocess, analyze and train the marked images, and finally get a model diagnosis, efficacy evaluation and prognosis prediction model of breast cancer.
4. Evaluating the model 1）Self-validation： Analyze the sensitivity, AUC of the breast cancer diagnosis model and the false-positive number on each ABUS volume.

2) Compared the sensitivity, AUC and the false-positive number with a commercial diagnosis model.

3)To test the screening and diagnostic efficacy of computer-aided diagnosis systems through prospective or retrospective studies.

4)By analyzing the size and characteristics of the lesions after neoadjuvant chemotherapy, and predicting the OS and DFS time, the therapy assessment and prognosis prediction model were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients over 18 years old who come to the two centers for physical examination or treatment;
2. Complete basic information and image data

Exclusion Criteria:

1. There is no complete ABUS and HHUS images data;
2. The image quality is poor;
3. In multifocal breast cancer, the correlation between the tumor in the image and the postoperative pathological examination is uncertain.
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars

Background: The acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance.

Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF) or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

Thirty patients suffering from moderate or severe acne scars were randomly assigned into two equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was assessed before and after treatment by using the clinical evaluation scale for acne scarring (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of life and the emotional impact of acne scars were evaluated by the facial acne scar quality of life (FASQoL) scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to severe acne scar
* Patients with acne scar in the face

Exclusion Criteria:

* Smokers and alcohol drinker
* Patients who had a history of diabetes, circulatory or sensory disorders
* Patients who had a history of frequent sunburns
* Patients with nodulocystic acne
Minimal Erythema Dose of UV-B in Normal Population of Taiwan

There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people. We will investigate the correlation of skin phototype, constitutive skin color, facultative skin color and minimal erythema dose in Taiwanese.

The skin phototype will be obtained from a structuralized questionaire. The constitutive skin color and facultative skin color will be obtained by chromameter. The minimal erythema dose will be obtained by physician's assessment.

Eligibility Criteria:
Inclusion Criteria:

10-65 years old normal healthy volunteers

Exclusion Criteria:

Age under 10 years old or older than 65 years old People with a past history of photo-sensitivity People who had been treated with phototherapy
Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland

The aim of this investigation is to determine whether the use of painPREMIER will significantly improve function in patients with low back pain in an occupational health clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of back pain and associated problems in order to treat them most effectively.

Patients presenting at feeder sites to be referred to low back pain clinic and assessed for eligibility A decision was made to terminate this study on 09 OCT 2013. The study was terminated for operational/business reasons. This study was not terminated for reasons of safety or efficacy.

Eligibility Criteria:
Inclusion Criteria:

* New episode of low back pain
* Member of Terveystalo health insurance scheme

Exclusion Criteria:

* Previous back pain related healthcare visit in the last 3 months
* Patients identified as having a 'red flag' condition