cyrilzakka/clinical-trials huggingface dataset:
Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who aged 18 years or older
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
4. Subjects with no other malignancy diagnosed within past five years except for:

   * Cured non-melanoma skin cancer
   * Cured cervical intraepithelial neoplasia (CIN)
   * Cured In-situ cervical cancer (CIS)
5. Subjects who are ECOG performance status of ≤ 1
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students

This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.


Eligibility Criteria:
Inclusion Criteria:

* Full-time medical student at a participating medical school
* Will remain enrolled as full-time medical student throughout duration of study

Exclusion Criteria:

* Not a full-time medical student at a participating medical school
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).

Primary Objectives

-To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.

Secondary Objectives

-To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.
2. Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
3. Age \> 18 years and \<= 75 years.
4. Karnofsky Performance Status \>= 70%.
5. Corrected DLCO \>= 40%
6. Left ventricle ejection fraction (LVEF) \> 30%.
7. ALT and AST must be \<= 3X normal. Total bilirubin \<= 3 mg/dL unless hemolysis or Gilbert's disease.
8. Estimated creatinine clearance \>= 50 ml/min.
9. Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.
10. Signed informed consent.
11. Patients with prior malignancies diagnosed \> 5 years ago without evidence of disease are eligible.
12. Patients with a prior malignancy treated \< 5 years ago but have a life expectancy of \> 5 years for that malignancy are eligible.

Donor Inclusion Criteria

1. Age \>=17.
2. HIV seronegative.
3. No contraindication to the administration of G-CSF.
4. Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate

Exclusion Criteria:

1. Uncontrolled active infection.
2. Uncontrolled congestive heart failure or angina.
3. Pregnancy or nursing patients will be excluded from the study.
4. Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.

Donor Exclusion Criteria

1. Serious medical or psychological illness.
2. Pregnant or lactating women are not eligible
3. Prior malignancies within the last 5 years except for non-melanoma skin cancers
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
* Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
* Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

* Subjects on felbamate with less than 18 months exposure.
* Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
* Presence of known pseudoseizures within the last year.
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
* Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
PCA Administration in Prosthetic Joint Infection

Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection

Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate

Eligibility Criteria:
Inclusion Criteria:

* 3 weeks or more after total knee arthroplasty
* One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
* WBC count of aspirate \>50,000 cells per μL

Exclusion Criteria:

* Not willing to undergo blood draw at 3 months.
Exercise Intervention for Employees of the University of Bern

As part of a Swiss National Science Foundation SNSF project (On-site multi-component intervention to improve productivity and reduce the economic and personal burden of neck pain in Swiss Office-Workers, NEXpro = Neck EXercises for productivity, SNSF no. 32003B_182389, BASEC no. 2019-01678), the investigators first developed a physiotherapeutic exercise intervention to improve the strength and mobility of the neck muscles. In the SNSF project NEXpro, the intervention took place on-site in the office. However, in view of the digital transformation, it is important to adapt the intervention delivery method to the new virtual work setting. The aims of the present project are therefore to implement, further develop and contextually adapt the exercise intervention in order to reduce musculoskeletal complaints and to reduce health-related presenteeism. The final product is a user-friendly virtual 6-week short exercise intervention that employees of the University of Bern can use independently, regardless of time and place. The effectiveness of the newly developed short exercise intervention (pain reduction, reduction of presenteeism) will be assessed during a short pilot phase.


Eligibility Criteria:
Inclusion Criteria:

* Employees of the Faculty of Human Sciences of the University of Bern who
* suffer from neck pain or would like to prevent neck pain
* are between 18 and 65 years of age
* understand German (written and oral)
* have a predominantly sedentary job
* have given written consent to participate in the study.

Note: Neither gender, age, education nor group affiliation play a role. The investigators particularly welcome participation from mid-level employees. If students are willing to participate, they may also do so, but this group will not be actively recruited.

Exclusion Criteria:

* Existing severe neck pain grade IV (neck trauma, neck injury, specific pathologies (e.g. congenital cervical anomalies, stenosis, radiculopathy), inflammatory conditions (e.g. rheumatoid arthritis), history of cervical surgery)
* If physical activity is contraindicated by the doctor for any reason (e.g. due to unresolved hypertension).
Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated as a technique to measure the density of VV. Previous studies have demonstrated a relationship between identification of VV and relationship to vascular events such as stroke and myocardial infarction. No previous study has reported the utilization of contrast-enhanced ultrasound identification of VV in the carotid bed as a means of identifying patients at high risk for acute coronary events.

Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels along with carotid intima media thickness (CIMT), a known marker for acute coronary events. The investigators will attempt to measure the correlation of VV with acute coronary events independent of traditional cardiovascular disease (CVD) risk factors and CIMT.

Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled. All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and measurement of CIMT while obtaining baseline histories and assessment of traditional risk factors for coronary artery disease. VV density and CIMT will be measured in all patients. Statistical differences in VV among the three groups will be assessed and analyses will be made to attempt to identify if VV in the carotid bed is an independent predictor of acute coronary events after controlling for CIMT and traditional risk factors.

Study population: The study population will reflect the patient population of UPMC. No individual will be excluded on the basis of race, gender, or ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals referred for elective left heart catheterization in the past three months or individuals who have undergone recent left heart catheterization for acute coronary syndrome in the past 3 months

Exclusion Criteria:

* Inability to provided informed consent
* Pregnancy or of lack confirmed urine or serum B-hcg testing in pre-menopausal women under the age of 50
* Known allergy to Definity (registered trademark)
* Contraindications to Definity including permanent or transient right to left or bidirectional cardiac shunts, allergy to perflutren, severe pulmonary hypertension
* Known cocaine abuse within the past year
* History of heart transplantation
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)

A prospective, interventional rehabilitation program was initiated to improve exercise capacity and psychosocial functioning in patients after lung transplantation (LTx) and to evaluate long-term effects on health-related quality of life (HRQoL).

Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.


Eligibility Criteria:
Inclusion Criteria:

* Lung transplant (single, double, combined heart-lung) (6-9 mts post Tx)
* Stable health condition at study entry (pt stays within home environment)
* Age ≥ 18 yrs
* Sufficient language skills to answer questionnaire
* Follow-up at our center
* Willingness to participate by written informed consent

Exclusion Criteria:

* BOS III diagnosis before study inclusion
* Episodes of recurrent acute rejections
* Medical contra-indication for regular exercise ergometer training
* Malignancy
* Multi-resistent pathogens
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.

Please see brief summary.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.
2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.
3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.

Exclusion Criteria:

1. Women who are pregnant, planning a pregnancy, or lactating.
2. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.
3. Current treatment of cancer or diagnosed with cancer in the past 6 months
4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).
5. Current use of TN or other forms of NRT.
6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).
Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.

This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.

Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.

Eligibility Criteria:
Inclusion Criteria:

(I) subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index \< 20%.

Exclusion Criteria:

(I) patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
* Moderate to severe depression
* Current MDE duration of at least 3 months

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute respiratory distress syndrome and death even in healthy young individuals. The respective roles of viral replication, bacterial infection and immune alterations of the host during such severe influenza H1N1v infection need to be clarified in order to optimize patients care. In this context, we aim to study immune and virological parameters in bronchoalveolar lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections and to peripheral blood immune and virological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Suspected influenza A/H1N1 infection
* Diffuse bilateral pneumonia \<96h with acute lung injury or respiratory distress syndrome
* Invasive or non-invasive ventilation in intensive care unit
* Age \> 13

Exclusion Criteria:

* Other cause identified of acute lung injury or acute respiratory distress syndrome
* Contraindicated bronchoalveolar lavage
Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy

This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion.

No investigation drug product will be administered in the study


Eligibility Criteria:
Inclusion Criteria:

* Treated with gene therapy of diabetes 2 type in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study
* Able to comply with study requirements
* Provision of written informed consent for this study by subjects or as applicable subject legal/parent guardian

Exclusion Criteria:

* There are no exclusion criteria for this study
Evaluation of California's SB 19 Pupil Nutrition Act

Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The impact of early implementation of SB 19 on academic achievement will also be assessed.

Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual.

The nutrition provisions in SB19 include assuring that NO elementary school sells carbonated beverages at any time and that no middle schools sell carbonated beverages until after the end of the lunch hour each day. The nutrition provisions also include some restrictions on the sale of high-fat, high-sugar snack foods as well as encouragement to make fruits and vegetables more available to students. The legislation further encourages school districts to invest more heavily in providing students with opportunities to be physically active. High schools are NOT affected by this legislation.

Over 5000 4th, 5th, and 7th graders from 28 schools will be evaluated at baseline, 4-month and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The principal outcome measure is sex- and age-adjusted BMI percentile as determined from the CDC growthchart percentiles. Other measures include waist circumference, time to complete one mile run/walk, and blood pressure.

The impact of early implementation of SB 19 on academic achievement will also be assessed, using students' standardized math and language arts achievement test scores.

Eligibility Criteria:
healthy 4th, 5th or 7th graders able to fill out a 30-minute questionnaire in English and able to participate in aerobic physical activity.