cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy

Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC.

The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR).

As secondary objectives, the following will be evaluated in both arms:

* Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.
* Progression free survival (PFS)
* Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers
* Overall survival (OS)

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven metastatic adenocarcinoma of the pancreas
* Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
* Signed written informed consent
* Age ≥ 18
* ECOG PS 0/1 at study entry
* Measurable disease
* Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
* INR/PTT ≤ 1.5x ULN
* Life expectancy of at least 12 weeks
* Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration
* Peripheral Neuropathy \< grade 2

Exclusion Criteria:

* Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
* History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
* Known hypersensitivity to any of the components, including excipients, of study treatments
* Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
* Pregnancy or breast feeding
* Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
* Unstable angina, congestive heart failure ≥NYHA class II
* Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg)
* HIV infection
* Complete DPD deficiency
* Liver failure, cirrhosis Child Pugh B or C
* Active chronic hepatitis B or C with a need for antiviral treatment
* Brain metastasis
* Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
* History of organ allograft
* Ongoing uncontrolled, serious infection
* Renal failure requiring dialysis
* Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
Peer Mentoring for Persons With Spinal Cord Injury (SCI)

A peer mentoring program for persons with SCI was developed. Individuals who experienced SCI in the past and have adapted well functionally were asked to serve as mentors for individuals with newly-acquired SCI. These individuals undergo volunteer and peer mentoring training prior to mentoring activities. They are a subset of the study participants. We are tracking their satisfaction with life, positive and negative affect, life adjustment, depression, and social support over time. We hypothesize that measures of adjustment will become more positive as involvement as a mentor increases. The second subset of study participants are the individuals with newly-acquired SCI. They complete a baseline assessment of the measures listed above and then at 6 months, one year, and two years after match with a mentor. We also collect information about the quantity and quality of the mentoring sessions from both the mentor and mentee. We hypothesize that the mentee's adjustment will be positively influenced by the number and quality of the mentoring sessions. Due to the relatively small number of SCI per year in our program, we opted to offer the mentoring program to all individuals with newly acquired SCI, thus there is no control group.


Eligibility Criteria:
Inclusion Criteria:

* experienced a SCI

Exclusion Criteria:

* no severe traumatic brain injury
* no severe psychiatric disturbance
Validity and Reliability of the Turkish Version of the Post-Liver Transplant Quality of Life Questionnaire

Liver transplantation is a crucial treatment for life-threatening liver diseases, including acute liver failure, end-stage chronic liver disease, primary liver cancers, and congenital metabolic disorders. Quality of life in liver transplant patients is vital. The World Health Organization defines quality of life as an individual's perception of their position in life within the context of culture, values, goals, and expectations. Liver transplantation improves quality of life. Recipients should be closely monitored and supported psychologically, with the effectiveness of the intervention in improving quality of life well-documented. Saab et al. developed the post-Liver Transplantation Quality of Life (pLTQ) questionnaire, which includes eight sub-dimensions across 32 items. To our knowledge, no Turkish-specific QoL tool for liver transplant patients currently exists. This study aims to validate and assess the reliability of the Turkish version of the pLTQ questionnaire.


Eligibility Criteria:
Inclusion criteria:

* Being 18 years of age or older,
* Having received post-liver transplant treatment at Hacettepe University Adult Hospital General Surgery Units and being referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit after routine clinical and laboratory examinations, if deemed appropriate for the study,
* Being willing to participate in the study.

Exclusion criteria:

* Having undergone combined liver-kidney transplantation and multiple organ transplantation,
* Having uncontrolled cardiovascular and neurological problems,
* Having a cognitive problem that will prevent understanding the questionnaires,
* Not being willing to participate in the study.
Actions Elicited by In-hospital Follow-up of Cardiac Devices

This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.

Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission.

These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.

Number of Pacemakers (PM) and Implantable Cardioverter Defibrillators (ICD) is rapidly growing due to enlarged indications. This fact causes an exponential increase in scheduled in-hospital follow-ups. For this reason, all the companies that produce PM and ICD have released systems that allow remote monitoring and follow-up of cardiac devices (both PM and ICD) and U.S. guidelines have already been changed, in order to suggest remote follow-up of these devices at appropriated intervals.

Nevertheless, informations on actions taken during scheduled in-hospital follow-up are incomplete.

ATHENS study has been designed to answer to 3 questions:

1. How often, during a scheduled in hospital follow-up physicians "change" something ? (device programming; drug therapy; scheduled device replacement ...)
2. The "rate of change" is different is the follow-up is required pby the general practitioner who normally takes care of the patients or by the patient itself?
3. Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?

Eligibility Criteria:
Inclusion Criteria:

* All patients with a cardiac device

Exclusion Criteria:

* Follow-up of a cardiac device at discharge from hospital after first implant
Effects of Pulses on Loudness

The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.

Primary objective:

- To assess the effect of the number and spatial distribution of active electrodes on the stimulation charge required to achieve the loudness associated with C and T levels (Experiment 2).

Secondary objectives:

* To assess how loudness is affected by changes in electrical charge of individual pulses made by adjusting the pulse amplitude versus adjusting pulse duration (Experiment 1).
* To assess how loudness elicited by a train of pulses is affected by the duration of that pulse train (Experiment 3).

Experiment 1:

The test will investigate the effect of loudness on changes in electrical charge of individual pulses, made by separately adjusting pulse amplitude or pulse width. The electrical charge required to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable") either when increasing the amplitude or the duration of the pulses.

Experiment 2:

The test will investigate the effect of the number of stimulating electrodes and their distribution within the cochlea on the stimulation levels required to achieve T-levels and C-levels and to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").

Experiment 3:

The test will investigate the effect on loudness of trains of pulses elicited by modifications to the duration of those trains, when operating around T and C levels. Stimulation durations ranging from 10 to 600 ms will be tested. Pulse trains will be presented to either one or several electrodes to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").

Eligibility Criteria:
Inclusion Criteria:

* Neuro One or Neuro 2 user
* Unilateral or bilateral recipient
* 12 months CI experience to allow for acclimatization to the CI sound processing and pathological changes that could alter the electrode - tissue interface and therefore T- \& C-levels.
* Having at least 7 step sizes on three electrodes in their current clinical map (for experimentation 1).
* Able and willing to provide reliable threshold and comfort level judgements

Exclusion Criteria:

* Medical conditions that contraindicate the study tests (e.g. tinnitus, dizziness)
* Unrealistic expectations from the candidate regarding the possible benefits, risks, and limitations that are inherent to the device
* Unwillingness or inability of the candidate to comply with all investigational requirements
* Vulnerable population
The Effect of Weight Loss on Ovarian Reserve

Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed.

The first line treatment for those women with obesity and infertility is weight loss.

The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility treatment outcome.

The investigators have outpatient clinic for obesity and infertility. the patients undergoing program of 3 months with diet and physical activity. Blood sample will take at the beginning of the program and at the end. The blood sample will evaluate for: AMH, Adiponectin, Leptin, CRP, Colesterol, CRP, Smac in addition TVUS will perform to evaluate AFC.

Eligibility Criteria:
Inclusion Criteria:

* undergoing weight loss program

Exclusion Criteria:

* dropp out before comletion the weighy loss target
Bioequivalence Study of Letrozole 2.5 mg Tablets

Bioequivalence

The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers in the age between 19 to 55 years old
* Subjects were neither congenital nor chronic diseases.
* Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.

Exclusion Criteria:

* Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS
* Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy)
* Current clinically significant disorder in history taking or physical examination
* Acute disease within 14 days preceding the first application of study medication
* Had an relevant allergic disease
* Had history of hypersensitivity to drugs or any food
* Positive for Hepatitis B antigen, Hepatitis C antibody, HIV antibody, or High Quality Syphilis Reagin Test
* Excessive caffeine, alcohol intake and smoker(caffeine\>5 units/day, alcohol\>3 units/day(1 unit = pure alcohol 10ml), cigarettes\> 20 cigarettes /day)
* Subjects who excessive alcohol intake or drug which affect drug metabolism enzyme intake within 30 days preceding study
* History of drug abuse or positive for urinary testing of drugs abuse (amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc.)
* Has donated whole blood within 60days or apheresis within 14days preceding the first application of study medication
* Received other investigational drug within 60days preceding the first application of study medication
* Taken any herbal medicine within 30days, prescription medication within 14 days or over-the-counter drug (except for vitamins, minerals) within 10days preceding the first application of study medication (might affect this study or safety of subjects as judged by the investigator)
* Subjects couldn't eat ASAN MEDICAL CENTER standard meal or were unsuitable for this study as judged by investigators
Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.

Objective: To compare the effectiveness between aquatic exercises (water aerobics versus Watsu) versus control groups, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression.

Introduction: Considered as the "21st century disease", depression is a silent disease that stands out for its high prevalence and high morbidity, leading to serious consequences. With treatments made in aquatic environment, among them the Water aerobics and Watsu. Objective: To compare the effectiveness between aquatic exercises versus Watsu and versus control group, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression. Methods: This study will be a randomized clinical trial, which will last for two months with a follow-up of one month. All participants will be assessed using specific questionnaires for each outcome and an Improvement Perception Scale (MS). Seventy eight (78) patients with a medical diagnosis of depression, aged 18 to 60 years, who will be allocated to three groups (26 patients for each group) will be treated. GROUP 1: Aquatic exercises (aerobic and resistance), collective session, twice a week lasting 50 min; GROUP 2: Watsu (water shiatsu), individual session, twice a week lasting 50 min; Group 3: control, people with depression. Statistical analysis: Normality distribution will be by Shapiro-Wilk test. For comparisons of the means between and within the outcome groups will be used through Generalized Estimation Equations, with its own syntax, linear distribution and, when necessary, multiple comparisons will be performed using the Bonferroni test to identify differences. Will be calculated for comparisons between the final and initial moments and initial follow-up in each group, statistics such as: mean difference (95% CI), standard deviation of the difference, effect size (Cohen's d). The statistical significance adopted was 5% and the analyzes were performed using the statistical programs SPSS 22.0 and R 3.2.4. The intention-to-treat analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years old;
* Sedentary and who have not had physical therapy and physical activity in the last three months;
* Clinical and cognitive conditions for performing pool activities and moderate aerobic exercise;
* Who have not undergone high complexity surgical procedures in the last six months; no neuro-musculosqueletal diseases;
* No contraindications to exercise; such as: urinary and / or fecal incontinence and dermatological diseases;
* Individuals with a medical diagnosis of depression.

Exclusion Criteria:

* If they have up to three absences during the intervention period;
* If they have any adverse effects, such as: allergy or dermatitis;
* Unable to continue study due to change of address or hospitalization.
Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain This Study Will Investigate and Compare the Effect of Lumbar Stabilization Exercises and Manipulation on Multifidus Muscle in Chronic Low Back Pain

Histological and morphological changes of multifidus muscle have been reported in lumbar disc herniation (LDH), but there is scarce research comparing the efficacy of different treatment programs that can correct multifidus dysfunction in chronic low back pain (LBP) with LDH. The purpose: this study will be to investigate and compare the effect of lumbar stabilization exercises and manipulation on multifidus muscle in chronic LBP patients with LDH. Subjects: sixty patients aged ranged from 45 - 65 years suffering from chronic LBP with LDH will be randomly assigned into three groups, each group includes 20 patients. Method: group (A) (control group) will receive general exercises for back muscles, group (B) will receive general exercises and lumbar stabilization exercises, and group (C) will receive general exercises and lumbar manipulation (B and C experimental groups). The outcome measurements pre and post 6 weeks of treatment will be pain intensity by visual analogue scale (VAS), functional disabilities by Oswestry disability index (ODI), lumbar repositioning by Biodex system (LR), cross sectional area (CSA) and the asymmetry of both sides of multifidus muscle at the fourth and fifth lumbar vertebrae by ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* The selected subjects had chronic LBP with magnetic resonance imaging (MRI) evidence of disc herniation at levels of L4-L5 and/or L5-S1 diagnosed by physician (orthopedist, neurosurgeon).
* A period of continuous complaints of pain for more than 12 weeks.
* All patients reported an average pain level of at least 5 on a scale of 0 to 10.

Exclusion Criteria:

* Acute inflammatory diseases of musculoskeletal system.
* Pathology or deformities of hip, knee and ankle joints.
* History of surgical approach to their back or had special pathology or non spinal condition causing referred back symptoms.
* Patient who indicated for surgery to treat lumbar disc herniation (i.e. sever intolerable pain, motor weakness, and cannot control urine and stool).
* Cardiopulmonary diseases which decrease the patient's tolerance and activities.
* Spondylolisthesis.
* Diabetic neuropathy.
* Osteoporosis.
* A recent history of vestibular disorder or inner ear infection with associated balance and coordination problems.
* A history of cerebral trauma with unresolved neurosensory symptoms or neurological deficits.
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriatic arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitivity against Etanercept
Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe

This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.

The paracaval portion of the caudate lobe is located in the core of the liver. Lesions originating in the paracaval portion often cling to or even invade major hepatic vascular structures. Open surgery is the traditional surgical method for resection of paracaval-originating lesions. With the development of laparoscopic surgery, paracaval-originating lesions are no longer an absolute contraindication for laparoscopic procedures. The high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Nevertheless, laparoscopic anterior hepatic transection for paracaval-originating lesion resection is still a challenging procedure, and only a few cases have been reported. This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Age: Between 18 to 70 years, both male and female
2. The general condition of the patient can tolerate anesthesia and surgery
3. Paracaval-originating lesion diagnosis is clear preoperative
4. No rupture of the tumor, no bloody ascites, no invasion of the surrounding tissues and distant metastasis
5. Liver function ≥ Child-pugh level B, indocyanine green retention rate at 15 min ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%.
6. Upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented
7. Volunteer to participate in the study and sign informed consent

Exclusion Criteria:

1. Age:Younger than 18 or more than 70 years old 2. Pregnant and lactating women 3. Severe cirrhosis, portal hypertension, or active hepatitis are present 4. Severe upper abdominal adhesions 5. The lesion originated in other parts of the liver other than the paracaval portion 6. Patients with poor general condition and could not tolerate surgery or anesthesia

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