cyrilzakka/clinical-trials huggingface dataset:
Suicide Prevention and Intervention in Spain: the SURVIVE Study

Suicide is one of the leading causes of avoidable death worldwide. Gathering population-representative data on the incidence of suicidal behavior, as well as developing effective secondary prevention strategies are imperative parts of evidence-based public health policies, currently lacking in Spain. The Suicide Prevention and Intervention Study (SURVIVE) is a multi-site-cohort study with nested randomized-controlled clinical trials. The principal aims of the SURVIVE study are to determine the incidence of suicide attempts in Spain and to investigate the efficacy of two secondary prevention programs.

Suicide is the leading cause of avoidable death worldwide, demanding urgent attention. Collecting national-representative data is the first step towards developing effective evidence-based public-policies.

The SURVIVE study presents four inter-connected objectives:

1. To determine the incidence of suicide attempts in Spain
2. To follow up suicide attempters with the aim of studying the probability of them re-attempting
3. To identify influential risk factors to explain suicide attempts and an increased risk of re-attempting
4. To determine the efficacy of secondary prevention programs to prevent suicide re-attempts in comparison to treatment as usual (TAU).

Study design: Multi-site-coordinated cohort study with nested randomized controlled trials. Participants will be recruited at mental-health sites distributed across Spain.

Participants: A cohort of 2.000 individuals presenting a suicide attempt will be established.

Individuals would be followed for 1-year, and assessed every 3 months.

Participants (age \>18) that meet inclusion/exclusion criteria will be randomly allocated to:

1) telephone-based management, or 2) iFightDepression for Suicide (iFD-Survive), a web-based-self-management tool. These interventions will be tested against TAU.

Participants (age between 12-17) that meet inclusion/exclusion criteria will be randomly allocated to: 1)a face-to-face individual intervention designed for youths Specific Aware of Mental Health Intervention for adolescents (SAM) or 2) TAU.

Eligibility Criteria:
General Inclusion Criteria:

* Female and males, age \>= 12 years
* Having attended a hospital emergency department due to a suicide attempt
* Willing and able to comply with study procedures and to give written informed consent

Specific inclusion criteria for iFD-S:

* Minimum knowledge of internet use and availability of an internet device (tablet, computer, smartphone)
* Depressive symptoms according to PHQ-9 scores above 15

Specific inclusion criteria for SAM:

* Age between 12-17
* Informed consent of legal guardians

General Exclusion Criteria:

* Incapacity to give informed consent
* Lack of fluency in Spanish
* Currently taking part in another clinical study which, in the opinion of the investigator, is likely to interfere with the objectives of the SURVIVE study.
Prediction of Response to Kinase Inhibitors Based on Protein Phosphorylation Profiles in Tumor Tissue From Advanced Renal Cell Cancer Patients

The rapid development of agents blocking kinases has established the use of molecularly targeted therapy as the preferred treatment approach for patients with metastatic renal cell cancer (RCC). Five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and pazopanib) are now approved for clinical use. Response rates differ among these agents, importantly depending on line of treatment. In first-line treatment sunitinib results in 47% objective response rates, where in second-line after cytokines 34% responds. Thus far, it is unclear which patient with advanced renal cell cancer will respond to targeted therapy. In order to select patients for targeted therapies, several profiling approaches have been explored but to date no adequate and reliable test is available. It is assumed that responses to targeted agents depend on specific receptor and protein signalling activities in tumor tissues. Therefore, we propose that protein phosphorylation profiling with phosphoproteomics may be a potential clinical diagnostic tool to predict for tumor response to targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced (unresectable and/or metastatic) renal cell cancer.
* Patients who will start treatment with sunitinib, pazopanib, sorafenib, axitinib or everolimus.
* At least one tumor lesion should be accessible for biopsy. Bone metastases are excluded as possible biopsy site.
* Age \>- 18 years.
* Patients must have at least one measurable lesion. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
* WHO performance status 0 - 2
* Able to provide written informed consent

Exclusion Criteria:

* Clinical findings associated with an unacceptably high tumor biopsy risk, according to the judgement of the investigator.
* Radiotherapy on target lesions during study or within 4 weeks of the start of drug.
* Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade

The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.

Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.

Exclusion Criteria:

* ASA IV and above
* Intolerance, allergy, or contraindication to use of any medications used in this study
* Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
* Uncontrolled hypertension (BP \> 140/90)
* History of prior ipsilateral thorascopic surgery
* Cardiac arrhythmias particularly prolonged QT syndrome
* Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
* Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
* Pregnant or lactating women
* Morbid obesity (BMI \> 40 kg/m2) AND/OR weight \> 150 kg
* Chronic renal failure ( creatinine \> 2.0 mg/dL)
* Liver failure e.g., active cirrhosis
* Alcohol or substance abuse within in the past 3 months
* Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
* Restrictive lung disease (pulmonary fibrosis, myasthenia gravis) or FEV1 or FEV less than 70% of predicted value.
* Type 2 diabetes
* Neuropathic pain
* Chronic opioid consumption (\>30mg oxycodone or greater per day)
* Cahexia from any cause
* systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.

In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.

Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
* Subjects must be able to take orally
* Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
* Within 4 weeks from the diagnosis of PD
* Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
* ECOG performance status ≤ 1
* Follow up Age 20 or over
* Life expectancy estimated more than 12 weeks
* Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
* Creatinine ≤ upper normal limit (UNL)
* Total bilirubin ≤ 1.5 X UNL
* Written informed consent

Exclusion Criteria:

* S-1 + CPT-11 was employed as a first-line
* Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
* After S-1 adjuvant
* Suspended cases by adverse events by S-1 or S-1 combination
* Excessive amounts of ascites require drainage
* Known brain metastases
* History of hypersensitivity to fluoropyrimidines and CPT-11
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Active double cancer
* Gastrointestinal bleeding
* Any subject judged by the investigator to be unfit for any reason to participate in the study
Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management

the role of transcranial magnetic stimulation over the primary motor cortex area on acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions.Transcranial direct current stimulation has been studied in patients with various disorders and multiple pain syndromes. There is also evidence that tDCS might be useful in postsurgical pain reduction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer

Exclusion Criteria:

* patients with intracranial metallic devices or with pacemakers or any other device.
* patients with Neurological or psychiatric disorders,
* patients taking major centrally acting drugs (antiepileptics or antidepressants), -opioid dependence,
* substance abuse,
* severe cardiopulmonary, renal, hepatic diseases, and
* those with extensive myocardial ischemia or unstable angina.
Quality Control of CE-Certified Phonak Hearing Aids - 2018_28

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

In this study a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and speech intelligibility in Quiet and in Noise. The experimental device contains direct connectivity functionality which will be investigated in terms of streamed Audio quality, streaming stability and Usability preferences of functions and Features which are related to direct connectivity. The active comparator device does not contain direct streaming functionality. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear Receiver in the canal hearing aids
* Informed Consent as documented by signature
* owning a compatible smartphone

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
* Central hearing disorders
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer

This study will evaluate the safety, and tolerability of neo-adjuvant treatment with tislelizumab in participants with early-stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG Performance status of 0 or 1.
2. Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local laboratory. Participants should be eligible for an R0 resection with curative intent.
3. Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.
4. Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose.

Exclusion Criteria:

1. Any prior therapy for current CRC, including chemotherapy or radiotherapy or immunotherapy.
2. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
3. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of GINST on Human Semen

The purpose of the study is to evaluate the effect of GINST on human semen. The study is a pilot study, designed as open-label, prospective randomized clinical trial using GINST either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng). Expected participants are to be male partners of female patients who visit infertility clinic at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone. Quality of life, sexual performance before and after taking GINST will be evaluated using questionaires.


Eligibility Criteria:
Inclusion Criteria:

1. partner of female patient who visit infertility clinic with chief complaint of infertility.
2. ≥0.5x106 of total motile sperm count on screening semen analysis.

Exclusion Criteria:

1. Those who have chronic, systemic disease or endocrinologic disorder.
2. Patients with hypertension (systolic blood pressure ≥ 140mmHg, diastolic blood pressure ≥ 90mmHg)
3. Patients who have undergone chemotherapy due to malignancy
4. Patient who has history of taking testosterone or anti androgen agents within 1 month.
5. Patient who has retrieved sperm surgically
Early Detection of Clinical Deterioration in Patients With COVID-19 Using Machine Learning

The aim of this study is to use artificial intelligence in the form of machine learning analysing vital signs as well as symptoms of patients suffering from Covid19 to identify predictors of disease progression and severe course of disease.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \>= 18 years
* Detection of SARS-CoV2 within the past 5 days

Exclusion Criteria:

* Inability to measure vital parameters and document symptoms
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.

A "SpermComet" assay will be used to characterize DNA fragmentation of surplus sperm samples remaining after in vitro fertilization (IVF) cycles. We will investigate potential correlation between these assay results and the outcomes of IVF cycles that used those sperm samples.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing IVF
* Surplus sperm available after oocyte insemination
* Consented

Exclusion Criteria:

* Surgical sperm extraction
* Use of donated sperm or oocytes
* No minors may participate
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease

Dr. Biolyse® is a device with artificial intelligence that works in sync with the immune system and can be integrated like an element of this system. It is designed to develop chemical immunity within the body against infections. It gives electrical signals to the body without causing any pain and suffering to the patient. The electric current it applies is of a type that is not used in homes, and it is the frequency feature of direct current.

The aim of this study is to evaluate the safety and efficacy of the Biolyse device. for minimizing the use of drugs in COVID-19 patients and treating drug-related organ damage during treatment We hope that by conducting this study, we will obtain sufficient data to obtain approval (CE certification) for routine use and marketing of this medical device in patients. Once this happens, we will be able to ensure that this device is accessible/usable for patients suffering from similar diseases, especially COVID-19, regardless of any studies.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18-65
* Patients with mild moderate complicated or uncomplicated COVID 19 pneumonias
* Those who accept to be followed up and treated as an inpatient
* Those who have at least one laboratory and clinical finding that can be evaluated during follow-up

Exclusion Criteria:

* Patients with severe course or COVID 19 pneumonia requiring intensive care follow-up
* Pregnant or breastfeeding women
* Epilepsy, Arrhythmia, Dementia, heart failure, severe lung disease, patients with active malignancy and those with pacemaker
* "Vulnerable Population" patients defined in ICU
Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array

Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a long time. However the study about the mechanism is scant. The question of biomarkers of knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On this basis, the aim of this study was to characterize the secreted protein factors behind the inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.

10\~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of inflammatory factors will be measured by a novel cytokine antibody array methodology. The study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid. Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array membranes incubated with tissue lysates will quantitatively depict as a histogram for relative cytokine induction or reduction in the synovial fluid. The cytokines messenger ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and after interventions will be compared. Differences between groups will be determined by the Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF isoforms pattern will be determined with the Spearman correlation.


Eligibility Criteria:
Inclusion Criteria:

* at least 6 months of symptomatic knee OA
* clinical criteria of moderate or moderate to severe knee OA ( the American Rheumatological Association grade II or III)

Exclusion Criteria:

* severe knee OA (grade IV)
* rheumatoid or other inflammatory arthritis
* received physiotherapy, oral NSAIDs, corticosteroids or anticoagulant, during previous 2 weeks prior the treatment
* received any knee intra-articular injections during previous one month prior the treatment
* poorly controlled diabetes mellitus with fasting blood sugar greater than 200 mg/dL-
* history of knee surgery
* dementia or psychological disease.