cyrilzakka/clinical-trials huggingface dataset:
Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma

This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.

Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
* Patients failed first-line chemotherapy containing fluoropyrimidines and platinums;
* ECOG (Eastern Cooperative Oncology Group)performance status 0-1;
* At least 1 measurable lesion should be present（RECIST1.1）
* Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN
* Signed informed consent.
* Life expectancy ≥3 months;

Exclusion Criteria:

* Previous treatment with Raltitrexed or Paclitaxel;
* Known history of allergic reaction to Raltitrexed or Paclitaxel;
* Known brain metastases;
* Pregnant or breast feeding women;
* Severe diarrhea,intestinal obstruction;
* other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
* Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia;
* Kown HIV infecton.
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.

Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Accept VA-ECMO or VV-ECMO
3. the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s.
4. sign the informed consent form

Exclusion Criteria:

1. previous history of allergy to heparin or bivalirudin
2. previous diagnosis of heparin-induced thrombocytopenia.
3. the pre-random ECMO assistance time is more than 48 hours.
4. pregnant female
5. have participated in this study before.
6. the researchers believe that there are other factors that are not suitable to participate in this study.
Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.

Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Eligibility Criteria:
Inclusion Criteria:

* age-related macular degeneration
* naïve subfoveal choroidal neovascularization
* best-corrected visual acuity less then 20/200

Exclusion Criteria:

* previous treatments
* any other condition able to limit the visual improvement
Investigator Initiated Study - Asenapine Early Psychosis

We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to "real-life" clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders
* having provided a consent to include data on our databank,and being able to provide informed consent
* willingness to participate to the assessments
* being over 18 years of age
* being in a clinical situation that warrants switch to asenapine

Exclusion Criteria:

* suffering from a primary drug-induced psychosis
* being at significant risk for suicide or assault
* unstable medical condition
* persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required
* being treated with antipsychotic for 5 years or more
* having contraindications(allergy to asenapine)
* being pregnant or lactating
Glucose to Goal: A Model to Support Diabetes Management in Primary Care

Diabetes education is a very important part of diabetes care. Most people with diabetes receive care in primary care practices where diabetes education is not always available. This project tests a model designed to improve access to diabetes education services.

Evidence that diabetes self-management education (DSME) can improve health outcomes has repeatedly been shown and is considered to be a critical component of care. Diabetes educators are highly skilled at addressing diabetes-related clinical and behavioral needs through DSME, but engagement with diabetes educators is underutilized. It has been suggested that poor referral practices and the way in which DSME service is delivered are the problems. Most patients receive diabetes care in primary care yet most DSME programs are distinctly separate from primary care practice. This limits care coordination and diabetes educator access to amenities currently available to primary care. Efforts are underway to change the US health care paradigm with a focus on quality in primary care that includes practice redesign, population management, and communication through electronic medical records. The purpose of this application is to evaluate the deployment of Glucose to Goal, a model relying on a systematic redesign of practice that links diabetes educators services with primary care. This will be compared to the traditional process for DSME delivery, without the direct connection to primary care processes, for an eighteen month period. The hypothesis is that the proportion of primary care provider referrals and patient utilization of diabetes educator services from primary care practices participating in Glucose to Goal will be higher compared to those associated with traditional DSME. It is anticipated that this model will appeal to primary care providers, demonstrate a feasible approach to offering diabetes education in the current health environment, and set the stage for future testing of the model, namely its impact on meaningful improvements on diabetes outcomes and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Patients referred to diabetes self-management education by their primary care provider
* Able to read and write English

Exclusion Criteria:

* Clinical diagnosis of type 1 or gestational diabetes
* Unable to speak or read English
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

US National Institutes of Health Division of AIDs (DAIDS)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subject chronically infected with HCV genotype 1 (GT-1)
* Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
* Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV

Exclusion Criteria:

* Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
* Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Motivating a Spectrum of Cancer Patients to Quit Smoking

This study will assess feasibility and acceptability of an intervention designed to increase smoking cessation motivation among patients with a cancer not widely known to be smoking related.


Eligibility Criteria:
Inclusion Criteria:

* Smoking at least 1 cigarette in previous 30 days
* Diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer within the last 6 months
* Able to read/write English
* Able to give informed consent
* Not currently enrolled in a smoking cessation program

Exclusion Criteria:

* Having distant metastases
* Male patients with breast cancer
ALF-STONE: Alfuzosin in Uretheric Stones

The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.

This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).


Eligibility Criteria:
Inclusion criteria:

* Patients with imagiologic evidence of uretheric stones

Exclusion criteria:

* Women pregnant or breast feeding
* Patients with renal impairment (creatinine \> 2mg/dl)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.

This trial provide aftercare treatment with Lamzede to French patients.

Eligibility Criteria:
Inclusion Criteria:

* the subject must have participated in previous Lamazym-trials: phase 2b: 2011-004355-40 or phase 3: 2012-000979-17
* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities
* The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

* Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial
* Pregnancy. Pregnant woman is excluded. Before start fot he treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception
* Psychosis; any psychotic disease, also in remission, is an exclusion criteria
* Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
* Adult patients who, in the opinion of the Investigator, would be unable to give consent, and who does not have any legal protection or guardianship
* total IgE \> 800 IU/mL
* Known allergy to the IMP or any excipients (Sodium-Phosphate, Glycine, Mannitol)
Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency

It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition.

Developmental stuttering is a fluency disorder that can negatively affect many aspects of an individual's life. Recent transcranial direct current stimulation (tDCS) studies with individuals with stuttering show that tDCS shows promise in increasing fluency when used in combination with situations that temporarily increase fluency. In this study, it was aimed to investigate the effect of bi-hemispheric tDCS on fluency in individuals with stuttering for 5 consecutive days. The hypothesis of the study is that bi-hemispheric stimulation, which includes anodal stimulation to the left hemisphere and cathodal stimulation to the right hemisphere, will be effective on reading and speech fluency when performed for 5 consecutive days. Thirty-six adults with developmental stuttering are expected to complete this double-blind, sham-controlled study. Participants will be divided into two groups by blocked randomization and one group will receive sham stimulation for 5 consecutive days and the other group will receive bihemispheric stimulation. Participants in the tDCS group will receive 20 minutes of tDCS stimulation accompanied by metronome-timed speech during the practice sessions. Reading and speaking fluency will be assessed immediately before, immediately after, and one week after the stimulation sessions. Data will be collected using the stuttering severity assessment instrument (SSI-4) Results will be compared both within and between groups in terms of percentage of stuttered syllables, stuttering severity, and evaluation of the speaker's experience of stuttering.

Eligibility Criteria:
Inclusion Criteria:

* developmental stuttering
* age between 18 and 60 years
* right hand dominant

Exclusion Criteria:

* history of seizures, head trauma, hearing problems, cochlear implant, intracranial metal implantation, medications that affects the central nervous system, implanted neurostimulators, cardiac pacemakers, or medication infusion devices
* any speech and language disorder other than developmental stuttering
* neurological or psychiatric disorders, brain surgery, tumours, neurodevelopmental disorders, or attention deficit hyperactivity disorder
Predicted Level of General Anaesthesia in Hip Fracture Surgery

The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing hip fracture surgery under general anaesthesia
* Age ≥ 18 years old
* ASA classification 1, 2 or 3

Exclusion Criteria:

* Patient not insured by a social security scheme
* Adult patient under tutorship or curatorship
* Age over 18 years old or under 90 years old
* Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm
* Body mass index \> 35
* Contraindication to one or more anaesthetics used in the study
* Pregnancy or breastfeeding
* Unweaned alcoholism
* ASA classification 4 or 5
* Patient undergoing hip fracture surgery under spinal anaesthesia
Dendritic Cell Vaccine in HIV-1 Infection

1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 \> 450 x 10 6 /L).
2. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (MD-DC) loaded with heat-inactivated autologous HIV in 12 HIV infected patients who had been receiving highly active antiretroviral therapy (HAART) since early chronic infection. Autologous HIV was concentrated from plasma (1,500 ml) obtained by plasmapheresis after a 3-month HAART interruption (STOP1) performed 78 weeks before therapeutic immunizations, and HAART was discontinued again (STOP2) after therapeutic immunization. There was a decrease of set-point plasma viral load (PVL) \>= 0.5 log after 24 weeks off HAART in 4 out of 12 patients. In addition, we observed a significant lengthening in mean doubling time of PVL rebound (p= 0.01), and significant decreases in the area under the curve of PVL rebound (p= 0.02) and in the mean peak PVL (p= 0.004) during the 12 weeks after STOP 2 compared with STOP1. This virological response was associated with a weak but significant increase in HIV-1 specific CD4 lymphoproliferative response, and with changes in HIV-1 specific CD8+ T-cell responses in peripheral blood and in lymphoid CTL cells after immunization. In lymphoid tissue, we also observed a trend towards a better control of HIV-1 replication coupled with an increase of CD4+ and CTL cells. No significant virological or immunological changes occurred in controls. We show that a therapeutic vaccine with autologous MD-DC pulsed with heat inactivated autologous HIV-1 is feasible, safe and well tolerated and elicited weak and transient cellular immune responses against HIV, associated with a partial and transient control of HIV replication in some patients.

we hypothesized that a DC vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* CD4 \> 450 x 10 6 /L
* baseline VL \>10,000 c/ml before any HAART
* Part I, patients off HAART at least during 6 months
* Part II, Patients on HAART with PVL \< 200 copies/ml at least during 6 months
* Written informed consent .

Exclusion Criteria:

* Patients with failure to HAART
* Patients with B or C symptoms (CDC classification 1993).
* Age \< 18 years old.
* Pregnant or breastfeeding women
* Patients with baseline creatinin \> 2.5 mg/dl
* Patients with baseline GOT/GPT \> 250 UI/L
Social Justice Advocacy Skills and Ethical Sensitivity

The aim of this study is to determine the effect of advocacy education on social justice advocacy skills and ethical sensitivity in undergraduate nursing students.

Advocacy is an effort to correct or change situations that affect people, society and systems.The origin of advocacy is to provide active support in the Latin "Advocates" dictionary. It is defined as "defense work" in Turkish dictionary advocacy is an ethical dimension of nursing practices in nursing science that shows how nursing care is needed and how the nurse will approach the individual, group and society in need.Social justice advocacy has an increasing importance as people are affected by pressure from the social system.Disease, weakness and early deaths are more common in ethnic and diverse races, poor people and societies that do not receive services.Within the scope of advocacy, the duties and responsibilities of individuals, families and society have been determined by laws and regulations in order to protect and improve the health of the society. Advocacy is the nurse's professional role and ethical responsibility.Total 80 students (İntervention and control group)was selected randomly from 112 4 th grade student. Students were randomly assigned to the experimental group(n=40) and the control group(n=40). The experimental group students will take advocacy intervention courses The control group students will the routine curriculum. In this study, effect size will be determined with 5% error margin by using sample size power analysis Gpower 3.1.9.2 program. Accordingly, it was calculated that 35 students were included in the intervention and control groups with 5% error margin and 80% power. İt was decided to include at least 40 people in each working group with 20% surplus, considering that they might be lost in data collection. Theoretical education, film and video screening, case study, Social Security Institution (SSİ) Study, WEB based work, The student will preparation of advocacy action plan, students prepared poster and advocacy awareness activity, poster were exhibited at the campus. Data Collection Tools: Student Information Form, Social Justice Advocacy Scale , Moral-Ethical Sensitivity Scale. Statistical Analysis:Similarity of experimental and control groups; number, percentage, average and standard deviation, pre-test, post test; scale scores difference in dependent groups t-test.

Eligibility Criteria:
Inclusion Criteria:

* Student who speak very well Turkish

Exclusion Criteria:

* Foreign students who do not speak very well Turkish.