cyrilzakka/clinical-trials huggingface dataset:
Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change

This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years of age at the time of hospital admission
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by the Health Care Protocol of the Health Secretariat of Federal District (SES/DF), with the following codes:

  * J41.0 - Simple chronic bronchitis
  * J41.1 - Mucopurulent chronic bronchitis
  * J41.8 - Mixed simple and mucopurulent chronic bronchitis
  * J42 - Unspecified chronic bronchitis
  * J43.1 - Panlobular emphysema
  * J43.2 - Centrilobular emphysema
  * J43.8 - Other emphysema
  * J43.9 - Emphysema, unspecified
  * J44.0 - Chronic obstructive pulmonary disease with acute lower respiratory infection
  * J44.1 - Chronic obstructive pulmonary disease with acute exacerbation, unspecified
  * J44.8 - Other specified chronic obstructive pulmonary disease
  * J44.9 - Chronic obstructive pulmonary disease, unspecified

Exclusion Criteria:

* Patients younger than 40 yeas of age at the time of hospital admission
The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases

Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - signs and symptoms.

A prospective randomized controlled study that will include 110 previously health 6months - 5 years children (55 in each group) with acute oral ulcer disease (\< 48 hours). Children will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - sings and symptoms by questioner to parents, and physical examination by there physicians. .

Eligibility Criteria:
Inclusion Criteria:

* Age \> 6 months or \< 5 years.
* Acute (\< 48 hours) oral ulcer disease.
* \> 5 ulcers.
* Cooperative parents .
* Signing inform consent.

Exclusion Criteria:

* All types of immunosuppression, IBD, SLE, recurrent oral ulcer, disease \> 48 hours, age , 6 \< months or \> 5 years.
Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics

The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

This project is a Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of specific evidence-based approaches for behavioral tobacco dependence treatment, Quitlines and text messaging, at the Manhattan and Brooklyn campuses of the VA New York Harbor Healthcare System (NYHHS). The project will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. Researchers will randomly assign clinical care teams at each VA campus to either an opt-out or an opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.

Eligibility Criteria:
Inclusion Criteria:

* Survey Cohort -- Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker
* Nursing Assistants/Registered Nurses -- Work on a PACT at the Manhattan or Brooklyn VA campus
* Administrative Cohort -- Have been seen by a PACT team at the Manhattan or Brooklyn VA campus AND Current smoker
* Patient Post-Visit Survey Population -- Had a visit with an NA/RN included in the study AND Current smoker

Exclusion Criteria:

* Survey Cohort -- Non-English speaking
* Nursing Assistants/Registered Nurses -- None
* Administrative Cohort -- None
* Patient Post-Visit Survey Population -- Non-English speaking
Non-vaccination Factors Against Hepatitis B Virus in Drug Users

Hepatitis B is one of the major public health problems in the world. According to World Health Organization (WHO) data, about 2 billion people have been in contact with the hepatitis B virus (HBV), and 257 million have chronic HBV infection.

Although France is a low endemic country, with just over 280,000 people with chronic infection, hepatitis B remains a public health problem due to its morbidity and mortality.

Drug users are a population at risk by their consumption practices (injection or sniffing), but also by other high-risk behaviours, particularly sexual behaviours.

Prevention therefore involves securing consumption practices (sterile and single-use equipment) and protection of sexual intercourse, but also by vaccination (protecting more than 90%).

Since 1982, HAS has recommended to systematically vaccinate drug users. However, according to the Marmottan study published in 2003, immunization coverage among drug addicts was already insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%).

This decrease can be explained by the controversy around the potential link, now refuted, between vaccine against HBV and demyelination, which has stopped the mass vaccination campaign launched by the French health authorities in 1995.

A study conducted between 2009 and 2012 on injecting drug users in Alsace, estimated vaccination coverage at 28%.

The hypothesize is that despite the recommendations in a population at high risk of contamination, and a balance of benefits and risks in favor of vaccination, vaccination coverage against the hepatitis B virus remains insufficient among drug users because of poor vaccination acquaintance, and hepatitis B in general, in this population.

Principal objective of this study is to identify non-vaccination factors against hepatitis B virus among drug users consulting at the Croix-Rousse CSAPA.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years)
* Patients with an addiction with product, substituted / weaned or not
* Patients consulting at the CSAPA of the Croix-Rousse hospital

Exclusion Criteria:

* Patients with an addiction without a product
* Patients who have never snorted or injected psychoactive product
* Patients protected by the law
* Patient refusing to participate to the study
Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
2. American Society of Anesthesiologists (ASA) scores I \& II.
3. Patients aged \> 20 years.
4. Agreement to complete the study.

Exclusion Criteria:

1. Patients with benign disease, trauma, and receive neoadjuvant therapy.
2. double primary cancers.
Brain fMRT In Takotsubo Cardiomyopathy

Certain cardiac and neurologic diseases influence each other via a still poorly understood "brain-heart axis". Subarachnoidal bleedings are well known to cause ECG alterations resembling those of myocardial infarction, along with a reduction of systolic myocardial function ("neurogenic stunned myocardium"). Alterations of the right insula region by a stroke or intracranial hemorrhage go along with a sympathetic activation (increased circulating catecholamine levels, tachycardia, arterial hypertension). In contrast, alterations of the left insula region often cause vagal reactions such as bradycardia, arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of heart attacks, often caused by psychological or physical stress (death of a beloved one, divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects postmenopausal women.

Functional MRT enables imaging of activated brain regions, either without ("resting state") or with specific stimuli. The investigators speculate that there is a specific involvement of the insula region during TTC.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females aged below 90 years
* Informed written consent
* TTC or NSTEMI / STEMI undergoing coronary angiography within 24 hours of symptom onset

Exclusion Criteria:

* Delayed coronary angiography (\> 24 hours after symptom onset)
* Inability to perform rsfMRT within the first 72 hours after coronary angiography
* Inability to communicate in German language
* Contraindications for a MRT examination (including pacemaker, implantable cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe adipositas)
* Drug addiction, under guardianship
* Inability to stick to the follow up examination
Self-administered COgnitive Personalized Training in Early Psychosis

The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.

Cognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions.

Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.

Our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent and young adults, both genders, aged 16 to 35,
* Seeking help in one of the recruiting centers,
* Newly diagnosed as experiencing an Episode of Psychosis (reaching criteria as described in the Comprehensive Assessment of at Risk Mental States (CAARMS) within the year
* Written informed consent signed (and from one legal guardian for minors).

Exclusion Criteria:

* Severe and unstabilized medical conditions,
* Insufficient level in reading and/or French language,
* Absence of medical insurance,
* Participation in another intervention trial,
* Enforced hospitalization (ASPDT, ASPPI, ASPRE),
* Intellectuel Deficiency (IQ\&lt;70), and / or sensorimotor deficits incompatible with the cognitive training,
Oral Corticosteroids for Post-infectious Cough in Adults

The purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related QoL of patients with post-infectious cough triggered by an Upper Respiratory Tract Infection (URTI) and seeking care in adult primary care practices. The study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients seeing a GP for a dry or productive post-infectious cough (3 to 8 weeks) after Upper Respiratory Tract Infection (URTI)
* Patients able and willing to give informed consent by themselves and to fill in the LCQ on day 0 with the GP and to answer phone calls from the research staff/study nurse at day 7, 14, and 28, and at 3 months for outcome assessment

Exclusion Criteria:

* Patients with known or suspected diagnoses associated with cough, such as: pneumonia or suggestive symptoms and signs (abnormal vital signs, i.e. heart rate \>100/min, respiratory rate \>25/min, fever), allergic rhinitis, sinusitis, bronchial asthma, chronic pulmonary disease (COPD), or gastroesophageal reflux disease,
* Patients with other chronic disease such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure.
* Use of inhaled or oral corticosteroids within the last four weeks
* Immunodeficiency/immunocompromised state (e.g. cancer chemotherapy, HIV infection, administration of immune-suppressive agents)
* Pregnancy/ breastfeeding
* Regular treatment known to be associated with cough (e.g. angiotensin converting enzyme inhibitors)
* Patients with pharmacotherapy for glaucoma or osteoporosis
* Experienced fractures due to osteoporosis
* Patients with uncontrolled diabetes (as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesised benefit on cough)
Early Diagnosis of Acute Renal Failure by Urine Trehalase Levels.

We think that in surgical patients requiring hypotensive anesthesia, acute kidney injury, which may occur due to intraoperative renal hypoperfusion, can be diagnosed early by evaluating the urine trehalase value using the ELISA method, and thus, early diagnosed acute renal failure can be treated quickly and patients can be protected from subsequent complications in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18 and under the age of 65
* Having signed the BGOF form to be included in the study,
* Being in ASA 1 or ASA 2 classification
* Not having kidney failure or kidney disease
* No history of single kidney or renal transplantation
* Not using nephrotoxic drugs or agents before surgery
* Renal function tests taken preoperatively should be within normal ranges.
* No urinary tract infection or urinary problems (such as polyuria, oliguria or anuria)

Exclusion Criteria:

* Those under the age of 18 or over the age of 65
* Those who do not want to participate in the study
* ASA 3 and above
* Having previously received treatment for kidney disease - including kidney stones -
* Having been previously diagnosed with acute or chronic renal failure
* Having a single kidney or a history of renal transplantation
* Using nephrotoxic drugs or agents (such as contrast material) before surgery
* Kidney function tests taken preoperatively are not within normal ranges
* Having a urinary tract infection or urinary problem (such as polyuria, oliguria or anuria)
* Having a history of kidney stones, acute renal failure or chronic renal failure
* Those with active infection or disease before surgery
* They were determined as patients for whom consent was not obtained for the study.
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.

In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The rationale for this trial is, that the addition of irinotecan might improve treatments results.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon
* Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0
* Age: 18 years or older
* World Health Organization (WHO) performance status ≤ 1
* Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
* Adequate laboratory findings:

  * hematological: hemoglobin \> 90 g/L (transfusion is allowed to attain this), absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L
  * hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 3 x ULN
  * renal: creatinine ≤ 1.5 x ULN (upper limit of normal)
* Fertile men and women must use highly effective means of contraception (failure rate \<1%) such as:

  * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration)
  * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration)
  * intrauterine device
  * intrauterine hormone-releasing system
  * bilateral tubal occlusion
  * vasectomised partner
  * sexual abstinence
* Signed written informed consent
* The patient must be able to comply with the protocol

Exclusion Criteria:

* Neuroendocrine or adenosquamous carcinoma
* Prior oncological treatment or surgical resection for the present disease
* Presence of other concurrent malignancies or previous malignancies within 5 years except for adequately treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix uteri
* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
* Active inflammatory bowel disease
* Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
* Known hypersensitivity to any contents of the study drugs
* Pregnancy (positive pregnancy test) and/or breast feeding
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Gynecological Cancer Women

The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual Health Education Program (GS-SHEP) in enhancing the sexual health of patients with gynecologic cancer.

This study recruited patients with cervical cancer from the gynecological wards of a large-scale medical center in northern Taiwan. A total of 63 participants were divided into two groups. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual self-efficacy", and "sexual activity". Data were collected at baseline, one week, six weeks, four months, and seven months after intervention and analyzed using the statistical software SPSS 20.0.

Eligibility Criteria:
Inclusion Criteria:

1. Women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks.
2. 20 to 80 years old.
3. Able to read, write, and speak Chinese.
4. In order to comply with the spirit of gender sensitivity in this study, participants do not exclude whether they have a partner or different sexual orientation.

Exclusion Criteria:

1. Presence of other malignant disease.
2. Impaired mental function.
3. sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity).
4. History of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.
Vasodilator Free Measure of Fractional Flow Reserve

Narrowing of coronary arteries interferes with blood flow and can cause chest pain. Cardiologists sometimes quantify the extent of the narrowing by measuring the fractional flow reserve (the ratio of the pressure in the aorta to the pressure downstream of the narrowing under conditions of maximal flow). We propose a new technique based on principles of wave intensity analysis (WIA) to better assess coronary stenosis and the significance of the narrowing without the need for administration of vasodilator agents such as adenosine. This would simplify assessment and improve our ability to advise patients whether stent treatment will help their symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary stenosis

Exclusion Criteria:

* Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
* Unable to consent
* Contraindications to adenosine
* Contraindications to cardiac MRI