cyrilzakka/clinical-trials huggingface dataset:
Health Promotion in Adolescents in Ecuador

Worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. Populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. This shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. Clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. This study aims to develop a culturally relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old) in Cuenca. The intervention will target behavioural nutrition and physical activity. Intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and (ii) the Comprehensive Participatory Planning and Evaluation protocol.

The study includes two phases:

1. A formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old.
2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.


Eligibility Criteria:
Inclusion Criteria:

* 11-13 years old
* school-going
* willing to participate

Exclusion Criteria:

* pregnant
* severe medical/physical disorder
Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.


Eligibility Criteria:
Inclusion Criteria:

* CIDP diagnosed according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010
* Age \> 18 years
* Able to give written informed consent
* Patient's signs and symptoms should not be better explained by another disease process
* Patients can be on prednisone as long as there has been no dose change for 4 weeks from baseline
* Patients can be on following drugs as long as there has been no change for 60 days from baseline visit including azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin (IVIg) or other immunosuppressive drugs
* INCAT score greater than or equal to 2

Exclusion Criteria:

* Presence of any other causes of polyneuropathy or multifocal motor neuropathy, which in the opinion of the investigator is the major contributor to the numbness and weakness.
* Other neurologic or orthopedic condition causing weakness
* Treatment with plasma exchange (PLEX) within the last 30 days from baseline
* Participation in another trial within the last 30 days from baseline or two ½ life of the drug being studied.
* Latent tuberculosis or active infection
* Contraindication per Acthar® Gel prescribing information scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
* History of prior sensitivity to Acthar® Gel or other porcine products
* Previous or present Infection with hepatitis C and hepatitis B
* Pregnancy or nursing mothers.
* Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* cytological or histologically proven NSCLC
* unresectable stage III NSCLC
* presence of at least one measurable lesion (RECIST criteria)
* adequate haematological, renal and hepatic function
* adequate lung function reserve
* good condition, weight loss \<10% over previous 6 months, life expectancy \> 3 months

Exclusion Criteria:

* previous chemotherapy for NSCLC
* distant metastasis or a pleural or pericardial effusion
* treatment for malignant disease in the past or serious concomitant medical or psychiatric disease
* active uncontrolled infection at time of inclusion
* interstitial lung disease
* auto-immune systemic disease with potential involvement of the lungs
* concomitant use of amiodarone
From PSA to Stockholm3: Study Part 1

This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.

Background:

Prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in Norway. It is also the leading cause of cancer death among men, and nearly 1100 Norwegian men died from prostate cancer in 2014. However, only about 30 percent of new cases have an aggressive form of the disease. Therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer.

The Prostate-Specific Antigen (PSA) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. PSA is used for screening in many countries, but the Norwegian authorities consider the harms of using PSA for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). Nevertheless, it has been documented that a substantial amount of opportunistic PSA screening takes place in Norway.

At present, a novel test called the Stockholm3 test has been developed. A large prospective study has shown that the efficacy of the Stockholm3 test is superior to PSA, and both the sensitivity and the specificity are substantially higher for Stockholm3 than for PSA.

Aim The aim of this study is to analyze the effectiveness of the Stockholm3 test in regular clinical practice, including both primary care and specialized health care.

Study Design From September 2017, the urological department at Stavanger University Hospital requires a Stockholm3 answer in referrals of patients for further diagnostics of possible prostate cancer.

Comparable clinical data will be collected for a period before - and from a corresponding period after the Stockholm3 test was taken into use.

An analysis will then be carried out where the results from the period where referrals were based primarily on PSA will be compared with the results for the period in which the Stockholm 3 test was used.

Power calculation Based on results from the original Stockholm3 study and aggregated figures regarding PSA testing, prostate biopsies and MRI of the prostate in Stockholm and Stavanger, a statistical power has been calculated. Based on a two-sided alpha at 0.05 (i.e., 5%) and a 90% power the study need about 8000 participants to reliably answer the main study questions. An interim analysis will be conducted in the inclusion phase. A new power calculation will be performed based on the registered data, and the need of participants will be adjusted if necessary.

Eligibility Criteria:
Inclusion Criteria:

* All men where a physicians in regular clinical work finds that there is an indication to take the test

Exclusion Criteria:

* known prostate cancer
[68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer

Preclinical studies have confirmed that \[68Ga\]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables \[68Ga\]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of \[68Ga\]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 18-85 years, expected survival ≥12 weeks.
* Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
* At least one measurable target lesion was present according to RECIST1.1 criteria.
* Obtain written informed consent and be able to follow up

Exclusion Criteria:

* Severe abnormal liver and kidney function
* Fertile subjects will need to use effective contraception during the study
* Unable to lie flat for half an hour
* Refused to join this clinical investigator
* Suffering from claustrophobia or other mental illness
* Other conditions deemed unsuitable for participation in the trial
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects

This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.


Eligibility Criteria:
Inclusion Criteria:

* 1. Males aged 18-50 years (inclusive); 2. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg; 3. Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound; 4. Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial; 5. After fully understanding the content of the trial and possible adverse reactions, the subjects who voluntarily participate in the trial, are willing to sign the informed consent form (ICF), and are able to complete the study in accordance with the trial protocol.

Exclusion Criteria:

1. With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions;
2. Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial;
3. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
4. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
5. With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
6. Intolerant to venipuncture or with a history of needle or blood phobia;
7. With a history of drug abuse within 6 months prior to screening;
8. Use of narcotics within 3 months prior to screening;
9. Subjects who have donated blood including blood components or lost blood (≥ 200 mL), received blood transfusion, or used blood products within 3 months prior to screening;
10. Subjects who have received anti-EGFR targeted drugs (including monoclonal antibodies and TKIs) or other monoclonal antibodies within 3 months prior to screening;
Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Weight regain of more than 10 kg from nadir
* Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass

Exclusion Criteria:

* Formerly leak at the gastrojejunostomy
* Formerly open abdominal surgery
* Anastomotic ulcer
Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)

This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. The study will be a single arm, open label study.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Candidate for elective endoscopy procedure
* Participants with known Lynch Syndrome
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and biopsy at 12 months visit.
* Participants taking Aspirin for chemoprevention must agree to stop it for at least 4 weeks prior to study entry and throughout the trial period
* Adequate organ and marrow function
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
* Men of child-bearing potential must not father a child or donate sperm while on this study and for 90 days after their last study treatment.

Exclusion Criteria:

* Current or anticipated use of other investigational agents while participating in this study.
* Psychiatric illness/social situations that could limit compliance with study requirements.
* Pregnant or breast feeding.
* Familial adenomatous polyposis, Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
* Previous or known active malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for more than 5 years
* Current use of anticoagulation therapy
* Current use of therapeutic doses of aspirin for reasons other than chemoprevention
* Use of omega 3 fatty acids or flaxseed supplements within 4 weeks before this study's screening/baseline colonoscopy
* Use of high dose omega 3 fatty acids within the past 3 months prior to study baseline/screening
* Current, regular use of non-steroidal anti-inflammatory drugs (NSAIDS)
* Allergy to fish and/or fish products
* Uncontrolled infectious disease
* Malabsorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
* Unable to swallow and retain oral medication
Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of pancreas
* Locally advanced or metastatic unresectable disease

Exclusion Criteria:

* No prior anti cancer chemotherapy, radiotherapy (except palliative \>4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;
Use of the Triggering Receptor Expressed on Myeloid Cells-1 (TREM-1) in the Diagnosis of Pleural Effusion

The aim of this trial is to evaluate the level of TREM-1 in different kinds of pleural effusion.

The triggering receptor expressed on myeloid cells-1 (TREM-1) is a member of the immunoglobulin superfamily, and its expression is upregulated on phagocytic cells in the presence of bacteria or fungi. Several experiments by Bouchon and colleagues showed that TREM-1 mediates the acute inflammatory response to microbial products. Human tissues infected with bacteria are infiltrated with neutrophils and macrophages that express high levels of TREM-1. Conversely, TREM-1 is only weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form in body fluids. The presence of a soluble form of TREM-1 in samples of bronchoalveolar lavage fluid from mechanically ventilated patients has been shown to be a good indicator of infectious pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pleural effusion
* Pleural effusion proved by chest sonography

Exclusion Criteria:

* Conditions for which thoracentesis are contraindicated
* Pregnancy
A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening

Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.

Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.

Eligibility Criteria:
Inclusion Criteria:

* Adults 50-75 years old;
* Asia-Pacific Colorectal Screening score(APCS): medium or high risk.

Exclusion Criteria:

* APCS score: low risk;
* People with history of intestinal surgery;
* People with history of CRC;
* People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
* People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
* Pregnancy, lactation or menstrual phase;
* Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients

The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

Data collection for this study will be conducted through 2 rounds of web-based surveys of health care professionals (HCPs). A meeting with the panelists will be held as a 3rd round if a consensus for pre determined key questions is not achieved after the 2 rounds of the survey.

Eligibility Criteria:
Inclusion Criteria:

* Urologist from university hospitals in South Korea.
* Has a minimum 10 years of practice experience (experience as a military or public health doctor could be considered practice experience)
* Sees a minimum of 50 mHSPC patients in a year.
* At least 10 publications in SCIE (Science Citation Index Expanded) journals in the past 5 years.

Exclusion Criteria:

* Urologist in private practice.
Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study

Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms.

In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.

Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.

A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* ICU admission for more than 3 days
* Admission for septic shock
* Patient with mechanical invasive ventilation

Exclusion Criteria:

* Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
* Seronegative patient for CMV
* Patient under anti-virus treatment
* Patient under guardianship