cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.

Eligibility Criteria:
Inclusion Criteria:

* Polyps equal or larger than 1 cm

Exclusion Criteria:

* Coagulopathy
* Inability to sign informed consent
Respiratory Microbiome and COPD Exacerbations (RESMECOPD)

The global objective of this coordinated project is to test the following hypotheses: 1) the lung microbiome in chronic obstructive pulmonary disease (COPD) is different in patients suffering from frequent exacerbations (FE) compared those who do not (NE ); 2) The microbial profile of patients with FE is associated with a different local and systemic inflammatory pattern; and 3) the inflammatory and immune characteristics of COPD are modulated by the intestinal microbiome.

The project is based on bronchoalveolar lavage (BAL) for sampling lung microbiome, and includes analysis of regional variability (intrapulmonary) and temporal variability. The project will also assess the correlation between BAL samples obtained from the proximal airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in them. A cohort of COPD patients (n = 50 FE; n = 50 NE) and healthy subjects (n= 30), matched by age, sex and tobacco consumption. Respiratory secretion samples will be collected in clinical stability samples, with resampling in a quarter of the participants at 6-9 months. Coordinator Project: Bacterial and fungal microbiota will be determined by 16S rRNA and ITS amplification and sequencing. Virome and functional metagenomics will be analyzed in a quarter of the participants. Subprojects: Regional variability in the lung, local and systemic inflammatory response, and the relationship between the intestinal microbiome and inflammatory and clinical characteristics of the disease will be determined. The integration of the results will be performed using network medicine methodologies. The results of this project will help to understand the pathogenesis of COPD and its exacerbations with the final aim to identify new therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Spirometry: FEV1/FVC \< 70%; FEV1 between 50 and 80% predicted (GOLD II/III)
* Clinical Stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - The treatment received will be registered for post-hoc studies stratified by this condition.

Exclusion Criteria:

* Drug addiction, alcohol abuse,
* Use of long-term oral or nebulised antibiotic therapy.
* History of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes.
* Other diseases: Severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.
Pancreatic Juice Diagnosis From Duodenum

Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient.

The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.

Eligibility Criteria:
Inclusion Criteria:

* Common inclusion criterion
* Age is 18 years or older.
* Informed consent was obtained.
* Inclusion criterion for normal cohort
* An upper GI endoscopy is scheduled to check upper abdominal symptoms.
* No findings of pancreatic disorder as documented by CT or MRI or EUS
* Inclusion criterion for PC suspicious cohort
* A EUS or ERCP is scheduled to suspected pancreatic disorder.

Exclusion Criteria:

* Common exclusion criterion
* Severe cardiac disease
* Severe respiratory disease
* Bleeding disorders
* Pregnancy
Gemcitabine Plus Oxaliplatin Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma

The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX) is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were age 18 to 75 years;
* The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography \[CT\]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
* ECOG score≤2;
* life expectancy 3 months;
* Barcelona Clinic liver cancer (BCLC) stage B or C disease;
* Child-Pugh stage A or B disease;
* Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin \<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT\<5 ×ULN could be recruited if total bilirubin was in the normal range.
* Patients had to provide signed informed consent to participate.

Exclusion Criteria:

* documented allergy to platinum compounds or other study drugs; any previous OXA or GEM treatment, except adjuvant treatment ﹥12 months before random assignment;
* Previous liver transplantation;
* concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
* CNS metastasis;
* Other serious illness or medical condition.
Telerehabilitation in COPD

The prevalence of chronic obstructive pulmonary disease (COPD) in Turkey is 10%. Patients with COPD have a decreased physical capacity. Decreased physical activity in COPD patients causes an increase in all-cause mortality. Pulmonary rehabilitation contributes to increasing physical capacity and quality of life in COPD patients. However, a limited number of patients have access to pulmonary rehabilitation. Some of the patients drop out of pulmonary rehabilitation due to reasons such as transport difficulties, low social support, and low professional support. In addition, disruption of daily routine is one of the important reasons for this situation. Telerehabilitation can enable more patients to access pulmonary rehabilitation. Education and exercise programs can be followed with telerehabilitation in patients with COPD. An increase in exercise capacity and a decrease in dyspnea have been achieved with telerehabilitation in COPD patients.

Different technologies such as telephone, video conferencing or web sites can be used for telerehabilitation. Also, mobile phone was used to telerehabilitation. To make pulmonary telerehabilitation completely patient-based, we have developed an application suitable for smartphones. The application contains videos which showing how to perform pulmonary rehabilitation exercise videos, and it allows the participants to follow up compliance with pulmonary rehabilitation daily. The application will be downloaded to the smartphones of the participants, and it will be shown how to use the application. Participants will not be shown pulmonary rehabilitation exercises.

This study aims to evaluate the effectiveness of telerehabilitation with the application program on physical capacity, quality of life, and dyspnea perception in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Being diagnosed with COPD
* Not have previously participated in pulmonary rehabilitation
* To able to use smartphone

Exclusion Criteria:

* Under age 18
* Pregnancy
* Have previously participated in pulmonary rehabilitation
* Having any malignacy
* Having any disorder that limit exercise
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma

Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;
* Age between 18 and 85 years old;
* Performance on the ECOG scale less than or equal to 2.
* Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.

Exclusion Criteria:

* Refusing to sign or inability to understand the consent term;
* Pain less than 2/10 on the numeric pain rating scale;
* Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
* Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;
* Previous cancer and previous oncological treatments;
* Previous autoimmune diseases, even if controlled;
* Current pregnancy.
Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Tenofovir To Abacavir In Hiv-1-Infected Subjects With Loss Of Bone Mineral Density

Most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of protease inhibitors (PIs) have been published. The more evident finding with respect to this issue is the more pronounced decrease of bone mineral density (BMD) in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.

The prevalence of osteoporosis in HIV-infected patients could be more than three times greater compared with HIV-uninfected subjects, according to the results of a meta-analytical review of cross-sectional published studies. The analysis includes data from 884 HIV-infected patients and 654 HIV-uninfected controls. Sixty-seven percent of HIV population had reduced bone mineral density (BMD), of whom 15% had osteoporosis (OR of 6.4 and 3.7, respectively, compared with HIV-uninfected controls).

In the same meta-analysis, when authors evaluated the role of antiretroviral therapy (ART) on BMD, comparing 202 antiretroviral-naive with 824 ART-treated patients, patients on treatment had a 2.5-fold increased odds of prevalent reduced BMD and osteoporosis. And finally, when 410 non-protease inhibitor (PI)-treated HIV patients were compared with 791 patients receiving a PI-containing regimen, those on PIs had increased odds of reduced BMD and osteoporosis.

As well, other studies support data of an impaired BMD in HIV-infected patients after starting antiretroviral therapy. These results let us confirm that HIV itself and antiretroviral therapy contribute to decrease the BMD.

However, most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of PIs have been published. The more evident finding with respect to this issue is the more pronounced decrease of BMD in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (=/+18 years old) having a diagnosis of HIV-1 infection.
2. Current HAART including tenofovir plus emtricitabine/lamivudine plus a PI, a NNRTI or raltegravir started at least 12 months before.
3. T-score ≤-2 measured by DEXA (within the last 6 months).
4. Maintained undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) for at least 12 months.
5. Absence of suspected or documented resistance mutations in the RT associated to abacavir.
6. Voluntary written informed consent.

Exclusion Criteria:

1. History of intolerance, toxicity or virological failure to abacavir.
2. HLA B\*5701 positive.
3. Secondary osteoporosis/osteopenia (vitamin D or testosterone deficit, thyroid disease, ...)
4. Therapy with biphosphonates within the last 12 months.
A Machine Learning-based Estimated Survival Model

Malignant tumors are the leading cause of death in elderly patients, and palliative care can improve the quality of life for elderly advanced cancer patients. One of the main reasons why these patients are not included in palliative care is the lack of accurate estimation of their survival period by patients, family members, and doctors. Both doctors and patients tend to be overly optimistic about the survival period of elderly advanced cancer patients, leading to overtreatment. Therefore, assessing the risk of death for these patients and further establishing a survival period estimation model can improve the accuracy of doctors' clinical predictions of patient survival, facilitate early referral to palliative care, and promote rationalization of medical decision-making.

1. By searching the literature, conducting systematic reviews, and meta-analyses, we aim to uncover the prognostic factors related to death in elderly advanced cancer patients.
2. Based on evidence-based data and considering the clinical conditions of elderly advanced cancer patients in China, we will establish relevant entries for a risk assessment scale for death in elderly advanced cancer patients. By using the Delphi expert consultation evaluation method, we will finalize the assessment scale framework, laying the theoretical foundation for the establishment and validation of a death risk prediction model for elderly advanced cancer patients in China.
3. Develop a survival estimation model for elderly advanced cancer patients; through metabolomics studies and other research methods, we will investigate metabolic biomarkers related to predicting the survival period of elderly advanced cancer patients.

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria for late-stage malignant tumor patients: Must meet Condition 1) and also meet either Condition 2), 3), or 4):

1. Clinical diagnosis of advanced malignant tumor: TNM stage III or IV
2. "Surprise question": If this patient were to die within the next 6 months, it would not be surprising to you.
3. Karnofsky performance status (KPS) score ≤ 50
4. Palliative Performance Scale (PPS) ≤ 50%

Exclusion Criteria:

1. Patients who refuse to participate in the study;
2. Patients who, for various reasons, are unable to cooperate and complete the questionnaire survey;
3. Patients who, for various reasons, are unable to cooperate and complete the follow-up.
Sleep, Mood, and Behavior Study

The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.

This study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of processes involved in the treatment response of anxiety disorders in youth. This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of impairment in their ability to sleep. Participants will have completed a 16 session intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
2. Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)"
3. The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:

   * difficulties going to sleep
   * difficulties waking during the night
   * difficulties getting up on time for school because of tiredness/sleepiness
   * daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep
   * erratic sleep-wake schedules

Exclusion Criteria:

1. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
2. Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
3. Acutely suicidal or at risk for harm to self or others.
4. Any motor impairments or eye-hand coordination problems
5. Sleep disorder or parasomnia.
6. Taking any medication that might interfere with sleep.
7. Has a medical problem that might interfere with sleep.
Chemo-immunotherapy (Gemcitabine, Interferon-alpha 2b and p53 SLP) in Patients With Platinum-resistant Ovarian Cancer

This study investigates the feasibility and immunogenicity of the triple combination of gemcitabine, Peg-Intron and p53 SLP vaccination in patients with platinum-resistant ovarian cancer.

Recurrent ovarian cancer has a dismal prognosis and there is a pressing need to identify more efficient therapies. Ovarian cancer is highly immunogenic and good survival is tightly linked to the presence of tumor-infiltrating T cells and the absence of immunosuppressive immune cells. This anti-tumor immune response might be primed by chemotherapy.

Gemcitabine has immune-modulatory properties in addition to its direct cytotoxic effect in platinum resistant ovarian cancer. Additionally, Peg-Intron allows the full maturation of dendritic cells, thereby enhancing the anti-tumor response. Moreover, the tumor-associated self-antigen p53 is commonly over-expressed in ovarian cancer and can serve as a target for immunotherapy. Therefore, chemo-immunotherapy with gemcitabine and Peg-Intron plus/minus p53 SLP vaccination seems an attractive treatment for recurrent, p53+ ovarian cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors)
* Tumor over-expressing p53
* Progression of disease or relapse after previous therapy with platinum
* Measurable disease (RECIST 1.1) or elevated CA125 \> 2 times the upper limit of normal within 3 months and confirmed
* Age ≥ 18 years
* WHO performance status 0-2
* Adequate bone marrow function: WBC ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l
* Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min
* Survival expectation \> 3 months
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Known hypersensitivity reaction to any of the components of the treatment
* Pregnancy or lactating
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent