cyrilzakka/clinical-trials huggingface dataset:
Flotufolastat F 18 PET in Men with Very Low PSA Recurrence

The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.

This is a prospective single arm study for the use of flotufolastat F 18 PET in men with very low prostate specific antigen recurrence. The research study involves collecting flotufolastat F 18 PET images to evaluate the detection rate. Flotufolastat F 18 is a radiopharmaceutical (radioactive agent) the U.S. Food and Drug Administration (FDA) has approved. Participation in this study will be for the duration of the flotufolastat F 18 PET scan. It is expected that about 50 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
* Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
* At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
* Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
* Age ≥18 years.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone \[LHRH\] agonist alone \[continuous or intermittent\]; LHRH antagonist alone \[continuous or intermittent\]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
* Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
* Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \<24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
Effect of Chemotherapy on TMB in NSCLC

Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
* Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient can not comply with research program requirements or follow-up;
* Patient will receive immunotherapy;
Evaluation of Drug's Risk in Pregnant Women

Medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.

To fill this gap, the investigators have put in place since 2004, a database, EFEMERIS, recording products given to women during pregnancy in Haute-Garonne (data from Primary Health Insurance Fund), fate of these pregnancies and the state health of newborns (Mother and child protection data, prenatal Diagnostic Centre and Medicalisation Program of Information Systems data).

Women included in this database (\> 90 000 to date) has allowed us to study the risks of taking certain medications still not assessed in pregnant women (for example phloroglucinol, the H1N1 flu vaccine , oseltamivir ...). Each year about 10 000 pregnant women join the cohort. The collection and management of data concerning require careful organization and mobilize multiple stakeholders.

The pursuit of these inclusions is needed to study medication less often prescribed but raise questions. For example, if the investigators consider that the relative risk of cardiac abnormalities following in utero exposure to paroxetine is multiplied by 1.5, it will take 1,000 women exposed to paroxetine for 5 additional cases observed. In December 2013, 0.3% of women EFEMERIS were exposed to paroxetine in the first quarter (274 women).

The objective of this project is to continue the EFEMERIS project (funded for 10 years public tenders until December 2015) by continuing to include pregnant women (about 10 000 per year) in order to explore the potential effects of exposure to different drugs on the newborn (prematurity, birth defects, neonatal diseases).

The processing of data will EFEMERIS to detect drugs at risk to the fetus and provide a warning role in terms of malformation effects, to monitor over time prescribing practices, participate in pharmacoepidemiology international multicenter studies including similar databases in general population.

Eligibility Criteria:
Inclusion Criteria:

* Women supported by the general scheme of the Primary Health Insurance Fund of the Haute-Garonne who gave birth or had a miscarriage between 1 January 2015 and 31 december 2017.
* Women not opposing that us to access to their data.
* Women for which at least one baby health certificate has been registered at the Mother and child protection, or the outcome of pregnancy was identified by prenatal diagnosis center or Medicalisation Program of Information Systems.

Exclusion Criteria:

* Women that refuses to give access to the data concerning them.
* Women for which no data on pregnancy outcome can be collected.
(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)

Pilot study to determine the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan, evaluated by the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.

In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method".

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients, 18 years ≤ age ≤ 85 years
* Diagnosis of Pulmonary Hypertension Group 1 according to Nizza Definition (PAH) confirmed by invasive methods, WHO functional class II and III
* Existing clinical need to repeat a right ventricular catheter examination (as recommended by the current "Kölner Konsensuskonferenz")
* Ability to understand study goals and agree to study participation
* Hemodynamic criteria of ventricular catheter examination:

  * Pulmonary vascular resistance (PVR)\> 240 dyn x sec x cm-5
  * Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg
* Clinical need to receive treatment with a drug approved for the treatment of PAH for the first time
* Potentially fertile women must agree to use highly effective methods of contraception, either through abstinence or the use of at least two methods of contraception from the date of consent until one month after the end of the study. An effective pregnancy protection consists in the combination of a hormonal contraceptive (oral, injectable or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
* Written consent to the clinical trial

Exclusion Criteria:

Existing therapy with positive inotropic drugs such as Catecholamines (including norepinephrine, dobutamine, suprarenin)

* Pregnancy or breastfeeding
* General contraindication for examinations to be performed during the study
* Hypersensitivity to the active substances or to a constituent of the study medication (in particular lactose and soya)
* Simultaneous participation in another medical therapy study
* Simultaneous participation in another non-drug study that would preclude participation in this study
* Participation within one month after completing another therapy study
* Heavy liver function disorders
* Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT))\> 3 × ULN
* Systolic blood pressure \<95 mmHg
* Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
* anemia (Hb \<10 g / dl)
* Concomitant medication with potential interaction to macitentan and/or riociguat according to the IB
* Severe kidney dysfunction
* Severe hemoptysis
* History of bronchial artery embolization
* smoker
Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).

Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva.

Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day.

All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started.

In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation.

Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
* Able to provide a written consent
* Willing and able to complete questionnaires
* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

* Lichenoid lesions suspected to be induced by contact allergy or drugs
* Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
* Pregnant or lactating
* Photosensitivity
* Use of antibiotics within 2 weeks prior the study
Bile Leak After Liver Surgery

The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).

Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.

Eligibility Criteria:
Inclusion Criteria:

* any patient submitted to hepatic resection at our Unit between the established frame time

Exclusion Criteria:

* any patient with incomplete data or follow-up
Downhill Walking in IPF

In this study; will examine the effects of downhill walking (eccentric exercise training) on exercise capacity, quality of life, and blood lactate levels in individuals with IPF. After the initial assessment, patients will be randomized into two groups: downhill walking PR group and Standard PR Group.

Individuals diagnosed with idiopathic pulmonary fibrosis who come to the Pulmonary Rehabilitation Unit of Istanbul Süreyyapaşa Chest Diseases and Chest Surgery Education and Research Hospital will be included in this study. Those who meet the inclusion criteria will be randomized into two groups: Downhill Walking Pr Group (n=17) and Standard Pr Group (n=17). Patients will have exercise sessions twice a week for 8 weeks. Patients will be evaluated immediately before the rehabilitation program and the end of 8 weeks exercise programme. In our study, downhill walking training will differ from traditional walking training only in terms of treadmill training protocol. Traditional walking training involves walking on a motorized treadmill with a neutral incline, progressing with increases in speed, while downhill walking training will be performed at a constant -10% incline.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of IPF according to the clinical diagnostic criteria of the American Thoracic Society and/or the European Respiratory Society (ATS-ERS).
* Being between the ages of 18 and 75.
* Being able to walk on a treadmill.
* Having the ability to cooperate.
* No change in current medication in the last month.
* Not participating in a structured activity program for at least six months.
* Accepting the purpose and method of this study voluntarily and give informed consent for the study.

Exclusion Criteria:

* Presence of physical or mental impairment that prevents informed consent or compliance with the protocol.
* Inability to attend more than 20% of pulmonary rehabilitation sessions.
* Presence of major cardiovascular disease (coronary artery disease, uncontrolled hypertension, arrhythmias, or heart failure).
* Presence of existing orthopedic and neuromuscular exercise limitations.
* Acute exacerbation
Intervention Program to Improve Body Image and Self-Esteem Among Female Athletes.

A controlled, randomized clinical intervention study which includes the development and activation of an intervention program designed to prevent eating disorders among adolescent female aesthetic athletes. Our hypothesis is that the intervention program will yield improvement in the participants' eating behaviors, drive for thinness, and body image as compared with the age matched control group. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the program. The Questionnaire will include validated questionnaires with good psychometric qualities.

Eating disorders can cause a decrease in athletic performance and affect the overall health of athletes. Athletes are exposed to an increased risk of developing pathological eating behaviors and dissatisfaction with their bodies. A number of studies have found higher rates of eating pathologies in aesthetic sports such as dance, ice skating, and gymnastics. Other studies have found that intervention programs designed to prevent eating disorders in athletes have yielded promising results. The current study will examine the effects of a controlled clinical intervention program designed to prevent eating disorders and improve the body image of female adolescent figure skaters and dancers. The program will consist of ten 45-minute interactive sessions led by the researcher. Each session will include a brief theoretical background, experiential activities (artistic or cognitive / emotional) and group discussions. The control group shall include age matched athletes who will not participate in the intervention program. The impact of the intervention shall be assessed with a nonrandomized, controlled experimental group design. To assess the impact and outcome of the intervention, all participants in the research and control groups will be asked to complete the study questionnaire at pre, post, and 3-month (after post) follow-up assessments. Process evaluation, which assesses program dissemination, attendance and relapse rates, as well as assessment of participants' satisfaction, will be performed at the end of the program. The study questionnaire includes: Personal and Demographic Information, EDI-2 (Eating Disorders Inventory), Body Esteem Scale-Mendelson, SATAQ-4 (Sociocultural Attitudes Towards Appearance Questionnaire-4), EDE-Q 8 (Eating Disorder Examination Questionnaire- 8), BAS (Body Appreciation Scale). All questionnaires have good psychometric properties. The study hypothesis is that the intervention program will result in improvement in the intervention group in terms of: disturbed eating behaviors, pursuit of thinness, body-dissatisfaction and external influences on body image compared with an age-matched control group that did not participate in the program.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 10-16
* Athletes in aesthetic sports: figure skaters, dancers and gymnasts.

Exclusion Criteria:

* Males
* Females under age 10 or over 16
* Athletes from non-aesthetic sports
* Non-athletes.
Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4

Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged \>60 years.

Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a morphologically proven diagnosis AML and both the following criteria:
* Age ≥ 60 years and \< 80 years.
* Not previously treated for their disease.
* With favourable or intermediate-risk cytogenetics. (Patients with urgent clinical need to begin treatment might be included before cytogenetic results, when necessary if they do not respond to Hydroxyurea. Patients might be included if the cytogenetic results are not expected in a time limit \< 5 days after AML diagnosis).
* Fit to receive intensive chemotherapy
* Cardiac function determined by radionucleide or echography within normal limits.
* Signed informed consent

Exclusion Criteria:

* M3-AML
* Presence of adverse cytogenetics (according to European LeukemiaNet recommendation.) (17) defined as one of the following abnormalities: -5/5q-, -7, t(6;9), t(v;11q23) excluding t(9;11), inv(3)(q21;q26.2) or t(3;3)(q21;q26.2), complex karyotype (3+ abnormalities)
* Secondary AML following treatment with radiotherapy or chemotherapy.
* AML following previously known myeloproliferative or myelodysplastic syndrome.
* ECOG performance status (PS) 0 to 3
* Serum creatinin level \> or = 2.5N; AST and ALT level \> or = 2.5N; total bilirubin level \> or = 2N
Difficult Colon Polypectomies

The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.


Eligibility Criteria:
Inclusion Criteria:

* colonic polyps that are deemed difficult to resect by the endoscopist

Exclusion Criteria:

* patient refusal to participate in the trial