cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)

The purpose of this study is to determine the safety and establish the maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory MDS.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* Informed consent;
* Low- and intermediate-risk MDS that has failed to achieve any hematologic improvement after at least 4 cycles of induction therapy or has relapsed after any duration of any hematologic response. Prior therapy with azanucleosides (i.e., azacitidine, decitabine), biologic therapies (i.e., lenalidomide, rigosertib) and hematopoietic cell transplant are permissible;
* Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2;
* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions:

  * Must agree to use physician-approved contraceptive methods throughout the study and for three months following the last dose of omacetaxine and
  * Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial;
* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving a child for 6 months following the last dose of omacetaxine.

Exclusion Criteria:

* Subjects who are eligible for hematopoietic stem cell transplant;
* History of atrial fibrillation related to azanucleoside therapy in the past;
* Active, uncontrolled, clinically significant infection;
* Pregnant and nursing patients are excluded because the effects of omacetaxine on a fetus or nursing child are unknown;
* Treatment with any anticancer therapy (standard or investigational) within the previous 14 days prior to the first dose of study drug or less than full recovery from the clinically significant toxic effects of that treatment.
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.

Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus
2. BMI between 35 and 50kg/m2.
3. Males and females
4. Age between 18 and 60 years.

Exclusion Criteria:

1. Severe ongoing psychiatric disorder, alcoholism and substance abuse.
2. Redo operations after previous bariatric procedures.
3. Type 1 diabetes or other non-type 2 forms of diabetes
4. End stage renal disease, retinopathy, neuropathy
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis

The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver cirrhosis according to current protocols.
* Conscious and cooperative adult patients.

Exclusion Criteria:

* Patients with hemodynamic and/or respiratory instability.
* Patients with contraindications for colonoscopy or fecal transplantation.
* Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
* Associated oncological pathology.
* Patients with other causes of severe immunodeficiencies.
* Lack of compliance with the conditions imposed by the research project.
* Patients who do not sign the informed consent.
Male breAsT cAncer preDisposition Factor

This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.

The study will be conducted on a population of 110 to 150 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male patient with a personal history of breast cancer
2. Age ≥ 18 years
3. Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
4. Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
5. Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).

Exclusion Criteria:

1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
ACCeptation and Qualitative Evaluation of Phone-delivered Intervention

Background: Previous suicide attempt is known to be a strong risk factor for repetition and repetition is common within the first year after an episode of deliberate self-harm (DSH). There has been growing interest in brief interventions for this population that are focused on maintaining long-term contact and/or offering re-engagement with services when needed. Despite telephone-delivered interventions have shown promising results in suicide reattempt prevention, subjective impact of such brief contact interventions and effectiveness mechanisms have never been evaluated.

Semi-structured in-depth interviews with 20 patients previously receiving a telephone-delivered intervention from our team. Six weeks and 3 months after a DSH, people included in telephone-delivered process will be interviewed by a social science researcher. Qualitative analysis using thematic analysis will be independently performed by two researchers.

Eligibility Criteria:
Inclusion Criteria:

* Deliberate self-harm in the previous week,
* 18 years old and older,
* outpatient care orientation after discharge from emergency department

Exclusion Criteria:

* Difficulties in french language,
* mental retardation
Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)

: An intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them

Study design: this study is a multicenter, international, prospective observational registry.

Setting: patients will be enrolled by participating investigators from European and Latinamerican countries. All sites are susceptible of treating pediatric cardiac arrest patients. Participating hospitals differ in levels of care but are all able to submit their data to the study's database.

Patient elegibility: Inclusion criteria: all children aged 1 month to 18 years who suffer a CA in hospital. For the study, CA is defined as the absence of vital signs requiring at least one minute of chest compressions. Subsequent episodes of CA may be included for the same individual.

Exclusion criteria: Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA. Patients who suffer a cardiac arrest and require ECMO for ROSC, after performing conventional CPR, will not be excluded. Duration of the data collection period 24 months.

Recruitment: Study candidates will be identified by a study physician, who will explain the study to parents or guardians. Written informed consent will be obtained from parents or guardians prior to inclusion in the study. A CONSORT (Consolidated Standard of Reporting Trials) flow diagram is shown in Figure 1.

Data collection: data will be collected, verified, and uploaded to a protected electronic web-based database (Xolomon) by their designated site coordinators/investigators under the oversight of their IRB. Database has been designed following the Utstein model (19). Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish.

Eligibility Criteria:
Inclusion Criteria:

* all children aged 1 month to 18 years who suffer a CA in hospital

Exclusion Criteria:

* Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.
* Duration of resuscitation \< 1minute
EUS-guided FNA in the Study of the Adrenal Gland

To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.

A review of 205 EUS-FNA of AG in 200 patients is included.

INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.

OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.

MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

Eligibility Criteria:
Inclusion Criteria:

* All adrenal gland (Left / Right) punctured by endoscopic ultrasound
Thrombus Formation Under Different Flow-conditions

Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Clinical studies indicate an important role for the proteins of the contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK)) on the risk of cardiovascular disease. There is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi and in vitro studies showed that collagen is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi. The investigators want to determine the role of the proteins of the contact activation system in platelet mediated thrombus formation in human blood.

Objective: The investigators will study the effects of the proteins of the contact activation system on platelet mediated thrombus formation, embolization and degradation on collagen in a perfusion flow model.

Study design: Blood will be collected from human volunteers via a venipuncture in the forearm. Each volunteer will donate maximally four times 30 ml of blood over a period of two days. This blood is used in perfusion flow experiments: blood flows over a coverslip covered with collagen in a flow chamber. The investigators will vary several conditions such as the concentration of the proteins and the shear rate. For perfusion flow experiments, the investigators need fresh whole blood because platelets are viable for four hours. After this time, new blood is needed.

Study population: For this study the investigators need blood from human volunteers with a coagulation defect in one of the proteins of the contact activation system, e.g. FXII, FXI, prekallikrein or HMWK and controls without any coagulation defects.

Main study parameters/endpoints: The investigators main study endpoint is the ex vivo formation of platelet-mediated thrombi on collagen in a perfusion flow model. The investigators hypothesize that thrombi formed from blood of patients deficient in FXII or FXI are less stable than those formed from blood from controls.


Eligibility Criteria:
Inclusion Criteria:

* Patient group:
* Age: ≥ 18 years
* Deficiency in factor XII, factor XI, prekallikrein or high molecular weight kininogen
* Control group:
* Age: ≥ 18 years

Exclusion Criteria:

* (Other) Coagulation defects
* Symptoms of active disease
* The use of antiplatelet drugs
* The use of aspirin/ascal
Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women

There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.

Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.

In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.


Eligibility Criteria:
Inclusion Criteria:

* females 60 - 75 years old
* caucasian race

Exclusion Criteria:

* CHD-diseases
* thrombosis, embolism
* fractures at lumbar spine or hip
* secondary osteoporosis
* hyperparathyroidism
* medication, diseases with impact on muscle or bone
* hip or knee implant
Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.

Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
* Understand and agree to abide by the study procedures.
* Adult #18 years of age at the time of inclusion in the study.
* Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
* Severity 3-4 according to the WHO 7-point ordinal scale.

Exclusion Criteria:

* ALT / AST\> 5 times the normal limit
* Stage 4 chronic kidney disease (GFR \<30) or requiring dialysis.
* Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
* Advanced dementia.
* Pregnancy or breastfeeding.
* Anticipation of transfer to another center in the 12 hours at the beginning of the study.
* Allergy to study medication.
* Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
* Streptococcus pneumoniae antigenuria positive before study start.
* Neutropenia \<500 / mm3.
* Thrombocytopenia \<100,000 / mm3.
* History of diverticulosis.
* Ongoing skin infection (eg, pyodermitis).
* Transplanted patient under immunosuppressive treatment.
* Previous evidence of latent untreated tuberculosis.
Gestational Diabetes and Offspring's Cardiovascular Health: MySweetHeart Cohort

MySweetHeart Cohort is an observational study to assess the effect of gestational diabetes mellitus (GDM) on early life offspring's cardiovascular health.

The primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis). The secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.

The main hypothesis is that offspring of women with GDM have a larger LVMI and a larger cIMT at birth (primary outcomes) compared with offspring of women without GDM. Further, other hypotheses are that offspring of women with GDM have more foetal cardiovascular alterations and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with offspring of women without GDM.

My SweetHeart Cohort is linked to MySweetHeart Trial, a randomized controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring. The principal investigators of this trial are Prof Jardena Puder and Dr Antje Horsch from Lausanne University Hospital.


Eligibility Criteria:
Inclusion Criteria:

Women aged 18 yrs or older, with or without GDM at 24-32 weeks of gestation, and understanding French or English.

Exclusion Criteria:

Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder
When Will I Feel The First Movements of My Baby?

This study aims to investigate average gestational week in which mothers feel the babies'movements for the first time and maternal-fetal factors affecting this time.

Most of the obstetricians face the question; "When Will I Feel The First Movements of My Baby?", in daily practice. It becomes a challenge for the obstetrician to answer this question. Because, there is not a sufficient data in the current literature on this issue. A broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round figures. So, when a woman in the 21st gestational week , asks this question to the obstetrician and informed according to aforementioned literature knowledge, the woman will ask another question immediately after: "What is the problem with my baby?". But, the obstetrician will not be able to give an assuring answer because of the lack of knowledge in the current literature.Thus, to cope with such a clinical situation, the investigators decided to investigate the average week in which pregnant women in a low risk population, felt the babies' movements for the first time and to find out the affects of probable factors which may act on this time.

Eligibility Criteria:
Inclusion Criteria:

* The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy

Exclusion Criteria:

* Multiple pregnancies, evidence of fetal or maternal infection, hypertensive disorders of gestation, gestational and pregestational diabetes mellitus, maternal drug use, evidence of fetal congenital abnormalities and amniotic fluid abnormalities were stated as the exclusion criteria for the study group.
Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery

This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day.

This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* having undergone a minimally invasive total knee by select surgeon
* voluntarily enrolled
* independent community ambulators
* only patients being discharged directly home

Exclusion Criteria:

* celecoxib allergy or intolerence
* Renal insufficiency (defined as serum creatine level \>1.5 mg/dL or BUN level \>22mg/dL
* History of bleeding gastic or duodenal ulceration
* New York Heart Association Class III or IV Congestive Heart Failure
* Previous myocardial infarction or cerebralvascular event
* Severe inflammatory bowel disease
* Known coagulation abnormality or hepatic disease
* Chronic coumadin administration
* Refusal by primary or cardiac physician
A Clinical Study of Omega-3 on Depression and Cognition

Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.


Eligibility Criteria:
Inclusion Criteria:

* current moderate to severe depressive episode (DSM-5)
* HAMD-17\>16
* 18≤Age≤45
* Never use of fluoxetine and no use of any antipsychotic and antidepressant drugs and mood stablizer at least 8 weeks
* Current physical or laboratory tests show good health
* negative usrine drug tests
* voluntray to sign the consent form

Exclusion Criteria:

* treat-resistant depressive disorder
* other axis I/II dignoses
* MMSE≤27 recent abuse history of alcohol or drugs pregnant or breast breeding