cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

This study is a requirement of Anvisa to add a new indication for off-label drug

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism;
* Who have provided their consent by signing the consent form.

Exclusion Criteria:

* Clinical evidence of Venous thromboembolism (VTE) in the selection;
* treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant
* suspicion or history of coagulumpathia
* Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin \[TIH\], thrombocytopenia associate with heparin \[TAH\] or thrombotic thrombocytopenia syndrome induce by heparin \[STTIH\]
* Active bleeding that can be increased by enoxaparin.
* Previous history of known intracranial hemorrhage
* Artery-venous malformation or a suspicion or known cerebral aneurism
* Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin.
* erosive diseases of the digestive tract especially gastroduodenal
* Uncontrolled hypertension (systolic blood pressure \[BP\]\> 180mmHg or diastolic BP\> 100 mm Hg) at randomization or clinical hypertensive urgency;
* bacterial endocarditis
* heart valve prosthesis
* characterized by severe renal insufficiency creatinine clearance \<30 ml / min
* Intra-arterial thrombolic therapy
* Thrombolic therapy within 24 hours.
* Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery
* disturbance of consciousness and coma
* Less than 6 months of expectative time life
* Chemical dependency
* Patient with anesthetic risk ASA III or ASA IV
* morbid obesity with Body Mass Index ≥ 40
* Chronic use of corticosteroids
* History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products.
* History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson
* Participation in another clinical study within 12 months prior to inclusion
* Potentially fertile woman without β-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study
* Changes the security checks up to 48 h before randomization:

  * Hemoglobin \<10 mg / dL;
  * ALT or AST ≥ 2.5 times ULN;
  * Platelet count \<100.000/mL;
  * INR ≥ 1.5;
* Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study.
Bortezomib and High-dose Melphalan at Myeloma Relapse

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.

Patients with multiple myeloma who have their first treatment demanding relapse after an initial treatment with high-dose melphalan with autologous stem cell support and who have more than 2.0 x 10\^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the trial.

After disease status with basic clinical biochemistry, M-protein in blood and urine, bone marrow investigation including immunophenotyping and total skeletal x-ray the patients are treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10\^6 CD34+ stem cells pr kg body weight.

The first month after high-dose therapy the patients are followed closely for toxicity according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), Version 3.0.

The patients are evaluated for response according to EBMT criteria and for event (death or progressive disease).

Eligibility Criteria:
Inclusion Criteria:

* First relapse after ASCT
* Symptomatic myeloma
* More than 2,0 x 10\^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support
* Signed informed consent given prior to any study related activities have been performed
* Age \> 18 years

Exclusion Criteria:

* Allogeneic transplantation scheduled as a part of the treatment
* Expected survival of less than one month.
* Performance status (WHO) \> 3
* Neuropathy \> Grade 3 (neurological symptoms interfering with ADL)
* Non-secreting myeloma
* Other concurrent disease making bortezomib treatment unsuitable
* Positive pregnancy test (only applicable for women with childbearing potential)
* Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
* Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
* History of hypotension or has decreased blood pressure (sitting systolic blood pressure \[SBP\] \<= 100 mmHg and/or sitting diastolic blood pressure \[DBP\] \<= 60 mmHg)
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer

Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy.

We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.

The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the attending clinician. Clinical management questionnaires completed by the study investigator will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy or radiotherapy
* Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months apart and an absolute PSA \> 0.2 ng/mL
* Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease

Exclusion Criteria:

* Evidence of metastatic disease
* Contradiction to 18F-FCH PET scan
* Contraindication to MRI
Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.

This is an expanded access-physician sponsored trial of PF-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy. This trial is designed for patients who have been on a previous Industry-sponsored phase I trial using PF-03084014 for\> 1 year. The study is designed to evaluate the safety of prolonged oral administration of single agent PF-03084014. There are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options. The goal of this protocol is to allow these subjects, who are clearly benefiting from PF-03084014, to continue to receive it

Eligibility Criteria:
Inclusion Criteria:

- Patients who are currently enrolled in A8641014 for \> 1 year are eligible

Exclusion Criteria:

* Prior treatment with a gamma secretase inhibitor for treatment of cancer
* Patients taking Tamoxifen
* Patients with active graft versus host disease
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
* Patients who are pregnant or breast-feeding
* Patients with clinical evidence of central nervous system disease
To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD

In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. Diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.

This study is a retrospective, non-interventional, and observational study. The clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the ABCD drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. If adverse events related to ABCD have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. It is hoped that the basic situation of Chinese invasive fungal patients is described, and ABCD is evaluated in the treatment of invasive fungal patients. In addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of ABCD.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.
3. Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.
4. There is no limit to the patient's previous treatment plan.

Exclusion Criteria:

1. Patients judged by clinicians to be unsuitable for this study.
2. Patients with incomplete data or other factors affecting the judgment of efficacy and safety.
Video-observed Therapy for Active Tuberculosis: a Feasibility Study

Tuberculosis (TB) is still present in Switzerland, and concerns mainly foreign-born subjects. Monitoring compliance to treatment by Directly Observed Therapy (DOT) is strongly encouraged by the World Health Organization (WHO). It is however time-consuming, costly and stigmatising. This study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone, a concept known as vDOT (Video-observed therapy). The study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance, compliance, and technical issues related to vDOT.

The study aims to include all patients who are treated de novo for active tuberculosis is our area. The aim of this study, was to show that vDOT was feasible in a low-incidence high income area, that it had a high acceptance rate among patients and health-care professionals, with a low rate of technical difficulties or pitfalls.

All patients with a diagnosis of tuberculosis irrespective of site(s) of infection, were invited to participate in this study. The Division of Pulmonology of Geneva University Hospital diagnoses and follows virtually all cases of tuberculosis in the Canton of Geneva. Annual number of cases in Geneva between 2020 and 2023 was on average 43/year (range: 36-53). Incidence was 7-10.3/105 inhabitants compared to a national incidence of 3.99-4.72 /105 inhabitants during the same period.

Specialized TB nurses were trained to use the vDOT platform and provided the training with the help of translators whenever required. The application (APP) was installed with the patient, and a test video was sent to the platform. The APP uses simple understandable pictograms and is thus not per se language-dependent . vDOT was started as soon as possible after initiation of TB treatment, either during a hospital stay or during the first outpatient follow-up visit at our centre. Whenever necessary, a portable cell phone was provided for the patient, for the duration of the treatment.

The SureAdhere platform was used for vDOT (https://dimagi.com/sureadhere/). Once the videos have been recorded, they are sent automatically as soon as the patients' cell phone has access to internet.

For each patient, the number of videos to be sent each week was specified (5 as default option).

Eligibility Criteria:
Inclusion Criteria:

* age above 16 years of age; providing informed consent (translators were used whenever necessary to ensure understanding of study and vDOT procedure); having a diagnosis of untreated active tuberculosis, irrespective of site of infection, confirmed by culture and/or Polymerase chain reaction test (PCR) and follow-up ensured by Geneva University Hospital.

Exclusion Criteria:

* refusal to participate, not fulfilling inclusion criteria
Seroprevalence of SARS-CoV-2 in Asymptomatic Frontline COVID-19 HCWs

This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.

Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear. Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients. Asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases.

A large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. The seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. In a combined study of three hospitals of Turkey, the seropositivity rate of the previously undiagnosed HCWs was 2.7%. A study done in China revealed 17.5 % seropositivity rate.

This study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* All HCWs who had been working in high exposure areas of COVID 19

Exclusion Criteria:

* Any HCW of high exposure areas of COVID 19 who suffered from COVID 19 themselves diagnosed on PCR or clinically
Impact of the Menstrual Cycle in Reproductive Aged Women with Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).

The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria for DM1 according to ADA
* Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system.
* Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year.
* Men under 50 years old.
* Acceptance of participation in the study and signing of the informed consent

Exclusion Criteria:

* Gestation
* Use of hormonal contraceptives (including intrauterine devices)
* Institutionalization, serious or terminal illness or renal replacement therapy.
* Refusal to participate in the study or to sign the informed consent
Neurobiology of Opioid Dependence: 2 - 2

The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.


Eligibility Criteria:
Please contact site for information.
The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.

The purpose of this research is to study postmenopausal female masters athletes to see if they will show greater myocardial stiffness and reduced exercise capacity than premenopausal females and similarly aged male masters athletes.


Eligibility Criteria:
Inclusion Criteria:

* Longstanding history of competitive endurance athletic performance defined as \>15 years of continuous athletic training for at least 7 hours per week and ongoing engagement in competitive events.

Exclusion Criteria:

* A current or prior diagnosis of cardiovascular disease as defined by the presence of structural heart disease, heart failure, symptomatic coronary artery disease, more than moderate valve disease or prior valve surgery,
* Current or recent pregnancy within 1 year
* Positive pregnancy test (study visit 1)
* Concurrent or use within 1 year of oral contraceptives or hormone replacement therapy,
* Unable to undergo a cMRI (Please refer standard clinical contraindications for MRI)
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positive or negative status.
* Blastomycosis or histoplasmosis.
* Life expectancy of at least 1 week.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Liver disease.
* Self-limiting fungal disease.
* Very severe fungal disease such as meningeal involvement.
* Acute respiratory disease.

Concurrent Medication:

Excluded at any time:

* Terfenadine.
* Astemizole.
* Oral midazolam.
* Triazolam.
* Cisapride.
* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.

Excluded during oral consolidation:

* H2 blockers.
* Chronic antacids.
* Omeprazole.
* Lansoprazole.

Patients with the following prior condition are excluded:

Hypersensitivity to azole antifungals.

Prior Medication:

Excluded at any time:

More than 3 days of amphotericin B, fluconazole, or ketoconazole.

Excluded within 2 weeks prior to study entry:

* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.

The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum :

* One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose
* One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.

The DiDo study evaluates efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy.

The objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (CAPD) patients using incremental peritoneal dialysis (PD) (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.

This is a phase IV open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un Europe.

It is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). The duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited.

There are 2 periods: a run-in period of 2 months and a treatment period of 18 months.

Eligibility Criteria:
Inclusion Criteria:

Run-in period

* Incident CAPD patients who require incremental PD and in whom a 1.5L dialysate can be safely instilled,
* Creatinine clearance \< 20 ml / min (calculated with the modification of the Diet in renal Disease \[MDRD\] formula),
* Age ≥ 60 years,
* Patients willing and able to give written informed consent and comply with the requirements of the study protocol.

Treatment period

* Patients having successfully completed the run-in period (achieving euvolemia)

Exclusion Criteria:

Run-in period

* Contraindication for CAPD according to local practice,
* Life expectancy \< 6 months,
* Known allergy to icodextrin (cloudy dialysate or skin rash),
* Need for amino-acid prescription,
* Treatment with any investigational product within 30 days prior to signature of the informed consent form (ICF)
* History of drug or alcohol abuse within 3 months prior to the signature of the ICF.

Treatment period

* Severe symptomatic arterial hypotension at the end the run-in period in the Investigator's opinion,
* Excessive ultrafiltration (UF) during the run-in period,
* Allergy to icodextrin discovered during the run-in period,
* Impossibility to achieve adequate PD regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psychosocial reasons)