cyrilzakka/clinical-trials huggingface dataset:
Multicenter Study Evaluating the Efficacy of an Intervention Aimed At Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation

Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is also recommended in patients at intermediate risk, especially when a femoral approach (TF) is possible (Baumgartner et al. Eur Heart J. 2017).

Currently, there is no recommendation regarding length of stay after TAVI and practices are extremely heterogeneous. Despite the growing experience of centers, better patient selection and a reduction in complications, the length of stay after TAVI remains very high in France.

Faced with the great disparity observed between the centers, efforts are necessary to educate the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study is to evaluate the effectiveness of an intervention based on training teams to reduce the length of stay after TF-TAVI.


Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18 years of age;
2. Patient hospitalized for TF-TAVI
3. Patient affiliated or benefiting from a health insurance scheme
4. Patient having read and understood the information letter and having signed the consent form.

Exclusion Criteria:

1. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 1
2. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
3. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure

1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver \& Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.
2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC \>250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.
3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).

Baseline evaluation:

Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.

1. Etiology of cirrhosis.
2. Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
3. Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
4. Laboratory investigations:

Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.

Eligibility Criteria:
Inclusion Criteria:

- Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -

1. Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
2. Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
3. No response to treatment with 3rd generation cephalosporins after 48 hours.

Exclusion Criteria:

1. Age less than 18 years.
2. Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
3. Post liver transplant, HIV patients.
4. Patients on systemic chemotherapy, immunosuppressant drugs.
5. Growth of bacteria resistant to intervention drugs in ascitic fluid culture.
Effectiveness Study of Occupational Therapy in Parkinson's Disease

The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.

Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities. The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies. The Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial.

The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients with PD.

Eligibility Criteria:
Inclusion criteria patients:

* Idiopathic Parkinson's Disease
* Indication for referral to occupational therapy
* Home dwelling

Inclusion criteria caregivers

* Available for informal support minimal two times a week to a patient who participates in the study
* Available to take part in the intervention

Exclusion Criteria:

* Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score \< 24).
* Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
* Current participation in other allied health research (i.e. PARKFIT)
* Having received occupational therapy intervention in the last 3 months
Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.


Eligibility Criteria:
Inclusion Criteria:

1. Age 14-28 years old, regardless of gender;
2. Meet DSM-V diagnostic criteria for bipolar depressive episodes;
3. Young Mania Rating Scale (YMRS) ≤ 6 points;
4. MARDS:12-30 points.
5. Han nationality, right-handed;
6. More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy.
6. Severe suicidal ideation and behavior
7. ECT or rTMS treatment was performed within six months
Measuring Cardiac Output and Stroke Volume Using the Physioflow Impedance Device in Pregnant Patients

Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic parameters classically requires insertion of a pulmonary artery catheter (PAC) into the heart. However, this invasive method carries significant complications and its use is now reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance device can be used as a reliable non-invasive monitor to measure hemodynamic parameters during elective CS under spinal anesthesia.

The Physioflow Impedance device employs a continuous non-invasive method of measuring ten cardiac hemodynamic parameters including flow, resistance, contractility and fluid content. It involves the application of electrocardiogram (ECG) leads on the neck and the thorax to measure resistance of pulsatile blood flow. Its benefits are that it is non-invasive, low cost, and easy to operate. Thoracic impedance has been validated against the gold standard method of PAC. Although the Physioflow device has been validated in non-pregnant patients, its use in pregnant patients is very limited.

Moderate to severe hypotension, experienced by these awake patients, can cause significant undesirable symptoms of dizziness, shortness of breath, nausea and vomiting, and also compromise fetal well-being. The etiology of hypotension is multi-factorial,and it is postulated that decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) may precede decreases in blood pressure. Continuous measurement of CO and SV by the Physioflow Impedance device may provide a better understanding of the cause of hypotension so that future management of these patients may include pharmacological interventions used prior to hypotension in order to avoid any undesirable symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective cesarean section
* Women classified as ASA 1 \& 2

Exclusion Criteria:

* Patients unable to communicate in English
* Patients with significant cardiac disease
* Height less than 4 feet or greater than 7 feet
* Weight less than 67 lbs or greater than 341 lbs
Analysis of Circulating Exosomes in Melanoma Patients

The hypothesis is that PD-L1\[Programmed Death-Ligand 1\] labeling in exosomes could be a biomarker of disease progression in melanoma. The rate of circulating exosomes, their size and the exosomal expression of PD-L1 could be correlated with the stage of the disease, the response to treatment and/or the prognosis of patients. In this study, blood samples (EDTA tubes taken as part of routine care at Besançon University Hospital) and associated clinical data are reused.


Eligibility Criteria:
Inclusion Criteria:

* Melanoma patients admitted in Besançon University Hospital
* exigible for immunotherapy such as anti PD-L1/PD-1
* Age ≥18 years
* Affiliation to a social security system,

Exclusion Criteria:

* Minor patients
* Patients who have expressed their opposition to the reuse of their data and biological samples
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures

The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is:

- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.

To assess the usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The surgeon and OR-assistant will fill in one survey after performing 3 operations with the ADEPTH sensor and one survey after performing 3 operations with the manual depth gauge.

Eligibility Criteria:
Inclusion Criteria:

* Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion)
* Needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5
* Adults (≥ 18 years)
* Written informed consent by patient

Exclusion Criteria:

* Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
* Variable angle plates
* Corrective surgery after previous plate osteosynthesis procedure or hardware removal
Naloxone to TReatment Entry in the Emergency Setting

The study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.

Randomized controlled trial. Subjects are included if they are being treated by an ambulance in the Malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. Subjects are randomized by ambulance staff to either an active intervention, or a control condition:

Intervention: A telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study.

Control: No telephone alert signal is sent, and the active outreach procedure is not carried out. Ambulance staff hand over written information to the individual about how she/he can apply actively for treatment.

Primary outcome is entry into formal assessment and treatment of the substance use disorder.

Eligibility Criteria:
Inclusion Criteria:

* survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent

Exclusion Criteria:

* patients unable to understand study information and to provide informed consent
Laser Acupuncture for Postpartum Weight Retention

Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.

Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided into laser acupuncture and control group. A single-blind clinical trial will be conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After about 3 weeks of treatment, the differences of the subjects' body weight, body mass index, and waist circumference will be analyzed with ANOVA between laser acupuncture and control group.

Objective: Gestational weight gain and weight retention at 1 year after delivery are associated with long-term obesity. The investigators aimed to investigate the effect of laser acupuncture therapy (LAT) on postpartum weight control.

Methods: The investigators randomly assigned 66 subjects with postpartum weight retention to a laser acupuncture group and control group. The subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25 (Tianshu), ST28 (Shuidao), ST40 (Fenglong), SP15 (Daheng), CV9 (Shuifen), and SP6 (Sanyinjiao) by using verum or sham laser acupuncture over 5 sessions per week. After 12 treatment sessions, the differences in the body mass index (BMI), body fat percentage (BFP), and waist-to-buttocks ratio (WBR) of the patients were analyzed, and compared between the laser acupuncture and control groups via analysis of variance, chi-square tests, and stepwise regression tests.

Eligibility Criteria:
Inclusion Criteria:

* postpartum duration of \<1 month;
* body mass index (BMI) \> 25;
* age \> 20 years;
* did not use any other medications for weight loss during the study period; and
* provided informed consent.

Exclusion Criteria:

* presence of a pacemaker;
* history of seizure or epilepsy;
* taking immunosuppressant medication;
* cancer;
* infectious disease of the skin;
* taking medications for weight loss, including Chinese herbal preparations, during the study period;
* receiving other treatment, including supplements, herbs, and medications for weight gain prior to entering the study;
* comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would affect the findings;
* unable to undergo LAT due to other medical conditions; and
* lack of informed consent.
Neurobiological Analyses Within the FORESEE III Study

In this observational, non-invasive clinical study different neurobiological analyses will be performed in a group of patients with severe treatment resistant major depression participating in an efficacy study of deep brain stimulation of the superolateral branch of the medial forebrain bundle (slMFB) - FORESEE III.

This study is a sub-project of the FORESEE III study (Controlled Randomized Clinical Trial to assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients with Treatment Resistant Major Depression). The FORESEE III study itself is a randomized, sham-controlled, double blind (patient and observer blinded) clinical trial to assess the antidepressant effect of DBS compared to sham.

The aim of this sub-project is to analyze the time-course of biological correlates of treatment resistant major depression as well as neurobiological markers of treatment response to treatment with DBS in a well-characterized patient population during 12 month of DBS.

Specific neurobiological analyses include testing of

1. epigenetic markers (DNA methylation in candidate genes of depression and epigenome-wide association studies, EWAS)
2. markers of neuroinflammation (cytokines, neuropeptides and other immune factors)
3. micro RNAs and transcriptome signatures
4. markers of neurodegeneration (neurofilament light protein)
5. metabolomic analyses and
6. endocrinological parameters including glucose tolerance.

All markers will be tested in blood samples (and urine samples for metaboloic profiling) before neurosurgery as well as at several time points during DBS and sham condition intervals.

Additionally hemodynamic parameters will be analysed at test stimulation of the slMFB during neurosurgery.

The results will be correlated with clinical and other biological response parameters of the FORESEE III study and are hypothesized to indicate treatment response as well as allowing prediction of response to DBS. All neurobiological analyses will be linked in a tightly integrated and comprehensive translational approach.

Further, a volunteer group of healthy controls will be recruited and tested for blood-markers of neurodegeneration (neurofilament light protein, 4.) as well as metabolomic analyses in blood and urine (5.).

Eligibility Criteria:
DBS Patients:

Inclusion Criteria:

* All enrolled subjects of the Controlled Randomized Clinical Trial to assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients with Treatment Resistant Major Depression (FORESEE III) may participate in this study.

Exclusion Criteria:

* Non-Caucasian (because of requirements for genetic/epigenetic analyses)
* Somatic diseases like diabetes, cancer and severe liver- and kidney-diseases

Healthy Controls:

Inclusion Criteria:

* All healthy volunteers without any clinically significant psychiatric or somatic symptoms are eligible.

Exclusion Criteria:

* Any clinically significant psychiatric symptoms
* Conditions like diabetes, cancer or severe liver- and kidney diseases
* Drug or alcohol abuse
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Breast Cancer

Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging) will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and treatment response, in subjects undergoing neoadjuvant therapy


Eligibility Criteria:
Inclusion Criteria:

* Participants will be ≥ 18 years of age
* Known or suspected (BIRADS 5 on imaging) primary breast cancer
* At least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. Patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included.
* Willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Packing of Perianal Abscess Cavities

The aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. Participants will be randomised 1:1 to either the packing or non-packing arm.

Perianal abscess is common, affecting 18,000 patients annually in England. Management has remained largely unchanged for over 50 years, and comprises surgical incision and drainage followed by continued internal wound dressing (packing) until healed. Packing is thought to reduce the rate of recurrent abscess and perianal fistula; a known complication of perianal abscess. Perianal fistula frequently requires multiple operations to resolve. The evidence for postoperative packing is limited¹ and may expose patients to painful procedures with no clinical benefit, and at considerable increased cost².

A multi-centre observational study of outcomes after drainage of perianal abscess (PPAC²) (n=141) found packing to be painful (2-3 fold increase in Visual Analogue Score pain scores during packing) and costly (estimated cost of £280 per patient; overall cost in the United Kingdom of £5 million annually). Fistula rate was 27%.

This study is a randomised controlled trial designed to assess whether there are differences between non-packing and packing of the perianal abscess cavity in terms of the short term negative effects of packing (pain, quality of life, return to work) whilst assessing the impact on key clinical outcomes (wound healing, fistulae formation) and resource use/cost.

All participants will be required to complete pain diaries following discharge from hospital. Clinical follow up to assess healing and other key clinical outcomes will take place at 4, 8 (if not healed at 4 weeks) and 26 weeks. Further data will be collected from National Health Service Registries at 52 weeks in order to assess abscess recurrences and fistulae formation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or over
2. Undergoing surgical incision and drainage of a primary perianal abscess

Exclusion Criteria:

1. Suspected inflammatory bowel disease
2. Fournier's Gangrene
3. Horseshoe (bilateral) abscess
4. Fistula-in-ano
5. Multiple abscess
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of malignant melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

Exclusion Criteria:

* Active Brain Metastasis
* Primary ocular or mucosal melanoma
* Prior Autoimmune disease
* Inadequate hematologic, hepatic or renal function
* Use of immunosuppressants
* Prior treatment with a CD137 agonist or cytotoxic T lymphocyte antigen 4 (CTLA-4) inhibitor