cyrilzakka/clinical-trials huggingface dataset:
Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients with Deep Brain Stimulation

The goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (DBS) influences brain networks. The investigators will enroll patients with dystonia implanted with DBS of the Globus Pallidus internus (GPi) with sensing implantable neurostimulators, capable of measuring GPi local field potentials (LFPs).

The main questions it aims to answer are:

* does DBS influence pallidal LFPs in the long term?
* how the basal-ganglia-thalamo-cortical circuit is modified after DBS?
* do LFPs changes correlate with clinical improvement? Participants will undergo to serial clinical evaluations, magnetoencephalography (MEG) and functional Magnetic Resonance Imaging (fMRI) studies. Primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. These features might be secondarily used in future to provide a framework for an effective application of closed-loop DBS in Dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus
* Patient implanted with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.
* Age\>12 years

Exclusion Criteria:

* Evidence of CNS pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology,
* Focal distribution of dystonia
* Contraindications to brain MRI or EEG/MEG
* Adult subjects unable to express consent to inclusion in the study
* Pregnancy, and breastfeeding.
Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours

Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with \>70% specificity and \>85% positive predictive value.


Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke
* evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit
* evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion
* complete native CT and CTperfusion performed on admission
* sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity
* known time of symptom onset.

Exclusion Criteria:

* None
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age.
* Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head \& neck (H\&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
* Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
* Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H\&N and esophageal cancer.
* Participants must have at least one measurable lesion.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Participants must have adequate hematologic, renal, and liver functions.
* Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
* Participants of childbearing potential must agree to use a medically accepted method of contraception.

Exclusion Criteria:

* Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
* Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
* Participants who received prior temozolomide or dacarbazine treatment
Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. Recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. One of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence.

At present, there are no options to prevent recurrence after surgery. In recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. This is in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree Celsius.

Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve survival.


Eligibility Criteria:
Inclusion Criteria:

1. Disease Characteristics

   1. Histologically proven soft tissue sarcoma of one of following high-risk groups:

      * Tumours with grade 2 or 3 histology
      * Size more than or equal to 5cm
      * Extracompartmental and deep extension
   2. Local recurrence of primary tumour
   3. Inadequate surgical excision of previously operated on tumour
   4. Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy
2. Patient Characteristics

   1. Age: ≥21 years old
   2. Performance status: ECOG 0-1
   3. Normal haematological, hepatic, coagulation, renal and electrolyte profiles
   4. Normal left ventricular ejection fraction
   5. Not pregnant or nursing

Exclusion Criteria:

1. Patient is medically unfit for surgery due to concurrent medical comorbidities.
2. Any medical or psychiatric condition(s) which would preclude informed consent.
3. Patient is pregnant or nursing.
Regional Treatment Flow and Prognosis ofTraumatic Thoracic Aortic Injuries：A Multi-center Retrospective Analysis in Zhejiang Province During 11 Years

Using keywords (main) artery dissection aneurysm (main) artery haematoma (main) To diagnose X-ray imaging reports and medical record home page is a search, check the unit 11 hospitals in Zhejiang Province during the year aortic injury clinical data of 11 years, through the electronic questionnaire to fill in the form of information, information of diagnosis and treatment of the basic information for the patient injury mechanism and so on carries on the statistical analysis. Basic information includes gender, age, history of hypertension. Injury information includes injury mechanism information and trauma information. Injury mechanism refers to injuries caused by car accidents, high falls and other causes. Injury information includes diagnosis, injury severity score, Glasgow coma index, and Stanford classification of aortic injury. The information of diagnosis and treatment includes the method of treatment, the reason for referral, the time of definitive treatment and the prognosis. The method of treatment is divided into the first treatment group and the referral group. The first treatment group refers to the patients admitted by the hospital for the first time, and the referral group refers to the patients transferred from other hospitals. The reasons for referral include: the suggestion of the hospital after comprehensive consideration, the lack of diagnosis and treatment qualification of the hospital, the subjective will of the patient's family members. Deterministic treatment time refers to the time from injury to imaging examination and the time from injury to surgery and other data to be statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of trauma patients with aortic dissection (aortic aneurysm) (aortic hematoma)

Exclusion Criteria:

* Patients with primary aortic dissection, limb pseudoaneurysm, non-aortic associated hematoma, etc.Incomplete or lost data, patients refused
Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery

There is a direct relationship between the sedative agent and the duration of ventilation.

Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Multi vascular lesions of the coronary arteries according to coronary angiography;
* Heart valve damage was confirmed by, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
* Age of patients from 18-80 years; • Patient consent to participate in the study;

Exclusion Criteria:

* Refusal to participate;

  * Hypersensitivity to propofol, dexmedetomidine;
  * Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
  * Occurred ischemic stroke;
  * History of the ischemic stroke;
  * History of the neurodegenerative diseases;
  * History of the mental disorders;
  * Use of neuroleptics, antidepressants for the last 5 years;
  * History of the cardiac surgery in the past;
  * Patients with chronic pulmonary disease (GOLD 3-4)
  * Patients with asthma (moderate or severe),
  * Participation in any other clinical trial;
  * Chronic renal failure (ClCr less than 50 ml / h)
  * Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
  * Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR\> 1.5)
  * If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
  * History of the hematological disease;
  * Alcohol abuse in the anamnesis (3-4 times a week).
  * Condition after chemotherapy;
  * Pregnancy, lactation.
Premature Ovarian Failure (Genetic and Physiopathologic Analysis)

Premature Ovarian Failure (POF), syndrome observed in young woman, present consequences on hormonal and leads at definitive infertility. It's a rare and complex syndrome and for this reason, we propose to initiate a collaborative team network to understand better his genetic and physiopathology.

We are going to realize a global study of this syndrome with clinical and fundamentals approaches. We wish that this project allows us to understand better the physiopathology of this rare disease. Finally, POF responsible genes identification is the base for future development of therapeutics approaches.

Premature ovarian failure (POF) is a rare but not exceptional disease concerning 0.1% of the more-than-thirty-years-old women. On the clinical aspect, patients present a primary or secondary amenorrhea depending on when the disease occurs in their lives. Infertility is most of the time definitive and the yet only available therapy is auto implantation of cryopreserved oocytes. Initiation of a substitutive hormonal treatment is also necessary to prevent the consequences of estrogenic hardship (i.e leading to osteoporosis).

POF has numerous possible origins, and can be linked to auto-immune diseases, metabolic disorders (i.e. galactosemia) or even genetic abnormalities. According to her origin, POF is characterized by (a) a depletion of primary follicles, (b) increased or accelerated follicle atresia (c) an alteration of the recruitment of dominant follicle and (d) stopped follicular maturation.

The purpose of our work is to organize a clinical and fundamental research network focussed on premature ovarian failure (POF). It will aim to collect clinical, biological, radiological and histological information on patients, and according to their phenotypes, to decide for searching possible genetic abnormalities leading to POF. And in the same time, the constitution of a broad tissue collection allows the study of ovarian transcripts, using POF as a pathologic model to describe ovaries and follicle development-involved genes.

Eligibility Criteria:
Inclusion criteria :

Experimental group:

* 18 years \<Age\> 39 years
* Patient with amenorrhea since at least 3 months
* Patient with at least 1 FSH dosage \> 30 mUI/L
* Patients between 40 and 45 years old with hormonal results indicating a POF declared before 39 years old will be included.
* Informed Consent Form Signature

Control group:

* 18 years \<Age\> 39 years
* Patient having a benign ovarian pathology justifying an ovarian surgery
* Informed Consent Form Signature

Exclusion criteria:

Not applicable
A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)

The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.


Eligibility Criteria:
Inclusion Criteria:

* At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
* Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
* Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

* Previous treatment with darifenacin
* Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for \<3 months
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator
Smart-TV Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients

Primary objective of our study is the development and validation of an application for smart-TVs for the self-examination of the distant visual acuity of patients diagnosed with macular edema.

Present study aims to develop and validate an application installed in Smart-TVs. This application will be referred to patients suffering from macular edema, allowing the self-examination of the patient in terms of distant visual acuity. The development of a simple but reliable way of self-examination of distant visual acuity would bring beneficial results in the overall management of these patients as significantly would reduce the flows to the outpatient ophthalmology clinics of the NSS Hospitals, would serve the purposes of the social distancing imposed by the current state of the pandemic but also any analogous situation and would help the patient to be vigilant and actively involved in the management of his disease.

Eligibility Criteria:
Inclusion Criteria:

* age-dependent macular degeneration
* diabetic macular edema

Exclusion Criteria:

* corneal diseases
* glaucoma
* psychiatric disorders
* inability to cooperate
Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation

Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease.

There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health.

And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.


Eligibility Criteria:
Inclusion Criteria:

* Control group : Patients diagnosed as periodontally healthy
* Test group:

  * Patients diagnosed with generalized periodontitis (Stage 3/4, Grade a,b or c).
  * Having at least 15 remaining teeth.
  * Mentally able to understand the communication and to express an informed consent

Exclusion Criteria:

* Systemic diseases with known effect on periodontal health
* Antibiotics/Anti-inflammatory drugs taken in the last month
* Women with suspected/known pregnancy, or taking any hormone-based treatment
* Patients suffering from Xerostomia.
* Patients smoking more than 20 cig/day.
* Previous periodontal therapy in the last 3-6 months
Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery

Lumbar degenerative disease surgery has been a routine clinical operation, and has good treatment effects. Although the patient's neurological symptoms improve after surgery, many patients still have postoperative muscle soreness. The postoperative rehabilitation intervention for the patients receiving traditional lumbar surgery has been confirmed to effectively improve pain and disability. However, in recent years, minimally invasive lumbar spinal surgery has gradually replaced traditional surgery, postoperative pain has been greatly reduced. Therefore, patients have the opportunity to receive early intervention in rehabilitation, but there is no standardization process for rehabilitation of minimally invasive lumbar spine surgery. Therefore, this study aims to establish a health education program for patients receiving minimally invasive lumbar spinal surgery, and conduct clinical trials to test its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 90 years old.
* Low back pain has been persisting at least 3 months.
* Clinical degeneration diagnosis supports the need of MI-TLIF.
* Able to understand Chinese.

Exclusion Criteria:

* Emergency surgery.
* Unstable vital sign.
* Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
* Had spinal surgery before.
* Pregnancy.
REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting

Emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. This study aims to examine, for the first time, REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is an internet based intervention that is administered as an add-on to psychotherapy. This study aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient setting. Participants will be randomly assigned to the study conditions. Outcomes are assessed at baseline, after six weeks and after twelve weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern
* Mental disorder present
* Internet access available
* Written informed consent

Exclusion Criteria:

* Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation
* Current or history of psychotic disorders or bipolar disorder
* Acute suicidality
* Insufficient mastery of German language