cyrilzakka/clinical-trials huggingface dataset:
Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors

BOLD-fMRI and DTI scans are performed to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the MRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of histological types and different degrees of malignancy. Intracranial GCTs make up 11.2% - 15.3% of primary intracranial tumors in Asian children compared with 3.6% in the US. And tumors located at the basal ganglia is much rarer.

The investigators realize that most of patients with tumors at this location are involved with motor disfunction. And after treatments, some patients get relieved dramatically, but some others failed to get similar outcomes. To better understand the mechanism causing this difference of treatment outcomes, the investigators perform BOLD-fMRI and DTI scans to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the fMRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥3 years;
2. no history of brain radiotherapy;
3. no other known cause of movement and cognitive impairment;
4. no contraindications to the magnetic resonance imaging (MRI) scan;

Exclusion Criteria:

1. patients can not tolerate MR scan;
2. head motion is greater than 3 mm during functional MRI scanning.
Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration

This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.


Eligibility Criteria:
Inclusion criteria:

* Male or female ≥ 50 years old, with aged related macular degeneration
* Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Exclusion criteria:

* Active intraocular inflammation or ocular infection in the study eye
* Eye disease that may result in visual loss during the study
* Chronic therapy with topical, local or systemic corticosteroids.
* Pregnant or nursing (lactating) women.
Application of Machine Learning Algorithms to Identify Optimal Candidates for Primary Tumor Resection in Patients with Metastatic Non-small Cell Neuroendocrine Tumors

This study was based on public use data from the SEER database. The study did not require informed consent from the SEER registered cases, and the authors obtained Limited-Use Data Agreements from SEER.

This study utilized publicly available data from the SEER (Surveillance, Epidemiology, and End Results) database, which is a comprehensive source of information on cancer statistics in the United States. The authors did not need to obtain informed consent from individuals whose cases are registered in the SEER database because the data is anonymized and is meant for public use. Instead, the authors acquired Limited-Use Data Agreements with SEER, which are legal contracts that allow researchers to access and use specific datasets under certain conditions while ensuring that the privacy of the individuals in the database is maintained. This agreement outlines the terms of data use, ensuring that the researchers adhere to guidelines for the ethical handling of data while still enabling them to conduct their research.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic Diagnosis of Non-Small Cell Neuroendocrine Carcinoma
* Known Surgical Information

Exclusion Criteria:

* Small cell lung cancer
* Age less than 18 years
Endometrial Flora in Women Undergoing IVF Treatments

Characterization of the female genital tract microbiome in women undergoing IVF treatment

The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .

Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.

The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.

Eligibility Criteria:
Inclusion Criteria:

* All undergoning IVF treatment
* Embryo transfer of one Blastocyst

Exclusion Criteria:

* More then one Embryo Transfer
* Recent antibacterial treatment
Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

The aim of this randomised, double-blind crossover study was to determine whether Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the immune response and whether such an effect could influence the clinical outcome.

Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is currently no evidence for improvement of symptoms after repeated or prolonged antibiotic treatment. However, clinical observations have indicated that some patients improve during treatment with doxycycline (DOX), but regain the symptoms some time after completed treatment. This may be due to an immunomodulatory effect of the drug. The aim of this randomised, double-blind crossover study was to determine whether DOX has an impact on the persistent symptoms through alterations in the immune response and whether such an effect can influence the clinical outcome.

A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were improvement of the persistent symptoms and physical and mental health, evaluated using the visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through physical examination with special emphasis on neurologic status at the follow-up visits. Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated cytokine responses.

Eligibility Criteria:
Inclusion Criteria:

* a history of adequately diagnosed and treated neuroborreliosis (presence of intrathecal borrelia-antibody production)
* persistence of symptoms (with debut in conjunction with neuroborreliosis) of typical character, such as headache, radiculitis, cognitive dysfunction, fatigue, mood disorders, paresthesia or paresis \> 6 months post-treatment of neuroborreliosis

Exclusion Criteria:

* systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
* ongoing infection at inclusion
* allergy against doxycycline
* pregnancy
* breast feeding
* psychiatric disease
* multiple sclerosis
* rheumatoid arthritis
* diabetes mellitus type 1 or II
* inflammatory systemic diseases
* liver ohc kidney dysfunction
* treatment with didanosine, quinapril, antacids
* malignancy
Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

Osteoarthritis is the most common joint disease affecting the joint in a comprehensive and progressive manner. It leads to increasing disability.

The recommendations of recent years favor the non-pharmacological treatment of osteoarthritis including regular physical activity, therapeutic education and weight loss Osteoarthritis population has a low level of physical activity due to a lack of information, motivation and false beliefs related to physical activity and kinesiophobia (fear of movement) A preliminary qualitative study (ARTHe1) evaluating the barriers and levers of the use of an e-health therapeutic education application in patients with osteoarthritis was carried out in order to guide the development of the ARTHe application.

The objective of this study is to have the application tested on a panel of patients in order to assess the benefits of using the application in terms of adherence to the practice of physical activity but also in clinical terms on function and pain, and the satisfaction of the patient

This is a prospective observational study including the evaluation of the use of the ARTH-e application after 3 weeks, 6 weeks and 3 months of use.

Patient recruitment will be done in the PRM department of Clermont-Ferrand University Hospital A subgroup of patients will receive a Garmin VivoSmart 4 connected wristband, which will record intrinsic stress measurement data during the test.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with osteoarthritis according to the ACR (American College of Rheumatology) criteria, symptomatic and diagnosed before inclusion by a specialist or not.
* Patients with least one knee impairment
* Patients with a smartphone or tablet with at least Android 5 or iOS 11.
* Volunteer patients willing to participate in the study.

Exclusion Criteria:

* Patients with no diagnostic criteria for ACR.
* Patients with comprehension disorders making it impossible to interview and complete questionnaires or use the application.
* Refusal to participate or being already included in a research protocol that could influence the current protocol.
* Patients under guardianship, curatorship or deprived of liberty.
Trial for the Treatment of Alcohol Dependence

The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.

The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
* Ages 18-65
* Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
* Willingness to give written informed consent
* Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal

Exclusion Criteria:

* Opiate abuse within the last one month
* Sensitivity to study medications or therapy with these drugs within 6 months
* Active major psychiatric disorder associated with psychosis or significant suicide risk
* Pregnancy or lactation
* Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)
Non-contact Endoscopy at Covid-19 Outbreak

The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.

The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, China) adds a remote control workstation and a audio-visual exchange system to the original well-establish MCE system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact MCE system.

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consents before joining this study

Exclusion Criteria:

* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
* Refused abdominal surgery to take out the capsule in case of capsule retention
* Implanted pacemaker, except the pacemaker is compatible with MRI
* Other implanted electromedical devices or magnetic metal foreign bodies
* Pregnancy or suspected pregnancy
Reiterative Development and Evaluation Study of OSA Therapy System

The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is between the ages of 18 and 80.
2. Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
3. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria:

1. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
2. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
5. Currently working nights, or rotating night shifts.
6. Current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
7. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in the Elderly 24-hour Care

This study aims to determine the effectiveness of the Lumoral device on oral hygiene, inflammatory load, and dryness of mouth in elderly 24-hour care residents. The second aim is to investigate the usefulness and benefits of the aMMP-8 chair-side test and the Lumoral device in improving the oral hygiene of elderly people. In addition, the study will investigate the usability of Lumoral assessed by different care professionals to evaluate the need for oral care and plaque control procedures in elderly residents.

The dental condition of elderly care customers is often poor. Cavities and dental connective tissue disease are widespread in people over 75 and older. Untreated oral infections in patients or residents living in institutional care predispose to pneumonia, among other complications. Chronic oral infectious diseases, and sometimes fatal complications, are preventable with good oral hygiene.

As people get older, their ability to function deteriorates, and the elderly, especially those living in round-the-clock care, have been found to have shortcomings in maintaining oral hygiene. Only a small part of the population had clean teeth, and the worse the level of oral hygiene, the worse the quality of life. Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping your mouth healthy. Unfortunately, this is not always the case with round-the-clock care, and new practices are needed to improve oral hygiene.

The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE-marked home medical device that has been shown to be effective in reducing the development of plaque and harmful bacteria in the plaque. The performance of the device is based on the aPDT method, in which the photosensitive substance in the Lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light. The antibacterial effect is applied directly to the plaque, reducing the impact on the normal oral flora. Preliminary studies have found that the method reduces inflammatory factors in periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* A 24-hour care resident;
* Understand and able to give consent to the study;
* At least 10 functional teeth in the mouth (including implants);
* Able to brush teeth and follow the instruction for use Lumoral treatment, based on the assessment by the nursing staff.

Exclusion Criteria:

* Incapable of participating in the study based on the assessment of the nursing staff
* Toothless or less than 10 functional teeth in the mouth (including implants)
* Unwilling or unable to give consent
Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.

The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.

Eligibility Criteria:
Inclusion Criteria:

* TKA subjects:

  1. Patients requiring primary knee arthroplasty;
  2. Knee osteoarthritis;
  3. Subject has sufficient quantity or quality of bone support;
  4. Subject has no previous or active infection in the affected joint or systemic infection;
  5. Subject judged to be available for follow-up through at least 1 year postoperative;
  6. All subjects in arthroplasty groups will be between 50-70 years of age
* Healthy subjects:

  1. Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
  2. All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
  3. All healthy persons will be 40-70 years.

Exclusion Criteria:

1. Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
2. Unable to return for follow up x-rays and clinical evaluation;
3. Unable to comprehending study protocol for any reason;
4. Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
5. Subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include Subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), Subjects receiving therapy to prevent homograft rejection, Subjects who have a documented history of acquired immunodeficiency syndrome (AIDS), or auto-immune diseases;
6. Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
Danish Cardiogenic Shock Trial

Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.


Eligibility Criteria:
Inclusion Criteria:

1. ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and
2. Cardiogenic shock of less than 24 hours' duration, confirmed by:

   * peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 \<55% with a normal PaO2) and
   * systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and
3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.

Exclusion Criteria:

1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
3. Severe aorta valve regurgitation/stenosis.
4. Predominant right ventricular failure.
5. Out of hospital cardiac arrest with persistent Glasgow coma scale \<8 after return of spontaneous circulation.
6. Shock duration\>24 hours.
7. Known heparin intolerance.
8. Already established mechanical circulatory support
9. Do not resuscitate wish.
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Eligibility Criteria:
Inclusion Criteria:

* Has completed study treatment in study FE200486 CS02.
* Has completed visit 16 in study FE200486 CS02.
* Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02