cyrilzakka/clinical-trials huggingface dataset:
Clinical Application of Sensimed Triggerfish Sensor (TS) With Wireless Signal Transmission for Continuous Intraocular Pressure Measurement

The study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of glaucoma

Exclusion criteria:

* Other opticus neuropathy than glaucoma
* Corneal abnormalities (e.g. scaring)
* Dry eye disease
Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks

The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section.

Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.

Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.

Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.

Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.

Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) classification II.
* Female patients scheduled for elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Patient refusal.
* Patients who are taking analgesics for chronic illness or have history of substance abuse.
* Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
* Patients with a history of coagulopathy.
* Patients weight less than 60 kilograms.
* Patient height less than 150 cm.
* Patients with known local anesthetics and opioid allergy.
* Patients with infection at the site of the needle puncture.
* Patients with major respiratory, cardiac, renal, or hepatic disorders.
Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.


Eligibility Criteria:
Inclusion Criteria:

1. type 2 diabetes
2. HbA1c \>6.5% and \<11.0%
3. male/non-pregnant, non-lactating female, at least 6 months postpartum
4. if female of childbearing potential, practicing method of birth control
5. Body Mass Index \> 18.5 kg/m2 and \< 43.0 kg/m2.
6. weight stable for past two months
7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months

Exclusion Criteria:

1. uses injected medications (e.g., insulin, exenatide) for glucose control.
2. history of diabetic ketoacidosis
3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
4. active malignancy
5. states he/she has had a significant cardiovascular event \< 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
6. end stage organ failure
7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
8. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
10. symptomatic in response to blood collection prior to enrollment into this study.
11. clotting or bleeding disorders.
12. non-typical eating pattern
13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
14. engages in strenuous exercise five or more times per week.
Safety and Tolerability Study of Drug to Treat Schizophrenia

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.


Eligibility Criteria:
Inclusion criteria:

* Successful completion of participation in protocol #D1050049

Exclusion criteria:

* Substance abuse
* Prolactin level of ≥200ng/mL at baseline
* Pregnancy
Graded Motor Imagery and Total Knee Arthroplasty

This study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis.

Participants aged 45-80 who are scheduled for total knee arthroplasty surgery after knee osteoarthritis will be included. Participants will be selected from the relevant population using a nonprobability random sampling method. Participants who agree to participate in the study and meet the inclusion criteria will be assigned to one of the groups (conventional rehabilitation-only or conventional rehabilitation with graded motor imagery) using the closed envelope method. Evaluations will be made one day before surgery, 6 weeks and 6 months after surgery for each group. Pain Visual Analog Scale; pressure pain threshold algometer; central sensitization Central Sensitization Inventory; the joint range of motion goniometer; muscle strength handheld dynamometer; kinesiophobia Tampa Kinesiophobia Scale; functional mobility and mental stopwatch Timed get up and go test; choice task Recognise™ application; motor imagery skill Movement Imagery Questionnaire-3; functional assessment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); The catastrophic degree of pain is planned to be evaluated with the Pain Catastrophizing Scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee osteoarthritis and being on the waiting list to receive unilateral total knee arthroplasty
* Approved by the orthopedist for early physiotherapy treatment after total knee arthroplasty

Exclusion Criteria:

* - Individuals undergoing revision total knee arthroplasty or undergoing bilateral total knee arthroplasty,
* Contralateral knee osteoarthritis (defined by activity greater than 4/10 pain)
* Having undergone any physical therapy intervention or other surgery in the last 6 months
* Any neurological, cardiac, pulmonary or psychiatric disease (eg, uncontrolled diabetes mellitus, neoplasms, uncontrolled blood pressure, neurological conditions) before or after surgery;
* Fracture, infection in the acute postoperative phase or presence of fever
* Cognitive impairments that alter the probability of correct understanding of the motor imagery program
* Body mass index \> 35 kg / m2
* Difficulties with understanding or communication
* Insufficient knowledge of Turkish to follow the study instructions.
Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers

The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the following criteria:

   medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests
2. Age 18 to 55 years (incl.)
3. BMI 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practise (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
11. Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
12. Inability to refrain from smoking on trial days
13. Alcohol abuse (more than 30 g/day)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Alanine aminotransferase (ALT) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of trial site
19. Galactose or lactose intolerance, galactose or glucose malabsorption
Study of Proteins in Head and Neck Cancer Cells

RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.

OBJECTIVES:

* Define the function and mechanism of LZAP in regulating ARF.
* Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
* Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.

OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Head and neck cancer tumor cell line

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Thread Embedding Vs. Electroacupuncture for Post-Stroke Aphasia

The goal of this clinical trial was to learn if thread embedding or electroacupuncture can treat language function impairment in patients with post-stroke aphasia, a condition affecting communication after a stroke. The main questions it aimed to answer were:

Does thread embedding improve overall language function more effectively than electroacupuncture, as measured by the Goodglass and Kaplan Aphasia Severity Rating Scale (ASRS)? How do thread embedding and electroacupuncture compare in improving specific language skills, such as motor speech, sensory language, reading, and naming, as assessed by the Boston Diagnostic Aphasia Examination (BDAE)? Researchers compared thread embedding (TE group) to electroacupuncture (EA group) to see if thread embedding provides better or similar effects on language recovery.

Participants:

Underwent a 30-day intervention with language assessments at the start and end of the period.

Were randomly assigned to either the thread embedding group, receiving treatment every 10 days, or the electroacupuncture group, receiving daily 20-minute sessions.

This study was designed as a randomized, open-label, parallel-group trial conducted at the Traditional Medicine Hospital in Dak Lak, Vietnam. It received ethical approval from the Biomedical Research Ethic Committee at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 739/HĐĐĐ-ĐHYD, dated December 14, 2021). The interventions were delivered by certified traditional medicine practitioners following strict protocols (STRICTA 2010).

Catgut Thread Embedding (TE group): Participants received thread embedding at the EX-HN21 acupoint.

Electroacupuncture (EA group): Participants underwent daily 20-minute sessions in 30 days.

Language function was assessed using standardized tools, and data were analyzed with R. Statistical tests (chi-square, t-tests) compared baseline characteristics and outcomes, with a significance level of p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with post-stroke aphasia (severity levels 0-4 on the Goodglass and Kaplan scale)
* Aged 18 years or older
* Fluent in Vietnamese
* Alert and mentally competent (no psychiatric or neurological disorders affecting communication)
* No pre-existing speech or language disorders
* Willing to participate and provide signed informed consent
* Treated as inpatients at the Traditional Medicine Hospital, Dak Lak

Exclusion Criteria:

* Severe physical exhaustion or skin ulcers/infections at intervention sites
* Presence of a pacemaker
* Allergy to catgut threads
* Post-stroke patients awaiting cranioplasty
* Complex disease progression requiring alternative treatments during the study (data analyzed as treatment failures)
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy

In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies obtained with flexible cryoprobes compared to standard techniques? For patients with peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue to be obtained and therefore, will increase the diagnostic yield over conventional techniques


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>18 years 2. Lung nodule (s) identified on CT scan 3. Clinical decision to obtain tissue biopsy of lung lesion 4. CT guided biopsy not preferred technique

  * Previous negative CT guided biopsy
  * Technically difficult nodule location
  * Perceived high risk of pneumothorax or other complications

Exclusion Criteria:

* 1. Lack of informed consent 2. Nodule less than 1 cm or greater than 6 cm long axis 3. Significant mediastinal adenopathy. 4. No suspected sites of disease outside the thorax amenable to biopsy 5. Evidence of endobronchial abnormality on chest CT 6. Medical contraindication to bronchoscopy 7. Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.

  8. Uncontrolled or irreversible coagulopathy
  * platelets \<100
  * INR \>1.3
  * Use of clopidogrel in the 7 days prior to bronchoscopy 9. Confirmed or suspected pregnancy 10. Clinically unable to tolerate a pneumothorax or single-lung ventilation 11. Pacemaker or implanted cardiac defibrillator if it is felt that ENB is needed
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

Patients who are participating in sports who have defibrillators will be invited to participate in a prospective registry to determine the rate of adverse events occurring during sporting activities. Patients will be followed for four years and adverse events quantified. Yale is the coordinating center for this multicenter registry.

Eligibility Criteria:
Inclusion Criteria:

* individuals between the ages of 10 and 60
* has a defibrillator
* plays a competitive/organized sport more vigorous than golf or bowling or participates in a dangerous sport

Exclusion Criteria:

* children under 10 years (as they engage in primarily recreational sports)
* individuals over the age of 60 years (maintain a homogenous population)
* inability to give informed consent
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia


Eligibility Criteria:
Inclusion Criteria:

* Friedreich ataxia diagnosis confirmed by evidenced mutation expansion of Frataxin gene
* Ambulatory patient, with depressed tendon reflexes and pyramidal syndrome associated or not to a loss of position or vibration senses or dysarthria
* Patient able to perform the tests of the study

Exclusion Criteria:

* Severe cardiac disease as assessed by echocardiography performed at least within 6 months before screening or during the wash out period (4 weeks)
* Absolute contra-indication to Nuclear Magnetic Resonance spectroscopy(NMR) examination: iron and any magnetic objects implanted in the whole body, e.g. some neurostimulators, cardiac pace-makers, vascular clips and other implanted orthopaedic prosthesis
* Patient who did not deplete at baseline phosphocreatine (PCr) pool by more than 30 % during the exercise bout
* Any continuous use of the following forbidden medications:
* other antioxidant such as idebenone, coenzyme Q, vitamin E/C taken for less than 4 weeks prior study treatment start (ie for antioxidant drugs a mandatory wash-out period of 4 weeks prior study drug start has to be observed),
* any other vasodilators
* tranquilizer such as benzodiazepine, meprobamate or buspirone, and/or antidepressant (only one), at non stable dose
Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective of JAK2 mutational status
* Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2)
* Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion
* Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3

Exclusion Criteria:

* Patients with prior treatment with ruxolitinib or other JAK inhibitors.
Neurosarcoidosis : Initial Presentation and Disease Course

Neurosarcoidosis represents up to 10% of sarcoidosis cases. Little is known about its long-term course, even if the disease remains mainly monophasic with/w.o. sequelae, or if bouts of new symptoms may arise over years (polyphasic).

Using retrospective data from patients diagnosed with neurosarcoidosis in three French referral centers for neuro-inflammation, the investigators aim to determine patterns of disease course, according to the initial presentation and the treatments used.

Sarcoidosis is a systemic inflammatory disease which a 10-20/100.000/year incidence rate. The nervous system is found to be affected in 5-10% in clinical series, rising to 14-27% in post-mortem studies. Mortality is as high as 5% mainly due to cardiac, pulmonary or neurological injury. The treatment of the disease uses cortico-steroids, and often steroid-sparing immunosuppressive agents such as methotrexate or cyclophosphamide. More recently, TNFalpha-blockers have been found to be highly effective.

Long-term data about the clinical and paraclinical course of the disease are lacking. "Bouts" or "relapse" of the disease are barely described, with no substantial information about their frequency, their sequelae, or their response to the treatments when initiated. Less is known about the risk of recurrence in each presentation of neurosarcoidosis (peripheral, spinal, brain or meningeal presentations). In the end, if a truly relapsing-remitting form of the disease exist is not sure, many patients presenting with a lond-standing pattern of invariant symptoms.

Due to this lack of knowledge about the natural history of neurosarcoidosis, even a "good treatment response" cannot be defined, and in many cases, it is difficult to attribute to treatments a seemingly favourable course af the disease.

In the current study, the investigators aim to build a retrospective cohort of patients diagnosed with neurosarcoidosis and seen at least once in three French referral centers for neuro--inflammation from Jan-1st-2000 to date : Nancy (Lorraine, North-Eastern), Bordeaux (Aquitaine, South-Western) and Strasbourg (Alsace, North-Eastern).

Demographics, clinical and paraclinical data at presentation will be collected(magnetic resonance imaging of the spine and brain, electroneuromyography if available, data of blood and cerebro-spinal fluid). After having clustered patients by presentation pattern, data about lines and types of treatments, change in clinical and paraclinical data will be collected. From this perspective, patterns of disease course on the mid/long-term will be established.

Estimated number of patients : 60-100. Estimated duration of follow-up : 5-10 years. Intervention : none (existing data).

Eligibility Criteria:
Inclusion Criteria:

* To have at least one documented visit in one of the three referral neurological centers (Nancy, Bordeaux, Strasbourg) between Jan-1st-2000 and Jan-1st-2021
* To be diagnosed with possible/probable/definite neurosarcoidosis

Exclusion Criteria:

- Denial to participate to the study