cyrilzakka/clinical-trials huggingface dataset:
TElemedicine for NARcolepsy

The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.

Open RCT assessing the non-inferiority of the multidisciplinary management of narcolepsy via Video Consultation (VC) through Mobile Telemedicine devices compared to usual in-office care. 202 children and adults with narcolepsy will be randomly allocated in 1:1 ratio to VC or in-office usual care for a 12 months follow-up. At baseline, all patients will undergo a neurologic, metabolic, and psychosocial assessment. Primary (i.e., excessive daytime sleepiness according to the Epworth Sleepiness Scale) and secondary endpoints (i.e., other symptoms, metabolic control, quality of life, patient and family satisfaction with care, feasibility, safety, and costs) will be measured at 6 and 12 months. The investigators expect the Telemedicine approach not only to be non-inferior for sleepiness control but also to significantly improve other patient-centred outcomes compared to the usual in-office care.


Eligibility Criteria:
Inclusion Criteria:

• Adolescents (≥14 years old) and adults with a diagnosis of narcolepsy according to ICSD-3 criteria at their first ("incident") or with established diagnosis ("prevalent" subjects), able to provide consent

Exclusion Criteria:

* inability to read, write, or using a tablet;
* major psychiatric disorders.
ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma

Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed non-Hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
2. Paraffin block of the lesions available for immunohistochemical analysis
3. Candidate for ESHAP salvage therapy
4. Evidence of at least one lesion with a diameter of 1.5 cm
5. Age of over 20 years
6. Eastern cooperative oncology group performance status (ECOG) less than or equal to 2.
7. Adequate kidney function with serum creatinine\< 2.5 mg/dL, creatinine clearance ≥ 50 mL/min
8. Adequate liver function with aspartate transaminase (AST)/alanine aminotransferase (ALT) lower than or equal to 3 times the normal upper limit; Total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
9. Adequate bone marrow function with absolute neutrophil count ≥ 1,000/uL; platelets ≥ 75,000/uL; hemoglobin ≥ 9.0 g/dL
10. Patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients

Exclusion Criteria:

1. Patients with history of exposure to imatinib or other Bcr-Abl tyrosine-kinase inhibitors
2. Known or suspected hypersensitivity to imatinib
3. Potential use or usage alteration of CYP3A4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 ESHAP. Exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the ESHAP regimen.
4. Known involvement of the central nervous system (CNS) by lymphoma.
5. Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
6. Serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with ESHAP-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
7. Prior history of malignancy other than to non-Hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
8. HIV positive and in treatment.
A Novel Tourniquet Technic for Massive PPH

In this study, the investigators aimed to find out the effect of a novel tourniquet technique, in cases of excessive bleeding during cesarean delivery.

In this retrospective comparative study, the investigators compared the peripartum features of patients who experienced profuse postpartum bleeding during C/S and this novel atraumatic tourniquet technique was used and not used.

In this technique; the uterus is exteriorized following the delivery of the baby and before the removal of the placenta to be able to apply the tourniquet technique. In this technique it is not obligatory to push the bladder before the procedure. Afterwards, the surgeon and the assistant palpate the ureters with both hands in the two sheaths of broad ligament and try to hear a 'click' sound which comes from ureter sliding out between both fingers. After confirming that the ureters are not in the surgical site, an atraumatic vascular DeBakey clamp is applied widely including both the infundibulopelvic ligament and uterine arteries. Thus, two-sided blood supply of the uterus is reduced significantly and this gives the surgeon some time, for planning further surgical procedures and also serves a minimal bloody surgical site. If the avascular state of the surgical site is needed for a prolonged time, for instance while preparing for a blood transfusion or while waiting until an experienced surgeon is available, the clamps were opened and closed intermittently for a maximum of 10 minutes, as to sustain the blood supply of the ovaries and the uterus.

Eligibility Criteria:
Inclusion Criteria:

* The women who experienced profuse postpartum haemorrhage during cesarean section

Exclusion Criteria:

* none defined
The Homburg Keratoconus Center (HKC)

Aim of this study is to conduct longitudinal and cross-sectional analyses about the corneal ectatic disease Keratoconus based on data obtained from Keratoconus patients in the Homburg Keratoconus Center (HKC).

The Homburg Keratoconus Center (HKC) was founded in 2010 and, up to now, comprises more than 3,000 Keratoconus patients. Topographic, tomographic and biomechanic characteristics of the disease are being analyzed with the intention to elucidate how the disease begins and develops during lifetime.


Eligibility Criteria:
Inclusion Criteria:

* All Keratoconus patients presenting in the department of ophthalmology, Saarland University Medical Center, Homburg, Saarland, Germany.

Exclusion Criteria:

* Patients without Keratoconus.
Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain

The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain

It is known that severe post thoracotomy pain can be reduced by half with some strategies to prevent pain development. It was thought that partial rib resection would reduce intercostal tension and prevent an uncontrolled fracture. Thus, it is argued that post thoracotomy pain can be reduced. Partial rib resection is applied in clinical practice in selected patient groups. However, we could not find a clinical study on this subject in the English literature. The aim of this study is to determine whether partial rib resection has an effect on the control of thoracotomy pain.

Before the thoracotomy incision, simple randomization will be performed by flipping a coin.

Routine thoracotomy incision will be performed in the control group. In the intervention group, approximately 1 cm segment of the 6th rib will be excised with a rib scissors before the thorax retractor was placed.

Pericostal suture technique will be used in both groups at thoracotomy closure. Demographic information of the cases, preoperative respiratory function parameters, body mass index, Visual Analogue Scale scores, complications and analgesic doses will be recorded in the Case Report Form regularly.

Eligibility Criteria:
Inclusion Criteria:

* Participants who underwent thoracotomy in our clinic in 2019-2020
* Participants signing an informed consent form

Exclusion Criteria:

* Thoracic wall tumor
* Invasion of the thoracic wall by extrathoracic malignancy
* Pleural pathology
* History of previous rib fracture
* History of previous thoracotomy
* History of thoracic radiotherapy
* Emergency surgery
* Simultaneous incisions other than thoracotomy
Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome

Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation


Eligibility Criteria:
Inclusion Criteria:

* ACS and coronary stenting one month ago

Exclusion Criteria:

* age under 18 and pregnancy
Pain: Screen and Treat

This study is looking at treating cancer pain in head and neck cancer. Patients are asked in outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with a pain score of 4 and above are randomised into the study.

Patients are allocated to continue with their current care (control group) or to be reviewed by the pain/palliative care team (intervention group). At baseline questionnaires are completed on level of pain, type of pain, quality of life and anxiety/depression. Information is also collected on the analgesia they've used in the past month and basic health economics (GP/hospital visits related to pain management and treatment).

Follow up in the trial is for 3 months and consists of questionnaires as above and further collection of information on analgesic usage and health economics.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending head and neck oncology clinics
* Patients with a cancer diagnosis who are receiving anti cancer treatment or who have received anti cancer treatment
* Patients who score 4 or more on the Brief Pain Inventory numerical rating scale screening question 'worst pain in past 24 hours'

Exclusion Criteria:

* age below 18 years
* patients unable to respond to an English written assessment
* patients with medical conditions that could affect their mental function or level of consciousness such as stroke, or dementia
* patients who score \<4 on the Brief Pain Inventory numerical rating scale screening question
* patients already under the care of a pain/palliative care service
Medical Data Collection for the Evaluation of Radiofrequency Ablation and Cement Augmentation for the Treatment of Secondary Metastases to the Spine

This study collects data on the use of radiofrequency ablation and cement augmentation for the treatment of cancer that has spread to the spine (metastases to the spine). Radiofrequency ablation with cement augmentation is a useful approach for the treatment of secondary metastasis to the spine. Information collected in this study may help doctors to learn the effectiveness of this therapy, and may help to evaluate optimal technique, appropriate patient selection, and management of complications.

PRIMARY OBJECTIVE:

I. To evaluate the use of radiofrequency ablation and cement augmentation for the treatment of secondary metastases to the spine.

OUTLINE:

Patients' medical data is collected retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent radiofrequency ablation with cement augmentation at the Department of Interventional Radiology at MD Anderson Cancer Center (MDACC) between 1/1/2017 and 9/26/2020

Exclusion Criteria:

* None
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)

This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient does not have hypertension or has Stage I or II hypertension and is taking \< 3 anti-hypertension medications
* Patient is willing to discontinue all anti-hypertensive medications during study
* Patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
* Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
* Patient will avoid strenuous physical activity during study
* Patient is a nonsmoker or has not smoked for the last 3 months

Exclusion Criteria:

* Patient has metal implants in the leg or artificial limbs
* Patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
* Patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
* Patient has a history of stroke or seizures
* Patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence
Clinical Evaluation of Efficacy of SLT to Topical Medication in Lowering IOP

The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on intraocular pressure reduction, treatment side effects, quality of life measures and costs in South Indian Population.

Selective laser trabeculoplasty (SLT), a lasering procedure, is equal to or better than using medication for lowering eye pressure,leading to a better quality of life and being less costly.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis: POAG, PXF glaucoma, pigmentary glaucoma or mixed mechanism POAG with a narrow angle, (if laser PI \> 3 months ago) defined by standard examination criteria Adequate visualization of angle structures (i.e. clear media and cooperative patient) On no glaucoma medications OU \> 1 month On no systemic medications known to IOP (steroids) Visual acuity \> 6/24 OU Age - more than 35 yrs and less than 72 yrs

Exclusion Criteria:

A cumulative lifetime use of eye drops for glaucoma that exceeded 14 days; Used any eye drops for glaucoma in the 3 weeks before baseline I visit (washout from \< 14 days of use will be permitted); CIGTS visual field score that exceeds 16 in either eye; Evidence of ocular disease other than glaucoma that might affect the measurements of IOP, assessment of visual function, visual field testing Proliferative diabetic retinopathy Previous intraocular surgery one or both eyes except laser PI more than 3 months ago and cataract extraction with PC IOL more than 4 months ago.

Undergone ophthalmic laser (other than laser PI \> 3 months ago), refractive, conjunctival, or intraocular surgery in either eye; Would likely require cataract surgery within 6 months of randomization Current or expected use of corticosteroids
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Eligibility Criteria:
Inclusion Criteria:

* Female: 50 years of age or older
* \>5 years since last menses natural or surgical
* have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* BMI \>32 kg/m
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Reversal of Neuromuscular Blockade in Diabetic Patients

In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

Aim: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

Methods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic (n=20). All patients were premedicated. After arrival in the operating room, all patients were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the neuromuscular monitoring system automatically identified supramaximal stimulating currents and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the supramaximal current were applied and by recording of second TOF value (TOF2) the patient was intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 % concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.

Eligibility Criteria:
Inclusion Criteria:

* The patients (diabetic and non-diabetic) between 18-65 years with risk of anesthesia I-II,
* For diabetic group patients with Diabetes mellitus Type 2 over 10 years.
* For non-diabetic group patients without any glucose metabolism disease

Exclusion Criteria:

* myasthenia gravis, myotonic dystrophia, motor neuron diseases
* diabetic neuropathy and nephropathy
* hepatic, renal and cardiac diseases
Effects of Anesthetics on High-Dose Rocuronium

This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (PTC) values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.

In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain can be reduced.

The results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent. However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.

Our primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) Ⅰ-Ⅲ patients
* between the ages of 18-65

Exclusion Criteria:

* Being under 18 of age or over 65
* disapproval of the informed consent
* rocuronium allergy
* sugammadex allergy
* pregnancy
* lactation
* hepatic or renal dysfunction
* obesity (BMI≥35kg/m2)
* Previous abdominal surgery
* long-term use of NSAIs
* neuromuscular disorders
Antibiotic Prophylaxis in Children With Pyelonephritis

Children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. The focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. Parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. This study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux.
* Acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) CFU/ml for catheterization specimens and =10(4) CFU/ml for clean catch specimens), and a positive DMSA scan (a discreet defect or generalized decrease in activity).

Exclusion Criteria:

* Neurogenic bladder
* anatomic congenital anomaly
* allergy to all prophylactic antibiotics
* children whose parents do not wish to participate
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival

Eligibility Criteria:
Inclusion criteria

* Ovarian cancer patient (FIGO stage III-IV)
* Preoperative CT showing CPLN with short axis diameter \> 5mm.
* Anathestically fit patient (ASA score I or II).
* Accepted pulmonary function test.
* Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
* Written informed consent.
* Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )

Exclusion Criteria:

* Anathestically unfit patient
* Unresectable disease
* Patient refusal
* No detected CPLN by preoperative radiology
Food Replacement on Weight Control in Overweight Volunteers

Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Body mass index more than 23 kg/m2
* No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
* Wiling to attend the study

Exclusion Criteria:

* Allergic to protein, grains, guar gum
* Take medicine, supplement, herbal substance for weight control within 1 month
* During intermittent fasting
* Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
* Cushing syndrome's
* Pregnancy and lactation