cyrilzakka/clinical-trials huggingface dataset:
Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis.

The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.

SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits.

10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group.

The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated.

The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.


Eligibility Criteria:
Inclusion Criteria:

* Male or female suffering from drug-resistant epilepsy
* Age ≥ 6 years old
* Inpatient in one of the participating EMUs for recording seizure during long-term VEEG monitoring (≥ 48 hours)
* Patient who gave its written informed consent to participate to the study, or for children, whose minimum one of parents had given its written informed consent

Exclusion Criteria:

* Age \< 6 years old
* Inpatient in one of the participating EMUs for performing short-term VEEG monitoring (\<48 hours)
* Pregnant or breastfeeding woman
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts

The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.

With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic Ethnicity (Child and Parent)
* Age 14-16 (Child) and Parent age \< 85
* BMI Percentile above the 85th (child)
* Ability to read and speak English (child)

Exclusion Criteria:

* Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))
* Involved in any formal weight-loss program in the past 6 months (Child)
* Diagnosed diabetes (type 1 or type 2 Child)
* Weight is less than 110 Ibs (Child and Parent)
Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).

* Time 0: Patients will be screened at the time of presentation to the hospital at participating centres
* Usually patients will be hospitalised for an acute dyspnea in relation with a pulmonary congestion. This congestion does not necessarily justify a hospitalization and for part of the patients a consultation and a dedicated treatment would be good enough to cure the symptoms.
* Thus, patients seen in emergency for a congestion and diagnosed or known to have a preserved left ventricular ejection fraction (LV EF \> 45%) will be proposed to participate to the study.
* Patients meeting inclusion criteria will be invited back to the clinic in stable condition, approximately 4-8 weeks after the initial hospitalization.
* Time 4-8 weeks after initial hospitalisation (NOT after discharge): Comprehensive history-taking and examinations.
* Any information necessary for the study will be collected by the principal investigator in each participating center in a dedicated, secure, e-CRF. The access to the e-CRF will be restrictive to the only principal investigator of each center. The lonely other persons able to take look to the e-CRF are the study monitors.
* Time 6, 12, and 18 months: Follow up by phone call or review of charts or other records such as death registries. This part of the study will be performed by the CRAs in the French Society of Cardiology

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting to the hospital with congestive heart failure, defined as:

  1. Clinical signs of heart failure

     Major criteria
     * Paroxysmal nocturnal dyspnea
     * Orthopnea
     * Jugular venous distension
     * Pulmonary crackling rales
     * 3rd heart sound
     * Cardiothoracic ratio \> 0.5 on X-ray
     * Pulmonary oedema on X-ray

     Minor Criteria
     * peripheral oedema
     * nocturnal cough
     * dyspnoea at exercise
     * hepatomegaly
     * pleural effusion
     * tachycardia (defined as ≥ 100 beats per minute)

     Heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria
  2. LVEF ≥ 45% by echocardiography within 72h
  3. BNP \> 100 ng/L or NT-proBNP \> 300 ng/L

     Exclusion Criteria:
* Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
* Known cause of right heart failure not related to left ventricular dysfunction
* Pericardial constriction
* Clinically significant pulmonary disease, as evidenced by requirement of home oxygen.
* End-stage renal disease requiring dialysis
* Bi-ventricular pacemaker (CRT)
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.

All participants will receive itraconazole during their inpatient post transplant stay. As an outpatient, ten subjects will be randomized to receive itraconazole 200mg orally once daily for 6 month and ten patients to receive voriconazole 200mg orally twice daily for 6 months . All subjects will be followed in the clinic as per the standard transplant treatment

Eligibility Criteria:
Inclusion Criteria:

* Bilateral-lung or single-lung transplant recipients between the ages of 18- 65 years old.
* Patients must be able to give informed consent prior to and again after transplantation

Exclusion Criteria:

* Lung transplant patients unable to give informed consent.
* Prior adverse reaction to the drug itraconazole or voriconazole
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
* Body Mass Index (BMI) of 21-35 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion Criteria:

* Treatment with insulin within the last 3 months preceding the trial
* Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
* Participation in any other clinical trial within 30 days of screening
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.


Eligibility Criteria:
Inclusion Criteria

* Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
* Confirmed to have a history of gastric or duodenal ulcer

Exclusion Criteria

-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus
Can Neck Circumference Measurements Less Than 43cm or Greater Than 43cm Predict Difficulty of Tracheal Intubation?

The circumference of a person's neck is a useful predictor of difficulty of insertion of a breathing tube.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-4
* Receiving general endotracheal anesthesia for surgery

Exclusion Criteria:

* Limited range of motion of the neck or jaw
* Cervical spine injuries
* Upper airway pathology
* Previous facial trauma, or goiter
* Patients receiving regional anesthesia or anesthesia other than general, endotracheal anesthesia
Comparing Protocols for Analgesia Following Elective Cesarean Section

Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia:

1. Scheduled doses of IV acetaminophen + PO Ibuprofen
2. Scheduled doses of PO acetaminophen + PO Ibuprofen
3. "On demand" doses of acetaminophen, dipyrone and ibuprofen.

A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores.

Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.

Number of participants: 120

Treatment:

All women will receive immediately after surgery, in the recovery room:

1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3
2. IV Tramal 100 mg, once

After Admitted to Mternity ward:

* 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
* 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
* 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS\>4, up to 4 times a day, at least 6 hours between doses.

Tab Tramadex 100 mg, for VNS\>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.

- 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:

* Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
* PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
* Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective cesarian section

Exclusion Criteria:

* known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of all ages, scheduled for TKA
* Primary osteoarthritis of the knee joint
* post traumatic arthritis
* rheumatoid arthritis

Exclusion Criteria:

* previous TKA in same joint
* evidence of neuromuscular or neurosensory deficiency
* immunologic suppression
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant patients with uncomplicated pregnancies:
* ASA (American Association of Anesthesiologists) class 1 or 2 patients.
* Singleton pregnancies.

Exclusion Criteria:

* ASA class 3 or 4 patients.
* Known drug allergy to intravenous oxytocin.
* Significant medical or obstetric disease.
* Known uterine abnormality.
* Known placental abnormality.
Assessment of Patient Satisfaction Program "Gestational Diabetes"

This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals.

This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* Gestational diabetes diagnosis based on OGTT glucose 75g, performed after 24 weeks of gestation
* Women aged 18 and over
* After 24th week of gestation
* Before 36th week of gestation
* initial management in therapeutic education at the University Hospital of Caen

Exclusion Criteria:

* Another form of diabetes (existing before pregnancy or diagnosed before 24 weeks of gestation)
* women under 18 years
* Initial management of gestational diabetes by health professionals outside the University Hospital of Caen
* Poor understanding of the French language
Epstein-Barr Virus as a Possible Cause for Chronic Fatigue Syndrome

The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms occurring at the same time, but the cause is still unknown.

Epstein-Barr virus (EBV) is the etiological agent for heterophile positive infectious mononucleosis (IM). It is also an oncogenic herpes virus associated with African Burkitt's lymphoma (BL),nasopharyngeal carcinoma (NPC) and AIDS-associated B-cell lymphomas. EBV is also among a group of viruses that have been associated with chronic fatigue syndrome (CFS), although the etiology of CFS still remains unknown.Findings may lead to hypothesize that EBV enzymes, such as the dUTPase, have the capacity to induce immune dysregulation of the T-cell and NK cell responses and that this immune dysregulation produces immunopathology that results in the symptoms that we call CFS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults for controls.
* Adults with chronic fatigue syndrome.

Exclusion Criteria:

* Individuals with significant medical illness in reference to immunosuppressant drug.

Note: We recruit participants in the Mississippi area who could come in our site to provide blood draw.
Topcon 3D OCT-1 Maestro Reference Database Study II

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Eligibility Criteria:
Inclusion Criteria for Normal Group

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. lOP \<= 21 mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives\> 33%, or false negatives\> 33%
5. Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:

   * On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
   * Glaucoma hemi-field test "outside normal limits."
6. Presence of any ocular pathology except for cataract
7. Narrow angle
8. History of leukemia, dementia or multiple sclerosis
9. Concomitant use of hydroxychloroquine and chloroquine
LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery

Low-level laser therapy (LLLT) is a well-studied technique that has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. This study will use two groups with patients randomly assigned to either the study group, receiving LLLT, or one receiving a placebo treatment, after they have lower jaw surgery. Measurements will be taken at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams to check pain, swelling and nerve function, and the two groups will be compared to see if the LLLT group has any difference

Low-level laser therapy (LLLT) is a well-studied technique to induce biomodulation of pain and wound healing. The technique has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. Previous studies have used split-mouth designs, short follow-up periods or, often, both. This study aims to have two groups, one receiving LLLT and one receiving a dummy treatment, at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams. At each visit, pain (via VAS), swelling (measured from the midpoint of the chin to the base of the ear, bilaterally), and nerve function (using a soft and hard sensory test, in 8 regions of the mandible and lower lip) will be performed, with additional measurements at 8 weeks and 20 weeks. The measurements will be analyzed for statistical differences between the LLLT intervention group and non-intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mandibular surgery with bilateral sagittal split osteotomies

Exclusion Criteria:

* patients must be free from pre-operative inferior alveolar neurosensory deficiencies
* intra-operative accidental fracture or rupture of the inferior alveolar nerve
Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation

Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.

The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.


Eligibility Criteria:
Inclusion Criteria:

* Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract \& IOL Research Center, Ahmedabad, India.
* Children older than 4 years undergoing cataract surgery with IOL implantation were included.

Exclusion Criteria:

* Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Korea

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, and complications in diabetic subjects in Asia.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months.
* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
* Patients willing to sign informed consent form.

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason.
* Unwilling to participate or unable to comply with protocol requirements.
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.


Eligibility Criteria:
Inclusion Criteria:

* All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)

Exclusion Criteria:

* Patients who require prolonged Foley catheter or suprapubic catheter