cyrilzakka/clinical-trials huggingface dataset:
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Lamotrigine (LMT) in last phases; Group B: Pre-treatment with LMT, treatment with LMT and ascending doses of ESL in last phases

Eligibility Criteria:
Inclusion Criteria:

* Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
* Male aged of at least 18 years but not older than 45 rears with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
* Healthy according to the medical history, laboratory results and physical examination
* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day I of thi s study The informed consent form must be signed by all volunteers, prior to their participation in the study.

Exclusion Criteria:

* Significant history of hypersensitivity to lamotrigine, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
* History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
* Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
* Presence of significant heart disease or disorder according to ECG
* Presence or history of significant central nervous system disorder like convulsion or depression
* Presence or history of significant ocular disease
* Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
Temporal Intervention Trial of a CPR Video in the ICU

To compare the decision making of family members of patients admitted to the ICU in regards to their CPR preferences for their loved ones with and without the use of a video decision aid.

Surrogate decision makers of patients admitted to an ICU and UNABLE to make decisions for themselves will be asked their choice for CPR preferences for their loved ones. This will occur during the first six months of the study.

After six months, surrogate decision makers of patients admitted to an ICU and unable to make decisions for themselves will view a video decision aid for CPR and then asked their choice for CPR preferences for their loved ones.

Eligibility Criteria:
Inclusion Criteria:

patient admitted to ICU and unable to make decisions with a known surrogate decision maker

Exclusion Criteria:

Cannot speak English
Heart Rate Variability During Acute Diverticulitis

The purpose of this study is to investigate heart rate variability during Acute uncomplicated diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the inflammation causes a decrease of High Frequency(HF)-power component of heart rate variability and this correlates with sleep quality and daytime fatigue.

An increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. The investigators are interested in investigating the heart rate variability (HRV) during an acute surgical non-inflammatory condition, and to exam whether there are correlations between: HRV and sleep stages, HRV and cytokine levels in blood and HRV and subjective fatigue.

Following methods will be applied

Device: Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)

Other: Karolinska Sleepiness Scale

Other: Physical Fatigue Scale

Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor)-alfa)

Procedure: Plasma CRP(C reactive protein) and leukocytes

Eligibility Criteria:
Inclusion Criteria:

* CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
* Pain and fever occurred less than 72 hours prior to the admission
* ASA (American Society of Anesthesiologists) score I to III

Exclusion Criteria:

* Surgical intervention needed
* Complicated diverticulitis
* Complications in relation to diverticulitis
* Pain and fever occurred more than 72 hours prior to the admission
* In anticoagulant treatment and heart rate control treatment
* Known Autoimmune disease
* Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
* Shift-work or jetlag
* Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
* Known psychiatry conditions in treatment with psychopharmaca
* Daily alcohol intake of more than 5 units or drug abuse
* Missing written consent
* Diabetes Mellitus
* Predicted bad compliance
* Pregnant or breast-feeding
* Urine or fecal incontinence
* Severe kidney disease
* Current cancer
Assessing the Level of Disability and Fear Avoidance Beliefs in Bankers of Karachi

An observational study will be conducted to determine the level of pain and disability among bankers working in different banking setups for past 2 years by using Neck Disablity Pain Index and Fear Avoidance Belief Questionnaire. the participant will be recruted fromdifferent private and public banking sectors of Karachi, including Habib bank limited, Silk bank,JS bank and other.

A cross-sectional study with a total sample size of 100 participants will be recruited for the purpose of the survey. The participants will be given Neck Disability Pain Index Questionnaire and Fair avoidance belief Questionnaire in order to determine the level of pain and disability among bankers who are performing their duties in bank from atleast two years.

Eligibility Criteria:
Inclusion Criteria:

* bankers with neck pain

Exclusion Criteria:

* neck surgery
Maximum Targeted Ablation of Atrial Flutter

Patients undergoing atrial flutter ablation will be randomized to either the standard ablation approach or voltage targeted approach. Patients will be followed for one year to assess outcome of the ablation technique


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing TV-IVC isthmus ablatin for atrial flutter

Exclusion Criteria:

* atypical atrial flutter
* \<18 years old any atrial surgery or pacemaker refusal to participate
IMPACT Trial: Intervention to IMProve AdherenCe Equitably

To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).


Eligibility Criteria:
Inclusion Criteria:

* Women or men age \>18 years
* Diagnosed with stage I-III breast cancer prescribed endocrine therapy
* Within 3-years of the end of early active treatment (e.g., surgery, chemotherapy not including human epidermal growth factor receptor 2 (HER2)-directed therapy, radiation)
* Patients must be prescribed at least 1 antihypertensive or statin medication for CVD prevention
* Self-report of at least some nonadherence ET or CVD medication on DOSE-Nonadherence Extent of Nonadherence questionnaire

Exclusion Criteria:

* Evidence of breast cancer recurrence
* Non-English or Non-Spanish speaking
* Not cognitively able to complete study requirements
* Do not follow with either a primary care provider or cardiologist within the New York Presbyterian Health system's Epic EHR
* Inability to provide informed consent
Evaluation of 3D Imaging Ulcer Camera

The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the wound is one of the major etiologic factors for delayed healing. Wound measurement is important in monitoring the healing process of wound and in evaluating the effect of treatment. Three-dimensional methods for measuring wound size have made it possible to evaluate the process of wound healing with respect to all dimensions. The investigators have developed a 3D camera, which is able to measure wound size (2D area, 3D area, perimeter and volume) and to assess wound characteristics.

The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients with wounds
* 18 years or older

Exclusion Criteria:

* Superficial ulcer (less than 5x5 mm with no substantial loss of subcutaneous tissue)
* Non-compliance (dementia, mental disorders)
Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR\<60 ml/(min\*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.
2. Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (\< 28 kg for males, \< 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (\< 1.0 m/s) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (\< 7.0 kg/m2 for males and \< 5.7 kg/m2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.
3. Patient can walk normally.
4. Provide the written informed consent.

Exclusion Criteria:

1. Patients with diabetes.
2. Obese/overweight patients (body mass index\>25 kg/m2)
3. Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
4. Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
5. Patients with acute infection (C-reactive protein\>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
6. Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.
7. Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.
8. Patients with hypercalcemia and amino acid metabolism disorder.
9. Those who are allergic to the active ingredients or other excipients of the Ketosteril.
10. Patients with poor compliance, unable to follow the study requirements for diet control.
11. Participated in other interventional clinical trials within 30 days before this study.
Portion Size and To-go Container on Dinner Intake

This study investigated whether the provision of a to-go container influenced the portion size effect at a meal. Following a screening visit, women came to the lab once a week for 4 weeks to eat a meal of multiple foods. At each visit, the portion size of the meal was varied in a counterbalanced order. Prior to their first meal, women were randomly assigned to one of two groups: a group that would have their leftovers packaged to go (to-go group) and a group that did not have leftovers packaged (control group). Women were instructed to eat ad libitum at the meals. They also answered questions about hunger and fullness as well as food characteristics before and after each meal. Following the final meal, subjects completed a series of questionnaires assessing subject characteristics as well as food characteristics. It was hypothesized that the effect of portion size on intake would be attenuated in subjects who received a to-go container with the meal. In addition, we aimed to identify any subject characteristics that moderated or exacerbated the portion size effect. It was also of interest to determine whether the portion size effect on individual foods were influenced by food characteristics such as perceived value.


Eligibility Criteria:
Inclusion Criteria:

* Regularly eats 3 meals/day
* Willing to avoid alcohol the day before and during test days
* Likes foods offered at test meals
* Body mass index 18 - 36 (kg/m\*m)

Exclusion Criteria:

* Smokes
* Athlete in training
* Pregnant or breastfeeding
* Taking medication that may affect appetite or food intake
* Food allergies or dietary restrictions
* Currently have or recently been diagnosed with disease or disorder known to affect appetite
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.

The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy

Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older at the time of implantation
2. Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, \& 4000 Hz) of \> 60dB HL.
3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below
4. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted
5. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%
6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation

Exclusion Criteria:

1. Individuals aged greater than 75 years
2. Duration of severe to profound hearing loss (above 2kHz) greater than 20 years
3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 500 to 1000 Hz
6. Deafness due to lesions of the acoustic nerve or central auditory pathway
7. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
8. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
9. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
10. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
UK Imaging Diabetes Study Seeing Diabetes Clearly

Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.

This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.

MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
* Participant willing and able to give informed consent for participation in the study.

Exclusion Criteria:

In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:

* myocardial infarction
* ischaemic stroke
* hospital admission/discharge for unstable angina
* heart surgery
* unstable angina
* transient ischemic attack
* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Patients with known autoimmune hepatitis, viral hepatitis, Wilson's disease or known significant structural renal tract abnormality.
* Patients with known alcohol dependency.
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries

The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.


Eligibility Criteria:
Inclusion Criteria:

1. Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
2. Patient is \>18 years old.
3. Patient understands the nature of the procedure and provides written informed consent prior to enrolment in the study.
4. Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
5. Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in the IFU for each device.

Exclusion Criteria:

1. Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
2. Known contraindication and/or allergy to (a component of) an investigational device.
3. Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
4. Life expectancy of less than 12 months.
5. Any planned surgical intervention/procedure within 30 days after the study procedure.
6. Any patient considered to be hemodynamically unstable at onset of procedure.