cyrilzakka/clinical-trials huggingface dataset:
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis

This study aims to provide an estimate of the incidence of paraneoplastic neurological syndromes and autoimmune encephalitides in France between the years 2016 and 2018. The study will describe the incidence of antibody subtypes and regional variations.


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of Paraneoplastic Neurological Syndrome (PNS) or Autoimmune Encephalitis (AE) made by the referring physician to the national center for PNS and AE in Lyon between 2016 and 2018

Exclusion Criteria:

* Data on location of diagnosis missing
* Patients diagnosed out of the mainland French territory
* Patients for whom insufficient data was available
Quelling of Excitotoxicity in Acute Stroke With Ketamine

The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.

After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. The infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 1 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.

Eligibility Criteria:
Inclusion Criteria:

1. All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time
2. An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate
3. Pre-stroke modified Rankin scale of 0-2
4. Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.

Exclusion Criteria:

1. Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy
2. Longer than 24 hours since last known well time
3. Pre-stroke modified Rankin scale of 3 or above.
4. Pregnant or lactating females
5. Pre-existing psychiatric illness
6. Intracranial hemorrhage of any type at presentation
7. Seizure at onset of symptoms
8. Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications
9. Known hypersensitivity or adverse reaction to prior administration of Ketamine
10. Inability/refusal to provide consent by the patient or through a proxy
The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field

The main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.

Aberdeen scientists are at the forefront of a new type of magnetic resonance imaging (MRI), having built in-house the only two available prototypes of Fast Field-Cycling MRI in the world - and these already have clinical imaging capabilities. Fast Field-Cycling MRI switches rapidly over a range of field strengths (0.2 T to 200 µT), providing a T1 dispersion curve. This information is invisible to fixed-field scanners and uncovers unique knowledge about motion and interaction between component molecules within a tissue (i.e. water/fat/proteins). In this application the investigators wish to use their in-house expertise further to extend the capability of our Fast Field-Cycling MRI to perform cardiac imaging by building the first-ever cardiac Fast Field-Cycling MRI coil and develop cardiac pulse sequences with ECG gating. The investigators will aim to establish the normalcy of T1 dispersion curves for left ventricular myocardium in healthy volunteers, and further on to distinguish the characteristics of post-myocardial infarction scar T1 dispersion curves.

Eligibility Criteria:
Inclusion Criteria:

* Participant who is willing and able to give informed consent for participation in the study
* Healthy volunteers willing to give informed consent for participation in the study
* Patients diagnosed with a previous myocardial infarction

Exclusion Criteria:

* Unwillingness to participate
* Claustrophobia
* Contraindication to MRI scanning such as implantable cardiac devices
* Participants who have had a previous myocardial infarction in the past of which they may not be aware and this is discovered whilst being scanned on the 3T MRI scanner, or who may have any other cardiology condition that they were previously unaware will not be included in the healthy control group, even if they present themselves to us as "healthy" at the time of the study visit
* Pregnancy
* Body habitus that may preclude comfortable positioning of the volunteer in either of the MRI scanners (\>50cm in diameter)
* Participants with abnormal kidney function that will preclude them from receiving a contrast agent
VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C

This study implement a values-based motivational interviewing (VBMI) intervention to promote treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30 Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C virus (HCV) infection.

The investigators will conduct a prospective study of 30 Veterans with treatment-naive genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center. Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be prescribed in accordance with the package insert.

Eligibility Criteria:
Inclusion Criteria:

1. Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
2. Current resident of the SARRTP program
3. Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
4. Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge

Exclusion Criteria:

1. Contraindications for therapy with FDC MK-5172/MK-8742
2. Unable to provide written informed consent
3. Hepatocellular carcinoma or other medical condition precluding HCV treatment
4. Acute HCV infection
5. Prior treatment for chronic HCV
6. History of decompensated cirrhosis
7. Platelet count \< 75 K/cmm and/or albumin \< 3 grams/dL
8. Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
9. Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing
Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability

This clinical trial aims to investigate the intra- and inter-rater reliability of pain pressure threshold algometry in lateral epicondylitis patients.

Tennis elbow, also known as lateral epicondylitis (or epicondylosis) of the elbow, was first described at the end of the 19th century. The community prevalence is 1% to 3%,38 with an even sex distribution and a peak incidence between 35 and 55 years of age.16 There is consensus that the mechanism of injury involves repetitive loads at the wrist and elbow, including supination and extension of the wrist.15 People affected by tennis elbow commonly have pain over the lateral humeral epicondyle, with flexion at the elbow also usually limited by pain, especially if the wrist is pronated and extended against resistance.

Assessment of reliability is a necessary first step in the validation procedures of clinical tests. The reliability of the PPT measurement is susceptible to the influence of rater behavior and judgment, such as the instructions to the participant, rate of force application, and reaction time of the rater.

We opted to investigate the intra- and inter-rater reliability of PPT in persons with lateral epicondylitis with three raters, rater blinding, and a pause of ≥20 seconds between each measurement. We hypothesized that clinicians with no former experience with the procedure can master it with good reliability after a single 30-min training session.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 and 90 years of age
* Clinical diagnosis of lateral epicondylitis (point tenderness over the lateral epicondyle and exacerbation of pain with chair pick-up test and maximal hand grip)

Exclusion Criteria:

* History of steroid injection for the treatment of lateral epicondylitis within six months
* History of oral steroid use for the treatment of lateral epicondylitis within six months
* History of elbow surgery
* History of elbow fracture
* History of elbow dislocation
* Cancer
* Rheumatoid arthritis
* Severe cognitive deficit
* Neurological deficits in the upper limb
* Inability to speak and understand English/Turkish.
Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers

The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects determined by results of screening
* Age 18 - 40 years
* Body Mass Index 18 - 25 kg/m2, at least 45 kg
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator
* Relevant gastrointestinal tract surgery
* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, pulse rate out of 45 to 90 beats per minute
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
* Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
* Inability to refrain from smoking when confined to the study site on trial days
* Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
* Drug abuse, in the investigator's judgment upon review of the patient's history and urine screening for abused substances
* Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within 48 hours prior to trial or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance according to the assessment of the investigator
* Inability to comply with dietary regimen of study centre
* Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 80 years old
* Gender: Male or female
* Status: Outpatients
* severe hypertension

Exclusion Criteria:

* Patients with a clinically significant allergy
* Patients who have received other investigational drug
* Alcoholic patients

Other protocol-defined inclusion/exclusion criteria may apply
Interpolated Flap Study

The primary purpose of this study is to address the limited knowledge regarding patient well- being and nasal function after interpolated flap repair of post-Mohs surgical defects on the nose. Improved understanding of the patient experience will allow providers to better counsel their patients pre-operatively and potentially identify patients who may benefit from additional interventions.

This project is a multi-center prospective cohort study evaluating postoperative complication rates, quality of life outcomes, and nasal function after interpolated flap repair of post-Mohs surgical defects of the nose. Our primary outcome is the incidence of short-term complications(within 4 weeks of surgery) defined by the American College of Mohs Surgery as: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. Secondary outcomes will include incidence of flap necrosis and evaluation of quality of life at 1, 4 and 16 weeks after repair. Quality of life will be investigated using the Skin Cancer Index (SCI)- a skin cancer specific quality of life instrument and the Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ). Previous literature has demonstrated that Mohs surgery in the outpatient setting has a very low complication rate but this literature is generally limited to single-institution studies or studies examining smaller repairs. Furthermore, it has been proven that receiving a skin cancer diagnosis is stressful and patient satisfaction with skin cancer surgery is related to their appearance and scarring or changes in appearance can decrease quality of life. Our study serves to fill the current literature knowledge gaps by examining repair of large defects and looking at both complications and quality of life outcomes. Data collection will begin pre-operatively on patients 18 and older who require an interpolated flap repair of a post-Mohs surgical defect. These patients will then be followed and asked to complete SCI and NAFEQ surveys as well as complication questionnaires at prescribed intervals. All data will be stored via a secure RedCap database.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older who are able to provide informed consent and may require interpolated flap repair of their post-Mohs surgical defect

Exclusion Criteria:

* People who are not adults, not able to give informed consent, or who's wounds are not being repaired by a fellowship trained Mohs surgeon
Glottic Visualisation During Laryngoscopy

In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.

Tree different head and neck positions will compare for glottic visualization and intubation success rates in obese patients (BMI\> 30 kg / m2) who required endotracheal intubation for general anesthesia between 18-65 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Being 18-65 aged
* Being obese
* Undergoing surgery under general anesthesia

Exclusion Criteria:

* Having difficult airway
* Being American Society of Anesthesiologist (ASA) 4 physical status
* Undergoing emergency surgery
Communication Bridge Speech Therapy Research Study

This is a study on Internet-based video-practice speech and language therapy for persons with primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or related conditions.

The purpose of this study is:

1. To evaluate the effectiveness of speech and language therapy on a person's ability to communicate immediately after treatment, 6-months after treatment, and 12-months after treatment.
2. To identify the most effective speech and language therapy strategies for persons with these conditions.
3. To determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions.

The study will involve 12 to 15 session over the course of 12 months. Some of these sessions will be in-person at the Northwestern Cognitive Neurology and Alzheimer's Disease Center (Chicago, IL), while others will take place over the Internet, using an online study portal.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia with language as a primary symptom (i.e. aphasia)
* An informant who knows the participant well and can answer questions the participant's communication ability
* Adequate hearing to follow conversation (correction permitted)
* Adequate vision (correction permitted)
Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin

Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with acute coronary syndrome after 24 hours from the coronarography

Exclusion Criteria:

* patients with a family or personal history of bleeding or thrombophilic disorders;
* platelet count \>600000/mmc or \<150000/mmc
* hematocrit \>50% or \<25%
* creatinine clearance \<30 mL/min
Paleolithic Diet in the Treatment of Glucose Intolerance

The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.

There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* Hyperglycemia
* Coronary Heart Disease
* Increased waist circumference

Exclusion Criteria:

* Body mass index \<20 kg/m2
* Serum creatinine \>130 µmol/L
* Poor general condition
* Dementia
* Unwillingness/inability to prepare food at home (by study participant or partner)
* Participation in another medical trial
* Chronic inflammatory bowel disease
* Drug treatment with hypoglycemic agents
* Drug treatment with warfarin
* Drug treatment with oral steroid
Stretch-Shortening Cycle Exercise: Potential Implications For Children With Obstetric Brachial Plexus Injury

This study was set out to evaluate the effect of a 12-week stretch-shortening cycle exercise (SSC-Ex) on muscle strength, bone mineral density, and upper extremity function in children with obstetric brachial plexus injury (OBPI). Fifty-six patients with OBPI were randomly allocated to the SSC-Ex group (n = 28, received SSC-Ex program, twice/week, over 12 weeks) or the control group (n = 28, received standard exercise program). Both groups were assessed for muscle strength, bone health, and upper extremity function before and after treatment.

Fifty-six children with OBPI were recruited from the Physical Therapy Outpatient Clinic of Prince Sattam Bin Abdulaziz University and three referral hospitals in Riyadh provenience, Saudi Arabia. The study included children who had a confirmed diagnosis of upper arm type of OBPI, classified as level I or II per Narakas classiﬁcation system, aged 10-16 years, had a functional level of grade III according to the Mallet scoring system, and were consuming a balanced diet. Children who had a history of corrective neuromotor or musculoskeletal surgery, shoulder dislocation/subluxation, calcium supplements, or cognitive issues were excluded.

Outcome measures

1. Muscle strength: The peak isometric muscle strength of the shoulder flexors, abductors, external rotators, elbow flexors, and extensors was measured using a hand-held dynamometer.
2. Bone mineral properties: Bone mineral density and bone mineral content of the humeral, radial, and ulnar shafts were measured through Dual-Energy X-ray Absorptiometry (DEXA) scanning.
3. Upper-extremity function: The functional performance was assessed using the brachial plexus outcome measure (BPOM) activity scale.

The SSC-Ex group received a 12-week therapist-led SSC-Ex training, for approximately 35 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC-Ex program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities. The SSC-Ex program preceded with a warm-up for 5 minutes and ended with a cool-down for 5 minutes. The control group received the standard exercise program, 35 minutes per session, two times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, manual guidance, and functional training.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of upper arm type of OBPI.
* Narakas classiﬁcation level I or II.
* Functional level of grade III per the Mallet scoring system.
* Age between 10-16 years.

Exclusion Criteria:

* History of neuromotor or musculoskeletal surgery.
* Shoulder subluxation/dislocation.
* Past fracture involving the upper extremities.
* Calcium supplement intake.
* Inability to adhere to the scheduled program.