cyrilzakka/clinical-trials huggingface dataset:
Angelman Syndrome Natural History Study-FAST UK

The goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of Angelman syndrome (AS) in children and adults. This will be performed by acquiring baseline measurements, and developing effective outcome measures and diagnostic tools for the syndrome, to prepare the healthcare system for forthcoming clinical trials.

This study is being conducted in anticipation of several candidate therapies which are approaching clinical readiness for Angelman syndrome. This study will comprehensively evaluate the natural clinical progression of the disease using scales and questionnaires for the assessment of motor function and global development, motor measuring devices (ActiMyo), and by collecting sleep and seizure diaries. In addition, proteomic analysis and electroencephalography (EEG) recordings will be collected to identify biomarkers which will indicate improvements in disease outcome following treatment.

Eligibility Criteria:
Inclusion Criteria:

For the candidate participants affected by AS:

* Genetically confirmed diagnosis of AS
* 0-99 years
* Male or Female
* Obtained consent forms and/or record of consultation by the carers.

In this study, the two primary carers for each participant diagnosed with AS will be also considered participants. Carers will have to meet the following inclusion criteria:

* Male or Female
* \>18 years
* Legal carer of the patient diagnosed with AS
* Willingness to follow study procedures, as assessed by the research team
* Willingness to sign the consent form
* Ability to understand all the information regarding the study, as assessed by the research team

Exclusion Criteria:

* The participant affected by AS may not enter the study if there is any comorbidity (\*) that could potentially affect the results of the study. This will be subject to the clinical judgement of the Chief Investigator (CI) and/or the Principal Investigator (PI). Participants of ongoing (interventional) clinical trials that assess the efficacy of potential treatments will be excluded as assessments need to be done on the basis that represent the natural progression of AS.

(\*) This includes any confirmed chronic or acute condition or disease affecting any system(s), which could interfere with the results of the study and/or the compliance with the study procedures.
To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.

To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.

Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.

Specific aims for this project include the evaluation of:

* KM width at 6 and 12 months following grafting with FGG and CTG
* Change in tissue thickness of the grafted sites at 6 and 12 months
* Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month
* Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group

Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. At least 18 years old
3. Must be a patient of the UAB Dental School, able to read and understand informed consent document
4. One or more adjacent dental implants having \<2mm in width of keratinized mucosa or attached mucosa \<1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
5. No crestal bone loss or minimal bone resorption not extending apical to first implant thread
6. Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
7. Implants requiring soft tissue grafting after placement (\>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration

Exclusion Criteria:

1. Non-English speaking
2. Less than 18 years old
3. Smokers/tobacco users (\>10 cigarettes/day)
4. Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
5. Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
6. Presence of soft tissue recession exposing threads at implant site
7. Presence of bony dehiscence at implant site (s)_ at time of surgery
8. Previous soft tissue grafting at the implant site (s)
Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

The purpose of this Phase 1/Phase 2 study is to evaluate how the body handles the drug and the drug's effect on the body of participants with mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD and who test positive for amyloid plaque.


Eligibility Criteria:
Inclusion Criteria:

Meets criteria for MCI due to AD or Mild AD

All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening

* Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows:

  * Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
  * Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
  * Positive scan for the presence of amyloid beta
* Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria:

  * Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months
  * Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46
  * Absence of dementia
  * Preservation of functional independence
  * Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible
  * Positive scan for the presence of amyloid beta
* Women must be postmenopausal
* Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods

Exclusion Criteria:

* Participant in another drug or device study
* Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder
* Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed.
* Have had a serious infectious disease affecting the brain in the past 5 years
* Have had a serious or repeat head injury
* Have significant retinal impairment or disease
* Have had a stroke or other circulation problems that are affecting current health
* Have had a seizure
* Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included
* History of schizophrenia, bipolar disorder, or severe mental illness
* History of alcohol or drug abuse
* Have asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine
* Have human immunodeficiency virus (HIV) or syphilis
* Are taking blood thinners
Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique

clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique

This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement

Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.

Secondary outcome: Histological analysis of remodeled bone.

Eligibility Criteria:
Inclusion Criteria:

* 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015)

Exclusion Criteria:

* 1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.

  3- Patients with poor oral hygiene or not willing to perform oral hygiene measures.

  4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)
Stretching the Posterior Capsule of the Shoulder in the Stability and the Throwing Performance in Handball Players

Introduction: Handball is a sport with a high prevalence of shoulder injuries due to the overuse that causes a glenohumeral internal rotation deficit, and excess of external rotation and scapular dyskinesia. Stretching is essential to restore physiological movement and improve strength.

Aim: To evaluate the efficacy of a posterior capsule stretching and strengthening of the shoulder and scapular program in handball players from 18 to 37 years old.

Study design: randomized clinical trial, multicenter, single-blind with follow-up period.

Methods: 60 handball players will be randomly assigned to the two study groups (experimental and control). The intervention will last 4 weeks, with 3 weekly sessions with a duration of 21 and 12 minutes each. The study variables will be: range of motion in internal and external rotation (goniometer), throwing speed (Ball Throwing Speed Test), functionality (DASH questionnaire), perceived exertion (Borg scale), glenohumeral stability (CKCUEST y YBT-UQ Test) and the throwing force (Overhead Medicine Ball Throw). The intervention will consist in the application of stretching of the posterior shoulder capsule with an exercise protocol. A Kolmogorov-Smirnov analysis will calculate the normality of the distribution. In case of homogeneity of the groups, with the t-student test of repeated measurements and an ANOVA of repeated averages, the difference between the different evaluations and the intra- and inter-subject effect will be calculated.

Expected results: Improved range of motion of the shoulder, strength and throwing speed after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Handball players federated in the Madrid Handball Federation
* With an age range between 18 and 37 years
* More than 2 years of handball sports
* Currently participate in amateur competitions of First National Women's category.

Exclusion Criteria:

* Have suffered a shoulder injury in the last six months
* Who are currently doing some physiotherapy treatment
* Who fail to participate in the established intervention and evaluation sessions
* Refusing to sign the informed consent document.
Omega-3 Fatty Acids and Insulin Sensitivity

This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. No existing studies have systematically evaluated the influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver.

A sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content of total, pro- (M1) and anti- (M2) inflammatory macrophages (immunohistochemistry), crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining), as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor ((U-13C)palmitate) infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (IC50(palmitate)f).

Eligibility Criteria:
Inclusion criteria:

1. Age 18-65 years
2. Insulin resistant (Homeostasis Model Assessment (HOMA) Insulin Resistance (IR) ≥2.6)

Exclusion criteria:

1. Current use of omega-3 nutritional supplements
2. Fasting plasma glucose ≥126 mg/dL
3. Active coronary artery disease
4. Participation in structured exercise (\>2 times per week for 30 minutes or longer)
5. Smoking
6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
7. Renal failure (serum creatinine \> 1.5mg/dl)
8. Chronic active liver disease (AST\>144 IU/L and alanine transaminase (ALT)\>165 IU/L)
9. Anti-coagulant therapy (warfarin/heparin)
10. International normalized ratio (INR) \>3
11. Use of systemic glucocorticoids
12. Chronic use of NSAIDS or aspirin
13. Pregnancy or breastfeeding
14. Alcohol consumption greater than 2 glasses/day
15. Hypothyroidism
16. Fish or shellfish allergy
Video Feedback Versus Verbal Feedback

The long term goal of our research is to develop a curriculum for Obstetrics and Gynecology resident physicians that regularly employs use of video assessment to improve surgical skills. Regular use of video feedback may enable improved self-assessment and allow for formal documentation of proficiency. The overall objective is to compare the use of video feedback to use of structured verbal feedback in the simulated task of laparoscopic vaginal cuff closure.


Eligibility Criteria:
Inclusion Criteria:

* Resident Physician in the Department of Obstetrics and Gynecology

Exclusion Criteria:

* Not a resident physician in the Department of Obstetrics and Gynecology
Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin

Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of co-administered drugs

Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics / pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years.
* A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria:

* Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel, digoxin or aspirin)
* Clinically relevant abnormal medical history that could interfere with the objectives of the study.
* A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
* A subject whose lab test results are as follows; Platelet count or PT, aPTT \< 0.9 x lower limit of reference range of \> 1.1 x upper limit of reference range.
* A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
* Clinically significant abnormal findings of ECG during screening test.
* Presence or history of drug abuse or positive result in urine drug screening test.
* Participation in other clinical trial within 2 months before first dose.
* Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
* Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
* Use of grapefruit juice within 1 week before first dose.
* Blood donation during 2 months or apheresis during 1 month before the study.
* Use of alcohol over 21 units/weeks
* Smoking of more than 10 cigarettes/days within 3 months before first dose.
* Subject judged not eligible for study participation by investigator.
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia surgery
3. Male or female
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Not suitable for nasal spray
2. Subjects who had received general anesthesia
3. Subjects with a history of myocardial infarction or unstable angina pectoris
4. Subjects with atrioventricular block or cardiac insufficiency
5. Subjects with a history of ischemic stroke or transient ischemic attack
6. Subjects with poor blood pressure control after medication
7. Subjects with abnormal clotting function
8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
9. Subjects with a history or possibility of a difficult airway
10. Subject with a history of substance abuse and drug abuse
11. Adrenoceptor agonists or antagonists were used before randomization
12. Abnormal values in the laboratory
13. Thyroid dysfunction
14. Allergic to a drug ingredient or component
15. Pregnant or nursing women
16. No birth control during the specified period of time
17. Participated in clinical trials of other drugs (received experimental drugs)
18. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination

Exclusion Criteria:

* Significant hypoxemia on room air
* Hemodynamic instability
* Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
* Refractory cough
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy
Computational Assessment of Bioprosthetic Aortic Valve Function

Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root.

The implantation of a bioprosthetic valve is the established surgical technique when replacing the aortic valve to treat various aortic valve diseases. Many different bioprosthetic valves are available. The design and implantation technique in each system would result in different interaction with the left ventricular outflow tract (LVOT) and the aortic root, leading to different flow profiles that may induce platelet aggregation and affect the long-term performance of the bioprosthesis and its durability. Additionally, complications such as valve thrombosis may occur. However, it is not currently clear which bioprostheses/patients are more prone to thrombosis or degradation of the valve. This study aims to develop fluid-structure interaction (FSI) models, which can model blood flow and wall/valve mechanics, using realistic patient-specific geometries and flow conditions which correlate with the true performance of the valve in the imaged patients, and to assess and compare such performances to understand the benefits and challenges with various bioprosthetic valves.

FSI models combine computational fluid mechanics (CFD) with structural wall mechanics modelling. This is an alternative approach that allows detailed assessment of flow patterns and estimation of wall shear stress and pressure within blood vessels, and therefore has been applied increasingly to gain better insights into the hemodynamics in cardiovascular diseases

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years or over.
* Patients diagnosed with aortic valve disease, and scheduled to undergo Edwards Magna Ease or Intuity Elite and free of exclusion criteria below.
* The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
* The patient must agree to comply with the study imaging protocol as required at prespecified times.

Exclusion Criteria:

* Inability to provide valid informed consent.
* Male and female patients aged \< 18 years of age.
* Contraindications for CT angiography: renal failure (Cr\>250 μmol/L or eGFR\<30 mL/min) due to the additional risk of contrast medium nephrotoxicity or allergy to iodine.
* Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding.
* History of cardiac pacing device insertion, or any other MRI incompatible device implants.