cyrilzakka/clinical-trials huggingface dataset:
Pilocarpine and Brimonidine in Patients With Monofocal Lenses

The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.

This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).

Eligibility Criteria:
Inclusion Criteria:

* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.

Exclusion Criteria:

* Individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. Patients using contact lenses.
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk equal to or above 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
Treatment of Calcium Deficiency in Young Women

This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.

This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.

Eligibility Criteria:
Inclusion Criteria:

* Women in good health
* Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13

Exclusion Criteria:

* Smoking
* Pregnancy
* Lactation
* Endocrine disease
Sevoflurane and Propofol Anesthesia on Postoperative Delirium

Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson \& Eiseman, 2008; Deiner \& Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status classification (ASA_PS) class I-III
* Aged 60 years or above
* Elective major surgery under general anesthesia

Exclusion Criteria:

* ASA_PS\>=IV
* Aged under 60 yr old
* Body mass index (BMI) \>30
* Neurologic disease
* Cardiac surgery and neurologic surgery
* Anticonvulsant drugs
* Chronic analgesics intake
* Participating in the investigation of another study
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis

The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing hemodialysis therapy
* Both sex

Exclusion Criteria:

* Less than 18 years old
* Patient has central vascular access
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.

This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75, male or unpregnant women
* Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI
* Native coronary artery target lesion
* Target lesion length \<=60mm, target lesion vessel diameter 2.25mm-4.0mm
* Target lesion diameter stenosis\>=70%
* For each target lesion, Firehawk stent implantation only
* Understand the study purpose, willing to participate and sign the letter of consent
* Acceptance of clinical follow-up

Exclusion Criteria:

* Acute MI within 72 hours
* Unprotected LM and intervention-required three-vessel lesions
* Calcified lesion failed in pre-dilation and twisted lesion
* Bridge vessel lesion
* Any stent implanted within one year
* Severe heart failure (HYHA\>=III) or LVEF\<40%
* Renal deficiency, blood creatinine \> 2.0mg/dl
* Bleeding tendency
* Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal
* Life expectation \<12 months
* History of not achieving study finish
* No compliances to the protocol
* Heart implantation subjects
Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones

When conventional endoscopic treatment of bile duct stones is impossible or fails, advanced endoscopy assisted lithotripsy can be performed by electrohydraulic lithotripsy (EHL), laser lithotripsy, or extracorporeal shock wave lithotripsy (ESWL). No systematic review has compared efficacy and safety between these techniques.

Extracorporeal shock wave lithotripsy (ESWL) and Laser Lithotripsy (LL) have emerged as alternate treatment options for difficult common bile duct (CBD) stones. There is limited data on efficacy and safety of the latest Dornier delta III lithotripter. This study examined the efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate, number of sessions required and safety in a large cohort of patients.

The initial lithotripter models used electrohydraulic energy and required general anesthesia, prone positioning, and water immersion. High clearance rates were reported, but newer models were then developed with use of electromagnetic coils, better focussing, use of a water cushion instead of water immersion, use of ultrasound and then later of digitalised X ray for localisation. The ductal clearance of ESWL is upto 90%. Known complications of this procedure are cholangitis and pancreatitis which occur at the rate of 9-14% apart from minor adverse effects such as pain and local hematoma formation. In a single randomised study that compared intracorporeal lithotripsy(ILL) versus extracorporeal lithotripsy, ILL was found more effective than ESWL in terms of stone clearance rate and treatment duration. However, the lithotripters used in the previous studies were of previous generations, and also commonly used for kidney stones as well. The current study is the first to use the Dornier delta III for the same.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stones that could not be extracted by conventional methods such as biliary sphincterotomy, balloon, basket or mechanical lithotripsy.
* Patients with biliary stones larger than 15mm.
* Intrahepatic or cystic duct stones.

Exclusion Criteria:

* Pregnancy.
* Coagulopathy which cannot be corrected.
* Ongoing cholangitis.
Physical Performance and 3D Shoulder Kinematics of Asymptomatic Unilateral/Bilateral Overhead Athletes and Non-athletes

This study compares the performance and 3-dimensional shoulder kinematics between sides in unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers) and non-athletes during two physical performance measures of the upper extremity, one in an open kinetic chain position (unilateral seated shot put test) and the other in a closed kinetic chain position (upper quarter Y balance test)

3-dimensional shoulder kinematics (e.g., scapular angular position/displacement) at key events of each test will be described and compared across sides and groups. For the unilateral seated shot put test, the events are based on humeral motion: a) initiation of humeral motion, b) maximal humeral flexion, c) end of humeral motion. For the upper quarter Y balance test the events are the a) initiation of free hand motion on "GO", b) maximal reach on the medial direction, c) maximal reach on superolateral direction, and d) maximal reach on the inferolateral direction (kinematics measured on the stance upper extremity). The best of 3 maximal-effort trials on each side will be used for analysis. Warm-up exercises and two submaximal practice trials will be performed for preparation for maximal efforts and familiarization with the tests. A rest period of at least one minute between trials will be given to guarantee good physiological conditions to maximally perform. Further resting time will be allowed, if necessary, upon request of the participant.

Eligibility Criteria:
Inclusion Criteria:

* Perform at least 150 degrees of arm elevation

Exclusion Criteria:

* history of shoulder dislocation
* surgery in the upper extremity ≥ 6 months
* injury in the past month
* evident abnormalities in posture and movement of the upper body quadrant
* pain at the time of testing
Self-Care Management in Older Adults

Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with achronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate thecompliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The researchwas planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronicdiseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will bedeveloped for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being in the 60-79 age group,
* Having a chronic disease that requires constant monitoring and treatment
* Using at least one medication for your disease regularly
* Having smart phone usage skills

Exclusion Criteria:

* Having vision and hearing problems
* Being 80 or older
* Having a neuro-psychiatric disease
Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial

Contamination of implant abutments could potentially influence the peri-implant tissue inflammatory response. The aim of the present study was to assess the radiographic bone changes around customized, platform switched, abutments placed according to the "one-abutment-one-time" protocol, with and without plasma of argon cleaning treatment.

After technical procedures, presence of contaminants (mostly Titanium wear micro-particles, Carbon and Aluminum traces due to lubricant used during customization) on the whole abutment surface, the internal connection and the screw can be found, even after the usually cleaning steps (steaming).

Such debris, present at titanium/connective-bone tissues interface (gingival portion of the abutment), could directly or indirectly deleteriously influence the inflammatory response on the peri-implant tissues.

Plasma of Argon cleaning treatment was demonstrated to have a double effect on titanium abutments: removal of pollutions following customization and increase of cell adhesion. Additionally, Plasma of Argon demonstrated very potent anti-biofilm activity. This prospective, match paired, triple-blinded randomized controlled trial was aimed to test if plasma treatment of customized abutments can affect radiographic peri-implant marginal bone level changes after 5 years of prosthetic loading.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, previously treated for periodontal disease according to a comprehensive treatment strategy,25 requiring a single implant-supported restoration in the anterior maxilla or premolar region with the presence of mesial and distal tooth.
* Bone crest allowing the insertion of a 4 mm platform implant without further bone augmentation procedures and with thin (≤ 1 mm) gingival biotype, measured by previously reported protocol.

Exclusion Criteria:

* no relevant medical conditions;
* non-smoker or smoking ≤ 10 cigarettes/day;
* plaque Index and bleeding on probing ≤ 25 %;
* impossibility of follow-up for 5 years after prosthetic loading;
* pregnant and lactating patients;
* patients with a history of bisphosphonate therapy;
* presence of sites with acute infections.
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.

Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).

Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.


Eligibility Criteria:
Inclusion Criteria:

1. Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) \>18 years.
2. 18-75 yr both male and female
3. Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
4. Healthy adult family member of the patient will be taken as a control.

Exclusion Criteria:

* Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
* Active gastrointestinal bleeding
* Intracranial bleeding
* Multi-organ failure (\>2) on mechanical ventilation
* SOFA score \>2
* On high inotropic support
* Paralytic ileus
* Pregnancy
* Hepatocellular Carcinoma
* Antibiotic,probiotic within last 3 months
Exercise Type That Faster Reduces Postprandial Glycemia.

It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.

Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.

Participants will undergo in a cross-over randomized fashion the following trials:

1. Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
2. Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
3. Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).
4. No exercise, followed by an oral glucose tolerance test (OGTT).

Eligibility Criteria:
Inclusion Criteria:

* Participant must be capable and willing to provide consent, understand, instructions and protocols.
* Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.

Exclusion Criteria:

* Smokers
* Pregnancy
* Any non-controlled medical condition which could influence results or could be worsened by exercise
Cognitive Behavioral Therapy for Depression in Parkinson's Disease

The purpose of this pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to depressive symptoms. This is the first time that this treatment has been used in a group setting for depression in PD.

Target population is patients in the Movement Disorders Clinic at Oregon Health \& Science University who have Parkinson's disease and mild to moderate depression.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease, mild to moderate depression, seen at Oregon Health \& Science University

Exclusion Criteria:

* Suicidal
* Cognitive impairment with MOCA \<26
Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged \<40 years and in 54% of patients aged \>60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery.

Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed.

The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability .
* Symptoms \> 3 months
* Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility)

Exclusion Criteria:

* Revision surgery
* Cervical pathology
* Adhesive capsulitis
* Multi-tendon tears
* Concomitant upper limb pathology (eg: arthritis, nerve compression)
* Infection
* Previous fracture
* Instability
* Pregnancy and lactation
* Professional athlete
* Worker's compensation or compensable claim
* Substance abuse or current mental illness
* Smoker
* Adverse reaction to bovine derived products