cyrilzakka/clinical-trials huggingface dataset:
Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve head (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure. The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments are designed to improve the investigators' knowledge of the physiology of regulatory mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow abnormalities in glaucoma. This is of importance, because there is an increased evidence, that vascular dysregulation plays a role in the development of glaucomatous damage.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults

Recent evidence has shown that transcutaneous electrical nerve stimulation (TENS) was effective in improving the cognitive function in healthy adult and people with dementia. However, lacking of evidence investigated the effect of TENS in improving the cognitive function and reversing the occurrence of dementia during the period of mild cognitive impairment (MCI), which is the crucial period to prevent the significant loss of cognition function. Therefore, the main objective of this study is to investigate the optimal TENS treatment protocol in improving the cognitive function in older adults with MCI.

This study aims to investigate the effectiveness of 3 intervention protocols (1) In the T1 TENS group, the subject will receive TENS on T1 spine. (2) In the vagus nerve TENS group, the subject will receive TENS on the concha of left outer ear. (3) In the sham stimulation group, the subject will receive sham stimulation on the T1 spine, in improving the cognitive function in older adults with MCI.

Eligibility Criteria:
Inclusion Criteria:

Should fulfil the diagnosis criteria of MCI (Albert et al., 2011):

1. Concern regarding a change in cognition
2. Impairment in one or more cognitive domains
3. Preservation of independence in functional abilities
4. no signs of dementia were to be present and confirmed by the medical staff and medical records.

Exclusion Criteria:

1. If their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders;
2. Having active implants, such as cochlear implants, pacemaker;
3. Having wounds and diseased skin on the electrode position.
A Peer E-mentoring Intervention to Improve Employment

Despite the strong business case of hiring people with disabilities, a significant proportion of youth with disabilities leave high school and neither work nor continue their education and are unprepared to meet the demands of a work environment. Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from, or have limited access to school and community vocational programs. One encouraging approach to address gaps in vocational programming is through peer mentoring, which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. The purpose of this study is to develop, implement and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-efficacy, career maturity and social support.

Our primary OBJECTIVE is: (1) to develop, implement and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-efficacy, career maturity and social support.

A mixed methods feasibility randomized controlled trial design will be conducted to develop and assess the usability of "Empowering youth towards Employment" intervention. Youth (aged 15-25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (12-week, interactive intervention, moderated by peer mentors). A qualitative thematic analysis will be conducted to analyze the content of discussion forums. Interviews with youth, parents and mentors will also be conducted about their experiences in the intervention.

Eligibility Criteria:
Inclusion criteria for youth participants:

* Able to read/write in English;
* A diagnosed physical disability (i.e., cerebral palsy, muscular dystrophy, spinal cord injury etc.); (4) currently enrolled in or have completed a high school diploma in the applied / academic stream (to screen for cognitive impairment);
* Aged 15-25;
* Have access to a computer and internet;
* Have no paid work experience.

Inclusion criteria for Parents:

* Are the parent of a youth meeting above inclusion criteria
* Can read/write in English
* Have access to a computer with Internet

Exclusion Criteria:

* Recently completed or currently participating in another employment readiness or peer support intervention.
Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome

This is a placebo-controlled clinical trial to assess the utility of Guanfacine Extended Release (GXR) in the management of patients with Prader Willi Syndrome (PWS) who have significant aggression or self-injury. The purpose of this trial is to establish the safety of GXR with a specific focus on metabolic effects.

Prader-Willi syndrome is a genetic disorder due to loss of function of specific genes. In newborns, symptoms include weak muscles, poor feeding, and slow development. Beginning in childhood, the person becomes constantly hungry, which often leads to obesity and type 2 diabetes. Also, mild to moderate learning disability and behavioral problems are typical.

Guanfacine Extended Release (GXR), the investigational drug in this study would be the first study to evaluate the drug in patients with Prader Willi Syndrome. "Investigational" means it is not approved by the Food and Drug Administration (FDA) to treat Prader Willi Syndrome. However, Guanfacine Extended Released (GXR) is an FDA approved drug used to treat children and adolescents with hypertension and attention deficit hyperactivity disorder (ADHD). GXR is thought to respond to parts of the brain that lead to strengthening working memory, reducing distraction, improving attention and impulse control. GXR is generally considered safe for children as long as it is used according to the dosing instructions (up to 4mg) of a qualified medical professional.

Eligibility Criteria:
Inclusion Criteria:

* 6 and 35 years of age
* diagnosis of PWS confirmed by genetic testing.
* rating of moderate or above on the Clinical Global Impression- Severity Scale will be required for entry.

Exclusion Criteria:

* Subjects with a positive pregnancy test, swallowing difficulty, and/or presenting with active psychosis or mania will be excluded.
* Individuals with pre-existing, clinically significant bradycardia (\< 8 years: \<64 bpm; 8 to 12 years: \<59 bpm; 12 to 16 years: \<53 bpm) or hypotension, defined as 5th percentile for height and gender,26 will be excluded from the study.
* Subjects receiving antipsychotic medications due to a documented history of psychosis or bipolar disorder will be allowed to continue taking the medication without dosage modification.
* Growth hormone, thyroid hormone replacement treatment, and non-psychiatric medicines will be allowed to continue.
* N-Acetyl Cysteine and anticonvulsant medication (only if prescribed for seizures) will be allowed to continue, with specific instructions to not make any dosage changes during the clinical trial.
The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects

Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Males aged 45-85 years
* \>60% of the voiding volume is above 100 ml per voiding verified by a urinary diary
* Able to read write and understand given instructions

Exclusion Criteria:

* Patients practicing CIC
* Ongoing symptomatic UTI
* Known Neurological Disease that is affecting the bladder function
* Known past or present alcohol or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrolment or randomisation of treatment in the present study.
* Suspected poor compliance based on less than 80 % compliance to voiding diary
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* On alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment
* Clinic flow below 100 ml
The Effect of Prioritization of Attentional Allocation on Postural-suprapostural Tasking

Postural-suprapostural task is defined as postural control takes place while at least one other concurrent task is being performed, and appropriate locus of attentional allocation is considered a critical factor for successful postural-suprapostural execution. Recent studies have indicated that the behavior performance of postural-suprapostural task would be affected by the prioritization of attentional allocation (postural-first vs. suprapostural-first); however, the inference of the appropriateness of attention prioritization is primarily limited to behavior observations and lacks direct neural evidences. How the effect of attentional priority between postural and suprapostural tasks on postural-suprapostural performance and its underlying cortical mechanism is rarely understood. By adopting postural-first and suprapostural-first strategies for postural-suprapostural task, the purpose of this 2-year research project is to 1) investigate the differences in performance quality and intrinsic neural mechanisms effect of a postural-suprapostural task for healthy adults with the analysis of event-related potential (ERP) and non-linear dynamics of behavior measures; 2) investigate brain plastic changes and the appropriateness of strategy use. In the first year, the attention prioritization effect on reciprocity of a postural-suprapostural task will be characterized by integrating the results of behavior performance and ERP causal connectivity with a special focus on validation of prevailing theoretical models. In the second year, the difference of task fluent for learning a postural-suprapostural task with postural-first/suprapostural-first strategy will be studied through the spatial and time variations in alpha rhythm after principle component analysis. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and motor suprapostural tasks, but to optimize treatment strategy for patients with balance or multi-tasking disturbances.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults without neuromuscular / cardiovascular disease

Exclusion Criteria:

* pregnant women
Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?

The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo

In order to conduct this study, the internal and external validation were considered.

The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery.

Anesthesic technique:

Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican

Post-operation prescription:

NPO util well awake, then free according to patient´s tolerance If nausea/vomit: metoclopramide 10mg IV If pain: dipyrone 1g IV qid If pain is intense: morphine 3mg IV 3/3 h If pain persists: morphine 1mg h/h

After hospital discharge:

If pain: sodium diclofenac 50mg tid

Eligibility Criteria:
Inclusion Criteria:

* All patients schedule for laparoscopic tubal ligation

Exclusion Criteria:

* Not willing to consent
* Use of analgesic within 12 hours prior the surgery
* Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer

The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.

The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
* Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
* Age range 18-70 years old
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

Previous serious cardiac disease

* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Chronic inflammatory bowel disease or intestinal obstruction
* Serious uncontrolled diseases and intercurrent infection
Intraoperative Tumor Margin Identification With ICG Dye Imaging

In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.

If you are present for a preoperative clinic visit the day before your surgery, ICG may be administered via injection. Otherwise, ICG will be administered in the preoperative unit via IV injection at the time of presentation approximately 4 hours before your surgery. You will be monitored during and after ICG dosing.

During surgery ICG fluorescence using a near-infrared imager will be performed at the time of and immediately following primary tumor resection. The imager will evaluate the primary tumor to ensure appropriate tumor fluorescence. Once the primary resection is complete and the surgeon believes that he/she has achieved negative or planned positive margins, fluorescence measurements of the tumor bed will be performed. If areas of positive signal remain, these areas will be resected if possible and sent to pathology for histologic evaluation. It will be recorded if the surgeon perceived negative margins but the device detected positive margins.

Tumor specimens and residual fluorescence positive samples will be evaluated using fresh frozen and permanent histology. Permanent samples will be evaluated for tumor and local fluorescence using confocal microscopy with an ICG cube. Positive fluorescence signal and its correspondence with neoplasm will be noted, a will tumor that does not fluoresce.

Tissue being removed is 1-2 mm from non-structurally important tissue that either has or does not have signal positivity for additional pathologic assessment. It should have no impact on patient outcome, does not represent intervention on sensitive areas (such as neurovascular structures), and can further be used as potential margin around the tumor.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.

Exclusion Criteria:

* Pregnant or nursing patients
* Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis)
* Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to complete.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
* Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
* Have a serum creatinine value within normal limits at screening
* Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
* Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
* Are women who are pregnant or lactating
* Have an abnormal blood pressure for the population as determined by the investigator
* Have renal insufficiency or major renal disorders
* Have proliferative retinopathy or maculopathy
* Have lipodystrophy
* Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
* Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
* Have a fasting triglycerides value \> 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
* Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
* Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
* Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
* Regular use or intended use of non-selective beta blockers
* Regular use or intended use of monoamine oxidase (MAO) inhibitors
* Are currently participating in a weight loss program or plan to do so during the course of the study
* Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
* Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries

The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.

The registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the current Instructions for Use (IFU) and followed clinically for 2 years.

Total enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion revascularization at 12 months.

The primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.

Eligibility Criteria:
Inclusion Criteria:

* ≥19 years of age
* Rutherford Clinical Category ≥4
* Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up
* Stenotic or obstructive vascular lesions in femoropopliteal artery(s)
* Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current IFU
* At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter)

Exclusion Criteria:

* Patient is currently participating in an active phase of another investigational drug or device study
* Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast
* Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion