cyrilzakka/clinical-trials huggingface dataset:
Ginkgo Biloba Prevention Trial in Older Individuals

This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.

Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Non-demented participants
* Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
* English is their usual language
* Willing informant who has frequent contact with the participant

Exclusion Criteria:

* Currently on anticoagulant therapy
* Cancer diagnosed and treated within the past two years (except for skin cancer)
* Participant with class III - IV congestive heart failure
* Currently being treated with psychopharmacological drugs for depression
* Hospitalized for depression within the last year
* Taking Aricept (or similar agents) for cognitive problems or dementia
* Baseline blood creatinine \>2
* Baseline SGGT is a marker of liver function (3 x normal\>or=90 IU)
* Baseline hematocrit\<30
* Baseline white blood count\>or=15,000
Imiquimod for Preventing Keloid Recurrence

This is an open-label, single-arm, pilot study on the effects of topical imiquimod treatment in preventing keloid recurrence after surgical excision. Keloids are abnormal scars that form in certain genetically predisposed individuals following trauma to the skin. They can be physically disabling and cause social impairment. Many therapies have been proposed and trialed for the permanent removal of keloids, but they all have limited efficacy. Topical imiquimod therapy has been reported to decrease keloid recurrence following keloidectomy in human patients. Given all previous reports of adjuvant imiquimod therapy to keloidectomy initiated imiquimod therapy after keloidectomy, the investigators would like to test the efficacy of topical imiquimod pre-treatment in preventing keloid recurrence after surgical excision. Therefore, the investigators are initiating an open-label pilot study of 10 patients age 18 or greater with keloids on the trunk and extremities excluding the groin and hands and feet who present to the dermatology clinic for standard of care keloid excision. Key exclusion criteria include vulnerable populations, immunocompromised state, hypersensitivity to study drug components, and keloids outside of specified areas. The main study intervention will be 6 weeks of treatment with topical 5% imiquimod cream, starting 1 week prior to surgical excision.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Men and women who present clinically with keloids requesting excision
* Any number of keloids
* Keloid no larger than 5cm in diameter at the base
* Clinical findings consistent with keloid formation
* Location of keloid in low-risk areas - areas other than above the neck, hands, feet, or groin
* Able and willing to give informed consent

Exclusion Criteria:

* Age \< 18
* Hypersensitivity to Imiquimod or to any of the excipients (methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, and stearyl alcohol)
* Involvement in a trial of another experimental intervention within 30 days
* Life threatening disease
* Use of immunosuppressive medications such as oral corticosteroids
* Bleeding disorders
* Not available for follow-up for 10 weeks
* Pregnant, intention to become pregnant during treatment phase of trial, or breastfeeding
Spinal Cord Injury Series of Tampere - Retrospective Study

This prospective study will assess thoroughly functional deficits and their significance in the light of rehabilitation in spinal cord injured patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of spinal cord injury
Artificial Intelligence Enables Precision Diagnosis of Cervical Cytology Grades and Cervical Cancer

Cervical cancer, the fourth most common cancer globally and the fourth leading cause of cancer-related deaths, can be effectively prevented through early screening. Detecting precancerous cervical lesions and halting their progression in a timely manner is crucial. However, accurate screening platforms for early detection of cervical cancer are needed. Therefore, it is urgent to develop an Artificial Intelligence Cervical Cancer Screening (AICS) system for diagnosing cervical cytology grades and cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women Aged 25-65 years old.
2. Availability of confirmed diagnostic results of the cervical liquid-based cytological examination, and satisfactory digital images from the liquid-based cytology pap test: at least 5000 uncovered and observable squamous epithelial cells, samples with abnormal cells (atypical squamous cells or atypical glandular cells and above).

Exclusion Criteria:

1. Unsatisfactory samples of cervical liquid-based cytological examination: less than 5000 uncovered, observable squamous epithelial cells, and more than 75% of squamous epithelial cells affected because of blood, inflammatory cells, epithelial cells over-overlapping, poor fixation, excessive drying, or contamination of unknown components.
2. Women diagnosed with other malignant tumors other than cervical cancer.
The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction

The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.

Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.

Eligibility Criteria:
Inclusion Criteria:

* a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
* anatomical nasolacrimal duct obstruction

Exclusion Criteria:

* previous probing
* glaucoma
* trauma
* lid malpositions
* craniofacial anomalies
* congenital mucocele of the nasolacrimal sac
Perception of Electrical Stimuli in Individuals with Stroke

To successfully manipulate objects in one's surroundings, such as when lifting a cup, one must accurately perceive their physical interactions. This includes accurately interpreting the tactile cues arising at one's fingertips when touching an object. Currently, tactile perception is assessed in individuals with stroke using passive protocols. Research has yet to explore whether activating one's muscles impacts the tactile perceptual process in individuals with stroke despite previous research demonstrating the effect of muscle activation on tactile perception in individuals who are neurologically intact. The proposed research will be the first to address the impact of muscle activation, in addition to stroke, on tactile perception. As such, the proposed research is significant for advancing our understanding of the extent to which tactile deficits occur in individuals with stroke, particularly during volitional movement.

Participants will detect an externally-applied electrical stimulus at their fingertip with the elbow: 1) relaxed and flexed to 2) 25% and 3) 50% of their maximum voluntary torque (MVT). We will compare the detection threshold for these three conditions between each arm of participants with stroke and similarly-aged controls. Based on pilot data, we hypothesize that the detection threshold will be largest at the paretic arm when flexing to 50% MVT due to the greatest inhibition of sensory signals. Findings will indicate whether stroke negatively impacts an individual's ability to detect tactile stimuli during volitional sensorimotor tasks.

Eligibility Criteria:
Inclusion Criteria:

* For the participants with stroke, i) a single unilateral cortical lesion that took place at least one year prior and ii) an absence of comorbid neurological impairments
* Ability to understand and complete the experimental tasks
* Capacity to provide informed consent
* At least 18 years of age

Exclusion Criteria:

* Major injury to either arm
* Sensory neuropathy
The ROVO Study: Radial Optic Neurotomy for CVO

The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity \< 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.

Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Onset of CVO not longer than 12 months
* On FLA 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 Snellen,or 3. perfused with no improvement of visual acuity over 4 weeks)

Exclusion Criteria:

* • Dense cataract\* (grade 3 and 4) which precludes judgement of the fundus.

  * Pregnancy
  * Allergy against Fluoresceine or Indocyanine green
  * Unable to come for follow up visit
  * Presence of other severe retinopathy or
  * Presence of advanced optic atrophy or uncontrolled glaucoma.
  * Visual acuity higher than 0.5 Snellen.
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are:

Question 1: the microbiome difference of the biofilm between IBS and healthy patients.

Question 2: the metabolic product patterns between IBS and healthy patients.

Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination.

Researchers will compare the IBS and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.


Eligibility Criteria:
Inclusion Criteria:

* IBS patients with IV type; no abdominal surgery;

Exclusion Criteria:

* age \<18 y;
* major disease;
* alcoholic addicted;
* antibiotic use in past 3 months;
* severe gastrointestinal disease
* severe cardiac disease;
* pregnant;
* ICU in past 1 year;
* vegeterian;
* immune disease (SLE etc.)
* mental disease;
Computer Assisted Total Knee Replacement

The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.

Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Eligibility Criteria:
Study participants must:

1. Be over 18 years of age.
2. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
3. The subject has given consent to the transfer of his/her information to the sponsor.
Cholinergic Nicotinic Receptors and Cognition in PD

Mild cognitive impairment and dementia are frequent non-motor complications of moderate to advanced Parkinson's disease. Brain positron emission tomography (PET) study findings confirm post-mortem evidence that cholinergic loss is related to cognitive impairment in Parkinson's disease. However, current cholinergic augmentation therapy is not always effective and it should only target those Parkinson's disease patients who have evidence of cholinergic system impairment. The objective of this study is to study the association of a particular subtype of cholinergic receptors, so-called nicotinic acetylcholine receptors, with cognition in Parkinson's disease using a novel PET marker of cholinergic system integrity.

Parkinson's disease patients will undergo nicotinic acetylcholine receptor PET imaging with the radioligand \[18F\]flubatine and MRI on one day and extensive neuropsychological testing on another day. The degree of nicotinic receptor expression obtained with PET imaging will be correlated with the neuropsychology test results.

Positive \[18F\]flubatine PET findings in this study would establish nicotinic receptors as an important contributor to cognitive dysfunction in Parkinson's disease and could kindle pharmaceutical interest in pursuing these agents for Parkinson's disease applications.

We expect that lower nicotinic receptor expression is associated with impaired cognitive functioning in Parkinson's disease. In a personalized medicine approach the PET radioligand \[18F\]flubatine could serve as an important marker to identify those patients who are expected to benefit most from nicotinic receptor drug treatment.

Eligibility Criteria:
Inclusion criteria:

* PD subjects (M/F, non-smoking, ≥ 50 years old, Hoehn \& Yahr stages 1-4)
* Normal control subjects (N=15, M/F, non-smoking, ≥ 50 years old)

Exclusion Criteria:

* Active smoking, use of other tobacco products, or use of nicotinic drugs such as nicotine patches or varenicline.
* Subjects with contra-indications to MR imaging, including pacemakers or claustrophobia.
* Evidence of large vessel stroke or mass lesion on MRI.
* Use of (anti-)cholinergic or neuroleptic drugs.
* Dementia or severe cognitive impairment confirmed by clinical and detailed neuropsychological assessment precluding safe study participation, performing study procedures, or unable to follow directions by study personnel.
* Evidence of atypical parkinsonism on neurological exam.
* Subjects limited by participation in research procedures involving ionizing radiation.
* Pregnancy (test within 48 hours of each PET session) or breastfeeding
Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Hyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders.

Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown.

The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes.

The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.


Eligibility Criteria:
Inclusion Criteria:

SAH group :

* Adults
* Hospitalized in the neurological intensive care unit for a Fisher modified aneurysmal SAH 3 or 4 with EVD and urinary catheter.
* With a catheter (arterial or venous) for repeated sampling.

Control group :

* Adults
* Performing a perfusion test in the operating room for normal pressure hydrocephalus

Exclusion Criteria:

* Patients with SAH without EVD.
* Patients with non-aneurysmal SAH.
* Pregnant or breastfeeding women.
* Patients under legal protection, guardianship, curatorship, safeguard of justice.
* Patients participating in a study that may interfere with the present study.
* Persons under forced psychiatric care.
Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

The purpose of this study is to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.

Functional dyspepsia is a common clinical disorder with significant impact on quality of life and with enormous social cost. Previous studies have revealed that functional dyspepsia is not a homogenous disease but a heterogenous symptom complex. Because of heterogeneity in etiology and pathogenesis, no specific treatment is appropriate for all patients with functional dyspepsia. Currently available treatments demonstrated efficacy only in subsets of patients.

Appropriate subgrouping of functional dyspepsia, which categorizes more homogenous patients into the same group, will correlate better with specific etiologic factors and pathogenetic mechanisms. Consequently patients may have appropriate specific treatment based on more directed pathologenesis and subgrouping. To this end, American Gastroenterology Association launched new edition of clinical guide for functional gastrointestinal disorder, the Rome III in May 2006. The new diagnostic criteria of Rome III de-emphasized functional dyspepsia as an entity and recommended sub-classification into two conditions: postprandial distress syndrome and epigastric pain syndrome. However whether this new diagnostic criteria and systems are effective and clinically relevant remains unknown.

Aims:

We aim to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.

Eligibility Criteria:
Inclusion Criteria:

* aged greater than 20 years
* fulfill Rome III diagnostic criteria

Exclusion Criteria:

* children and teenagers aged less than 20 years
* Organic lesions such as ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy
* concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria
* diagnosis of organic disease for dyspeptic symptoms by treating physicians
* history of abdominal surgery
* concurrent user of aspirin and NSAID
* history of allergy or severe side effects to lansoparzole
* pregnant or lactating women
NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

Postoperative neurocognitive disorders (NCD) are of high priority in perioperative management. The risk of suffering from NCD after surgery may be increased due to perioperative impairment of cerebrovascular autoregulation and thereby inadequate cerebral perfusion. Cerebrovascular autoregulation refers to the ability of cerebral arterioles to ensure constant cerebral blood flow independently of fluctuations in systemic blood pressure.

Cerebrovascular autoregulation can be measured based on mean arterial pressure (MAP) and a surrogate for cerebral blood flow using the correlation method. Until today, measurement of cerebral blood flow velocity assessed with transcranial Doppler sonography (TCD) is most commonly used as a non-invasive surrogate for cerebral blood flow. Alternatively, cerebral oxygenation measured with near-infrared spectroscopy (NIRS) can be used as another surrogate.

The study includes three substudies:

1. To compare NIRS and TCD for the assessment of perioperative cerebrovascular autoregulation in patients undergoing major non-cardiac surgery with an increased risk of bleeding.
2. To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
3. To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Elective surgery with a minimum duration of 120 minutes
* General anesthesia
* expected blood loss \> 500 ml

Exclusion Criteria:

* Temporal bone window failure
* Cerebrovascular disease
* Cardiac surgery
* Neurosurgery