cyrilzakka/clinical-trials huggingface dataset:
Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery

Patients presenting intra-abdominal abcesses following bariatric surgery complicated by fistulae are classically treated by external drainage and endoprosthesis or surgical redo. Morbidity and mortality being increased in case of necrotic collections, an endoscopic debridement treatment might be proposed in certain cases. This present study aim to review the evolution of the patients treated by this method from 2007 to 2011 in the investigators institution.

This retrospective study in an academic tertiary center will review the files of patients who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks . The decision for endoscopic treatment was made by the medico-surgical team in charge of this type of surgery, who had to weigh the high risk of mortality in case of re-intervention, along with endoscopic access to abscesses via the transluminal or percutaneous route based on abdominal imaging.

Data collection will lead to the evaluation of the technical success rate, the clinical success and potential complications.

Eligibility Criteria:
Inclusion Criteria:

* All the patient treated in an academic tertiary center who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks from october 2007 to April 2011
* septic state

Exclusion Criteria:

* All other necrosectomies performed for pancreatic disorders were excluded from the study
Randomized Clinical Trial of Bifocal Lenses Versus Computer-specific Progressive Addition Lenses

This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO Computer Lenses for persons using a computer. We hypothesize that lenses specially designed for computer use may allow more comfortable and productive work on a computer.

This is a research study designed to test the utility of D-shaped bifocal lenses and PRIO Computer Lenses for persons using a computer. These are different types of eyeglass lenses and are commonly used when performing computer work. D-shaped bifocal lenses are designed for general purpose use and PRIO Computer Lenses are progressive addition lenses designed for using a computer and are not useful for driving or other tasks requiring clear distance vision. The study will examine how much work a subject completes during a 2-hr visit to the laboratory (productivity) and how a subject feels when working (symptoms). The UAB Department of Optometry sponsors this research study. Interested individuals must be at least 40 years of age and have relatively good vision in each eye when wearing glasses and to do at least 4-hrs of computer work per workday. There are no other restrictions to enter the study.

Participating subjects will be provided one of two different types of lenses and a choice of eyeglass frames. All subjects will be required to use the pair of glasses provided for all computer work for a period of 4 months. During the fourth and eighth weeks of this period, subjects will be required to complete three short surveys over the phone (10 questions) a day for five days (morning, noon and afternoon) on how the glasses affect their work on a computer and how they feel. These surveys should take about 5 minutes or less to complete. During the fifth or sixth week, subjects would be required to visit the laboratory at the School of Optometry to do 2-hours of editing tasks on a computer and complete the same short survey before beginning and after finishing. Participants would be called once a week to confirm that they are wearing the glasses. These calls would last about 2-3 minutes or less.

Upon qualifying for the study, subjects will be randomly (like the flip of a coin) assigned by a computer to receive either the bifocal lenses or the variable focus computer glasses. This will be a single-blind study, which means that neither your doctors completing the survey and the on-site visit will not be informed which type of glasses the subject is using.

The following periodic measurements will be made during the study: visual and upper extremity comfort (surveys) and productivity (editing task). Subjects will be asked to return to the clinic for 1 2-hr visit. At each visit subjects will be asked if they have experienced any undesirable reactions and how they are tolerating the glasses.

Eligibility Criteria:
Inclusion Criteria:

* 40 yrs of age or greater
* 20/40 or better corrected visual acuity in each eye
* 4 hrs or more of computer use per workday

Exclusion Criteria:

* None
Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= +20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 100 ml (\<= 4 weeks prior to administration or during the trial)
* Excessive physical activities (\<= 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range or clinical relevance
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?

during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change \& blood loss is estimated and will compared.

All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted.

nephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.

Eligibility Criteria:
Inclusion Criteria:

* renal stones\>2 cm

Exclusion Criteria:

* coagulopathy, congenital anomalies, active Urinary tract infections
Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.

Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18-75 years old
2. PSA \>1 ng/ml but \<15 ng/ml
3. Negative DRE
4. Signed informed consent

Exclusion Criteria:

1. Previous prostate biopsy or prostate surgery
2. Previous prostate mpMRI
3. Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
4. Patients in the Texas Department of Criminal Justice (prisoners)
5. Patients with acute urinary symptoms including urinary retention and urinary tract infection
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).


Eligibility Criteria:
* Inclusion Criteria

  1. Provide written informed consent prior to any study-related procedures.
  2. Are 18 years of age or older.
  3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
  4. Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.

Exclusion Criteria:

1. Unanesthetized Schirmer test score in either eye \<2 mm/5 minutes at Visit 1.
2. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
3. Have corneal erosive disease (e.g., confluent staining \[National Eye Institute (NEI) grade 4\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
4. Have a history of glaucoma or intraocular pressure (IOP) \>25 mmHg at Visit 1 or a history of elevated IOP (\>25 mmHg) in either eye.
5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke

Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.

The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation

INTRODUCTION

Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.

The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .

OBJECTIVE

To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health

METHODS

The investigators will recruited 20 chronic stroke patients presenting with stiff knee gait. The patients will be randomly assigned to a surgical group treated by rectus femoris tenotomy (10 patients) and to a medical group treated by rectus femoris botulinum toxin A injections.

Patients will be assessed before treatment, 2 months and 6 months after treatment by an assessor blinded therapist among the 3 domains of the International Classification of Functioning Disability and Health

PERSPECTIVE

The investigator hope to demonstrate the effectiveness of the rectus femoris tenotomy as a treatment of stiff knee gait after stroke

Eligibility Criteria:
Inclusion Criteria:

* stroke lasting for more than 6 months
* stiff knee gait
* rectus femoris spasticity (\> Ashworth 2)
* transient improvement with previous botulinum toxine A injection in the rectus femoris
* stiff knee gait improved after rectus femoris diagnostic motor nere block
* able to walk on treadmill

Exclusion Criteria:

* pregnant women
* botulinum toxin A injections in the rectus femoris \< 6 months
* previous surgery for stiff knee gait
CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study

The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.

The CHAAMP Internal Pilot is a pilot and feasibility study conducted to evaluate the feasibility of the trial methods before a full-scale screening effort is launched. Black and/or African American adults 30 years of age or older residing in Charlotte or surrounding area will be screened for MGUS over one-year period with a target enrollment of 1665 participants. Individuals screening positive for monoclonal gammopathy will be provided a clinic referral for further diagnostic evaluation to confirm MGUS, SMM, or other PCD-related disorder, and will be given the opportunity to consent for the Longitudinal portion of the study. Participants diagnosed with MGUS and smoldering multiple myeloma will be prospectively followed for 10 years per protocol. Participants diagnosed with other plasma cell disorders will have their diagnosis and baseline data captured in the registry and followed for overall survival only.

Eligibility Criteria:
SCREENING Inclusion Criteria:

* Self-identify as Black and/or African American
* Age 30 years or older at the time of consent
* Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately
* Reside in Charlotte, NC, or the surrounding area, based on self-report

SCREENING Exclusion Criteria:

* Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.

LONGITUDINAL Inclusion Criteria:

* Test positive for monoclonal gammopathy during screening portion of the study
* Consent to the longitudinal portion of the study

LONGITUDINAL Exclusion Criteria:

* The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.
Lexical Tone Perception in Tone language--a fMRI Study

Tone language refers to a language that uses fixed pitch pattern to distinguish words (Yip, 2002). Understanding the functional anatomy of the brain during lexical tone processing will provide useful hints for an effective intervention strategy such as brain stimulation. The present study investigate the cortical organisation of the brain in lexical tone perception of Cantonese speakers by the use of functional magnetic resonance imaging (fMRI).

Tone language refers to a language that uses fixed pitch pattern to distinguish words (Yip, 2002). Cantonese is one of the main tone languages spoken by over 70 million around the world (Li et al.,1995; Adolfsson, 2010). Individuals with significant hearing impairment often present great difficulty in tone perception, affecting their understanding of words and hence, hamper their overall communication. The poor tone perception persists even with intensive auditory training coupled with advanced hearing technology such as cochlear implants.

Understanding the functional anatomy of the brain during lexical tone processing will provide useful hints for an effective intervention strategy such as brain stimulation. Researchers have been investigating the neural basis for tone perception in the past decades but failing to come to a consensus on the location of the brain that is responsible for lexical tone processing. The discrepant results may be due to the fact of the differences in subject selection (animals, healthy adults, brain-injured patients, tonal-language and non-tonal language speakers), testing materials and tasks employed (linguistic versus non-linguistic stimuli; dichotic listening versus discrimination and identification tasks) and outcome measurements (performance score, reaction time, accuracy rate, PET scan and fMRI).

Cortical organization, or brain mapping, refers to functional anatomy of the brain. The present study is the first study to systematically investigate the cortical organization of the brain in lexical tone perception of Cantonese speakers by the use of functional magnetic resonance imaging (fMRI). A comprehensive set of auditory stimuli specifically for investigating the different levels of lexical tone processing will be constructed. Native Cantonese speakers with normal hearing were recruited. They underwent fMRI while listening to the carefully designed auditory stimuli.

Once the cortical organization of lexical tone processing in Cantonese is identified, the valuable findings could be applied in further brain intervention procedures to tackle the long lasting, unresolved tone perception difficulty encountered by people with hearing impairment or other related disorders.

Eligibility Criteria:
Inclusion Criteria:

* native Cantonese speaker
* right-handed
* normal hearing
* no reported of neurological disorder

Exclusion Criteria:

* neurological disorder
* left-handed
* hearing impairment
Research Framework Exploring Sleep Health

This is a digital health study in which participants are recruited to collect sleep and activity data from digital activity trackers. We are also collecting survey/questionnaire data on baseline health and sleep characteristics as well as bi-weekly assessments of sleep quality and mood. Overall, we aim to examine how sleep relates to physical and mental health in a large population of activity tracker users.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Residing within the United States
* Ability to use the REFRESH app on the participant's own smartphone device

Exclusion Criteria:

* In-ability to consent
Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.

This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.

Recombinant anti-tumor and anti-virus protein for injection, 10μg,im,3 times for the first week, followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week. Treatment continued until the patient died or had unacceptable toxicity or had disease progression or required to discontinue the treatment. At the time of disease progression, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with recombinant anti-tumor and anti-virus protein for injection,but only survival follow-up datas will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Have been fully aware of the study and voluntarily signed the informed consent.
* At least 18 years old.
* Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), the pathology must meet one of the following criteria: (a) primary site of lung or thymus (carcinoid) with mitotic count of ≤ 10/10 High Power Field \[HPF\]) (b) other primary site (including primary unknown) with mitotic count of ≤ 20/10 High Power Field \[HPF\] and Ki67 index of ≤ 20%，or with Ki67 index of \> 20% and well-differentiated.
* Patients who have failed standard treatment or are unable to receive standard treatment, and have disease progression within the past 12 months;
* At least one measurable lesion according to the RECIST 1.1 criteria that has not been previously locally treated.
* ECOG performance status 0, 1 or 2.
* Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Prior treatment with Recombinant Anti-tumor and Anti-virus Protein for Injection.
* Prior treatment with Interferon.
* Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
* Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
* Patient who were allergic to Interferon-α or who had interferon-α antibody.
* Have brain metastases or previous history of brain metastases or history of seizures.
Detection of Helicobacter Pylori in Ulcerative Colitis Patients

Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.

Several bacterial and viral agents may have a role in the aetiology of IBD. In theory, H. pylori infection could be involved in IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ulcerative colitis

Exclusion Criteria:

* Other diagnosis