cyrilzakka/clinical-trials huggingface dataset:
Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Silicone oil has been used as a surgical tool in complicated retinal detachment surgery. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. Silicone oil emulsification is one of the complication that may result in severe sequels that are difficult to treat. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. This prospective study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of complicated retinal detachment associated with advanced proliferative vitreoretinopathy. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. These complications may occur during surgery and after the surgery. Silicone oil emulsification is one of the complication that may result in severe sequels including band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat. The commonly used silicone oil includes low viscosity and high viscosity type. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. Retrospective medical review of these patients using 1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes, as well as complication rates including emulsification, were similar in both groups. To the best of authors' knowledge, there has been no prospective study on this subject. This study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
* Age ≥ 18 years
* Sign informed consent form

Exclusion Criteria:

* Inflammatory eye diseases i.e. uveitis
* Corneal scar
* History of scleral buckling procedure
* History of using surfactant drugs
* Glaucoma
Pregnancy Chances in Classic Galactosemia

With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
* Eighteen years of age or older
* Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
* Capable of giving informed consent

Exclusion Criteria:

* Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
Sleep Behavior and Rest-activity Circadian Rhythm (RAR) in Hip/Knee Prosthesis

The consequences of chronically insufficient sleep are both behavioral and medical. . Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization The aim of the present study is to evaluate the changes inrest-activity circadian rhythm (RAR) and objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

The National Health and Nutrition Examination Survey found that 22% of the US population reported 6 h of sleep or less and another 15% registered 5 h of sleep or less per 24 h (1). The consequences of chronically insufficient sleep are both behavioral and medical. Quantity and quality of sleep represent important factors for the quality of life, which can have positive or negative influence on individual health (2-4). Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization (5,6) Such patients experience acute postsurgical pain and discomfort, including restriction of their leg movement to prevent dislocation of the hip implant in the acute stage. The results of previous post-surgery studies have shown that REM sleep was severely reduced and awake time increased on the first postoperative night compared with the preoperative night (7,8).It is necessary for patients to secure the appropriate amount and quality of sleep to facilitate recuperation after surgery. Sleep disturbance is also related to the presence of delirium. The aim of the present study is to evaluate the changes in objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Male of female subjects aged between 50 and 80 years old.
* Knee or Hip Arthroplasty at IRCCS Galeazzi Orthopedic Institute.
* Cognitively intact
* Inclusion in the rehabilitation program within the Orthopedic Specialist Rehabilitation Unit of IRCCS Galeazzi Orthopedic Institute.
* Informed signed consent.

Exclusion Criteria:

* Cancer history.
* Body Mass Index \< 18.5 e \> 40.0.
* Melaton consumption.
* Previous clinical sleep disorders.
PASS MIS® Post-market Clinical Follow-up

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

Eligibility Criteria:
Inclusion Criteria:

* Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
* Patient \> 18years
* Patient with a mature skeleton
* Patient able to understand the protocol and the planning visit
* Patient able to complete a self-administered questionnaire
* Patient who have signed the informed consent form

Exclusion Criteria:

* Patient presenting other medical indication than thoracolumbar fracture
* Patient unable or who refuse to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
* Patient who need to receive or who received an open procedure
* Patient who has been not implanted with the PASS MIS® system
* Pregnant women or intending to get pregnant within the next 2 years after the surgery
* Patient with contra-indications to do radiographies
* Local infectious state
* Allergy or intolerance to the materials, suspected or known
* Any contra-indications present in the notice of the product
Efficacy of Drug and Risk Behavior Counseling Intervention Among Injecting Drug Users at Opioid Substitution Treatment

Behavior drug and risk reduction counseling (BDRC), a structured, non-intense, cognitive-behavioral approach intervention designed to increase methadone maintenance treatment retention and reduce drug use and related risk behaviors among IDUs.

Techniques of the Cognitive Behavior Therapy combined with drug dependence psychoeducation was developed by research team. BDRC consists of 12 sessions, including an initial session, 3 drug education sesssions, psychosocial counseling and behavioral skills. This initial session is designed to introduce the counselor, review the purpose and expectations of counseling, review the rules of confidentiality, agree on attendance times and rescheduling rules, and to begin to collect information from the participant on their drug use and risk behaviors. Behavioral contracting is a key component to this counseling approach. Drug education focuses on how heroin may influence patients' cognitive function and their HIV/HCV risk behaviors. Counseling and behavior skills trained patients to reflect their thoughts and learned new life skills in order to delay or abstrain from heroin use.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in opioid substitution treatment
* Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
* 20 or more years of age
* Meets ICD-10 criteria for opiates dependence with physiologic features
* Agrees to keep bi-weekly appointments if selected
* Current address within Taipei and Keelung, and not planning to move
* Willingness and ability to give informed consent and otherwise participate
* Provision of adequate locator information

Exclusion Criteria:

* Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder
* Advanced neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make hazardous patient's ability to participate
* Physiologically dependent on alcohol, benzodiazepines or other sedative type drugs
* Concurrent participation in another treatment study
* Planning to enter inpatient or residential treatment within next year
* Pending legal charges with likely incarceration within next 12 months
An Open Label Study of Oral Enzastaurin in Participants With Cancer

This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.

The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.


Eligibility Criteria:
Inclusion Criteria:

* You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study.
* You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer.
* You must have lesions (areas of cancer in your body) that your doctor can either measure or detect.
* You either must not be able to become pregnant, (because you've had surgery \["tubes tied" or hysterectomy\], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
* You can be either male or female, and must be at least 18 years old.

Exclusion Criteria:

* You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial).
* You must not be pregnant or breastfeeding.
* You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.)
* You must not have another serious disorder, including active infections that will interfere with your participation in the study.
* You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers

The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.

This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent.
* With or without dry eye.
* Willing to discontinue contact lenses during the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Chronic, recurrent, or severe inflammatory eye disease.
* Ocular trauma within the past 6 months.
* Ocular hypertension or glaucoma.
* History of punctal plug/canalicular stent insertion.
* Other protocol-defined exclusion criteria may apply.
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.

Kidney stones affect 9% individuals within the United States, and the prevalence is increasing. Over the last few decades, ureteroscopy has become the most commonly performed stone procedure. However the complication rate after ureteroscopy is not insignificant. Reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization.

A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. The rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. On the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. Additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use.

The clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. Prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed \~15 years ago. Surgical techniques and device innovations have changed the procedure since that time. To date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. In addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

Eligibility Criteria:
Inclusion Criteria:

* nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy

Exclusion Criteria:

* age \< 18 years
* pregnancy status
* ureteral stone
* preoperative hydronephrosis
* indwelling nephrostomy tube
* planning bilateral ureteroscopy or subsequent staged ureteroscopy
* solitary kidney or eGFR \<60 mL/min (CKD stage 3 or greater)
* variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction
Assessment of Vitamin D Supplementation and Immune Function

Hypothesis:

Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose vitamin D supplements (400 IU per day).

Specific Aim 1:

Determine if high dose vitamin D supplements decrease the production of proinflammatory and increase the production of regulatory cytokines and chemokines by innate immune cells stimulated ex vivo.

Specific Aim 2:

Determine if high dose vitamin D supplements decrease serum markers of inflammation and increase serum and cellular levels of defensive molecules (e.g., cathelicidin).

Specific Aim 3:

Determine if high dose vitamin D supplements decrease blood levels of proinflammatory T-helper type 1 (Th1) and Th17 cells and increase levels of anti-inflammatory T-regulatory (Treg) and Th2 cells.

Specific Aim 4:

Determine if high dose vitamin D supplements increase antigen specific T cell and B cell responses after tetanus vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-49 (men) and 20-45 (women)
* BMI 18.5-30
* Serum 25OH Vitamin D 25-50 nmol/L

Exclusion Criteria:

* Pregnant or nursing women
* Daily smoker
* Anemia (Hgb\<12 mg/dL for women and \<13 mg/dL for men) determined at initial visit
* Any report or diagnosis of disease or chronic condition that may affect vitamin D absorption such as cystic fibrosis, celiac disease, surgical removal of part of the stomach or intestines, and some forms of liver disease
* Diagnosis of hyper parathyroidism and chronic granulomatous disease, which increases risk of hypercalcemia.
* Planned to travel to a location at which either altitude or latitude would result in significant vitamin D synthesis during the study period.
* Not previously vaccinated with TT, or vaccinated within five years
* Use of steroids or antibiotics within the past 4 weeks
* Current use of nutritional supplements that may alter immune function such as omega 3 fatty acid supplements
* Current use of anti-inflammatory or anti-convulsion medications
* Self reported history of significant adverse response to previous vaccinations
The Therapeutic Effect of Different Doses of Capecitabine

To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.Different administration regimens of capecitabine were given, and the treatment course was appropriately extended. The therapeutic effect and incidence of adverse reactions were observed.

To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.The control group was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose group and 1,500 mg/m2 capecitabine for the low-dose group. Afterward, the response rate, quality of life, and adverse reactions of the three groups were collected for comparison.

Eligibility Criteria:
Inclusion Criteria:

* According to the diagnostic criteria for colon cancer in the Consensus on Screening, Diagnosis and Treatment of Early Colorectal Cancer and Precancerous Lesions in China , colon cancer was confirmed by pathology
* TNM(tumor node metastasis) clinical stage was III or IV
* Predicted survival period \> 3 months

Exclusion Criteria:

* Patients with heart, liver, kidney and other important organ failure and contraindications to chemotherapy
* Patients who received other anti-tumor therapy before admission
* The disease progressed rapidly and could not be successfully completed by this researcher
* Allergic to related drugs
Increasing Serrated Polyp Detection With a Brief Awareness Training

In this non-randomized controlled trial, a semi-random group of Dutch endoscopist receive an oral training about the significance of serrated polyps. The primary aim of this training is to improve the endoscopist's awareness of the significance of serrated polyps, ultimately leading to increased detection. In addition, a random group of endoscopists that will not receive this training will be used as a reference group.

Data will be collected as part of routine care within the Nationwide Dutch Bowel cancer screening program. The serrated polyp detectionrate of each endoscopist will be extracted from anonymized data that will be prospectively collected as part of routine care within the Dutch Nationwide bowel cancer screening program. Data will be anonymized and provided by Rijksinstituut voor Volksgezondheid en Milieu (RIVM) and ScreenIT.


Eligibility Criteria:
Inclusion criteria:

- Endoscopists accredited to perform colonoscopies within the Dutch Nationwide colorectal cancer screening program

Exclusion criteria:

- Absent during both training sessions while employed in one of the trained hospitals
Personalized Feedback Intervention for Latinx Drinkers With Anxiety

The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety.

In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI). In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI). Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.

Eligibility Criteria:
Inclusion Criteria:

* Being between the age of 21 to 75 years of age
* Being self-identified as Latinx or Hispanic
* Fluent in Spanish
* Meeting criteria for current hazardous drinking pattern
* Meeting criteria for clinical anxiety
* Being able to provide written, informed consent

Exclusion Criteria:

* Being involved in alcohol or other substance use program
* Currently pregnant
* Current engagement in psychotherapy for anxiety