cyrilzakka/clinical-trials huggingface dataset:
Melatonin Decreases Eye Pressure in Normotensive Patients

Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases intraocular pressures when given depressive patients.

Melatonin has been shown to be effective to decrease intraocular pressure in experimental animal researches. Agomelatine is a melatonin derivative drug approved for the treatment of depression, which is also available in our country. Depending on animal experiments, it can be assumed that agomelatine can decrease intraocular pressure. Demonstrating that agomelatine is effective to reduce eye pressure may give a concurrent treatment of depressive patients with glaucoma. With this it may be possible to treat both diseases at the same time with single drug. In this study, the researchers intended to investigate the changes in ocular tension in normotensive depressive patients treated with agomelatine.

Eligibility Criteria:
Inclusion Criteria:

* Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.

Exclusion Criteria:

- Any past history of ocular surgery, ocular trauma or existing ocular diseases
Effect of Modified Stylet Angulation on the Intubation With GlideScope®

The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.

The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring endotracheal intubation for general anesthesia

Exclusion Criteria:

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Fragile teeth
* Contraindication for videolaryngoscope
* Head and neck surgery
Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.

Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
* Willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery

Exclusion Criteria:

* Pregnant
* Unable to understand English
* Mentally impaired
* Incarcerated
* Has nonlinear closures
Ultrasound Guided Intercostobrachial Nerve Block

The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators compare a proximal and a more distal approach to the nerve referred to onset time, sensory blocked area and duration.

The participants will be randomized into two groups:

Group one receives a modified PECS 2 (thoracic wall) block above the second intercostal space with injection between the Musculus serratus anterior and Musculus pectoralis minor.

Group 2 receives a subpectoral block under the pectoralis major muscle at the medial boarder of the axillary triangle.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for vascular access surgery of the upper arm
* surgery planned under regional anaesthesia

Exclusion Criteria:

* patients refusal
* age under 18
* allergy against local anaesthetics
* polyneuropathies
Initial Assessment of the Effect of the Addition of Disulfiram (Antabuse) to Standard Chemotherapy in Lung Cancer

Recent studies in laboratory animals demonstrate the ability of disulfiram to significantly inhibit the growth and metastasis of a mouse model of lung cancer. Work with cells in vitro support the idea that this inhibition is mainly due to the inhibition of angiogenesis - the formation of new blood vessels in the tumor. Furthermore, it was found out that the best effect has been obtained when disulfiram has been used not at the highest dose but at an optimal dose, which is smaller. Thus, this trial will assess the addition of disulfiram to chemotherapy in non-small cell lung cancer (NSCLCA).

Metastatic non small cell lung cancer remains a deadly disease with median survival times of several months. Any treatment which can prolong patients' survival without causing severe side effects is of course an important addition to our limited arsenal in the fight against this disease. A recent article by Marikowsky and colleagues extended significantly our knowledge regarding the possible activity of disulfiram (well known in its commercial name Antabuse) as an anticancer agent (Marikowsky et al Int J of cancer 97 :34 2002). In this article it was demonstrated that disulfiram has potent antitumor activity and that it can act as a significant inhbitor of angiogenesis.

Since disulfiram has been well tolerated by thousands of patients, and there are observations that anti angiogenic therapy enhances the effect of chemotherapy (for example bevacizumab in combination with chemotherapy in colon carcinoma) we decided to conduct a clinical trial assessing the effect of the addition of this drug at moderate doses to chemotherapy which is used as one of the standard therapies in lung cancer. In order to obtain information regarding the effect of the addition of this drug, only 50% of the patients will be treated with the drug and the rest will be treated with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic non-small cell lung cancer
* Previously untreated
* ECOG performance status (PS) 0-1
* Liver function tests within the norm

Exclusion Criteria:

* Over 18
* Willingness to abstain from alcohol
* Not pregnant
* Without a psychiatric history
Analysis of Procedural Times Using Colpassist for Robotic-Assisted Sacrocolpopexy; a Randomized Controlled Trial

The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning device during robotic-assisted sacrocolpopexy.

The purpose of this research study is to evaluate the efficiency of the Colpassist (Boston Scientific, Natick, MA) vaginal positioning device used during robotic-assisted sacrocolpopexy. Traditionally, vaginal positioning during robotic-assisted sacrocolpopexy is done using a device that was not designed specifically for sacrocolpopexy, commonly a vaginally placed endo anal sizer. It is possible the Colpassist device will result in shorter operative times because Colpassist is flat which makes it easier to sew against. Also, the width of the device is designed to be similar to the width of the vagina which should improve visibility during surgery.

Enrolled patients will be randomized to undergo their planned robotic-assisted sacrocolpopexy using either a vaginally placed endo anal sizer or a vaginally placed Colpassist vaginal positioning device. Both surgeon and patient will be blinded to which device was used at the time of surgery. Length of time to complete each step of the sacral colpoexy that involves use of a vaginal positioning device (dissection of the anterior and posterior vaginal walls, attachment of anterior and posterior vaginal mesh, attachment of sacral mesh) will be recorded during the surgery to measure operative efficiency. Surgeon and surgical-assistant satisfaction will be recorded with each device.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Planned robotic-assisted sacrocolpopexy
* English speaking
* Prior hysterectomy (either total or supra-cervical)

Exclusion Criteria:

* Age less than 18 years old
* Non-English speaking
* Pregnant women, or women desiring future pregnancy
* Planned concomitant hysterectomy
MANTA Registry for Vascular Large-bore Closure

The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.


Eligibility Criteria:
Per MANTA VCD Instructions for Use (IFU)
Taenia Solium Control Case Study in Zambia

Summary Diseases due to T. solium and soil transmitted helminths (STHs) are of cosmopolitan distribution and strongly linked with poor sanitation and poverty. These infections are to a great extent perpetuated by open defecation (OD). Community-Led Total Sanitation (CLTS) is an approach in which people in rural communities are facilitated to do their own appraisal and analysis, come to their own conclusions, and take their own actions. To date no rigorous study has been conducted to evaluate the impact of CLTS on the transmission of taeniasis/cysticercosis or STHs, despite the worldwide acclaim which CLTS has received as an approach to improve sanitation. The overall aim of the study is to contribute to the reduction and subsequent control of T. solium and STH infections through the implementation of CLTS approaches in 1 districts in the Eastern Province of Zambia. By using CLTS it is hypothesised that toilet acquisition and usage will be increased with a resultant reduction in OD which will in turn reduce the transmission of T. solium and STH infections in the district. This will be measured by porcine/human cysticercosis prevalence (serological test) and STH infections in humans (quantitative coprological test).

The study procedure will consist of conducting a pilot study with census to establish the sample frame, shortly followed by a baseline survey during which baseline data on human cysticercosis, porcine cysticercosis (serological test), STH infection prevalence (quantitative coprological test) and anthropometric data (weight, height, arm circumference) will be obtained from the study communities (infected people will receive treatment). The study communities will be subsequently randomly allocated a status of intervention or control community, and this will determine the point at which CLTS will be administered, but all communities will ultimately receive CLTS. CLTS will be conducted in intervention communities for 12 months by UNICEF. A post-intervention survey will follow the 12 month CLTS campaign, and all factors investigated at baseline will be revisited in both intervention and control communities. The compliance of the CLTS approach will also be measured. CLTS will be administered to control communities after the completion of the post-intervention survey. Baseline data will be used to show that the groups are comparable; in the primary analysis the difference between intervention and control at follow up will be analyzed to evaluate the impact of CLTS. If this intervention can be demonstrated to have an impact on the occurrence and burden of sanitation-linked diseases, then this will provide advocacy for such an approach at policy-maker level.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to collaborate
* Accessible by road all year round, even during the wet season
* No current promotion of water, sanitation or hygiene programs
* Rural setting
* Minimum of 10 pig-keeping households (HHs)
* Maximum of 100 HHs

Exclusion Criteria:

* Other ongoing sanitation programmes
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.

This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age
* Body mass index of 19-30 kg/m2 at screening
* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
* If subject is male, he must agree to reduce the risk of a female partner becoming pregnant

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinically significant medical condition or observed abnormalities
* Clinically significant illness within 30 days of the first study drug administration
* History of opioid dependence
* Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
* Positive resolut for any serology test performed at screening
* Use of alcohol-, caffeine-, or xanthine-containing products
* Tobacco use within 90 days before the first study drug administration
* Participation in a clinical trial within 30 days before screening
* Requirement of a special diet other than vegetarian, or significant food allergy or intolerance
rTMS for Cognitive Rehabilitation After TBI

A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for use in depression and migraine. It is under investigation for use in a number of other neurologic and psychiatric disorders. In addition to its potential to improve affective symptoms, recent research has suggested that TMS targeted to select cortical regions can also improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a course of stimulation of the parietal area improved objective measures of learning and memory. Among persons with TBI, there have been case reports supporting improvement in cognitive function and postconcussive symptoms; however, there have not yet been any controlled studies of TMS for TBI-related cognitive dysfunction.

Subjects with a history of TBI will be recruited into this double-blind, sham controlled, crossover with washout study design. Study will involve one week (5 consecutive days) of treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold will determine level of stimulation, and active rTMS stimulation will occur of the right DLPFC. Subjects will be paid for their time.

Eligibility Criteria:
Inclusion Criteria:

1. one or more mild to moderate TBIs\*;
2. at least one year but no more than 20 years from worst injury;
3. ability to complete cognitive and neurophysiological testing;
4. available for duration of study;
5. between 18 and 65 years of age;
6. mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale

Exclusion Criteria:

1. severe or penetrating TBI;
2. history of psychotic or manic illness;
3. history of intracranial surgery;
4. history of skull fracture;
5. history of seizures in candidate or candidate's family
6. ferrous metallic implants or implantable medical device;
7. medications that are known to reduce seizure threshold;
8. pregnancy.
9. history of multiple sclerosis, stroke, brain tumor, epilepsy
The Effects of a Carotenoid Intervention on Cognitive Function

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Eligibility Criteria:
Inclusion Criteria:

* visual acuity correctable to 20:40 or better, Snellen notation
* able to swallow a dietary supplement
* free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale

Exclusion Criteria:

* GI conditions that interfere with lipid absorption
* presence of or past diagnosis of age-related macular degeneration
* visual acuity poorer than 20:40, Snellen notation
* has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months
* presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale
Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18 or older
* Hereditary colorectal cancer syndrome with one of the following:

  * Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
  * Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)

Exclusion Criteria:

* Unable to provide informed consent for testing
* Unable to complete English language questionnaire
* Receiving active chemotherapy
* Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
* No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
* No history of inflammatory colitis (Crohn's disease or ulcerative colitis)
Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults

The purpose of the study was to determine the effects of growth hormone and an insulin sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants received a combination of two drugs: (1) recombinant human growth hormone (or its placebo) and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar levels of participants before and after 40 weeks of treatment.

Treatment with recombinant human growth hormone (GH) has been shown to reduce visceral adipose tissue (VAT) and improve insulin sensitivity in normoglycemic adults, but glucose levels may rise transiently. Pioglitazone, a thiazolidinedione (TZD) drug, counters the short-term diabetogenic effect of GH in rodents, but combined use of these drugs has not been evaluated in humans.

The purpose of this study was to determine the effects of GH and a TZD, alone and in combination, on glucose metabolism, visceral adiposity and insulin sensitivity in abdominally obese adults with impaired glucose tolerance. The hypothesis that combined treatment attenuates GH-induced increases in glucose concentrations, reduces VAT, and improves insulin sensitivity over time was tested. Sixty-two adults received GH and pioglitazone for 40 weeks in a double-blind, randomized, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years
* BMI \> 27 kg/m2
* Waist circumference \>100 cm for men and \> 88 cm for women
* Impaired glucose tolerance (documented by a 75 gram OGTT)

Exclusion Criteria:

* Diabetes mellitus
* Malignancy
* Premenopausal women who are breastfeeding or decline contraception
* Congestive heart failure
* ALT \> 3 times upper normal limit
Perspectives Patient Education Randomized Study

This is a randomized clinical trial evaluating the educational program called My Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.


Eligibility Criteria:
Inclusion Criteria:

1. received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during a hospitalization for the PCI procedure,
2. were greater than 50 years old (funding agency requirement),
3. spoke and understood English.

Exclusion Criteria:

1. inability to give informed consent
2. allergy to aspirin
Does educatıonal Escape Game Affect Students' motıvatıon, academıc Self-effıcacy and Success Levels: a quası-experımental Study

This is a semi-experimental study. The study aimed to examine the effects of an educational escape game on students' motivation, academic self-efficacy and achievement levels. Students studying in an elderly care program will be included in the study. Students will be divided into 2 groups according to their branches: experimental (educational escape game) and control (question-answer).

H1. Students participating in the escape game will show significantly higher motivation in the "Motivation Scale for Teaching Materials" than students participating in the question-answer method.

H2. Students participating in the escape game will show significantly higher self-efficacy in the "Academic Self-Efficacy Scale" than students participating in the question-answer method.

H3. Students participating in the escape game will show significantly higher success in the "Achievement Test" than students participating in the question-answer method.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Receiving education in an elderly care program,
* Not having previously taken the "Elderly Care Principles and Practices I" and "Elderly Care Principles and Practices II" courses,
* Providing attendance during data collection processes.
* Having a phone and internet that can enter Google forms.

Exclusion Criteria:

* Being under 18 years of age,
* Not cooperating,
* Having previously taken the "Elderly Care Principles and Practices I" and "Elderly Care Principles and Practices II" courses,
* Being absent.