cyrilzakka/clinical-trials huggingface dataset:
Examining a Text Message Intervention for Smoking Cessation

The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of treatment) and both 3 and 6 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35
* Current daily smoker
* Has a cell phone with text messaging capability
* Uses text messaging at least once monthly
* Interested in quitting smoking
* Willing to set a quit date within the next 30 days
* Has access to a physician

Exclusion Criteria:

* Does not read and speak English with adequate comprehension
* Is currently participating in a smoking cessation program
* Concurrent drug/alcohol abuse
* Mental health issues that would interfere with study compliance
The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients

The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed.


Eligibility Criteria:
Inclusion Criteria:

* ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994)

Exclusion Criteria:

-
Neuromodulation Effects in Older Adults

The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control

The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task.

The investigators will test the following hypotheses:

1. Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions.
2. Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham.

The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-95 years
* Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)
* Able to receive electrical stimulation
* Adequate motor capacity to participate in intervention and training sessions

Exclusion Criteria:

* Contraindications to MRI recording
* Left-handed
* Inability to communicate in English
* History of neurological/psychiatric disorders and traumatic brain injury
* Incidence of stroke
* Severe visual and hearing impairment precluding completion of study assessments
The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare self-reported comfort during each section of the pelvic exam and how comfort during the examinations related to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age with chronic vulvovaginal conditions.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center

Exclusion Criteria:

* Non English Speaking
* Patients who cannot read or write
* Those who are pregnant
* Those who do not have a chronic vulvovaginal condition
* Patients other than "new" patients
* Patients who would not otherwise need a speculum exam
Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis

This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* willing to adhere to protocol
* premenopausal
* positive Candida microscopy and/or culture
* at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner

Exclusion Criteria:

* vaginal use of any products 1 week or less before randomization
* use of oral or local antimycotic treatment 1 week or less before randomization
* unprotected sexual contact 24 hours preceding randomization
* vaginal douching 24 hours preceding randomization
* patient does not agree to participate in the study
The Long Term Outcomes After Pull-through of Long Segment Hirschsprung Disease

Hirschsprung disease (HSCR) is characterized by the absence of ganglion cells (aganglionosis) in the distal bowel extending proximally for varying distances that results in persistent spasm in the affected bowel and functional intestinal obstruction. Patients can be classified as rectosigmoid HSCR when aganglionosis confined to the rectosigmoid and long-segment or total colonic HSCR when aganglionosis extends beyond the upper sigmoid. Aganglionosis of long-segment HSCR can extend to the descending colon, transverse colon, ascending colon, but not to the terminal ileum. To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair for long-segment HSCR. In general, a pull-through with standard of care for the intestine and mesentery, which avoids excessive resection of the colon and coloanal reconstruction, is performed for long-segment HSCR.There are reports that a significant percentage of long-segment HSCR patients continue to have difficulty with soiling and incontinence,however there were also reports long-segment HSCR patients have the same continece as rectosigmoid HSCR.The outcome of long-segment HSCR should be thoroughly evaluated. The present study was designed to evaluate the long-term outcomes of long-segment HSCR.

Hirschsprung disease (HSCR) is characterized by the absence of ganglion cells (aganglionosis) in the distal bowel extending proximally for varying distances that results in persistent spasm in the affected bowel and functional intestinal obstruction. Patients can be classified as rectosigmoid HSCR when aganglionosis confined to the rectosigmoid and long-segment or total colonic HSCR when aganglionosis extends beyond the upper sigmoid. Aganglionosis of long-segment HSCR can extend to the descending colon, transverse colon, ascending colon, but not to the terminal ileum. To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair for long-segment HSCR. In general, a pull-through with standard of care for the intestine and mesentery, which avoids excessive resection of the colon and coloanal reconstruction, is performed for long-segment HSCR.There are reports that a significant percentage of long-segment HSCR patients continue to have difficulty with soiling and incontinence,however there were also reports long-segment HSCR patients have the same continece as rectosigmoid HSCR.The outcome of long-segment HSCR should be thoroughly evaluated. The present study was designed to evaluate the long-term outcomes of long-segment HSCR.

The long-term outcome would be indicated by bowel function SCORE.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Hirschsprung disease Must be performed with the operation of pull-through Must be followed up more than 3 years

Exclusion Criteria:

Clinical diagnosis of Down syndrome Clinical diagnosis of tolal colonic Hirschsprung disease Clinical diagnosis of degestive malformation except Hirschsprung disease
Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating; they have bloating and have stomach pain. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

All patients who have completed study ITOFD04-03 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the 8 week double-blind study ITOFD04-03
* Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion Criteria:

* Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry
A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION)

To determine if the investigators are able to deliver highly focused, intense radiation to tumours in the abdominal region or chest cavity whilst limiting the dose to surrounding organs using a high field strength MR-Linac.

Stereotactic Ablative Radiotherapy (SABR) for tumours in the thorax and abdomen is becoming the standard of care for patients with small, localised disease. Recent publications and guidelines provide evidence for safe, effective treatment prescriptions in most of these tumour sites. However this guidance is based on the use of x-ray based guidance systems, without the use of functional imaging or real-time adaptation. To investigate the potential benefits of MRI-guided SABR, including superior at-treatment imaging, gating, real-time adaptation and the integration of functional or biological information, the investigators propose to undertake MR-guided SABR using established guidance. In doing this the investigators will be able to evaluate the patient experience (for example the MR Linac is considerably noisier than a standard treatment machine); the investigators will be able to acquire images (with no additional radiation) to interrogate motion, and deformations in real-time to assess whether or not real time adaptations would benefit the patient experience and/or outcomes; the investigators will be able to compare the outcomes of the patients treated on a machine with superior imaging to those undergoing the same (or similar) treatment on standard machines using the UKCAT database; the investigators will be able (should participants choose to give consent) to acquire research images interrogating tumour and normal tissue physiology/biology and determine if and how this information may be able to improve treatments and/or predict response. For these reasons it is important to make this change in practice (from x-ray guided SABR to MRI-guided SABR) within the confines of an observational clinical study.

Eligibility Criteria:
Inclusion criteria:

1. Have no MRI contra-indications.
2. Eligible for abdominal SABR in accordance with the NHSE SABR Consortium Guidelines or eligible for central lung SABR in accordance with RTOG Guidelines.
3. Be able to give informed consent.
4. Anticipated life-expectancy \> 6 months.
5. Not more than 3 oligmetastatic sites treated in total per patients.
6. Performance status ≤ 2.
7. Willing to attend follow-up and have details collected on prospective basis for a minimum of 1 year.

Exclusion criteria:

1. Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
2. Unable to tolerate MRI scans.
3. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator make it undesirable for the patient to participate in the study.
4. Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.
5. Any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne

The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.

The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.

The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will up to 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥9 years
* The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
* Chest/back affected allowed, but not required
* Topical therapy of acne with Epiduo® is indicated, the decision about treating the patient with Epiduo® has been made independently from this study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Acne inversa
* Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones
* Hypersensitivity to the medication or any of the ingredients
* Other contraindications mentioned in the Epiduo® SPC
Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents

Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported expanders. However, there is no consensus in the literature regarding their activation protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow and rapid activation rates of miniscrew-supported expanders on the skeletal changes, dento-alveolar changes and the pain experience.

Transverse maxillary deficiency is one of the problems that are commonly encountered in the orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality for the treatment of transverse maxillary deficiency. However, controversies still exist regarding the activation protocol. One of these controversies is whether using a slow activation protocol would be more beneficial to the patients compared to a rapid activation protocol. Another question that consequently ensues is whether such activation protocol would result in less pain compared to the rapid activation protocol.

The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.

Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition.
* Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
* Good oral hygiene

Exclusion Criteria:

* History of previous orthodontic or orthopedic treatment
* History of maxillary trauma
* Patients with congenital craniofacial malformations
* Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response
The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy

Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Lung Lobectomy or pneumonectomy
* Adult
* Open surgery

Exclusion Criteria:

* Current infection
Cranberry Effect on Urinary Tract Infections

This is a retrospective chart review using Electronic Privacy Identification Center (EPIC) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the incidence of UTI.

The incidence of urinary tract infection (UTI) in women undergoing pelvic floor gynecologic surgery is high, ranging from 10-64%. A recent randomized trial showed that cranberry juice capsules significantly reduced the incidence of UTI in patients undergoing elective gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79).

Cranberry juice capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. Currently, all patients who undergo pelvic floor gynecologic surgery and are discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed cranberry juice capsules to reduce the risk of UTI.

The purpose of this study is to determine if the addition of cranberry juice capsules to the discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery significantly reduced the incidence of UTI, compared to a separate cohort that did not have cranberry prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Underwent pelvic floor gynecologic surgery between April 2015 and September 2015, and April 2016 and September 2016
* Required indwelling urinary catheter use upon discharge from the hospital.

Exclusion Criteria:

* Intraoperative bladder injury, fistula repair, urethral diverticulectomy, or any other need for prolonged catheterization
* Complications in the 2 weeks following surgery requiring reoperation and subsequent catheter use
* Allergy to cranberry or its components
* Failure to present for both the two-week and six-week postoperative office visit
The Relationship Between NLR and PONV and ESPB

This study aims to investigate whether preoperative NLR (Neutrophil-to-Lymphocyte Ratio) serves as a biomarker for PONV (Postoperative Nausea and Vomiting). It also examines the impact of erector spinae plane block on NLR and PONV. Furthermore, the research explores the effect of erector spinae plane block on postoperative pain relief in spinal surgery and its influence on the usage of opioid medications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective posterior lumbar spine surgery in a prone position under general anesthesia.
2. ASA classification grades I to II.
3. Age between 18 and 80 years old.
4. Signed the informed consent for this study.

Exclusion Criteria:

1. Preoperative blood transfusion.
2. Uncontrolled systemic diseases.
3. Gastrointestinal system disorders.
4. History of antiemetic and anticholinergic drug use.
5. Adverse reactions related to surgery.
6. Severe spinal deformities.
7. Infection at the puncture site.
8. Coagulation disorders.
9. Long-term use of sedatives and analgesic drugs before surgery.
10. Patients with mental illness or communication barriers.
11. Allergic to ropivacaine.
12. Participants involved in other clinical studies within the past 3 months.
13. History of previous lumbar surgeries.
14. Subjective unwillingness to participate in this study.