cyrilzakka/clinical-trials huggingface dataset:
Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?

The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 80 years;
* Biopsy proven clinically localized prostate cancer;
* Informed consent obtained and signed;
* Understanding of, and willingness to comply with, the study procedures.

Exclusion Criteria:

* Pre-operative incontinence;
* Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment);
* Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers;
* History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;
Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment

The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.

The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

-Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.

Exclusion Criteria:

* Bone-related diseases
* Previous or current use of biphosphate therapy
* Previous mucogingival surgery in the area
* Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate

  - History of previous orthodontic treatment less than 4 years ago
* Smoking \>10 cigarettes/day )
* Medical history that contraindicates surgical treatment,
* People who are not cognitively able to give consent,
* Pregnancy
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses within 12 hours preceding enrollment
* Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
Plexin D1 as a Potential Biomarker inPM/DM

evaluation of level of serum circulating plexin D1 on extacellular vesicles in adult PM/DM patients and juvenile dermatomysitis.

Polymyositis (PM) and dermatomyositis (DM) are autoimmune inflammatory diseases that primarily target muscle.

autoimmune Dermatomyositis (DM) is a rare inflammatory disease that mainly affects skin, muscle, and lung.

Inflammatory myopathies (IMs) often have distinct histopathologic features suggesting humorally mediated involvement of the microcirculation in dermatomyositis (DM), including early capillary deposition of the complement C5b-9 membranolytic attack complex (MAC) and secondary ischaemic changes; and CD8 T-cell-mediated and MHC1-restricted autoimmune attack of myofibers in polymyositis (PM) and inclusion body myositis.

Plexins are a conserved family of large proteins (\~200kDa) that are the canonical receptors for semaphorin molecules. Plexins are divided into four classes, A through D.

Recently, plexin and semaphorin molecules have been shown to control cell movement and cell-cell interaction in the immune system .

Extracellular vesicles (EVs) are lipid bilayer membrane vesicles that exist in various bodily fluids. EVs are released by normal, diseased, and transformed cells in vitro and in vivo and are capable of carrying lipids, proteins, mRNAs, non-coding RNAs, and even DNA. They are abundant in serum and plasma and have been a source of considerable interest as potential disease biomarkers. Normally, they maintain physiological functions by transferring biological information to neighboring cells and facilitating intercellular communication, but are also involved in the pathogenesis of numerous autoimmune diseases LC/MS analysis identified 1220 proteins in serum EVs. Of these, plexin D1 was enriched in those from PM/DM patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult PM/DM patients .
2. Juvenile dermatomyositis patients.

Exclusion Criteria:

* 1-Patients with other autoimmune diseases ( rheumatoid arthritis ,systemic lupus erythematosus, polyarteritis nodosa sarcoidosis, scleroderma, spondylarthritis and inflammatory bowel disease) 2-Patients with malignant tumors 3-Patients with active infection 4-Patients with severe heart, lung, and kidney dysfunction
Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.

Eligibility Criteria:
Inclusion Criteria Include:

* 18 years of age or older;
* Comfortable speaking and reading in English;
* Smoked at least 100 cigarettes in their lifetime;
* Smoked, even a puff, in the past 7 days;
* Smoked at least 5 cigarettes a day;
* Are interested in quitting smoking someday, but not in the next month;
* Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
* Are willing to upgrade their phone operating system, if needed;
* Agree to download and try the app;
* Do not use Virtual Private Network (VPN) on their smart phone;
* Live in the United States and have a valid U.S.-based mailing address and phone number;
* Have been diagnosed with HIV

Exclusion Criteria Include:

* Refusing to answer all screening questions
* History of dementia or psychosis
* Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
* Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)
A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.

This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Female/male aged 18 years and over
3. History of edentulism in the study area of at least 3 months
4. At least 4 months healing after last grafting procedure in the study area
5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
7. Deemed by the investigator to be suitable for one stage surgery
8. Deemed by the investigator to be suitable for immediate loading
9. Deemed by the investigator as likely to present an initially stable implant situation.
10. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion Criteria

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathological processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
9. Present alcohol and/or drug abuse
10. Current need for bone grafting and/or augmentation in the planned implant area
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrolment in the present study.
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)

This Study aims to develop machine learning models with the ability to predict patients' BMI and complications after Bariatric Surgery (CABS-Score).

This Study also aims to develop machine learning models with the ability to predict diabetic (DM II)patients' remission rate after Bariatric Surgery.

The service mentioned above will be publicly available as a web-based application


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bariatric surgery
* Patients \>18 years

Exclusion Criteria:

* Patients \<18 years
* Patients who cannot be followed up on for more than 6 month after surgery
* Patients who are unable to provide informed approval to participate according to each centre's rules will be excluded.
Mindfulness IN-home for Diabetes and Sleep Health

The study investigates the effects of a mindfulness intervention on sleep and subsequent cardio-metabolic risk in an adult Atlanta population aged 18 and older.

Type 2 diabetes mellitus has been identified as a leading cause of death in the United States. This problem is alarmingly higher in southern state, including Georgia. Sleep, a modifiable health behavior, may be a target for reducing the burden of diabetes. This research study will enroll adults from the community to participate in a mindfulness-based stress reduction program (MBSR) via an app on his/her cellular phone. Participants will also wear a wrist monitor to estimate activity and sleep as well as provide a blood sample before and after the MBSR. Following the 6-week intervention program, participants will provide information via focus groups to obtain feedback on his/her experiences during the program.

This pilot study will enroll (N=20) racially diverse men and women who are 18 years and older and reside in Atlanta. Participants will be recruited from the community via advertisements, community events and existing community partnerships. Trained research assistants will screen potential participants. Eligible participants will be contacted via phone and scheduled to attend a baseline visit to collect a blood sample and attend a sleep education session.

Eligibility Criteria:
Inclusion Criteria:

* Resident in the Atlanta, Georgia area
* Proficient in English
* Have a smartphone
* Sleep quality score \>5 on the validated Pittsburgh Sleep Quality Index
* Prediabetes (defined as fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%)

Exclusion Criteria:

* Pregnant women
* Sleep quality score less than a score 5 on the validated Pittsburgh Sleep Quality Index
* Refusal to download Mindfulness mobile application
* Diagnosis of HIV, AIDS, Liver disease (diagnosed, i.e. chronic or alcoholic hepatitis, cirrhosis), Renal/Kidney disease
* Current Cocaine, heroin, or methamphetamines use and/or has a history of treatment for alcohol or drug abuse
* Pre-diabetes: defined as a score greater than 3 on the American Diabetes Association 60-Second Type 2 Diabetes Risk Test
Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia

The purpose of this study is to compare physical versus visual distractions to determine which technique reduces perceived pain better during local anesthesia injections.

Before the local anesthesia injection, patients will be asked to give a preliminary VAS score based on what level of pain 0-10 they anticipate they will feel during the local anesthesia injection. Following the injection the participant will be asked to quantify the pain felt during the injection on a 0-10 Visual analog scale (VAS). The VAS scores will only be taken from the first injection of the appointment. Participants will be asked their gender, race, age, geographic location they spent most of their lives as well. Participants will be de-identified and randomly assigned a number that will be recorded along with their collected data on a two-factor, password protected web server. Information collected during this study may be used for further analysis and publication.

Eligibility Criteria:
Inclusion Criteria:

* Patients needing a dental procedure that requires a buccal infiltration with Septocaine 1:100,000 epinephrine (EPI) (Articaine hydrochloride 4% and EPI 1:100,000) or an inferior alveolar nerve block injection with 2% lidocaine with 1:100,000 epinephrine.
* Adults greater than 18 years old.
* Patients with limited English proficiency will be included only if their primary language is Spanish.

Exclusion Criteria:

* Patients with a known or suspected allergy to anesthetic agent, sulfites, amide-type local anesthetic, or to any ingredient in anesthetic solutions will not be included.
* Any patients taking medications affecting pain response on the day of the dental appointment.
* Children younger than 18 years old.
* Patients with limited English proficiency with a primary language other than Spanish
Abdominal Muscle Volume and a Neuromuscular Blocking Agent

With the recent development of image analysis and artificial intelligence, it has become possible to measure the muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

Deep neuromuscular blockade improves the condition of surgeon's surgical field during the surgery and reduces the acute postoperative pain. The dosage of neuromuscular blocking agent has been usually administered according to the patient's actual body weight, but even with the same body weight, the ratio of muscle to fat varies from individual to individual, and there are many differences depending on age, gender, and exercise level.

Therefore, if the dose of neuromuscular blocking agent is administered according to actual body weight, additional doses may be required due to insufficient neuromuscular blockade, or excessive doses may occur. However, it was difficult to quantify the muscle mass, with the recent development of image analysis, it has become possible to measure the abdominal muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily agreed and signed the written consent form before participating in the study
* American Society of Anesthesiologists physical class (ASA class) 1-3
* Patients scheduled for elective colon surgery under general anesthesia
* Patients undergoing abdominal computed tomography for routine preoperative preparation

Exclusion Criteria:

* Pregnant women
* Decreased renal function (GFR\<60mL/min/1.73m2).
* Patients taking drugs that affect deep neuromuscular blockade
* Patients with a history of neuromuscular and muscle disorders
Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing

The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.

Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.

Patients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses.

Possible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing.

Eligibility Criteria:
Inclusion Criteria:

* OAB symptoms for at least one month
* \>20 years

Exclusion Criteria:

* Allergy to mirabegron, urinary tract infections, unstable hypertension
The Value of Traction in Treatment of Lumbar Radiculopathy

The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.

Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.

The two primary aims of this study are:

1. Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
2. Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.

Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
* Oswestry disability score of at least 20%
* Age at least 18 years and less than 60 years
* At least one of the following signs of nerve root compression:

  1. Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise \< 70 degrees)
  2. Sensory deficit to pinprick on the ipsilateral lower extremity
  3. Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
  4. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity

Exclusion Criteria:

* Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
* Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
* Patient reports the complete absence of low back and leg symptoms when seated
* Recent surgery (\< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
* Recent (\< 2 weeks) epidural steroid injection for low back and/or leg pain
* Current pregnancy
* Inability to comply with the treatment schedule
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
6. Has an astigmatism of ≤ 1.00 D in subjective refraction;
7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
8. Demonstrates an acceptable fit with the study lenses;
9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Is an employee of the Centre for Ocular Research \& Education;
10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
11. Has participated in any clinical trials within a week prior to the study.