cyrilzakka/clinical-trials huggingface dataset:
Inhibitory Control Adult Weight Management

The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with overweight or obesity.

This two-arm pilot study will be used to estimate the effect size in weight loss of supplementing the WW (formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) among adults with overweight or obesity. Participants ages 18 and older (n=30) will be randomly assigned to one of two study arms: (1) WW (formerly Weight Watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All participants will complete demographic, medical history questionnaires and cognitive assessment battery at baseline/enrollment and after completing the 3-month intervention protocol. All interactions with PolyRules! and WW will be passively recorded to monitor the frequency of interaction with WW and PolyRules!.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Read, write and speak English with acceptable visual acuity
* BMI between 25-40 kg/m\^2

Exclusion Criteria:

* Currently enrolled in weight loss interventions or undergoing bariatric surgery
* Pregnant women
* Individuals with severe cognitive delays or visual/hearing impairment
Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice

The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.


Eligibility Criteria:
Inclusion Criteria:

* Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.
* Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.
* No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.
* Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.

Exclusion Criteria:

* Do not follow the contraindications and warnings of the Summary of Product Characteristics.
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Not Required

Eligibility Criteria:
Inclusion Criteria:

The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

1. Subject is between 18-55 years of age.
2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
3. Subject has a BED diagnosis.
4. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met:

1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.
3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
5. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
6. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
7. Subject has a history of moderate or severe hypertension.
8. Subject is female and pregnant or nursing.
9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody

The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.

Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.

Eligibility Criteria:
Inclusion Criteria:

* All patients at the Houston VA with documented C. difficile infection

Exclusion Criteria:

* None
Sufentanil Intranasal

Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.

The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.

Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more

Exclusion Criteria:

* pregnant
* \<18 years
* prisoners
* lesions of head, face or abdomen
* no consent given or possible
* pain not scorable
* known drug abuse or substitution therapy
* chronic level 3 pain medication
* intake of level 3 \< 8 hours
* intoxicated patient
* allergy or intolerance to opiates
* renal or hepatic insufficiency
* \< 50kg body weight
* hemodynamic instability
Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines

The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.


Eligibility Criteria:
Inclusion Criteria:

* A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study (eg, for at least 90 days after receiving study intervention).
* Participant must have sufficient visual acuity without the use of eyeglasses (contact lans use acceptable) to accurately assess their facial lines, in the opinion of the investigator.
* Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active COVID-19 infection.
* Be nonsmoking and a nonuser of cannabis and nicotine-containing products, or have not smoked or used cannabis or nicotine-containing products, including e-cigarettes, within the previous 2 years.

Exclusion Criteria:

* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
* Rosacea, skin infection, or any other skin disease or disorder that would represent a safety concern and/or interfere with the ability to either administer treatment or assess the treatment effect, as determined by the investigator.
Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series

This study evaluates the effectiveness of personalized physical activity coaching combined with the use of a physical activity monitor to support increased levels of daily physical activity in individuals with multiple sclerosis. All five participants will receive the intervention over the four week intervention phase.

Individuals with multiple sclerosis engage in less daily physical activity than the general population for a variety of reasons. This research project is intended to evaluate whether individualized coaching combined with the use of a Fitbit physical activity wristband monitor will improve physical activity levels in individuals with multiple sclerosis.

Following admission into the study, participants will be visited once a week for four weeks at home by a physical therapist. The participants in consultation with the physical therapist will set daily physical activity goals for the following week and the participants will be taught how to monitor their daily activity using a Fitbit physical activity wristband.

The goals of this study are to determine whether this intervention is effective in helping participants increase their levels of daily physical activity and their confidence that they can successfully engage in daily physical activity. In addition, there will be an evaluation of changes from pre-intervention to post-intervention in quality of life measures.

Eligibility Criteria:
Inclusion Criteria:

* must have a physician diagnosis of multiple sclerosis and deemed suitable for engaging in a physical activity program by their physician
* must be ambulatory with or without an assistive device
* must be able to speak and read English
* must have a home computer or device capable of tracking and recording the daily Fitbit physical activity reports

Exclusion Criteria:

* participants will be excluded if any contraindications to engaging in independent exercise are identified during the intake examination by the physical therapist: cardiovascular issues or safety issues with walking.
Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

This study aims to determine the treatment effect of vision therapy on myopic children by assessment of accommodative function before and after therapy.

1. Specific aims of the proposed clinical trial:

   1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group.

   1.2 To minimize the influences of confounding variables by randomly assigning the intervention.

   1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length.
2. Hypothesis:

VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.

Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in the trial must:

* be within the age range of 8 to 12 years old inclusive
* -0.75D to -4.50Dspherical equivalent by cycloplegic autorefraction in both eyes
* astigmatism≤1.5D in both eyes
* anisometropia≤1.0D
* monocular accommodation lag at near(33cm)in right eye by non-cycloplegic autorefraction≧1D
* have vision correctable to at least 0.8 or better in each eye.

Exclusion Criteria:

Subjects enrolled in the trial must NOT have:

* current or prior use of PALs, bifocals, or contact lenses in either eye( prior or current use of SVLs allowed)
* history of any of the following functional defects: strabismus, amblyopia, nystagmus
* history of diabetes or seizures
* history of any ocular systemic, or neuro-developmental condition that might influence refractive development
* use of ocular or systemic medications containing atropine, pirenzepine, and anti-epileptic medications in recent 3 months
* history of any ocular surgery that might influence refractive development
* developmental disability, attention deficit hyperactivity disorder(ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
* relocation anticipated for 1 year
* birth weight lower than 1250 grams（2lbs,12oz）
* siblings in the study.
Shared Decision Making in Older Adults With Distal Radius Fractures

This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.

Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.

Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.

This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.

Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture within the past 2 weeks
* Initial appointment seeing Attending
* Age 65+

Exclusion Criteria:

* Non english speaker
* Dementia or other mental limitation preventing ability to complete survey
* Other traumatic injuries in extremity that would affect surgical decision
Analgesic Effects of LED Light on Temporomandibular Disorders.

Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.

Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Method: This study proposes an evaluation of analgesic effect in TMD (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared LED, red LED and Control Group using infrared Laser).

Eligibility Criteria:
Inclusion Criteria:

Thirty patients (from 18 to 50 years old) presenting signs and symptoms of TMD were selected to participate in the study. The patients received care at a private dental office in Ribeirao Preto, São Paulo, Brazil (NILO- Integrated Center for Laser in Dentistry). The patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the TMJ area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.

Exclusion Criteria:

The exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids.

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E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus
Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage

Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.

A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.

Eligibility Criteria:
Inclusion Criteria:

* multiparous participants
* abnormal uterine bleeding
* postmenopausal bleeding
* myoma uteri causing menometrorrhagia
* cervical polyp
* tamoxifen treatment for breast cancer
* adnexial mass

Exclusion Criteria:

* abortions
* pregnancy
* primiparity
* diabetes mellitus
* tendency to bleed such as thrombocytopenia
* factor deficiency
* functional disorders of platelets
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism

The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)

In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between the ages of 18 and 75;
* Diagnostic criteria for mild subclinical hypothyroidism :TSH\>10mIU/L, thyroxine and free thyroxine levels were normal
* Positive thyroglobulin antibody and/or Thyroperoxidase antibody
* No previous use of drugs affecting thyroid function

Exclusion Criteria:

* The contraindications indicated in the Chinese instructions of the drug
* Liver function impairment
* Renal function impairment
* Claustrophobia
* Mental disorders
A Study of Exclusion Criteria in a University Population

Much of community transmission of seasonal and pandemic influenza occurs in younger individuals, because of their susceptibility and their social interaction patterns.Universities are places where transmission of influenza is facilitated because of the age of individuals involved, their close contact with each other, and low vaccination coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified as one of the most efficient ways to reduce influenza transmission, but there are still insufficient data on the effects of social distancing to be able to make recommendations for future pandemics or even outbreaks of seasonal influenza.

The investigators are conducting a study on the effect of voluntary sequestration during illness on the transmission of influenza among social networks in University residence housing units at the University of Michigan. The sequestration interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. In all selected residence halls, specimens will be collected when illness meeting a case definition for influenza-like illness occurs.

This study in a university population will evaluate the acceptability and magnitude of effect that can be expected from such an intervention, and determine the number of days that sequestration should be practiced.


Eligibility Criteria:
Inclusion Criteria:

* Live in a participating residence hall at the time of enrollment
* Be at least 18 years of age
* Be willing to report social habits and illness information electronically on a weekly basis
* Be willing to have a throat swab specimen collected if you have signs of illness during the influenza season
* Be willing to nominate close social contacts living in eligible residence halls for participation in the study
* Be willing to participate in a 3-day sequestration protocol as randomly assigned.

Exclusion Criteria:

* Non-residence in selected Residence Halls
* Unwillingness to participate in voluntary sequestration protocol and complete online surveys
* Already study employee