cyrilzakka/clinical-trials huggingface dataset:
Essential Tremor in Children and Adolescent

Essential tremor (TE) is the most common abnormal movement of the adult. His diagnosis is based on a bundle of clinical arguments (Movement Disorders Society, 1998). Well characterized in the adult, little data is available concerning child. The objective of this work is (1) to define the demographic and clinical characteristics of the TE of children and adolescents, (2) to determine the electrophysiological characteristics in the child, (3) evaluate the functional impact of TE, and assess the functional impact of TE, and assess the current management modalities of TE in children and adolescent.

A multicenter, descriptive cross-sectional study will include children and adolescents whose diagnosis of TE has been retained by an abnormal movement specialist before the age of 18 years.

Each child will benefit from an examination and a neurological and general clinical examination, a functional questionnaire, an electromyogram with accelerometer.

Will be determined: demographic characteristics (age, sex and ethnicity), family history of essential tremor, age of onset of tremor, tremor characteristics (location, occurrence conditions, aggravating or precipitating factors, scalability); additional examinations carried out and the treatments proposed or taken by the child as well as the functional repercussions of TE in the child.

Patients with tremor who meet the inclusion and exclusion criteria will be selected retrospectively or prospectively from the active queue of patients at each center.

Eligibility Criteria:
Inclusion Criteria:

* Subject whose age is between 3 and 18 years
* Subject affiliated to a social security scheme
* Parents or subjects who have been informed of the course and consequences of the study by an investigator and who have signed the informed consent form for prospective inclusion or who have given their non-opposition for retrospective inclusion.
* Diagnosis of essential tremor established according to the diagnostic criteria of the Movement Disorders Society (1998), by a neuropediatrician or a neurologist, specialist in abnormal movements. The diagnosis is based on the presence of the following criteria: bilateral action tremor of the hands and forearms, absence of other neurological signs.
* Availability of an electromyogram for retrospective inclusions.

Exclusion Criteria:

* Abnormal neurological examination outside tremor
* Family history or personal dysthyroidism
* Existence of a global psychomotor or motor developmental delay
* Taking medication that may induce tremor
* known poisoning by heavy metals, bismuth, mercury, methyl bromide
* Severe appearance of the tremor
* Tremor suggestive of a psychogenic origin
* Abnormal or non-existent brain MRI if family case
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.

Total duration of the study period per subject is about 4 months broken down as follows:

The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and willing to sign the ICF
2. Healthy male and female subjects, non-smokers, 18-55 years of age
3. In the opinion of the investigator, with no significant medical history, and in good health.
4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
5. Subjects are able to follow the study protocol and complete the trial.

Exclusion Criteria:

1. History of hypersensitivity to similar drugs to 611 or their excipients.
2. Pregnant, or nursing females.
3. HepBsAg or HepCAb positive.
4. Human immunodeficiency virus (HIV) positive.
5. Positive urine drug screen, or cotinine test.
6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70.
* History of end-of-day or low-humidity dryness with contact lenses.
* Healthy eyes.
* Best-corrected visual acuity of 20/50 or better for each eye.
* Usable pair of eye glasses.
* Willing and able to attend required study visits.
* Sign informed consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ocular or systemic allergies or diseases which might interfere with contact lens wear.
* Clinically significant ocular findings which would contraindicate contact lens wear.
* Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
* Participation in another clinical study currently or within 30 days of study entry.
* Spectacle astigmatism of \>1.00 diopter.
* Other protocol-defined exclusion criteria may apply.
Vibration Therapy Effects on Muscle Firing Patterns

The purpose of this study is to determine the effects of whole body vibration therapy on muscle firing patterns as measured by EMG analysis.

Proprioception is the specialized sensory modality that informs the body as to movement, position, and spatial orientation through mechanisms that track sensations accompanying joint movement and position. Mechanoreceptors in joints, along with vestibular, visual, muscle spindle, Golgi tendon organ, ligament and tendon sensory receptors, comprise the propriosensory system, which conveys information to the motor system to maintain equilibrium on a reflexive, automatic basis. Alterations in somatosensory input from mechanoreceptors have been identified as causing aberrant muscle firing patterns.

Eligibility Criteria:
Inclusion Criteria:

* Logan student, staff, or faculty with no history of ankle injury
* Ages 18 - 60 years old
* Logan student, staff, or faculty with no history of ankle surgery
* No visual or vestibular condition that would affect balance

Exclusion Criteria:

* Systemic illnesses that have an adverse effect on balance
* Local infection, injury, or other malignancy affecting the lower extremity
* Any unstable joints of the lower extremity
* Any spinal manipulation within 48 hours
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Pregnancy
Evaluation of Clinical Approaches to Accelerate Orthodontic Tooth Movement

This study will compare the techniques of piezocision and alveolar corticotomies in accelerating orthodontic retraction movement of canines. In a second phase, this clinical trial will evaluate the effectiveness of micro-osteoperforations in accelerating the retraction of maxillary incisors.

The first phase will consist of a split-mouth study in patients who require the extraction of the first premolars to correct malocclusion. The canine will be retracted using corticotomy and piezocision surgical techniques, as well as without any intervention, being this the control side. In addition, it will be evaluated the inflammatory biomarkers present in the gingival crevicular sulcus during the dental movement, as well as data related to pain and discomfort. The second phase will evaluate the effects of micro-osteoperforations in the retraction of maxillary incisors. The following parameters will be evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

Eligibility Criteria:
Inclusion Criteria:

* Patient with orthodontic need for bilateral upper first premolar extraction.
* Adequate dento-oral health
* ASA I and ASA II
* Compliance with clinic visits every 2 weeks

Exclusion Criteria:

* History of periodontal disease
* Smokers
* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
* Pregnancy
* Presence of cleft or any syndrome
Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism

The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .

The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels

Eligibility Criteria:
Inclusion Criteria:

* Males with age 30-60 years inclusive.
* PSA \< 2.6 ng/ml or \< 3.75 ng/ml with a negative prostate biopsy in the last 6 months.
* IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study

Exclusion Criteria:

* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c \>10%;
* h/o prostate carcinoma;
* Hepatic disease (transaminase \> 3 times normal) or cirrhosis;
* Renal impairment (serum creatinine \> 1.5);
* HIV or Hepatitis C positive status;
* Participation in any other concurrent clinical trial;
* Any other life-threatening, non-cardiac disease;
* Use of over the counter health supplements which contain androgens;
* Use of an investigational agent or therapeutic regimen within 30 days of study.
* Use of testosterone in the past
* Hematocrit \> 50%.
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171

RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.

OBJECTIVES:

Primary

* To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of atypical glandular cells of unspecified significance (AGUS) to predict the presence of significant glandular lesions (i.e., adenocarcinoma in situ \[AIS\] or invasive cancer) and/or squamous lesions (i.e., cervical intraepithelial neoplasia \[CIN2 or CIN3\]) of the cervix.

Secondary

* To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei, and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from patients with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (i.e., AIS or invasive cancer) and/or squamous lesions (i.e., CIN2 or CIN3) of the cervix.

OUTLINE: Previously collected slides from Pap smears of patients enrolled on clinical trial GOG-171 are assessed for nuclear chromatin distribution, the shortest distances between the central points of neighboring cell nuclei, and nucleoli area/nucleus area (N/N) ratio via morphometric analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically confirmed atypical glandular cells of unspecified significance

  * Original Pap smear used to define the diagnosis must be available for review
* Previously enrolled by GOG-JAPAN onto clinical trialGOG-171

  * Must have been eligible and evaluable for the primary objective of GOG-171
  * Gave permission to use specimens for future cancer research in GOG-171
* Underwent a loop electrosurgical excision procedure/large loop excision of the transformation zone (LEEP/LLETZ) procedure on clinical trial GOG-171 to determine the presence of cervical intraepithelial neoplasia (CIN-2 or CIN-3), significant glandular lesions (AIS), or invasive cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Anterior Vaginal Wall Reconstruction

The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.

Objective: The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.

Methods: Fifty Caucasian women 50 to 77 years old (mean age 66.6 years), 2 pre and 48 post menopausal with stage II-IV pelvic organ prolapse, enrolled into the study. Vaginal reconstructive surgery included an anterior colporrhaphy in all patients, posterior colpoperineorrhaphy in 28 patients and hysterectomy in 36 patients. They were randomly divided in a control group of 22 women and a study group of 28 women. As reinforcement to the anterior colporrhaphy procedure a polypropylene tape (TVT-O) was placed not under the midurethra, as originally described in case of stress incontinence, but underneath the bladder base and was fixed there with polyglactin sutures, in the study group. The postoperative follow up was carried out in frequent intervals of 4 months (total 48 months). The assessment of the anatomic result included evaluation of the operated sites and of the position of the tapes inserted on clinical grounds and after perineal sonography, which measured the distance of the bladder base to the inferior edge of the symphysis pubis.

Results: In all patients the postoperative correction of the anterior vaginal wall was sufficient; the mean distance of the bladder base to the inferior edge of the symphysis pubis was 1.5 cm (range 1.0-2.2 cm). Mean residual urine volume was 30 ml. There were postoperatively 2 cases of stress incontinence and two cases of urge incontinence one in each group. There was no case of tape erosion noted, no dyspareunia and no recurrent cystocele in the study group. Four cases of recurrent cystocele (20%) were reported in our control group.

Conclusion: The tension free vaginal tape, particularly TVT-O, placed underneath the bladder base, when performed concomitantly to the anterior colporrhaphy appears to be safe and effective. While the preliminary results of our study are encouraging, larger series of patients and longer follow up are required to verify the effectiveness of the aforementioned modification.

Eligibility Criteria:
Inclusion Criteria:

* Women 50-77 years old with stage II-IV organ prolapse
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.


Eligibility Criteria:
Inclusion Criteria

* Patients with SSc-constipation from Aim 1 of the study
* Patients with SCT (\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
* Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Exclusion Criteria

-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
everlinQ Endovascular Access System Enhancements (EASE) Study

Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.

A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects will be followed for up to 12 months post index procedure based on Investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for a native arteriovenous fistula.
2. Adult (age \>18 years old).
3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
4. Target vein diameter(s) ≥ 2.0 mm or large enough to accommodate device diameter.
5. Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.
6. Estimated life expectancy \> 1 year.
7. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure

Exclusion Criteria:

1. Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation.
2. Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by everlinQ System as deemed by the interventionalists' clinical judgment.
3. Prior surgically created access in the planned treatment location.
4. Functioning surgical access in the planned treatment arm.
5. Pregnant women.
6. New York Heart Association (NYHA) class III or IV heart failure.
7. Hypercoagulable state.
8. Known bleeding diathesis.
9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
10. Documented history of drug abuse including intravenous drugs within six months of AVF creation.
11. "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
12. Currently being treated with another investigational device or drug.
13. Known allergy to contrast dye which cannot be adequately pre-medicated. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
15. Patients who do not have an ulnar or radial artery.
16. At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
17. Evidence of active infections on the day of the index procedure.
18. Written informed consent not obtained.
The Objective is to Evaluate the Anterior Chamber Angle After BANG Procedure, the Study Will Recruit 12 Patients Who Will Undergo Planned Goniectomy for Uncontrolled POAG, Anterior Segment OCT Scan Will Be Used to Evaluate the Anterior Chamber Postoperatively.

Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are being treated for primary open angle glaucoma using eye drops.
2. Patients with uncontrolled intraocular pressure \&gt;21 mm Hg
3. All recruited patients should have open anterior chamber angles demonstrated on gonioscopy examination.
4. Patients giving consent for operation and follow up

Exclusion Criteria:

* 1- Pseudophakic patients 2- Advanced glaucoma patients. 3- Patients who are to have trabeculectomy or laser trabeculoplasty. 4- Patients with secondary glaucoma. 5- Patients who are unable to give consent for surgery or follow up. 6- Patients with previous trauma to the eye
Reliability Study Using Electrodermal Activity to Measure Sensory Processing in Children With and Without Autism Spectrum Disorder

The purpose of this study is tTho establish test-retest reliability of electrodermal markers used to quantify physiologic response to sensation using the Sensory Challenge Protocol in children with and without Autism Spectrum Disorder (ASD).

This methodological research design is a prospective exploratory test-retest design assessing the use of electrodermal activity (EDA) as an index of sensory processing. EDA will be measured using skin conductance response (SCR). The purpose of this study is to investigate if using EDA is a reliable measure over time within the context of response to sensation. Scores from test one and test two of each subject will be correlated to determine reliability of EDA measure. Reliability in this context will establish the utility of EDA as an index of sensory processing. Testing will occur two times within a six week period.

Eligibility Criteria:
Inclusion Criteria: Boys ages 4 - 11 years old.

* Able to sit for 30 minutes and follow simple directions.
* Children with confirmed Autism Spectrum Disorder via school records or parent report.
* Typically developing children free of medical or neurological conditions

Exclusion Criteria:

* Medical or neurological conditions other than Autism.
* Hearing loss or visual impairments.
* Children taking medications known to affect arousal.
* Children who are not able to follow simple commands.
Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography

This study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet.

Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. The orodispersible Tramadol tablet is a new galenic form and is available on the Belgian market for the last three years. Pregastric absorption leads to a quicker onset of action.

So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG) procedure is only significantly reduced by IV opioid analgesia. This study evaluates the analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its respiratory depressant effect is negligible.

Four arm prospective randomized double blinded trial

Patients that need a HSG as part of their diagnostic work-up and are eligible for randomization are counseled about possible participation. After signing the informed consent patients will be randomized in one of the following four groups:

Group 1: Fast-release Orodispersible Tramadol Tablet + metal cannula Group 2: Placebo + metal cannula Group 3: Fast-release Orodispersible Tramadol Tablet + balloon catheter Group 4: Placebo + balloon catheter

Tablets are administered 30 min before the procedure

Primary Endpoint:

* VAS at the six different assessment points

Secondary Endpoint

* adverse effects and complications such as: nausea, vomiting, constipation, drowsiness, respiratory depression, hypotension, allergic reaction and infection

Eligibility Criteria:
Inclusion Criteria:

* \> 18 and \< 45 years
* Written informed consent

Exclusion Criteria:

* Contra-indication to tramadol, morphine or to other opioids

  * Concomitant use of MAO inhibitors or use less than 2 weeks prior to procedure
  * Use of any other CNS-acting drug
* Contra-indication to radio-contrast medium (allergy)
* Patient already taking analgetics
* History of cervical stenosis
* Presence of pelvic inflammatory disease or any other condition causing pelvic pain
* Clinical and/or laboratory evidence of any major disease
* Pregnant or lactating