cyrilzakka/clinical-trials huggingface dataset:
Attention Deficit Disorder and Exposure to Lead

We are examining the past exposure to lead in 250 well characterized children with ADHD, and a suitable group of controls. Our measure of past exposure is bone lead levels obtained by XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. By comparing the lead concentrations in these two groups, controlling for other factors which could confound, we will estimate odds ratios for ADHD given elevated bone lead, and estimate the contribution of lead to this disease of childhood.


Eligibility Criteria:
Case subjects are drawn from adolescents aged 10 to 18 previously seen at Western Psychiatric Institute and Clinic for evaluation, and meet the DSM-IIIR criteria for diagnosis of ADHD based on a structured parent interview and standardized parent and teacher rating scales. Cases were also systematically observed and evaluated in the summer treatment program between 1987 and 1996 at WPIC. Controls are demographically matched non-ADHD adolescents, recruited from surrounding communities and pediatric practices.
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee

An initial screening visit was performed in order to assess subject medical history and the potential eligibility of subjects. Following the initial screening visit, all potential subjects underwent a washout period from their usual arthritis medication and returned to the study center for a baseline visit to verify their eligibility.

At the completion of the baseline visit, all eligible subjects were randomly assigned to a treatment group and instructed on the dosing regimen for their assigned study medication.

Subjects returned to the study center for follow-up visits after Week 1 and Week 2 of treatment and a final visit after Week 4 of treatment or upon discontinuation from the study.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
* A history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.
* Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
* Subjects' physical ability was to be either American College of Rheumatology (ACR) Function Class I or II
* At the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.

Exclusion Criteria:

* Medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.
* Medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.
* History of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as NSAIDs including aspirin.
* Use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.
* Signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.
* Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
* ACR functional class III or IV, or unable to walk without assistive devices.
* Pregnancy, lactation, or expect to become pregnant within one month of study completion.
Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease

The overarching goal of this prospective cohort study is to test the hypotheses that greater severity of hyposmia is associated with increased risk of cognitive decline in PD and that worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals of this project, patients with PD without dementia or at-risk of dementia or with dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE \[11C\]PMP or VAchT (vesicular acetylcholine transporter) \[F18\]-FEOBV PET will be performed both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and PET outcome measures.

Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson disease
* Hoehn \& Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
* 50 and older

Exclusion Criteria:

* other disorders which may resemble PD
* subjects with definite dementia
* subjects with unstable or severe medical disorders
* subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs
* subjects in whom MRI imaging is contraindicated
* subjects who have received ionizing radiation that would, together with the current project exposures, exceed exposure limits permissible to research volunteers
* pregnant
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers

Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field.

The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function.

Methods: After screening 100 competitive adolescent swimmers to obtain \~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed.

Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.


Eligibility Criteria:
Inclusion Criteria:

* members of swimming team
* training at least 15 hours/week
* low vitamin D plasma levels (\<30 ng/ml)
* signed consent forms

Exclusion Criteria:

* chronic health conditions
* taking prescription medications
* taking diet supplementations
Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer

HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
* Recurrence of anytime necessitating a new line of chemotherapy
* Patient having received adjuvant chemotherapy
* Informed consent signed prior any study specific procedures

Exclusion Criteria:

* More than 3 lines of chemotherapy
* Pregnancy or breastfeeding
* History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye Discomfort

The puropose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.

Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects (male or female) must be ≥ 18 years of age;
2. Subject able to provide Informed Consent, in compliance with the good clinical practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects);
3. Subjects with ocular discomfort resulting from mild to moderate dry eye in one or both eyes determined by:

   * Scoring of ocular surface staining with fluorescein using the National Eye Institute (NEI) scale. Total score per single eye range 6-33 summing the score of cornea and conjunctiva. (Considering a normal score of 0-33);
   * Tear film break-up time with fluorescein (TFBUT) ≤ 10 seconds; The TFBUT value will be recorded as the average of 3 measurements;
   * Symptom Assessment in Dry Eye (SANDE) questionnaire ≥ 35.
4. Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator;
5. Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication;
6. Subject who in physician's opinion will benefit from this treatment.

Exclusion Criteria:

1. Corneal injuries or abrasions of traumatic origin in the eye of study;
2. Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye);
3. Sjögren's syndrome;
4. Stevens-Johnson syndrome;
5. Systemic lupus erythematosus;
6. Pathologies associated with corneal thinning;
7. Taking drugs that may interfere with tear gland secretion (beta -blockers);
8. Patients using any topical therapies such as non-steroidal antiinflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) the eye of study;
9. Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study;
10. Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device.
11. Participation in another clinical trial within the previous 30 days;
12. Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results.
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure

This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.

The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. This trial will investigate the on body performance of novel patch pump delivering the novel formulation. Study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7mL in patients with heart failure (HF). Recruitment will be restricted to 1 site with a recruitment target of 20 patients. All trial related activities will be conducted in an inpatient environment.

Eligibility Criteria:
Inclusion Criteria:

* • Written informed consent

  * Male or female ≥18 years of age
  * Meet ESC criteria for diagnosis of HF(4)
  * Inpatient with a primary diagnosis of HF requiring treatment with intravenous furosemide at dose

Exclusion Criteria:

* • Unable to consent to inclusion in study due to lack of capacity

  * Requiring treatment with intravenous furosemide at dose \>200 mg per day as determined by the usual care team
  * Current inotropes, vasopressors or intra-aortic balloon pump therapy
  * Concomitant use of diuretics in 12 hours preceding administration of study drug with SQIN-Infusor
  * Systolic blood pressure (SBP) \<90 mmHg
  * Pregnancy or breastfeeding
  * Left sided valve disease with planned surgery or percutaneous intervention
  * Type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5)
  * Any surgical or medical condition which prevents patient from ambulation during the infusion
  * Renal impairment, defined as eGFR \< 30 mL/min/1.73 m2 at screening.
  * Patient on active cardiac transplant waiting list
  * Potassium \<3.0 mmol/L
  * Potassium \>6.0 mmol/L
  * Sodium \<125 mmol/L
  * Any contraindications for furosemide administration as per furosemide SmPC
  * Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
Strength Training Study for Survivors of Breast and Gynecologic Cancer

The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.

As a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. In cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's physical functioning and quality of life. However, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. Therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. It is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.

Eligibility Criteria:
Inclusion Criteria:

* Female Survivor of Breast or Gynecologic Cancer
* Completed Primary Treatment (hormone treatments are ok)
* 18 years of age or older
* Physician's Permission to Participate

Exclusion Criteria:

* High Risk Individuals (determined by questionnaire)
* Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures).
* Report participating in a strength training program in the past six (6) months
* Have had a change in medication in the past 30 days
Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis

VKH disease is a vision threatening condition.The investigators consider that ozurdex intravitreal implant is an effective line of treatment in recurrent VKH posterior uveitis.

Baseline ,and postoperative 1 ,6 ,12 and 24 months full ophthalmic examination was done.

Procedure included intravitreal injection of Dexamethasone implant 0.7 mg (Ozurdex(®); Allergan, Inc, Irvine, CA)

Eligibility Criteria:
Inclusion Criteria:

* Recurrent VKH posterior uveitis

Exclusion Criteria:

* retinal pathology, other causes of posterior uveitis
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients with Advanced Cancer

This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual well-being, and mood in caregivers of patients with advanced cancer.

PRIMARY OBJECTIVES:

I. Determine feasibility as measured by total number of caregivers enrolled in 1 year, adherence.

II. Determine acceptability as measured by satisfaction with the research process, as measured by the Was It Worth It (WiWi 2.0) questionnaire.

III. To evaluate preliminary efficacy of group MCP-C for personal meaning as measured by Life Attitude Profile-Revised (LAP-R), spiritual wellbeing as measured by Functional Assessment of Chronic Illness Therapy (FACIT) Spiritual Well-Being Scale (SWBS), depression and anxiety symptoms as measured by Hospital Anxiety and Depression Scale (HADS), meaning in caregiving as measured by Attitudes Towards Caregiving Scale (ATCS), social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Questionnaire (FSSQ), benefit finding as measured by Benefit Finding Scale (BFS).

IV. Determine participants' perceptions of their experience with the intervention, including potential benefits they experienced, which components had the greatest impact, and whether they would suggest any changes to the intervention.

OUTLINE:

Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.

After completion of study intervention, caregivers are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* English fluency
* No diagnosed severe cognitive impairment
* Caregiver of a patient with diagnosis of advanced, solid tumor cancer (stage III/stage IV)
* Provide written (paper or electronic) informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Patient baseline distress score \>= 4/10
* Have ability to utilize the technology to participate in virtual groups

Exclusion Criteria:

* As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded
* Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
* Cognitive impairment likely to interfere with participation
Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes

This protocol will determine the prevalence of hyperglycemia and diabetes in the elective orthopedic population at the University of Wisconsin. It will also determine if there is a difference in outcomes. The study hypothesizes that at least 10% of patients will have some degree of impaired glucose regulation that has previously been undiagnosed.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years or older
* Undergoing elective total knee, hip or lumbar spinal surgery

Exclusion Criteria:

* Pregnancy
* Unable to give consent
NeuroGyn Genital Neuromodulation System for iOAB Treatment

The NeuroGyn study is designed to evaluate the safety and effectiveness to the NeuroGyn Genital Neuromodulation System as an aid in the treatment of the symptoms of idiopathic overactive bladder in patients who have failed or could not tolerate more conservative treatments.

not provided

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older (adult and older adult, all sexes)
* Diagnosed (urodynamic testing) with idiopathic overactive bladder (iOAB)
* Symptoms of urinary urgency, frequency, and/or urge incontinence for at least 6 months
* Failed conservative treatments (e.g., lifestyle modifications, medications)
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation
* Patients have already undergo a successful GNS-test phase with adhesive electrodes (reduction symptoms greater equal or more than 50%)

Exclusion Criteria:

* History of pelvic surgery affecting the pubic bone or genital nerves
* Current urinary tract infection
* Neurological conditions affecting bladder function (neurogenic OAB)
* Pregnancy or planning to become pregnant during the study period
* Contraindications to local anesthesia or surgery
* Female patients with significant prolapse (i.e., prolapse beyond the introitus).
* Patients with primary stress incontinence and primary pelvic pain symptoms.
* Patients with less than 12 months from last intravesical botulinum toxin A therapy
* Patients with mechanical infravesical obstruction and/or Interstitial Cystitis.
* Vulnerable patients with co-morbid conditions should be excluded from this study. These co-morbid conditions include all pathologies of the cardiovascular system (Angina Pectoris, Infarct, Thrombose, Embolie, Hypertonia), pulmonary system (asthma, COPD, chr. Bronchitis), intestinal system (morbus Crohn, diverticulitis..) and any malignant disease. These co-morbid conditions also include neurologic diseases (i.e., stroke, multiple sclerosis, spinal cord injury), sacral dermal pathological conditions, congenital or other anatomical sacral anomalies (e.g. spina bifida, sacral agenesis, trauma sequelae), mobility deficits, medically complicated/uncontrolled diabetes, fecal motility disorders (fecal incontinence/constipation), chronic pelvic pain, history of recurrent urinary tract infections (UTIs), gross hematuria, prior pelvic/vaginal surgeries (incontinence/prolapse surgeries), pelvic cancer (bladder, colon, cervix, uterus, prostate), deeply infiltrating endometriosis of the pelvic plexus, sacral plexus or of the bladder, Reiter´s syndrome, and pelvic radiation.
* Patients suffering from other CNS disorders (mental disorders, severe psychological problems, cerebrovascular accident less than 6 months ago).
* Patients suffering from polydipsia/polyuria are excluded from the study. Similarly, patients suffering from diabetes insipidus (DI) and diabetes mellitus (DM) are also excluded from the study.
* A female with a positive urine pregnancy test
* A female who is breastfeeding
* Allergies again local anesthesia (Lidocain), Tranquillizers and Antibiotics