cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.

Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body.

Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information.

Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones.

The main purpose of this study is to collect and study information from men with nmPC about:

* the length of time they continued treatment with an ARI as prescribed by their doctors.
* the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body.

Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US.

The data collected will be from May 2019 to June 2023.

Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
* Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
* Age ≥ 18 years at index date
* At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
* At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.

Exclusion Criteria:

* Patients with multiple ARIs recorded at index date
* Use of an ARI agent or abiraterone acetate prior to the index date
* Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
* Evidence of metastatic disease any time before or 30 days after index date.
* No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) during the study period
Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration

This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.


Eligibility Criteria:
Inclusion Criteria:

* Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head \& Neck Cancer
* Over 18 years old
* Eligible for concurrent Chemoradiation in the first line setting
* Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
* Able to read \& write English or Spanish

Exclusion Criteria:

* Under 18 years old
* Underlying Anxiety or Depression (must pass screening tools)
* Medically Diagnosed with a Cognitive Impairment
* No prior Chemotherapy or Radiation treatment
* No access to a telephone
* Blind or Deaf or Illiterate
* Requires assistance with Self-Care ADLs
Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite

A cancer diagnosis affects not only patients but also their caregivers. The purpose of this study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the mental health of cancer patients and caregivers.

Cancer patients and/or their caregivers will receive access to the mobile app suite, IntelliCare, as well as phone coaching that will focus on how to use the apps. IntlliCare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). The apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). IntelliCare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to comply with scheduled visits and study procedures.
* Caregiver/support person of patient undergoing treatment for cancer in the Breast Care Clinic OR patient undergoing treatment for cancer in the Breast Care Clinic
* Owns a smart phone or they are willing to carry one during the study if one is provided.

Exclusion Criteria:

* Under 18 years old
* Non-English Speaker
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.

Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure
* Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
* Current use of any antipsychotic medication at study entry

Exclusion Criteria:

* Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
* History of psychoses, bipolar disorder, or severe personality disorder
* History of alcohol or drug dependence in the last year
* Severe physical disability that may interfere with the study
* Neurological impairment
* Active suicidal ideations
* Current use of antidepressant medication(s) at the start of study medication
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension

This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination) versus Telmisartan, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential hypertension uncontrolled by Telmisartan and Amlodipine Combinations.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
2. Aged ≥ 65 with essential hypertension
3. Patient with uncontrolled essential hypertension at screening

   * If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg
   * If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg

Exclusion Criteria:

1. Patient who has history of drug allergic reactions
2. Known hypersensitivity to components of the investigational product
3. Patient who is unable to stop taking prohibited drugs
4. Test results showing the following values at screening

   * The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements
5. Pregnant or lactating women
6. Patient who is unable to maintain proper night sleep
7. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
8. Administration of other investigational products within 3 months prior to screening.
9. An impossible one who participates in clinical trial by investigator's decision
Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent.
* Male or female, 18 years of age or older, with a diagnosis of MS.

Exclusion Criteria:

* Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit.
* Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months.
* Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study.
* Previously participated in this study.
* Has received an experimental drug in the last thirty (30) days.
The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence

* Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
* UUI usually associated with reduced bladder capacity.
* The pathophysiology is unclear.
* Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
* Standard treatment includes anticholinergic medication and behavior modification.
* The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
* Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
* This study addresses three issues:

  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.

The study has 3 phases: Before treatment (phase I), immediately after 3 months of treatment (phase II), and 1 year post-entry (phase III)

Women with UUI will be divided randomly into one of the four treatment groups. Every subject will participate in 4 visits. The drug group treatment consists of administration of tolterodine SR 4 mg daily for 3 months. Subjects who assigned to the pelvic floor rehabilitation, pelvic floor muscle training, and bladder training groups will be treated via 4 visits to a physical therapist, who is trained in the procedures. The chief researcher (RK) will be blinded to the treatment groups and will perform the outcome measures in all phases.

Study variables will include impairment ratings, quality of life, and cost-effectiveness

Eligibility Criteria:
Inclusion Criteria:

* complaints of urinary leakage \> 3 in last month (not stress incontinence)
* functionally independent subjects

Exclusion Criteria:

* urinary tract infection
* urogenital prolapse
* unstable diabetes
* neurological or psychiatric disease
* narrow angle glaucoma
* after colposuspension or sling surgery
* Mini Mental State Examination \<24
Remineralizing Efficacy of Giomer Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients

To evaluate the remineralizing capability of biosmart S-PRG barrier coat varnish and its employment in clinical practice


Eligibility Criteria:
Inclusion Criteria:

* • Age range between 18 and 40 years.

  * Patients with no systemic diseases, syndromic abnormalities, or proven/suspected milk protein allergy and/or sensitivity
  * Patients with fair oral hygiene (mild to moderate plaque accumulation).
  * Patients with non-cavitated initial carious lesions grade 0 or 1 caries in accordance with The Nyvad caries diagnostic criteria.
  * The patient did not receive any remineralizing agent other than the regular toothpaste during the past three months.

Exclusion Criteria:

* • Severe or active periodontal disease.

  * Patients had received therapeutic irradiation to the head and neck region.
  * Patients had participated in a clinical trial within 6 months before commencement of this trial.
  * Patients unable to return for recall appointments
  * Presence of abnormal oral, medical, or mental condition.
  * Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
  * Patients with glass ionomer restorations because the glass ionomer restoration release fluoride in the oral cavity, potentially impacting the results.
Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.

Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily for 3 months period.

Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other complications were monitored at screening and as per eligibility criteria 50 patients were enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during and at the end of treatment. The safety profile has also been monitored during the treatment period. Investigator collected and recorded all the data of visits in CRF which was analyzed through SPSS version 20.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders from 18 to 75 years of age
2. Must have a serum urate level ≥ 6.8 milligram per deciliter (mg/dL) and/or subjects recruited with Gout; must meet American College of Rheumatology criteria for Gout.
3. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
4. Patient willingly provides written informed consent

Exclusion Criteria:

1. History of significant concomitant illness
2. Active liver disease (SGPT\> 1.5 times the upper limit of normal range)
3. Severe renal impairment (Serum Creatinine level \>2mg/dl)
4. Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator
5. Cardiac disease or stroke (current or previous history)
6. Has a known history of infection with hepatitis B, hepatitis C, or HIV
7. Has a history of cancer within 5 years prior to the first dose of study medication
8. Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation
Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans

The efficacy of compounds having agonistic activity at the glycine site associated with the N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy human organism are not known. The investigators studied neuropsychiatric and neurochemical effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects using a randomized, controlled crossover challenge design including a baseline assessment day and two treatment administration days (DSR and placebo in randomized order). Thirty-five subjects aged 23-29 years participated in the study and received a 2.1g orally administered DSR dose. The main outcome measures were the changes in scores of mood-related Visual Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey Auditory Verbal Learning Test (RAVLT).

The study employed a randomized, double-blind, placebo controlled crossover design according to which, following a baseline assessment session, subjects were tested under two acute treatment conditions on two separate days. Following the baseline assessment day, 16 subjects were randomized, using a computer-generated random number sequence, to receive during test day 1 DSR and 19 to receive placebo. During test day 2, these two groups of subjects were crossed over to receive the alternative experimental treatment. The time intervals between the baseline assessment day, test day 1 and test day 2 were two to three weeks and 1 month respectively, in order to avoid the possibility of any carry-over effects.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* history of psychiatric, medical, neurological illness or substance abuse
Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy

Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5).

Present multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with acute lower GI bleeding

Exclusion Criteria:

* age below 18 years
* bleeding patients with an upper GI source
Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism

The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.

This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* Preoperative total corneal Pachymetry 490um or above
* BCVA 20/20 or better
* Stable refractive error \<0.50D MRSE change in preceding year
* Good general and ocular health
* Preoperative exam completed within three months of surgery
* Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
* Residual stromal bed greater than 270um
* Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
* Candidates who elect to target both eyes targeted for emmetropia
* ≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees

Exclusion Criteria:

* Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
* Pachymetry below 490
* Autoimmune or immunodeficiency diseases, Pregnant or nursing women
* Subjects with signs of inability to understand consent for study and procedure planned
* Subjects with history of previous ocular surgery

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.