cyrilzakka/clinical-trials huggingface dataset:
Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs

Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.

Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol. Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms will be measured via the PCL-5. The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process, resources, management, and scientific basis of the planned trial. As such, the proposed study will primarily assess feasibility outcomes and not efficacy outcomes. The investigators will assess number of participants screened, number meeting inclusion criteria, adherence of participants to the proposed treatment (measured via number of sessions attended), standard deviation of the outcome measure (PCL-5), response rates to questionnaires, and loss to follow-up. The investigators will also measure clinicians' adherence to protocol and acceptability of the treatment to patients.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are current engagement in treatment at the Battle Creek VA PTSD Residential Rehabilitation Treatment Program.

Exclusion Criteria:

* Exclusion criteria are severe cognitive impairment that in the judgment of the PI or the patient's clinical providers make it unlikely that the patient can adhere to the study protocol.
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.


Eligibility Criteria:
Inclusion Criteria:

* - 18 to 65 years of age
* Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject)
* Fixed home/place of residence and can be reached by telephone
* On a stable dose of antipsychotic medications
* Able to swallow capsules

Exclusion Criteria:

* Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
* Treated with clozapine in past 30 days
* Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
* History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
* Uncontrolled hypertension
* History of thyroid disorder that has not been stabilized on thyroid medication
* Glaucoma
* Pregnant or nursing
* Subject has received an investigational product or participated in a clinical study within 30 days
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease

This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stage 3, 4 and 5 (CCl \< 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.

Exclusion Criteria:

* Patients previously known by nephrologists.
* Estimated life expectancy \< 1 year
* Refusal or inability to sign writing consent
A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Dry eye chamber challenge trial.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen to 70 years of age at the time of screening (either gender and any race)
* Ability to provide written informed consent
* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
* Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
* Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the Investigator, could interfere with trial conduct or assessments
* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
* Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
* Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
* Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function

The study design is to assess the between groups factor (controls, chronic pain, addicted individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a longitudinal component to assess stress, pain and addictive behaviors in daily life.

This proposal aims to systematically examine the physiologic, neuroendocrine and behavioral stress and pain responses to an adapted Cold Pressor Test and also assess specific cognitive and executive function tests in community volunteers with a history of stress and trauma, social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use disorder, opioid use disorder, cocaine use disorder and chronic pain.

Eligibility Criteria:
Inclusion Criteria:

1. Between ages 18-50 years;
2. Able to read and write English;
3. 50 individuals meeting DSM V criteria for Binge Heavy drinkers, using NIAAA criteria for alcohol intake 50 individuals meeting DSM V criteria for Cannabis Use Disorder 50 individuals meeting DSM V criteria for Alcohol Use Disorder 50 Individuals with Moderate to Severe Pain 50 individuals meeting DSM V criteria for Opioid Use Disorder who are initiating treatment
4. Physically healthy as determined by Physical Exam, EKG and blood analyses
5. Body Mass Index (BMI) in the 18-30 range;

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
2. Any Current Substance Use Disorder including alcohol, cannabis, cocaine, opioids, sedatives/hypnotics. For alcohol, cannabis, and opioid subjects, exclusion for the abused drug will not apply.
3. Individuals taking any prescription medications or over-the counter medications regularly;
4. Women with irregular menstrual cycles or who are nursing, dysmennorheic, amenorrheic, menopausal, or had premenstrual dysphoric disorder or those on birth control pills;
5. Women who are pregnant as determined by the urine pregnancy test at each laboratory admission;
6. Inability to give informed consent;
7. Traumatic brain injury or loss of consciousness;
8. Individuals with current or past history of seizure disorders
Dose Finding Study to Treat High Phosphate Levels in the Blood.

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Females and males aged ≥18 years
2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months
3. Prescribed and taking at least 3 doses of phosphate binder per day
4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

1. Severe hyperphosphatemia defined as \>10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
2. Serum parathyroid hormone \>1200 pg/mL
3. Significant metabolic acidosis
4. Clinical signs of hypovolemia at randomization

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Capsaicin Effect on Cytokines Profile in Dyslipidemia

The increased mortality from cardiovascular disease has a significant impact on the population, and the prevalence of these diseases it become one of the major problems, since it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease according ENSANUT; the above is attributed to the increase of diseases associated with an inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes mellitus (DM).

The cholesterol is a major risk factor in the development of cardiovascular disease, and in turn increases the chances of death; however, the treatment of choice is based on changes in lifestyle, which for most people are difficult to maintain long-term. As for the drug therapy treated with drugs many people do not achieve their therapeutic goals, and therefore the inflammatory condition that underlies this disease remains.

Recent studies have focused on the possible role of capsaicin in the inflammatory state through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the expression of certain genes involved in this process induced. Capsaicin is a natural choice and well tolerated with few side effects limited to the gastrointestinal tract such as dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect of capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.

It will conduct a clinicala trial, double - blind, randomized and placebo control group. Female and male patients, with dyslipidemia. Two groups will be formed with 17 patients each (capsaicin 150 mg per day or Magnesia calcinada). At the beginning and end of the intervention clinical and laboratory determination. The data obteined were analyzed using SPSS statistical software version 22. It was considered statistically significant at p \<0.05

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of dyslipidemia at the time of screening
* BMI of 25 kg /m2 to 34.9 kg / m2
* Without drug treatment in the last three months
* Signature of consent information in writing

Exclusion Criteria:

* Pregnant or lactating
* Total cholesterol ≥ 239 mg / dL, ≥400 TG, LDL-C ≥139
* Other inflammatory diseases
* consumption of some type of supplement
* Diagnosis or history of kidney or liver disease ∞ History of hypersensitivity to the compounds used in the study
Effects of Coenzyme Q10 in PSP and CBD

To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years
* Age \> 40
* Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit.
* Patients agreeable to participate in the study.

Exclusion Criteria:

* Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit.
* Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs.
* History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
* Previous use of coenzyme Q10 within 60 days of the baseline visit.
Validation of Methods to Estimate Body Fat

The purpose of this study is to evaluate various methods for estimating body composition in human subjects. Each subject is evaluated by several methods that are then compared to a criterion value. We hypothesize that the prediction method will yield the same result as the criterion value. The risks to subjects are minimal and all techniques are routinely performed.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and female (pre-menopausal) volunteers

Exclusion Criteria:

* post-menopausal and pregnant women
A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia

The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.

This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).

Eligibility Criteria:
Inclusion Criteria:

* dysuria associated with BPH for at least 12 weeks before providing consent
* a total IPSS core of 13 or higher
* a QOL score of 3 or higher
* a maximum urinary flow rate (Qmax) of ≥4 mL/sec and \<15 mL/sec.
* a prostate volume of ≥20 mL.

Exclusion Criteria:

* A postvoid residual volume (PVR) of \>350 mL
* A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
* A cataract operation scheduled to be performed during the study period
* Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
* Hypersensitivity to ASP4901 or tamsulosin hydrochloride
* Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer.

OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in these patients on this regimen. III. Determine the overall survival, disease free survival, and distant relapse rates of these patients on this regimen.

OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually until death.

PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV No distant metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular: No symptomatic coronary artery disease No angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No initial surgery (except diagnostic biopsy of the primary site or neck)
Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.


Eligibility Criteria:
Inclusion Criteria

* Male or female, 18-75 years of age at the time of consent.
* Provide written informed consent.
* Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
* Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Adequate organ and bone marrow function
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study

Exclusion Criteria:

* Pregnant or nursing females.
* Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
* Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
* Any active autoimmune disease or documented history of autoimmune disease.
* Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
* Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
* History of clinically significant cardiac disease.
* Uncontrolled current illness.
Custom Foot Orthoses & Venous Status

The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects.

Exclusion Criteria:

* Prior diagnosed conditions such as neurological, vascular or traumatic disorders.
Correlations Between Lens Star and Phacoemulsification.

To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.

To analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.

Eligibility Criteria:
Inclusion Criteria:

* patients that will undergone phacoemulsification for their mild to moderate senile cataracts.

Exclusion Criteria:

* congenital and developmental cataract.
* cases with congenital lens anomalies as ectopia lentis and spheophakia.
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone.

Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* FSGS
* To receive either a live donor or deceased donor kidney transplant

Exclusion Criteria:

* Not having FSGS