cyrilzakka/clinical-trials huggingface dataset:
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.

This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD (ICD9=332.0)
* MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
* Urological work-up within 3 months of enrollment to:

  * Rule out treatable causes of urinary symptoms

    * Urinalysis (UA)
    * Post-void residual ultrasound (PVR)
    * Urinary cytology
  * Documented symptoms OAB on screening 3-day voiding diary:

    * Average of 1 urgency episode / 24 hours, and
    * Average of 8 micturitions / 24 hours
    * Subjective complaints of symptoms for 3 months

Exclusion Criteria:

* Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
* Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
* Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
* Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
* Uncontrolled narrow angle glaucoma
* History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
* History of hepatic or renal impairment
* History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
* Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient greater than or equal to 35 years of age
* High resolution CT scan indicates unilateral or bilateral emphysema
* High resolution CT scan indicates homogeneous or heterogeneous emphysema
* Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
* Total Lung Capacity greater than 100% predicted
* Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
* Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
* Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

* Patient has a change in FEV1 greater than 20% post-bronchodilator
* Patients DLCO less than 20% predicted
* Patient has a history of recurrent clinically significant respiratory infection
* Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
* Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
* Patient has clinically significant bronchiectasis
* Patient has giant bullae greater than 1/3 lung volume
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies with 30 days prior to this study
* Patient is taking greater than 20 mg prednisone (or similar steroid) daily
* Patient is on Plavix or has not been weaned off prior to procedure
* Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, either gender, and any race.
* Psoriasis affecting \>=5% of body surface, PASI score \>=10 (maximum score 72).
* History of plaque psoriasis for \>6 months.
* Informed written consent.
* Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa \[PUVA\], or systemic therapy).
* Negative chest x-ray and purified protein derivative (PPD) within 1 month.
* Understand and be able to adhere to dosing and visit schedules.
* Screening laboratory tests must meet protocol-specified criteria.
* Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.

Exclusion Criteria:

* Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment.
* Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb \[UVB\], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins.
* Received previous immunobiologics.
* Have HIV, hepatitis B or C.
* Recently transplanted (exception - corneal transplant \>3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence).
* Concurrent medications that are not permitted.
* congestive heart failure (CHF)
* Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.
* Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening.
* Treatment with any investigational drug within 3 months prior to Screening.
* Allergy to murine proteins.
* Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.
* History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening.
* Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
* Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk.
* History of current alcohol or drug abuse.
* Not observed designated washout periods for any of the prohibited medications in protocol.
Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome

SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.


Eligibility Criteria:
Inclusion Criteria:

* Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003

Exclusion Criteria:

* Refusal to continue the study
Point-of-Care System for Determination of Bilirubin Capacity in Neonates

The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates.

The status of bilirubin binding to albumin (Alb) is central to personalized management of unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced neurologic dysfunction (BIND) (1). Our objectives were to validate the Aviv Bili-4 Hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical studies and surveys of end-users. In addition, we continued our efforts to validate the Bili-4 device in order to facilitate Aviv, Inc. in their development of claims of the most appropriate use of bilirubin binding capacity (BBC) information in the management of neonates. Neonatal blood samples were obtained from newborns born at Stanford University's LPCH with gestational ages (GA) ranging from 22-40 wks. Total bilirubin (TB), Alb and apparent serum unbound bilirubin (UB) concentrations were measured or calculated. Ratios of bound bilirubin (BB) to reserve Alb binding capacity for bilirubin (RABC) were also determined. Bilirubin binding capacity (BBC) by hematofluorometry (Hmf) was compared to the calculated BBC (or 8.8 × Alb) using Alb levels as measured by the clinical laboratory. We report the progress of this inquiry at the Stanford University (1).

Eligibility Criteria:
Inclusion Criteria are in vitro testing of blood samples obtained from eligible babies:

* Subjects must meet all of the following inclusion criteria to be considered eligible for study enrollment soon after birth or re-admission (for phototherapy):

  * Parental informed consent
  * Male and female newborns with a GA ≥ 24 wks with a birthweight ≥ 500 g as well as sick or unstable late preterm newborns infants with GA ≥ 35 wks with a birthweight ≥ 2500 g.
  * Enrollment at age less than 14 days and more than 6h

Exclusion Criteria:

* None.
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).

The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;
* Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;
* Was 18 years of age or older; and
* Had an elective popliteal artery aneurysm procedure.

Exclusion Criteria:

* Bilateral popliteal artery aneurysms with initial treatment on the same day
* Had previous surgery for the popliteal artery aneurysm in the study limb
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body

The purpose of this study is to determine the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment.

Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for treating a number of blinding diseases by removing and replacing the diseased vitreous body. Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to regenerate after surgery. We have devised a novel foldable capsular vitreous body (FCVB) consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body in our previous study.

Eligibility Criteria:
Inclusion Criteria:

1. Refractive error less than ±3D
2. Visual acuity worse than finger count
3. Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm
4. Signed the informed consent form

Exclusion Criteria:

1. Serious heart, lung, liver and kidney dysfunction
2. Serious eye inflammation
3. Silicone oil filled eyes
4. The contralateral eye is non-functional
5. Patients with diseases that the researchers consider not suitable participated in this clinical trial
Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers

PENFUP FASE 2, It is a multicenter study by parallel conglomerates, planned in order to evaluate the efficacy between two levels of frequency of postural change in intensive care units for adults of hospitals in various regions of Colombia.

Taking into account a design effect of 6.7, Investigators planned to include 150 participants from each ICU. Investigators did calculate that a total of 22 ICUs are required, in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until obtaining a total of 1,650 patients in each arm of the study and a total of 3,300 participants in the study.

Eligibility Criteria:
Inclusion Criteria:

* The ICU manage adult patients, over 18 years of age, with any type of emphasis (surgical, medical, neurological, or mixed);
* Patients are admitted in critical condition (with life support);
* The director accepts the commitment of the care assigned in the randomization (for a period of 3 months).

Exclusion Criteria:

* Intermediate care units in which patients mobilize themselves.
* Covid patients or other patients exposed to different mobilization patterns (e.g., 12 hours prone vs 12 supine)
Genetic and Neural Factors in Alcohol-Related Cognition

This study is about how genetic and brain factors impact cognitive processes and behavior after alcohol consumption. Participation in this project will contribute to a better understanding of biological factors that influence alcohol misuse. This study will be completed in two laboratory visits.

Some study details are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* No current or regular use of prescribed or illicit psychoactive drugs
* Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
* Free of a neurological or psychiatric disorders
* No current drug abuse (e.g., recreational drug use).
* Right hand dominant
* Free of claustrophobia
* Free of pregnancy or suspected pregnancy
* Absent MRI risk factors (e.g., implanted medical device, body mass index \> 35, braces)
* Free of medical conditions that render individuals with overly sensitive hearing
* Non-naive to alcohol consumption

Exclusion Criteria:

* Not meeting inclusion criteria listed above
A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease

The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects


Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Male and female subjects aged between 18 and 79 years (inclusive) at screening.
* Body mass index (BMI) of 18.0 to 34.0 kg/m2 (inclusive) at screening. Body weight of at least 50 kg.
* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day-1. They must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) a highly effective method of contraception with a failure rate of \< 1% per year and must use condoms, diaphragm or cervical cap with spermicide, or be sexually abstinent. Hormonal contraceptive must be initiated at least 1 month before study treatment administration.

Renal function impairment subjects:

• At screening and on Day -1, the stage of renal function impairment will be defined by Creatinine Clearance (CLcr) by the Cockcroft-Gault (C-G) equation:

* Mild renal function impairment: CLcr 60-89 mL/min (Group A).
* Moderate renal function impairment: CLcr 30-59 mL/min (Group B).
* Severe renal function impairment: CLcr \<30 mL/min (Group C).

The stage of renal impairment will need to be confirmed at Day -1 and the CLcr values on Day -1 will need to remain within ± 25% of the screening value.

Healthy subjects:

• Normal renal function confirmed by a CLcr ≥ 90 mL/min. Normal renal function will need to be confirmed at Day -1 and the CLcr value on Day -1 will need to remain within ± 25% of the screening value.

Exclusion Criteria:

All subjects:

* Pregnant or lactating women.
* Known hypersensitivity to ID-085 or treatments of the same class, or any of its excipients.
* Known hypersensitivity or allergy to natural rubber latex.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Renal function impairment subjects:

* Subjects on dialysis.
* Hemoglobin concentration \< 9 g/dL.
* Serum potassium concentration \> 6 mmol/L.
* Platelet count \< 100 × 10\^6/mL.
* History of severe renal stenosis.
* History of clinically relevant bleeding disorder.
* Gastrointestinal bleeding within 2 weeks prior to screening.
* Presence of unstable diabetes mellitus.
Prevention of Traveler's Diarrhea

The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy bikers
* Able to pass the Amazonia forest by bike

Exclusion Criteria:

* None predifinied
A Study of Pertuzumab in Participants With Metastatic Breast Cancer

This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Females at least 18 years of age
* Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Karnofsky performance status at least 80%
* Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
* Left ventricular ejection fraction (LVEF) at least 50%
* Adequate liver function

Exclusion Criteria:

* Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
* Pulmonary or central nervous system (CNS) metastases
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
* Previous treatment with any drug that targets the HER2 receptor family
* Previous treatment with corticosteroids as cancer therapy
* History of significant cardiac disease
* Major surgery or trauma within 4 weeks of Day 1
* Pregnant or lactating women