cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cognitive Functions on Upper Extremity Functionality in Parkinson's Patients

Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.

Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. Involvement of nigrostriatal dopaminergic neurons is associated with the motor manifestations of the disease. The most common of these symptoms are; resting tremor, bradykinesia, rigidity and balance disorder. However, non-motor symptoms related to the involvement of nervous system structures other than the dopaminergic nigrostriatal system can be observed in PD. However, due to the predominance of motor symptoms in PD, it took many years to notice cognitive changes. Traditionally, cognitive impairments in PD have been expected to occur in the advanced stages of the disease. However, cognitive impairments in the early stages are reported in approximately 30-35% of patients. Cognitive dysfunction is defined in PD, ranging from mild impairments in certain cognitive domains to severe dementia. Cognitive impairment primarily affects executive and visuospatial functions, and memory is secondarily affected.

Executive functions are higher cognitive processes that use and modify information from many cortical sensory systems in the fore and hindbrain areas to modulate and teach behavior. The frontal cortex, especially the prefrontal cortex and its striatal connections are very important neuroanatomical regions for executive functions. The relationship between the effects of cognition and motor performance and parameters in groups such as the elderly, PD and Alzheimer's patients in which these centers are affected has been an issue that has attracted the attention of many researchers. Most of the studies have focused on the lower extremity performance of cognition. However , it has been reported that cognition has positive effects on upper extremity performance and early acquired upper extremity skills have positive effects on cognitive performance .

The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Parkinson's Disease.
* Not having hearing and vision problems.
* To be able to take the commands required for the manual dexterity tests.
* Agree to participate in the study.

Exclusion Criteria:

* Having undergone musculoskeletal surgery for the upper extremity.
* Having vision and hearing problems.
* Having an additional disease that may affect cognitive tests.
Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

Treatment of schizophrenia currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.

Treatment of schizophrenia (SZ) currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of targeted cognitive training (TCT) in schizophrenia. This project tests a rational and empirically supported platform for augmenting the benefits of TCT in antipsychotic medicated SZ patients by adjunctive daily treatment of 20 mg memantine, an FDA approved medication for the treatment of cognitive dysfunction in Alzheimer's Disease. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Written informed consent to participate in the study
* Age 18-65
* Absence of dementia or mental retardation
* Urine toxicology negative for recreational drugs
* Fluent and literate in English

Exclusion Criteria:

* Meets DSM-IV criteria for current substance abuse or dependence and has been substance abstinent for less than 30 days
* A history of traumatic brain injury
* Auditory or visual impairments severe enough to prevent study participation
* Under conservatorship (determined by Anasazi)
* Pregnancy
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old

To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 6-11 years at time of enrollment
* General good health, as judged by the Investigator
* History of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver
* Agreement to refrain from using other topical medical, over-the counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence
* Agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence
* Subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative).
* Willingness to comply with all requirements of the study.

Exclusion Criteria:

* Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)
* Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders
* Administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study
* Administration of an immunomodulatory agent within the past 30 days
* History of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle
* Clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures Nursing or pregnant (Pubescent females require pregnancy testing)
Assessment of Differential Renal Function by CT in Living Donors

The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).


Eligibility Criteria:
Inclusion Criteria:

* Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment
* Mandatory enrollment in a health security plan (French Social Security)
* Subject having signed an informed consent

Exclusion Criteria:

* Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy
* Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney)
* Subjets under a legal protection measure
Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.

A prospective observational trial of patients with metastatic cancer of various entities which aims at both clarifying the significance of liquid biopsy and establishing a foundation for translational research.

ALPS is a prospective observational trial to assess liquid biopsy as diagnostic tool in patients with various metastatic neoplasms. Liquid biopsy will be correlated not only with the tissue biopsy, but also to imaging modalities and classical tumor markers. In addition, the study aims to investigate clonal heterogeneity and evolution of different cancers during patient treatment courses. A third aspect of the study is to survey and assess patients' knowledge about biomarkers and personalized medicine in general and about liquid biopsy as a new diagnostic tool.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥ 18 years
* Histopathologically confirmed metastatic or locally advanced cancer
* No curative treatment options, except for germ cell tumors
* Written Agreement to be followed up at Augsburg University Medical Center
* Signed written informed consent for the Biobank Augsburg (Biobank-A)
* Willing to undergo treatment according to standard of care
* Availability or anticipated availability of tumor tissue at time point of inclusion
* Anticipated life expectancy of at least 3 months at time point of trial inclusion

Exclusion Criteria:

* Psychological condition that would preclude informed consent
* Additional tumor treatment between acquisition of tumor tissue and trial inclusion
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age or older
* Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision.
* Terrien's Marginal Degeneration
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

* Severe corneal scarring that markedly affects vision
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease
Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation.

Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* The study included healthy individuals of both sexes,
* between 18 to 65 years,
* without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values,
* ability to verbal commands understand and
* willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.
NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

Primary objective:

To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.

Secondary objectives:

1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.
2. To evaluate patient experience when self-operating the Notal-OCT V2.5.

To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to give informed consent (IC)
* 18 years of age or older
* Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
* Ability to undergo OCT (optical coherence tomography) testing
* Visual acuity of 20/400 Snellen (6/120) or better in the study eye

Exclusion Criteria:

- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.
Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors

To compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor HRQoL and identify predictors of poor donor HRQoL.

There is limited data to show the effects that donation has on pediatric donors to their siblings. There is widespread agreement that it is critical to investigate the medical and psychosocial aspects of sibling pediatric HSC donation for multiple reasons including (a) the vulnerability of the pediatric population undergoing donation, (b) increasing use of pediatric HSC donation as a therapeutic option, (c) evidence that \~20% of pediatric HSC donors experience clinically important HRQoL deficits, and (d) the impact that improved understanding of factors predicting poor HRQoL will have on our ability to develop guidelines and/or interventions for assisting at-risk donors/families. The proposed study will help to compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor HRQoL and identify predictors of poor donor HRQoL.

Eligibility Criteria:
Inclusion Criteria:

* Participants must fall into one of the following categories:

  * Donor between the age of 5 and 17 who is donating to a sibling
  * Parent/caregiver of study participating donor
  * Recipient sibling aged 5 to 17 of study participating donor
  * Any of the donor's non-donor/non-recipient siblings between 5 and 17
  * Any child between 5 and 17 with a brother or sister (also between 5 and 17) receiving a transplant from an unrelated source
* Be willing and able to provide signed informed consent:

  * Adults must give consent for their children's and, if applicable, their own participation
  * Assent will be obtained in accordance with guidelines at the participant's transplant institution
* Be willing and able to respond to psychological assessment questions
* Must be the donor's first donation
* Recipient must consent to the CIBMTR research database

Exclusion Criteria:

* For families with pediatric donors aged 5 to 17, at minimum, the donor child and/or one parent must consent/assent to participation. If that minimum is not met, the family will be excluded
* Donor or non-donor siblings who do not live in the same household as the recipient at lease half of the time
* Unable to consent/assent or complete a phone interview in English

  * Parents may consent/assent in Spanish
* No access to a telephone
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study

This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial with empagliflozin compared to placebo that is added to open-label ramipril.


Eligibility Criteria:
Inclusion criteria:

* Signed and dated written informed consent.
* Male or female patients diagnosed with type 1 diabetes (T1D) at least 6 months prior to informed consent or type 2 diabetes (T2D) or non-diabetic obese patients.
* T1D patients must use and be willing of and be willing to continue throughout the duration of the trial either:
* multiple daily injections of insulin OR
* continuous sub-cutaneous insulin infusion of any insulin type, with at least 3 months experience
* For patients with T1D or T2D,HbA1c of 6.5 - 11%
* Age at least 18 years of age
* Body mass index of \>=18.5 kg/m\^2
* Estimated glomerular filtration rate greater than or equal to 60 ml/min/1.73m2
* Blood pressure greater than 90 /60 mmHg and less than or equal to 140 / 90 mmHg
* Use of a highly effective method of contraception.
* Further inclusion criteria apply

Exclusion criteria:

* For patients with T1D, treatment with an antihyperglycaemic agent within 3 months prior to visit 1
* occurrence of severe hypoglycaemia within 3 months prior to visit 1
* hypoglycaemic unawareness within 3 months prior to visit 1
* occurrence of diabetic ketoacidosis within 3 months of visit 1 and until visit 3 Further exclusion criteria apply
Covid-19 Patients Management During Home Isolation

The study will investigate management of Covid-19 patients in home isolation.

A clinical trial concerned with the treatment of home isolated COVID-19 patients

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 patients American Society of Anesthesiologists (ASA) class I \>= 21 years old \<= 40 years old

Exclusion Criteria:

* Not being consistent with home-isolation regimen
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial

It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.

Exclusion Criteria:

* Stone size greater than 1.5 cm on preoperative imaging
* Pregnancy
* Stent placement prior to ureteroscopy ("pre-stented patients")
* Patients with solitary kidney
Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants

The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.

Design: Prospective, controlled, randomized, multi-center.

Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours.

Conditions of measurements:

Primary endpoint: Proportion of failure in both arms during the first 24 hours.

Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2

Statistic: Intention to treat Analysis.

Expected number of patients: 135 per arm: 270 children.


Eligibility Criteria:
Inclusion Criteria:

* age \< 6 months
* bronchiolitis
* mWCAS \> or =3
* hospitalisation: PICU
* signed consent form by parents

Exclusion Criteria:

* Intubated patient
* Neurological or cardiac disease
Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.


Eligibility Criteria:
Inclusion Criteria:

* Males 45 to 64 years of age
* Lower urinary tract symptoms \> 6 months
* International Prostate Symptom Score \> 12

Exclusion Criteria:

* Prostate Specific Antigen \> 3 ng/ml
* Residual urine volume \> 150 m
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
* Other exclusion criteria apply acc. to Summary of Product Characteristics
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.


Eligibility Criteria:
Inclusion Criteria:

* Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
* Signed informed consent

Exclusion Criteria:

* Any major violation of protocol AC-052-366 (NCT00313222)
* Pregnancy or breast-feeding