cyrilzakka/clinical-trials huggingface dataset:
A Novel Hepatitis c micrOelimination Program in Non imprisonEd SenTenced With Alternative Measures

The objective of this study is to carry out a Micro-elimination program for HCV infection in a vulnerable population (people sentenced to non-custodial sentences). This group shares certain peculiarities with the prison population (vulnerability, addictions, mental disorders, etc.), is three times higher than the imprisoned population, and is regularly attended by Social Insertion Centers (CIS) in Spain. An additional objective is to link these people with the specific plans of the Government of Cantabria (Chronicity Plan, Care for Serious Mental Disorders, Harm Reduction Programs and the Center for Attention to Drug Addicts) as well as the Extended Bridge Program for Penitentiary Institutions, implementing the figure of a Navigator (a specialized professional in charge of helping subjects overcome barriers). It is an observational study based on the screening of disease in accordance with the recommendations of the health authorities. Once detected, patients will be referred to the corresponding specialized care following the usual clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* the entire population served in the Management of Penalties and Alternative Measures Service (SGPMA) of the José Hierro SIC, including new admissions within the study period.

Exclusion Criteria:

* they are not willing to participate and do not sign informed consent.
Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream

Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.

The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.

The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).

The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50
* female patient must be in post-menopause (\> 2 years)
* Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands

Exclusion Criteria:

* non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma
* intolerance against an ingredience of pigmanorm® cream
* acute inflammation or eczema on back of the hands
* patients with renal disease
* intake of photosensibilisating medication in the past 3 months
* treatment of solar lentigines on back of the hands in the past 6 months
* solarium or sun exposure about 6 weeks before and after treatment
* immunsuppressed patients
The Effect of Special Discharge Training in the COVID-19

This study aimed to evaluate the impact of specialized discharge education on the daily life activities and quality of life of geriatric patients hospitalized in COVID-19 wards. The motivation behind this study stems from the vulnerability of elderly patients during the COVID-19 pandemic and the necessity of tailored education to support their daily life activities and enhance their quality of life after discharge. The primary objective of this article is to determine the specific type of specialized discharge education that geriatric patients in COVID-19 wards require to improve their ability to sustain daily life activities and enhance their quality of life.

The central idea of this study is that providing specialized discharge education to geriatric patients in COVID-19 wards can result in improvements in their daily life activities and quality of life. The main findings of the study demonstrate a significant enhancement in daily life activities and quality of life among patients who received specialized discharge education. These individuals exhibited increased independence in mobility, improved performance in daily life activities, and reported an overall improvement in their quality of life.

These findings underscore the significance of specialized discharge education for geriatric patients hospitalized in COVID-19 wards and highlight its positive impact on their health outcomes and quality of life.

Purpose: This research aimed to determine the impact of specialized discharge training on the daily living activities and quality of life of geriatric patients admitted to the COVID-19 ward.

Materials and Methods: A quasi-experimental study was conducted on geriatric patients admitted to a training and research hospital's COVID-19 ward between April 1 and July 1, 2022. A control group of 40 individuals and a study group of 40 individuals, both meeting the inclusion criteria, were established. Research data were collected using the Descriptive Features Form, Katz Index of Independence in Activities of Daily Living, and SF-12 Quality of Life Scale.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study were as follows; Willingness to participate in the research, Age 65 and over, Hospitalized geriatric patients in the pandemic service, Openness to communication and cooperation, Sound mental health, Absence of sensory impairments such as vision, hearing, and speech.

Exclusion Criteria:

* patients who do not meet the inclusion criteria
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

The duration of treatment is 4 months.

Eligibility Criteria:
Inclusion Criteria:

* High cholesterol

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Adult Dacryocystocele Among Patients With Epiphora

Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.

Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Lacrimal sac mucocele
* Acquired type

Exclusion Criteria:

* No previous lacrimal sac surgery
* Suspected lacrimal sac malignancy
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.


Eligibility Criteria:
Inclusion Criteria:

* - peritoneal malignant mesothelioma

Exclusion Criteria:

* opposition to reuse personnal data
Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.


Eligibility Criteria:
Inclusion Criteria:

* female, 40 to 70 years of age
* non-lactating and either surgically sterile or postmenopausal
* body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

* no use of a bisphosphonate within 1 month
* no history of GI disease
* no use of any medications within 7-14 days prior to scheduled dosing day
Safety Study of MGAH22 in HER2-positive Carcinomas

The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it has an effect on tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed carcinoma that overexpresses HER2 by immunohistochemistry (2+ or 3+ positivity by HercepTest or equivalent).
* Progressive disease during or after last treatment regimen.
* Appropriate treatment history for histological entity.
* ECOG Performance Status \<= 1.
* Life expectancy \>= 3 month.
* Measurable disease
* Acceptable laboratory parameters and adequate organ reserve.
* Baseline LVEF \>50%

Exclusion Criteria:

* Lifetime anthracycline exposure \> 350 mg/m2 of doxorubicin or equivalent
* Major surgery within four weeks before enrollment.
* Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
* Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
* History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
* History of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment.
* Known history of central nervous system (CNS) metastatic disease with evidence of residual or recurrent disease upon entry.
* New York Heart Association class III or IV heart disease.
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)

The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).


Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of GERD by a gastroenterologist
2. minimum of 3 months of GERD symptoms prior to screening.
3. currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening
4. experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy
5. experienced GERD symptoms, defined as heartburn (with or without regurgitation or other GERD symptoms) on ≥ 3 days during the week prior to screening

Exclusion Criteria:

1. evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening
2. has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks)
3. unstable or severe medical condition
Rotator Cuff Surgical Outcomes in Women

The overall purpose of this work is to use a prospective cohort study to examine patient-specific but shoulder-extrinsic factors and how they influence the results of rotator cuff surgery. There are undoubtedly many factors that play a role in patient outcome, however, this project will focus on three: the effect of gender on outcome, the effect of mood disorders and coping style on outcome, and the effect of patient height and reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have a significant influence over outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Referred for surgical treatment of predominantly unilateral rotator cuff syndrome

Exclusion Criteria:

* unable to speak or read English
* unable to complete 12 month follow-up
* significant cervicogenic arm and shoulder pain in the affected arm
* significant chronic pain diagnoses felt at least as likely to be the cause of the symptoms as the rotator cuff condition as evaluated by the surgeon
Chronopharmacology of Valsartan in Normotensive Subjects

The choice of drug administration time may affect the pharmacokinetics and/or drug response, and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects or to enhance efficacy. This study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.

International guidelines recommend the use of long acting, once-daily medications that provide 24h efficacy; they improve adherence to therapy and minimize BP variability with smoother and more consistent BP control.

Valsartan has been approved to be used once-daily, without any specification of treatment-time in package insert. Several trials have investigated the differential effects of morning versus evening administration of valsartan in hypertensive patients, however, the results of these studies were contradicting. Furthermore, the specific administration time dependent dose response curve have not been previously investigated. So, this study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old and not more than 45 healthy male volunteers
2. Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
3. Who had passed all the screening parameters including physical examination, laboratory tests.
4. Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
5. diurnal active subjects with eight hour night sleep.
6. free of any drug exposure known to interfere with the pharmacokinetics/pharmacodynamics or assay of valsartan for at least 10 days prior to the study

Exclusion Criteria:

1. Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
2. Susceptibility to allergic reactions to valsartan.
3. Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
4. Gastrointestinal diseases.
5. Renal diseases.
6. Cardiovascular diseases.
7. Pancreatic disease including diabetes.
8. Hepatic diseases.
9. Hematological disease or pulmonary disease
10. Abnormal laboratory values.
11. Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.
12. Nocturnal active subjects
Efficacy and Safety of Fermented Ginseng Powder on Liver Function

This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation index, and Multidimensional Fatigue Scale.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-70 years with ALT 35-105 IU/L

Exclusion Criteria:

* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding etc.
Study of the Human Skin Microbiome

Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.

Subjects age 18 and above may be included in the study. It is the goal of the study to survey multiple skin locations of humans at multiple time points. The subjects' samples will be analyzed using DNA methods in order to identify the types of microbes present on the swabs. Other substances such as proteins, RNA, and other metabolites may also be analyzed. DNA or other molecular components of the sample will be extracted. Alternately, microbes in the sample can be cultured directly. The samples will be explored using molecular analyses. The backbone of the analyses will be shotgun metagenomic sequencing and 16S rDNA amplicon sequencing. The results of these analyses will be used to identify and describe the microbiome of the skin.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Subjects must be able to consent for themselves.
* Must be willing to participate to a swab of the skin.

Exclusion Criteria:

* Subjects cannot be 17 years of age or younger.
The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer

Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.


Eligibility Criteria:
Inclusion Criteria:

1. Age, between 19 and 79
2. Patients with gastric adenoma or early gastric cancer
3. Patients with ECOG-PS 0 or 1
4. Patients with adequate renal function
5. Patients with adequate hepatic function
6. Patients with adequate bone marrow function

Exclusion Criteria:

1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD.
2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.
3. Patients who has undergone gastrostomy
4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide.
5. Pregnant or breast feeding.
LocalVancomycinPowderToPreventPeriprostheticJointInfection.

The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.

Periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (TJA), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. Surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent .

Despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. Thus, there is significant interest in developing and systematically evaluating new PJI prophylaxis measures to reduce this rate.

Historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. The earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. The use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). Similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery.

Importantly, data on topical vancomycin powder used alone remain inconclusive for TJA, with some stating that it may increase aseptic wound complications, and others stating that it reduces PJI significantly .

Eligibility Criteria:
Inclusion Criteria:

all patients population who will undergo primary total knee or total hip arthroplasty

Exclusion Criteria:

* patients with diabetes mellitus inflammatory arthritis diseases smokers BMI \> 40