cyrilzakka/clinical-trials huggingface dataset:
Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy

The aim of this study is to investigate the effectiveness of Non-powered Negative Pressure Wound Therapy (NPWT) on the healing of abdominal surgical wounds. It is designed as a randomized controlled trial with an experimental group (using NPWT) and a control group (conventional wound care). The study aims to recruit 160 participants: 80 with acute wounds and 80 with chronic wounds. Participants will be randomly assigned to either the experimental group (40 acute wounds, 40 chronic wounds) or the control group (40 acute wounds, 40 chronic wounds). The study will assess wound healing rates and speed, quality of life, self-perceived health status, pain levels, complications, and wound care costs using indicators. Effectiveness will be analyzed using Generalized Estimating Equations (GEE). The study anticipates that results will contribute to evaluating the effects of Non-powered NPWT on wound healing, quality of life, pain, and cost-effectiveness in patients with acute and chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute wounds (wound duration \<4 weeks) or chronic wounds (wound duration ≥4 weeks).
2. Wound depth \<2 cm.
3. Age ≥18 years.
4. Patients who have been evaluated and approved for participation by their attending physician.

Exclusion Criteria:

1. Patients with unstable vital signs.
2. Presence of ischemia in the wound or surrounding tissues.
3. Fragile skin around the wound.
4. Severe wound infection or necrotic tissue.
5. Wound size \>10 × 20 cm.
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pancreatic invasive ducatal adenocarcinoma
* 2. Life expectancy of at least 3 months
* 3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

* 1. Patients with severe complication
* 2. Patients with multiple primary cancers
Measuring Patient Expectations for Thyroid Surgery

The purpose of this study is to learn more about what patients undergoing surgery for thyroid cancer expect from their surgery. Your input may help us to better prepare and inform patients about their disease and its treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* English speaking
* Patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision

Exclusion Criteria:

* Inability to speak or understand English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
* Prior thyroid surgery
* Prior radioactive iodine treatment, external beam radiation or chemotherapy
Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery

Major vascular operations put the body under stress. We are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital.

There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery.

Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.


Eligibility Criteria:
Inclusion Criteria: Patients attending vascular pre assessment clinic Age \> 60 -

Exclusion Criteria: Refusal or inability to provide informed consent. Patients under 60 years of age. Patients not undergoing a vascular procedure.

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A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/= 18 years of age
* Chronic hepatitis C, genotype 1, 2, 3
* Compensated liver disease
* Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion Criteria:

* Decompensated liver disease
* Signs or symptoms of hepatocellular carcinoma
* Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis

The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, capable to provide informed consent;
* Referred for a FDG-PET/CT study
* Classified as having Possible IE prior to FDG-PET/CT imaging;
* Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan.

Exclusion Criteria:

* Subjects with prosthetic cardiac valve and/or CIED;
* Pregnant or breastfeeding female;
* Body mass index \> 45 kg/m2.
Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic hernia inguinalis
* \> 18 years
The Cardiovascular Prevention Program

Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.


Eligibility Criteria:
Inclusion Criteria:

* primary prevention: age ≥ 30 years with a negative history of cardiovascular events
* secondary prevention: age ≥ 30 years with a negative history of cardiovascular events

Exclusion Criteria:

* severe obesity
* high-grade renal failure
* severe and/or dialysis
* oncological disease in active phase
* pregnancy
The Treatment of the Median Nerve for the Elimination of the Symptoms Associated With the Carpal Tunnel Syndrome

In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle.

We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms.

Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is done on each visit for a total of 15(without Charge).

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 60 years old,
* Numbness in the hand affecting the thumb, the index finger, the middle finger and half the ring finger,
* To have suffered from discomfort on a daily basis for at least three months and to agree to a course of 15 chiropractic treatments at no cost.

Exclusion Criteria:

* History of upper limb or neck surgery,
* Pregnancy and systemic pathologies possibly related to CTS, such as hypothyroidism, diabetes and rheumatoid arthritis.
Memantine for the Treatment of Social Deficits in Youth with Disorders of Impaired Social Interactions

This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Male \& female subjects ages 8-18 years (inclusive).
* Diagnostic Statistical Manual (DSM)-5 Autism Spectrum Disorder (ASD) diagnostic criteria as established by clinical diagnostic interview
* At least moderate severity of social impairment as measured by a total raw score of ≥85 on the parent/guardian-completed Social Responsiveness Scale-Second Edition (SRS-2)14 and a score of ≥4 on the clinician-administered Clinical Global Impression-Severity scale (CGI-S)17.

Exclusion Criteria:

* IQ ≤70 based on the Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary and Matrix Reasoning subtests
* Impaired communicative speech
* Subjects currently treated with the following medications (known to impact glutamate levels): Lamotrigine, Amantadine, N-acetylcysteine, D-cycloserine
* Subjects treated with a psychotropic medication not listed above on a dose that has not been stable for at least 4 weeks prior to study baseline.
* Co-administration of drugs that compete with memantine for renal elimination using the same renal cationic system, including hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine, and nicotine
* Initiation of a new psychosocial intervention within 30 days prior to randomization.
* Subjects who are pregnant and/or nursing.
* Subjects with a history of non-febrile seizures without a clear and resolved etiology.
* Subjects with a history of or a current liver or kidney disease.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
* Subjects who meet on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-E) for alcohol or drug dependence or abuse. If the subject has a recent history of substance abuse, there will be a two-week washout period before initiating the trial as an added precaution. There are no known safety issues relating to memantine and recent history of substance abuse.
* Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* Subjects with severe hepatic impairment (LFTs \> 3 times ULN).
* Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular acidosis, severe infection of the urinary tract).
* Known hypersensitivity to memantine.
* Severe allergies or multiple adverse drug reactions.
* A history of intolerance or adequate exposure to memantine, as determined by the clinician.
* Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Surgical Versus Medical Treatment of Acromegaly

Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone).

Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Acromegaly diagnosis
* treated with Somatostatin analogues or surgery
* in treatment control

Exclusion Criteria:

* treatment with GH-antagonist
* never treated
* not in treatment control
Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers

Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression) activated by UV radiation


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers between 18 and 30 years
* With skin type I or skin type II
* Body Mass Index \> 25
* Non-smokers
* Volunteers who have given their written informed consent according to Good Clinical Practice (GCP) and local regulations

Exclusion Criteria:

* Any serious disorder that may interfere with her participation to the trial and evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication
* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* High performance sports people
* Alcohol and drug abuse according to Diagnostic and Statistics Manual (DSM-IV)
* Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, intrauterine device (IUDs), sterilization)
* Pregnancy and/or lactation
* Known abnormal values of the lab tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
* Abnormal values of Aspartate Transferase (SGOT/ASAT), Alanine Transferase (SGPT/ALAT)-, Gamma-glutamyl transpeptidase, Low density Lipoproteins/Triglycerides (LDL/TGL) levels in blood
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
* Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
Fungal Infections During and After the SARS-CoV-2 Pandemic: A Retrospective Comparison

his study aims to retrospectively compare fungal positivity rates between the SARS-CoV-2 pandemic and the post-pandemic periods. During the pandemic, Candida species had a positivity rate of 17.36%, and Aspergillus had a rate of 2.22%. Post-pandemic, these rates decreased to 9.29% and 1.00%, respectively. The overall fungal positivity rate decreased from 9.15% during the pandemic to 5.13% post-pandemic. Statistical analysis revealed a significant decrease in fungal positivity rates post-pandemic (p \< 0.01). These findings underscore the effectiveness of post-pandemic healthcare interventions and infection control strategies.

The study aims to retrospectively compare fungal positivity rates by focusing on Candida and Aspergillus species during the SARS-CoV-2 pandemic and in the post-pandemic period. The dataset includes samples collected during the pandemic period (N=623) and the subsequent post-pandemic period (N=818). Fungal positivity rates were calculated and statistically analyzed using chi-square tests, and significance was determined as p\<0.01.

During the SARS-CoV-2 pandemic, Candida species showed a positivity rate of 17.36%, while the rate in the post-pandemic period significantly decreased to 9.29% (p=0.002). In contrast, Aspergillus species did not show a significant change in positivity rates between the pandemic (2.22%) and post-pandemic (1.00%) periods (p=0.186, NS).

Overall, the study provides valuable insights into the epidemiology of fungal infections during and after the SARS-CoV-2 pandemic, suggesting possible shifts in fungal pathogen prevalence and healthcare priorities. The findings contribute to the development of targeted healthcare strategies and surveillance measures for fungal infections in the post-pandemic era.

Study Design: Retrospective comparative analysis

Data Analysis: Chi-square tests, p\<0.01 considered significant

Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years of age of both genders

Exclusion Criteria:

* Patients under 18 years of age,
* Patients whose demographic, clinical and laboratory data investigated in the study could not be accessed, patients who were diagnosed with fungal infection during hospitalization
Ion Prostate Irradiation

The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of the prostate with carbon ions or protons using the raster scan technique.

as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

http://www.ncbi.nlm.nih.gov/pubmed/24641841

Eligibility Criteria:
Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.

The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).


Eligibility Criteria:
Inclusion Criteria

1. Provision of informed consent
2. Female or male spinal cord injured subject aged 18 years and over
3. Bacteriuria of \>10\^5 CFU/mL of \>1 bacterial species verified during screening visit
4. Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
5. Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator

Exclusion Criteria

1. Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
2. Ongoing antibiotic treatment
3. Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
4. Subject with severe catheterisation difficulties, as judged by investigator
5. Known hypersensitivity to chlorhexidine
6. Use of other instillation products
7. Pregnancy
8. Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
9. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
10. Previous enrolment or allocation of treatment in the present study.
11. Simultaneous participation in another clinical study that may interfere with the present study.
12. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Adaptation and Evaluation of the KEEP Model

This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for Native, Hispanic/Latino, Black/African American, and sexual and gender minority youth. The knowledge gained from the study will impact all current and future large-scale implementations of KEEP and will bolster our scientific understanding the impact of KEEP on youth mental health outcomes.

This study capitalizes on a contract with the Oregon Department of Human Services Child Welfare to implement KEEP state wide in Oregon with a focus on increasing access to services for minority youth populations. To help the child welfare system meet their goal of achieving health equity, adaptations to the KEEP curriculum have been made for minority groups, and KEEP is being delivered in "affinity groups". Affinity KEEP groups are tailored to meet a specific population's needs and are comprised of parents who all share a common interest, purpose, or key characteristic. To date, Affinity KEEP groups are being offered for foster/kin parents of populations defined by sexual and gender minority youth and Native youth, and for Spanish-speaking parents. The curriculum is currently being revised for transracial foster/kin placements where the youth and one or more parents are of a different race/ethnicity. The current proposal seeks to study N = 166 new families, as part of the ongoing Oregon KEEP implementation, and aggregate existing data from four KEEP studies to use propensity score matching to reduce selection bias and strengthen causal inferences that can be drawn from the potential benefits of providing KEEP to underserved minority populations. By leveraging two decades worth of data on the KEEP intervention and using state-of-the-art data harmonization techniques and a quasi-experimental design, this study affords a rigorous evaluation of whether tailoring the KEEP curriculum to minority populations' specific needs, and providing KEEP to foster/kin parents, improves youth mental health outcomes (i.e., depression/anxiety, post-traumatic stress disorder symptoms, suicidality, and externalizing behaviors) (Aim 1). The study could have a wide reach, impacting our understanding of how to improve and inform equitable delivery of services to youth and families involved in the child welfare system, and effectively address youth mental health disorders and improve care quality and long-term outcomes for a high-risk, underserved population of youth.

Eligibility Criteria:
Inclusion Criteria:

Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:

* is a dependent of Child Welfare Services in the state of Oregon
* is between the ages of 4 and 21 years.

Exclusion Criteria:

Foster/resource parents who have been recruited to attend KEEP and have a focal youth for the intervention that:

* is younger than 4 years of age.