cyrilzakka/clinical-trials huggingface dataset:
Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis

The purpose of this study is to determine if the, MR guided, laser interstitial thermal therapy (LITT) treatment technique can be safety and efficiently used for the human liver metastasis

This new "minimally invasive" technique has been tested so far, with success, on animal brain and prostate tumors. LITT has also tested with success by other teams for the treatment of liver metastasis.

The main purpose of this study is to determine if the Visualase, MR guided, laser interstitial thermal therapy device can be safely and efficiently used for the treatment of human liver metastasis originating from the colon and rectal primary tumors.

As secondary objectives for this clinical study is to explore the tolerance of the treatment and its contra indications.

The clinical trial will include a statistical sample of 25 patients and will run over a period of 24 months. The inclusion period will be of 12 months and the patients will be followed up during a period of 7 days after the intervention.

The clinical trial will be performed at the Cochin University Hospital of Paris and the patients will be coming from the oncology / surgery departments of the hospital.

The patients recruited for this study are those who developed several liver metastasis and are planned for the a surgical resection for part of the liver (where metastasis are located). Prior to the surgical resection, a LITT procedure will be performed on one of the metastasis. After the surgical resection histological analysis will be elaborated to compare the real necrosis volume created by the LITT procedure to the expected predicted volume.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients with liver metastasis, originating from colon and liver cancer and proved by histological analysis
* Patient that are scheduled for a surgical resection of part of the liver,
* Patient having a liver metastasis, originating from colon and rectal cancer, smaller or equal to 3 cm
* Patients having the liver metastasis at a distance of at least 1 cm or from the hepatic capsule or/and from a vascular structure

Exclusion Criteria:

* Patients younger than 18 years old
* Patients presenting contra indication for MRI studies
* Patient presenting contra indication to liver surgery
* Patients who already had other interstitial treatment on the targeted lesion
Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool

Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.

Triads of parents, primary care physicians, and transplant sub-specialists will be enrolled to use a pre-transplant immunization tool while their child awaits transplant. The tool will provide information about vaccines, information about vaccine-preventable infections in the transplant population, a central easily accessible vaccine record, and a communication portal. The tool will also send vaccine reminders when vaccinations are due. The investigators will assess 1) the effectiveness of the tool in improving pre-transplant immunization rates, 2) the acceptability of the tool to users and 3) the feasibility of the tool.

Eligibility Criteria:
Inclusion Criteria:

* Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant

Exclusion Criteria:

* Non English speaking
* No access to a smart phone or computer
Effect of Technology on Cognitive Function in Elderly

Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.

Aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. A significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (MCI). Currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. As such, the WHO has suggested that preventing cognitive decline and dementia is a global mental health priority. In addition to impacting the patient, dementia also has a significant impact on the family and society in general. Age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. Non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. Over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded .

Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.

Eligibility Criteria:
Inclusion criteria

1- Age ≥ 65 years. 2- Literate with ≥ 15 years of education. 3- Older adults with mild dementia. 4- Montreal cognitive assessment score 18-26 .( Pinto et al .,2019). 5- Android smartphone user. 6- Well ability to write and read. Exclusion criteria

1. Major Cardiovascular events , such as Stroke or Myocardial infraction in past three months.
2. Alzheimer's disease.
3. Sever cognitive dementia.
4. Sever hearing difficulty or visual disturbance.
5. Brain injury.
6. Limitation in communications.
7. Chronic kidney diseases.
8. Liver diseases.
9. Low or high educated.
10. Uncontrolled diabetic patients.
11. Thyroid disturbance.
12. Mental and psychological instability .
Relationship Between Constipation and Inguinal Hernia

The purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale.

Causes of inguinal hernia are known to be multifactorial, although not fully understood. Besides family history, and connective tissue diseases, the sudden increase in abdominal pressure as heavy lifting, chronic constipation , coughing, straining , situations such as difficulty urinating facilitate the formation and emergence of hernia.

Constipation severity scale(CSS) was developed by Varma et al in 2008. CSS is a scale to determine the individuals defecation frequency, the intensity and difficulty during defecation.CSS has three subscales including Pain, Congestion stool and Large Intestine laziness(0-73 points).High scores indicate that serious symptoms.

Investigators found no studies that show how constipation impact on groin hernias. Investigators are planning to understand the effect of constipation on direct and indirect hernia formation.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers(n:100)
* patients above age of 18(n:100)
* patients with groin hernia(n:100)

Exclusion Criteria:

* previous inguinal hernia surgery
* patients who did not accept the procedure
* patients under age of 18
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.

Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.

Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.

Exclusion Criteria:

--Participants who have developed any discontinuation criteria as defined in Study M19-977.
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
* HER2-positive, ie. immunohistochemistry \[IHC\] 3+ or IHC 2+ and fluorescence in situ hybridisation \[FISH\]-positive according to ASCO/CAP 2018 guidelines
* complete clinical pathological information
* Eastern Cooperative oncology Group \[ECOG\] 0-1
* Currently not pregnant or breast-feeding
* Fine organ function
* Have good compliance with planned treatment, understand the study process and sign a written informed consent

Exclusion Criteria:

* Bilateral or metastatic breast cancer
* Receiving neoadjuvant treatment
* Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
* Severe systemic infections or other serious illnesses
* HIV infection, active hepatitis B or C infection
* Known allergy to or intolerance to a therapeutic drug or its excipients
* Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
* Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
* Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
* History of mental illness or drug abuse that may affect compliance with the trial requirements
* The researchers determine that the patients were not suitable for the study
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002

Eligibility Criteria:
Inclusion Criteria:

1. men and women 18 years or older
2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
3. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria:

1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
2. \<18 years of age
3. pregnant or women of childbearing potential not using acceptable birth control
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.

Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of \>7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond \>7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemia (serum uric acid ≥8.0 mg/dL).
* Must meet American College of Rheumatology criteria for gout.
* Must have adequate renal function (serum creatinine \<1.5 mg/dL).
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

* History of xanthinuria
* Alcohol consumption \>14/week
* Has a history of significant concomitant illness.
* Has active liver disease.
* Has a body mass index greater than 50 kilogram per meter² (kg/m²)
* Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Integrated Community Based Health Systems Strengthening Preliminary Study in Kozah Togo

This preliminary study aims to inform the design and delivery of the integrated facility and community-based health systems strengthening (ICBHSS) model in four Kozah District health facilities over a period of 48 months. Specific aims include: (1) Assess maternal and child health outcomes and health service utilization rates in the 4 ICBHSS model intervention sites catchment areas; (2) Identify barriers to and facilitators of access and quality services related to ICBHSS model; and (3) Assess changes in health care services coverage, effectiveness, and adoption of ICBHSS model.

Intervention: The investigators have adapted an integrated facility and community-based health systems strengthening (ICBHSS) model to improve primary healthcare services in Togo. The ICBHSS model includes a bundle of evidence based interventions including (1) community engagement meetings and feedback; (2) the elimination of facility user fees for children under five and pregnant women; (3) pro-active community based IMCI using Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing \& referrals; (4) clinical mentoring and enhanced supervision at public sector facilities; and (5) improved supply chain management and facility structures.

Study: The investigators will conduct a mixed methods assessment, using the RE-AIM framework to evaluate the impact and implementation of the ICBHSS initiative in Kozah district. It will include: (1) a repeated cross-sectional study to obtain annual coverage, effectiveness, and adoption metrics using a population-based household survey as well as (2) qualitative key informant interviews and focus group discussions conducted at 12 months for each intervention health facility. The primary outcome will be under 5 year old mortality rate, with secondary outcomes including under-one mortality rate, maternal mortality rate, as well as maternal and child health service utilization.

Eligibility Criteria:
Inclusion Criteria:

* Female of reproductive age (aged 15-49 years)
* Individuals aged 15-17 years will only be included if they have children and/or are pregnant
* Lives in selected household within study catchment area
* Informed consent is obtained for participants 18-49
* Waiver of parental permission is obtained for 15-17 year-old participants

Exclusion Criteria:

-
Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.


Eligibility Criteria:
Inclusion Criteria:

* Previously have had radical radiotherapy for localised prostate cancer
* Due to undergo routine post-treatment prostatic biopsies
* Suitable for MRI scan
* Adequate renal function
* No previous reaction to gadolinium
* Able to give informed consent
* No recent prostate biopsy within 6 weeks of enrolment
* Performance status (Eastern Cooperative Oncology Group \[ECOG\]) 0 or 1

Exclusion Criteria:

* Not suitable for MRI scan
* Previous reaction to gadolinium
* Impaired renal function
* Inability to give informed consent
The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly

The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years or more, articulate in Korean
* Patients diagnosed with asthma, at least 1 year in duration.

Exclusion Criteria:

* Patients being followed-up for asthma treatment less than 1 year before baseline
* Patients taking immune therapy
* Patients previously enrolled/randomized in the present clinical trial
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial

The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms.

The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms, evaluating the plasma concentration of angiogenic factors, microparticles of endothelial cells and the cell number circulating endothelial progenitor.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing and able to give informed consent for participation in the study
* Ability to understand study procedures and to comply with it for the duration of the study.
* Subjects of both sexes, the age range between 18 and 70 years old.
* Serum uric acid above 7 mg / dl.
* Estimated glomerular filtration rate by MDRD abbreviated formula less than 60 ml / min / 1.73 m2 and above 15 ml / min / 1.73 m2.
* Stability of renal function (serum creatinine increase without exceeding 50% in the three months before the start of the study).
* Clinically stable in terms of no hospitalizations of cardiovascular events in the 3 months before the study began.

Exclusion Criteria:

* Drop active in the 60 days prior to study initiation.
* Use of allopurinol within 60 days preceding baseline
* Active infections within 30 days prior to baseline.
* Patients with systemic inflammatory disease
* Infection with HIV, Hepatitis C and Hepatitis B.
* History of cancer within 5 years prior to the first dose of study medication
* Chronic liver disease.
* Immunosuppressive therapy.
* Pregnant women, breastfeeding or planning to become pregnant.
* Allergy or sensitive to allopurinol.
* Addiction to drugs or alcohol, in the opinion of the investigator, may interfere with compliance with study requirements.
* Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.
Relevance and Salience During Attention Task

In this line of research, the researchers are examining the influence of relevance of a salient item on task performance, depending on overall task set.

When finding a target item during visual search (looking for a pencil), a salient item can capture attention (your phone flashing from a message). Typical attention studies only examine salient items when shown as distractor during search, to ensure any attention to the items are driven by salience alone. However, the impact of salience may interact with the relevance of the item for the search task (e.g. how likely the salient item is to be the target). Here, the researchers investigate these interactions in a basic science study when participants perform an easy task or a difficult search task.

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-