cyrilzakka/clinical-trials huggingface dataset:
BVAIT: B-Vitamin Atherosclerosis Intervention Trial

The purpose of this study is to examine whether vitamin B supplementation will reduce the progression of early atherosclerosis in individuals over 40 years old and without clinical evidence of cardiovascular disease (CVD).

The primary hypothesis to be tested is that daily vitamin B supplementation reduces progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and CT will be used to measure coronary and aortic calcium. The beneficial effects of vitamin B supplementation are expected to occur with or without a change in LDL-C levels.

A total of 506 men and women will be randomized to receive either 1) vitamin B supplementation consisting of folic acid 5mg, vitamin B12 0.4mg, and vitamin B6 50mg, or 2) a matching placebo. Participants will receive ultrasonography at baseline and every 6 months for 2.5 to 4.5 years, and CT scan at baseline and end of study (2.5 to 4.5 years).

Eligibility Criteria:
Inclusion Criteria:

* Male or female (postmenopausal)
* 40 years or older
* Fasting plasma homocysteine 8.5 micromoles per liter (µmol/L) or greater

Exclusion Criteria:

* Any clinical signs or symptoms of cardiovascular disease (CVD)
* Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
* Triglyceride (TG) levels 500mg/dL or greater
* Serum creatinine greater than 1.6 mg/dL
* Uncontrolled hypertension (systolic blood pressure 160 mmHg or greater and/or diastolic blood pressure 100 mmHg or greater)
* Thyroid disease (untreated)
* Life threatening disease with prognosis less than 5 years
* Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug use, cocaine use)
Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients

NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.

Randomized, open and prospective clinical trial.

Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:

Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.

After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old.
* Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
* Patient with a BMI equal to or greater than 30 Kg / m2
* Patients with clinical and radiological criteria of knee osteoarthritis.
* Patients with indication for primary TKA according to medical criteria.

Exclusion Criteria:

* Pregnancy or lactation.
* Inability to give informed consent in the absence of a legal representative.
* Subjects that are participating in a study with medicines or other medical devices.
* Those who show inability to follow the instructions or collaborate during the development of the study.
* If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
* Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
* Need a simultaneous bilateral TKA.
* Have a varus angle or valgus ≥ 15 °.
* Total revision knee arthroplasty.
A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)

The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.


Eligibility Criteria:
The main inclusion criteria include but are not limited to the following:

* Be in good health

The main exclusion criteria include but are not limited to the following:

* History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* History of cancer (malignancy).
Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children

There are difficulties in the progress of the study and cancel the plan. The purpose of this study is to evaluate the postoperative pain control using non - opioidal analgesics in children. The investigators will investigate the effect of single use and combination of caldorol(ibuprofen) compare to denogan(propacetamol) in children.

Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years old are divided 3 groups(caldolor, denogan, combination). Each groups are received a medication by protocol during surgery. After operation patient's pain score and use of additional analgesics are recorded in postanesthesia care unit and general ward.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo laparoscopic inguinal hernia surgery
* American Society of Anesthesiologists physical status classification 1 or 2
* Children aged 6 months to 6 years

Exclusion Criteria:

* history of Gastrointestinal bleeding
* history or laboratory finding of suspected renal or hepatic dysfunction
* bronchial asthma
* bleeding disorder
* hypersensitivity to NSAID or propacetamol
* disagreement of investigation
* The researcher determines that participation is inappropriate due to other reasons.
Museum Prescription by a Physician for a Visit to the MBAM

In recent years, museums have participated in the patient care journey by using art to enhance their quality of life and well-being. Since 2015, the Montreal Museum of Fine Arts (MMFA) and Dr. Beauchet have developed an Action-Research program exploring the effects of participatory art activities for community elders conducted at the MMFA, known as the Arts \& Longevity Lab (ALL). The mandate of ALL is to improve the well-being, quality of life and health (i.e. mental and physical state) of individuals and patients through the practice of visual arts activities (i.e. arts that produce objects perceived by the eyes).

Since 2019, the MMFA has developed in collaboration with Médecins Francophones du Canada museum visits prescribed by a primary care physician as a new intervention. Today, it is necessary to improve the knowledge on the effects of this museum visit prescription

The overall objective of this study is to examine the effects of a visit to the MMFA prescribed by a primary care physician on the mental health (well-being and quality of life) of patients living in Montreal.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and over
* having Internet access at home with an electronic device (computer, keyboard, or smartphone)
* having no dementia
* speaking English or French
* committing to visiting the museum within 3 months of the prescription.

Exclusion Criteria:

* individuals participating in a clinical trial at the same time, to avoid interference with the results of the intervention being studied in this protocol
* individuals with dementia. There are no tests for dementia. The physicians involved in the pre-recruitment process are aware of the cognitive status of their patients. Therefore, they will be able to avoid offering the study to a patient with dementia if such a diagnosis appears in the medical file.
Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

The investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with BZN 150mg/day (30d/150mg) vs. a 60-day treatment with BZN 300 mg/day (60d/300mg). The investigators will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six months postpartum, and follow them up with the following specific aims:

Specific Aim 1: To measure the effect of BZN 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive PCR (primary outcome) and by real-time quantitative PCR (qPCR), immediately (Specific Aim 1a) and 10 months (Specific Aim 1b) after treatment.

Hypothesis 1a: The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority \[NI\] margin for PCR: 10% absolute difference) to BZN 60d/300mg.

Hypothesis 1b: The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg will be non-inferior (NI margin for PCR: 9% absolute difference) to BZN 60d/300mg.

Specific Aim 2: To measure the frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg.

Hypothesis 2: The frequency of serious adverse events leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg.

A 24-month recruitment period is planned in four hospitals with 23,436 deliveries in 2015 and frequencies of T. cruzi seropositive women varying from 1.5% to 4.8%. The investigators are planning to enroll 600 T. cruzi seropositive women.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the mother.
* T. cruzi seropositivity confirmed by at least two positive tests.
* Live birth.

Exclusion Criteria:

* Women residing outside of the provinces of Chaco, Santiago del Estero, or Tucumán.
* Previous trypanocide treatment (BZN or nifurtimox).
* Female sterilization; no intention to use modern contraception methods during treatment.
* Positive pregnancy test.
* History of severe alcohol abuse within two years; renal insufficiency.
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

The study is a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

The primary objective of this study is:

To evaluate the efficacy of fostamatinib when used in combination with standard of care (SOC) in subjects hospitalized with COVID- 19 and requiring oxygen supplementation, as measured by days on oxygen.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at screening.
* The subject or a legally authorized representative has provided written informed consent.
* Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs.
* Male or non-pregnant, non-lactating female subjects with SARS-CoV-2 infection documented by a hospital approved diagnostic test (eg, a Food and Drug Administration authorized test in the US) within 7 days prior to randomization.

Exclusion Criteria:

* Pregnant or lactating female of childbearing potential.
* Use of extracorporeal membrane oxygenation (ECMO).
* Uncontrolled hypertension (systolic blood pressure \[BP\] ≥160 mmHg and/or diastolic BP ≥100 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment at screening.
* History of myocardial infarction within 1 month prior to screening.
Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Eligibility Criteria:
Inclusion Criteria:

* A newborn is a baby born between 32-36 weeks of gestation
* No medical adhesive tape should be applied to the newborn's lips beforehand.
* The newborn does not have any skin diseases
* OG will be inserted into the newborn for the first time
* Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen

Exclusion Criteria:

* The newborn is not a baby born between 32-36 weeks of gestation
* Applying medical adhesive tape on the newborn's lips beforehand
* The newborn has any skin disease
* OG has been inserted into the newborn before and detected.
* Supporting and detecting the newborn's breathing by intubating it
Management of Uterine Leiomyomata and Adenomyosis

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

The aim of the present study is:

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Eligibility Criteria:
Inclusion Criteria:

- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.

(3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;

Exclusion Criteria:

* (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.
A Study of Acute Kidney Injury in Children at Sohag University Hospital

Acute kidney injury (AKI) has been traditionally defined as an abrupt loss of kidney function leading to a rapid decline in the glomerular filtration rate (GFR), accumulation of waste products such as blood urea nitrogen (BUN) and creatinine, and dysregulation of extracellular volume and electrolyte homeostasis . Acute kidney injury (AKI) is a very common condition, especially among hospitalized patients.

this work aims to study the demographics, etiology, clinical characteristics, and outcome of acute kidney injury in children in Sohag University Hospital - Pediatrics Department.


Eligibility Criteria:
Inclusion Criteria:

* All children with acute kidney injury with an age range from 1 month to 16 years old

Exclusion Criteria:

1. patients with chronic kidney disease (CKD)
2. Patients with irregular follow up
3. Patients with incomplete data
4. Patients whose medical guardians refuse participation in the study
Evaluation of the Tantalus System in Type 2 Diabetic Subjects

Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* T2DM subjects inadequately controlled on a maximum of three oral agents
* Subjects with HbA1c between 7 and 9%
* Subjects with FBG between 120 and 200 mg/dL
* Subjects who are 21-60 years old
* Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
* Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
* Subjects with waist circumference \>94 cm (males) and \>80 cm (females)
* Subjects on stable medication program for at least three months with any oral medication program
* Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
* Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
* Able to provide voluntary informed consent.

Exclusion Criteria:

* Subjects at high risk of general anesthesia or surgery
* Subjects with prior pancreatitis
* Subjects with chronic hepatitis
* Subjects with elevated serum creatinine
* Subjects with proliferative diabetic retinopathy
* Subjects with gastroparesis or intestinal pseudo-obstruction
* Subjects with motility disorders of the GI tract
* Subjects who are receiving medications known to affect gastric motility
* Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
* Subjects who are pregnant (proven by positive hCG), or lactating
* Subjects who have had prior bariatric surgery
* Subjects with a history of peptic ulcer disease
* Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
* Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
* Subjects with a life-threatening co-morbidity or life expectancy of less than one year
* Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
* Subjects with a history of malignant disease
* Subjects who are currently on chemotherapy treatment
Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

PRIMARY OBJECTIVES:

I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.

II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.

III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.

IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.

OUTLINE:

Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.

After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky/Lansky performance score \>= 30
* A signed written informed consent
* Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment
* Paraffin blocks of the patient's tumor tissue are available and accessible for analysis

Exclusion Criteria:

* Karnofsky/Lansky performance score \< 30
* Life expectancy \< 3 months
ERAS in Colorectal Surgery: Benefits of Late Adoption

The aim of this single-center retrospective cohort study is to explore the effect of late adaptation of an ERAS protocol in a high-volume colorectal surgical unit.

The primary endpoint is the surgical outcome measured by early postoperative complications, defined by the comprehensive complications index. Secondary endpoints include amongst others LOS (length of stay), cost analysis, short-term follow-up in the ERAS group.

At Clarunis - University Center for Gastrointestinal and Liver Diseases at St. Claraspital between 2019 und 2020, all colorectal patients were treated according to a standardized perioperative protocol. As of 2021 until today, an ERAS protocol was established and all colorectal patients who met inclusion criteria participated in this program automatically as part of a new standardized care. Perioperative data was collected in a clinical information system (Phoenix - CGM Clinica Information Systeml).

In this retrospective cohort study, we compare demographic, perioperative and postoperative data among the two groups "ERAS" and "non-ERAS" using a weighted propensity score analysis for patients who underwent surgery as part of the ERAS program and for patients without a standardized ERAS protocol.

All patients treated at the colorectal unit from 2019 until August 2022 and who are considered for the analysis have given written general consent for the use of health-related data for research projects (attached to this document).

Eligibility Criteria:
Inclusion Criteria:

* written general informed consent
* patients undergoing a colorectal procedure between 2019 and August 2022 at colorectal unit, Santa Clara Hospital, Basel

Exclusion Criteria:

* All patients undergoing an emergency procedure or a combined procedure with the colorectal procedure not being the main indication for surgical treatment (i.e. gynecological debulking, liver resection, etc.) were excluded from the analysis.