cyrilzakka/clinical-trials huggingface dataset:
ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:

1. a western style diet, WSD, with a low fiber content and
2. a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.

We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.

A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.

Eligibility Criteria:
Inclusion Criteria: At least 3 out of 5 following criteria:

* Central obesity (Female \> 80 cm, Male \> 94 cm)
* HDL cholesterol (Female \< 1,03 mmol/L, Male \< 1,29 mmol/L)
* Bloodpressure (\> 130/85 mmHg)
* Fasting Blood Glucose \> 5,6 mmol/L

Exclusion Criteria:

* Diabetes
* Gastrointestinal disease
* Serious liver, heart or kidney disease
* Anticoagulation treatment
* Anaemia
* Corticosteroid treatment
* Waist circumference above 130 cm
* Alcohol or drug addiction
* Pregnancy or lactation
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
* Subjects who have ≥7 Vasomotor Symptoms per day on average
* A body weight of ≥45 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values
A Study of BMS-863233 in Patients With Hematologic Cancer

To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer


Eligibility Criteria:
Inclusion Criteria:

* AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
* ECOG performance status \<= 2
* Accessible for treatment, PK sample collection and required study follow-up
* Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
* Hyperleukocytosis (defined as peripheral WBC \>50,000/uL)
* Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
* Subjects a history of gastrointestinal disease
* Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
* Determine the pharmacokinetic parameters of this regimen in these patients.
* Determine the antitumor response of these patients treated with this regimen.

OUTLINE: This is a dose-escalation study of irinotecan and capecitabine.

Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy
* Bidimensionally measurable or evaluable disease
* No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 4,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10.0 g/dL

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST and ALT less than 2 times normal

Renal:

* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* No known hypersensitivity to fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior large-field radiotherapy and recovered

Surgery:

* Not specified
Evaluation of PKU Explore

To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a renovated Phe free protein substitute for the dietary management of PKU in children from 6 months to 5 years.

This is a prospective, acceptability study to evaluate the gastrointestinal tolerance, palatability and adherence of PKU explore in a four-week period for 15 participants aged between 6 months and 5 years for the dietary management of PKU.

The outcome of this assessment will be used in a submission to the regulatory authorities, Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on prescription in the UK.

The participant's dietitian will advise on an appropriate amount of PKU Explore based on individual requirements. Parents/carers will be asked to substitute their usual Phe-free protein substitute with PKU Explore for one (1) month. The sponsor will supply PKU Explore free of charge.

Parents/guardians will be asked to record information about the following:

Daily PKU Explore intake Stools Vomiting and Spit-up Feed / Fluid Intake Compliance Phenylalanine Levels (from their routine blood spot testing)

Final Evaluation about the presentation of the product, ease of preparation and use.

Eligibility Criteria:
Inclusion Criteria:

i. A diagnosis of PKU on new-born screening requiring a low protein diet and Phe-free L-amino acid supplements.

ii. Aged between 6 months and 5 years.

iii. Already taking a second stage concentrated protein substitute as part of their PKU management OR is at the stage in their PKU management when a second stage concentrated protein substitute is recommended to commence.

iv. Willingly given, written, informed consent from parent/guardian.

v. Willingly given, written assent (if appropriate).

Exclusion Criteria:

i. Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary treatment with a low protein diet and Phe-free L-amino acid supplements.

ii. Diagnosis of a concurrent condition which may adversely affect developmental progression and feeding ability.

iii. Participation in any other clinical trial/acceptability study.

iv. Any serious medical precluding the study intervention.

v. Use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
Early Hydration in Acute Myocardial Infarction

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.

Exclusion Criteria:

* contrast medium administration within the 10 days
* end-stage renal failure requiring dialysis
* refusal to give informed consent
Olfactory and Visual Perception in Depressed Patients

The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* no cognitive impairment that could prevent instruction comprehension
* no more than 10 cigarettes/day
* signed informed consent
* group 1: current major depressive disorder
* group 2: no current major depressive disorder

Exclusion Criteria:

* pregnancy
* visual impairment
* olfactory impairment
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures

This study describes the changes in preference to arthroscopic surgery in two orthopedics departments in Denmark under the COVID-19 pandemic.

Background:

Covid-19 has impacted all aspects of society. In hospitals around the world focus has been on treating the deadly virus, and elective orthopedic surgical procedures has been postponed in Denmark, causing a stop for most arthroscopic procedures for months. It is established that certain conditions leading to arthroscopic orthopedic intervention has fluctuating symptoms symptoms and can have a favorable outcome on conservative treatment. Amongst these conditions who are also treated with non-surgical methods are subacromial decompression impingement\[1\]\[1\], degenerative knee disease \[2\] and anterior cruciate ligament injuries\[3\]. An issue with further understanding the non-surgical effect on this patient group has beencould be reluctance to undergo conservative non-surgical treatment and opt for a surgical treatment. procedure. Because all elective surgery has been postponed in Denmark, and the following longer waiting period for surgery, this has created a unique opportunity to further investigate this patient category.

Aim of study: Investigate the impact of time on waiting list for surgery under COVID-19 pandemic on the preference for surgery in patients planned for arthroscopic surgery.

Discussion The current study will provide information on the change of preferences forto arthroscopic surgery in a patient population who are forced to wait for surgery for a longer period of time, with no possibility of seeking treatment in other hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for arthroscopic intervention in knee or shoulder.
* Patients seen by an orthopedic surgeon and planned for surgery before 13/3-20

Exclusion Criteria:

* Surgery performed in another hospital
* Death
* Emigration
MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.

The objective of this research is to establish a contemporary and simple to construct AF management registry that expands progressively over the continuum of care for each individual patient. The registry will be used to determine the course and progression of AF management in preventing thrombo-embolic events using rhythm and rate control interventions.

Primary endpoints:

1. Atrial fibrillation natural history
2. Thrombo-embolic event
3. Death

Secondary endpoints:

1. Bleeding
2. Pro-arrhythmia
3. Patient adherence
4. Treatment complication

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of valvular or non valvular atrial fibrillation
2. ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder

Exclusion Criteria:

1. Age below 18 years.
2. Clinical evidence that death within 6 months is possible
3. Inability to consent to the research or sign a consent form
4. Inability to follow up at the research clinic at least annually for continuity of AF care and management
Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography

Patients recruitment will be curry out in 31 geriatric or cardiologic centres.

Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months).

The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data.

Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre.

The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution.

Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 80 years
* Hospitalised for decompensation of heart failure in the last 12 months
* Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm)
* Subjects able to undergo a bone scintigraphy scan
* Subjects willing to participate

Exclusion Criteria:

* Subjects refusing to participate
* Subjects admitted to palliative care unit.
* Subjects under guardianship
* Subjects with a definite diagnosis of cardiac amyloidosis
Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Speak Arabic or English

Exclusion Criteria:

* History of cervical surgery
* Known hypersensitivity to topical analgesics
* First trimester abortion or miscarriage in the previous six weeks
* Second trimester abortion or miscarriage in the previous 12 weeks
Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.

The effect will be assessed by the milk and blood.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \>-18 years of age with low-risk obstetric

Exclusion Criteria:

* Pregnant women expecting a multiple birth
* Take vitamin A supplements during postpartum apart from study intervention
* Premature birth
* Newborn babies with birth defects and / or other serious diseases
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
* Aged 20 years or older
* Treatment naive or treatment experienced
* At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

* Previous exposure to an NS5A or NS5B inhibitor
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Pregnant or nursing female or male with pregnant female partner

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Development and Evaluation of a Growth Mindset Intervention for Adolescents in Youth Custody Frameworks: Pilot Study

The purpose of this study is to develop and evaluate a daily-activity-based intervention aimed at fostering a growth mindset among adolescents in youth custody frameworks and their staff. The study seeks to answer whether this intervention can improve participants' perceptions of their ability to adapt, enhance daily life participation, and identify barriers and facilitators for promoting a growth mindset in this unique population. Using a mixed-methods design, the study includes pre- and post-intervention assessments with the Canadian Occupational Performance Measure (COPM), structured questionnaires, and focus groups to evaluate the effectiveness of the program.

This study aims to develop and evaluate an intervention program designed to promote a growth mindset among adolescents residing in youth custody frameworks and their staff. The intervention is grounded in daily-activity-based approaches, emphasizing practical engagement in meaningful activities and reflective learning. The program is tailored to address the unique challenges and strengths of participants within these frameworks, with the goal of fostering adaptability, resilience, and improved participation in daily life tasks.

The research employs a mixed-methods design to comprehensively assess the intervention's impact. Quantitative data will be collected using the Canadian Occupational Performance Measure (COPM) to measure changes in participants' perceptions of their performance and satisfaction with daily tasks. Structured pre- and post-intervention questionnaires will further evaluate shifts in growth mindset attitudes. Qualitative data will be gathered through focus groups with adolescents, alumni, and staff, providing insights into the intervention's feasibility, perceived barriers, and opportunities for adaptation.

The study is conducted at two youth custody institutions, Alma and Mitspa-Yam, which provide residential care for adolescents in high-risk situations. Participants include adolescents currently in care, alumni, and staff members. Findings from this research are expected to inform the development of evidence-based guidelines for integrating growth mindset interventions into youth custody settings, with implications for enhancing long-term outcomes for participants.

Eligibility Criteria:
Inclusion Criteria:

Adolescents currently residing in youth custody frameworks who are selected by the institution's staff based on their suitability for the study.

Alumni of youth custody frameworks who are contacted directly by the research team.

Exclusion Criteria:

Adolescents whose mental or physical condition prevents them from participating in the study.

Individuals who are unable to complete questionnaires or reflectively describe their experiences.
Renal Response to Lower Body Negative Pressure in Pre-hypertensive States

The purpose of this study is to determine whether in pre-hypertensive and hypertensive states such as white coat hypertension, obesity related hypertension or resistant hypertension, renal function is more sensitive to orthostatic stress.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 Kg/m2 (obesity group)
* office BP \>140/90 and daytime ambulatory blood pressure \<135/85 (white coat hypertension group) _daytime abpm \>135/85 mm Hg or nighttime abpm 120/70

Exclusion Criteria:

* History of allergic reaction
* Diabetes type 1 or type 2
* History of renal artery stenosis
* Acute illness