cyrilzakka/clinical-trials huggingface dataset:
Does Class of Dietary Fat Affect Insulin Resistance?

It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated).

The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.

Type 2 Diabetes and cardiovascular disease are closely linked. A common abnormality in both conditions is insulin resistance. The primary cause of insulin resistance in not known. A significant question is what dietary components contribute to the development of insulin resistance. Based on epidemiologic data, it seems that the type of dietary fat is a significant contributor to the development of insulin resistance. However, some researchers argue that the main determinant is total amount of fat, not the composition.

This study is intended to determine if the main types of fat (saturated, monounsaturated and polyunsaturated) ingested over a short time can cause insulin resistance in lean, healthy people. It has been demonstrated that 6 hours of intravenous fat infused into lean, healthy subjects can result in insulin resistance, as well as blood pressure elevation and endothelial dysfunction. Whether this is so with oral fat is not known. The question is important because there is debate about whether the type of fat is as important as the quantity of fat in a person's daily diet. Settling this debate will enhance the ability of health care personnel to determine the optimal dietary recommendations.

This study will make use of a high fat diet consisting of vegetable oils high in the 3 main fatty acids in plasma (palmitate, oleate and linoleate). Because large fat loads can cause intestinal discomfort, a feeding tube will be used to bypass the stomach. The 3 oils will be assigned randomly following a base line study with saline 2 weeks prior to the intervention. Our primary endpoint is insulin resistance, which will be measured by a euglycemic, hyperinsulinemic clamp. Secondary measures will include changes in blood pressure and in vascular reactivity as measured by ultrasound after brief occlusion of a forearm vessel. The changes will be compared to baseline and to the other 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Lean,healthy adults 18 - 40
* No chronic medications (birth control pills allowed)
* Weight stable
* Normal fasting labs performed at screening
* Body mass index ≤ 25 kg/M\^2 .

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
* History of diabetes or heart disease
* History of type 2 diabetes in parent or sibling
Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.

This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients.

From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients.

In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population.

Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project.

Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years;
* Patients who received optimal treatment (surgery, chemotherapy ...)
* Patients with epithelial ovarian cancer after first-line treatment;
* Patients without other cancer (except basal cell skin carcinoma and breast cancer in situ);
* Patients without clinical relapse, biological or radiological documented at least 3 years after the initial treatment (from the end date of first line chemotherapy);
* The interviews treatments are not recognized in the period;
* Patients may be included regardless of the stage of cancer at diagnosis (early or late)
* Patients who have signed their written consent to participate in the part 2 of the study Vivrovaire;
* Patients who participated in part 1 of Vivrovaire study.

Exclusion Criteria:

* Psychiatric pathology can disrupt the conduct of the study or to prevent the interpretation of results;
* Persons deprived of liberty;
* Major subject to a measure of legal protection or unable to consent.
Determination of Glycemic and Insulinemic Indices

The aim of this study to investigate methodological aspects that may affect glycemic index (GI) and insulinemic (II) values. In addition, we will measure GI and II values for typical Finnish carbohydrate-rich foods and provide a database of GIs for Finnish foods.

The specific aims of this study are:

* to compare glycemic responses and GIs analyzed from capillary and venous blood to compare glucose against white bread as the reference food, and to study the effect of number of reference tests on GI values. For each setting of the tested parameters, we determined the glycemic indices of rye bread, oatmeal porridge and instant mashed potato
* to examine the glycaemic and insulinaemic responses of a mashed potato-based meal when a high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein and salad together were added to the meal. Furthermore, we studied how the predicted and measured GI values of the mixed meal differed from each other.
* to examine the effects of two different coffee portions with glucose and caffeine-containing soft drinks on postprandial glucose and insulin responses. Further objectives were to study how coffee and different accompaniments affect glucose and insulin responses.
* to measure GI values for typical Finnish foods
* to study the effects of berries on glycemic and insulinemic responses
* to examine the effects of overweight and glucose tolerance on the glucose, insulin and lipid responses to an HGI meal and an LGI meal.Furthermore, the second aim was to study the effect of BMI and glucose tolerance on the GI measured.
* to compare methodological choices in insulin measurement
* to investigate the effect of alcohol on postprandial glucose and insulin responses, and to determine glycemic and insulinemic indices values for beer and non-alcoholic beer


Eligibility Criteria:
Inclusion Criteria:

* For Studies 1-9 a total of 12 to 24 volunteers per study with a normal glucose tolerance based upon a 2 h 75g oral glucose tolerance test (OGTT).
* For Study 7 a total of 24 volunteers with impaired glucose tolerance based on an OGTT.
* For Studies 1-6 and 8-9 with an age of 20 to 60 and with a BMI of 18 to 30 kg/m2.
* For Study 7 an age of 62 to 72 and with a BMI of 20 to 35 kg/m2.

Exclusion Criteria:

* First-degree family history of diabetes
* An active gastrointestinal or metabolic disease
* For Studies 1-6 and 8-9 chronic medication (oral contraceptives were allowed)
* For Study 7 regular medication that would have affect glucose and lipid metabolism
* Smoking
* Pregnancy
* Breastfeeding
* History of polycystic ovary syndrome
* History of gestational diabetes
PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU

To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.

To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.

Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.

This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent
* Patients with the possibility to participate during up 6 month follow-up.
* At least one of these criteria:
* Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
* Patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology
* Patients with medium, high or very high risk of developing a pressure ulcer following Braden Scale.

Exclusion Criteria:

* Age \< 18 years
* Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
* Patients in the terminal stage or receiving chemotherapy.
* Patients with more than 3 active pressure ulcers.
HIP-STITCH (Wound Recovery After THA)

This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.

This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.

The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.

Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years or older.
* Scheduled to undergo Total Hip Arthroplasty via the anterior approach for any indication at the RHOC.
* No prior operations to the hip which is to be operated on.
* A good command of the Dutch language
* Able to give written informed consent.

Exclusion Criteria:

* Usage of cytostatics in the period ranging from fourteen days prior, to ninety days after the operation.
* Unable to, or difficulty with communicating in the Dutch language (e.g. due to mental disability, inability to understand/speak/write Dutch, et cetera).
Weight Loss Diet in Obesity With Metabolic Syndrome

Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.


Eligibility Criteria:
Inclusion Criteria:

- fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII).

Exclusion Criteria:

* diabetes
* the presence of current or recent pregnancy or intention to conceive within the trial's period
* chronic renal or liver disease
* past bariatric surgery
* current participation in any dietary/ medical program with current continuous weight loss.
Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant

Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure caries in this tooth is therefore of great importance for the preservation of a healthy dentition in one's life long time.

It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly effective method to prevent pit and fissure caries. It has also been shown that the performance of sealing pits and fissures by glass ionomer materia l (the high viscosity, classification type 2 GIC material) using finger press method used in the atraumatic restoration method is as significant as that of using the traditional resin sealant material and technique.

The purpose of this study is to evaluate the long-term cost-effectiveness performance of the two sealing materials in the prevention of pits and fissures caries in young permanent molars of schoolchildren in a dental public health program to be held in primary schools. The findings will provide valuable information for decision making on the election of proper material and method for use in dental public program, especially for child population in the rural or social-economically deprived areas.

Primary school children will be recruited and cluster randomized into three groups. Baseline dental check-up will be conducted to all the recruited children and dental status will be recorded. Placement of resin sealant or sealant using the glass ionomer material to the eligible permanent first molars or providing of oral health education will be interventions to the three groups respecively according to the group allocation. All the interventions will be provided only once in this study, and the children will be followed for at least 24 months at an six month interval to motor the dental caries of the included permanent first molars. Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated and reported.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy grade 1-2 school children
* with written parental consent
* with at least 1 sound and fully erupted permanent first molar

Exclusion Criteria:

* Can not cooperate with the treatment
* Can not obtain the child's parental consent
The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.

The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.


Eligibility Criteria:
Inclusion Criteria:

* Male between the ages of 40-65 years old.
* Fulfill at least three of the five diagnostic criteria for the Metabolic Syndrome.
* To be able to give their written consent to participate in this study.

Exclusion Criteria:

* Abnormal Liver function tests ≥ 3 times upper limit of normal (ULN).
* Chronic liver disease other than NAFLD.
* Previous gastric or small bowel surgery.
* Abnormal Thyroid-stimulating hormone (TSH) level.
* Known Tobacco Smoking more than 10 cigarettes per day.
* Known alcohol consumption more than 2 drink per day.
* Use of medications that include: Insulin or Insulin secretagogues, Thiazolidinediones, Glucocorticosteroids, Hormone replacement therapy.
* Fever \> 38.2 °C in the past 2 weeks.
* Autoimmune or Auto-inflammatory disease.
* Chronic kidney disease ≥ stage III.
* Nephrotic syndrome.
* Hemoglobin \<12 g/dL.
* Metal clips or implants that preclude magnetic resonance imaging.
FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer

This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in patients with irradiated lung cancer in comparison with FDG-PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* history with lung cancer, small cell or non-small cell
* radiotherapy of lung cancer ended within the last 24 months
* radiotherapy might be normofractionated or stereotactic
* current suspicion of relapse
* written and oral consent

Exclusion Criteria:

* communication difficulties
* pregnancy or lactation
CADx - Radiomics to Distinguish the Origin of Ovarian Tumors

In women with an ovarian tumor, it is often unclear whether the tumor is benign or malignant. To differentiate, tumor markers (CA125 and CEA), a transvaginal ultrasound and, depending on the ultrasound image and the CA125 concentration, a CT scan are performed. The quality of radiological imaging in diagnosing abdominal pathology is often not accurate enough, making additional interventions no-dig for proper classification and interpretation of the tumor.

Objective: To improve accuracy for distinguishing benign from malignant disease in patients presenting with an ovarian mass by using a computer aided detection algorithm.

This research focuses on improving the accuracy of the determination of the nature (benign or malignant) of ovarian tumors by making use of artificial intelligence by creating a CT-scan algorithm. This because a correct preoperative classification of ovarian tumors is essential for appropriate treatment. Existing prediction models often lead to unnecessary referrals to gynecological oncology hospitals, resulting in higher costs and increased stress for the patient. It is therefore important to evaluate other strategies to differentiate between benign and malignant ovarian tumors.

Artificial Intelligence (AI) for radiology is currently being developed by the Eindhoven University of Technology (TU/e) and Philips Research Europe and may provide a potential solution to this problem.

The currently developed algorithm (CADx), using a support vector machine (SVM), showed within a small population of about 100 patients a sensitivity of 74% and specificity of 74%. These are promising results to train this algorithm even further with more CT-scans images and the addition of clinical variables and even liquid biopsies.

Type of study: Retrospective study cohort This is a retrospective analysis on known data in which definitive patients diagnosis has already been established and current analysis will not affect treatment plan.

No products for patients are used, only computer aided diagnosis is used on existing radiological imaging, namely CT-scans.

This study is linked to two other Dutch trials in which ovarian tumor biomarkers are assessed in order to find out the origin of ovarian tumors preoperatively.

The first is the HE4-prediction study, with local protocol ID NL58253.031.16. The second is the OVI-DETECT study, with clinicaltrial.gov number NCT04971421.

Eligibility Criteria:
Inclusion Criteria:

* patients with an ovarian tumor of which it is unknown whether it is benign or malignant (Risk of Malignancy Index (RMI) \>200)
* underwent surgery
* histological proof of tumor

Exclusion Criteria:

* indefinite pathology report
* lack of correct description of staging in OR report when applicable
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Normal menstrual periods (24-35 days)
* Good general health
* Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
* Willing and able to return to clinic for bi-weekly blood tests

Exclusion Criteria:

* Pregnant or breast feeding
* Polycystic ovarian disease
* Gastrointestinal conditions (i.e.gastric ulcer)
* Currently using birth control
* Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
* Diabetes
* Cardiac disease or hypertension
* Moderate to severe heartburn (GERD)
* Obesity (BMI greater than 30)
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.


Eligibility Criteria:
Inclusion Criteria:

* History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
* Capable of taking study medication as outpatients and recording its effects.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
* Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.