cyrilzakka/clinical-trials huggingface dataset:
Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia

Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of intestinal triglyceride rich lipoproteins in patients with isolated fasting hypertriglyceridemia.

The objective of this study is to compare the serum apoB48 rate after a standardized load test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.

Two major studies in 2007 showed that the occurrence of myocardial infarction and death was more frequent in subjects with the highest "non-fasting" triglycerides level. This is an important point that supports the hypothesis that the development of atheromatous lesions also depends on "remnant" of triglyceride-rich lipoproteins (TRL) products such as chylomicrons in the intestine. The elevation of triglycerides in postprandial period depends on the intestinal production of TRL that can be excessively increased as has been shown in diabetes. Accordingly, it is necessary to distinguish between hepatic and intestinal production of TRL in hypertriglyceridemic patients particularly during postprandial period. TRL contain a single molecule of apolipoprotein B (apoB), apoB100 when produced by the liver or apoB-48 when they are produced by the gut. It is well known that apo B100 is the lipoprotein of the VLDL which is increased in hypertriglyceridemia. But preliminary works showed that fasting concentrations of apoB48 were correlated with triglycerides in some hypertriglyceridemic patients. These results suggest an intestinal part in fasting triglycerides levels. It therefore appears that the liver and intestine contribute to hypertriglyceridemia, but the intestinal part is not established particularly in isolated hypertriglyceridemia. The detection of abnormalities in the production of LRT would consider intestinal bowel as a target organ for the initiation of specific lipid-lowering therapy.

Eligibility Criteria:
Inclusion criteria :

1. Patient who provided his consent in writing before the completion of any procedure related to the Protocol
2. Patient affiliated to the French social security system or to another similar insurance
3. Men and women aged from 18 years to 75 years
4. Patient of Department of Endocrinology-Metabolism and hospitalized for a medical checkup
5. Fasting hypertriglyceridemia \>1.5 g / L
6. No lipid-lowering treatment or omega 3
7. Patients with an untreated systolic blood pressure \<130mmHg and diastolic \<85mmHg
8. Stable weight (variation less than 5 kg in the month before inclusion)

Inclusion in the metabolic syndrome group if :

* Fasting glucose \> 5.6 mmol / L but \<7.0 mmol / L and
* Waist perimeter \>94 cm in men and \>80cm in women.

Inclusion in isolated hypertriglyceridemia group: patients not having the criteria of the group "metabolic syndrome"

Exclusion criteria :

1. Diabetic Patient
2. Any recent changes (less than one month) of any treatment
3. Patient participating in another clinical study
Gel-One Treatment in Knee Osteoarthritis

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.


Eligibility Criteria:
Inclusion Criteria:

* Have a knee pain
* Grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion Criteria:

* BMI greater than 35 kg/m2
* Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
* Had a joint replacement of the target knee
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures

This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.

This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. Patients who require operative treatment of hand and wrist fractures are randomly assigned to a group that receives a postoperative phone call or the control group that receives the standard postoperative care. Patient reported and medical outcomes are observed starting at 1 month postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated injuries of the hand who present to a specific level 1 trauma center in the Midwestern United States
* Patients who have planned surgical treatment by a pre-specified group of surgeons

Exclusion Criteria:

* Patients who have significant trauma to other organ systems proximal to the wrist
* Patients who have open ("compound") fractures (i.e., bone is exposed)
* Children
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants

The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).


Eligibility Criteria:
Inclusion Criteria:

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

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
* Has body mass index (BMI) ≥18 and ≤32.0 kg/m\^2

Exclusion Criteria:

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

* History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
* History of cancer (malignancy)
* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Computer Assisted Measurement of Colorectal Polyps

Adenomas are polyps of the colorectum that have the potential to develop into colon cancer. However, some adenomas never become malignant tumors, or if so, progression from adenoma into cancer takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.

The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps. The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be inserted into the colon through a small working channel of the endoscope. Information on the actual adenoma size is crucial as surveillance recommendations depend on the size of the resected polyps. Moreover current guidelines contain the possibilities to disregard hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that diminutive hyperplastic polyps (\< 5mm) do not necessarily require resection due to their benign dignity. However, there is increasing evidence that large human bias effects exist in estimating the size of polypoid lesions. For example, it has been shown that endoscopists exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In consequence the human bias problem might lead to wrong adenoma surveillance decisions.

There is no doubt that technical devices are needed which can support endoscopists in finding the right declaration of polyp sizes. The aim of the current project is to create a computer program that is able to automatically measure polyp sizes during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* patients \>= 18 years

Exclusion Criteria:

* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin
Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology in polycystic ovary syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during IVF/ICSI.


Eligibility Criteria:
Inclusion Criteria:

* PCOS women undergoing IVF/ICSI.
* Age: 18-39 years.
* Both ovaries present.

Exclusion Criteria:

* Age ≥ 40 years.
* History of three or more previous IVF failures.
* Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
* Patients who previously undergo Unilateral Oophorectomy.
* Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.
* Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases,
* Cancer.
Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling

The goal of this observational study is to explore the ability of intravascular pressure gradients to identify hemodynamic disturbance in patients with intracranial atherosclerotic diseases (ICAS). The main questions that aim to answer are:

* The correlation between intravascular pressure gradient and cerebral blood flow (CBF)
* The threshold for intravascular pressure gradients to predict hemodynamic disturbance in ICAS

Patients will undergo intravascular pressure measurement and arterial spin labeling (ASL) for CBF during pre- and post-operation respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 40 years or older.
2. Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (vertebral artery, basilar artery or intracranial internal carotid artery and their major branches).
3. 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
4. Informed of the study protocol and objectives.

Exclusion Criteria:

1. Non-atherosclerotic MCA stenosis
2. Combined with moderate or severe stenosis of other extracranial and intracranial arteries
3. Previous endovascular treatment or surgery for cerebrovascular diseases
4. Large cerebral infarction (more than 1/2 MCA perfusion area)
5. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
6. Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
7. Liver and kidney dysfunction, or severe allergy to the contrast agent
8. Severe coagulation dysfunction
9. Pregnancy or in the preparation for pregnancy
10. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
11. Patients with severe dementia or mental disorders, who cannot cooperate with examination
Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses

A total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.

With the release of DEFINE-FLAIR and iFR SWEDEHEART, coronary physiology and namely iFR, have robust clinical data supporting its routine use in the cardiac catheterization lab. Unfortunately, iFR is a proprietary algorithm owned by Phillips Volcano Corporation (San diego, California, USA) limiting the use of iFR to those centers with Volcano hardware. Whole cardiac cycle Pd/Pa has been another resting measure that has been evaluated and generally performs poorly compared to FFR. Although iFR is measured during the wave free period in diastole, to date there has been no assessment of diastolic Pd/Pa measurements and its potential correlation with the severity of coronary stenoses. Most importantly, evaluating the pressure differential across the entirety of diastole must by definition contain the "iFR value" and therefore should correlate very close with the iFR assessment. Preliminary unpublished data analyzing physiologic data in benchtop modeling from the VERIFY and CONTRAST studies suggest a very high correlation between iFR and diastolic Pd/Pa. This relationship strengthens when measurements are limited to 65% of diastole, hereby named the Diastolic hyperemia-Free Ratio (DFR). These data strongly suggest that DFR could be used as surrogate for iFR when iFR is not available and thus leverage the large clinical outcomes data for iFR in a new measure that is widely available to all standard coronary pressure wires.

Although this preliminary data is strong, none of these measures where made prospectively in actual patients and the iFR was measured off simulated benchtop pressure waveform modeling. This study aims to perform a real-time correlation and agreement between iFR and DFR in patients with moderate coronary stenoses and indications for physiologic assessment.

Eligibility Criteria:
Inclusion Criteria:

* Moderate Coronary lesion deemed to need iFR assessment - Angiographic severity of 40-70% that operator feels needs physiologic assessment
* Age 18-90 year old
* Single worst lesion per patient- Patients may have more than one lesion assessed but only 1 lesion will be evaluated per patient in this study

Exclusion Criteria:

* STEMI- Angiographic severity of 40-70% that operator feels needs physiologic assessment in setting of STEMI or 48hours within STEMI
* Atrial fibrillation
* Inability to provide informed consent- No surrogate or healthcare proxy will be allowed to consent for this study
* Severe tortuosity- Vessel tortuosity that the operator feels would be difficult to pass 2 pressure wires down or where pseudo lesions may be formed.
* Saphenous Vein Graft Lesion
Formula Diet Treatment for NASH Patients.

Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.

Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25 kg/qm

Exclusion Criteria:

* history of drug or alcohol abuse
* acute or chronic diseases (except type 2 diabetes)
* pregnancy or breast feeding
Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients

The aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (ACT)would help chronic pain patients.

The present study investigates internet-delivered ACT for persons with chronic pain. The use of internet as a delivery format for interventions could be a way of overcome many barriers (financial obstacles, reluctance to seek treatment and paucity of clinicians trained in ACT) that hinder persons with chronic pain to seek or receive adequate help. Persons were randomized to either treatment for 7 weeks or to a control group who were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* that participants had undergone medical investigation (within one year)
* had regular access to the internet
* had functional impairment caused by chronic pain
* had internet access

Exclusion Criteria:

* ongoing medical investigations or treatment that could interfere with participation in the study, such as planned surgery and suffering from acute physical or psychological conditions
* not fluent in the Swedish language
Oropharyngeal Candidiasis (OPC) and S-ECC

The overall objective of this study is to investigate the association of early Candida infection (known as oral thrush or oropharyngeal candidiasis, OPC) in children during the first year of life with the onset and severity of severe early childhood caries (S-ECC).

The overall goal of this study is to conduct a longitudinal observational study to investigate the association of early OPC with the onset and severity of S-ECC to better understand the role of Candida (particularly C. albicans) in severe childhood caries. The investigators will test the hypothesis that OPC is associated with S-ECC by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease.

For this study, a total of 70 infants (aged 9-15-month-old) with or without a history of OPC in their first year of life will be enrolled, based on the inclusion and exclusion criteria. Subjects will have their medical/dental history reviewed from medical records. At each study visit (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. Dental plaque/oral swab samples will be collected at each study visit. In addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals at the age of 9-15-month-old
* Must have at least one fully erupted tooth at baseline visit
* Parent/guardian willing and able to provide informed consent
* With or without a history of OPC (the study team will enroll 35 participants with and 35 participants without a history of OPC)

Exclusion Criteria:

* Presence of a systemic medical condition (e.g. Down syndrome etc.)
* Presence of an orofacial deformity
* Presence of dental caries
* Use of systemic antimicrobial therapy within 30 days of the baseline visit
* Presence of any condition which, in the opinion of the investigator, makes participation in the project not in the individual's best interest.
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).


Eligibility Criteria:
Inclusion Criteria:

* Participant has androgenetic alopecia (AGA)
* Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.

Exclusion Criteria:

* History of hair loss for reasons other than AGA
* Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
* Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
* Hair-weaving within 6 months
* Use of hair colorants or dyes within 6 months.
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB

The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the clinical significance of this co-infection will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* New patients with pulmonary TB
* Sputum AFB smear-positivity

Exclusion Criteria:

* Non-applicable
A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)

A real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. A total of 200 patients planned to be enrolled.

This is a non-randomized, uncontrolled, multicenter real-world study. The total number of subjects is 200. The objective is to observe and evaluate the efficacy and safety of Trifluridine/Tipiracil alone or in combination with other therapies in the treatment of metastatic colorectal cancer in real-world environment. The primary endpoints is Progression-free survival (PFS). Secondary endpoints are overall survival (OS), Objective response rate(ORR), Disease control rate(DCR), progression-free survival (PFS), and Quality of life (QoL).

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:

* Male and female patients with ≥18 years of age;
* Patients with metastatic colorectal cancer confirmed by histopathology;
* Be willing to use reliable contraceptive methods and refrain from sperm donation throughout the study period and within 3 months after the last dose;
* Voluntarily join the study and provide written informed consent to participate in the study;
* Have traceable medical history during the treatment;
* Doctor believe the patients can benefit from the study.

Exclusion Criteria:

Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study:

* Failure to sign informed consent;
* Patients with contraindications to Trifluridine/Tipiracil;
* Female subjects who have a positive pregnancy test or are breastfeeding;
* Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation.