cyrilzakka/clinical-trials huggingface dataset:
Dietary Treatment Study of Fat Synthesis and Risk of Cardiovascular Disease

The purpose of this study is to find out how the amount of fat or sugar in a person's diet, or the number of meals eaten each day, affect the amount of fat that people's bodies make, the types of fats in the bloodstream, and how much fat is stored in the liver. The study is funded by the National Institutes of Health.

The study consists of two 10-day feeding periods that are separated by approximately two weeks. During each feeding period all food and beverages to be consumed will be provided by the study.

In Study 1, participants will be randomly assigned to receive one of two diets. Both diets are designed to maintain weight at a constant level. The diets are balanced nutritionally and have the same amount of protein. One diet has higher amounts of sugar, while the other has higher amounts of fat. For one 10-day period, the diet will be fed as two large meals ('meal-feeding'). For the other 10-day period, the identical diet will be fed as 8 small meals ('nibbling'). Half of the participants will meal-feed first, while the other half will 'nibble' first. The order of nibbling or meal feeding will be determined randomly.

In Study 2, the number of meals eaten per day will remain fixed at three (no nibbling or meal feeding). Participants will receive both the diet higher in sugar and the diet higher in fat. However, they will be randomly assigned to start one followed by the other for each 10-day feeding period.

At the end of each 10-day feeding period, participants will spend two nights in a research ward (Clinical Research Center) to undergo testing.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese men and women
* ages 20-65 years

Exclusion Criteria:

* pregnancy or lactation within the past six months
* type 1 or 2 diabetes mellitus\]
* AST and ALT above upper limit of normal (ULN)
* fasting triglyceride or total cholesterol levels \>ULN
* Hgb below the lower of limit of normal
* positive HIV antibody test or hepatitis serologies
* use of any antidiabetic medications or lipid-lowering drugs
* history of surgery for obesity
* change in body weight \>5% within preceding 6 months (self report)
* claustrophobia, presence of metal implants
* weight over 350 lbs
Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.

An experienced interventional cardiologist can perform FFR in a brief period of time. This procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation. Performing FFR without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated. Performing FFR without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

* Therapeutic anticoagulation
Vitamins D and K Effects on Vascular Function in Obese Adults.

A prospective, randomized, placebo-controlled, double-blind study that aims to evaluate the effects of combined vitamin D3 and K2-MK7 supplementation on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and deficient or insufficient serum levels of vitamin D.

Overweight and obesity are public health issues of epidemic proportions nowadays. They constitute risk factors for several chronic diseases with vascular, metabolic, and inflammatory changes. Adequate serum levels of vitamin D are correlated with good cardiovascular and metabolic health, since its deficiency and insufficiency (highly prevalent in obesity) have an inverse correlation. Likewise, vitamin K, especially K2, is related to the reduction of arterial stiffness, suppression of the inflammation in the vascular wall, favorable action on the lipid profile, whereas insufficiency is related to increased cardiovascular risk. The combined use of vitamin D and K aiming to reduce cardiovascular risk has been studied, however, the results of randomized clinical trials are still controversial. This prospective, randomized, placebo-controlled, double-blind trial aims to evaluate the effect of supplementation of vitamins D3 and K2-MK7 on vascular function, sympathetic tone, metabolic biomarkers and inflammatory factors in a population of overweight or obese adults and serum levels of deficient or insufficient vitamin D. Individuals of both sexes, aged between 40 and 70 years, body mass index (BMI) ≥ 25 and \< 40 kg/m² and vitamin 25OHD3 \<30 ng/ml will be randomized into 3 groups (A/B/C) to receive supplementation (Placebo/VitD3 7000 IU/VitD3 7000IU+K2-MK7-180mcg) daily for 16 weeks. Individuals will be rated at 4 visits namely:

* V0 screening according to inclusion and exclusion criteria; clinical, anthropometry and electrical bioimpedance, laboratory and vascular evaluation before supplementation;
* V1 supplementation begins;
* V2 after 8 weeks;
* V3 at the end of the intervention. The laboratory evaluation consists of blood count, biochemistry, electrolytes, glucose, lipid, liver and thyroid profiles, vitamin D3 and parathyroid hormone, in addition to the urinary excretion of calcium and creatinine. Sympathetic tone is assessed by a frequency meter (Polar® Verity Sense), arterial stiffness by measuring the pulse wave velocity by oscillometry (Mobil-O-Graph®) and endothelium function by measuring post-occlusion microvascular reactivity using laser speckle contrast image-LSCI.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D deficiency;
* Vitamin D insufficiency;
* Obesity;
* Overweight;

Exclusion Criteria:

* Diabetes mellitus;
* Arterial coronary disease;
* Beta blocker use;
* cancer;
* ESRD;
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.

Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
* Age ≥18 years
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients \< 18 years old
* Patients who are pregnant
* Patients with a history of previous pancreatic surgery
* Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
* Patients with prior cystogastrostomy procedure
* Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
* Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
* Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
* Patients who undergo oversewing of the pancreatic transection margin
* Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
* Patients who are unable to provide informed consent
Use of Thermal and 3D Imaging to Quantify Arthritis

One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.


Eligibility Criteria:
Inclusion Criteria:

* at least 4 years of age

Exclusion Criteria:

* less than 4 years of age
DARWIN Study: A Randomization/Withdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome (C-IBS)

Irritable Bowel Syndrome (IBS) is the most commonly identified functional gastrointestinal disorder, affecting 10-20% of the population in the Western world, seen predominantly in females and with a negative impact on quality of life, characterized by recurrent and often disabling abdominal pain associated with altered frequency or appearance or passage of the stool.

IBS aetiology is unknown and its treatment remains largely empirical and directed to the relief of symptoms. One possible target for IBS treatment has been identified in drugs that modulate the action of Cholecystokinin (CCK), a peptide gut hormone implicated in the regulation of motor and sensory functions at various levels of the gastrointestinal tract.

The biological actions of CCK in the gastrointestinal tract are mediated by CCK1-receptors.

Dexloxiglumide is an oral potent and selective antagonist of CCK1-receptors. The mechanism by which dexloxiglumide might be beneficial in IBS is its ability to modulate visceral hypersensitivity and gut dysmotility.

The DARWIN study has been designed to confirm the efficacy of dexloxiglumide according to a so-called randomized/withdrawal design. In this design all participants start the study treatment and only improved patients (the "responders") are randomized to active treatment or placebo, expecting a more frequent and/or a more rapid relapse of their symptoms in patients randomised to placebo than those on active.

Female and male patients, aged 18-70 yrs meeting IBS diagnostic criteria whose main complain is constipation, with a disease of at least moderate severity, will receive dexloxiglumide or placebo during a double-blind treatment phase of 24 weeks, following a first treatment of up to 12 wks during which patients will have to qualify as "responders" to the study treatment.

The responder status of each patient over each 4-wk assessment period, will be based on a weekly global patient-based assessment of relief and control of symptoms using a telephone/internet-based diary.

Additional secondary efficacy parameters will include: effect of treatment on IBS cardinal symptoms (e.g. abdominal discomfort/pain, bloating, straining, incomplete evacuation, urgency, stool frequency and consistency), on rescue laxative consumption, and on quality of life.

Standard safety parameters include vital signs, adverse event reporting, physical examination, routine laboratory screen, 12-lead ECG and gallbladder ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Rome II criteria for IBS and manifesting supportive symptoms for the sub-classification of C-IBS, with a disease of at least moderate severity.

Exclusion Criteria:

* standard exclusions apply
Amplatzer PFO Occluder Post-marketing Surveillance Study

The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").

Eligibility Criteria:
Inclusion Criteria:

* Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

* Refer to Amplatzer PFO occluder IFU
Early Detection of Lung Cancer With Machine Learning Based on Routine Clinical Investigations

This observational, cross-sectional study in lung cancer patients and lung cancer-free controls aims to develop a machine learning model for early detection of LC based on routine, widely accessible and minimally invasive clinical investigations. The model with adequate predictive performance could later be used in clinical practice as an aid in defining the optimal population and timing for lung cancer screening program.


Eligibility Criteria:
All patients:

* Age ≥ 50 years and \< 80 years at the index date of diagnosis (for Cases) or pseudodiagnosis (for Controls).
* Presence of at least one extended blood analysis, spirometry and DLCO report within the 6 months before the index date.
* Chest CT scan performed in a non-urgent setting (electively) within the 6 months before the index date (= index CT).
* Active smokers at the index date or former smokers that ceased smoking within 15 years before the index date.
* Smoking history ≥ 20 pack-years.

Additional for Cases only: Confirmed histological diagnosis of bronchogenic lung cancer in the time period ≥ 2010 and ≤ 2020.

Additional for Controls only:

* Absence of lung cancer at all times ≤ 2020, confirmed by chest CT scan at the index date.
* Documented to live without diagnosis of lung cancer for at least 3 years after the index date.

Extended criteria for the lung cancer prediction subgroup:

In addition to the above stated inclusion criteria, patients in this subgroup have at least one extended blood analysis, spirometry and DLCO report available in the time interval between 3-5 years before the index date.
ExBRAC - the Pilot Study

The EXBRAC pilot study will investigate the quality of life of patients with breast cancer, and the effect of an intervention with expressive writing. This is a pilot study with two purposes, the first is to create a questionnaire specifically developed for the ExBRAC study, and the second to evaluate the feasibility of the expressive writing.

In the first stage of the study, patients newly diagnosed with breast cancer will be interviewed using a semi-structured method. Based on the transcriptions from the interviews, themes will be gathered and transformed into questions. The questions will be compiled into a questionnaire and an expert group will review the questionnaire to ensure no topic is lacking and an adequate number of response options is present. Lastly, the questionnaire will be face-to-face validated, meaning a patient completes it with a research nurse present to apprehend any ambiguities or questions needing clarification.

In the second part of the pilot study, patients will be included to test the feasibility of the interventions consisting of expressive writing. The intervention consists of expressive writing during 20 minutes. The writing should be of the breast cancer, the treatment or other related topics. The patient is invited to write once every week in a separate place. The intervention ends after four weeks. The written text is not collected. In the pilot study, the intervention will be followed by a telephone call about five weeks after inclusion. To test the feasibility of the intervention, 20 to 25 included patient is considered sufficient.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer

Exclusion Criteria:

* Does not understand swedish
Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy

Interventional (low intervention level), non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice.

Interventional, non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice. This protocol is classified as "interventional" (low intervention level) since that, if possible, an additional quantity of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids. Involves the prospective recruitment of patients undergoing diagnostic bronchoscopies for suspected lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* patients with suspected diagnosis of centrally located and accessible lung cancer endoscopically;
* patients for whom it is indicated to undergo in-depth diagnostic testing through bronchoscopy for the purpose of determining the histotype of the lung neoplasm, according to clinical practice standard;
* aged over 18;
* patients who express informed consent to the study.

Exclusion Criteria:

* medical contraindication to taking biopsy samples;
* medical contraindication to carrying out endoscopic investigations;
* patients with suspected lung cancer not accessible endoscopically;
* patients with lung neoformation already subjected to diagnostic sampling;
* contraindications to taking an additional quantity of tissue.
National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group

The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas \[RESOS\] / French expert network dedicated to the pathology of sarcomas \[RREPS\]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas \[NETSARC\]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.

Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.

With the financial support of the French National Cancer Institute \[Institut National du cancer \[INCa\]).


Eligibility Criteria:
Inclusion Criteria:

* sarcoma

Exclusion Criteria:

-
Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration
* Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints
* Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing
* Female subjects not pregnant and not nursing

Exclusion Criteria:

* Subjects with chronic inflammatory autoimmune disease other than RA
* Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
* Body mass index (BMI) below 18.0 or above 35.0 kg/m\^2
An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity

Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.

A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Both TPOAb and TgAb in all the subjects were measured before ART procedure
2. Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
3. Women underwent first embryo transfer without previous IVF history.

Exclusion Criteria:

1. Abnormal thyroid function test
2. Women with known autoimmune diseases or clinical presentations of autoimmune disorders