cyrilzakka/clinical-trials huggingface dataset:
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children

The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.


Eligibility Criteria:
Inclusion Criteria:

* age 15-18
* body mass index 85% percentile or higher for age/sex
* weight stable

Exclusion Criteria:

* ±5 lbs weight change in the the 3 months prior
* use of medications
* dietary allergies
* metabolic disorder
* eating disorder
* behavioral or psychological disorders
The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis

In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be administered before the first and second EPO/placebo administration. The 24-week treatment period will be followed by a 24-week observation period.

Patients with primary progressive MS or secondary progressive MS without relapses during the last 1 year will be suitable for the trial. In all 56 patients will be enrolled into the study.

The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.

Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 60 years
* primary progressive MS or secondary progressive MS without relapses during the last one year
* duration of the disease of at least 2 years Clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. In addition, progression must be documented by an increase in the EDSS score of at least 0.5 points at any time during the 2 years prior to Screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
* EDSS (Expanded Disability Status Scale) 4.0-6.5
* MRI fulfilling the Barkhof criteria for MS
* written informed consent

Exclusion Criteria:

* pregnancy or period of breastfeeding or missing adequate contraceptive protection
* treatment with steroids in the last 30 days
* treatment with interferons, glatiramer acetate or IVIG in the last1 month prior to enrolment
* treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
* cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic \> 180, diastolic \> 110)
* history of any haematological disorder
* history of renal insufficiency
* any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
* contraindication for contrast enhanced MRI (e.g. pace maker, aortic clip or any metal implant)
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Self-reported having had a full eye examination in the previous two years;
5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
7. Habitually wore spherical soft contact lenses, for the past 3 months minimum:

   It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

   - For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
8. Had refractive astigmatism no higher than -0.75DC in each eye;
9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or intraocular surgery.
Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

Metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is a major determinant of cardiovascular mortality.

Intermittent claudication is a symptom of an early stage of atherosclerosis.

The aim of this study is to determine the prevalence of the metabolic syndrome in patients with intermittent claudication and its correlation with age, gender, localization of arterial obstruction and association with coronary artery disease.

Studies correlating metabolic syndrome and several illnesses are being published, especially affections associated with atherosclerosis, like coronary artery disease, cerebrovascular disease and peripheral arterial disease.

The term peripheral arterial disease, however, refers to several stages of the development of atherosclerosis in the extremities, comprising since asymptomatic patients as far as individuals with critical ischemia.

Intermittent claudication is a symptom of an early stage of atherosclerosis, when medical interventions may still prevent the progression of the disease. Despite the importance of a precocious diagnosis of metabolic syndrome to initiate adequate treatment, its prevalence among these patients is not well determined in the literature.

This is the biggest casuistic in the literature as far as we know.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with complaints compatible with intermittent claudication of the lower limbs, absence or weakness of arterial pulses on the limb or limbs that are limiting deambulation, ankle-brachial index simila or lower than 0.9

Exclusion Criteria:

* patients with critical limb ischaemia
Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake

honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated

Forty fatty liver (non-alcoholic from) patients with obesity are included to be divided into group 1 who will contain 20 patients who will receive honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks. Group 2 who will contain 20 patients who will receive low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* fatty liver (non alcoholic form)
* both sexes included
* obese subjects (class I)

Exclusion Criteria:

* cardiac insult
* respiratory insult
* renal insult
* lower limb insult
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks

Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area

Exclusion Criteria:

1. Participants who are receiving any other investigational agents.
2. Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
3. Patients with arrhythmias other than AF
4. Patients with hemodynamically unstable AF
5. Patients with untreated hyperthyroidism
6. Patients with known or suspected pregnancy
7. Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0-1
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
* Adequate hematologic and end-organ function, laboratory test results.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) • Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Exclusion Criteria:

* Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
* A history of bleeding, any serious bleeding events.
* Important blood vessels around tumors has been infringed and high risk of bleeding.
* Coagulant function abnormality
* artery/venous thromboembolism event
* History of autoimmune disease
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
* Long-term unhealing wound or incomplete healing of fracture
* urine protein ≥2+ and 24h urine protein quantitative \> 1 g.
* Pregnancy or lactation.
* Thyroid dysfunction.
* Peripheral neuropathy grade ≥2.
* People with high blood pressure;
* A history of unstable angina;
* New diagnosis of angina pectoris.
* Myocardial infarction incident .
Oral Versus Intravenous Dexamethasone

The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature \>38°C or \<35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (\>10 g/l, \<4 g/l or \>10% rods in leucocyte differentiation), C-reactive protein \>3 times the upper normal limit Corticosteroid naive at time of presentation

Exclusion Criteria:

* Patients needing corticosteroid treatment above study medication
* Failure to obtain written consent to participate
* Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine)
* Moribund patients (defined as expected to die within 24 hours)
* Patients with proven or suspected allergy to dexamethasone
* Patients not capable of taking tablets orally
Schnitzler Syndrome: Clinical Study, Physiopathological and Search for Genetic Factors

The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In 2001, the investigators proposed criteria to diagnose this syndrome, which are currently admitted in the literature. The main complications of the Schnitzler syndrome are a difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative disorders. About 15% of patients with a Schnitzler will eventually develop a lymphoproliferative disorder; thus this syndrome allows studying the relationship between lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic auto-inflammatory syndromes. The investigators stipulate that this could also be the case in the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently individualized this particular eruption, significantly associated with systemic inflammatory disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3) the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor, within hours after the first injection, similar to what is reported in the PAPA (pyogenic arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a direct pathogenic effect of IL-1.


Eligibility Criteria:
Inclusion Criteria:

* patients with the Schnitzler syndrome according to criteria established by Lipsker D et al. Medicine (Baltimore) 2001;80:37-44

Exclusion Criteria:

* children and pregnancy
Evaluation of Regret in Kidney Transplantation

Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. This decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. Although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. The DONOR study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. The decisional regret will be assessed by the DRS ("Decisional Regret Scale"), associated with the RetransQoL, a quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplantation in the Lille University Hospital
* Functional kidney graft after 28 days post transplantation

Exclusion Criteria:

* Previous other solid organ transplant
* Combined transplantation (kidney and liver for example)
* Cognitive disorders
* Lack of French language skill
Enabling Microbiomics- Driven Personalized Nutrition

The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions.

The main question investigators aim to answer is:

Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Gastrointestinal patients with or without genomic sequencing results available for the following cohorts:

  * Inflammatory Bowel Disease (IBD)
  * Irritable Bowel Syndrome (IBS)
  * Crohn's Disease
  * Celiac Disease
  * Diarrhea
  * Constipation
* Healthy age and sex matched controls with or without genomic sequencing results available

  o Control is defined as patients without gastrointestinal disease or no symptoms at time of sampling
* Able to provide written, informed consent
* Participant has a smartphone device with access to internet connection

Exclusion Criteria:

* Patients with cognitive impairment
* Active use of antibiotics at the time of stool collection
Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

This early phase I trial studies the side effects and feasibility of cryoablation, atezolizumab, and nab-paclitaxel in treating patients with triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cryoablation, atezolizumab and nab-paclitaxel may improve response to the disease.

PRIMARY OBJECTIVE:

I. To determine the safety and feasibility of cryoablation of a primary breast tumor followed by PD-L1 blockade in patients with locally advanced or metastatic triple negative breast cancer (TNBC).

SCONDARY OBJECTIVE:

I. To evaluate the systemic immune response to cryoablation of a primary breast tumor and PD-L1 blockade.

OUTLINE:

Patients undergo cryoablation of the primary tumor over about 1 hour. After 2-3 weeks, patients receive atezolizumab intravenously (IV) on days 1 and 15 and nab-paclitaxel IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-3 weeks post surgery and then periodically thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic PD-L1 positive TNBC (TNBC is defined as estrogen receptor \[ER\] \< 10%, progesterone receptor \[PR\] \< 10%, and HER2 non-amplified; and PD-L1 positive is defined as \>= 1%.)
* Presents with primary breast tumor lesion amenable to cryoablation
* Have at least one additional distant lesion feasible for biopsies
* Agreeable to start on atezolizumab and nab-paclitaxel as per standard of care
* Patients with locally advanced disease must be ineligible for curative surgery for any reason, including but not limited to comorbid status precluding surgery due to safety, unresectability, or patient refusal
* Patient may have received prior systemic chemotherapy regimens

Exclusion Criteria:

* History of autoimmune disease
* History of human immunodeficiency virus (HIV)
* Previous immune checkpoint targeting therapies
* No primary breast lesion amenable for cryoablation due to size (greater than 5 cm) or location (proximity of \< 0.5 cm to the skin or nipple-areola complex)
* Pregnancy
FMT for Alcohol Use Disorder in Cirrhotics.

* Title "FMT for Alcohol Use Disorder in cirrhotics: A Randomized Controlled Trial"
* The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects. The project will be conducted at ILBS over the period of 1 year.
* The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.

Hypothesis :- - FMT is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking, through modulation of gut microbiota and correction of dysbiosis

Aim and Objective -

- To assess the efficacy of FMT in decreasing lapse, relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis

Study population:

- Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS, New Delhi

Study design:

- Open label, parallel group, randomized, controlled study.

Study period:

- 1 year

Sample size with justification:

- Assuming that abstinence in Placebo group is 50% and we assume that there will be 40% absolute increase in FMT group (90%; Bajaj JS, Hepatology 2021) with alpha 5 and power of 80%, investigator need to enroll 48 cases, further assuming 10 % dropout rate it was decided to enroll 54 cases that is 27 in each group.

Eligibility Criteria:
Inclusion Criteria:

1. All consecutive patients with alcohol related cirrhosis with serum bilirubin \<5mg/dl with an active alcohol consumption atleast within last 4 weeks aged between 18 -70yrs.
2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

Exclusion Criteria:

1. Pregnancy
2. Acute illness or fever on the day of planned FMT
3. Ongoing/Past 2 weeks antibiotic use
4. Unclear diagnosis of CLD
5. Non-elective hospitalization within last month
6. Serum bilirubin \>5mg/dl
7. Grade 2 or more Ascites
8. Any Episode of HE Grade 2 or more or requiring hospital admission within 3 months
9. Episode of AVB within last 3 months
10. Treatment with corticosteroids/Immunosupression within the past 60 days
11. Unwilling to participate
12. Dependence on any other substance (except Nicotine)
13. Psychiatric disorder requiring pharmacotherapy/Suicidal tendency
14. Known untreated, in-situ luminal GI cancers \& chronic intrinsic GI diseases.