cyrilzakka/clinical-trials huggingface dataset:
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer

In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs \<90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

STF during neadjuvant chemotherapy aiming to improve the chemotherapy efficacy and decline the side effects in patients with stage II-III HR+, HER2- breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage II-III (cT1cN+ or ≥T2 any cN, cM0), HR+, HER2- breast cancer
* Detectable and measurable disease (breast and/or lymph nodes)
* World Health Organization (WHO) performance status 0-2
* Adequate organ function assessed by standard pre-treatment assessment:
* Adequate bone marrow function: white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Available for treatment and follow-up
* Written informed-consent
* Willing to fill in Quality Of Life and Cognition questionnaires
* Ability to read and understand Dutch language, accessibility to a computer with internet connection and independent use of computer

Exclusion Criteria:

* Patient history of invasive or ipsilateral non-invasive breast cancer
* Active malignancy in the last 5 years, with the exclusion of basal cell carcinoma or pre-invasive cervical neoplasia/dysplasia.
* Body mass index (BMI) \< 18.5 kg/m2
* Pregnancy or lactating
* Food allergy for ingredients of FMD (nuts, soy, honey)
* A metabolic condition affecting gluconeogenesis or adaptation to periodic fasting. (Diabetes Mellitus for example)
It's Your Game: An Innovative Approach to Preventing Teen Dating Violence

The purpose of this study is to evaluate Me \& You: Building Healthy Relationships, a classroom- and computer-based healthy relationships and dating violence prevention curriculum for 6th grade students, in a large, urban public school district in Southeast Texas.

The purpose of this three year study is to evaluate Me \& You: Building Healthy Relationships, a classroom- and computer-based healthy relationships and dating violence prevention curriculum for 6th grade students, in a large, urban public school district in Southeast Texas. This curriculum was adapted from an existing effective sex education and relationship curriculum, It's Your Game...Keep it Real (IYG), which was enhanced to more explicitly address teen dating violence (TDV) and encompass multiple levels of the social-ecological model (e.g., youth, family, school staff). A randomized two-arm, nested design was conducted among 6th grade students, where students receiving the curriculum were compared to students receiving usual care. Ten middle schools participated in the study, five schools were randomly assigned to receive the curriculum and five to receive usual care. Outcomes were assessed at baseline, immediately following the intervention, and 12 months after baseline. Parental permission and student assent were obtained prior to administration of the surveys. The primary hypothesis is that students who receive the curriculum will have significantly lower TDV perpetration than those who do not receive the curriculum.

Eligibility Criteria:
Inclusion Criteria:

* 6th graders attending regular classes in ten study schools in large, urban school district in Southeast Texas

Exclusion Criteria:

* No students were excluded based on race/ethnicity, age, or gender.
* Students were informed that surveys and the intervention were only available in English and were asked to consider their comfort level with participating in the study.
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation

Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease

The overarching goal of this small exploratory open-label pilot study is to explore metabolic (glucose metabolism, butyrate) and cognition (MoCa) before and after open-label treatment with the short-chain fatty acid (SCFA) prodrug tributyrin in a small pilot study in PD and normal control older adults. Positive findings in this small exploratory pilot trial may support target engagement study of SCFA supplementation in normal adults and PD.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control volunteers over 45 years of age
* People with Parkinson Disease over 45 years of age

Exclusion Criteria:

* Subjects with contra-indications to MR imaging, including pacemakers or claustrophobia;
* Evidence of large vessel stroke or mass lesion on MRI
* Regular use of anti-cholinergic, benzodiazepines or neuroleptic drugs
* History of significant GI disease
* Significant metabolic or uncontrolled medical comorbidity
* Poorly controlled diabetes
* Pregnancy or breast feeding
* Dementia requiring informed assent
* Suicidal ideation
Reports on Sleep Quality and Thermoregulation Among Veterans

To assess and compare the quality of sleep self- reported by veterans with sleep disorders before and after use of the Chilipad cooling mattress pad

A non-randomized convenience sampling study of N=20 adult male or female veterans (\> 18 years of age) with self-reporting sleep disturbance and will utilize a Chilipad cooling mattress for the 5-week study period

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female veteran patients (\> 18 years of age)
* Self-report of sleep disturbance, defined as "sleep of poor quality, timing, efficiency, or duration"

Exclusion Criteria:

* Non-adult patients \< 18 years of age.
* Patients with chart documentation or self-report of illegal drug use, impaired orientation and cognition or currently incarcerated.
* Initiated CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
* Changed dose of a CAM or non-CAM treatments for sleep disturbance in the last 4 weeks.
* Initiated antidepressants in the last 3 months.
* Changed of an antidepressant in the last 3 months.
* Patients who describe their health as fair or poor.
Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital

The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital.


Eligibility Criteria:
o Inclusion criteria : Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice Aged 18 years

o Exclusion criteria : Patients with negative blood culture recorded at the microbiology laboratory of University Hospital of Nice
COVID-19 and SARS-CoV-2 Antibodies in Multiple Sclerosis Patients

Rationale: Patients with MS are possibly more vulnerable to infection with SARS-CoV-2. Furthermore the use of immunomodulatory treatment could have an effect on the course of COVID-19 disease. This has resulted in an alteration of current immunomodulatory treatment strategies and delaying the start of certain medications, which could induce MS disease activity. However, certain immunomodulatory treatments are also hypothesized to have a positive effect on COVID-19 disease. Besides lack of information regarding the effects of MS treatments on COVID-19, there is significant uncertainty in how we should advise MS patients in terms of self-isolation, resulting in many patients staying at home reluctant to perform their work or other daily activities. Nationally and locally, we are collecting information regarding COVID-19 in MS patients but numbers are low and only those who are severely affected are tested. Furthermore, there is no information regarding SARS-CoV-2 immunity in MS patients, which could be affected by certain MS treatments. Consequently, there is an urgent need for reliable information about infection rates/immunity and course of COVID-19 in relation to MS characteristics and treatments.

Objectives: The objectives of this study are 1. to study the course of COVID-19 in MS patients in relation to immunomodulatory treatment and other patient and MS characteristics and 2. to study the proportion of MS patients with SARS-CoV-2 antibodies and 3. to establish the antibody profile in positive tested patients and 4. to study the longitudinal course of these antibody profiles in positive tested patients.

Study design: This is a mono-center cohort study in patients of the MS Center Amsterdam.

Study population: All patients with a diagnosis of MS currently under follow-up in the Amsterdam MS Center.

Intervention (if applicable): Single venous puncture for drawing blood and questionnaire. For a minority of patients (max 25%) who test positive for antibodies we will draw blood a again with questionnaires after six and twelve months.

Main study parameters/endpoints: Course of COVID-19 in MS patients in relation to MS immunomodulatory treatment.


Eligibility Criteria:
Inclusion Criteria:

* a current diagnosis of multiple sclerosis and age ≥18 years.

Exclusion Criteria:

* lack of informed consent.
Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study

The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).

The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.


Eligibility Criteria:
Inclusion Criteria:

* Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)

Exclusion Criteria:

* The intern refuses to participate in the study
* The internal is not available for training and/or evaluation
The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows progressive damage with characteristic loss of visual field. Glaucoma is very commonly associated with raised pressure in the eye (intraocular pressure \[IOP\]). IOP has been shown to increase when lying down in normal subjects as well as patients with glaucoma. It is possible that this effect can make glaucoma worse. This study is designed to investigate the effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each patient will be required to attend for 2 separate 24 hour visits. On one visit the patient will be required to sleep flat and on the other visit at a 30° head up sleeping position. During this time the patient will be required to wear a soft contact lens (SENSIMED Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP measurements are wirelessly transmitted to a recorder.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) that is progressing based on recent or recurrent optic disc hemorrhage
* age 18-85 years
* not more than 4 diopters of spherical equivalent or 2 diopters of cylinder equivalent in study eye
* stable anti-glaucoma treatment for 4 weeks before first session
* for women of childbearing potential, adequate contraception

Exclusion Criteria:

* unwilling or unable to sleep in a flat or 30 degrees head up position
* ocular surgery in previous 3 months
* corneal or conjunctival abnormality
* wear of full frame metallic glasses during monitoring session
* severe dry eye
* secondary forms of glaucoma
* allergy to corneal anaesthesia
* patients with contraindications for contact lens wear
* pregnancy and lactation
* patients unable to understand the character and individual consequences of the investigation
* simultaneous participation in other research
A Study to Evaluate Abuse Potential of Istradefylline

This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. Subjects will participate in an outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a 6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be approximately 25 weeks total.

Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1) for the Qualification Phase. During the Qualification Phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. Following evaluation of eligibility, subjects may be discharged (those who fail Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and then proceed directly to the Treatment Phase. The washout interval between last drug administration in the Qualification Phase and first drug administration in the Treatment Phase will be at least 96 hours (4 days).

Following confirmation of eligibility from the Qualification Phase, subjects will be randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will receive single oral doses of each of the 6 treatments in a randomized, double-blind, crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg, Phentermine 45 mg, Phentermine 90 mg, Placebo.

Each drug administration will be separated by at least 21 days. Serial pharmacodynamic evaluations will be conducted up to 24 hours after each study drug administration to confirm exposure to istradefylline.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who will provide written informed consent
* Healthy volunteer, male and female between 18 and 55 years of age, inclusive
* Subjects with a body mass index (BMI) within 18.0 to 33.0 kg/m2, inclusive
* Subjects who are recreational drug user

Exclusion Criteria:

* Subjects who have an alcohol or substance dependence within the 12 months
* Subjects who have ever been in treatment for substance use disorder
* Subjects who consume on average more than 5 servings of caffeinated beverages per day
* Subjects with a history of or presence of any clinically significant cardiovascular disease
* Subject with hyperthyroidism or glaucoma.
Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery

To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.

Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra two days

Eligibility Criteria:
Inclusion Criteria:

* healthy status (ASA class I);
* nonsmoker;
* not pregnant or breastfeeding;
* no medication consumption in the past 21 days;
* good oral hygiene;
* bony impaction of one mandibular third molars;
* the presence of the first and second molars;
* compliance to cooperate with the research protocol.

Exclusion Criteria:

* chronic systemic disease;
* medications with potential interaction to paracetamol-codeine or ibuprofen;
* a history of intolerance or hypersensitivity to the study drugs;
* any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.
Comparison of Multiradius and Singleradius Total Knee Arthroplasty

The Investigators would like to compare multiradius and single-radius total knee arthroplasty using with association between sagittal patellar offset and anterior knee pain in subjects having undergone bilateral total knee replacement.

A prospective, interventional study. A total of to 494 subjects requiring bilateral multiradius( n=247) and singlerasius(n=247) knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain. In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset". Sagittal patellar offset is accepted by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of end-stage primary gonarthrosis

Exclusion Criteria:

* History of malignancy,
* Severe extraarticular deformity,
* Posttraumatic and septic arthritis sequel
Surgical Manipulation of the Aorta and Cerebral Infarction

The purpose of the study is to compare two surgical strategies for coronary artery bypass grafting with respect to the occurrence of cerebral infarctions made visible by magnetic resonance imaging

Stroke is one of the most devastating complications following coronary artery bypass grafting (CABG) with an overall incidence ranging from 2.0 % to 3.2 %. The presumed etiology for the majority of strokes after CABG is atheroembolism from the diseased aorta ascendens caused by surgical manipulation. Off-pump coronary artery bypass grafting (OPCAB) allows the construction of bypass grafts without surgical manipulation of the aorta. Yet a trial comparing different surgical strategies with stroke as the primary end point would require several thousand patients to achieve an adequate statistical power. The number of patients can be substantially reduced, if cerebral damage is assessed by diffusion-weighted magnetic resonance imaging (DW-MRI). Using DW-MRI we have recently demonstrated that 25% of a patient population undergoing CABG without an increased risk of stroke showed new cerebral infarctions. These new cerebral lesions all showed an embolic pattern, became visible at T2-weighted images and were clinically silent, e .g. did not cause a new focal neurologic deficit. Given the much higher frequency of cerebral lesions assessed by DW-MRI than clinically apparent stroke, DW-MRI is an ideal surrogate parameter for the assessment of cerebral damage in patients undergoing CABG.

The aim of the study is therefore, to investigate the influence of the surgical technique on the occurence of new ischemic cerebral lesions as assessed by DW-MRI in patients undergoing CABG in a prospective randomized setting. We hypothesize that OPCAB, which enables sparing of aortic manipulation, will reduce cerebral infarctions in patients with an increased risk for perioperative stroke.

Eligibility Criteria:
Inclusion Criteria:

* age \> 72
* history of stroke
* cerebrovascular artery disease with stenosis \> 50%
* peripheral arterial disease.

Exclusion Criteria:

* urgent or emergency operation
* unstable angina
* reoperation
* concomitant valvular disease requiring surgery
* implanted pacemaker or other incorporated ferromagnetic material
* claustrophobia.
Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion

The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.

The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE).

In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.

Eligibility Criteria:
Inclusion Criteria:

* Student at Nord-Trondelag University College
* Healthy (no known condition)
* Males and females aged 19 to 29 years

Exclusion Criteria:

* Fish allergies
* Ongoing consumption of omega-3 fatty acids
* Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment
* Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity