cyrilzakka/clinical-trials huggingface dataset:
Effect of Consumption of a Novel Functional Yogurt on Blood Biomarkers of Healthy Participants

The purpose of the study is to assess the effect of a dietary intervention that includes the consumption of a novel functional yogurt (enriched with probiotics and polyphenols) on the blood biomarkers of healthy participants.

After having been informed about the study and the potential risks, all participants giving written informed consent will undergo screening to determine eligibility for study entry (inclusion criteria). At baseline (t0), a fasting blood sample will be taken by venipuncture from the participants, and they will be randomly assigned in a double-blind manner (investigator and participant) to one of the intervention groups, i.e. meal including the consumption of the functional yogurt (yogurt enriched with probiotics and polyphenols) or consumption of yogurt enriched with probiotics or consumption of placebo yogurt. The participants have to finish their meals within 15 minutes (t1) and after the meal, blood sampling will be repeated for the times, t2 = 30 min, t3 = 90 min, t4 = 180min. After a washout period of 7 days, the participants will consume the functional yogurt, or the yogurt enriched with probiotics, or the placebo yogurt, in a cross-over design, and the blood sampling will be carried out as described above. Finally, after a washout period of 7 days, the participants will consume the functional yogurt, or the yogurt enriched with probiotics or the placebo yogurt in a cross-over design, and the blood sampling will be carried out as described above. Throughout the interventional period participants' dietary intake, anthropometrical data, medical history, and dietary habits will be monitored.

Eligibility Criteria:
Inclusion Criteria:

-healthy individuals aged 18-65 years old, of both sexes/genders

Exclusion Criteria:

* BMI \> 30 kg/m\^2
* contraceptive pills taking
* lactose intolerance or food allergy to any of the ingredients of the food under study
* probiotic supplements or medications that affect bowel function
* pregnant or lactating women
* illicit drug use or chronic alcoholism or total daily alcohol intake \> 50 g/d
* people with a chronic condition (cancer, active liver disease, severe kidney dysfunction, severe stroke in the last six months and conditions associated with an increased risk of bleeding) or individuals with any other serious medical condition that may affect their ability to participate in a dietary intervention study
* individuals who are considered unreliable by the researcher or who have a shorter life expectancy than the expected duration of the study, due to some illness or if they are in any condition which in the researcher's opinion does not allow their safe participation in the study
Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.

The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.

The specific aims of the study are to:

* Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination
* Determine neutralizing antibody titer after yellow fever vaccination

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and give informed consent
* Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination
* Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.

Exclusion Criteria:

* Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)
* History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)
* Required use of immunosuppressive medications
* Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form
* Recipient of a blood product or immune globulin product within 42 days of study visit
* Reporting pregnancy
Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?

The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this scale has never been validated. As a quality improvement program, it is important to study the reproducibility of the scale between different operators and the operators himself.

Method: During upper endoscopic examinations, one investigator performed the procedure and the second investigator look at the endoscopic image. The degree of gastritis and duodenitis is graded. The results of the grading are blinded to the other investigator.

The endoscopic video is stored for reassessment to determine the intra-rater reliability. The patient identifier is stored in serial number. The investigator will not retrieve the report of the first assessment during the second assessment.


Eligibility Criteria:
All patients undergo upper endoscopy are included after written informed consent is obtained
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study

Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction.

Design 36-month, 4-group parallel, randomized trial.

Setting Oulu, Finland.

Participants 120 obese adults (body mass index ≥ 30).

Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6.

Measurements Body weight (primary outcome) and waist circumference (secondary outcome)


Eligibility Criteria:
Inclusion Criteria:

* Body mass Index \> 30
* Age 18-64

Exclusion Criteria:

* Pregnancy
* Health reasons preventing exercise and exercise test
* Medication preventing exercise and exercise test
* Previously diagnosed diabetes
Voriconazole For Chronic Bronchopulmonary Aspergillosis

To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary


Eligibility Criteria:
Inclusion Criteria:

* Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
* Complex aspergilloma non primarily operable,
* Chronic necrotizing pulmonary aspergillosis,
* Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

Exclusion Criteria:

* Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval \> 450 msec in men and \> 470 msec in women.
* Simple aspergilloma with primary indication of surgical treatment.
Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia

This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.

Endometrial polyps are frequent gynecological pathologies leading to metrorrhagia, infertility, miscarriages and the risk of transformation into malignant pathology. The discovery of an endometrial polyp requires its removal.

The treatment of endometrial polyps is conventionally carried out by hysteroscopic resection under general anesthesia with a bipolar resector of 22 Charrières (Ch) or more after dilation of the uterine cervix in the operating room.

Following the recent appearance of a 15 Ch. bipolar mini-resectoscope, it seems that uterine dilation and anesthesia could be avoided by reducing the caliber of the instrument.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18 or over
* Patients with 1 to 2 endometrial polyps
* Polyps diagnosed by ultrasound and / or diagnostic hysteroscopy following a check-up for menometrorrhagia, infertility or during a check-up
* Polyps measuring less than 3 cm
* Have signed a consent form
* Be affiliated with a Health Insurance plan.

Exclusion Criteria:

* Pregnant or lactating patient
* Cervical stenosis
* Patient having more than 2 polyps
* Polyps measuring 3 cm or more
* Malignant cells on histology
* Associated indication of endometrectomy or other endo-uterine gesture
* Hypersensitivity to remifentanil or to other fentanyl derivatives or to any of the excipients of the specialty used
* Hypersensitivity to propofol or to any of the excipients of the specialty used
* Cardiac pathology
* Diaphragmatic hernia
* Morbid obesity (BMI\> 35)
* Invasive cervical cancer
* Chronic obstructive pulmonary disease
* Patient presenting a strictly greater than 4 on a pain scale (from 0 to 10) during a diagnostic hysteroscopy
* Does not speak and / or understand French
* Be deprived of liberty or under guardianship.
Etonogestrel Implant as Emergency Contraception

The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation. The researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an LH surge.

Based on data from the Food and Drug Administration label for Nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. Given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an LH surge. This study is novel as there have been no published studies evaluating an etonogestrel implant for this indication.

The contribution of this proposed research to the literature is significant because current recommendations from the Center for Disease Control (CDC) regarding timing of etonogestrel implant placement are stringent and not patient-centered. Any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. If results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.


Eligibility Criteria:
Inclusion Criteria:

* BMI less than or equal to 28kg/m2
* Intact uterus with at least one ovary
* Regular menstrual cycles that occur every 21-35 days
* If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment
* If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment
* Desires insertion of an etonogestrel contraceptive implant for contraception
* Not currently pregnant or trying to become pregnant
* Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study

Exclusion Criteria:

* Have a known hypersensitivity or contraindications to etonogestrel.
* Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)
* Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.
* Uncontrolled thyroid disorder.
* Use of long-acting injectable hormonal contraceptive within the past 9 months
* Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)

A database has been established to track the outcomes of all cases performed in the University Hospitals Department of Surgery in an effort to improve quality of surgical performance and case management.

Specifically, the purpose of the database will be used as a quality improvement tool for analyzing process and outcome measures and to accurately track cases performed by surgeons.

Since the Institute of Medicine report, titled "To Err is Human", there has been an increasing trend to evaluate outcomes in healthcare. While optimal outcomes in delivery of healthcare are something that hospitals and their medical, nursing and administrative staff have always tried to achieve, this has often been attempted without having much information to assess the outcomes that actually occur.

For this reason, programs such as NSQIP (the National Surgical Quality Improvement Project) have been brought from the VA system into private and academic healthcare systems, to sample surgical outcomes and provide hospitals with benchmarks that can be achieved, as well as informing them where they rank in the overall results. Unfortunately, systems such as NSQIP are based on sampling a percentage of cases performed each week, but do not track all cases or all providers. Many cases are therefore not tracked in any way.

Certain centers have now established databases to track their own surgical outcomes. These are usually specific to certain surgical specialties, and provide an opportunity to perform quality improvement. These also have the added value of being useful tools for maintenance of certification and for clinical research.

Primary goals of this study:

We propose to further develop the General Surgical Outcomes Quality Improvement Database(GSOD)-subsequently renamed UH-SOCRATES-which will track all surgical, medical, and radiological encounters occurring at University Hospitals Case Medical Center(UHCMC)as well as at UH's Richmond and Geauga campuses. This database will have several goals:

1. UH-SOCRATES will be used as a quality improvement tool for analyzing process and outcome measures, for example being able to evaluate patients with prolonged length of stay so that cases can be defined and evaluated for specific risk factors or in-hospital events.
2. By using hospital coded CPT codes, UH-SOCRATES will be able to accurately track cases performed by surgeons for maintenance of certification purposes.

All of these goals are related to quality improvement and assessment, and are considered "not human subjects research" under 45 CFR 46. In the future it is hoped that UH-SOCRATES will also be a powerful resource for formal research into surgical outcomes. Future IRB submissions will be submitted for this purpose. This IRB submission therefore only addresses the quality improvement perspective of the UH-SOCRATES.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving surgical,medical,or radiological services at University Hospitals Case Medical Center,Richmond,or Geauga campuses.

Exclusion Criteria:

* None
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks

GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.


Eligibility Criteria:
Inclusion criteria:

* Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
* Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).

Exclusion criteria:

* History of eating disorders.
* Recent history of weight loss or gain.
* Had gastrointestinal surgery for treatment of obesity.
* Type 1 or type 2 diabetes mellitus.
* Have a positive urine drug screen.
* Have liver disease.
* Have hepatitis B, hepatitis C, or HIV antibodies.
* Have a thyroid disorder that is not under control with medication.
* Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
* Are unable to participate in an exercise program.
* Have used weight loss drugs within 3 months before the start of the study.
* Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or antiretroviral medications.
* Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
* High or low blood pressure.
IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.

This is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting IVIG administration within 48 hours of mechanical ventilation. The exploratory objective is to analyze the blood before, during and after IVIG administration. The blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via Mass Spectrometry.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COVID-19 positive test result
2. Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
3. Age \>18 years old.
4. Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
5. Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.

Exclusion Criteria:

1. Superimposed bacterial pneumonia or bacteremia
2. Severe allergy to any IVIG product formulation
3. Hypersensitivity to corn
4. Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg)
5. Active participant in another research treatment study
6. Advanced dementia
7. Severe renal disease (CrCl\< 20 mL/min)
8. Active cancer malignancy
9. Active treatment with cancer chemotherapy or immunotherapy
10. Congestive heart failure clinically or by history (EF\< 25%)
11. Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab)
12. Venous or arterial thrombosis \< 90 days prior
13. Are receiving cytotoxic or biologic treatments such as TNF inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions:

    * B-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer)
    * TNF inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and
    * JAK inhibitor: a washout period of 1 week or 5 half-lives (whichever is longer).
Modulation of Cognitive Control by Transcranial Direct Current Stimulation

Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of an enhancement of dlPFC activity in MDD patients by anodal transcranial direct current stimulation (tDCS) on cognitive control.

In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD patients and healthy controls. To assess the cognitive control the investigators use a delayed response working memory (DWM) task with pictures of varying valence presented during the delay period.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* informed consent
* in the patients group: Major depressive disorder, no antidepressant medication or stability over 1 week

Exclusion Criteria:

* seizures
* cardiac pacemaker
* deep brain stimulation
A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee

The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years.

The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged between 45 and 85 years inclusive.
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
* Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
* Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Revision of an existing knee implant (including unicompartmental implants).
* Female subjects who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
* Subjects who are currently involved in any personal injury litigation claims.
* Subjects involved in personal Medical-Legal claims.
* Subjects with a known history of poor compliance to medical treatment.