cyrilzakka/clinical-trials huggingface dataset:
Study of Serum Hepcidin Rate Variations During Menstrual Cycle

Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.

The interpretation of hepcidin dosage results requires to know the physiological variations of this hormone.

This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

Hepcidin is the major hormone regulating Iron Metabolism. Synthesized primarily by hepatocytes, it interacts with the cellular iron exporter ferroportin, causing its internalization and preventing the release of iron from enterocytes and macrophages.

In a normal organism decrease iron stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.

Since valid methods for the determination of hepcidin serum rate are available, this dosage is increasingly used to diagnosis iron metabolism pathologies, in particular iron overload. The interpretation of hepcidin dosage results requires to know physiological variations of this hormone.

Several works have shown that hepcidin varies according to a circadian cycle, that its values differ by sex and, in women, by age. As far as the investigators know, no study has focused on possible variations in serum hepcidin rates values during menstrual cycle in women. Yet this question seems relevant since it has been shown that during the menstrual cycle blood loss can cause significant iron and hemoglobin variations, which can significantly modulate the synthesis of hepcidin.

This study investigate whether there are significant variations in the values of serum hepcidin rates during the menstrual cycle in order to make recommendations on the practical dosage determination of hepcidin in premenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Woman aged over 18 and under 45 years,
* Having given free and informed written consent,
* Having regular cycles (defined by a constant interval between periods of 28 to 30 days),
* Having periods for a duration of 4 + / - 1 days
* Not using contraception or using oral oestroprogestative contraception.

Exclusion Criteria:

* Contraceptive IUD
* Metrorrhagia
* Pregnancy,
* BMI under 18 kg / m² and above 30 kg / m²,
* Presence of at least one of the following abnormalities in serum iron balance : Hemoglobin \<11.5 g / dl, transferrin saturation under 15% or greater than 50%, serum ferritin under 15μg / l or greater than 150 µg / l
* Active smoking or quit within the last 6 months
* Drinking more than 20 g of alcohol per day ,
* Iron supplementation or blood transfusion within 12 months before inclusion
* Blood donation within 3 months before inclusion,
* Stay in altitude\> 1500 m in the previous month before inclusion
* Chronic inflammatory disease,
* Incapable people over 18 (judicial protection, guardianship) and persons deprived of their liberty.
The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis

Sepsis is the body's response to a life-threatening infection. This study will determine if zinc supplementation is safe to use in patients with severe sepsis or septic shock. This study will also gather preliminary information to evaluate the impact that zinc has on the immune system (the body's defense system against infection) and whether zinc can help monocytes and macrophages (specific types of cells that remove infections from the body) work more effectively.

Previous research has shown that zinc supplementation reduces the length and severity of some types of medical infections (examples include the cold virus and diarrhea). Because zinc has been shown to improve the immune system's function, some doctors provide mineral supplements such as zinc to their patients in the Intensive Care Unit. However, there are no studies to show how effective zinc is or that have evaluated what dose(s) of zinc are safe in patients with severe sepsis/septic shock. Nor have studies examined if tolerable doses for septic patients can improve how the immune system functions.

If zinc is shown to improve how the immune system functions during sepsis, it could be used in the future as part of the treatment regimen for patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to an Ohio State University Medical Center medical Intensive Care Unit
* ≥ 18 years
* Have consensus criteria for severe sepsis (two of four systemic inflammatory response syndrome \[SIRS\] signs \[tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia\]) and a known or suspected infection resulting in an organ failure (i.e. respiratory failure, renal failure, etc.)
* Patient must consent to enrollment within 36 hours of a new episode of sepsis and be able to receive supplementation within 12 hours of enrollment but not to exceed 36 hours since sepsis onset to be eligible.

Exclusion Criteria:

* Consent not available or declined,
* Prisoner, Women who are pregnant or lactating
* Chemotherapy within past 4 weeks or Absolute Neutrophil Count\<500
* AIDS defining illness or Cluster of Differentiation 4 \< 200
* Acute Pancreatitis or amylase/lipase \> 2x normal
* Small Bowel Obstruction or GI condition preventing enteral route of feeding
* C.difficile colitis or active diarrhea
* Active vomiting or current use of Total Parenteral Nutrition within past 30 days
* Predicted ICU length of stay \< 72 hours or moribund
* End Stage Renal Disease on chronic intermittent dialysis
* Previously enrolled in this zinc supplementation study or currently enrolled in another nutritional supplementation trial.
Thoracic Surgery by the Medtronic Hugo™ Robotic System

The introduction of robot-assisted surgery is one of the biggest breakthroughs in surgery, and represents the most significant advancement in minimally invasive surgery of recent decades. One of the first surgical uses of the robot was in orthopaedics, neurosurgery and cardiac surgery. However, it's use has now been well recognized in thoracic surgical procedures ranging from mediastinal tumour resection to complex major lung resections.

Robotic surgery by the da Vinci Surgical System (Intuitive Surgical, Inc) has been one of the most commonly used robotic systems in surgery. The robotic system overcomes the limitations of the standard thoracoscopic approach and allows for precise dissection in a confined space. These advantages include stable operator-controlled camera, high- definition 3D magnified view of 10 to 12 times, articulating instruments with seven degrees of freedom, motion scaling, and tremor filtration.

Recently the Medtronic Hugo™ surgical robotic system has passed the CE mark. This robotic platform, made up of modular surgical arms on wheeled carts, has started its operation in human in Latin America, Europe and the Asia-Pacific region. The Hugo™ system is designed to provide a lower barrier to entry for hospitals looking to expand their reach in robotic surgery. Compared to the platform by Intuitive Surgical, Hugo™can be customized with up to four independent arms, and rolled to different locations in a hospital when needed.

The investigator's centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, the investigator have established the centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures.

In this study, the investigator evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by the Medtronic Hugo™ surgical robotic system.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 - 80 years
2. Body mass index \<35 kg/m2
3. Suitable for minimally invasive surgery
4. Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria:

1. Contraindication to general anaesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Non-correctable coagulopathy
5. Emergency surgery
6. Vulnerable population (e.g. mentally disabled, pregnancy)
The Refreshing Older Adults' Driving Skills (ROADSkills) Program

Drivers aged 65+ depend on their car(s) to get to the places and see the people that are important to them. Losing a license in later life has been linked to higher rates of loneliness, depression, and even admission to long-term care; a fact that is particularly relevant when considering the impact of the COVID-19 pandemic. While drivers in this age group are among the safest on the road, they have one of the highest risks of collision when distance driven is considered and are more likely to be seriously injured or killed. Motor vehicle crashes and falls are the top causes of injury-related hospitalizations in seniors. Through a partnership with older adults, driving instructors, and health professionals, we developed the Refreshing Older Adult Driving Skills (ROADSkills) program. This program uses a Global Positioning System (GPS) device that can be placed in people's cars, which can track their real-world, everyday driving patterns, including speeding and hard braking, alongside video data of their behind-the-wheel behaviour. Using this data, a personalized video will be created using information captured by the device in the older driver's car. This study will determine if the older drivers who receive this video feedback perform better than those who do not receive such feedback. Because this is the first time a study will use this type of behavioural intervention, we are interested in hearing from older drivers about their experience of participating in the study. The findings will help us to design a larger, national study of the ROADSkills program in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65-79 to reduce co-intervention bias, as the Ministry of Transportation has a Senior Driver Renewal program that screens drivers aged 80 and older
* Hold a valid driver's license
* Owner and access to insured vehicle
* Speak and understand English fluently
* Visited an optometrist in last two years
* if corrective lens are required for driving, prescriptions should be up-to-date

Exclusion Criteria:

* If participated in a recent Randomized Controlled Trial that examined the effectiveness of video-based intervention, will be excluded due to potential for bias
* Known serious or terminal illness or presence of contraindications for driving
* Performance on cognitive screening: 1) score of \< 21 on the Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) 2) taking longer than 180 seconds or 3 or more errors on the Trail Making Test B (Bowie \& Harvey, 2006).
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body.

Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance.

NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk greater than or equal to 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and who are not using highly effective contraceptive methods (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or who are pregnant, breast-feeding or intend to become pregnant
Contraceptive Awareness and Reproductive Education

The purpose of this study is to increase the initiation and continuation of highly effective contraceptive use while incarcerated and upon release, as well as decrease unsafe sexual activity.

Unplanned pregnancies and sexually transmitted infections are important and costly public health problems in the United States resulting from unprotected sexual activity. Women with a history of incarceration are at increased risk for these problems given the high rates of substance abuse and commercial sex work in this population. This proposal is designed to evaluate an innovative intervention Motivational Interviewing with Computer Assistance (MICA) designed to improve contraceptive use for incarcerated women who do not want a pregnancy and are soon to be released into the community. The investigators will utilize the Title X program which, in conjunction with RI Department of Corrections (RI DOC), provides reproductive health services in jail and then transitional services in the community after release. The investigators plan to recruit 400 women from the RI DOC women's jail and randomize them to two interventions: two sessions of personalized MICA or two sessions of Didactic Educational Counseling (DEC), both delivered individually by trained counselors. The two counseling interventions will be similar in length and timing, but will vary in content, counseling style and the individualized computer generated feedback that is reviewed with the counselor.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-35;
2. Currently sexually active with men defined as having coital sex at least monthly in the past three non-institutionalized months;
3. Expected place of residence after release in Providence County or within 15 miles of follow-up site;
4. Willing to comply with protocol, follow-up and provide at least one locator;
5. Fluent in English.

Exclusion Criteria:

1. Inability to give informed consent secondary to organic brain dysfunction, not having own legal guardianship, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that impair ability to participate in computerize assessment or counseling);
2. Pregnant or trying to become pregnant within the next year;
3. Hysterectomy, bilateral oophorectomy, tubal ligation, IUD or Essure (coil), implantable contraceptive devices (Implanon) or other procedures which make it very unlikely to become pregnant;
4. Women who are monogamous for more than one year whose partner has had a vasectomy;
5. Housed in segregation as we will be unable to recruit them for the study
Follow-up of SPTS in Patients With Raynaud's Phenomenon

Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established.

Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed.

Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Raynaud's phenomenon of the hands
* Scheduled SPTS as treatment for RP
* Age ≥ 16 years

Exclusion Criteria:

• SPTS for other indications than RP
68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer

As a new dual targeting PET radiotracer, 68Ga-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-Biotin in patients with various types of cancer and compared them with the results of 68Ga-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAPI.

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Biotin is overexpressed in various tumor cells and underexpressed in normal cells. We assume that expanding molecular probes targeting FAPI and biotin with dual targets to enhance the targeting ability of the tracer, improve the sensitivity and specificity of tumor lesion detection. 68Ga-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAPI-Biotin, and performed a head-to-head comparison with 68Ga-FAPI or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility Criteria:
Inclusion Criteria:

Various solid tumors with available histopathological findings; Signed informed consent.

Exclusion Criteria:

Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline

Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.

Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.

Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.

Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).

Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 65 and older
* BMI between 18.5 and 34.5
* Close individual to report memory decline

Exclusion Criteria:

* History of central nervous system or psychiatric disorders
* Dementia or Alzheimer's diagnosis
* Diabetes
* Smoking \>20 cigarettes/day
* Gastrointestinal/digestive disorders
* Uncontrolled chronic disease