cyrilzakka/clinical-trials huggingface dataset:
The Effect of Thyme and Sumac on the Thermic Effect of Food and Comparison Between Warm and Cold Temperament People

The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on the thermic effect of food, activity of sympathetic - parasympathetic system: comparison between warm and cold temperament people.

Human body needs to energy in order to preserve life.There are three forms of energy consumption at body, consumption at baseline or resting, consumption at energy expenditure for Thermic effect of food and energy is spent in physical activity.Also from the perspective of traditional medicine, cold and warm natured people are determined based on certain mental and physical protests.

There are different temperament not only in Traditional Iranian Medicine, but in traditional Chinese medicine, Indian, Greek, Arabic, Romanian, and there are European.As various factors on the basal metabolism and thermic effect of food , also are several factors such as age, sex, physical condition of the environment that have an impact on individual temperament.

Since the protests seem warm and cool temperament and factors affecting on their basal metabolic rate and thermogenesis so that food may explain the relationship between warm and cold temperament to mind is the basal metabolism; It seems those are hot temperament, their basal metabolic rate is higher BMR than normal and those who are cold temperament, have a lower BMR.

On the other hand seems that thermic effect of food in people who have hot temperament is higher than thermic effect of food in people who have cold temperament.

So that we need to use of two nutrient foods, in this way we consided the multiple criteria and then were selected sumac and thyme.

On the other hand, in order to study possible mechanisms affecting basal metabolism, thermogenesis of food, according to previous studies and also matches that there are between sympathetic - parasympathetic and thyroid function, with symptoms of cold and warm temperament there, checking of activity of these organs seems necessary.

Because to maintain basal metabolic rate is essential for human life, so that each factor in order to better understand these is helpful to human life.And the need for such study makes clear;Through this step help toward improving public health

Eligibility Criteria:
Inclusion criteria:

* Age 18 to 40 years
* Having to suffer any ill health and lack of attention to history and physical examination
* Willing to cooperate with the project

Exclusion Criteria:

* Catching any disease.
* Use of specific dietary patterns such as vegetarianism
* Having a BMI outside the normal range
* Use of any drugs or supplements in past month
* Allergic reaction to food allergy and non-prescription
* An unwillingness to cooperate in any of the stages of implementation
Longitudinal Care: Smoking Reduction to Aid Cessation

The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.

Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.

Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.

Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Current and regular smoker 5 or more cigarettes per day
* Interested in making a quit attempt in the next 14 days
* Personal phone available

Exclusion Criteria:

* Pregnancy or plans to become pregnant in the next year
* Cannot speak English
* Not a union member or employee of specified worksite or immediate family member
* Member of household is currently enrolled in the study
* Not willing to comply with study protocol
Shifting Salty Taste Preferences in Children

The goals of the proposed research are to determine whether repeated exposure to a low sodium food will result in reduced preference for salt in that food among children; and to determine whether such reductions in preference are related to dietary intake of salt, taste receptor genotype, and anthropometric and physiological measures.

This is a within- and between-subjects randomized controlled trial on children consuming either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated exposure to the low sodium cereal is effective for reducing preference for salt in that food. Children will be genotyped for markers related to taste, dietary intake will be recorded, and anthropometric and physiological measures will be collected at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Willingness to consume no other cereals during intervention

Exclusion Criteria:

* Allergies and/or taking medication that affects taste
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

The aim of study is to assess the possible impact of assisted hatching on delivery rate after transfer of vitrified-warmed human blastocysts.

Zona pellucida (ZP) manipulation, termed "assisted hatching" (AH), has been introduced in order to favor embryo hatching and ultimately improve assisted reproductive technology success but with poor proofs of safety and biological plausibility.

Vitrifying and warming of blastocysts may impair the successful hatching process of the embryo out of its ZP and its following implantation into the uterus. Theoretically, AH may facilitate the hatching process and subsequently increase implantation rates.

In this prospective randomized controlled trial (RCT), the hypothesis is to test whether the application of a partial AH to vitrified/warmed blastocysts might affect patients' delivery rate.

Patients with vitrified blastocysts will be randomized at the time of blastocyst warming to a study group (with AH) or a control group (without AH). AH will be performed at the expanded blastocyst stage using a laser technique and a laser opening will be initiated at the 1 o'clock position. Consecutive laser shots will be applied to reach the 5 o'clock position of the blastocyst. The blastocysts will then be cultured at least 2 h and subsequently transferred into the patient's uterus.

Eligibility Criteria:
Inclusion Criteria:

* single embryo transfer of vitrified/warmed blastocyst (SET)
* first or second frozen IVF (with or without Intracytoplasmic Sperm Injection) cycle of blastocysts
* first or second oocyte retrieval

Exclusion Criteria:

* Preimplantation Genetic Testing (PGT) cycle
* BMI \> 35 kg/m2
* severe male factor
* abnormal uterine cavity
A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy

This was a non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT). This study utilized de-identified individual patient data from the United States (US) ConcertAI Patient360 Breast Cancer database, sourced from electronic health records (EHR) (i.e., secondary use of data). Patients were indexed at their start date of the earliest alpelisib plus fulvestrant regimen and followed until their death date or last confirmed activity date in the absence of an observed death.


Eligibility Criteria:
Inclusion Criteria:

* Had a curated record for advanced or metastatic breast cancer diagnosis.
* Note: Diagnosis of a/mBC is based on a curated record of M stage=M1, Stage 4/4a/4b, presence of metastatic tumor, Stage 3b/3c or presence of secondary neoplasm.
* Had patient activity documented in ConcertAI Patient 360 Breast Cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date.
* Had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date.
* Had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). This included (neo) adjuvant therapies.
* Age ≥18 years on the index date.

Exclusion Criteria:

* Had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or HER2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results).
* Patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date.
* Patients with "negative" PIK3CA test before index date (in case of multiple tests, the one closer to the index date was used).
Ultrasound Markers of Systemic Inflammation

The aim of this study was to measure whether the flow rate through the brachial artery and inflammatory markers were associated with the development of tissue edema in the surgical intensive care unit patients.

The study was performed using a ultrasound machine with linear probe settings at 50 mm depth and 40 decibel \[dB\] gain that did not change during the study. The probe was placed on vascular ultrasound measurement. The diameter of the brachial artery in the middle of the upper arm and the flow rate through the artery was measured on postoperative days 1 and 2. The presence of the edema was measured above the 3rd metacarpal bone as the distance from the skin surface to the periosteum. An average of three assessments was shown. Patient's age, body mass index (BMI), type of admission, white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) were also registered.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Postoperative surgical patients
* Signed informed consent

Exclusion Criteria:

* Refusal to give informed consent
* A previous thromboembolic event of the brachial artery
* Acute infection of the upper extremity
Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the patients of diabetic peripheral neuropathy.

Diabetes is a serious, long-term condition with a major impact on the lives and well-being of individuals, families, and societies worldwide. Diabetic neuropathy is its most common clinical consequence. Diabetic Peripheral Neuropathy (DPN) is defined as "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes." A person with DPN is up to 20 times more likely to fall than a non-diabetic of the same age, making falls an even more significant therapeutic concern. As a result of decreased balance, people with DPN are predisposed to falls, which can lead to injury, decreased balance confidence, fear-related avoidance of activities, and decreased quality of life. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the population of DPN and it will also predict which of them is the most responsive and sensitive and first evaluates changes in balance of patients with DPN. After the comparison of responsiveness and sensitivity of these scales, it can predict the best tool for early assessment of balance impairment in the people with DPN. This study will be beneficial in early identification of fall risk and minimization of fall related injuries and complications.

Eligibility Criteria:
Inclusion Criteria:

* Either gender.
* Age between 40 to 60 years
* Known history of diabetes mellitus treated with by oral hypoglycemic drugs or insulin therapy.
* Known case of diabetic peripheral neuropathy (DPN)
* Patients who met the criteria of DN4 scored equal or greater than 4.
* Patients who have positive SHARPEND ROMBERG TEST.
* Balance impairment on BBS (21-40).

Exclusion Criteria:

* Lower limb muscles strength less than 3 on manual muscle testing.
* Any inflammatory condition, congenital or acquired malformation, vestibular system pathologies.
* Contraindication for engaging in physical activity (osteoarthritis, orthostatic hypo tension or any acute illness).
Fulminant Severe CAP - an Observational Study

Severe community-acquired pneumonia (CAP) represents a major cause of hospital mortality. Among severe CAP cases, some exhibit a rapidly progressive evolution, leading to severe ARDS/acute respiratory failure and septic shock within hours to a few days. This type of pneumonia, known as "fulminant pneumonia," is characterized by its rapid onset and deterioration, often necessitating immediate medical intervention. Despite its severity, the true incidence and optimal treatment for fulminant pneumonia are not well understood. This knowledge gap is due to the lack of attention towards pneumonia as a potential time-dependent illness and the separation of overlapping clinical topics: severe pneumonia, ARDS, and sepsis.

In clinical practice, pneumonia is the most frequent cause of both ARDS and sepsis. However, these conditions are often considered separately, combining ARDS and sepsis from various extra-pulmonary causes with those originating from pneumonia. The COVID-19 pandemic, with its vast number of severe CAP cases in a short period, has highlighted the existence of fulminant pneumonias, underscoring the need for further investigation. Recent randomized clinical trials (RCTs) and experiences from COVID-19 have suggested that early and prolonged corticosteroid administration can reduce mortality in patients with severe SARS-CoV-2 infection and severe CAP/ARDS of bacterial origin.

The aim of this observational study is to analyze the rate of fulminant pneumonia and assess the impact of early corticosteroid treatment in a multicentric population of hospitalized patients with severe pneumonia.

A list of consecutive patients with severe CAP from the 5 participating centers from January 2018 to July 2024. Patients recruited for concomitant randomized clinical trials were allowed. Each Center used an early antibiotic policy (\<6 hours) in case of sepsis and/or severe pneumonia diagnosis. The use of corticosteroids varied from several reasons (e.g. RCT protocol, internal policy, physician on duty with not restriction to this.

Both COVID and non-COVID patients were recruited if PaO2:FiO2 \<300, bilateral community acquired pneumonia, and 2 or more of the following: increased CRP \> 99mg/L, respiratory rate\>25bpm or signs of respiratory distress, need for respiratory support (CPAP, MV, HFNC), creatinine\>1,49mg/dl, ALT\>70. Hospital-acquired and Healthcare-acquired pneumonia were excluded. Also, chronic end-stage illness (e..g. metastatic cancers, advanced neuromuscolar disorders, etc) were excluded.

The following patient caractheristics and clinical data were collected at admission: oxygenation state, vital signs, age, type of unit at admission, admission to ICU, length of hospital stay, type and duration of mechanical ventilation (MV), initial and maximal PEEP administered, ALT, WBC, platelets, Haemoglobin, presence of obesity, comorbidities, risk factors (smoking, abuse).

Eligibility Criteria:
Inclusion Criteria: severe community acquired pneumonia according to ATS/IDSA -

Exclusion Criteria: incomplete outcome data

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Reward and Drug Effects on Mood and Brain Response

The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.


Eligibility Criteria:
Inclusion Criteria:

* must be able to give informed consent
* age 18-25 at the time of signing the consent form
* fluency in English
* body mass index of 19-26 (normal/overweight but not obese due to limitations of MRI)
* negative urine drug screen (UDS) for all substances except THC (THC allowed)
* must be medically and neurologically healthy
* must not be taking psychoactive medications that would interfere with dronabinol and/or interpretation of fMRI data, including but not limited to the following classes of psychotropics: antidepressants, anxiolytics, sedative hypnotics, stimulants, antipsychotics, mood stabilizer
* have used cannabis at least 10 times in their life, but report current and past lifetime cannabis use less than 7 days/week (daily)

Exclusion Criteria:

* any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol, interpretation of fMRI data, and/or interfere with study procedures
* current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol/Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide.)
* current Axis-I Diagnostic Statistical Manual-5 diagnosis (although mild and moderate Cannabis Use Disorder (CUD) and mild and moderate Alcohol Use Disorder (AUD) are allowed)
* score \>3 on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for individuals with current AUD
* lifetime other lifetime Substance Use Disorder (although lifetime severe CUD and lifetime severe AUD are allowed)
* currently seeking or engaged in CUD treatment or have desire to cut down or stop cannabis use.
* in recovery or enrolled in treatment for any substance (including cannabis and alcohol)
* lifetime psychosis, mania, Attention-Deficit/Hyperactivity Disorder, Obsessive-Compulsive disorder, Feeding and Eating disorder, or Post-Traumatic Stress Disorder
* score \>7 on the Hamilton Depression Rating Scale or score \>7 on the Hamilton Anxiety Rating Scale
* less than a high school education
* lack of fluency in English
* night shift work
* currently pregnant confirmed by urine pregnancy test or planning pregnancy or lactating (women)
* unwilling/unable to sign informed consent document
* inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report
* left-handed
* presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
* positive UDS for any drug except THC
* positive breathalyzer for acute alcohol intoxication
* heavy alcohol use (\>4 days week) in the past month
* heavy nicotine use (\>20 cigarettes per week) in the past month
35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

HA35 (Bioactive HA or B-HA or HA35) have good tissue permeability (B-HA injection, Ministry of Health, Registration number L20200708MP07707). HA35 might not lose HA's bioactivities of binding to a variety of hyaluronan's binding proteins or receptors, including the analgesic and anticancer effects of hyaluronan, therefore being named bioactive HA or B-HA (10) (B-HA injection, Ministry of Health, Registration number L20200708MP07707).

The previous study has shown that naked mole rat who has high tissue content of hyaluronan and its fragments is insensitive to pain. The previous study has also shown that hyaluronan modulates pain-regulated TRPV1 channel opening, reducing peripheral nociceptor activity and pain. The previous study has again shown that local injection of 35kDa hyaluronan fragment HA35 is effective in treating inflammatory and neuropathic pain. This study employs freshly made HA35 injection for treatment of pain associated with radiotherapy for treatment of colorectal and rectal cancer. A numerical rating scale from 0 to 10 was used to assess the pain after 1 hour, 3 hours, 24 hours, 48 hours and 72 hours of the injection.

Eligibility Criteria:
Inclusion Criteria:

* All patients had different degrees of metastasis of the cancers, including bone metastasis.
* All patients undergo targeted radiotherapy shortly before this study.
* All the patient volunteers included in this study were allowed to use antibiotic compounds on and off during the treatment in order to prevent possible infection associated with the cancers for ethnic consideration.
* The included patients were aged 48 to 60 years.

Exclusion Criteria:

* Can not independently determine the level of pain.
* Severe bleeding and severe inflammation
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study

Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study


Eligibility Criteria:
Inclusion Criteria:

* Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
* Those who understand and voluntarily sign an informed consent form

exclusion criteria

* None