cyrilzakka/clinical-trials huggingface dataset:
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study

Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis.

Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.

Breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. While breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. The challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. Many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. Despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ).

Patients scheduled for surgical resection of the tumor Availability of both preoperative tumor size assessments and pathologic measurements post-surgery

Exclusion Criteria:

Patients with recurrent breast cancer Inflammatory breast cancer Patients who did not undergo surgery Patients whose preoperative tumor size data is not available or deficient for analyzing
One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c

The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported Type 2 diabetes diagnosis
* Has not changed treatment regimen in the last 3 months
* HbA1c levels ≥ 7.5% by self-report and verified by lab test
* Motivated to use a daily diabetes self-management coaching program to improve diabetes control
* Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously

Exclusion Criteria:

* Current use of a smartphone application to manage their diabetes
* Currently participating in a diabetes self-management education or coaching program
* Currently pregnant
* Does not understand English
* History of serious mental illness or dementia
* Has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection
Omega-3 Fatty Acids in Adolescent Depression

Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment.

Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.

Title: Omega-3 Fatty Acids in Adolescents with Depression

NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. However, psychotherapy cannot be initiated at the time of entry into the study.

Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.

Summary: Informed consent will be obtained from parent/guardian and assent obtained from participant. Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be obtained. Eligible participants will be randomized to receive either omega-3FA or matching placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage will be titrated based on clinical response and side effects. At end of double-blind phase, participants will be referred to a clinician who will be informed of subjects' treatment. Depending on treatment received during double-blind phase, post-study treatment options will include treatment with omega-3 fatty acids or an SSRI.

Eligibility Criteria:
Inclusion Criteria:

* Age: 12-19
* Depressed with DSM-IV diagnosis of MDD
* Duration of depressive episode greater than 6 weeks

Exclusion Criteria:

* Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental disorder (PDD), and Tourette's disorder.
* Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine).
* Adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves.
* Current antidepressant treatment, or taken within 60 days prior to enrollment
* Neuroleptics taken within 90 days prior to enrollment
Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia

Unpredictable difficult endotracheal intubation remains a challenge especially if difficult ventilation occurs. Difficult intubation is associated with many severe fatal complications including air way trauma, laryngospasm, hypoxemia, arrhythmias and potential cardiac arrest. Therefore, preoperative evaluation and prediction of potential difficult airway is very important.

Several screening tests are used in clinical practice to identify patients at the risk of difficult airway. Despite their accuracy and beneﬁt, a small number of patients classiﬁed to an easy airway may still present an unexpected difficulty. Predicting a difficult airway is not at all an easy task for all patients .

Incidence of difficult airway and difficult intubation varies from 5% to 22% with important implications for clinical practice and patients' outcomes .

There are multiple scores used for airway assesment ,the commonest one is LEMON score. LEMON is an airway assessment score that measures factors associated with difficult intubation such as obesity, head and neck movement, jaw movement , receding mandible, long upper incisors, Mallampatti scores, maxillary incisor characteristics, decreased mouth opening ,shorten thyromental distance and short neck .

Diagnostic criteria for LEMON scoring system :

L- Look. E- Evaluation using the 3-3-2 rule. M- Mallampati. O- Obstruction. N- Neck mobility. Ultrasound (US) imaging technique is simple, portable, noninvasive tool helpful for airway assessment and management. In the last few years, there have been some reports that described various roles of US imaging in airway management. It helps in rapid assessment of the airway anatomy, not only in operation theatre but also in the intensive care unit and emergency department.

Various clinical applications of US imaging of the upper airway include identification of endotracheal tube (ETT) placement, guidance of percutaneous tracheostomy and cricothyroidotomy, detection of subglottic stenosis, prediction of difficult intubation and post-extubation stridor, prediction of paediatric ETT and double-lumen tube (DLT) size.

Recently there are researches about airway assesment by ultrasound. Several airway assesment indicies are used to help in prediction of difficult endotracheal intubation. The most commonly used indices are distance from skin to epiglottis, distance from skin to vocal cord level, and distance from skin to hyoid bone.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients from 18- 50 yrs old
* Patients who require endotracheal intubation for surgery under general anesthesia.

Exclusion Criteria:

* Patients with history of previous difficult intubation.
* Neck deformity such as swelling , scar ,etc.
Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Counseling Latina women suffering from POP is often complex due to a variety of factors, including language barriers, limited patient understanding of anatomy and disease etiology and confusion regarding surgical versus nonsurgical treatment options. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment, empowering these women as active participants in their healthcare instead of relying on provider input alone.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic Women
* Referred for evaluation of pelvic organ prolapse for the first time

Exclusion Criteria:

* Women previously referred or treated for pelvic organ prolapse
* Women who do not live in El Paso, Texas
Phe for Me? The Effects of L-Phe on PKU Carriers and Non-carriers

This is a clinical intervention study of PKU carriers (cases) and non-carriers (controls). Upon completing the informed consent process, participants will complete baseline measures of chronic mental health prior to the intervention (PHQ-9, GAD-7, BIS-11). Participants will attend the Human Nutraceutical Research Unit (HNRU) at the University of Guelph, fasted, and first undergo baseline measures of cognition and acute mental health (mood) and provide samples or saliva, urine and dried blood spots to evaluate phenylalanine (Phe), tyrosine (Tyr) and their metabolites (PAH pathway functioning) as well as for genetic testing of the PAH gene. Participants will also complete a brief questionnaire which will include age, sex, ethnicity, income, weight and height (measured using a stadiometer and calibrated weigh scale), and confirmation that participants arrived to the lab fasted (i.e. have only had water to drink and no other foods/ beverages prior to analyses). Blood pressure and heart rate will also be measured at baseline.

Following baseline tests, participants will consume a pure L-Phe supplement dosed at 100 mg/kg mixed with 125 mL of water and 125mL of orange juice. Blood pressure and heart rate will be repeated at 1-hour post-L-Phe consumption. Two-hours postprandial, participants will repeat the cognitive tests and acute mental health (mood) assessment, blood pressure and heart rate measurement and provide follow-up saliva, urine and dried blood spot samples. Participants will also be asked to report any side effects they experienced with the L-Phe consumption.


Eligibility Criteria:
Inclusion Criteria:

* Carrier or non-carrier of PKU
* At least 18 Years of age
* Comfortable fasting the morning of the study (no food or drink other than water)

Exclusion Criteria:

* Have a child with PKU
* Diagnosed with: PKU, severe neurodegenerative conditions affecting cognition (e.g. Alzheimer's, Parkinson's, dementia), melanoma, hypertension, liver disease and/or kidney disease
* Diagnosed with hypertension or hypotension
* Taking a monoamine oxidase inhibitor anti-depressant
* Pregnant or breastfeeding
* Orange/citrus allergy or intolerance
* Body weight 150 kg or greater
* History of fainting during blood sampling
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).


Eligibility Criteria:
Inclusion Criteria:

• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).

MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.

• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

* Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
* Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
* Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
* Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent

Other protocol-defined inclusion/exclusion criteria apply
β-hydroxybutyrate, Glucose Metabolism and Prediabetes

The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.

New-onset prediabetes is the most significant risk factor for diabetes. Clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state.

Participants will visit the COSMOS clinic on two occasions and will be randomly allocated to receive either the HVMN ketone drink or placebo, in a cross-over design. Blood samples will be collected sequentially every 30 minutes for up to 150 minutes. Blood samples will be assayed for glucose and other markers of glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over 18 years
* Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
* History of at least one episode of acute pancreatitis
* Written informed consent

Exclusion Criteria:

* Individuals who are on a ketogenic diet or consuming nutritional ketone supplements
* History of cancer or chronic pancreatitis
* History of bariatric or gastrointestinal surgery
* Pregnant or breastfeeding women
* Individuals involved in intensive endurance training or competitive athletics
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training

The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group.


Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria

Exclusion Criteria:

* Regular high intensity endurance (two or more times per week of vigorous exercise).
* Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
* On-going pregnancy.
* Breast feeding within 24 weeks
* Cardiovascular disease or endocrine disorders
Rehabilitation in Severely Ill Inpatients With COVID-19

Inpatient rehabilitation of severe-to-critical COVID-19 patients(A longitudinal, single-center retrospective cohort)

Patients who underwent intensive care at least two days and classified as severe-to-critical COVID-19 (WHO ordinal scale 5-7) were enrolled. Patients received comprehensive rehabilitation including active exercise program, nutritional support, and psychological support.

Eligibility Criteria:
Inclusion Criteria:

COVID-19 patients who

1. underwent intensive care at least two days,
2. eventually got negative conversion with two consecutive tests,
3. were classified as severe COVID-19 (WHO ordinal scale 5-7) and
4. participated in the inpatient rehabilitation program were included.

Exclusion Criteria:

COVID-19 patients who died (WHO ordinal scale 8) before discharge were excluded
Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

1. Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
3. sit SBP \> 140 mmHg, sit DBP \> 90 mmHg
4. Alcohol or Drug abuse within 1 year
Upper Limbs Assessment in Children With Cerebral Palsy

Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment.

While the rates of perinatal and infant mortality have declined toward the end of the last century,the rate of cerebral palsy has remained at 2 to 2.5 per 1,000 live births. A high percentage of children with cerebral palsy have difficulty keeping up with the handwriting demands at school. The neurological impairments in children with cerebral palsy frequently limit the functionality of these children taken in to account the upper limbs variables. It should be interesting to describe a clinical profile based on this assessment.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy diagnosis.
* Aged between 6 and 10 years old.
* Children attending a school.

Exclusion Criteria:

* Severe cognitive impairment.
Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.

The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.

Previous studies have indicated that ginseng root may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine FSS(fatigue severity scale), CIS, lactate, Ammonia, Exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

- CIS \> 76 points

Exclusion Criteria:

* A person who feels tired due to surgical operation within 6 months.
* drug/alcoholic hepatitis, cirrhosis, and fatty liver
* anorexia or bulimia
* a person on night duty, shift work, or heavy redundancy
* A person who is unable to perform an exercise load test
* A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
* A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
* A person who continues to exercise regularly within three months of visiting
* Immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines
Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method

We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome


Eligibility Criteria:
Inclusion Criteria:

* - Patients treated by ponseti method for clubfoot-

Exclusion Criteria:

* - other malformation associated / congenital