cyrilzakka/clinical-trials huggingface dataset:
Gender Differences in Dietary Patterns and Physical Activity: A PCA Approach

This study investigates gender differences in dietary patterns and physical activity using Principal Component Analysis (PCA). It aims to identify distinct eating and activity behaviors between men and women in order to develop gender-specific interventions that promote better metabolic health. The study was conducted at a metabolic health center in Rome, Italy, with 2,509 participants. Data were collected through questionnaires and body composition assessments, and PCA was applied to classify participants into groups based on their behaviors.

The study was designed as a cross-sectional analysis of gender differences in dietary patterns and physical activity, utilizing Principal Component Analysis (PCA) to identify distinct behavioral groups. A total of 2,509 participants were recruited from a metabolic health center in Rome, Italy, between May 2023 and June 2024. The study collected detailed data on eating habits, physical activity, and body composition through questionnaires and bioimpedance analysis. Five distinct behavioral groups were identified through PCA, with significant differences in dietary patterns and physical activity levels between men and women. Men were found to consume more meat and participate in strength training, while women favored vegetable-rich diets and had more structured eating routines. These differences also translated into body composition, with men having more lean mass and women more fat mass.

The study highlights the importance of gender-specific interventions in nutrition and physical activity to improve metabolic health outcomes. The results suggest that men could benefit from increased vegetable consumption, while women could benefit from engaging in more physical activity, particularly strength training. Future research should explore these patterns longitudinally to better understand how these behaviors evolve over time and to develop more tailored interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older.
* Participants attending the metabolic health center in Rome, Italy.
* Participants who provided informed consent.
* Participants with complete data on dietary patterns, physical activity, and body composition.

Exclusion Criteria:

* Individuals under 18 years of age.
* Participants with diagnosed psychiatric disorders.
* Pregnant women.
* Participants with incomplete or inconsistent data.
* Individuals with alcohol dependence.
* Participants with significant medical conditions that could affect dietary or physical activity assessments (e.g., severe chronic illnesses).
Cardiovascular Complications of Sickle Cell Disease

In this research study, we are using heart imaging exams and blood testing, in order to gain an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart) complications that often occur in sickle cell patients. Information gathered from the healthy volunteers that participate in this study will be compared to information from the sickle cell patients in this study in order to help further our understanding.

Cardiac magnetic resonance (CMR) has gained increasing clinical application in cardiopulmonary diseases. Due to its 3-dimensional nature, CMR is considered the gold-standard for quantifying left and right ventricular systolic function and size. Additionally, its high tissue contrast allows for a detailed characterization of myocardial tissue. Specifically, the use of techniques such as late gadolinium enhancement can be used to detect the presence of tiny amounts of myocardial scar. Other techniques have been shown to correlate strongly with myocardial iron content. Just as importantly, CMR perfusion imaging can accurately quantify myocardial blood flow and can provide tremendous insight into the function of the microcirculation. CMR's high spatial and temporal resolution, its 3-dimensional approach, its ability to characterize the tissue, and its ability to evaluate the micro- and macro-circulation make it a comprehensive technique for the evaluation of heart disease. Recently, one CMR study has already shown the presence of cardiac microvascular disease in a subset of adult sickle cell disease (SCD) patients in the absence of infarcted myocardium, myocardial iron overload, or coronary artery disease, increasing the evidence for the contribution of left heart disease to pulmonary hypertension (PH) development in these patients; unfortunately, strong conclusions could not be made because the study was underpowered. Thus, this proposal will leverage the advantages offered by CMR to better characterize and detect the PH and cardiopulmonary subphenotypes in the SCD patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18+
* Patients who were diagnosed with SCD confirmed by high-pressure liquid chromatography or hemoglobin electrophoresis will be eligible for the study
* Only patients in stable condition will be included
* Patients receiving transfusions will not be excluded

Exclusion Criteria:

* Patients with vaso-occlusive crises or an episode of acute chest syndrome within the previous four weeks (after 4 weeks have passed, the patients may be re-evaluated for eligibility)
* Patients with high degree heart block; active, hemodynamically significant, ventricular arrhythmias; unstable coronary syndromes; history of myocardial infarction within 1 month of the study.
* Contraindications to gadolinium-enhanced magnetic resonance examination such as severe claustrophobia, Pacemaker, defibrillators, cerebral aneurysm clips, or neurostimulator.
* Pregnancy
* Patients with sinus node dysfunction
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)

The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

Primary Objectives:

* To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.
* To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.

Secondary Objectives:

• To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.

Eligibility Criteria:
Inclusion Criteria

1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.

Exclusion Criteria

1. Patient is unable or unwilling to provide informed consent.
2. Patient is deaf or hearing-disabled.
3. Patient is less than 18 years in age.
4. Patient was previously enrolled in the study.
5. Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
6. Subjects on contact isolation precautions.
The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis

A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.


Eligibility Criteria:
Patients are eligible for inclusion in this study when they meet the following criteria:

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

- Patients that where included in the previous FIND-UC trial

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Patients who not receive their surveillance colonoscopy with CE
* Patients who not undergo their surveillance colonoscopy within 3 months of the surveillance recommendations

Withdrawal of individual subjects

A patient will be excluded from the study if any of the following events occur:

* Withdrawal of informed consent
* The patient requests to be discontinued from the study
* The bowel preparation is scored as Boston Bowel Preparation Scale \<6
* Incomplete colonoscopy because the endoscopist is unable to intubate the cecum during the colonoscopy
* The Mayo-score \> 1 in at least in one of the bowel segments
AMPED Outcomes Registry of Post-ED Pain Management

Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.

Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will meet the following criteria:

  1. Eligible diagnoses:

     musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
  2. Age GTE 18 years;
  3. Decision to discharge from ED to community already made;
  4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
  5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
  6. Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.

Exclusion Criteria:

* Eligible subjects will meet none of the following criteria:

  1. Patient admitted or placed on observation status from ED;
  2. Patient unwilling or unable to comply with telephonic follow-up;
  3. Fracture that requires surgical repair (even if at a later date);
  4. Patient has diagnosis of any chronic pain syndrome;
  5. Patient already routinely takes NSAID or opioid agent;
  6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
  7. Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).
Single vs Multi-fraction SRS Patients on Immunotherapy

This study is meant to compare different surgical approaches to brain cancer.


Eligibility Criteria:
Inclusion Criteria:

i. Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.

ii. Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain metastases.

iii. Well-circumscribed, measureable intraparenchymal brain metastasis(s) with maximum tumor diameter ≤3.0 cm. If multiple metastases are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one metastasis must be ≥ 0.5 cm in maximum diameter to be considered measurable disease.

iv. Negative urine or serum pregnancy test done ≤ 21 days prior to CT simulation, for women of child bearing potential only.

v. Ability to understand and willingness to sign a written informed consent document.

vi. Must have received immunotherapy (PD-1/PD-L1 and/or CTLA-4 inhibitor(s)) within the past 6 months or plan on receiving immunotherapy within the next 1 month.

vii. Must have a Gustave Roussy Immune Score (GRIm-Score) of 0 or 1 (neutrophil-to-lymphocyte ratio \> 6 = 1 point, LDH \> Upper Limit of Normal = 1 point, and Albumin \< 3.5 g/dL = 1 point).

Exclusion Criteria:

i. Diagnosis of germ cell tumor or hematologic malignancy. ii. Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).

iii. Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately adjacent lesion(s) of interest or to the current lesion(s) of interest.

v. Prior history of pseudoprogression or radionecrosis from cranial radiotherapy.

vi. A neurosurgical resection cavity deemed too large by the radiation oncologist to be treated with a single fraction of stereotactic radiosurgery.

vii. Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR \<30, gadolinium allergy).

viii. A Gustave Roussy Immune Score (GRIm-Score) \> 1 (neutrophil-to-lymphocyte ratio \> 6 = 1 point, LDH \> Upper Limit of Normal = 1 point, and Albumin \< 3.5 g/dL = 1 point).
Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups

The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.


Eligibility Criteria:
Inclusion Criteria:

1. Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30 - 6:30 pm) starting Monday, April 5, 2021
2. 25 years of age or older
3. Completed chemotherapy and/or radiation treatment for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
4. English speaking
5. Graduated from high school
6. Able to see, hear, speak (with or without assistive devices)
7. Able to provide own transportation to sessions
8. Willing and able to commit to attend all 8 intervention sessions
9. Access to computer or tablet and adequate internet connection to participate in video conference

Exclusion Criteria:

1. Stage 4 breast cancer or any other cancer
2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

* Primary brain tumor.
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder

To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

Case-control study Repeated measures design

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR major depressive disorder
* aged between 20 and 80
* durg-naive or drug-free

Exclusion Criteria:

* DSM-IV-TR substance-related disorders (except nicotine)
* significant medical or neurological conditions
* mental retardation or organic brain damage
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
* Body weight ≥35 kg.
* Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.
* Subjects must have an eligible CFTR genotype:

  * Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA.
  * Cohorts 2A, 2B: Homozygous for F508del.
* Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.
* Stable CF disease as judged by the investigator.
* Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit.

Exclusion Criteria:

* History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
* History of cirrhosis with portal hypertension.
* Risk factors for Torsade de Pointes.
* History of hemolysis.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.
* Clinically significant abnormal laboratory values at screening.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug.
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* An acute illness not related to CF within 14 days before the first dose of study drug.
* A standard digital ECG demonstrating QTc \>450 msec at screening.
* History of solid organ or hematological transplantation.
* History or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the Screening Period.
* History of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator.
* Ongoing or prior participation in an investigational drug study with certain exceptions.
* Use of commercially available CFTR modulator within 14 days before screening (applies only to Cohorts 1A, 1B, and 1C).
* Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1.
Cesarean-scar Thickness and Closure Technique

The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.

The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery.

The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer.

Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI).

The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section
* Cesarean section during labor

Exclusion Criteria:

* Emergency cesarean section
* Declined to participate