cyrilzakka/clinical-trials huggingface dataset:
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).

Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
* Free of known gastrointestinal disease
* No supplements use (excluding multivitamin)
* Participate in less than 1 h of exercise per week
* Have not taken antibiotics in the last six months

Exclusion Criteria:

* Men and women with fruits and vegetable intake exceeding 2 servings/day
* Men and women with whole grain intakes exceeding 1 serving/day
* Pregnant
* Do not fit the inclusion criteria
Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial

This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.

This is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. To evaluate the effect, each subject will be treated with either oral estradiol or placebo for 6 months. Subjects will be randomly assigned to 1 of 2 groups as follows:

Double Blind Treatment Group Open-Label Regimen A1 1 mg Estradiol daily for 180 days B1 Placebo for 180 days

Each group will be given oral Progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. Subjects will be asked to keep a menstrual calendar throughout the trial. Serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. Magnetic resonance angiography (MRA) studies of the brain will be performed at month 6.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women, 40-52 years of age.
* At least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography.
* Clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms.

Exclusion Criteria:

* Known or suspected estrogen-dependent neoplasia.
* Endometrial proliferation, hyperplasia, or malignancy at screening.
* Known hypersensitivity to estrogens, progestins.
* History of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure.
* Known or suspected pregnancy, or recent breast feeding (within 6 months).
Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)

According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.

According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.

Eligibility Criteria:
Inclusion Criteria:

* First visit or first admission to CRO occurred in the period from September 2023 to September 2028
* Diagnosis of NSCLC any stage

Exclusion Criteria:

- Diagnosis of tumor not of certain lung origin (uncertain origin)
Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity

Spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important.

This study will investigate the effect of muscle energy technique compared to myofacial release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).


Eligibility Criteria:
Inclusion Criteria:

* Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles . All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion Criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention .
* None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
* hey had neither visual, auditory defect.
A Mindfulness-Based Self-Compassion Program

The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels.

The research was designed experimentally. The research will be conducted between February 2025 and April 2025 with female patients diagnosed with breast cancer who were treated in the oncology service of Cumhuriyet University Faculty of Medicine hospital in Sivas-Central province in the middle of Turkey and who meet the inclusion criteria. The study will be carried out face to face after obtaining the necessary institutional permissions. Participants to be included in the research will be included in the sample by taking into account the inclusion criteria at each stage. After the subject, purpose and method of the study are explained to the participants to be included in the study, they will be asked to fill out the informed consent form. Participants will then be divided into intervention and control groups by simple randomization method. Before the intervention, an information form, Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to both groups. The implementation of the study will be carried out at the patient's convenience, in a time period that will not interfere with his treatment in any way, and in a special area determined by the hospital management, while preserving his privacy. A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group. No intervention will be applied to the control group. At the end of the intervention program, the Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be administered to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with breast cancer,
* Women who are aware that they have been diagnosed with breast cancer,
* Women who volunteer to participate in the study,
* Women over the age of 18 with sufficient communication skills

Exclusion Criteria:

* Being diagnosed with any mental illness
Dichoptic Virtual Reality Therapy for Amblyopia in Adults

This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Interpupillary distance of 60-66 mm
* Age 15-40
* Anisometropic amblyopia or strabismic amblyopia
* Best corrected visual acuity of 20/30 or worse in the amblyopic eye
* No prior therapeutic use of the software
* No other ongoing therapies including patching or recent eye muscle surgery
* No vested interest in the product
* Ability attend visits and complete the training session, and to stop the intervention after the specified intervention period

Exclusion Criteria:

* Stimulus-deprivation amblyopia.
* Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).
* Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).
* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
* Patients diagnosed with Photosensitive Epilepsy.
* Inability to comply with the follow-up visits required.
* History of pathologic nystagmus (congenital or sensory).
Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors

The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:

1. Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
2. Must not have metal implants, other than those approved as safe for use in MRI;
3. Must not be claustrophobic or have physical characteristics that will preclude undergoing MRI; - Subjects enrolling to the Dose Expansion Cohort must have at least one tumor that is amenable to DCE-MRI evaluation (e.g., greater than or equal to 3 cm lesion outside the thoracic cavity) - Have Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Presence of untreated CNS metastasis or symptoms of brain metastases - Presence of leukemia or myelodysplastic syndrome - History of high-dose chemotherapy requiring bone marrow or peripheral stem cell support - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\] or cardiac arrhythmia) - History of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) within 6 months of study day 1 - History of bleeding diathesis or hypercoagulopathy within 6 months of study day 1 - Active peptic ulcer disease or gastritis - Unresolved toxicities from prior anti-cancer therapy, excluding alopecia - Anti-tumor treatment within 3 weeks of study day 1. If anti-tumor treatment was an antibody therapy, the interval must be 6 weeks - Anticoagulation therapy, except a low dose of Coumadin™ (less than 2 mg) for prophylaxis against central catheter-related thrombosis - Major surgery within 4 weeks of study day 1 - History of allergic reaction to bacterially produced proteins - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus or chronic hepatitis B infection - Pregnant or breastfeeding - Not using adequate contraceptive precautions, in the judgment of the investigator
Improving Self-Management in Adolescents With Sickle Cell Disease

The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.

The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21.

Eligibility Criteria:
Inclusion Criteria:

* Patient of CCHMC Sickle Cell Clinic.
* Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype.
* 13-21 years of age.
* On or eligible for disease-modifying therapies.
* Caregiver (or AYA \> 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location.

Exclusion Criteria:

* another chronic disease (which would complicate measurement of behavioral activation)
* Non-English-speaking (\<5% of the target population); or
* cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. Patients who desire participation but are not eligible will be referred to the SCD Clinic social worker for assistance with self-management as this is the usual procedure.
Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

-Elective laparoscopic Cholecystectomy, ASA status 1-2 -

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding diathesis
* Use of any anti-coagulants
* Inability to provide informed consent
* Severe kidney or liver disease
* Inability to operate PCA system
* Patient with psychiatric disorders
Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center

The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of hospitalized patients.

Animal Assisted Therapy is being provided by the Caring Canines program and is formally available to patients by referrals. In this study, we would like to capture why patients are being referred and to measure the influence of AAT on the symptoms and feelings of patients.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria (Patients):

* Patients admitted to St Mary's or Methodist Hospital and subsequently referred for AAT.
* Subjects undergoing Animal Assisted Therapy as part of their standard care.
* Patients 18-80 years of age.
* Patients who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.

Inclusion Criteria (Care Team Members):

* Care team members of the study participants.
* 18-80 years of age.
* Who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.

Exclusion Criteria:

Exclusion Criteria (Patients):

* Patients with diagnoses of bipolar disorder, schizophrenia or dementia.
* Unable to give consent.
* Pregnant women (as verbalized by participant).

Exclusion Criteria (Care Team Members):

* Care team members of the study participants who do not want to participate.
Impact of Patient Selected Visual Art in the Hospital Room During Antepartum Admission on Hospital Satisfaction Scores and Patient Experience

The purpose of this study is to assess whether patient-selected visual art for patients admitted to the antepartum unit will increase hospital satisfaction compared to routine care.


Eligibility Criteria:
Inclusion Criteria:

* patients who are greater than or equal to 18 years of age
* patients admitted to the study hospital's antepartum unit for care
* currently pregnant
* willing and able to provide informed consent and complete the provided questionnaire

Exclusion Criteria:

* patients less than 18 years of age
* patients who are not pregnant
* patients who are not admitted to study hospital's antepartum unit
* patients who cannot provide informed consent in English
* patients who have participated in this study during a previous admission
Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane

The situation of demand for surgical conditions is quite high when lymph node resection involved in the surgery type, especially abdominal aortic lymph node dissection, and commonly, the surgeons complained about the interference from the intestine which pushed the investigators to increase the level of neuromuscular blockade close to deep NMB. To avoid the application of deep NMB and promote good surgical conditions for laparoscopic gynecological surgery with lymph nodes resection, the investigators explored other preoperative ways to cooperate with surgeons more harmoniously. It's well known that epidural anesthesia and epidural anesthesia combined with spinal anesthesia have the effect of muscle relaxation which has been applied in clinical practice widely. One study indicated that the Transverse Abdominal Plane (TAP) block could change muscle thickness and achieve the effect of muscle relaxation. It leads investigators to a hypothesis that the sheath of rectus abdominis block combined with transverse abdominal plane block may suppress the signal transmission of abdominal nerve, and may be beneficial to improve surgical conditions.

The investigators conducted this study to test the hypothesis that compared with moderate NMB， the sheath of rectus abdominis block combined with transverse abdominal plane block may reduce the frequency of additional ask for muscle relaxants to optimize surgical conditions, and also provide postoperative analgesia on the premise of moderate NMB.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grade I\~ II;
2. aged 18-55 years;
3. BMI 19 \~ 23kg/m2;
4. laparoscopic total hysterectomy and bilateral adnexectomy and/or pelvic lymphadenectomy under elective general anesthesia lasted for more than 2 hours; 5. informed consent has been signed.

Exclusion Criteria:

1. the patient had a history of abdominal surgery;
2. For patients who are professional athletes and weight trainers, abdominal muscle tension can be changed through strength training need to be excluded.
3. allergic to any of the drugs used in the experiment;
4. pregnant or lactating women;
5. patients with severe mental and neurological symptoms cannot cooperate with the study;
6. those who participated in other clinical trials within 3 months before being enrolled in the study;
7. the researcher believes that other reasons are not suitable for clinical trials;
8. patients who have changed their surgical methods or received only palliative surgical treatment;
9. patients with abnormal coagulation function;
Safety and Efficacy of the URECA CTO Device

Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.

Peripheral Arterial Disease (PAD) restricts blood supply to the lower limbs. The disease causes obstructions that can affect blood vessels in both the proximal and distal regions. When these vessel obstructions exist for more than 3- 6 Months they are classed as chronic total occlusions. Without sufficient collateral formation this can lead to to chronic limb-treatening ischemia (CLTI), which is characterized by chronic pain and tissue loss. Without revascularization this frequently leads to amputation. The purpose of this clinical study is to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \>= 18 and \<= 85 years old
* Clinically diagnosed for endovascular treatment of peripheral vascular disease and chronic total occlusion in the iliac artery, superficial femoral artery or in the proximal popliteal artery determined by duplex, CTA, MRA and/or DSA.
* Patient has been assessed by an independent vascular surgeon and an interventional radiologist.
* Written and signed informed consent

Exclusion Criteria:

* 1. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy; 2. Severe infection or soft tissue loss that may preclude any meaningful attempt at limb salvage; 3. Known or suspected allergies or contraindications to contrast agents; 4. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study; 5. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study; 6. Patient unable to give consent; 7. Pregnant and breastfeeding women; 8. Patients who recently suffered from a stroke and/or a myocardial infarct (Within 2 months) 9. Patients with an uncontrollable diabetes; 10. Severe intercurrent illness that, in the opinion of the investigator, may put the subject at risk when participating in the study 11. Patients with hypercoagulopathy; 12. Stent in place in the to be treated artery