cyrilzakka/clinical-trials huggingface dataset:
Whole-Brain Tumor Burden Metrics with Inflammatory and Molecular Markers to Predict Postoperative Neurocognitive Decline in Glioma

Although surgical resection improves overall survival in patients with diffuse Low-grade gliomas (DLGG), it can also result in deterioration of neurocognitive function, which are poorly understood and lack effective predictive models. This study aims to develop a model using whole-brain tumor burden metrics, inflammatory and molecular markers for predicting high risk of neurocognitive decline (ND) postoperatively. The study involved 192 patients with left frontal DLGG. MRI data were analyzed to derive whole-brain tumor burden metrics, including tumor radiomics, whole-brain cortical thickness, myelin content, and network characteristics. postoperative inflammatory and molecular markers were collected. Postoperative follow-up neurocognitive function was assessed using the Montreal Cognitive Assessment at 3 months and 1 year. Machine learning models were constructed using Pycaret.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically proven DLGG based on 2021 WHO criteria
2. Age ≥ 18 years,
3. Karnofsky Performance Status ≥ 70%,
4. Tumor involved unilateral left frontal lobe and did not reach the central sulcus.

Exclusion Criteria:

1. With previous treatment before image acquisition,
2. Presenting cognitive impairment pre-operatively based on The Montreal Cognitive Assessment (MoCA)
3. Survival of less than 3 months post-surgery
4. Lack of compliance with neurocognitive assessments in 3-month and 1-year after surgery
Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels

Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. Common bean-based snacks are potential healthier alternatives to replace conventional snacks.

Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces blood lipid levels in overweight people with altered blood lipid levels.

Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels.

Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, LDL, HDL, among others.

* Intervention phase: Common bean baked snack intervention.
* Control phase B: No intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25.0 and 29.9 kg/m2,
* Abnormal serum lipid levels:

  * Total cholesterol: ≥200 mg/dL,
  * Low-density lipoproteins: 100 to 190 mg/dL,
  * High-density lipoproteins: \<50 mg/dL in females and \<40 mg/dL in males,
  * Triglycerides: 150 to 500 mg/dL.

Exclusion Criteria:

* Pregnancy or lactation,
* Plans to lose or gain weight in the next three months,
* Modification of diet or physical activity in the last three months,
* Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
* Smoking or drug use,
* Sensitivity for bean consumption,
* Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction

Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.

The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI.
* Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain.
* Only patients in whom complete revascularization is achieved are being enrolled in the study.

Exclusion Criteria:

* Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.
Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma

The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade NHL or low-grade lymphoma that had transformed to intermediate- or high-grade histology.

Exclusion Criteria:

* Subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
* Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
* Prior stem cell transplant.
* Active obstructive hydronephrosis.
* Evidence of active infection requiring intravenous (IV) antibiotics at the time of study entry.
* New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
* Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
* Known HIV infection.
* Known brain or leptomeningeal metastases.
* Subjects who are pregnant or nursing.
* Previous allergic reactions to iodine. This does not include reactions to intravenous iodine-containing contrast materials.
* Prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
* Prior radioimmunotherapy.
* Progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with \>3500 cGy.
* Current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
* De novo intermediate- or high-grade lymphoma.
Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life

The main objective of this study was to determine the frequency of the practice of colonic irrigation (CI) among patients with a colostomy,.

Other objectives are:

* To compare the quality of life between a group of patients with a colostomy and practicing CI versus a group of patients with a colostomy without CI.
* To determine the causes of non-realization of the CI or failure.
* To determine the conditions of realization of colonic irrigation by the return of user experience (time of day when the CI is practiced, amount and type of fluid used, time spent in the bathroom, time to recurrence of stool, media used between two irrigations).


Eligibility Criteria:
Inclusion Criteria:

* The subject was informed about the implementation of the study's objectives, constraints and the rights of the subject
* The subject is aged at least 18 years
* The subject is a member of the Ostomy Federation of France
* The subject has had a terminal colostomy for more than 6 months

Exclusion Criteria:

* The subject is under guardianship or curatorship
* The subject is under judicial protection
* The subject formalizes his/her opposition
* It is not possible to inform the subject
Geriatric Lateral Compression 1 Pelvic Fractures

Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.

1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>/= 60 years of age
* Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
* Low energy mechanism of injury or an insufficiency fracture without a precipitating event
* Acute injury within four weeks of presentation
* Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up \& Go" (TUG) assessment, or inability to complete the TUG assessment.

Exclusion Criteria:

* Dementia
* Vertically or rotationally unstable pelvic ring injuries
* Pathologic fracture secondary to tumor
* Non-ambulatory prior to injury
* Acute neurologic deficit
* High-energy mechanism of injury
* Concomitant injuries affecting ambulation
* Presence of another injury or medical condition that prevents ambulation
* Presence of implant or sacral morphology that prevents percutaneous sacral fixation
* Enrollment in another research study the precludes co-enrollment
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
* Incarcerated or pending incarceration
Natural Topical Treatment for Vulvar and Vaginal Atrophy

Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).

Eligibility Criteria:
Inclusion Criteria:

* Age between 45-65 years
* Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria)
* No previous treatment for VVA
* Informed written consent signed

Exclusion Criteria:

* Pregnancy
* Previous or concurrent neoplasms
* Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
* Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.
Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)

The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).

If cardiac arrest is not treated immediately, it causes sudden death. Intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest or other brain injury. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin reduces brain injury in animal experiments and has been used to try to improve brain degeneration in patients with Alzheimer's disease in doses up to 160 units.

Eligibility Criteria:
Inclusion Criteria:

* Participants in good health based on medical history, physical exam, and routine laboratory testing
* Female participants must have a negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age \> 45 years with the absence of menses for greater than 12 months.
* Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
* Willing and able to stay at the clinical research facility as required by the protocol
* Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
* Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
* Ability to lie flat for a minimum of 2-hours

Exclusion Criteria:

* Known allergy to insulin.
* Preexisting diabetes.
* Current or previous use of diabetes medication or insulin.
* Any nasal disease or congestion that may interfere with intranasal drug absorption.
* Baseline hypoglycemia (blood glucose ≤ 65 milligrams per deciliter (mg/dL)) or hyperglycemia (blood glucose \> 200 mg/dL) as evident from the screening labs.
* Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
* Treated with an investigational drug within 30 days.
* Individuals with inadequate venous access.
* Claustrophobic, uncontrollable shaking, or unable to lie still for a lengthy period.
* Any metals or implanted devices within the body.
* Any foreign metallic objects in the body.
* Females that are pregnant, trying to become pregnant, or breastfeeding
Preoperative Nutritional Status and Postoperative Acute Kidney Injury

There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies.

The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 65 years
2. intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration.
3. surgery duration lasting longer than 2 hours.

Exclusion Criteria:

1. patients with an American Society of Anesthesiologists (ASA) physical status V.
2. those with concurrent cardiac or renal surgeries.
3. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
4. those did not have sufficient data required for nutritional evaluation or AKI evaluation.
Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)

The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen independent prostate cancer whom have a rising PSA while on chemotherapy. The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease (If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate overall survival for this combination. There will be between 18 and 35 subjects at least 18 years of age enrolled on this single site study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Confirmed androgen independent prostate cancer with evidence of rising PSA (two successive increases in PSA, at least 4 weeks apart) while on chemotherapy. If the PSA is less than 5, the increase in PSA must be at least 50%. Must also have castrate testosterone levels (\<50 ng/ml)
* Patients could not have received more than 2 previous chemotherapy regimens.
* No anthracyclines within the past 6 months.
* No prior single agent thalidomide in the last 12 months. No prior cytotoxic chemotherapy + thalidomide given in conjunction
* Age \> 18 years of age
* Performance status ECOG 0-2
* Peripheral neuropathy must be \< grade 1
* Must have adequate hematologic, hepatic and renal function
* Men of reproductive potential must be willing to consent to using effective contraception while on treatment and for at least 4 weeks thereafter
* Patients must have left ventricular ejection fraction of \> 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring
* Must have been off an anti-androgen for at least 4-6 weeks (Flutamide and Bicalutamide respectively) and documented as having a rising PSA
* Measurable or evaluable disease (PSA elevation will constitute evaluable disease). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques CT scan or as \>10 mm with spiral CT scan. See section 6.B for the evaluation of measurable disease
* Life expectancy of greater than 3 months
* Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program
* Ability to understand and sign written informed consent approved by the Institutional Review Board \[IRB/Ethics Committee\], which will be obtained prior to study entry.

Exclusion Criteria:

* Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within the last 3 months
Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up

Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.

Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room has the potential to be an effective point of intervention to provide referral to primary care in addition to health education on preventive health topics.

The investigators therefore, conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and to determine if referral to care results in actions taken by the patient.

The investigators determined the proportion of patients who have elevated blood pressure. Patients were referred appropriately and the proportion of participants who followed the recommendation to meet with their primary care doctor for elevated blood pressure at 4-6 weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and admitted to smoking cigarettes were offered smoking cessation assistance through a quit line. Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age presenting to the glaucoma service and general eye service at Wilmer Eye Institute.

Exclusion Criteria:

* Non-English speakers
* Unable to provide written informed consent
Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude

In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Sleep related breathing disturbances will be evaluated by respiratory polygraphy.

An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides