cyrilzakka/clinical-trials huggingface dataset:
Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

The study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures.

Carotid endarterectomy (CEA) is a vascular surgical procedure that is aimed at reducing accumulated cholesterol and fats in carotid arteries. While some research indicates that CEA is associated with improvements in neuropsychological functioning, other studies have identified deficits in neuropsychological functioning following CEA. The factors associated with these different outcomes are unclear. Identification of the factors that mediate post-CEA neuropsychological functioning outcomes may allow for the development of interventions that would improve such outcomes. Recent research has identified a relationship between post-CEA neuropsychological deficits, and cerebral blood flow in certain areas of the brain, with some indication that brain cell loss following CEA may be a key factor. The proposed study will explore changes in cerebral blood flow through the use of diffusion-weighted magnetic resonance images (DW-MRI) to investigate the relationship between neuropsychological functioning and brain perfusion in 70 CEA patients and to compare neuropsychological functioning of the CEA patients to a control group of 30 patients undergoing other peripheral vascular surgical procedures. Patients' neuropsychological functioning will be assessed pre, post and six months after the CEA or peripheral vascular surgery. Additionally DW-MRI will be assessed pre and post surgery for the patients undergoing CEA.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures.
* Ages 40-90

Exclusion Criteria:

1. History of Substance Use:

   History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.
2. Conditions that affect brain MRI/contraindications for MRI:

   Diagnosis of HIV. History of any traumatic brain injury. History or current diagnosis with any form of brain tumor. Current normal pressure hydrocephalus. Patients with any implanted metallic medical device, or non-removable metallic material in their body
3. Conditions that affect neuropsychological assessment:

   Diagnosis with Attention Deficit/Hyperactivity Disorder. Current major depressive episode. Current manic episode. Current psychotic episode. Diagnosis with any developmental disorder. Diagnosis with any form of dementia (MMSE\<24). A score higher than 3 on the Modified Rankin Scale indicating a major stroke.
4. General Contraindications:

Diagnosis with or history of any medical condition that, based on reasonable clinical judgment, would clinically contraindicate the patient undergoing any of the study procedures.
Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry

Background Cancer and cardiovascular diseases combined account for more than 50% of the overall mortality burden in the USA. Accumulating evidence indicates that saturated fat intake is related to an increase, while unsaturated fat intake is related to a decrease in all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to unsaturated fat.

Objective The aim of the present study was to estimate the mortality risk reduction related to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat intake.

Design The American National health and nutrition examination surveys conducted between 1999 and 2010 were linked to the 2011 national US death registry resulting in an observational prospective mortality study. Proportional hazards Cox models were used to evaluate the association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric substitution of 10% of the energy from dietary fat intake applied to the substitution of saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.


Eligibility Criteria:
Inclusion Criteria:

* Included NHANES 1999-2010
* age \>= 30 years old

Exclusion Criteria:

* Record not reported in the mortality linked file
* Cancer, type-II diabetes, cardiovascular disease at baseline
* Missing data on covariates used in the model
Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention

The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.

Potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. If the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. The catheter insertion will be carried out by the research staff after the inclusion and randomisation of the participants.

After catheter insertion, participants and their family, friends, or other informal caregivers will receive information about wearing an indwelling urinary catheter and specific information to randomly inserted, standard Foley, or T-Control® catheters. Standard catheter care is permitted during the trial both managed by the participants and participants' caregivers. Additionally, participants will receive an incident diary in which participants can record any type of incident during the bladder catheterisation period. Two weeks after indwelling bladder catheter insertion, participants will be contacted by urology outpatients for a follow-up visit, during which the study catheter will be removed.

Finally, within a maximum period of two weeks after the follow-up visit, the participants will be invited to participate in an interview to assess the quality of life perceived by the participants during the study

Eligibility Criteria:
Inclusion Criteria:

* Males with Acute Urine Retention
* Equal or over 50 years of age
* Absence of symptoms of infection on the inclusion day
* Not having been previously catheterized on the day of inclusion
* Indication of bladder catheterization for 2 weeks
* Maintained cognitive and physical capacity for self-monitoring the catheter valve
* Signed consent agreement

Exclusion Criteria:

* Current or recent urinary tract infection in the last 2 weeks
* Use of current treatment/antibiotic in the last 2 weeks
* Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
* Catheter insertion requiring more than 1 attempt
* Overactive bladder
* Patients with bilateral obstructive uropathy
A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients

The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.


Eligibility Criteria:
Inclusion criteria:

* Have a history of intermittant asthma.
* Have asthma symptoms less than once per week.
* Have no other significant disease.
* Do not take regular oral or inhaled steroids.
* Are a non-smoker for the past 12 months with a pack history of less than 5 years.

Exclusion criteria:

* Have a history of drug or alcohol abuse.
* Have poorly controlled asthma or a history of life-threatening asthma.
* Have a history of hypersensitivity to bronchodilators.
* Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.
* Have received oral steroids within 3 months of study entry.
* Have been hospitalized for your asthma within 3 months of study entry.
* Have had treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Measuring Heart and Lung Function in Critical Care

This is a feasibility study of the use of a novel technique called 'Inspiwave' to measure heart and lung function in adult patients in critical care.

The preliminary work has already been undertaken in animal models and in healthy volunteers. The ultimate aim of this study is to develop a clinical tool for measuring (and therefore being able to make treatment changes based on) indices of heart and lung function in critical care patients. This study is the first assessment of the technique in this population, and whilst we know it works in patients undergoing general anaesthesia, we now need to assess whether Inspiwave can be used at all in critical care patients who may have much more physiological derangement. The purpose of this phase of the research is to determine whether it is feasible to use Inspiwave in critical care.

Inspiwave generates a sinusoidally modulated tracer gas signal in the inspired air. It also measures the resulting signal in the expired air. The unique handling of this signal by the patient can used be to derive key variables related to cardiopulmonary function such as lung volume, pulmonary blood flow, the deadspace (wasted ventilation) and the degree to which ventilation and blood flow are non-uniform. These are 'vital signs' in sick patients, yet are currently technically difficult to measure, particularly non-invasively.


Eligibility Criteria:
Inclusion Criteria:

* patients requiring mechanical ventilation in a critical care area

Exclusion Criteria:

* decision of participant not to be included
* consultee declaration not to be included
* Severely impaired gas exchange as declared by the managing clinician
* oxygen requirement exceeding 90% FIO2
Influence of Intragastric Fructose Infusion on Behavioural and Neural Responses to Negative Emotion Induction

The investigators will test whether a subliminal, intragastric dose of fructose is able to influence the emotional state at the behavioural and neural level, as has been previously shown for fatty acids. They will also examine the potential involvement of gut peptide release. Based on previous research using fatty acids, an attenuating effect of fructose compared to placebo on the induced negative emotional state is hypothesized at the self-report as well as the brain level.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (N=15)
* Male and female
* Age 18 - 60
* Body Mass Index (BMI) of 20 - 25 kg/m2
* Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

* Abdominal or thoracic surgery. Exception: appendectomy
* Gastrointestinal, endocrine or neurological diseases. Exception: IBS if the participant will be recruited in the patient group
* Cardiovascular, respiratory, renal or urinary diseases
* Hypertension
* Food or drug allergies
* Anemia
* Eating disorders
* Psychotic disorders
* Depressive disorders
* Emotional and/or restraint eating
* No medication on a regular basis, exception: oral contraception
* No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
* Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
* Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, ...
* Pregnant or breastfeeding women
* Claustrophobia
Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.

Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Eligibility Criteria:
Key Inclusion Criteria:

* Relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an IMiD® drug (including an analogue).
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
* Corrected calcium \<10.6 mg/dL.

Key Exclusion Criteria:

* Candidates for stem cell transplantation willing to undergo transplantation. (Subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.)
* Autologous stem cell transplantation \<3 months post-transplant.
* Prior allogeneic stem cell transplantation.
* Nonsecretory myeloma.
* Plasma cell leukemia (\>2000/µL circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells \>100,000/µL), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), or primary systemic amyloidosis.
* Subjects who cannot undergo a brain magnetic resonance imaging (MRI) study.
* Clinically significant (as determined by the Investigator) 12 lead electrocardiogram (ECG) abnormalities, including QTc prolongation (\>450 ms in males, \>470 ms in females).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia

Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.

The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.

Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.

This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).

The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.

Eligibility Criteria:
Inclusion Criteria:

* Women who are at least 18 years old
* Are not pregnant (negative urine test) or breastfeeding
* Referred for colposcopy or LEEP treatment
* Can provide written informed consent

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Women who have had a hysterectomy
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

The primary objectives of this study are the following:

1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and
2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis
* Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart \< 11.0 g/dL
* Transferrin saturation (Tsat) greater than or equal to 20%

Exclusion Criteria:

* Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
* other hematologic disorders
* upper or lower gastrointenstinal bleeding within 6 months prior to randomization
* uncontrolled hypertension
* prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack
* prior history (within 6 months prior to randomization) of thromboembolism
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma.

OBJECTIVES: I. Determine the objective response rate in patients with metastatic or recurrent thymoma treated with octreotide. II. Determine the duration of remission in these patients. III. Determine the toxicity of the octreotide regimen in this population. IV. Determine the response rate, duration of remission, survival and toxicity of prednisone added to octreotide in patients with stable disease following octreotide alone.

OUTLINE: All patients receive octreotide subcutaneously three times daily for 1 month. After two courses of treatment, patients are assessed for response. Patients experiencing partial or complete response continue octreotide for a maximum of 1 year (12 courses) in the absence of unacceptable toxicity or disease progression. Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses. These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for the next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: There will be 38 patients accrued into this study over approximately 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy Must have extensive disease defined as: - distant disease - pleural disease with or without mediastinal involvement - recurrent progressive disease in site of previous radiotherapy Measurable disease with at least one bidimensionally measurable lesion Must have octreotide scan prestudy that demonstrates activity in the area of measurable disease within 6 months prior to registration

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Other: No diabetes mellitus or any other complications to high dose corticosteroid therapy No acute concurrent complications such as infections Other prior malignancy(ies) must have been curatively treated and demonstrate no evidence of recurrence Not pregnant or nursing Negative pregnancy test Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed if disease progression is demonstrated prior to study entry Endocrine therapy: Prior or concurrent corticosteroids for myasthenia gravis allowed Radiotherapy: Prior radiotherapy allowed Surgery: No postsurgical complications
Extended Versus Limited Thoracoscopic Sympathectomy: Its Impact on Palmar and Plantar Hyperhidrosis

Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.

ABSTRACT Objective: The aim was to carefully evaluate and compare the results of extended sympathectomy versus T3, T4, and T5 resection in cases of palmer, axillary, and planter hyperhidrosis as regards decreased sweating and recurrence rates.

Methods: This was a randomized controlled prospective trial conducted at the Department of Vascular Surgery Mansoura University Hospitals on a total of 120 patients with hyperhidrosis who were divided into two groups; group 1 who had undergone limited sympathectomy and group 2 who had undergone extended sympathectomy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hyperhydrosis
* Able to take drugs
* Palmer and planter hyperhydrosis
* Age from 6-24 years
* Interfere with daily activities

Exclusion Criteria:

* Not fit for surgery
* Thyroid disease
* age less than 6 years
* Chest or cardiac problems
Protection From Cisplatin Ototoxicity by Lactated Ringers

The purpose of this study is to determine if Lactated Ringer's solution is effective in patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to cisplatin-induced hearing loss.

About one-third of people who have been given Cisplatin, as part of their chemotherapy treatment, develop hearing loss. The purpose of this study is to determine if some degree of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To study this, patients will use drops in their ears; Lactated Ringer's will be placed in one ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop antibiotic will be placed in each ear at the same time. Each participant will receive a hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after the final treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer to be treated with cisplatin.
* Patients expected to receive a minimum of 3 rounds of chemotherapy.
* Patients receiving a minimum dose of cisplatin of 70 mg/m2

Exclusion Criteria:

* Patients who have had middle ear surgery.
* Patients who have active external or middle ear disease
* Patients who have preceding pure tone average of \>40 dB HL