cyrilzakka/clinical-trials huggingface dataset:
Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

Neuropsychological and functional long-term consequences of subarachnoid hemorrhages (SAH) represent a great challenge, since sometimes considerable cognitive deficits occur without evidence of substantial brain damage. In this study, we want to examine if the frequently observed memory deficits are associated with hippocampal atrophy.

Long-term or even permanent neuropsychological impairments are frequently observed after aneurysmal subarachnoid hemorrhages (aSAH). Among the most common impairments after aSAH are memory deficits. Volumetric MRI studies suggest an association of memory dysfunctions with temporal atrophy, especially of the hippocampus. In a previous study, 77 patients with good or moderate clinical outcome after aSAH were examined one year after discharge (Bendel et al., 2006). Temporomesial atrophy was detected without direct brain damage, e.g. by secondary ischemia. Due to the effects of complex cognitive impairments on the quality of life and participation in social and professional life, this relationship will be examined in more detail in the planned study. Specifically, we will investigate to what extent the frequently observed discrepancy between severe memory impairment and normal structural imaging results (no focal lesions in temporomesial areas) is due to hippocampal atrophy. In contrast to Bender and colleagues, this question will be investigated in the acute phase of the disease, immediately after admission to inpatient neurological rehabilitation.

Over a period of 24 months, 29 neurological rehabilitation patients with aSAH (Hunt \& Hess grade I and II) are going to be included. Within the first week (day 1 to 7) after study enrollment, a native MRI examination (without contrast agent) is performed, in which a high-resolution 3D-MPRAGE sequence (T1 weighting) is measured in the sagittal plane. After checking the data quality of the 3D-MPRAGE sequence, especially with regard to its suitability for hippocampal volume determination, a comprehensive neuropsychological examination is performed, in which specific memory and attentional functions are tested.

Eligibility Criteria:
Inclusion Criteria:

* neurological rehabilitation patients in phase B - D
* at minimum eight weeks after disease onset
* aneurysmal subarachnoid hemorrhage (Hunt \& Hess grade I or II)
* written consent from the patient's legal representative
* exclusion of pregnancy

Exclusion Criteria:

* insufficient cardiorespiratory stability
* previous brain damage
* mental disorders (dementia, depression)
* colonization with multi-resistant pathogens
* MRI contraindications
* claustrophobia
* weight \> 120 kg
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement
* Be in sinus rhythm at the time of enrollment
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Be in New York Heart Association (NYHA) IV functional class
* Have prior left ventricular (LV) lead implant
* Be pacemaker-dependent
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Exhibit Cheyne-Stokes respiration
* Be less than 18 years of age
* Be pregnant or planning to become pregnant during the duration of the investigation
* Be currently participating in any other clinical investigation
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.

To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.

Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.

Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).

To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.

Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications.

Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).

Primary Endpoint:

- First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC.

Other events of interest:

* Rate of successful transmissions received and stored on the HMSC platform;
* Hospital admissions related to cardiologic outcomes, at any time throughout the FU period;
* A composite outcome of any of the following device-related complications: Need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death or wound infection, within 60 days after the ICD insertion.

Eligibility Criteria:
Inclusion Criteria:

1. Indication for implanting of a single chamber ICD (primary or secondary prevention) according to current guidelines;
2. Sustained sinus rhythm as the current prevalent atrial rhythm;
3. Planned de novo implantation with a BIOTRONIK single chamber DX ICD system;
4. Patient is able to understand the nature of study and to provide written informed consent;
5. Patient is willing and able to perform all follow up visits at the study site;
6. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

1. Age \< 18 years
2. Any limitation to contractual capability;
3. Female patients who are pregnant or breast feeding or planning pregnancy during the course of the study;
4. Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment;
5. Life expectancy \< 2 years;
6. Patient is participating in any other interventional clinical investigation.
Effectiveness of a Novel Warm-up in Decreasing Risk Factors for ACL Injury in Female Youth Soccer Players

There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.

It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce biomechanical risk factors at the knee compared to a control after the training program.

There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.

A core position and control movement strategy (Core-PAC) may be one method of modifying high-risk movements such as side-cutting. The Core-PAC is a simple method of getting the centre of mass (COM) closer to the plant foot or base of support (BOS). Moving the COM closer to the BOS may bias joint loading to the sagittal rather than the frontal and transverse planes, which often occurs in female athletes and poses a risk for ACL injury.

In this study, we will conduct a randomized controlled trial to compare a Core-PAC trained group to a control group for peak flexion angles and peak abduction moments at the knee during a side-cut and an unanticipated side-cut prior to kicking a soccer ball and a side-hop task after a six-week training program.

It is hypothesized that a Core-PAC group would have greater peak flexion angles and lower peak abduction moments at the knee compared to a control after the training program.

Eligibility Criteria:
Inclusion Criteria:

* 14-17 years of age;
* have no injuries for six weeks prior to testing;
* have no medical problems preventing them from participating in the study.

Exclusion Criteria:

* have a previous ACL injury or repair;
* have a back or lower limb injury that kept them from playing or training for greater than 30 days in the past year;
* presently using a supplemental exercise based program;
* have any medical or neurologic condition that would impair their ability to perform the tasks.
The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit

Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.

Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.

At Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.

Currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique

Eligibility Criteria:
Inclusion Criteria:

* Patient who consents to participate and signs the informed consent.
* Patient candidate for radical open cystectomy and ileal conduit.

Exclusion Criteria:

* Patient who is unable to complete the study questionnaires.
* Patient who has a life expectancy of less than 1 year.
* Candidate patients for other urinary diversions other than ileal conduit as a first option
* Candidate patients for laparoscopic or robotic cystectomy..
Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions

The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. The Armeo Spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns.

Aim of the study is to compare the Armeo device with standard physiotherapy in chronic patients with acquired brain lesions.

The result of the trial should show which treatment is more effective in the clinical practice. A significant better outcome of one arm should suggest to follow one treatment strategy more than the other.


Eligibility Criteria:
Inclusion Criteria:

* 6 month after the onset of disease
* acquired brain lesions in adults with upper limb hemiparesis
* modified Ashworth \<= 3
* muscular strength MRC =\>1 mano; MRC =\>2 elbow e shoulder
* Fugl Meyer =\> 18

Exclusion Criteria:

* NYHA \>III
* MMSE (mini mental status examination test) \< 24
* muscular strength (MRC) \< 1
* Dystonia, spasticity (Ashworth =\> 3)
* articular contractions in the upper limb
* previous upper limb lesions
* cognitive/language impairment likely to influence assessments
* any diagnosis likely to interfere with rehabilitation
Efficacy and Safety of Sodium Heparin in Patients

The objective of this study is verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.
MRI Superficial Temporal Artery

Repeat MRI of the Superficial temporal Artery in 5 volunteers

Repeat MRI of the Superficial temporal Artery in 5 volunteers

Eligibility Criteria:
Inclusion Criteria:

* controls with normal temporal arteries

Exclusion Criteria:

* contraindication to MR
LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.


Eligibility Criteria:
Inclusion Criteria:

1. Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
2. Are within 5 years of last menstrual period (LMP);
3. Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
4. Are able to give written informed consent;
5. Must have clear urine toxicology screen upon recruitment;
6. Are fluent in written and spoken English;
7. Are right-handed;
8. Negative urine pregnancy test if still menstruating.

Exclusion Criteria:

1. Mini-mental status exam score of less than or equal to 24;
2. Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia;
3. Lifetime history of drug addiction or abuse, except nicotine;
4. Regular use of other psychotropic medication;
5. Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
6. Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia;
7. History of seizures;
8. History of cardiac disease including known cardiac defect or conduction abnormality;
9. Abnormal electrocardiogram during screening;
10. Use of estrogen therapy within previous 2 months;
11. Current pregnancy or planning to become pregnant;
12. Metallic implant;
13. Claustrophobia.
Auricular Muscle Zone Stimulation for Parkinson Disease

A Multicenter, Randomized, Blinded, Electronic Device in Subjects with Parkison Disease.

This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female ≥18 years of age.
2. Subject has Parkinson's Disease and is on levodopa therapy.
3. Subject experiences OFF periods with an "ON" score ≥20% better than the OFF score as measured by the MDS-UPDRS motor score (MDS-UPDRS Part III).
4. The subject's daily "OFF" time duration is ≥2 hours per day.
5. The subject's Hoehn-Yahr stage when "OFF" must be less than Stage 4 (i.e., subject must be able to walk without the use of an assisted device, such as a cane or a walker).
6. Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
7. Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
8. Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
9. Subject is willing to provide Informed Consent to participate in the study.
10. Subject is willing and able to comply with all study procedures and required availability for study visits.

Exclusion Criteria:

1. Subject has a medical or psychiatric comorbidity that can compromise participation in the study.
2. Subject has cognitive dysfunction defined by a Montreal Cognitive Assessment (MoCA) score \<24.
3. Subject has moderate levodopa-induced dyskinesias as indicated by a score \>2 on items 4.1 and/or 4.2 in the MDS-UPDRS Part IV.
4. Subject has clinically significant depression as determined by the Beck Depression Inventory-II score \>15.
5. Subject is pregnant as determined by a urine pregnancy test at the screening visit.
6. Subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception.
7. Subject has a form of Parkinsonism other than Parkinson's Disease, such as Drug-induced Parkinsonism or Multiple System Atrophy.
8. Subject has an implanted deep brain stimulator (DBS).
9. Subject is receiving direct intestinal infusions of levodopa.
10. Subject has epilepsy.
11. Subject medications are anticipated to change during the two (2) week study period (Note: the study requires stable medications during the device testing period).
12. Subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.
Dual Time Point PET Imaging in Lymphoma

Comparison of single time point with dual time point PET imaging in the accuracy of diagnosing active lymphoma. Biopsy results or clinical/radiological progression will be used in conjunction with the PET data.


Eligibility Criteria:
Inclusion Criteria:

- Age 16 and above Diagnosis of Hodgkin's or Non-Hodgkin's lymphoma PET scan scheduled as part of management

Exclusion Criteria:

* Pregnant or lactating Diabetes mellitus
Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.
Characterization of Clonal B Cell Populations in HCV Infection

The purpose of this study is to investigate the mechanism of autoantibody production during chronic hepatitis C virus (HCV) infection. 10-50% of individuals with HCV have symptoms of mixed cryoglobulinemia (MC). By studying the B cells from HCV-infected individuals with and without MC, as well as from healthy controls, we hope to gain insight into the mechanisms of autoantibody production and develop new strategies for treatment of MC.

Hepatitis C virus (HCV) infects approximately 170 million people worldwide. About 10-50% of persons with HCV have MC. MC is associated with the development of autoimmune symptoms and B cell proliferative disorders. We plan to study B cells from individuals chronically infected with HCV as well as from healthy controls. We sort B cells into different types, and we analyze these types for differential levels of gene expression. We are testing the hypothesis that certain types of B cells from subjects with MC have increased expression of genes that allow for increased cell survival.

People interested in participating in this study will have a complete history and general medical examinations before beginning the study. Following the screening, you will have a procedure called leukapheresis, in which white blood cells are removed, but your own red blood cells are returned. The procedure takes approximately 3 hours and is similar to blood donation. The leukapheresis is done during a same day admission to the hospital by an outside blood collection company with trained nurses and certified equipment.

Some aspects of this study are experimental which means the fluid and cells collected will be studied and analyzed to determine more precisely how your body's immune system is responding to the virus. These tests are experimental in that they are not part of the usual routine care of patients.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Ability to give informed consent.
* WBC greater than 3,000/mm3.
* Platelets greater than 80,000/mm3.
* Hb at least 9.5 g/dl.
* INR less than 1.5.
* Biologic therapy: Greater than 6 months post-Rituximab therapy.
* Greater than 6 months post IFN- alpha and Ribavirin therapy.

Exclusion Criteria:

* Decompensated cirrhosis.
* Serious uncontrolled medical illness.
* Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
* Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Alcohol or drug use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements.