cyrilzakka/clinical-trials huggingface dataset:
Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease

Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.

In a within subjects design, all patients take part in four conditions. In each condition, sentences describing actions will be displayed. In a control condition, they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; and in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task. The main criterion used in our statistical analyses will be the discrimination threshold.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease by one of the consulting physicians, neurologist and/or geriatrician of whom the patient has been informed.
* Early stage (MMSE ≥ 22)
* Neuropsychological assessment within 6 months of inclusion.
* Affiliation with a social security scheme
* Age equal to or greater than 60
* French mother tongue
* Agreement to participate / signature of consent form

Exclusion Criteria:

* Uncorrected perceptual disorders
* Other neurological or psychiatric history
* Inability to communicate
* Delusional or psychotic state
* Person unable to give informed consent
* Refusal to participate
* Participation in a study on a drug/medical device/care technique likely to affect cognitive functions
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

Eligibility Criteria:
Inclusion criteria:

* Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy.

Exclusion criteria:

* Age \< 18 years
* LDL-C \< 160 mg/dL (\< 4.14 mmol/L) at the screening visit (Week-3).
* Fasting serum triglycerides \> 400 mg/dL (\> 4.52 mmol/L) during the screening period.
* Known history of homozygous familial hypercholesterolemia.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice

The main aim of this study is to check for side effects from treatment with niraparib.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.


Eligibility Criteria:
Inclusion Criteria:

An individual who corresponds to any of the following:

* Ovarian cancer patients after initial chemotherapy (maintenance therapy)
* Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy)
* Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

Exclusion Criteria:

Has a history of hypersensitivity to any of the ingredients of this drug.
Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.


Eligibility Criteria:
Lung Recipient Inclusion Criteria:

* A recipient must meet the following requirement to enroll into the study:
* Requires a single or bilateral lung transplant and is listed for lung transplant at UNC.
* Male or Female, 18 years of age or older.
* Subject or Subject's Representative provides a legally effective informed consent.
* Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
* Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria are eligible for study participation.

Lung Recipient Exclusion Criteria:

* Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
COVID-19 Vaccination in Patients With Rheumatic Diseases

The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.

This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed.

The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age.
* Diagnosis of rheumatic disease treated or not with immunosuppressive agents
* Patients who have received at least one dose of a SARS-CoV-2 vaccine
* Signature of informed consent.

Exclusion Criteria:

* Patients who express their desire not to participate in the study or who are unable to give their informed consent.
Contact Registry for Clinical Trials

The purpose of the Contact Registry for Clinical Trials is to develop a database/listserv of persons interested in clinical trials occurring at the University of Central Florida College of Medicine.

Sign up for the UCF College of Medicine's Contact Registry for Clinical Trials to learn about clinical research and clinical trials in areas of interest to you!

https://ucf.qualtrics.com/jfe/form/SV_do4WGvKlz4f8Wwe

The Contact Registry for Clinical Trials allow persons to sign up to learn more about clinical trials and clinical research around certain medical indications that will be occurring at the University of Central Florida College of Medicine. Persons are not asked to provide any personal health information. Persons are asked to provide identifying information needed to provide the requested information.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Persons who do not read English could register through the assistance of their friends or software for translation

Exclusion Criteria:

* Children may not register
* Persons who are unable to consent may not register
Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.


Eligibility Criteria:
* Patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (HSCT)
* Patient must be capable of understanding an informed consent form (ICF) or the parent or legal guardian of the patient is able to understand and sign a written ICF prior to the initiation of any treatment procedures.
* Patient must have HSCT- TMA defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia.
Ultrasound Guided Ureteroscopy and Ureteric Stones

The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
2. Age group 18 years old or above.
3. Stone size 15 mm or less.

Exclusion Criteria:

1. Patients with bilateral ureteric stones
2. Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
3. Previously failed ureteroscopy or previous ureteroneocystostomy.
Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT

This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.

It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.

Eligibility Criteria:
Inclusion Criteria:

* Have an age equal to or greater than 18 years
* Having chronic pelvic pain of six or more months of evolution.

Exclusion Criteria:

* Failure to grant informed consent.
* Have fibromyalgia.
* Present a pacemaker or other type of electronic implant.
* Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
* Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
* Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy).
* Have myelopathy and osteomyelitis.
* Have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia ...
* Have an alteration of the central nervous system (traumatic or spinal vascular injury)
* Suffer oncological processes with sacral involvement.
* Have a severe mental disorder.
* Have vulvodynia
* Be pregnant.
* Have undergone surgery in the last 3 months in the pelvic area.
* Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact.
* Inability to correctly complete the questionnaires or understand the study protocol.
* Having initiated other pelvic physiotherapy treatments during the study intervention.
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection

An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical suspicion of febrile (≥38 °C) urinary tract infection.
2. Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.

   1. Suprapubic bladder aspiration: any growth of bacteria.
   2. Sterile intermittent catheterization: monoculture with ≥10\^3 cfu/ml.
   3. Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10\^4 cfu/ml.
   4. Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test.
   5. Midstream urine x 1 (≥10 years of age): Monoculture with ≥10\^5 cfu/ml.
3. 3 months to 13 years of age (corrected age in case of premature birth).
4. Parents fluent in Danish or English.
5. Informed consent both parents.

All children who do not receive any empirical antibiotic therapy but have a positive urine culture (approximately 48 hours after urine sample collection) can be included if fever (≥ 38.0 °C) is present and the child is initiated with relevant antibiotic therapy. ¨

Children can be included regardless of whether intravenous or oral antibiotics were given as empirical therapy.

Exclusion Criteria:

1. Non-Danish civil registration number.
2. Not resident in the Capital Region or Region Zealand in Denmark at primary visit.
3. Previous inclusion in the trial.
4. History of febrile (≥38 °C) urinary tract infection in the last 28 days before the primary visit.
5. Antibiotic treatment in the last two weeks before the primary visit.
6. Three or more episodes with febrile (≥38 °C) urinary tract infection within one year of the primary visit (including the current episode).
7. Previous complicated episode of febrile (≥38 °C) urinary tract infection (e.g., renal abscess or urosepticemia)
8. Non-compliance ≥3 doses of antibiotics during empirical therapy.
9. Elevated creatinine.
10. Prophylactic antibiotic treatment.
11. Known urogenital abnormalities (i.e., obstructing uropathies; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; polycystic kidney disease; neurogenic bladder dysfunction; hypospadias).
12. Septic.
13. Positive blood culture (if contamination is not suspected).
14. Immune deficiency.
15. Systemic immunosuppressive therapy.
Unicentric Form of Castleman Disease - Surgery Therapy Benefit

Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy.


Eligibility Criteria:
Inclusion Criteria:

* patient with unicentric form of Castleman disease
* underwent surgery resection

Exclusion Criteria:

* multilocalised Castleman disease
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males or females
2. Age 18-50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition
Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

The purpose of the trial is to determine the safety and efficacy of Gleevec" in idiopathic hypereosinophilic syndrome (HES) and to characterize the molecular basis for the therapeutic benefit of Gleevec" in HES.


Eligibility Criteria:
Inclusion Criteria:- At study entry, absolute peripheral blood eosinophil count greater than upper limit of normal at the laboratory where the analysis is performed.

* Patients must have symptomatic disease, e.g. signs or symptoms of organ involvement related to eosinophilia. Examples include pulmonary, cardiac, GI, or central nervous system disease, hepatomegaly, splenomegaly, or skin disease.
* BCR-ABL-negative by PCR.
* Patients are imatinib-naive.
* Ability to understand and the willingness to sign a written informed consent document.
* Ability to swallow capsules.\&#xA; Exclusion Criteria:- Pregnant or nursing women. Patients of childbearing potential must have a negative pregnancy test prior to initiation of study drug. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control during the study and for 3 months following discontinuation of study drug.
* Serum creatinine \>2.0.
* Total serum bilirubin \>2.0 mg/dl. AST(SGOT) and ALT (SGPT) more than 2.5 x the upper limit of normal range (ULN) at the laboratory where the analyses is performed.
* Presence of clonal T-lymphocyte population by PCR or southern blotting.
* ECOG Performance Status Score \> or = to 3.
* Busulfan within 6 weeks of starting treatment.
* IFN-a within 14 days of starting treatment.
* Low dose cytosine-arabinoside or vincristine within 14 days of starting treatment.
* Hydroxyurea within 1 day of starting treatment.
* Prednisone or other immunosuppressives (e.g. azathioprine, cyclosporine-A) within 14 days of starting treatment.
* AML/ALL-type induction chemotherapy within 4 weeks of starting treatment
* Persistent peripheral blood count toxicity of grade 2 or higher after receiving AML/ALL-type induction chemotherapy.
* Treatment with other investigational agents within 28 days of starting treatment.
* History of non-compliance to medical regimens.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (Grade 3 / 4 New York Heart Association Criteria), unstable angina pectoris or cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of HIV-positivity.
Holter of Movement in Patients with Multiple Sclerosis in Uncontrolled Environment.

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification.

The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MS diagnosis,
* Over 18 years old,
* Ambulant patients,
* Signed informed consent,
* No clinical and / or radiological relapse within 3 months.
* EDSS \< or = à 5,5,
* Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.

Exclusion Criteria:

* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

OBJECTIVES:

Primary

* Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission.

Secondary

* Evaluate the emergence of an immune response.
* Determine the relapse rate.
* Assess the occurrence of residual disease.

OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myelogenous leukemia (AML)

  * Myelomonocytic (M4) or monocytic (M5) subtype
  * In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation
* No (15;17) translocation
* No AML M3
* HLA-A2 positivity
* CD14 ≥ 20% on peripheral blood mononuclear cells
* Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available
* Must not be eligible for HLA-matched allogeneic transplantation
* No progressive disease

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No contraindication to cytopheresis or chemotherapy
* No HIV or HTLV positivity
* No hepatitis B or C activation
* No prior psychological disease
* Not deprived of liberty and able to give consent
* Must be able to speak and read French
* No other cancer except for basal cell or cervical

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent participation in another clinical study