cyrilzakka/clinical-trials huggingface dataset:
Neuroinflammation and Cognitive Decline in Alzheimer Disease

The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of \[18F\]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).

The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of \[18F\]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).

(DPA-714 : N,N-diethyl-2-\[4-(2-fluoroethoxy)phenyl\]-5,7-dimethylpyrazolo\[1,5-a\]pyrimidine-3-acetamide)

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age more than 50 years (included)
* necessary knowledge of French (write and oral) to do neuropsychological tests
* Study level upper (or equal) than 7 years (considering first year of grammar-school as start)
* People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
* Social security affiliation.

Exclusion Criteria:

* MMSE score lower than 15 and upper or equal to 26
* Evolutive disease which could possibly had consequences on central nervous system
* Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L
* Chronic use of alchohol and/or drug
* Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18
* Surgical or medical condition in the last 3 months
* Long term treatment which could possibly interfere with inflammatory process (especially the month before PET \[18F\]DPA-714 imaging).
* Treatment by N-Methyl-D-Aspartate antagonist
* Treatment by Minocycline
* Treatment by benzodiazepine (especially the month before PET \[18F\]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted)
* Anomaly at neurological examination which is not a classical symptom
* Contraindication to magnetic resonance imaging (RMI)
* Florbetapir\[18F\] hypersensibility
* Participation to an other experimental protocol with drug.
* people under guardianship
Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition

This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.

Subjects will be randomized to one of two groups: one group will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; the other group will take placebo 15 minutes prior to the three main meals of the day. Subjects will be on the investigational product or placebo for 12 weeks. Participation in this study involves four study visits.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Body mass index of 30 or greater
* Agree to keep diet, exercise and all current health habits stable during participation in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning to become pregnant
* Prior bariatric surgery
* Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
* Obesity as a result of a clinically diagnosed endocrine problem
* Currently taking an anti-psychotic medication
* History of peptic ulcer disease
Nasal Swab Home Collection Kit (NSHC Kit) Study

The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).


Eligibility Criteria:
Inclusion Criteria:

* Fever
* Nasal Congestion
* Rhinorrhea
* Sore Throat
* Cough

Exclusion Criteria:

* Unable to read and understand or refusal to sign the appropriate informed consent/assent forms
* Refusal to complete the patient's demographic and medical history
* Treatment with anti-influenza antivirals within the previous 7 days
* Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
Prevalence of Pulmonary Hypertension in COPD Patients

The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.

The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension.

Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics.

All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Prior admittance to hospital with exacerbation in COPD
* Informed consent

Exclusion Criteria:

* Exacerbation in COPD less than 6 weeks before examination
Exploratory Study Investigating Urodynamic Parameters During Catheterisation

The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH.

The healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).

The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).

The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.

Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be male
4. For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit
5. For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture
6. For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months

Exclusion Criteria:

1. Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
2. Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)
3. For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Prognostic Value of CTC in HNSCC Patients

We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.

1. Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)
2. Disease status: locally advanced or recurrent/metastasized at initial presentation
3. Age \>=20 years old
4. Could understand and signed the informed consents of this study
5. Enrolled patients were classified into three distinct subgroups:

   1. Patients underwent curative surgery followed by adjuvant chemoradiotherapy (CRT) because of some pathologic features such as positive margin, pathologic N2, and extracapsular spread (ECS) of involved lymph nodes indicating early relapse according to recommendation from National Comprehensive Cancer Network(NCCN) guidelines;
   2. Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);
   3. Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.
6. Blood samples were collected within 7 days before the first dose of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytopathologically proven head and neck squamous cell carcinoma Age ≥ 20 years. Measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.

Ability to sign informed consent.

Exclusion Criteria:

* Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.

Inability to comply with study and/or follow-up procedures.
Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery

The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 65 or over
* Candidate for scheduled major oncological surgery and/or surgery with high morbidity
* Patient able to walk for 10 minutes on the walking platform at the time of the test
* Patient affiliated to a social security system
* Signature of informed consent prior to any specific study-related procedure

Exclusion Criteria:

* Patient with severe undernutrition (BMI\<18, and/or weight loss \>15% in 6 months or \>10% in 1 month)
* Emergency surgery
* Physical contraindications preventing use of the platform
* Simultaneous participation in another clinical study that could compromise the conduct of this study
* Patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent.
* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.
Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)

The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae


Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of urinary tract infection (UTI) defined by the presence of at least one of these signs: fever \> 38°C and/or sus-pubic pain and/or dysuria and/or pollakiuria and/or urinary burns and/or macroscopic hematuria and/or acute urinary retention and/or pain with the rectal examination and/or confusion
* And urinary analysis with leukocyturia \> 10 / mm3, bacteriuria \> 10\^3 CFU/mL with ESBL producing enterobacteriaceae and resistance associated with fluoroquinolones (FQ) and cotrimoxazole (CTX) but sensitive to fosfomycin.

Exclusion Criteria:

* allergy to fosfomycin and/or trometamol
* Presence of material in the urinary tract
* Severe immunosuppression
* Chronic prostatitis
* Prostate abscess
* Acute pyelonephritis
* Hemodynamic instability
* Chronic renal failure (clearance \<60 mL/min)
* Prior antibiotic therapy, with an antibiotic sensitive on the antibiotic susceptibility test except: amoxicillin - clavulanic acid, cefixime, nitrofurantoin.
* Co-treatment with metoclopramide
Fluoxetine on Motor Rehabilitation After Ischemic Stroke

Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved.

Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.

Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged from 18 to 85
* No motor relapse from a previous stroke
* Inclusion from day 5 to day 10 after stroke
* Ischemic stroke with unilateral motor deficit
* Motor NIHSS ≥ 5 on the affected side of the body
* NIHSS \< 20
* Fugl Meyer Motor Scale \<55
* Modified Rankin Scale between 1 and 5
* Informed consent obtained from the subject or a member of his family

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Woman able to procreate without valid contraception
* Subject protected by law
* Concomitant disease with unfavourable prognosis within 1 year
* Drug addiction
* Allergy to fluoxetine
* Hepatic failure (TGO and TGP \>2N)
* Permanent Renal failure (Creatinin \>180micromol/l)
* Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
* Depression requiring pharmacological treatment
* Previous stroke with motor relapse
* Fugl Meyer Motor Scale \> 55
* Modified Rankin Scale = 0 or 6
* Patients needing carotid surgery within 3 months
* Aphasia preventing correct evaluation of motor and depression scales.
Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)

Data are currently insufficient to guide the management of very small gastrointestinal stromal tumors（GISTs）（\< 2 cm) discovered incidentally on endoscopy,this study is designed to collect the medical records of patients in different treatment group with long-term follow-up data,and attempts to evaluate the usefulness of regular endoscopic ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.

OBJECTION:to evaluate the usefulness of regular endoscopic ultrasound（EUS） surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD） for small GISTs(\<2cm),thus providing evidences for the revision of the guideline.

OUTLINE:This is a randomized controlled trial. Eligible patients are divided into 2 group with 45 in each.The experimental group undergo ESD for GISTs,while the investigators do no treatment to the control group.Then,the 2 groups will be follow up for 5 years.All data are analysed with the Statistical Product and Service Solutions（SPSS）statistical software.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female chinese patients of 18-70 years old.
2. Patients with very small gastric GISTs (\< 2 cm) with no high-risk EUS features.
3. Patients voluntarily join this study with informed consents.

Exclusion Criteria:

1. Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment.
2. Patients with distant metastasis on computed tomography(CT)scan.
3. patients with an extremely poor general condition or a very short life expectancy.
4. Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.
Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients

in this study the investigators will measure the colchicine trough levels in 80 FMF patients taking stable doses of colchicine

80 FMF patients will enroll: 20 taking 1 mg colchicine a day 20 taking 1.5 mg colchicine a day 20 taking 2 mg colchicine a day 20 taking 2.5 mg colchicine a day one blood sample for trough colchicine levels will be taken. response to treatment, colchicine side effects and anthropometric data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* constant colchicine levels
Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults with Dementia

Abstract:

Objectives: (i) To investigate the test-retest and inter-rater reliability, construct and known-group validity of four independent step tests in older adults with mild to moderate dementia (Phase 1); and (ii) the feasibility and effects of a 12-week step training on the step performance, physical and functional outcomes in this population (Phase 2).

Design and subjects: Older adults who have mild to moderate dementia, and able to walk independently without walking aids, with stick or quadripod will be recruited to participate in this study. Participants will perform four step tests, including Four Square Step Test (FSST), Choice Stepping Reaction Time Test (CSRTT), Maximum Step Length Test (MSLT) and Alternate Step Test (AST) on three separate testing occasions conducted by two independent raters at the baseline (Phase 1).

The participants will then join either an intervention or control group. Those in the intervention group will receive a 12-week step training, while the control group will receive usual care. The stepping performance using the step tests validated in Phase 1, cognitive and functional outcomes and prospective falls will be compared between the intervention and control groups at 12 and 24 weeks (Phase 2).

Interventions: The step training consists of two 30-minute training sessions per week. The participants will receive an individualized, progressive training that is tailored to their stepping ability and cognitive function.

Main outcome measures: Stepping performance using the four step tests, 2-minute walk test, 10-meter walk test, 30-second sit to stand test, Berg Balance Scale, Montreal Cognitive Assessment and prospective falls at 12 and 24 weeks.

Expected results: (i) The four step tests are reliable in older adults with mild to moderate dementia, and the findings of the step tests are moderately associated with the functional outcomes, and (ii) the participants in the intervention group will have better stepping performance, better functional outcomes and fewer falls compared with the control group at 12 weeks, and the effects will sustain at 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or above
* able to walk independently without walking aid, with stick or quadripod
* clinical diagnosis of dementia

Exclusion Criteria:

* unstable cardiac or pulmonary conditions
* acute musculoskeletal or severe neurological conditions affecting stepping performances
* severe hearing or visual impairment limiting communication
* severe cognitive impairment
* recent hospitalization in the past 30 days
The Level of Knowledge and Awareness of Dry Needling Treatment in the Turkish Population

The study will employ a cross-sectional design to assess the level of knowledge and awareness of dry needling therapy in the Turkish population.

A representative sample of individuals will be selected for participation in the survey. A structured questionnaire will be developed specifically for this study, consisting of questions related to the knowledge and awareness of dry needling therapy. The questionnaire will be administered through face-to-face interviews. Data collected from the survey will be analyzed using appropriate statistical methods to determine the overall level of knowledge and awareness of dry needling therapy among the Turkish population.

Eligibility Criteria:
Inclusion Criteria:

* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Any illness or disability that can prevent filling out the form or communicating.