cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients

In this study the Investigators explore two questions: if the attentive reaction times differs in parkinsonian patients from health controls and if an intensive, focused and aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT) tailored mainly for motor problems, could have a specific positive effect on multiple choices Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal circuits. The hypothesis is that the MIRT could have a positive effect on the top-down control mechanisms, since the continuous feedback given by physiotherapist during exercises and the use of cues and devices (such as treadmill plus and stabilometric platform), stimulate the selective attention processes that enable goal-directed, internally-driven decision, helping the patients to overcome externally-driven decision based on stimulus salience and novelty

Objective: To evaluate the attentive performances in Parkinsonians in comparison with healthy controls and the effect of motor-cognitive rehabilitation program on attention.

Methods: 103 Parkinsonians (stage 2,5-3 H\&Y) hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment and 34 healthy controls were enrolled. All subjects underwent three different attentive tasks: visual reaction times, auditory reaction times and multiple choices reaction times tasks. To evaluate the effect of rehabilitation on attention, patients performed the same battery at discharge. To investigate the effects of MIRT on motor functions and quality of life we also assessed UPDRS III, Timed Up and Go test and Parkinson's Disease Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* stage 2.5-3 according to the Hoehn \& Yahr scale
* pharmacological treatment for the last 8 weeks and during the hospitalization
* Mini Mental State Examination (MMSE) ≥ 24

Exclusion Criteria:

* any focal brain lesion detected in brain imaging studies (Computed Tomography or Magnetic Resonance Imaging) performed in the previous twelve months
* disabling drug-induced dyskinesias
* disturbing resting and/or action tremor, corresponding to scores 2 to 4 in the specific items of Unified Parkinson's Disease Rating Scale section 3 (UPDRS III)
* behavioral disturbances (evaluated with Neuropsychiatric Inventory)
* visual and auditory dysfunctions according to the general clinical evaluation and medical history
The Effect of Probiotics on Functional Constipation in the Elderly

The main scope of the proposed research in the framework is to investigate the effect of probiotic bacteria Lactobacillus acidophilus LA3, Bifidobacterium animalis ssp. lactis BLC1 i Lactobacillus casei BGP93 on functional constipation and on the quality of life of the elderly in a nursing home. The experimental part will consists of double-blind, placebo-controlled clinical trial over 12 weeks.

During the first four weeks, the subjects were monitored primarily concerning bowel discharges and general health. After that initial four weeks, they are re-evaluated compliance with inclusion and exclusion criteria. Participants were allocated to the double-blind section of the trial (12 weeks), using o computer-generated to a placebo group or in the probiotic group in the form of a liquid oral formulation once a day. On first day of intervention participants provide a blood sample. All investigators, participants and study personnel were blinded to the order of randomization. Participants were told to consume 9 drops of study probiotics once a day for next 12-week intervention. On last day of intervention, participants provide a blood sample. The last four weeks of the double-blind section (week 9-12) participants an evaluation period in which the respondents were evaluated for the outcomes of the study. After completing the double-blind study, the participants were followed for an additional four weeks. Inclusive / Excluded criteria are evaluated on two occasions, at the time of inclusion in the 4-week introductory section and its end.

Eligibility Criteria:
Inclusion Criteria:

* age 65 years or more
* signed informed consent for study participation
* functional constipation defined by Rome IV criteria
* ability to understand the procedure

Exclusion Criteria:

* suspicion of obstructive ileus or previous obstructive ileus
* suspected or confirmed diagnosis: irritable colon syndrome, ulcerative colitis, Crohn's disease, malignant digestive tract disease
* diarrhoea of any cause within the last month
* acute infectious disease within the last month excluding people who use antibiotics
* persons who have opioid analgesics in pharmacotherapy
Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion Criteria:

* pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC

The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.

In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Karnofsky index \>70%
* Child-Turgotte-Pugh A or B liver score.
* An initial diagnosis of primary HCC or recurrence.
* A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
* HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
* Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
* Hb \>10.5.0 g/%, WBC \>3.000 cells/mm3, platelets \>50.000 cells/mm3, bilirubin \<2 mg/dl, aspartate and alanine aminotransferase levels \<5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
* Serum creatinine \<1.7 mg/dl
* Previously incomplete TAE or TACE with radiologically defined residual disease.
* Informed consent

Exclusion Criteria:

* Extrahepatic disease and refractory ascites.
* Previous abdominal radiation therapy (RT)
* Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
* Pregnant or breastfeeding patients.
* Patients with uncontrolled infections or HIV seropositive patients.
* Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.

Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* American Society of Anesthesiologists Physical Status classification I and II

Exclusion Criteria:

* history of ventral hernia
* walking disability
* chronic obstructive respiratory disease
* malignancy
* chronic pain syndrome
* open conversion
* inability to complete the questionnaire
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).

The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).


Eligibility Criteria:
Inclusion Criteria:

INCLUSION CRITERIA GROUP C (CONTROLS) :

* age \> 18 years
* a person who has given oral consent
* Non-diabetics
* Fasting plasma glucose \< 6.10 mmol/L (1.1 g/L)
* Triglyceridemia \< 1.7 mmol/L (1.5 g/l)
* HDL-C concentration \> 1.30 mmol/L (for women and 1.03 mmol/L for men)
* Glomerular filtration flow rate \> 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)

INCLUSION CRITERIA GROUP T1D-N (WITH NORMAL ALBUMINURIA) :

* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* normal albuminuria (albumin/creatinine ratio \< 2.5 mg/mmol in men and \< 3.5 in women)
* glomerular filtration rate \> 90 mL/min/1.73m2

INCLUSION CRITERIA GROUP T1D-MICRO (WITH MICROALBUMINURIA)

* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* Microalbuminuria (albumin/creatinine ratio \> 2.5 mg/mmol in men and \> 3.5 in women, and \< 30 mg/mmol)
* glomerular filtration rate \> 90 mL/min/1.73m2

INCLUSION CRITERIA GROUP T1D-MACRO (WITH MACROALBUMINURIA)

* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* Macroalbuminuria (albumin/creatinine ratio \> 30 mg/mmol)
* glomerular filtration rate \> 45 mL/min/1.73m2

Exclusion Criteria:

* Protected adult
* Patient not affiliated to a social security scheme
* Pregnant or breastfeeding woman
* Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
* BMI \> 30 kg/m2
Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study

1. To describe the morbidity and clinical characteristics among HIV-infected patients and HIV-uninfected patients.
2. To identify the risk factors for the complication or morbidity among HIV-infected patients and HIV-uninfected patients.
3. To describe the mortality among HIV-infected patients and HIV-uninfected patients.
4. To identify the risk factors for the cause of death among HIV-infected and HIV-uninfected patients.

The information obtained from this study would be very important in planning future holistic care of HIV-infected patients in our institutes as well as in national policy. Results from the study could be used to develop proper long-term management guidelines for people living with HIV (PLHIV) in Thailand targeted at preventable conditions such as metabolic diseases and certain cancers.

Eligibility Criteria:
Inclusion Criteria:

HIV-infected patients group

* HIV positive
* 30 years of age or older, both male and female
* Thai nationality
* Written research informed consent

HIV-uninfected patients group

* HIV un-infected
* 30 years of age or older, both male and female
* Thai nationality
* Written research informed consent

Exclusion Criteria:

HIV-infected patients group

* Systolic BP ≥ 130 or Diastolic BP ≥ 85mm Hg or on the treatment
* Fasting blood sugar \> 126 mg/dl or on the treatment
* Proteinuria
* Creatinine \> 1.5 mg/dl
* Recent hospitalization
* Patient who are having mental disease HIV-uninfected patients group
* Systolic BP ≥ 130 or Diastolic BP ≥ 85mm Hg or on the treatment
* Fasting blood sugar \> 126 mg/dl or on the treatment
* Proteinuria
* Creatinine \> 1.5 mg/dl
* Recent hospitalization
* Patient who are having mental disease
Clinical Trial of Minimally Invasive Robotic Spine Surgery

The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery.
* Primary surgery and revision surgery
* Patient capable of complying with study requirements
* Signed informed consent of patient or legal guardian

Exclusion Criteria:

* Infection or malignancy
* Primary abnormalities of bones (e.g. osteogenesis imperfecta)
* Primary muscle diseases, such as muscular dystrophy
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
* Paraplegia
* Patients requiring anterior release or instrumentation
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
* Patient cannot follow study protocol, for any reason
* Patient (or legal guardian, when applicable) cannot or will not sign informed consent
Nasal Photodisinfection COVID-19 Proof of Concept Study

The study proposes to test photodisinfection (PDF) on SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in he nostril of patients infected with SARS-CoV-2. Participants are swabbed for SARS-CoV-2 before and after the PDF treatment. For the study, a small group of healthcare workers who have tested positive for SARS-CoV-2 will be included. They will not undergo the treatment but will need to swab their noses multiple times over the next 5 days. This nil group will provide the effect (if any) of swabbing SARS-CoV-2 levels in the nose.

The study proposes to test photodisinfetion (PDF) on levels of SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in patients infected with SARS-CoV-2 . Currrently, PDF is being used at some institutions before surgery to lower the risk of postoperative infection. PDF uses a Methylene Blue (MB) nasal spray, followed by 5 minutes of red-light exposure through a small light-diffusing applicator. This will need to be placed into each nostril. Participants are swabbed for SARS-CoV-2 before and after treatment. In addition to the patients testing positive for SARS-CoV-2, there will also be a small group of healthcare workers who have tested positive that will be included. Though they are not undergoing treatment, they will swab their own noses multiple times over a period of 5 days. This will allow us to evaluate the effect (if any) of swabbing on SARS-CoV-2 levels in the nose. The study hypothesis is that MB-mediated PDF will show the ability to kill SARS-CoV-2 which will consequently confirm its efficacy as a first line defense against the virus.

Eligibility Criteria:
Inclusion Criteria (patient population):

* Recent SARS-CoV-2+ diagnosis
* Present in hospital

Inclusion Criteria (healthcare workers):

* Recent SARS-CoV-2+ diagnosis
* Ability to self-administer nasal swabs

Exclusion Criteria (patient population):

* Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway

Exclusion Criteria (healthcare workers):

* None
Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease

Chronic kidney disease (CKD) consists of kidney damage, with a consequent progressive and irreversible loss of kidney function. In the early stages of the disease, there is already a reduction in circulating levels of α-klotho protein, which is related to worsening renal function. Therapeutic strategies that increase serum α-klotho levels can be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the efficiency rate of dialysis, suggesting a systemic effect in patients with end-stage CKD. The aim of this study is to evaluate the effects of bioelectric stimulation on renal function and physical capacity in patients with CKD. For this, patients will be randomized into bioelectric stimulation or a control group. Bioelectric stimulation will be performed three times a week for eight weeks. The control group will only be evaluated and re-evaluated. The following pre-and post-intervention assessments will be performed: analysis of the plasma content of α-Klotho and soluble creatinine to assess renal function, six-minute walk test to assess functional capacity; dosage of interleukins and tumor necrosis factor to analyze the inflammatory profile; sit and stand test with 10 repetitions and load cell dynamometry to assess lower limb muscle strength and application of the EuroQoL-5D questionnaire for quality of life. Biochemical analyzes for renal function and inflammatory profile will also be performed after four weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years of age;
* CKD with glomerular filtration rate (GFR) between 15-59 ml/min (III and IV stage of CKD) for more than 3 months;
* To be able to ambulate \> 300 meters in 6 minutes walk test.

Exclusion Criteria:

* Cognitive dysfunction that prevents the performance of evaluations, as well as an inability to understand and sign the informed consent form;
* Intolerance to the electrostimulator and/or alteration of skin sensitivity;
* Skin lesions/burns at the electrode placement site;
* Patients with stroke in past 6 months with residual limitation to ambulation;
* Disabling musculoskeletal disease;
* Uncontrolled hypertension (systolic blood pressure \> 230 mmHg and diastolic blood pressure \> 120 mmHg);
* Grade III or IV heart failure (NYHA);
* Patient with a pacemaker;
* Uncontrolled diabetes (fasting blood glucose \> 250 mg/dL);
* Unstable angina;
* Coronary stent placement in past 3 months;
* Recent acute myocardial infarction (two months);
* Fever and/or infectious disease;
* Peripheral vascular disease in the lower limbs that limits ambulation or deep vein thrombosis;
* Chronic obstructive lung disease that limits ambulation or need for oxygen therapy;
* Obesity (Body Mass Index≥35);
* Patient with active cancer.
An Innovative Method Fluid-jet to to Remove Residual Lens Fibers

Residual lens fibers (RLFs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. However, conventional polish is inconvenient and time-consuming. We use an innovative fluid-jet method to remove RLFs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification.

Purpose: Residual lens fibers (RLFs) on the posterior lens capsule during cataract surgery can cause after cataract, affecting visual quality and increasing the medical cost for further laser posterior capsulotomy. However, conventional polish is inconvenient and time-consuming. We use an innovative fluid-jet method to remove RLFs, and compare the efficacy of fluid-jet and polish to prevent posterior capsular opacity after phacoemulsification.

Design: Single-center, prospective, randomized controlled clinical study Subjects of study: Age-related cataract patients receiving phacoemulsification from Zhongshan Ophthalmic Center, Guangzhou, China.

Methods: patients are 1: 1 randomized to two groups. Polish group: After irrigation and aspiration (I/A), the RLFs on the posterior capsule are removed by polishing before intraocular lens (IOL) implantation; Fluid-jet group: Polish is not performed. RLFs on posterior capsule are removed by jetting fluid with an irrigating syringe after IOL implantation. The posterior capsular images of all the patients are obtained immediately before and after IOL implantation, and at the end of surgery, then the amount of RLFs is quantitatively analyzed by using LYZ-PCO, a software we developed. Best corrected visual acuity and parameters of visual quality, such as objective scattering index(OSI), Strehl ratio (SR) and Modulation Transfer Function (Mtf)-cut off are evaluated by objective visual quality analyser (OQAS) at 1 day, 1 week and 1 year after surgery. The patients receives telephone follow-up every month. The severity of posterior capsular opacification (PCO) and incidence of laser posterior capsulotomy is recorded.

Main indicators for the study: The incidence of laser posterior capsulotomy a year after surgery.

Eligibility Criteria:
Iinclusion criteria:

1) cataract patients aged between 50 and 80 years; 2) graded 5 or less for lens opalescence by the Lens Opacities Classification System, version III (LOCS III); 3) listed for phacoemulsification combined with intraocular lens implantation in topical anesthesia; 4) Signed informed consent.

Exclusion criteria:

1) a history ophthalmic trauma or surgery; 2) other ophthalmic diseases such as glaucoma, uveitis, high myopia; 3) diabetes requiring medical control; 4) disagree with follow-up monitoring; 5) Other factors inappropriate to participate in this project, including but not limited to severe cataracts, very shallow anterior chambers, etc.