cyrilzakka/clinical-trials huggingface dataset:
Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty

Background and study aims Osteoarthritis (OA) is the most common type of arthritis, which most often affects the knee. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, which can cause stiffness, pain and a reduction in a person's range of movement. A knee joint replacement is a common procedure where the weight bearing surfaces of the knee joint are replaced with metal and plastic components to relieve the pain and disability brought on by OA. Tranexamic Acid（TXA） is a traditional method to reduce blood loss, pain score and complications. It is not known however, what is the best method of TXA for the patients with TKA. The aim of this study is to find out whetherVisual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in patients who have had knee replacement surgery.

Who can participate? Adults who have OA and need a total knee replacement. What does the study involve? Participants are randomly allocated to one of three groups. For the interventions field, could you please provide a brief methodology for each of your treatment arms, and the total duration of treatment and follow-up? Group A: Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement. Group B: No Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.

The blood loss, VAS pain scores, length of their hospital stay, swelling and bleeding, and range of motion of the affected knee are assessed in the days following surgery.

What are the possible benefits and risks of participating? Participants who are allocated to receive treatment with Visual Field Infiltration of Tranexamic Acid may benefit from a reduction in blood loss, pain, swelling and blood loss after surgery, shortening their hospital stay.

There is a small risk of discomfort, frostbite or deep vein thrombosis (a blood clot in a major vein in the leg) when using Visual Field Infiltration of Tranexamic Acid.

Eligibility Criteria:
Inclusion Criteria:

Adults who have OA and need a total knee replacement.

Exclusion Criteria:

1. Patients had abnormal blood coagulation.
2. Patients were diagnosed as rheumatoid arthritis, traumatic osteoarthritis, ankylosing, spondylitis, hemophilic arthritis, peripheral vascular disease.
3. Cold urticaria.
4. Preoperative anticoagulation, patients had preoperative deep vein thrombosis (DVT).
5. Preoperative history of anemia.
Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders

Alzheimer's disease and related disorders are chronic, progressive diseases that have a major impact on the lives of sufferers and their families. They lead to a decline in cognitive function and are associated with a loss of independence and quality of life for sufferers. The loss of autonomy associated with major cognitive disorders can lead to feelings of worthlessness and loss of self-esteem. People may feel sad, depressed and, above all, very anxious. When this anxiety is linked to relationships with others, it can become major social anxiety, which aggravates the negative feelings and contributes to the deleterious progression of the neurodegenerative disease. Feelings of low self-esteem and/or the anxiety that accompanies them cannot be treated solely by long-term psychotropic drugs, as these can worsen the disorders through iatrogenesis. In this context, non-drug approaches can be seen as an essential complement.

Cognition-based therapies, including cognitive stimulation, are based on a neuroeducational approach that can be deployed at different stages of the disease, either individually or in groups. Other patient-centred cognitive stimulation techniques have also been developed. In recent years, research has focused on serious digital games, which seem to combine rehabilitation possibilities in a playful form, making it easier for patients to adhere to them. They can also be used to work on motor skills, spatial reference, reflexes and speed and potentially improve verbal and non-verbal learning. Several recent meta-analyses have shown that brain games are an innovative and potentially effective approach to cognitive training for elderly people with cognitive disorders.

Based on the existing literature, experimenting with a serious digital cognitive game could potentially produce beneficial results by improving parameters such as self-esteem and anxiety in patients with early or moderate Alzheimer's disease or a related illness. As part of their weekly cognitive stimulation programme at the day hospital, they plan to use the interactive digital table 'Le Village' ©, which can be used to offer fun exercises on working memory, semantic memory, explicit memory and sensory memory, with game objectives focusing on reaction, reminiscence and dexterity. The digital table simulates a village, allowing 6 people to play simultaneously and interact. This digital table can be used for individual or group sessions.


Eligibility Criteria:
Inclusion Criteria:

* Person aged ≥ 65 years
* A person with Alzheimer's disease or a related disorder established by a full medical diagnosis according to DSM-5 criteria, at a mild to moderate stage defined by a Mini-Mental State (MMSE) ≥ 15/30
* A person who regularly attends the day hospital at Charles Foix Hospital Persons able to give their consent to take part in the study

Exclusion Criteria:

* Person with severe neurocognitive disorders (MMSE \< 15/30)
* Person refusing to participate
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.


Eligibility Criteria:
Inclusion Criteria:

1. Must be between the ages of 12 and 17
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Recent (within past 3 months) change in antidepressant medication
3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months
4. Unable or unwilling to sign the informed consent documents
5. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy

The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.

Maintenance

Dexamethasone

Patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. Response will be assessed at least every 3 months while on maintenance therapy. Appropriate H2 blocker and antibiotics will also be given.

Thalidomide

Thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. Thalidomide will be given as an oral, once daily dose at bedtime. Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant.
* Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
* Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
* Patients must have a SWOG performance status of 0-2.
* Patients must have adequate renal function, as defined by serum creatinine \< or = 3.0 mg/dl.
* Patients must be off chemotherapy (including steroids) and local radiotherapy for \> or equal 3 weeks prior to entering the study.

Exclusion Criteria:

* No other concurrent therapy for myeloma is permitted while on protocol.
* There must be no evidence of active infection requiring IV antibiotics.
Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?

Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.

50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status I-II
* Patients undergoing ERCP procedures

Exclusion Criteria:

* uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)
* difficulty in communication (language problems, such as deafness)
* who are allergic to the drugs used
* pregnant women
Effects of Nut Consumption on Metabolic Syndrome

This study aimed to investigate the effects of nut consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in Korean adults with metabolic syndrome.

A randomized, controlled, parallel, dietary intervention study was designed. Subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the Nut group, which were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks; or allocated to the Control group. Metabolic markers were evaluated at baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.

Exclusion Criteria:

* Subjects were excluded if they had a nut allergy, peptic disorder, a history of cancer or cardiovascular disease including coronary artery disease, heart valve disease, or stroke, or established chronic diseases such as chronic renal insufficiency or cirrhosis. Subjects were also excluded if they:1) were receiving treatment with hypoglycemic agents for diabetes or had HbA1c \>7%; 2) were receiving corticosteroid treatment; 3) had started antihypertensive or lipid-lowering agents, or changed their doses within the previous month; 4) had a weight change ≥5 % of body weight during the three months prior to the study; 5) were pregnant; or 6) were regular nut consumers (\>15g/day of nuts at least three times a week).
Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.


Eligibility Criteria:
Inclusion Criteria:

* ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery

Exclusion Criteria:

* patients who were diagnosed with excisional biopsy and patients undergoing mastectomy
Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France

From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of Bicêtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the Bicêtre hospital for COVID-19 during the 1st wave of the epidemic in France and having survived this hospitalization. This cohort included 478 patients. The article resulting from the analysis of the data collected is accepted for publication in JAMA.

This evaluation, the aim of which was both clinical and scientific, was carried out largely thanks to human and material resources then demobilized because of the epidemic and thanks to the investment of doctors and psychologists who carried out the work in addition to their usual work.

The response to the current call for projects aims to bring together the means to continue this monitoring work during the 2nd epidemic wave, while the means and staff are this time completely mobilized by the care of patients with COVID-19 and other. It also aims to raise funds that will allow an in-depth analysis of the residual symptoms presented by the patients.

The current project aims to continue the work started with the COMEBAC "1st wave" cohort with:

* The inclusion of patients hospitalized after the 1st wave.
* An assessment of symptoms according to the SARS-CoV-2 variant.
* A 12-month follow-up of symptomatic patients during the evaluation in COMEBAC "1st wave".

Eligibility Criteria:
For the 6-month evaluation of patients from the 2nd epidemic wave

* Inclusion criteria

  * Age ≥18 years old
  * COVID-19 defined either by a reverse transcriptase-polymerase chain reaction (RT-PCR) or by a combination of clinical signs and compatible lung CT scan
  * Hospitalization for COVID-19 after 1st July 2020
  * Living out of the hospital
* Exclusion criteria

  * Death occurring between index hospitalization and reassessment
  * Patient refusal
  * Discovery of a positive RT-PCR for SARS-CoV-2 during hospitalization for a reason other than COVID-19
  * Nosocomial COVID-19

For the 12-month evaluation of patients from the 1st epidemic wave

* Inclusion criteria

  ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
* Exclusion criteria

  * Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
  * Patient refusal
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.


Eligibility Criteria:
Inclusion Criteria:

* Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
* A total International Prostate Symptom Score (IPSS) of ≥13
* A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
* A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion Criteria:

* Any significant Post Void Residual volume (\>150 mL)
* A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
* Evidence of a symptomatic urinary tract infection
Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be enrolled from the practice of the primary investigator.
* Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
* All patients will have responsivity to levodopa.
* Individuals with normal or mild cognitive impairment.

Exclusion Criteria:

* Clinically significant dementia
* Other significant neurological or psychiatric disease
* Previous brain surgery including pallidotomy or thalamotomy
* Previous placement of other implantable devices
Effects of Respiratory Rehabilitation on ICU Patients

Effects of respiratory rehabilitation on patients after extubation

The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 \< heart rate less than 120 beats/min, 90 \< systolic blood pressure \< 200mmHg, 55 \< mean arterial pressure \< 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was \>10 and\< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P \< 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18
* The hemodynamics are stable
* 50 \< heart rate less than 120 beats/min
* 90 \< systolic blood pressure \< 200mmHg
* 55 \< mean arterial pressure \< 120mmHg
* Do not increase the dose of vasopressor for at least 2 hours
* Intracranial pressure was stable and there is no seizure within 24 hours
* The breathing condition is stable
* the oxygen satiety of the patient's finger vein is ≥88%
* 10\<the breathing frequency \< 35 times/min

Exclusion Criteria:

* Pregnancy
* Acute myocardial infarction (ami)
Does Hyaluronic Acid Affect Periodontal Treatment?

Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in patients with periodontitis.

Design: A total of 24 Stage II-III periodontitis patients will be included in this split-mouth, randomized-controlled study. The study population will be divided into four groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3 (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by spectrophotometric analysis.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy
* moderate-to-severe periodontitis
* at least five sites with ≥5mm probing depth (PD)
* at least ≥20 teeth
* Stage II-III periodontitis according to the 2017 World Workshop
* Age between18-55

Exclusion Criteria:

* receiving systemic or local antibiotics within the past six months
* prior surgical or non-surgical periodontal treatment within the past six months
* smoking
* pregnancy
* lactation
* age ≤18 years or ≥55 years
* hypertension
* known chronic systemic diseases (i.e., diabetes mellitus, rheumatoid arthritis), - - known hypersensitivity to one of the ingredients of the HA preparation.
Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid

The main purpose of this study is to determine how the study drug, clavulanic acid, affects glutamate in the brain using Magnetic Resonance (MR/MRI) scans. In this study, subjects will receive the study drug, clavulanic acid and undergo 4 MRI scans. This is being studied to determine the correct dosing of clavulanic acid, and to gather data so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for cocaine use disorder, moderate to severe in early remission.
* Be male or female adult volunteers ages 18-65 inclusive.
* If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.

Exclusion Criteria:

* Be unable to complete an MRI scan

(For full inclusion/exclusion criteria or for more information, please contact the site directly.)
A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

* Not receiving antiretroviral therapy, refusal to provide informed consent