cyrilzakka/clinical-trials huggingface dataset:
Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia

The goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty.

The main questions it aims to answer are:

* question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?
* question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?

Patients with American Society of Anesthesiologists classification status I-III scheduled for elective primary TKA using standard spinal anesthesia enroll for this trial. After surgery patient divided two groups: 1- adductor canal blockade 2- distal adductor canal blockade + anterior femoral cutaneus nerve blockade. At postoperative 3th, 10th, 24th hour VAS (visuel analouge scale), VAS move, incision plase pain-for top and down of patella, drain place pain, motor strenght for femoral nerve and siyatic nerve, first analjesic requirement time, opioid consumption, total analcesic requirement will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Total knee artroplasty
* Spinal anesthesia
* ASA 1-3

Exclusion Criteria:

* Bupivacaine allergy
* Coagulopathy
* Infection on injection site
Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis

Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.

The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.

The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.


Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* Patient with relapsing remitting multiple sclerosis and eligible for treatment with Tysabri
* Patient affiliated to a social security scheme
* Patient who signed informed consent
* Patient who have been informed of the results of the prior medical examination

Exclusion Criteria:

* Patient not currently eligible for treatment with Tysabri
* Contraindication to MRI scanning
* Unability to provide informed consent (subject in an emergency situation, difficulties in understanding , ...)
* Patient under judicial protection
* Patient under guardianship or curatorship
* Pregnancy (women of childbearing age in the absence of effective contraception)
* Breastfeeding
Effect of Aromatherapy on Anxiety in Relatives of Emergency Patients.

This study aims to determine the effect of aromatherapy (lavender oil) application on the anxiety level of relatives of patients admitted to the emergency department.

The hypotheses of the study are as follows:

H1: Aromatherapy (lavender oil) application has an effect on the anxiety level of relatives of patients presenting to the emergency department.

H0: Aromatherapy (lavender oil) application has no effect on the anxiety level of relatives of patients presenting to the emergency department.

In the experimental group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. The participants will be made to smell lavender oil dropped on gauze by the researchers for an average of 3-5 minutes. After the intervention, the state and trait anxiety scales will be applied as a post-test approximately 15 minutes later.

In the control group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. No intervention will be made to the participants in the control group. After a certain waiting period (after an average of 15 minutes), the state and trait anxiety scales will be applied as a post-test.

Eligibility Criteria:
Inclusion Criteria:

1. Being 18 years of age or older
2. Not having a problem with smell
3. Accompanying the patient
4. Not having a psychiatric problem

Exclusion Criteria:

1. Refusing to participate in the study or wanting to leave
2. Having an upper respiratory tract infection
3. Known history of allergy (lavender oil)
4. Having a chronic respiratory disease
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease

The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* For patient:

  * Diagnosis of Probable Alzheimer's Disease per DSM-5 criteria;
  * In the early stage of AD (MMSE from 20 to 25);
  * Age from 60 - 80 years old;
  * Had greater than 5 years of formal education.
* For Caregiver:

  * Members (including, but not limited to partners, children, relatives, lived-in helper of the patient) that are important for care delivery and provide care-related tasks (eg personal care, eating, cooking, cleaning) and everyday decision making to the patients. They are not required to live together or spend a specific amount of time with the patients;
  * Older than 18 years of age;
  * Possess adequate Vietnamese language skills and no cognitive impairment to conduct interview and evaluation

Exclusion Criteria:

* For patient:

  * Patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions;
  * Diagnosed with significant neurologic disease other than AD (Parkinson's disease, multi-infarct dementia, schizophrenia, history of significant head trauma followed by persistent neurologic defaults, ...), major depression within the past 1 year, or taking psychoactive medications (antidepressants with significant anticholinergic side effects, neuroleptics, chronic anxiolytics or sedative hypnotics, etc) within the past 1 month;
  * Having major visual, auditory, reading, or writing impairments;
  * Patients and/or caregivers who decline to participate.
* For cargiver:

  * Having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team;
  * Having significant visual, auditory, reading, or writing impairments;
  * Caregivers who decline to participate
Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.

Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain.

Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation.

The ideal pain management procedures are based on the multimodal analgesia model, based in turn on the combination of products and / or techniques to improve the quality of analgesia, reduce the side effects linked to the use of opioids, reduce responses to surgical stress, reduce postoperative recovery and allow rapid rehabilitation of the patient.

The aim of our study is to investigate whether clonidine combined with levobupivacaine in the pudendal block reduce the total consumption of opioids in proctological surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signature of informed consent

Exclusion Criteria:

* Refusal to participate ;
* Allergy to either local anaesthetics or clonidine;
* Local infectious pathologies (e.g. acute ano-perineal suppuration)
* Pregnancy
* Breastfeeding
* Severe bradyarrhythmia due to sinus node disease or second and third degree atrioventricular block
* Severe depressive condition
* Severe coronary artery disease
* Raynaud's disease
* Heart failure
* Obliterating thromboangiitis
* Epilepsy
* Spinal anesthesia
Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position

The Left interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position


Eligibility Criteria:
Inclusion Criteria:

* elective shoulder surgery
* Age 50- 80 years old
* ASA II - IV

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurological deficit on the side to be operated
* Allergy to local anesthetics
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Failure of the interscalene block
Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.

In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.

A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.

Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.

Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol.

139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria. Thereafter each subject will be followed according to the approved protocol

The proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day 28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)will be evaluated.

secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients
* Aged 6 to 59 months
* Body weight between 7.5 to 30 kg
* uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL
* Ability to tolerate oral therapy
* Informed consent, oral agreement of the child if appropriate

Exclusion Criteria:

* Still in IPTi trial and/or still in any other intervention trial
* Known G6PD-deficiency
* Presence of severe malnutrition
* Inability to drink or breastfeed
* Recent history of convulsions, lethargy or unconsciousness;
* Signs of severe and complicated
* Mixed/mono infection that includes a non-P. falciparum species.
* Hb \< 7g/dl
* Inability to attend stipulated follow-up visits.
* History of hypersensitivity reactions to the drug being evaluated
Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling

Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* breast cancer stages II-III
* adjuvant or neoadjuvant chemotherapy with docetaxel regimens (TAC or anthracyclines followed by docetaxel 100 mg/m2 x 4)

Exclusion Criteria:

* contraindications for adjuvant docetaxel and or anthracyclines
A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients

The aim of this clinical trial is to apply a new objective titration procedure in obstructive sleep apnea hypopnea syndrome (OSAHS) patients treated with mandibular advancement device (MAD), and to compare this new objective titration procedure with the subjective titration procedure which is commonly used in clinical practice. The remotely intelligent sleep monitoring system (RISMS) will be used in the new objective titration procedure. The main questions it aims to answer are:

1. The efficacy of MAD therapy after each titration procedure.
2. The titration time efficiency and the improvement of subjective symptoms after each titration procedure.

In this study, patients diagnosed with OSAHS and referred for MAD treatment will be recruited. The amount of mandibular protrusion seems to be a key factor in the treatment of MAD. Patients will experience either of the two titration procedures to obtain the optimal mandibular protrusion. One procedure is a new objective titration procedure which will use the RISMS for the treatment of MAD, which will help the clinician instruct the titration according the objective therapeutic indicator. The other procedure is the subjective titration procedure which is commonly used in clinical practice. Finally, the researchers will compare the efficacy of the MAD therapy, the titration time efficiency and the improvement of subjective symptoms between the two titration procedures.

Eligibility Criteria:
Inclusion Criteria:

* OSAHS patients with AHI≥15
* 18≤age≤70 years;
* Subject is capable of giving informed consent
* refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery
* Normal clinical, periodontal and temporomandibular joint examination

Exclusion Criteria:

* Active periodontal problems including tooth mobility
* active temporomandibular joint dysfunction
* Edentulous patients or Insufficient teeth to support MAD
* patients with severe unstable systemic diseases or suffering from psychiatric disorders
* Enlarged palatine tonsils (Friedman grade IV tonsils)
Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation

The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 19 years of age
* Diagnosis of NVAF
* Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
* Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
* Written informed consent of the patient

Exclusion Criteria:

* Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Planned treatment with other anticoagulants.
* Expected renal-replacement therapy within the next 3 months
Efficacy and Safety Study of ABT-436 in Major Depressive Disorder

The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
* No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
* Can safely be treated on an outpatient basis.
* A condition of general good physical health.
* Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.

Exclusion Criteria:

* History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
* Inadequate response to more than two different antidepressant medications during the current major depressive episode.
* History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
* History of transcranial magnetic stimulation during the current major depressive episode.
* Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty

The purpose of this study is to investigate the effects of balance training in patients with THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were candidates for THA were recruited to the study. Sixteen patients with THA completed the study protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR, n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50 foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty due to osteoarthritis
* First time hip surgery/prothesis
* no involvement in any exercise program in the past 12 months

Exclusion Criteria:

* THA due to hip fracture,
* revision hip prothesis,
* arthritis in other joints limited function
* neurologic problems that limited function and balance,
* body mass index greater than 40 kg/m2.
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.


Eligibility Criteria:
Inclusion Criteria:

* Moderate liver disease
* Test positive for hepatitis B surface antigen or hepatitis C antibody
* Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
* Age 18 years or older

Exclusion Criteria:

* Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
* Received radiation therapy within 4 weeks before randomization
* Major surgery within 4 weeks before randomization
* Minor surgery within 2 weeks before randomization
* Systemic steroids within 1 week before randomization
* Hepatic encephalopathy, per the investigator's evaluation
* History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
* History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
* Known brain or spinal cord metastases
* History of other cancers within 5 years before enrollment
* Pregnant or breast-feeding women
* Known HIV infection
Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation

Recent studies have shown positive results in the application of phototherapy for the improvement of performance and acceleration of the healing process of the body homeostasis. Among the methods used to assess the recovery post-exercise has cardiac autonomic modulation assessed by heart rate variability (HRV), a tool widely used in sports to evaluate medium global behavior of the autonomic nervous system. Objective: analyze and compare the effect of a special protocol of phototherapy using different light sources interacting with a combined training with an autonomic modulation of heart rate in different moments (baseline; tracking daily; recovery post-exercise and after training). Method: 45 male participants will be allocated from a stratified randomization into three groups: control (n=15), placebo (n=15) and group special protocol of phototherapy (n=15). Participants will perform a combined training of sprints and squats twice a week for twelve weeks divided into two phases. The application of phototherapy and placebo was administered in phase 2, after sprints and just before the squat. The phototherapy was used combine different light sources and wavelength (red and infrared). Was analyze HRV in five moments: baseline; traking daily; week target of phase I and II; after training. The weeks target consist of training sessions with greater energy expenditure (largest intensity). The sphericity of the data was tested by Mauchly test. In case of violation of the sphericity assumption, the correction of Greenhouse-Geisser was performed. The data was analyzed using analysis of variance for repeated measures (Bonferroni post-test), which provide information on the effects of time, group and interaction. All statistical analyzes assume the significance level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patient (self-report);
* Male gender;

Exclusion Criteria:

* History of cancer;
* Smokers or alcoholics;
* Use drugs that influenced cardiac autonomic activity;
* Cardiovascular, metabolic or endocrine diseases;
* Occurrence of musculoskeletal injury during the study.