cyrilzakka/clinical-trials huggingface dataset:
Objective Measurement Methods for Autoimmune Disease and Dry Eye Syndrome

To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome

Objective: To explore the association among TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis for Autoimmune disease and Dry eye syndrome

Method:

This study wants to establish the objective measurement of Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects. And the investigators want to use the objective measurement tools to explore the association of TCM pattern, heart rate variability (HRV), TCM tongue diagnosis and TCM pulse diagnosis among at least 50 each AID group subjects and at least 50 DES subjects.

Expected Results:

1. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each AID groups.
2. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis for the each DES groups.
3. To evaluate the difference among TCM pattern, HRV, TCM tongue diagnosis, TCM pulse diagnosis among the AID groups and DES group.

Keyword: Autoimmune disease, Dry eye syndrome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis

Eligibility Criteria:
Sjögren's syndrome

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA

Systemic lupus erythematosus

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) fulfilled the 1982 ACR revised Systemic lupus erythematosus criteria Exclusion Criteria: NA

Rheumatoid Arthritis

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) fulfilled the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria Exclusion Criteria: NA

Systemic Sclerosis

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) fulfilled the 1980 ACR eSystemic Sclerosis criteria Exclusion Criteria: NA

Ankylosing spondylitis

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) fulfilled the 1984 Ankylosing spondylitis Modified New York criteria Exclusion Criteria: NA

Dry eye syndrome

Inclusion Criteria:

* (1) aged between 20 and 75 years
* (2) Schirmer's test less than 10 mm/5 min
Psychometric Validation of the Competitive Attention Test

This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

* a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
* testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
* testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.


Eligibility Criteria:
Inclusion Criteria:

healthy major participants:

* Age from 18 to 90 year-old
* Informed consent to participate in the study
* No neurological or psychiatric disorder
* No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder

healthy minor participants:

* Age from 6 to 17 year-old
* Informed consent of parents or guardians for the child's participation in the study
* No neurological or psychiatric disorder
* No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, Attention deficit disorder

ADHD minor patients:

* Age from 6 to 17 year-old
* Informed consent of parents or guardians for the child's participation in the study
* ADHD Diagnosis with or without hyperactivity
* No psychiatric history other than ADHD.
* For Experience 3: treatment in progress.

Exclusion Criteria:

healthy major participants

* Age below 18 or above 90 year-old
* unaffiliated or non-beneficiaries of the social security scheme

healthy minor participants:

* Age below 6 or above 18 year-old
* unaffiliated or non-beneficiaries of the social security scheme

ADHD minor patients:

* Age below 6 or above 18 year-old
* unaffiliated or non-beneficiaries of the social security scheme
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate

Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory rheumatic disease
* Self reliant in daily life

Exclusion Criteria:

- conditions that might influence ability to fly to Spain and participate in rehabilitation in warm climate (Unstable heart disease, Serious lung disease, Chronic open ulcers, Serious mental health conditions, alcohol or drug addiction, Intolerant of sun and heat)
Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

Port-A-Cath is a totally implanted central venous access system and one of the most frequently used systems for administration of chemotherapies in oncological patients .

The currently used techniques for placement of totally implantable venous access devices involve the open insertion by cut down technique, or percutaneous puncture of the central vein either by anatomical landmarks or image guided approach by using ultrasound guidance which is increasingly being preferred over the traditional anatomical landmark due to its low complication rate and high technical success rate; as this technique enables the direct visualization of needle entrance and advancement into the target vein


Eligibility Criteria:
Inclusion Criteria:

* cancer patients
* Indicated for receiving long term chemotherapy
* Accepted coagulation profile.

Exclusion Criteria:

* Severe uncorrectable coagulopathy.
* Prior incidence of central vein thrombosis.
* Patients with active infection.
Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF

The purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (AHF) patients receiving an intravenous (IV) infusion of clevidipine in comparison to standard of care (SOC) and placebo.

Randomization will occur in two stages. Stage 1 patients will be randomized in a double-blinded manner in a 1:1 ratio to receive either clevidipine or placebo IV infusion. Upon completion of Stage 1, Stage 2 patients will be randomized in an open-label manner in a 1:1 ratio to receive either clevidipine or standard of care (SOC) IV infusion. At the time of randomization, a patient-specific, prespecified systolic blood pressure (SBP) target range will be determined and recorded prior to study drug treatment. Up to 500 patients may be enrolled to achieve a total of 100 Stage 1 and 300 Stage 2 patients with confirmed AHF per protocol.

A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor the safety of patients. Adverse events will be assessed for 7 days post-study randomization or hospital discharge, whichever occurred sooner. Serious adverse events (SAEs) were assessed for 30 days following study randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and providing
* Presentation consistent with AHF as manifest by pulmonary congestion
* Dyspnea score (sitting) ≥ 50 mm on a 100 mm visual analog scale
* In Stage 1, baseline SBP ≥130 - 160 mmHg (measured immediately prior to initiation of study drug); in Stage 2, baseline SBP ≥ 130 mmHg

Exclusion Criteria:

* Administration of an IV or oral antihypertensive agent within the previous 2 hours of randomization (short acting oral or sublingual nitrates are permitted)
* Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrome
* Known or suspected aortic dissection
* Acute myocardial infarction (AMI) within the prior 14 days
* Dialysis-dependent renal failure
* Requirement for immediate endotracheal intubation
* Suspected pregnancy or breast feeding female
* Intolerance or allergy to calcium channel blockers
* Allergy to soybean oil or lecithin
* Known liver failure, cirrhosis or pancreatitis
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.

The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.

This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.

The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).

Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex

Exclusion Criteria:

* Current DVT
* Recurrent varicose veins
* Arterial disease (ABPI\<0.8)
* Vein diameter \< 3mm
* Patient who are unwilling to participate
* Inability or unwillingness to complete questionnaires
* Adverse reaction to sclerosant or cyanoacrylate
* Not been involved in another venous trial for at least 6 months
Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

Eligibility Criteria:
Inclusion Criteria:

* Meets requirements outlined on Lyric Candidacy Form
* Current Lyric hearing instrument user
* 18 years of age or older at time of enrollment in the study
* Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
* Good understanding (read/write/speak) of the English language
* Willingness to comply with all study requirements

Exclusion Criteria:

* Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
* Difficulty understanding/reading instructions when corrected for vision loss
* Impairments that would restrict participation in any of the evaluations
* Ear health conditions present at baseline that prevent immediate device replacement
* Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)

the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction

systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.

Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then

* group A, the socket will be filled with A.PRF
* group B the socket will be filled with PRF.
* group C no bio-additive will be added.
* Criss cross horizontal mattress suture will be applied to close the extraction wound.

PRF and A-PRF preparation :

10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.

* Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
* Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one non restorable tooth in upper inter-bicuspid region.
* Stable periodontal condition with no acute periapical infection.
* Systematically healthy conditions.
* Cooperative patients.
* Intact buccal plate of bone.

Exclusion Criteria:

* Smokers.
* Patients seeking immediate or early implants.
* Pregnant females.
* Bone diseases.
* Drugs and diseases that may affect platelet count or function.
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients

The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.

Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.

Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1-infected diagnosis
* Naive of antiretroviral treatment
* Plasma viral load (VL) over 5000 copies/ ml
* CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
* Written, informed consent after approval by the local human research ethics committee

Exclusion Criteria:

* Acute opportunistic infection
* Pregnancy or breast feeding
* Cytotoxic systemic chemotherapy except for Kaposi sarcoma
* Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
* Polynuclear neutrophils below 750/mm3
* Hemoglobin below 8 g/dl
* Platelets below 20 000/mm3
* Creatinine level over 1.5 (upper normal) UN
* ASAT, ALAT, bilirubin level over 3 UN
Salt Intake and Lactobacillus Abundance

To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* 18 - 50 years
* Body mass index 18,5 - 29,9 kg/m2

Exclusion Criteria:

* Clinically relevant heart, lung, liver, and kidney disease
* Current or chronic infections
* Habitual intake of probiotics or dietary supplements
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis

This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.

This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.

To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 75 years-old
* Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
* Working understanding of the English language and able to fully understand the procedure
* Capable of providing informed consent
* Able to complete online, in-person or phone surveys for the purposes of follow-up
* Capable of understanding pre- and post-procedure care instructions
* Ambulatory at baseline
* Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

* Age \< 25 or \> 75 years old
* Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis
* Prior total or partial joint replacement surgery or surgery involving cartilage regeneration
* Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months
* Co-morbidity with the rheumatologic condition, inflammatory arthritis
* Currently undergoing immunomodulatory therapy
* Uncontrolled endocrine disorder
* BMI \>40 or joint space not visible by ultrasound
* Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection, and poorly controlled diabetes (HgA1C \>7.0)
* Pregnancy or planned pregnancy
* previous stem cell injection into treatment joint
* Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
* Coagulopathy or anticoagulant treatment
* Chronic pain involving multiple body parts or opioid medication management
* Diagnosis of fibromyalgia
* Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear
Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption

Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.

Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.


Eligibility Criteria:
Inclusion Criteria:

1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.

Exclusion Criteria:

1. allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
2. use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
3. congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
4. Pregnant women and patients unable to sign their own consent form
Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial

The purpose of pilot trial is to compare the efficacy of lifestyle intervention, metformin intervention, lifestyle combined with metformin intervention in improving assisted reproductive technology in non-polycystic ovary syndrome(pcos) patients with overweight/obesity and insulin resistance compared with conventional clinical education. Subjects who meet the inclusion criteria will be randomized to four groups: lifestyle intervention group, metformin intervention group, lifestyle combined with metformin intervention group, and routine clinical education group. Subjects of above three intervention group will start ovulation stimulation treatment after reach the aim or duration of intervention and routine clinical education group has no intervention. All subjects are treated with the same procedures, including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. The primary outcome is ongoing pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

1. Women ages 18 to 36 years.
2. Women BMI at least 25kg/m2.
3. Women who are non-pcos patient(2003 Rotterdam criteria).
4. Women with insulin resistance (HOMA criteria).
5. Women who are participating in their first or second fresh embryo cycle of in- vitro fertilization(IVF) or intracytoplasmic sperm injection (ICSI).
6. Women who are indicated IVF or ICSI.

Exclusion Criteria:

1. Women with endometriosis.
2. Women with untreated hydrosalpinx.
3. Women with a uterine cavity abnormality, such as a uterine congenital malformation; untreated uterine septum(except shallow uterine septum), adenomyosis, submucous myoma, or intrauterine adhesions.
4. Women who are indicated and planned to undergo preimplantation genetic diagnosis(PGD)/preimplantation genetic screening(PGS).
5. Women with endocrine abnormalities, such as Cushing syndrome, congenital adrenal hyperplasia, pituitary amenorrhea, thyroid dysfunction etc.
6. Women who had participated in other treatments known to affect diet or weight (such as diet drugs and dietitian intervention) for past 3 months.
7. Women who are unable to follow verbal and written instructions.
8. Women who use donated oocytes to achieve pregnancy.
9. Women with poor ovarian response(Bologna criteria).
10. Women with diabetes mellitus, abnormal glycosylated hemoglobin.
11. Women who has a history of recurrent spontaneous abortion.