cyrilzakka/clinical-trials huggingface dataset:
Ro60 Expression in Macrophages in Sjogren's Disease

Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with SSp Subjects aged between 18 and 75, without chronic disease; Subject meeting the classification criteria for SSp; Subject with positive anti-SSA serology; French-speaking subject able to give written consent; Subject affiliated to the Sécurité Sociale or an equivalent scheme; Subject willing to have blood samples taken;
* Control subjects Subjects aged between 18 and 75, without chronic disease and not meeting SSp classification criteria; Subject who understands and speaks French and is able to give written consent; Subject affiliated to the French Social Security system or an equivalent scheme; Subject willing to have blood taken;

Exclusion Criteria:

* Subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months;
* Subject undergoing biotherapy or cytoreductive treatment;
* Subjects with positive serologies for human immunodeficiency virus (HIV), viral hepatitis B virus (HBV) and viral hepatitis C virus (HCV) in the 3 months preceding the inclusion visit;
* Protected persons as defined in articles of the French Public Health Code.
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG

A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma


Eligibility Criteria:
Inclusion Criteria:

1. Visual acuity +1.0 logMAR or better
2. Willing to give informed consent
3. Ability to washout from current intraocular pressure lowering medications -

Exclusion Criteria:

1. All secondary glaucomas
2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
3. Refractive surgery
4. Ocular infection or inflammation
Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries

Intrapartum asphyxia and prematurity are the leading causes of neonatal mortality in low and middle income countries. Neonatal resuscitation training reduces asphyxia-related newborn mortality and morbidity, but in the absence of continuing low-dose, high frequency practice, these initial gains rapidly decay. The investigators propose to develop and evaluate innovative mobile virtual simulations for refresher training on neonatal resuscitation and essential newborn care to support the retention of knowledge and skills among health care workers in low and middle income countries.

The main goal of this study is to improve newborn mortality and morbidity by using affordable and accessible mobile virtual simulations to provide quality skills training and maintenance for healthcare workers in Low/Middle income countries (LMIC). The investigators hypothesize that mobile devices will provide a readily accessible, standardized alternative to in-person training to maintain skills. This study has the following Specific Aims:

Specific Aim 1: Co-develop and pilot test the usability and efficacy of mobile virtual simulations on early newborn care skills among healthcare workers who attend deliveries in community and health facility-based settings.

Specific Aim 2: Evaluate the impact of the mobile virtual essential newborn care (vENC) training on neonatal resuscitation and care educational indicators and performance outcomes among healthcare workers who provide newborn care in community and health facility-based settings.

Specific Aim 3: Evaluate the impact of virtual simulation refresher training on the rates of neonatal mortality in primary, secondary and tertiary healthcare facilities in Nigeria.

Eligibility Criteria:
Inclusion Criteria:

* Must have a direct clinical role related to newborn care
* Is able and willing to attend and complete study-related engagements

Exclusion Criteria:

* Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment
The Effect of Esketamine on Sleep Disturbance

To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance

Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.

Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older with sleep disturbance;
2. American Society of Anesthesiologists physical status I-III;
3. A gestational age below 12 weeks;
4. Elective surgery is proposed;
5. BMI of 19-30 kg/m2;
6. Patients who agreed to enroll in this study voluntarily

Exclusion Criteria:

1. Any contraindications to ketamine or esketamine;
2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
3. Respiratory insufficiency, respiratory failure;
4. Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
5. BMI\<18 kg/m2 or BMI\>30kg/m2;
6. Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
7. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study

The proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care.

The aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (Taper Only).

The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-cancer pain (≥ 6 months in duration)
* Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months

Exclusion Criteria:

* Unable to provide informed consent
* Unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of English fluency)
* Moderate to severe opioid use disorder
Detecting PNES With Single-channel sEMG

This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or Female between the ages 22 to 99.
4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

* Intracranial EEG electrodes are being used.
Differences Between Women With COVID-19 and Long Covid

The coronavirus disease of 2019 (COVID-19) has infected more than 630 million people and resulted in more than 6.5 million deaths worldwide. Among the possible sequelae of the virus, a disorder called long COVID has shown to affect about 10% of those infected, mostly adult women, without comorbidities.

Long COVID corresponds to a multisystemic syndrome following the acute period of the disease, in which the person maintains persistent symptoms such as fatigue, dyspnea, cough, memory loss, muscle and joint pain, among others.

Now that time has passed, it is necessary to verify why there are women who present symptoms of long covid and others do not.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 65 years
* That they have passed COVID-19 at least once.
* Whether or not they have symptoms secondary to COVID-19.

Exclusion Criteria:

* They do not want to sign the informed consent.
Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease

The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:

* 1-year progression free survival rate
* 1-year overall survival rate
* Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
* Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
* Rate of Neutrophil and platelet engraftment
* Efficacy of donor specific antibody desensitization
* Relapsed rate
* Primary and late graft failure
* Safety and complication of haploHSCT
* Complication of viral, bacterial, and fungal infection
* Viral reactivation
* Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
* Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including

  1. Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
  2. Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
  3. severe aplastic anemia
* Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
* Eastern Cooperative Oncology Group (ECOG) 0-2
* normal AST and ALT, creatinine \&lt;2g/dL, and left ventricular ejection fraction ≥50%
* age \&gt;18 years
* Capable of informed consent and provision of written informed consent before any study procedures
* Capable of attending all study visits according to the study schedule
* Female subjects who is childbearing potential must have a negative result for pregnancy test

Exclusion Criteria:

* HIV infection, active hepatitis B, active hepatitis C
* active infection
* history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
* A pregnant woman and/or refusal of contraception
Remote Ischemic Conditioning for Treatment of Chronic Wounds

The goals of this series of studies is to test the effect of RIC on chronic leg ulcers (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled study.

After getting patients informed consent. Initial evaluation that includes: Venous and Arterial vascular evaluation, Medical past History including medications and surgeries Documentation of the chronic wounds by description and photography with scale.

Base line blood test for CBC, HbA1C, Electrolytes, Urea, Cr, Liver enzymes. IL 1 IL 6 VEGF NO CD34 Adenosine All patients will received the standard wound care in use by the staff of the chronic wound clinic. Care givers will be blinded as to the study allocation of each patient. Patients will be divided randomly into two equal groups. Pressure cuffs will be applied to both arms of all subjects. The cuffs will be inflated and deflated intermittently for three cycles of 5 minutes each. In the study group, the cuffs will be inflated to 50 mmHg above systolic blood pressure while the performing investigator examines the radial pulse to ensure complete blood flow obstruction. In the control group, inflation will be up to 10 mmHg only. The patients will be followed for 10 weeks.

During this period, they will be examined every 2 weeks (5 follow-up visits); and in each of these visits the above procedure will be repeated including blood collection before intervention and 24-48h after intervention.

In each visit a "blinded" physician will photograph with scale the wound and grade the granulation tissue covering the wound on a scale from 0 to 5.

The primary end point of the study is the number of healed wounds and wound area change among the two groups. Secondary outcomes will be the degree of granulation tissue and levels of IL 1 IL 6 VEGF NO CD34 Adenosine

Eligibility Criteria:
Inclusion Criteria:All patients presented to Chronic/Hard to heal wound clinic at Soroka University medical center and Sherutei Briut Clalit regional clinic.

Wound that did not heal under proper medical care for over two months.

Exclusion Criteria:Ulcers suspected or proven to be malignant tumors. Patients that are planned for vascular intervention within the next month Patients that are planned for amputation within the next month
Autogenous Particles Harvesting During Implant Surgery

The aim was to compare the osteoblast activity and osteogenic potential of autogenous bone particles harvested using three different techniques, determine the most advantageous method of collecting autogenous bone particles.

Bone particles were harvested during dental implant surgery using low-speed drilling and high speed drilling. After the osteoblasts were cultured, cell proliferation, migration, mineralization, transcription of osteogenesis-related genes, secretion of osteogenesis-related proteins, and osteoinductive protein content in the bone particle matrix were evaluated

A total of 60 individual dental implants will be placed in this study. Each patient will receive two dental implants (Spain), each measuring 10 mm in length and 4 mm in diameter, for the replacement of missing teeth in the right and left mandibular first molars. The surgery will be performed under local anesthesia (0.5% articaine with epinephrine) with the elevation of a mucoperiosteal flap. For the randomization of the implant osteotomy milling protocol in each hemimandible, an online randomization service (www.randomization.com) will be utilized.

In each patient, the conventional high-speed milling protocol with irrigation using physiological saline will be employed in one hemimandible. In the other hemimandible, the implant osteotomy will be performed using a low-speed milling protocol without irrigation.

The milling sequence for the conventional high-speed milling protocol with irrigation will be as follows: the osteotomy will be initiated with a 2.0 mm diameter marking drill, followed by a pilot drill of the same diameter. Subsequently, drills of 2.6/3.2/ and 3.6 mm diameters will be used consecutively. All drills will be used at a speed of 800 rpm and at a depth of 10 mm.

On the other hand, the milling sequence for the low-speed milling protocol without irrigation will be the same, but all drills will be used at a speed of 50 rpm (at the same depth of 10 mm). Finally, once the dental implant and closing screw are inserted, the mucoperiosteal flap will be sutured with simple stitches using synthetic polyamide suture, without immediate prosthetic loading. In all cases, postoperative medication will include 500 mg/8 h amoxicillin for 7 days (in cases of penicillin allergy, 300 mg/8 h clindamycin for 7 days), and 600 mg/8 h ibuprofen for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Legal age
* Informed consent signed
* Bilateral mandibular dental absence of 3.6 and 4.6 for more than 3 months
* Normal bone density in the posterior mandibular sector with type II/III bone (range of 500-850 HU) according to the classification of Norton and Gamble
* No medical contraindications for the performance of oral surgical procedures (ASA I/II).

Exclusion Criteria:

* Presence of any disease, condition, or medication that may compromise the healing and/or osseointegration of dental implants (such as diabetes mellitus, bisphosphonate administration, or severe osteoporosis)
* Presence of any severe mental disorder
* Patients who have undergone head and neck radiotherapy in the previous 18 months.
A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes

To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-75 years at the time of signing the informed consent (both ends included)
2. Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included)
3. Diagnosed with type 2 diabetes for at least 90 days prior to screening
4. Tested by local laboratory, HbA1c is 7.5%-10.5% (including both ends)
5. Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days
6. Stable treatment with metformin alone or in combination with another OAD for ≥60 days prior to screening. Metformin dose ≥1500 mg/ day or maximum tolerated dose.
7. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug product or its components or excipients;
2. Systemic glucocorticoid use within 3 months prior to screening
3. Use of weight loss drugs within 3 months prior to screening
4. Insulin therapy other than basal insulin was used within 3 months prior to screening
5. Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening
6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
7. Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
8. Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
9. Known or suspected abuse of alcohol or narcotics;
10. Previous history of pancreatitis (acute or chronic)
11. During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product;
12. Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity

The purpose of the study is to explore the effects of GLP-1 receptor agonist (GLP-1 RA) semaglutide on modulation of taste sensitivity, tongue tissue transcriptome, modulation of neural response in central reward processing regions and gastric emptying rate. In addition, we aim to investigate the associations between semaglutide induced modulation of taste sensitivity, neural responses and gastric emptying with changes in body mass, eating- behavioural pattern, food perception and food intake.


Eligibility Criteria:
Inclusion Criteria:

* Informed written consent
* Diagnosed with PCOS by Rotterdam criteria
* BMI \> 30 kg/m2
* Age 18 years-menopause

Exclusion Criteria:

* Severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
* Current history of neurological disease including traumatic brain surgery
* Current history of diagnosis of type I or type II diabetes or plasma haemoglobin A1c 6.5% at inclusion
* Impaired hepatic function (liver transaminases\>3 times upper normal limit)
* Impaired renal function (estimated glomerular filtration rate (eGFR)\< 50 ml/min
* Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase \>2 times upper limit)
* Bleeding disorders
* Women who are pregnant, breast feeding or have intention of becoming pregnant within the next 9 months
* Women who are planning any operation within the next 6 months
* History of medullary thyroid carcinoma (MTC) and/or family history with MTC and/or multiple endocrine neoplasia syndrome type 2
* Cardiac problems defined as decompensated heart failure (New York Herat Association functional class III or IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 110 mmHg
* Receiving GLP-1 agonist within the last 12 months
* Use of any weight-lowering pharmacotherapy within the preceding 3 months
* Contraindication for MR scanning (magnetic implants, pacemaker, claustrophobia etc)
* Any condition that the investigator feels would interfere with trial participation