cyrilzakka/clinical-trials huggingface dataset:
Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases

Rheumatic diseases regroup a variety of disorders affecting the locomotor system including joints, muscles, connective tissues and soft tissues around the joints and bones. Inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic diseases. Such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases (IRD), include arthritis of various origins such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondylarthritis (SpA). Patients with autoimmune diseases such as RA or SpA are in higher risk of fractures compared to the general population.

Initial pharmacotherapies for IRD remain NSAID treatment for pain relief, and anti-resorptive agents (e.g., TNF-alpha blockers) which aim at reducing bone loss and preventing occurrence of new bone erosions. Yet current treatments may have strong side effects and are not always effective (e.g., 35-40% of the patients treated with TNF-alpha inhibitors will initially or progressively loose response). Therefore there is a need for further treatment modalities in IRD, which would focus on both suppressing inflammation and treating bone disorders.

Current research studies indicate that Bone Therapeutics' allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to osteo-regenerative and immune-privileged properties).

The present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases. In this purpose, in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells (PBMCs) of subjects diagnosed with RA, PsA and SpA.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of 18 years of age or older
* Subjects must belong to one of this group: Rheumatoid Arthritis (RA) Subjects OR Psoriatic Arthritis (PsA) Subjects OR Spondylarthritis (SpA) Subjects

Exclusion Criteria:

* Subjects diagnosed with other autoimmune/inflammatory diseases other than Crohn's disease, psoriasis, uveitis, Sjögren's syndrome and auto-immune thyroiditis
* Subjects with an active cancer and currently receiving a cancer treatment
* Women with known pregnancy
* Breastfeeding women
* Subjects with a known history of HIV and/or Hepatitis B and/or Hepatitis C infection and/or positive for HBs antigens
Comparison of Gold Fish Exercises and Cervico-thoracic Postural Correction Training in Patients With TMJD

The aim of this randomized controlled trial is to determine the effect of Gold Fish exercises and cervico-thoracic postural correction training in patients with temporo-mandibular joint dysfunction to improve pain, ROM and maximum mouth opening of jaw.

Goldfish Exercise works on the principle of pulsatile motion of Goldfish in water \& thereby imitating the same motion for health benefits. It can be thought of stretching the fibrous bands, reducing TMJ stiffness \& resulting in improvement of mouth opening. It would be beneficial to use this technique on daily basis and as far there are no contraindications of this exercise because it's done within the pain limits \& further progression depends on the mouth opening of the patient.

Posture can affect the three-dimensional movement of the jaw during opening which is seen most clearly in the slumped posture as reduced maximal mouth opening. While mouth opening and head extension are linked, there is variability in the amount of head extension when opening wide and the relationship between head extension and mouth opening is negated when opening in a slumped posture. This has implications for the association of neck dysfunction, posture, and temporo-mandibular joint disorder which should be explored further.

Eligibility Criteria:
Inclusion Criteria:

- Age group 20-40 Both males and females Forward head posture and temporo-mandibular joint dysfunction for more than 3 months.

Pain provocation during neck movement, chewing and yawning; more than 5 on the Visual analogue scale.

Exclusion Criteria:

* History of cervical spine injury or surgery
* Pain due to underlying condition i.e. neoplasm, vascular disease
* Infection, inflammation
* Erupting 3rd molar/dental origin
* Congenital condition of cervical spine or TMJ
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 40 years of age scheduled for cataract surgery
* Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
* Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

Exclusion Criteria:

* Use of any corticosteroids within 7 days prior to Day 0
* Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.
Visual Performance After RESTOR Implantation

The purpose of this study is to evaluate the distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Prospective study of 50 patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation. Uncorrected distance vision acuity (UDVA), corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA), and distance-corrected intermediate visual acuity (DCIVA) were measured postoperatively. A patient-satisfaction and visual phenomena questionnaire was administered at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Any race
* Either gender
* Diagnosis of cataracts both eyes
* Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
* Subjects must have \< 1.00 diopter of astigmatism
* Biometry results for the Restore patients should target emmetropia or +0.25.

Exclusion Criteria:

* Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
* Retinal abnormalities
* Diabetes mellitus steroid or immunosuppressive treatment
* Connective tissue diseases
AZA Combined With NAC for PIT After HSCT

Prolonged isolated thrombocytopenia (PIT) that is refractory to conventional treatments has remained a critical complication after allogeneic hematopoietic cell transplantation since decades years ago. Recombinant human thrombopoietin (rhTPO) is the main therapy in clinical practice, but remains low efficiency for PIT. Demethylating drugs have shown thier potential in high-risk myelodysplastic syndromes (MDS) and acte myeloid leukemia (AML). In addition, decitabine has demonstrated its efficacy of over 70% for response rate in treatment for PIT in early clinical trials with elusive mechanism. Preliminary experiments revealed that PIT was associated with abnormality of oxidation microenvironment, and N-Acetyl-L-cysteine (NAC) was the most commonly used antioxidant. Therefore, the investigators have been wondering whether Azacitidine in combination with NAC could improve PIT post HSCT and explore the possible mechanism of it.

Prolonged isolated thrombocytopenia (PIT) that is refractory to conventional treatments has remained a critical complication after allogeneic hematopoietic cell transplantation since decades years ago. Recombinant human thrombopoietin (rhTPO) is the main therapy in clinical practice, but remains low efficiency for PIT. Demethylating drugs have shown thier potential in high-risk myelodysplastic syndromes (MDS) and acte myeloid leukemia (AML). In addition, decitabine has demonstrated its efficacy of over 70% for response rate in treatment for PIT in early clinical trials with elusive mechanism. Preliminary experiments revealed that PIT was associated with abnormality of oxidation microenvironment, and N-Acetyl-L-cysteine (NAC) was the most commonly used antioxidant. Furthermore, AZA had shown its potential in immune regulation. Therefore, the investigators have been wondering whether Azacitidine in combination with NAC could improve PIT post HSCT and explore the possible mechanism of it.

Eligibility Criteria:
Inclusion Criteria:

* Platelet count ≤ 30 × 10\^9/L persistently at day 60 post-HSCT or later;
* Neutrophil and hemoglobin were well recovered;
* Full donor chimerism was achieved;

Exclusion Criteria:

* Patients with malignancy relapse;
* Active infections;
* Grade Ⅲ-Ⅳ acute graft-versus-host disease or severe chronic graft-versus-host disease according to National Institute of Health criteria;
* Severe organ damage;
* Thrombosis requiring treatment;
Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure

In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.

Single center, prospective, randomized, intention-to-treat clinical trial. The study has been performed within a two tier EMS system of a major city. Prehospital emergency physicians are on scene in every patient enrolled to the study.

Patients with acute respiratory failure (SaO2 \< 90%, respiratory rate \> 20/min) were enrolled to the study using envelopes for randomisation for either "conventional" (O2 + medication) or "NIV." Vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started.

Primary endpoints are 28-day mortality, hospital-, ICU- and respirator-days, SAPS, SOFA II and complications. Secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* acute respiratory failure
* at least 18 years old
* cooperative

Exclusion Criteria:

* cardiac arrest
* respiratory arrest
* unconscious
* uncontrollable agitation
* less than 18 years old
A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast adenocarcinoma.
* Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
* Prior first-line systemic therapy in the metastatic setting.
* Demonstrated progression of disease by radiological or clinical assessment.
* Female patient, aged ≥18 years old.
* Estimated life expectancy \>3 months.
* Normal Left ventricular function
* Adequate haematological, hepatic and renal functions.
* For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
* Ability to swallow oral capsules or tablets.

Exclusion Criteria:

* More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
* Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
* Active central nervous system metastases, cerebral oedema, and/or progressive growth.
* Patients with impaired cardiac function.
* Uncontrolled arterial hypertension
* Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
* Serum potassium level below Lower Limit of Normal
* Uncontrolled hypothyroidism.
* Pregnant or breastfeeding women.
Evaluating Therapeutic Massage for Chronic Neck Pain

This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP).

Neck pain is one of the most common problems affecting the health of Americans and is a leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic massage is one of the most popular CAM treatments for neck pain, but little is known about its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain.

The study will involve two phases. During Phase I, researchers will develop and pre-test key components for a randomized clinical trial. In Phase II, the safety and efficacy of massage for CNP will be evaluated. The changes in symptoms, function, and quality of life in massage and self care groups will be evaluated midway through treatment, at the end of treatment and at 6 months post randomization.

Eligibility Criteria:
The inclusion and exclusion criteria will be developed through consultation with a medical expert on neck pain and several massage consultants
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male, ages 18 - 55
* Able to consume a regular diet and one high fat meal; no specific dietary requirements
* Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage

Exclusion Criteria:

* Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
* Has been on a ketogenic diet as supported by review of a food diary
* Has positive Urine Drug Screen or alcohol results at Screening
Effects of Male-specific Antibodies on Sex Ratio

Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men.


Eligibility Criteria:
Inclusion Criteria:

* Vasectomized men

Exclusion Criteria:

* Men who do not understand the study information
Effect of Remimazolam on Postoperative Delirium

Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists status ≥Ⅳ
* history of neurologic or psychiatric diseases
* difficulty in communication
* abuse of drug or alcohol
* suspected allergy to propofol or benzodiazepines
PASIMAT: Automatic Measure of PASI

To quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. PASI (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis assessment. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes.The primary objective of this study would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of patients with psoriasis human body in a few minutes

Psoriasis is a chronic inflammatory skin condition resulting in a significant impact on patients' quality of life. To quantify the severity of psoriasis in a consistent and clinically meaningful way is important in order to decide the therapeutic orientation to take for the patient. PASI (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis assessment. However the measure of the PASI score is very complex. Given this complexity, the PASI is influenced by inter and intra-rater variation. In addition the PASI assessment process is time consuming. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system performing standardized photos from head to feet and from all angles, which allows to map the entire skin covering all the human body in a few minutes. The mapping of the entire body is automatically done by the use of a digital camera performing 20 pictures of the patient with 8 successive positions. The system is coupled to a software of automatic analysis of these pictures for the measure of the PASI score. The primary objective of this study would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of patients with psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Subject is affiliated to a National Health System at screening visit
* Understand and sign an Informed Consent Form (ICF) at screening, prior to any investigational procedures being performed.
* Patient with moderate to severe Plaque psoriasis.
* The patient is willing and able to be evaluated by the Bodystudio ATBM: 3 minutes for a young patient and until 7 minutes for an oldest.
* The patient is able to staying up during all the total body mapping procedure

Exclusion Criteria:

* The subject is vulnerable (such as deprived from freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
* Pregnant woman or who are breast-feeding
* Patient with tattoos that could influence the PASI assessment.
* Patient with skin type (phototype) V or IV according to Fitzpatrick classification
* Male patients with exceeding facial or skin hair that could influence the automatic PASI assessment.
* Patients with exceeding varicose veins.
* Patients with sun burn
the Effect of Retrolaminar Block on Postoperative Pain

In recent years, as a part of multimodal analgesia, paravertebral blocks are replacing epidural analgesia due to the less side effects. Although the risk of pneumothorax is the most feared complication in paravertebral blocks, retrolaminar block (RLB) -which is a paravertebral block- significantly reduces this risk due to the anatomical technique of procedure. The investigators aim to investigate the effect of retrolaminar block with ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra surgery.

Retrolaminar block will applie before general anesthesia induction when patients will be awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the preoperative block area in sitting position using in-plane approach. After sterilising the skin, the investigators will perform block by using 7-18 MHz convex ultrasound probe ( Esaote My Lab 6 US Machine, Florance, Italy) and a 22-gauge, 100-mm Stimuplex needle (B. Braun, Germany). The investigators will pass in a sagittal plane from medial to lateral at the mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and pleura.

The L3 laminae will be identified approximately lateral of the spinous process. The needle will insert in-plane, cephalad to caudad. After lamina contact and negative aspiration, 20 ml bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on each side and spread of local anesthetic between laminae and paraspinous muscles will be seen without pain or paresthesia. Then 30 minutes later, the patient will be taken to the operating room.

After general anesthesia prosedure, the patients will evaluate whether they have pain throughout 24 hours after the operation. The pain scores will be evaluated with visuel analogue scale.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old
2. ASA 1, 2, 3 patients
3. undergoing lumvar vertyebra surgery

Exclusion Criteria:

1. pregnant woman
2. child
3. patint wiht cognitive disfunction
Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.

The study hypothesis is that the 5 \& 2 \& 2 Meal Replacement Plan and the 4 \& 2 \& 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females, 18 years of age or older at the start of the weight loss program.
* Subject has a BMI ≥ 25 kg/m2.
* Subject started a weight management program at the MWCC location on or after January 1, 2012.
* Subject followed the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
* Subject signed the Personal Health Information Consent Form.

Exclusion Criteria:

* Subject was concurrently following another weight loss program other than the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan while on that respective plan.
* Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan.
* Subject completed initial consultation but did not participate in any follow-up visits.
* Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
* Written request by subject to revoke consent to use health information is present in subject chart.