cyrilzakka/clinical-trials huggingface dataset:
Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography

Diabetic macular edema is one of the major causes of visual impairment in diabetic retinopathy patients especially in the working age group. The problem is likely to increase in the future with statistics showing a growing number of the diabetic population especially in the Middle East . .

The worldwide prevalence of diabetic macular edema was reported as 6.81% among patients with diabetes. Other research reported that the 10-year incidence of diabetic macular edema was 14% in individuals with type 2 diabetes, and progression to diabetic macular edema occurred in 29% of individuals with type 1 diabetes over 25 years if left untreated . Although diabetic macular edema resolves spontaneously in about 33% to 35% of patients, it tends to be chronic in most patients..Diabetic macular edema can occur at any stage of diabetic retinopathy . The symptoms of diabetic macular range from slight visual blurring to complete blindness if left untreated . Optical coherence tomography is an objective non-invasive method for high-resolution cross-sectional imaging of the retina .

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1or type 2 Diabetes Mellitus.
* Fundus examination and optical coherence tomography can be done with no significant hazy media

Exclusion Criteria:

1. Previous ocular surgery (e.g. vitreo-retinal surgery, glaucoma surgery).
2. Presence of co-existing retinal or choroidal disease (e.g. high myopia, retinitis pigmentosa and Age-related macular degeneration)
3. Other associated ocular conditions (ex. glaucoma \& corneal opacity \& iritis).
4. Previous history of trauma.
5. Pregnancy induced diabetes
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification

Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that patients with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).

Debate is present concerning the optimal level of humidification for obstructive sleep apnea (OSA) patients who need continuous positive airway pressure (CPAP) therapy. Recent evidence has shown that using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores. Anecdotal evidence exists, in the form of clinical observation, when ThermoSmart® technology is utilized during CPAP titration, patients laboratory titrated pressure may in fact prove to be lower. The possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher CPAP pressures to overcome upper airway resistance and flow limitation. Therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements. The goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree. Patients who are titrated on Continuous Positive Airway Pressure devices with ThermoSmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients over the age of 18
* Apnea Hypopnea Index (AHI) ≥15
* Patients must have at least 5 hours sleep time on each titration night
* Stable medications for 2 weeks prior to entry to the study and for study inclusion duration including sleep aids

Exclusion Criteria:

* Receiving or requiring bi-level ventilation
* Use of a full face interface or chin strap
* Previous UPPP surgery or palatal reconstruction
* Recent angina symptoms within 2 weeks of entry
* CHF with EF \< 40%
* Obesity Hypoventilation Syndrome
* Cheyne Stokes respiration
* \> 50% Central apneas recorded on diagnostic polysomnogram
* Supplemental oxygen use
* Use of narcotic pain medication
* Hypoxemia as determined by room air pulse oxymetry of less than 89% on room air at rest awake
* Inability to tolerate positive pressure therapy
* Split Night Evaluations
Impact of Intraoperative Cell Salvage

Patients presenting for elective cesarean section will be screened for pre-procedural anemia. If the potential subject meets the selection criteria they will be presented with the option of participating in the study. Once consented the participant is randomized by envelope. The two groups studied are: standard of care with intraoperative cell salvage and standard of care without cell salvage. If the participant is randomized to the cell salvage group, the study team will notify the anesthesia and obstetrics (OB) team and will set up the cell salvage system per protocol. The primary end point is to determine the difference in postoperative hemoglobin at 48hrs, need and quantity of allogeneic blood product transfusion, length of hospital stay between the two groups studied. The secondary endpoints Investigate the impact of using IOCS on clinical parameters associated with maternal postpartum stability and well being and include estimation of blood loss, need for pressors, uterotonics, return to the operating room, uterine compression devices, ICU admission, postoperative blood product transfusion, IV iron supplementation, blood chemistry, coagulation parameters, oliguria, diagnosis of acute kidney injury, postoperative dialysis, acute respiratory distress syndrome, pulmonary edema, pneumonia, deep vein thrombosis, pulmonary embolism, oxygen requirement, new arrythmias APGAR scores, anemia fatigue scale at 24hr and 48 hrs, OBSQOR10 score 24 hours and 48 hours postpartum and 6 week postpartum EPDS score.


Eligibility Criteria:
Inclusion criteria:

* Women aged 18-55 years.
* Presenting for elective cesarean section.
* With hemoglobin less or equal to 11 mg/dL.
* Able to provide informed written consent.

Exclusion criteria:

* Refusal of blood product administration.
* Refusal of intraoperative blood salvage.
Role of SIRT1 in Regulation of Epithelial-to-mesenchymal Transition in Breast Cancer Lymph Nodes Metastasis

Luminal A breast cancer is a kind of breast cancer with low rate lymph node metastasis and good survival. But in clinical practice, Luminal A breast cancer can present with early, unexpected lymph node metastasis some time, indicates poor survival. Silent information regulator 2 homolog 1 (SIRT1) plays a different role in breast cancer with different molecular typing. Previous study supports a role of SIRT1 protein as tumor suppressor in Luminal A breast cancer, in association with apoptosis-related proteins. The epithelial-to-mesenchymal transition(EMT) process results in loss of cell-cell adhesion, increased cell mobility, and is crucial for enabling the metastasis of cancer cells. But no similar study in Luminal A breast cancer. Hence, this study will 1) investigate the expression pattern of SIRT1 in primary tumor and lymph node metastasis; 2) investigate the different expression pattern of SIRT1 in T2/T3 , lymph node negative tumor and T1, lymph node positive tumor; 3) investigate potential role of SIRT1 enzyme in regulating cell migration and invasion in Luminal A breast cancer cells.

The study has three parts.

1. In large specimens of human Luminal A breast cancer with T1 tumor and positive axillary lymph node, study the difference expression of SIRT1 and related p53, Bcl-2, autophagy-related protein caspase-3, apaf-1 between primary tumor and lymph node metastases. Collect 50 pairs of T1 primary tumors and corresponding metastatic lymph node specimens. Using immunohistochemistry, anti-SIRT1, p53, Bcl-2, caspase-3 and apaf-1 antibody staining to identify the expression of above proteins in the primary tumor and lymph node metastases.
2. Eighty patients with Luminal type A breast cancer (T1N+) were enrolled in this study. At the same time,eighty patients were enrolled in the paraffin-embedded specimens of the patients with T2N+ and T3N+,too. And all patients were followed up. Immunohistochemical staining with anti-SIRT1, p53, Bcl-2, caspase-3, apaf-1, E-cadherin, N-cadherin, Vimentin antibodies to determine the relationship between above protein expression and routine clinicopathological and survival.
3. Explore the involvement of SIRT1 in hormone receptor-positive human breast cancer cells at the cellular level. The molecular mechanism of EMT-related protein regulation, which affects the proliferation, invasion and metastasis of tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer Luminal A subtype T1 and lymph node positive or T2/T3 with negative lymph node

Exclusion Criteria:

* Missing clinical pathology data
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria include but are not limited to:

* Diagnosed with diabetes mellitus
* Macular edema secondary to diabetic retinopathy
* Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria include but are not limited to:

* Any other ocular disease that could compromise vision in the study eye
* Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
* Capsulotomy of the study eye within 30 days prior to study start
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group.

The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
* The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
* The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
* The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.

  * Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
* The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
* The participant was hospitalized for severe asthma in the last 30 days.
* The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.

  * Additional criteria apply, please contact the investigator for more information.
Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.

Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody. Ustekinumab is expensive and primary non-response is high in both CD and psoriasis. Currently, there are no predictors of response to ustekinumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain a better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling ustekinumab. This study aims to gain insight into ustekinumab distribution and concentrations in the gut. The current study aims to identify the ustekinumab target cells in the inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qFME). By gaining insight into local ustekinumab concentrations, drug distribution, and by discovering target cells, we expect to gain insight into the mechanism of action of ustekinumab.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of CD or PsO
* Non-responsive to conventional therapy
* Active disease:

  * CD cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin \> 200 ug/g;
  * PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist;
* Age ≥ 18 years;
* Written informed consent.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
* Prior ustekinumab treatment within the last 15 weeks (except for patients in the treatment arm and control group);
* Ustekinumab contraindicated as therapy;
* Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria

* Participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
* Participants may be inpatients or outpatients
* Participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
* Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) at screening
* Participants who have taken risperidone by the start of investigational treatment and the record can be confirmed Exclusion Criteria
* Participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
* Participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
* Participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
* Participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
* Participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition
Resilience Among Individuals With Opioid Use Disorder

The goal of this clinical trial is to develop a human laboratory model of resilience in people with opioid use disorder (OUD). The investigators aim to learn if objective tasks that measure cognitive, emotional, and control aspects of resilience match up with self-reported resilience during stress and non-stress situations.

This study is an outpatient, within-subject, randomized controlled trial designed to develop and validate a novel laboratory-based model for assessing resilience in individuals with opioid use disorder (OUD). The study employs a dual-condition design where participants complete two experimental sessions administered in a randomized order: one under a stress condition and under a non-stress condition. In each session, participants will perform a series of standardized laboratory tasks aimed at evaluating cognitive, emotional, and control aspects of resilience. Objective measures (e.g., task performance data and physiological indices) and subjective ratings of stress reactivity will be collected to capture both behavioral and self-perceived responses.

Eligibility Criteria:
Inclusion Criteria:

1. Can provide informed consent and can comply with study procedures
2. Adults aged ≥18 years
3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for current opioid use disorder or are currently receiving pharmacotherapy for the treatment of OUD (e.g. methadone or buprenorphine maintenance treatment \[remission\])
4. Urine sample that tests positive for opioids
5. Test negative for pregnancy at screening (females only)

Exclusion Criteria:

1. Being pregnant or breastfeeding
2. Significant mental health or physical disorder, or life circumstances, that is judged by the investigators to interfere with study participation
Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.


Eligibility Criteria:
Inclusion Criteria:

* SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

Exclusion Criteria:

1. Pregnant woman
2. Other pigmentary disorder affecting the face
3. Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion
Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their donor/recipient origin and the correlation of DC reconstitution kinetics with treatment, clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

Blood and skin DC reconstitution shall be investigated in patients affected by hematological diseases and receiving HLA-matched, mobilized peripheral blood stem cells from related or unrelated donors. We plan to simultaneously collect and process double biopsies, i.e. from graft versus host disease affected and non-lesional skin of patients at onset of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. Emigration assay, Chimerism analysis and immunohistochemistry will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing an allogeneic hematopoietic stem cell transplantation
* Older than 18 years
* WHO-Performance-Status 0 to3
* Informed consent
* Graft versus host disease of the skin

Exclusion Criteria:

* Clotting parameters more than double of normal
* Infection of the skin
* Leucocytes \< 1000/µl; Thrombocytes \< 20 000/µl
Local Anesthesia and Pain Perception During an Amniocentesis

This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.

Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Signed consent to participate in the trial
* Women between the ages of 18 and 45 years
* Gestational ages 15 - 24 weeks

Exclusion Criteria:

* Multiple gestation
* Refusal to participate in the trial
* Known hypersensitivity to lidocaine
* Amniocentesis during this pregnancy
* Amnioinfusion/amnioreduction where the procedure is likely to be prolonged
Transmeridian Travel in Elite Female Athletes

The study will investigate whether maintaining a home-based time zone schedule will attenuate any decrements to sleep and performance experienced following transmeridian travel in elite female athletes.


Eligibility Criteria:
Inclusion Criteria:

* Athlete on the roster of an NCAA Division 1 Team
* Has worn WHOOP device for at least 3 months

Exclusion Criteria:

* Musculoskeletal injury or cardiometabolic disease limiting participation in regular team activities
* Pre-diagnosed sleep condition that would negatively affect sleep quantity or quality