cyrilzakka/clinical-trials huggingface dataset:
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns

Globally, type 2 diabetes mellitus (DM) and obesity are considered to be the fastest growing disorders and their prevalence has increased dramatically over the last twenty years.

Recent studies have shown that about 19% of UAE population has been diagnosed with DM and 57% of Emirati patients with type 2 DM are obese.

Optimal glycemic control and weight management involve comprehensive lifestyle approaches including nutrition recommendations and adequate levels of physical activity.

However, recent views have suggested that there are other factors, such as sleep deprivation and stress, contribute to development of type 2 DM.

Taking into account the previous findings, the present study was designed to investigate the effects of a personalized intervention on weight and glycemic control in Emirati patients with type 2 DM. The intervention involves assessment and modification of sleep patterns and stress levels.

The present study is a randomized controlled trial which was conducted at Rashid Centre for Diabetes and Research (RCDR) in Ajman which in one of the seven Emirates of the United Arab Emirates (UAE). The study was approved by the research ethics committee of Al Qassimi Clinical Research Centre, Al Qassimi Hospital (Ministry of Health, UAE).

The study population is comprised of Emirati individuals (n = 51) who attending RCDR diabetes clinics in a quarterly basis (an initial visit and three follow-up visits per annum). The participants were recruited from RCDR diabetes clinics and through different methods including (i) direct contact (ii) distribution of informative flyers and (iii) phone calls using Diamond, an electronic medical database of RCDR patients. The screening process involved 110 Emirati patients with T2DM and 51 individuals were eligible to participate in the present trial based on the following inclusion and exclusion criteria. The inclusion criteria were (i) Age between 18-60 years (ii) Body Mass Index (BMI \> 25 Kg/m2) and (iii) T2DM. The exclusion criteria were (i) Age \< 18 and \> 60 years (ii) BMI \< 25 Kg/m2) (iii) type 1 DM (iv) diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block and (v) heart transplantation.

The eligible participants were randomly allocated into an intervention group (n = 26) and or into a control group (n = 25). Non-compliance was the main obstacle to maintain the same number of the randomized participants in each group and 19% and 24 % of the participants in the intervention and control group, respectively, did not attend the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years
* Body Mass Index (BMI \> 25 Kg/m2)
* T2DM

Exclusion Criteria:

* Age \< 18 and \> 60 years
* BMI \< 25 Kg/m2)
* Type 1 DM
* Diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block heart transplantation
High Resolution, High-speed Multimodal Ophthalmic Imaging

Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye.

The use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea.

The use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. The combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease.

The purpose of this project is to observe structures that are not detectable with routinely used systems.

The goal of the project is the capture and analysis of images with the IMA-MODE systems, in order to evaluate the performance of these systems compared to the existing clinical imaging devices used at the National Hospital of Ophthalmology.

This project should identify the best techniques to image the eye, and select the most promising techniques to evolve towards a possible development of a medical device.

Eligibility Criteria:
Inclusion Criteria:

* People over 18
* Patient with a pathology affecting the eye or healthy volunteer
* Participant who signed the consent
* Beneficiaries of the health insurance

Exclusion Criteria:

* Patients with a history of photosensitivity.
* Patients who have just received a photodynamic therapy treatment (
* Patients taking drugs with photosensitivity as a side effect.
* Persons with pacemakers or other implanted electronic medical device
* Patients with viral conjunctivitis or any other infectious disease.
* Patients with skin lesions on the neck or forehead
* Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
* Pregnant or lactating women
* Participant unable to be followed throughout the study
* Vulnerable people
* Subjects with predisposition to closure of the iridocorneal angle
Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users

This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.

Depression and injection drug use often come hand-in-hand. This is especially true in populations with limited access to mental health care and with a high risk of illness and HIV transmission. Depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of HIV. This cycle has created a significant public health problem. It is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. This study will evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk behaviors in depressed intravenous drug users.

Participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. Participants in the treatment group will meet with a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. Participants in the treatment group may also receive referrals for other services if necessary. Participants assigned to receive no treatment will be contacted at Months 3 and 9 to verify their contact information; they will also receive any necessary referrals. All participants will partake in interviews at baseline and Months 6 and 12 to assess changes in HIV risk behavior and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
* Score of greater than 14 on the Hamilton Rating Scale for Depression
* Current opiate or cocaine use
* History of injection equipment sharing
* English-speaking

Exclusion Criteria:

* History of injection equipment sharing within 6 months of study entry
* Currently at risk for suicide
* Currently experiencing symptoms of psychosis
* Currently taking any other psychotropic medication
* Diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or paranoid disorder
* Informed that treatment with antidepressant medications is medically inadvisable
* Pregnant
St. Jude Medical Angio-Seal VIP Vascular Closure Device

The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access.
2. Patient is of legal age.
3. Patient has given written informed consent for participation prior to the procedure.
4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

1. Patient is unable to provide written informed consent.
2. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements.
3. Patients who are pregnant or lactating.
4. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics

This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records
* Evidence of stability of symptoms for 3 months at screening, that is, without hospitalizations for schizophrenia or increase in level of psychiatric care due to worsening of symptoms of schizophrenia
* Participants with schizophrenia clinical symptom severity defined by the following: hallucinatory behavior item score less than or equal to (\</=) 5 and a delusion item score \</= 5 of the PANSS
* Participants on a stable regimen of antipsychotic therapy for at least 3 months at screening and receiving no more than two antipsychotics

Exclusion Criteria:

* Participants with current DSM-5 diagnosis other than schizophrenia including bipolar disorder, schizoaffective disorder and major depressive disorder
* Clinically significant neurological illness or significant head trauma that affects cognitive function, in the judgment of the principal investigator
* Full scale intelligence quotient \</=65 on the Wechsler Abbreviated Scale of Intelligence at screening
* Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency virus-1 and 2
* Moderate to severe substance use disorder (other than nicotine or caffeine), as defined by the DSM-5, within the last 12 months
* Suicide attempt within 1 year or currently at risk of suicide in the opinion of the Investigator
A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Must have measurable disease as outlined in the protocol.
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: ECOG performance of \<= 1.
* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
* Must be naïve to treatment with ABBV-383.
* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383.

Exclusion Criteria:

* Arm A: Received BCMA-targeted therapy.
* Arm C: Rapidly progressing disease per investigator.
The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients

The dissertation will focus on the possibilities of using pressure sensors during physiotherapy care. A single-blind randomized study will be conducted on a sample of at least 40 probands of working age with chronic LBP in the age range of 30-65 years. The following exclusive criteria are established: signs of serious spinal pathology (red flags), severe musculoskeletal trauma in the last year, vestibular, visual or neurological dysfunction affecting stability, ongoing pregnancy or breastfeeding, acute respiratory disease, cognitive dysfunction leading to misunderstanding of instructions and severe cardiac or internal disease. Inclusive and exclusive criteria will be evaluated by a rehabilitation doctor during a comprehensive examination before the start of therapy. All probands will undergo six-week outpatient therapy once a week. The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week. The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device. Before the start and at the end of the six-week therapy, all probands will be blindly evaluated for the quality of activation and use of intra-abdominal pressure with the DNS Brace device. At the same time, the Oswestry Disability Index questionnaire will be used to subjectively evaluate the probands before and after a series of therapies. The aim of the study is to demonstrate the possibility of using pressure sensors to improve the effect of physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* patient with chronic Low Back Pain
* age range of 30-65 years.

Exclusion Criteria:

* signs of serious spinal pathology (red flags)
* severe musculoskeletal trauma in the last year
* vestibular, visual or neurological dysfunction affecting stability
* ongoing pregnancy or breastfeeding
* acute respiratory disease
* cognitive dysfunction leading to misunderstanding of instructions
* severe cardiac or internal disease
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing

Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate procedure. We sought to compare the effect of ATE with another known source, platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.

The investigators enrolled 24 participants with an indication for skin graft. Two or more split-thickness grafts are harvested per patient, one serving as control and the other as experimental. The experimental sites were covered with either autologous PRP gel or ATE prepared in the OR, which was selected in an unblinded manner due to surgical theater convenience. However, donor sites were randomized through a computer generator. Covered with a semiocclusive film, wounds were separated and followed up on days 3,5,7,10,14 for wound healing and 30 and 60 for scar evaluation. Digital photography and specto-photocutometry was employed to know the hemoglobin and melanin content of the wounds, and custom-made software was used to calculate the percentage of wound re-epithelialization.

Eligibility Criteria:
Inclusion Criteria:

* donor site indication

Exclusion Criteria:

* immunosupressive states
* terminal renal insufficiency
* pregnancy
* coagulation dyscrasias
* active infection in donor site
Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

1. Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately .
2. Is to compare the efficacy of chlorohexidine to povidone iodine.
3. Compare patient comfort after instillation of each disinfectant .
4. To find which disinfectant is more effective tolerated and more safe for use .

Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.

Eligibility Criteria:
Inclusion Criteria:

* Current patient of the Assiute University Hospital arranged for ophthamic surgery
* Age greater than 12.

Exclusion Criteria:

* Documented allergy to PI or AC
* Current diagnosis of infectious keratitis
* History of unilateral contact lens wear in the past 30 days
* Current unilateral use of prescription eye drops.
Prevention of Ovulation Achieved by Single Intra-vaginal Administration of Levogel as Compared to Oral LNG

It has been proposed that levonorgestrel (LNG) in a vaginal gel could be used as an 'on demand' contraceptive when used before coitus. Levonorgestrel was selected as it is a component of many approved oral contraceptive pills and also it is the active agent in Plan B, an FDA-approved regimen for emergency contraception (EC). In previous studies it was demonstrated that an LNG vaginal gel was absorbed and was effective in preventing follicular rupture. The overall proportion of cycles with lack of follicular rupture within 5 days of LNG administration or with ovulatory dysfunction (follicle rupture preceded by an inadequate LH surge) was 96% for LNG gel and 39% in the inert gel cycles (control group).

A dose of 0.75mg of LNG in a vaginal gel was shown to prevent ovulation in a higher percentage than what has been observed with oral LNG at the approved doses for EC of 1.5mg. Results from a study with a1.5 mg LNG oral dose or a single 0 ,75mg dose demonstrated that the proportion of cycles without follicle rupture or ovulatory dysfunction within 5 days was 86% and 79% respectively (Croxatto et al, 2004) , whereas lack of follicular rupture or the presencr of ovulatory dsyfunction was 96% with administration of a LNG gel formulation. In the group of women with follicle size ≥18mm the gel induced 50% ovulation suppression while oral LNG in previous studies blocked only 16% of ovulation in the same follicle size group . These encouraging results could be explained by higher bioavailability of LNG when administered vaginally. This comparison was made using historical data from another study; therefore this study will compare vaginal administration of LNG to oral in a direct cross-over comparative study.

LNG is known to affect the cervical mucus by making it hostile to sperm penetration and its effect may appear after only a few hours following oral administration (Kesseru, 1984; Brache, unpublished observations). Application of LNG gel in the vagina close to the cervical os may exert a direct effect on the cervical mucus. The potential local action of LNG on the cervical mucus may be another important mechanism by which protection is conferred to women who do not experience ovulation suppression.

An "on demand" precoital contraceptive is an attractive alternative to the post-coital emergency contraception currently available, especially due to the higher efficacy of this route of administration on ovulation suppression as compared with oral tablets of LNG. Should the present study confirm the superiority of vaginal administration of half the dose of the oral dose of LNG approved for emergency contraception, further development of that formulation and method would be warranted.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 21-39 years with regular menstrual cycles (25-35 days) and not at risk of pregnancy.

Exclusion Criteria:

* All contraindications to the use of progestins
Chronic Lymphoid Leukaemia Observatory in Finistere Area, France

Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
* Willing and able to provide informed consent
* Willing and able to provide blood sample at time of enrollment

Exclusion Criteria:

* Diagnosis of other B-cell malignancies
Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)

The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Less than 50 years of age.
* Other protocol-defined exclusion criteria may apply.