cyrilzakka/clinical-trials huggingface dataset:
Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis

This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.

Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.

Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication.

This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting MS
* Diagnosis of depressive disorder
* Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Score of 25 or greater on the Mini-Mental State Examination (MMSE)
* Currently taking antidepressant medication for at least 3 months prior to study entry

Exclusion Criteria:

* Currently taking fatty acid supplements
* Consume more than 6 oz of fish per week within 1 month prior to study entry
* Severe depression
* Suicidal thoughts
* Other psychological disorders
* Currently taking more than two types of antidepressants
* Any serious medical condition that would interfere with the study
* Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry
* Current enrollment in another fish oil study
* Pregnancy
Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility Criteria:
Inclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):

* Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
* Subjects who agree to participate in the study.

Inclusion Criteria -Pathologic Adults (29-80 years old)

* Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
* Subjects who agree to participate in the study;
* At least one eye with any of the following conditions:

  * History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy;
  * History of corneal transplant;
  * Physical injury or trauma to the cornea;
  * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies)
  * Keratoconus;
  * Long term PMMA contact lens use (greater than 3 years).

Exclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)

* History of corneal transplant;
* Long term Fuch's dystrophy (and other corneal endothelial dystrophies);
* Keratoconus;
* Guttata;
* Diabetes mellitus type I or type II;
* History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
* All contact lens wearers;
* Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.

Exclusion Criteria -Pathologic Adults (29-80 years old):

* Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye.
Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.


Eligibility Criteria:
Inclusion Criteria:

1. Registered in I-Pledge and has not started the Isotretinoin medication
2. Females and males ages 12-21 years old
3. Able to undergo 3 MRI scan

Exclusion Criteria:

1. Participants taking additional vitamin A, D or Calcium supplements
2. Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc)
3. Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease
4. relocation within the next 6 months
5. participation on a research study involving drug medication within the past 30 days
Ezopiclone Improves the Quality of Overnight Polysomnography

Patients often have difficulty sleeping during overnight sleep testing in a lab environment. The purpose of this study is to determine if taking a sleep aid will improve sleep and therefore the quality of the sleep study.

The increasing awareness of sleep-disordered breathing (i.e obstructive sleep apnea) has created a growing demand for polysomnography (sleep study), resulting in excessive waiting times in many laboratories. Sleep centers have therefore needed to develop methods to improve their efficiency. Unfortunately many patients find it difficult to fall asleep in the unfamiliar environment of a laboratory setting (the "first-night effect"), circumstances that may prolong falling alseep and staying sleep. Likewise, intolerance of continuous positive airway pressure (CPAP) may also reduce the quality of the sleep study. Poor quality studies may lead to an inability to make a diagnosis or adequately titrate CPAP therapy. Unsatisfactory studies may need to be repeated.

Sleep aids (hypnotics) are commonly used to treat both acute and chronic insomnia. These agents have minimal side-effects and do not disrupt normal sleep architecture or alter respiratory events. These attributes make such agents ideal for use to improve the quality of sleep studies and enhance the efficiency of sleep centers.

In a recent retrospective review, we found that the use of a hypnotic prior to the sleep study resulted improved patient satisfaction and improved quality of the sleep study with significantly less studies needing to be repeated. Although promising, these results must be validated with a prospective, randomized, placebo-controlled trial.

Eszopiclone (Lunesta) is a new non-narcotic, non-benzodiazepine hypnotic agent which received FDA approval on December 15, 2004 for the treatment of acute and chronic insomnia. Multiple clinical trials have found that eszopiclone decreases sleep latency, improves sleep efficiency/maintenance and reduces wake time after sleep onset (WASO). Given its efficacy in promoting sleep onset and sleep maintenance and its excellent safety profile, this agent should be ideal as a pre-study sedative. The purpose of this study is to validate the use of Lunesta in improving the quality of overnight sleep studies.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aged 18-65, evaluated by a sleep medicine provider in the Walter Reed Army Medical Center Sleep Disorders Clinic, who are referred for PSG for suspected Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

* Pregnancy
* Liver dysfunction or history of EtOH abuse
* Concomitant use of benzodiazepines, narcotics or ketozonazole
* Decompensated CHF
* CVA within 3 months
* Uncontrolled psychiatric disorders
* Patients \< 18 years old
* Patients over 65
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* primary refractory or relapsed AML
* confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
* aged at least 18 years

Exclusion Criteria:

* initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
* patient in blast crisis stage of chronic myeloid leukemia
* received high-dose cytarabine (total cumulative dose of \>6g/m sq)in last 6 months
* interval of \<6 months between first onset of last complete remission and current relapse
* those with primary refractory leukemia who have received more than three previous induction cycles
* relapsed patients who have received more than three previous treatment regimens
The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes

It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* 40 years and older
* Diagnosed with type 2 DM at least 1 year ago
* Treated at the hospital where the study will be conducted
* Using antidiabetic agents
* No communication problem
* Contactable by phone

Exclusion Criteria:

* Those who do not meet the inclusion criteria for the study
* Participants who did not give consent at any stage of the study and left
Cognitive - Behavioral Therapy

The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia.

This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.

Eligibility Criteria:
Inclusion Criteria:

Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:
Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.

The patient will receive treatment arm A or B :

Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.

20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer subjects over 18 years old
* Having signed a free and informed consent
* Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
* Having an antidepressant treatment not modified since 3 weeks
* Score to MADRS scale ≥ 21
* Subject affiliated to a social security regimen

Exclusion Criteria:

* Depression with psychotic caracteristics
* Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
* Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
* Patient hospitalized under duress or under legal protection (guardianship, curatorship)
* Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization.
* Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
* Pregnancy
* Simultaneous participation to another interventionnal study
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device

Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University

Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.

Materials \& Methods: Ten patients with displaced root in maxillary sinus will be included in this study.

surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.

Preoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.

Eligibility Criteria:
Inclusion Criteria:

root displaced in maxillary sinus absence of infection

Exclusion Criteria:

* • patients taking medications that affect bone healing
* patients underwent head and neck radiotherapy
Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

Eligibility Criteria:
Inclusion criteria:

* Male and female aged \> 18 years
* TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
* Implants placed in both arches
* Patients with gingivitis or treated periodontitis (i.e., absence of residual PD \> 5 mm)
* Presence of at least 2 mm of keratinized mucosa at implant sites.

Exclusion criteria:

* presence of medical conditions contraindicating treatment of peri-implant mucositis,
* regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment

  * Presence of systemic diseases
  * Pregnant and lactating females
  * Smokers \> 10 cigarettes/day
  * Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  * Implants with modified (i.e. micro-rough) necks
  * Interproximal open contacts between implant restoration and adjacent teeth
  * Peri-implantitis (Renvert, et al., 2018)
LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable HCC (PARIS Registry)

The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.

Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the eight in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries.

Available treatment options depend on the size, number, and location of tumors; degree of cirrhosis, if present; and comorbidities; overall performance status; patency of portal vein; and presence of metastatic disease. They include surgical (liver resection, liver transplantation), medical (e.g. sorafenib...), ablative (ethanol ablation, radiofrequency ablation, cryoablation) and intra-arterial (chemoembolization, radioembolization) modalities.

Trans Arterial Chemo-Embolization (TACE) with various drugs (anthracyclines being among the most commonly used ones) has been an important therapeutic option for treatment of patients with intermediate stage HCC according to BCLC/EORTC guidelines (REF). In order to maximize therapeutic efficacy of TACE, chemotherapy loadable beads were developed allowing to lower systemic toxicity of chemotherapy, to deliver high and sustained chemotherapy concentration to the tumor, and to prolong delivery of drug and embolization to the tumor.

The purpose of this registry is to evaluate liver and systemic toxicity, treatment efficacy, and safety of Drug Elutable Beads -TACE using anthracyclin loaded Life-Pearls -TACE for unresectable hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients, more than 18 years old, with unresectable hepatocellular carcinoma eligible for treatment with anthracyclin loaded LifePearls, allocated to TACE treatment at multidisciplinary tumor board and who agree to data collection in the registry by signing informed consent form.

Exclusion Criteria:

* This is an observational registry and there are no exclusion criteria apart from patient refusal.
Exercise Timing and Gestational Diabetes

The aim of this study is to understand if the timing of exercise around food intake can help improve blood sugar management in pregnant individuals with diabetes.

Between 3 - 20% of women develop gestational diabetes mellitus (GDM) during pregnancy, a condition in which blood sugar control is poor and can have serious health effects for both mom and baby. Women with GDM are at elevated risk of developing dangerously high blood pressure during pregnancy and type 2 diabetes later in life. GDM also puts the baby at an increased risk of excessive birth weight, low blood sugar at birth, and future risk of type 2 diabetes.

The 2019 Canadian Guideline for Physical Activity throughout Pregnancy recommends that women be physically active for at least 150 minutes spread over at least 3 days each week. Managing high blood sugars with exercise improves outcomes for mom and baby; however, optimal timing of exercise has not been investigated.

The goal of this study is to determine if exercising after meals in shorter bouts is more effective at controlling post-meal blood sugars than exercising in larger amounts between meals.

This is a fully remote study; participants will receive all necessary equipment in the mail and all interactions with the researcher will be done via phone, video call and email.

The study will recruit 30 pregnant women diagnosed (or not) with diabetes (gestational, pre-, or type 2 diabetes mellitus) after 20 weeks' gestation to participate in this 2-week study. Following a 2 day baseline period, they will be randomly assigned to: 1) walk for 10 minutes after each meal (SHORT), or 2) walk for 30 minutes once per day at any time except in the hour after eating (LONG) for 5 days. Following a 2- day washout period, women will then complete the alternative exercise protocol for an additional 5 days. Women will wear a Continuous Glucose Monitor to track blood sugars, and an accelerometer to track activity patterns (e.g., compliance to the intervention) for seven consecutive days. The Investigators hypothesize that women who walk for 10 minutes after each meal will have a blunted rise in blood sugar following food intake, compared to the women in the 30- minute walking group. Findings from this novel study may help better treat GDM, improving lifelong health for moms and babies around the world.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* singleton pregnancies
* healthy pregnant individuals or diagnosed with gestational, pre- or Type 2 diabetes

Exclusion Criteria:

* less than 18 years of age
* presents with contraindications to prenatal exercise (e.g., preeclampsia)
* multiple pregnancies (i.e. twins, triplets etc.)
* currently taking Metformin