cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the Treatment of Post-Traumatic Stress Disorder: A Randomized Controlled Trial

This randomized controlled trial aims to compare the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Post-Traumatic Stress Disorder (PTSD). Adult patients diagnosed with PTSD will be randomly assigned to receive either EMDR therapy or SSRIs for a period of six weeks. The primary outcome is the rate of remission as measured by validated PTSD symptom severity scales at Week 6. Secondary outcomes include changes in functional impairment and patient-reported quality of life. The study seeks to determine whether EMDR therapy is a non-pharmacological alternative to SSRIs for achieving symptom remission in PTSD.


Eligibility Criteria:
Inclusion Criteria:

Age 18-60 years Clinical diagnosis of Post-Traumatic Stress Disorder (PTSD) Duration of illness ≥ 6 months Able to provide informed consent

Exclusion Criteria:

Current substance abuse or dependence History of psychotic disorder or bipolar disorder Active suicidal ideation Concurrent psychotherapy or psychiatric medication (except study-assigned SSRI)
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.

NAFLD is a poorly understood disease which may cause an enlarged liver, abnormal liver test results, and scarring of the liver. It may occur more often in people with obesity, high levels of cholesterol (blood fats), diabetes (high blood sugar), or the insulin resistance syndrome (where a person's body does not respond to the hormone insulin which helps keep blood sugar levels normal). Currently, no effective drug treatment for NAFLD exists. There is increasing evidence that NAFLD may be a condition due to a problem with metabolism (the way your body uses energy). Previous studies have shown that high glucose (sugar) levels may play an important role in the development of fatty liver disease. Medications that decrease your natural glucose level may reduce the amount of fat in the liver and, therefore, might be useful in the treatment of NAFLD. Metformin, a drug approved by the U.S. Food and Drug Administration (FDA) for use in patients with diabetes, has been shown to improve fatty liver in animals and in a small number of human beings.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven NAFLD, determined within 12 months of study initiation

Exclusion Criteria:

* \> 20 grams of alcohol/day
* impaired oral glucose tolerance test
* known diagnosis of diabetes mellitus
* hepatitis C infection
* cirrhosis
Music for Health Project

The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural areas. The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide. If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.

The project has two primary aims and one exploratory aim. 1.0 Revise and adapt the Live Network (LN) program and manual for rural persons living with HIV/AIDS (PLWHA) and develop into a mobile application.

2.0 Conduct a randomized controlled trial to test the efficacy of the program. When compared with an educational music control condition at 3, 6, and 9 months post-baseline, those randomized to the LN will have: H1: Significantly higher mean antiretroviral therapy (ART) adherence rates (measured by pill counts, self report).

H2: Significantly higher mean levels of ART drug levels in hair sample analyses.

H3: Significantly better clinical indicators: higher mean CD4 lymphocyte counts and percents, a larger proportion achieving virologic suppression (proportion with HIV RNA PCR \<50 copies/ml), and smaller proportion with evidence of drug resistance, all as measured by medical record review.

3.0 Explore: a) the effects of LN on symptoms and symptom management; b) the roles of self-efficacy, outcome expectancies, and personal goal setting as mediators, and depression and health literacy as moderators of adherence.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ individuals initiating ART for the first time (except women who may have had ART during pregnancy); or HIV+ individuals changing ART regimen within the past 3 months due to side effects or virologic resistance; or HIV+ individuals with a detectable viral load ≥ 40copies/ml; or HIV+ individuals on ART medication
* English speaking
* Willing to complete 4 assessments
* Willing to complete monthly, unannounced pill counts
* Willing to allow collection of hair samples
* Willing to be randomly assigned to either condition
* Willing to participate in study activities that include using smart phone and mobile app

Exclusion Criteria:

* Have a history of bilateral hearing loss (health care provider diagnosed or self-identified)
* Homeless
* Have a cognitive impairment (inability to comprehend the informed consent)
* Display psychotic symptoms, as determined by the Brief Symptom Inventory (BSI)
Adjuvant Radiotherapy in High Risk Locally Advanced DTC

This study is a phase III randomized controlled clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.


Eligibility Criteria:
Inclusion Criteria:

1. The patient voluntarily joined this study and signed an informed consent form;
2. Age: ≥ 14 years old,\<80 years old, male or female not limited;
3. Histopathological diagnosis of differentiated thyroid cancer;
4. Surgical total or near total thyroidectomy;
5. The surgery did not achieve R0 resection, and R1/ R2 resection was performed. The volume of residual tumor in R2 resected patients is less than 2cm3;
6. The main organ functions are normal;
7. Good compliance and cooperation with follow-up.

Exclusion Criteria:

1. Previously received radiation therapy for the head and neck area;
2. Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
3. There is distant metastasis;
4. Previously received 131I treatment;
5. Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
6. Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group;
7. Pregnant or lactating women;
8. Other physical illnesses that affect patients' ability to receive standard treatment;
9. According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data;
10. Individuals with claustrophobia who are unable to undergo radiation therapy;
11. Patients deemed unsuitable for inclusion by other attending physicians.
Colchicine in ST-elevation Myocardial Infarction

* There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction
* The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction


Eligibility Criteria:
Inclusion Criteria:

The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation \>1 mm in two contiguous limb leads or ST segment elevation \>2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.

Excluded patients:

* \> 80 years old
* with active inflammatory diseases, infectious diseases or known malignancy
* under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
* with known hypersensitivity-allergy to colchicine
* under chronic treatment with colchicine
* with severe renal failure (eGFR \< 30 ml/min/1.73 m2)
* with hepatic failure (Child - Pugh class B or C)
* presenting with cardiac arrest
* presenting with ventricular fibrillation
* presenting with cardiogenic shock
* with stent thrombosis
* with angina within 48 hours before infarction
* with previous myocardial infarction
* with occlusion of the left main or left circumflex coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
* with metallic implants (ferromagnetic material)
BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).

Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.


Eligibility Criteria:
Inclusion criteria:

1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
2. Indication for a treatment with platinum therapy as judged by the investigator
3. Age 18 years or older
4. Written informed consent consistent with ICH-GCP and local legislation
5. ECOG performance score lower or equal 2
6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)

Exclusion criteria:

1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
2. Pregnancy or breastfeeding
3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
5. Second malignancy currently requiring another anti-cancer therapy
6. ANC less than 1500 / mm3
7. Platelet count less than 100 000 / mm3
8. Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
10. Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent) or creatinine clearance \<70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
12. Pre-existing clinically relevant hearing loss
13. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial
15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
16. Patients unable to comply with the protocol
17. Active alcohol or drug abuse
Electroretinogram in Autistic Spectrum Disorders

This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG) b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition which becomes apparent as children grow. Children with ASD are slow to develop language and have problems interacting socially with others. It is not clear why ASD occurs, but there is some evidence that the signals that tell the brain how to grow are altered which causes the brain to develop and function differently in people with ASD. Eyes develop from the same embryonic tissue as the brain. This means that the retina, which is the light sensitive layer at the back of the eye, shares the same signals as the brain. Investigators can listen to retinal signals outside the eye and the retina can, in this way, act as an accessible part of the brain.

The investigators will detect retinal signals as electrical messages. Sensors placed near the eye pick up the electrical changes in the retina each time a light flashes. This non-invasive, routine clinical test is called an electroretinogram, (ERG). The investigators have carried out a study that showed differences in the ERGs recorded from adults with ASD compared to control participants.

The main aim of this project is find out how common ERG differences are in children with ASD compared to controls. If it is common, investigators could use the ERG to make an earlier diagnosis of ASD and help families sooner. It could help investigators better understand the way the ASD brain signals and give investigators a way of measuring if therapies work.

Eligibility Criteria:
Inclusion Criteria:

* cohort 1: individuals with diagnosis ASD with an IQ measure exceeding 85
* cohort 2: typically developed controls without diagnosis of ASD

Exclusion Criteria:

* a history of eye disease or treatment or seizure medicines that may alter retinal function
Omega-3 and Blueberry Supplementation in Age-Related Cognitive Decline

The aim of this study is to determine the efficacy of 6 months' dietary supplementation with omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older adults. The effects of each of these interventions alone will also be assessed in order to determine whether the combined treatment confers synergistic or additive benefit relative to the effect of each therapy.

After meeting inclusion criteria, one hundred-forty men and women, aged 62 to 80 years old, will be enrolled and randomly assigned to one of four groups: 1) omega-3 fatty acid and blueberry powder supplement, 2) omega-3 fatty acid and placebo powder, 3) placebo oil and blueberry powder supplement, or 4) placebo oil and placebo powder. They will participate in a 24-week intervention with major assessments including neuropsychological and functional evaluation at pre-treatment baseline and during the final week of the intervention. In addition, an interim evaluation of neurocognitive function will be conducted at 12 weeks. Subjects will be asked to maintain diet diaries for three periods during the study. Mood will be assessed as a potential covariate of the neurobehavioral outcome measures and data on red blood cell fatty acid content, metabolic parameters, inflammation, and anthropometric factors will be gathered to assess compliance and explore individual differences in response to the intervention and to evaluate potential mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged 62 to 80 years and older
* age-associated decline operationalized as Clinical Dementia Rating = 0, Auditory Verbal Learning Test cumulative acquisition score between 1.0 standard deviation below and 1.0 standard deviation above the age-corrected mean or Montreal Cognitive Assessment score greater than 25, and Geriatric Depression Scale score less than 16
* ability to comprehend and comply with the research protocol
* provision of written informed consent.

Exclusion Criteria:

* established dementia or neurological disorder including but not limited to probable Alzheimer's Disease, Parkinson's Disease, Frontotemporal dementia, multi-infarct dementia, and leukoencephalopathy
* current or past severe psychiatric disorder such as psychosis or major mood disorder requiring hospitalization and/or causing a change in level of occupational or social functioning
* current or past alcohol or drug abuse disorder causing physiological dependence or change in functional capability (nicotine dependence is permitted)
* diagnosis of diabetes or other metabolic disorder or kidney or liver disease
* use of medication that might affect outcome measures or interact with omega 3 fatty acid supplements such as benzodiazepines, aspirin, and serotonin reuptake inhibitors
* hematological coagulation disorder
* allergy to shellfish or seafood; 8) current supplementation with fish oil or consumption of fish more than once per week.
Somatosensory Evoked Potential (SSEP) Monitoring for Detection of Intraoperative Positional Neuropraxia

PNI (Peripheral Nerve Injury) occurs in 5-15% of patients in cardiac surgery. So far, the mechanism of injury has never been researched. In this study, we will compare minimally invasive cardiac surgery with conventional cardiac surgery using a novel portable SSEP device to pinpoint the mechanism and timing of PNI during cardiac surgery.

General objectives The general objective of this study is to identify the causative insults during various kinds of cardiac surgeries. To attain this objective, we have three specific aims. Firstly, surgical insults such as excessive or asymmetric sternal retraction have long been regarded as the main causes of PNI. Therefore, we will investigate this by comparing cardiac surgeries with sternotomy to the ones without sternotomy. Secondly, more and more cardiac surgeons utilize minimally invasive techniques these days. In the current study, we will investigate the incidence, mechanisms and patterns of PNI in minimally invasive cardiac surgeries by comparing conventional surgeries to minimally invasive surgeries. Thirdly, recent studies have suggested systematic insults such as ischemia, inflammation, and underlying neuropathy might play more prominent roles in the mechanism of PNI. In this study, we will analyze various factors such as intraoperative hemodynamics and baseline patient characteristics to pinpoint the most responsible factors.

Background The studies regarding mechanisms of PNI in cardiac surgeries have not been done over the past few decades. With respect to minimally invasive cardiac surgeries, no studies have been done to investigate the mechanism of PNI.

Regarding the device used in this study The conventional SSEP device is large in size, invasive, and requires expertise to interpret. These characteristics have prevented its use in the operating room. This new portable SSEP device is devoid of these properties.

Significance Identification of causative insults will help clinicians to recognize and possibly prevent PNI during cardiac surgeries.

Eligibility Criteria:
Inclusion Criteria:

●all adult (age\>18, \<95 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG

Exclusion Criteria:

* any patients with contraindication to SSEP monitoring, which include skin burns or trauma at SSEP electrode sites
* lack of written consent
* emergency surgery
* language barrier
* fluctuating neurological signs/symptoms
* regional anesthesia (spinal, epidural, nerve block)
* CABG with radial artery harvest, combined cardiac surgeries
Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years old.
* Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
* Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
* Healthy ASA type I and II patients.
* Full-mouth plaque index \<20.

Exclusion Criteria:

* Smokers ≥10 cigarettes/day.
* Presence of implant-supported restorations adjacent to the study site.
* Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
* Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
* Uncontrolled diabetes.
* Severe bruxism.
* Pregnancy.
* Previous history of radiotherapy.
Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis

Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus biweekly support meetings with research personnel via phone or video. Questionnaires will be used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition, adherence, and safety information will also be collected. This study is significant because addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological options for improving sleep quality and MS symptoms in individuals with MS. This study is innovative because CBT-I has never been delivered via a web-based application to individuals with MS which may increase access to services.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* diagnosis of MS by physician
* report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months
* ≥10 on Insomnia Severity Index (ISI)
* English speaking
* reports access to internet service and phone
* has a high school diploma to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study.

Exclusion Criteria:

* known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>3 on STOP BANG indicating risk of sleep apnea
* increased risk of restless leg syndrome
* nervous system disorder other than MS
* relapse and/or corticosteroid use in past 8 weeks
* score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* performs shift-work.