cyrilzakka/clinical-trials huggingface dataset:
Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

Family members are often shocked and devastated by the death of their loved one, especially when it is sudden and unexpected. On the scene, families often don't really believe it happened because they didn't have time to absorb the fact of their loss. They hear the words and explanation given by the prehospital emergency medical services (EMS) team, but do not comprehend the full impact. Emotions seem frozen. They feel disoriented, restless, stunned and unable to think.

Most often, after cardiac arrest resuscitation attempt, the prehospital EMS team leaves the scene, letting the family without any further medical bond and support. Families are left alone facing this tragedy. After a while, families need medical counseling trying to understand what happens and why but they don't know who to consult. Instead, they remain without medical explanation or guidance with the fear regarding their own future, in particular, regarding the risk of dying from sudden death. This fear may be based on the knowledge of the eventuality of familial diseases increasing the risk of sudden death, or simply on a mechanism of identification with the deceased.

One important factor credited by experts is to encourage first-degree family members to seek sudden death counselling. However, the literature concerning this problem lacks of reliable data.

The aim of this clinical trial is to evaluate the psychological consequences of a sudden death counselling on family member after a relative's sudden death compared to the usual family management.

This study will compare the percentage of depression in a group of family members after a relative's sudden death for whom a sudden death counselling has been proposed by the prehospital medical team versus a group for whom the medical team has not modified its usual strategy.

Eligibility Criteria:
Inclusion Criteria:

A first-degree relative of a:

* patient aged 18-75 years
* with an out-of-hospital sudden death\*
* and cardiopulmonary resuscitation attempted Relative aged ≥ 18 years Given consent for the study. Sudden death definition\*: An unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms).

Exclusion Criteria:

Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C5-T12).
3. Classification ASIA A with no significant further improvement.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

1. A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms

This study evaluates the effects of combination probiotic, prebiotic, and enzyme supplementation on the colonic microbiome of individuals with GI symptoms (e.g. diarrhea, constipation, increased gas). Half of the participants will receive the placebo while the other half will receive the supplement for 28 days.

The purpose of this research is to identify if there is a relationship between GlutenShield, a combination prebiotic, probiotic, and enzyme supplement, and the gut environment.

The study will be a split, 28-day randomized, partially blinded design. Subjects will be randomly assigned to one of two groups. One group will complete a 28-day treatment period with GlutenShield taken 3x/day with meals. The other group will complete a 28-day placebo period with the placebo taken 3x/day with meals. The placebo will contain Avicel (cellulose) and bentonite powder (to have a similar color as GlutenShield). Participants will be blinded to which group/ treatment they are being given. Serum and fecal samples will be collected at baseline and on day 29. Participants will also complete a gastrointestinal symptoms questionnaire, a food frequency questionnaire and a psychosocial measures of self questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who express gastrointestinal symptoms more than three times per week as identified through the Gastrointestinal Symptom Questionnaire (such as abdominal pain/ discomfort, heartburn, acid regurgitation, bloating, nausea and vomiting, abdominal distention, eructation (burping), increased gas, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation, or feeling of incomplete evacuation)
* Healthy with few health complications
* Adults ages 18 or older

Exclusion Criteria:

* Anyone under the age of 18
* Individuals diagnosed with celiacs, IBS, Crohn's disease, ulcerative colitis, or short bowel syndrome
* Individuals who have previously taken GlutenShield
* Individuals who are currently taking prebiotics, probiotics, enzymes, non-steroidal anti-inflammatory drugs, fish oil, and/or fiber supplements (unless use is halted in the voluntary 2-week washout period prior to the study)
* Individuals who are pregnant or intend to become pregnant during the duration of the study
Combination Of PAXIL Tablet And Benzodiazepines

This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).


Eligibility Criteria:
Inclusion criteria:

* Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria.
* Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D.
* Patients who have continuously received Benzodiazepine anxiolytics.

Exclusion criteria:

* Patients with a strong suicide tendency.
Mobile Food Market Cluster Randomized Trial

Mobile food markets have been proposed as a strategy for mitigating health disparities related to poor nutrition and diet/weight-related health conditions because they bring low-cost, healthy food directly to underserved populations. Full-service mobile markets may improve multiple aspects of the diet by providing foods to meet all dietary needs through a convenient one-stop shop. The full-service mobile market to be tested (Twin Cities Mobile Market) sells nutritious and staple foods from a bus that regularly visits low-income neighborhoods. Foods are sold at prices \~10% below those of grocery stores. SNAP/EBT is accepted, and a state-funded fruit/vegetable incentive program (Market Bucks) is available to shoppers. Working in partnership with our community team members, we will enroll 12 total sites and recruit 22 participants per site (N=264). We will collect baseline data and randomize sites to either receive the full-service mobile market intervention or serve as the waitlist control. We will then implement the full-service mobile market at intervention sites, follow participants for 6 months, and collect follow-up data. After follow-up data collection, waitlist control sites will receive the full-service mobile market intervention. Diet quality will be assessed through dietary recall interviews, food insecurity will be assessed by survey, and fruit and vegetable purchases will be measured by collecting one month of food purchase tracking forms at baseline and follow-up data collection. Analyses will determine whether the full-service mobile market changes diet quality, food security, and food purchasing outcomes.


Eligibility Criteria:
Inclusion Criteria:

Community sites (e.g., public housing hi-rise, low-income senior living residence) must meet the following criteria:

* locale for low-income populations that experience difficulty in accessing healthy, affordable foods (e.g., public housing residences; low-income senior housing) or a community center in a low-income, low-food access (0.5 mile) census tract;
* willingness to be randomized to the intervention or waitlist control;
* located over 0.5 miles apart from other trial sites;
* willingness to allow for recruitment and data collection to occur in onsite community rooms

Participants must meet the following criteria:

* being aged 18 years or older;
* identifying as the primary food shopper in their household;
* being able to speak English or ASL;
* living within a half mile of the community site location; and
* reporting to be likely or somewhat likely to shop at the market in response to: "how likely would you be to shop regularly at the Twin Cities Mobile Market if it came to your neighborhood each week (response options: likely to unlikely).
* willing and able to participate in all study data collection activities

Exclusion Criteria:

* planning to move in the next 12 months
* currently shopping at the mobile market
* not having a phone number or mailing address
* presence of a condition or abnormality that would prohibit participation in the study or the quality of the data
Big Data Supporting Public Health Hearing Policies

Hearing Loss (HL) affects over 5% of the world's population (WHO 2014) and is the 5th leading cause of Years Lived with Disability. HL is currently managed with Hearing Aids (HAs), i.e. programmable sound amplification devices that are worn by the hearing impaired subjects to address their hearing difficulties. HA use however is often problematic, costly and with poor overall benefits. The holistic management of HL requires appropriate public health policies for HL prevention, early diagnosis, long-term treatment and rehabilitation; detection and prevention of cognitive decline; and socioeconomic inclusion of HL patients. Currently the evidential basis for forming such policies is limited.

The EVOTION project proposes to address this by collecting and analysing a big set of heterogeneous data, including HA usage, audiological, physiological, cognitive, clinical and medication, personal, behavioural, life style, occupational and environmental data.

This will be done by:

i. accessing big datasets of existing HA user data from the EVOTION clinical partners (UCL/UCLH and GST in the UK; OTICON in Denmark) ii. collection of prospective HA user data who will be recruited to the prospective EVOTION study and who will undergo some additional assessments iii. collection of real time dynamic data of the human participant HA users who will be given a smart phone with different apps (auditory tests; auditory training), sensors (recording of heart rate, blood pressure, respiratory rate etc.) and smart HAs (recording environmental factors such as noise levels, type of noise etc.) so that real life contextual factors that affect HA usage and outcome can be identified.

These data will be analysed with big data analysis/data mining techniques in order to identify relationships between these in order to use this information to derive and support public health decisions.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Basic understanding of oral and written English
* Unilateral and/or bilateral mild to severe sensorineural hearing loss
* Willing to use smart hearing aids for at least 2 hours daily on average
* Willing/capable to use a mobile phone

Exclusion Criteria:

* Dementia (MoCA\<22 )
* Not agreeing or able to attend for f/u appointments
* Not agreeing or able to use HA \>2 hours daily (average)
* Not sufficient vision to use smartphone ap
A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18 to 65 years, inclusive.
* Body mass index (BMI) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at Screening.
* No clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the Investigator.
* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception, willing and able to comply with the study requirements and to provide written informed consent.
* For Japanese cohorts, subjects of Japanese descent are defined as people carrying a Japanese passport, descendants of 4 Japanese grandparents, and have not been outside Japan for more than 5 years.

Exclusion Criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, and other inflammatory diseases, or dermatological or connective tissue diseases or disorders.
* Active serious mental illness or psychiatric disorder.
* Clinically significant ECG abnormalities. Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant.
* Known history of allergic reaction to an oligonucleotide or GalNAc.
* History of intolerance to subcutaneous injection.
Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.

Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.

Eligibility Criteria:
Inclusion Criteria:

* Wagner classification DFU 2;
* age 40-60 years;
* mild to moderate diabetic neuropathy;
* ABI\>0.7
* wound surface area\>1.5cm2

Exclusion Criteria:

* fracture in a lower limb,
* a severe infection,
* a malignancy,
* kidney failure,
* skin diseases,
* osteomyelitis,
* pregnancy,
Benchmarking Intra-tumor Heterogeneity In Ovarian Cancer: Linking In-vivo Imaging Phenotypes With Histology And Genomics

The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging \[MRI\] and Positron Emission Tomography \[PET\] scans. No direct clinical benefits will come from the results of this study.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age on the day of signing the informed consent.
* Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer.
* Scheduled to undergo primary debulking surgery.

Exclusion Criteria:

* Pregnant patients
* Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of ovarian cancer cannot give valid informed consent
* Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
* Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/
* Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
* Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
* Stage not greater than IB
* No more than superficial myometrial invasion
* No vascular or lymphatic invasion
* No poorly differentiated subtypes, including serous, clear cell, or other FIGO Grade 3 lesions.
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. Patients may have received prior adjuvant chemotherapy for breast cancer.
* With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excluded.
* Unresolved bowel obstruction.
* History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study.
* Absence of target lesions (\> 2.0 cm) on staging CT
* Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places \[i.e. falciform ligament or porta hepatis\], suprarenal retroperitoneal lymphadenopathy)
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.

This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 22 years)
* Self-report of daytime somnolence
* Body mass index (BMI) ≤ 32
* Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
* Evidence of palate and tongue base collapse on supine fiberoptic examination
* Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (\< 4 hours per night by patient report)
* No prior surgical treatment for OSAS other than nasal surgery
* Willing and capable of providing informed consent

Exclusion Criteria:

* Another significant sleep disorder (e.g., insomnia, periodic limb movement)
* Tonsillar hypertrophy
* Chronic Obstructive Pulmonary Disease (COPD)
* Interstitial Lung Disease (ILD)
* Cystic Fibrosis
* Acute Repiratory Distress Syndrome (ARDS)
* Nasal or supraglottic obstruction on fiberoptic examination
* American Society of Anesthesiologists (ASA) class III ,IV, V
* Latex allergy
* Lidocaine allergy
* Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.
* Major depression or non-stabilized psychiatric disorder
* Drug or alcohol abuse
* Previous palatal or tongue surgery
* Stable or unstable angina
* congestive heart failure (CHF)
* moderate or severe valvular disease
* transient ischemic attack (TIA)/cardiovascular accident (CVA)
* Carotid stenosis or endarterectomy
* Anemia
* Room air oxygen saturation (SpO2) \< 95%
* Pulmonary hypertension
* Dialysis
* Central or mixed apnea ≥ 10% of respiratory events
* Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study
Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

Exclusion Criteria:

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.