cyrilzakka/clinical-trials huggingface dataset:
Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)

Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been partially evaluated and would increase the risk of progression to dementia. These classical data are based on non-standardized assessments and non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a standardized assessment tool for behavioural dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Support to the consultation memory for a neurological disease ( frontotemporal dementia , vascular dementia , Alzheimer's disease , mild cognitive disorder, Huntington's disease ( with genetic diagnosis confirmed : number of CAG triplets \> 36 symptomatic : UHDRS score ≥5 ) with MMS \> 15
* Age 40 to 85 years
* French
* Informing reliable
* Agreeing to participate in the study.

Exclusion Criteria:

* Presence of other disease disturbing behavior ( current depressive syndrome , schizophrenia, psychosis , past psychiatric disorders requiring a stay \> 2 days in a specialized environment ) or cognition (mental retardation , illiteracy , respiratory failure, kidney , liver , heart ) or preventing the realization of the tests ( perceptual or motor deficit ) intrecérébrale pacing therapy or stem cell transplant , patient protected ( under supervision or guardianship ) , pregnant and / or breastfeeding and lack of consent
Study to Compare Different Formulations of AZD3355

The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Female subjects with no childbearing potentials or using highly efficient contraceptive methods
* Clinically normal physical findings

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation.

The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter.

However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.


Eligibility Criteria:
Inclusion Criteria:

Acute circulatory failure defined as : systolic blood pressure\<90mmHg or mean arterial pressure \<65mmHg and blood lactate \> 2mmol/L

Exclusion Criteria: Pregnant women
Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

Eligibility Criteria:
Inclusion Criteria (Group A):

* Age \> 18 years
* Maddrey score \> 32
* Liver biopsy confirming the diagnosis of alcoholic hepatitis
* Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \> 25) despite a low Lille score (\< 0.45)
* Hospitalization stay \< 1 month
* Algorithm score ≥ 220/250.

Inclusion Criteria (Group B):

* Age \>18 years
* Diagnosis of alcoholic cirrhosis
* Alcoholic withdrawal of 6 months minimum before inscription on the transplant list
* MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \< 5 cm or 3 nodes \< 3 cm)
* MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component
* No recommendation of MELD score for patients having obtained an "expert" component

Non-inclusion Criteria (Group A and B):

* Bacterial or viral infection uncontrolled by medical treatment
* Fungal or aspergillosis uncontrolled infection
* Hepatocellular carcinoma or invasive cancer
* Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV
* Portal thrombosis
* Pregnancy or breast-feeding woman
Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

The investigators aimed to compare the effect of consuming high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas vs. consuming Ensure (a conventional well-known commercial formula) on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES) in the elderly people with dysphagia risk.

The investigators aimed to determine the effect of 3 high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas ((1) white sesame soy milk smoothie (WS), (2) black sesame soy milk smoothie (low carbohydrate, BSLC), and (3) Chicken shitake smoothie (CS); 1 kcal/ml) from natural ingredients as compared with Ensure. The double blind randomized placebo controlled cross-over design study involved 63 subjects aged above 65 years old. They were also divided into asymptomatic (n=32) or symptomatic swallowing difficulty (n=31) group based on self-reported swallowing difficulty symptoms. All subjects assessed five drinks (WS, BSLC, CS vs. Ensure) for sensory testing, product acceptance and marketing survey using questionnaires. Swallowing capacity was determined by using Flexible Endoscopic Examination of Swallowing (FEES) only for each of the three drinks (SW, CS vs. Ensure) in a blinded random sequence.

Eligibility Criteria:
Inclusion Criteria:

* swallowing difficulty group (SSD) who with symptomatic swallowing difficulties or with a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition
* control group (WSD) who without a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition

Exclusion Criteria:

1. People with chronic illnesses and tube feeding
2. People with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects

This study is being conducted to assess the safety and tolerability of ascending multiple oral doses of SCA-136 administered to healthy Japanese male subjects.


Eligibility Criteria:
Inclusion criteria:

* Healty Japanese men willing to use a medically acceptable form of contraception.

Exclusion criteria:

* Any significant disease
* Positive urine drug screen
* Increased liver function tests
* Use of prescription drugs.
Lidocaine Gel During Transrectal Sonography

The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.

TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* All virgin women who were scheduled to undergo transrectal sonography invited to participate.

Exclusion Criteria:

* Allergy to lidocaine or other local anesthetics;
* Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
* A bleeding diathesis and/or anticoagulant treatment;
* Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
* An inability to rate a visual analogue scale
Multi Modal Brain Monitoring and Cardiac Surgery

Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.

The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery with cardiopulmonary bypass
* Valve replacement
* Coronary artery bypass

Exclusion Criteria:

* Emergency surgery
* Hepatic
* Renal impairment
* Diabetes Mellitus
Dietary Approaches for Cardiovascular Health Study

The primary purpose of this study is to examine the efficacy of family meal frequency as an intervention target in addressing the primary prevention of CVD.


Eligibility Criteria:
Inclusion Criteria:

* Parents who have a male or female child aged 6-12 years-old with a BMI-for-sex and age \<95th percentile
* Parent age is ≥18 years-old
* Parent reports at least 2 of the following CVD risk factors: smoking, high cholesterol, high blood pressure, physical inactivity, overweight/obesity, diabetes
* Parent is able to read, speak and understand English

Exclusion Criteria:

* Parents who live with their child \<5 days per week
* Parents who do not have access to the internet and/or are unable to attend intervention sessions
* Parents who report a medical condition that impacts growth or requires a specific eating plan for themselves or their child.
Oral Losartan in Prevention of Post-ERCP Paancreatitis

Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient indicated for ERCP
* Patients with obstructive jaundice.
* Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.

Exclusion Criteria:

* Patients refusing to undergo the procedure or signing the informed consent
* Patients with clinically evident acute pancreatitis before the procedure
* Patients with previous endoscopic or surgical sphincterotomy
* Patients with current use of losartan
* Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
* Patients receiving NSAIDS within a week prior to assessment
* Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.
Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.

The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age \> 18 years admitted to surgical ICU.
* Severe acute pain with pain scale \> 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries.
* Women of childbearing age must have a negative urine/serum pregnancy test.

Exclusion Criteria:

* Regional anesthesia during surgery
* Heart failure with ejection fraction \< 20%.
* Allergy to amide local anesthetics
* Neuraxial anesthesia during surgery
* Post-liver transplant patients
* Hemodynamically unstable patients on two or more vasopressors
* Child-Pugh Class C or MELD \>20
* Any investigational drug use within 30 days before enrollment
* Pregnant or lactating females
* Patients with chronic opioid-dependence
* Intubated and mechanically ventilated patients on intensive care unit analgo-sedation
* Subjects who do not agree to participate or may be non-compliant with study schedules or procedures.
Medication Repurposing to Stop Cognitive Decline in Dementia

Dementia creates a great personal and societal burden and there are currently no treatments to stop memory loss. Many patients with dementia take medications to treat other conditions, e.g. high blood pressure and cholesterol. Some of these medications may have central effects on the pathophysiological processes leading to dementia.

Medication repurposing is a cost and time-effective way to discover new treatments. Swedish registers are a unique tool to detect medication candidates for repurposing. The Swedish Dementia Registry (SveDem) has \>100000 patients and ca. 144000 measures of cognition over time (measured with the Mini-Mental State Examination-MMSE), making it perfect to examine whether certain medications are associated with less cognitive decline in patients with dementia. Cholesterol and kidney function affect treatment and cognition and are available for 25000 patients. The investigators propose a study combining traditional cohort studies and newer artificial intelligence (machine learning) techniques to detect medications associated with slower cognitive decline in patients from SveDem. The investigators will test pre-specified hypotheses since the investigators suspect specific medications are better candidates to prevent cognitive decline, but the investigators will also let the machine learning algorithms explore the data to find associations that the investigators do not suspect in advance. Finally, the candidate medications will be tested in animal and cellular models to determine the mechanisms of their effects.


Eligibility Criteria:
Inclusion Criteria:

All patients with dementia registered in SveDem.

Exclusion Criteria:

Lack of Swedish personal identification number or coordination number.
Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF, or the study is discontinued by the Sponsor (whichever is sooner).

Efficacy assessments will include spirometry (forced expiratory volume in 1 second \[FEV1\] and forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) Questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and diffusion capacity of lungs for carbon monoxide (DLCO). Safety assessments will include monitoring for the development of AEs/SAEs, vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. In addition, up to 24 eligible subjects may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Eligibility Criteria:
Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.
3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
4. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
5. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion Criteria:

1. Subject is pregnant or lactating.
2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

The investigators plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, the investigators will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T12

The investigators will recruit 66 couples in which one person has type 2 diabetes. Power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. Couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. All couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. The intervention group will receive the communal coping intervention. Couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. After the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. During the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). An in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes for one year

  * married or living with someone for at least one year who is willing to participate in the study as the study partner
  * age 18 and over
  * reliable access to the internet at home

Exclusion Criteria:

* Non-English speakers

  * Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently --undergoing treatment for cancer)
  * Partner does not consent to participate in study
  * Partner has diabetes
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

sudden sensorineural hearing loss:

* idiopathic in most cases
* 5-20/100,000 new cases annually in the U.S
* no establishes pathogenesis
* treated with oral steroids in most cases
* \~50% improvement in hearing levels
* bed rest - acceptable treatment, not well investigated


Eligibility Criteria:
Inclusion Criteria:

* patients with sudden sensorineural hearing loss

Exclusion Criteria:

* age less than 16 years
* contraindication for oral steroid treatment
* prior steroid treatment for hearing loss
* pregnent women