cyrilzakka/clinical-trials huggingface dataset:
Seamless Follow up and Support System for Frail Elderly Living at Home

The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.

Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are :

1. connected soles to evaluate different parameters of the volunteer walking
2. connected weighing machine to evaluate the volunteer weight and equilibrate
3. machine to measure gripping force because gripping force is correlated to physical condition.

The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficiency of the solution to prevent disability.

Eligibility Criteria:
Inclusion Criteria:

* patient living at home;
* pre-frail or frail volunteers;
* Informed and written consent by the patient or the legal representative or the reliable person when appropriate.

Exclusion Criteria:

* patient's life expectancy less than 12 months; patient presenting disability with an Activity of Daily Living score \< 4/6 ant/or a Mini - Mental State \<20/30, not walking or walking with a technical support;
* Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
The Effects and Predictors of Patella Taping in the Treatment of Patellafemoral Pain Syndrome

Background: Taping has been used for more than 20 years for patellofemoral pain syndrome (PFPS) but the effectiveness is still controversial.

Purpose: This prospective study was conducted to investigate the effect and predictors of effectiveness of taping in treating PFPS.

Study design: Prospective cohort study Methods: One hundred consecutive patients with the diagnosis of PFPS were included in the study. Factors including sex, age, body mass index (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each patient by McConnell approach. Before and after taping, patients completed a visual analog pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used for the difference of the VAS score measured before and after taping. Patients with improvement of more than 1 point in VAS score after taping were considered responsible, and others were non-responsible. The results were analyzed by logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* (1) between the age of 20 to 60 years, (2) antero-, retro-, or peri-patellar pain from at least two of the following: prolonged sitting, ascending or descending stairs, prolonged walking, squatting, and (3) insidious onset of symptoms unrelated to a traumatic incident.

Exclusion Criteria:

* (1) symptoms or signs of any intrarticular derangement of the knee joint, such as effusion, ligament laxity, and meniscal tear, (2) tenderness over the patella tendon, iliotibial band, or pes anserinus tendons, (3) Osgood-Schlatter disease or Sinding-Larsen-Joahanssen syndromes, (4) referral pain from hip or lumbar region, (5) a history of patellar dislocation, previous knee surgery or infection, (6) malignancy, (7) present pregnancy, (8) recent treatment for the PFPS, such as physiotherapy, non-steroid anti-inflammatory or corticosteroid medication, (9) advanced osteoarthritis of the knee joint.
Prospective Study Assessing Two Scales for Identification of Complex Elderly Patients in the Emergency Department

With the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. These complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. These risks could be reduced by early adapted care specific to this type of patient. To do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway.

Screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. The purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the Hospital Emergency Department environment.

This study assess the diagnostic performance of the ISAR and SoCoLoc scales for complex elderly patients.

The assumption of the study is that at least one of these two scales (ISAR or SoCoLoc) is adapted to the constraints of hospital emergencies and that it presents good performances for the screening of elderly patients in complex medico-social situations (sensitivity ≥ 90% and specificity ≥ 50%).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 years of age
* Patient presenting to the "Emergency Department" of the Annecy Genevois hospital, whatever the reason for consultation, from Monday to Friday between 8:00 a.m. and 8:00 p.m.
* Patient informed of the study and not opposed to participation

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients under the safeguard of justice
* Patient presenting for a life-threatening emergency
* Patient unable to answer the questions on the scales
* Patient does not speak French
* Patients who have already been included in the study: any patient already included in the study and making another trip to the emergency department cannot be included a second time.
Symptom Clusters in Children With Leukemia

The purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.

A repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.

Exclusion Criteria:

* Children without a definite diagnosis of leukemia will be excluded.
* Children must be able to understand and answer the questions on the questionnaires.
* Children with have a cognitive impairment (e.g. Down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.
Intramuscular Dexmedetomidine as Premedication

Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-55 years old, American Society of Anaesthesiologists physical status I, scheduled for elective suspension laryngoscopic surgery of benign vocal fold lesions.

Exclusion Criteria:

* Patients with neurological deficits
* Pregnancy
* Imprisonment
* Morbid obesity (body mass index ≥ 30 kg•m-2)
* Preoperative heart rate \<45 beats•min-1
* Second or third degree atrioventricular block
* Antihypertensive medication with α-methyldopa, clonidine or other α2-adrenergic agonist
Effect of Non-Surgical Periodontal Treatment on Biomarker Levels

Periodontitis is a destructive disease that follows untreated gingivitis and is characterized by gingival inflammation, clinical attachment loss, alveolar bone loss and periodontal pocket formation, increased tooth mobility and tooth loss. Although the primary etiological factor is microbial dental plaque, the host response plays an important role in the transition from periodontal health to disease. Smoking is a major risk factor for periodontitis and affects the formation and severity of the disease and healing after periodontal treatment by changing the host response to plaque. Proinflammatory and antiinflammatory cytokines have an important role in the pathogenesis of periodontal disease. Among these cytokines, interleukin (IL)-1β, IL-10 and currently IL-39 have been associated with periodontal disease. Further studies with post-treatment longitudinal evaluation are needed to elucidate the functions of IL-39 and its possible role in the pathogenesis of periodontal diseases. In this study, it was aimed to investigate the effects of non-surgical periodontal treatment on salivary and gingival crevicular fluid (GCF) IL-39, IL-1β and IL-10 levels in smokers and non-smokers with Stage 3 Grade B periodontitis and periodontally healthy individuals, both smokers and non-smokers. To the best of our knowledge, there is no study investigating the effects of non-surgical periodontal treatment and smoking on IL-39.

50 individuals with periodontitis and 50 periodontally healthy individuals (total 100 individuals) will be included in our study, and these two groups will be divided into two sub-groups as smokers and non-smokers. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), saliva and GCF samples will be taken from all individuals at the beginning of the study. Non-surgical periodontal treatment will be performed in individuals with periodontitis. Saliva and GCF samples will be collected before treatment. The clinical measurements, saliva and GCF collection will be repeated 12 weeks after the treatment. The saliva and GCF levels of IL-39, IL-1β and IL-10 will be analyzed by ELISA. Cotinine levels will be examined to evaluate the effects of smoking before and after treatment in periodontal health and periodontitis.

With this study, we aimed to develop IL-39 diagnostic kits for the diagnosis of periodontal diseases, detection of disease activity, follow-up of response to treatment and healing.


Eligibility Criteria:
Inclusion Criteria:

* Periodontal healthy group
* Stage III Grade B and C Periodontitis Group
* To meet the above-mentioned periodontal health and disease criteria

Exclusion Criteria:

* Chronic alcohol use,
* Oral contraceptive use, pregnancy, pregnant,
* Last 6 months antibiotic or anti-inflammatory drug use,
* To have periodontal therapy in the last 6 months
Ergometer Cycling After Replacement of the Hip or Knee Joint

Despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices.

In particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery.

Therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis of diagnosis of osteoarthritis or femoral head necrosis

Exclusion Criteria:

* A history of septic arthritis
* Hip fracture
* Intraoperative complications
* History of implant surgery on the joint to be operated on
* Rheumatoid arthritis
* Amputations
* Inability of complete the questionnaires because of cognitive or language difficulties
Carpal Tunnel Release Through Mini Transverse Approach

Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.

Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
* Participant cooperation sufficient to operate under local anesthesia

Exclusion Criteria:

* Un controlled diabetes mellitus type 1 and 2
* Patients with non controlled Vascular hypertension
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* Patients with history of Carpal Tunnel release surgery failure
Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes

The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological outcome, length of ICU stay, and length of hospital stay will be measured.

Central nervous system dysfunction is a major cause of morbidity after cardiac surgery. This study seeks to evaluate the effects of cerebral oxygen saturation on the neuropsychological outcome of cardiac surgery patients. Currently, monitoring of cerebral oxygen saturation levels is not part of routine and standard practice.

Subjects will be assigned to a control and intervention group. Anesthesia and surgery will be performed as per usual standards of care. Patients in both groups will be monitored with an oxygen sensor placed over the forehead. The data will be recorded continuously on a floppy disk. The control group will be treated according to current standard of care; the readings of brain oxygen saturation will not be visible to the clinician. In the intervention group, the reading of brain oxygen saturation will be monitored by the anesthesiologist throughout surgery. Interventions will be performed to maintain cerebral oxygen saturations above 40%. Neuropsychological tests will be completed pre-operatively and at two time points post-operatively. The tests used are the ASEM (antisaccadic eye movement) and the MMSE (mini-mental state examination).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Elective cardiac surgery with cardiopulmonary bypass
* Coronary artery disease or valvular heart disease or combination of both
* Ability and willingness to give informed consent

Exclusion Criteria:

* Pediatric patients
* Emergency surgery
* Unable to understand English
* Allergic to tape used to attach oxygen sensor
Study Of 323U66 SR In Major Depressive Disorder

This study was designed to evaluate the efficacy and safety in major depressive disorder patients.


Eligibility Criteria:
Inclusion criteria:

* Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
* Must have rating scores as outlined.

Exclusion criteria:

* Current or past history of seizure disorder or brain injury.
* Current or past history of anorexia or bulimia nervosa.
* History of manic episode.
* Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
* Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
* Pregnant, possibly pregnant or lactating.
* Must not be suicidal.
* Blood pressure of SBP\>160mmHg, DBP\>100mmHg.
* History or complication of cancer or malignant tumour.
Remote BP Monitoring in the PP Period

The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.

Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women
* Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
* At least 18 years of age
* English or Spanish speakers

Exclusion Criteria:

* Non-English or Spanish speakers
* Women who are not planning on obtaining their postpartum follow up at CUIMC
* Women who are physically unable to hold or use the tablet
* Women who do not have a working phone
* Provider unwilling or unable to set up escalation pathway
* Women who reside outside of New York State
* Hypertension diagnosed postpartum
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh

Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.

The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-65
* Absence of all exclusion criteria

Exclusion Criteria:

* women who are currently pregnant at the time of recruitment and/or plan to become pregnant within 2 months
* individuals taking nutritional supplements at the time of recruitment
* individuals who have taken nutritional supplements within the last 3 months
* participants enrolled in any other clinical trial
* women who are currently breastfeeding
* individuals known to have coronary heart disease, cerebrovascular disease, hypertension, renal disease, chronic obstructive pulmonary disease, asthma, cancer, or liver disease
* participants with protein or glucose in their urine sample (dipstick test)
* individuals whose drinking water history is complete for \< 3 months
Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.

Data will be collected from participating centres on en bloc resection, curative resection, R0 resection and complications/adverse events over a 2 year follow up period.

Demographic details on the patients included in the study will be captured alongside details on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
* Participant is able to give informed consent for participation in the study

Exclusion Criteria:

* Patients under the age of 18
* Patients unable to give informed consent