cyrilzakka/clinical-trials huggingface dataset:
Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

Context :

Behavioral and Psychological Symptoms of Dementia (BPSD) arouse researchers' interest because they are frequent manifestations responsible for a large share of the suffering of patients and caregivers. Apathy is the most frequent of them.

Systematic literature reviews on non-pharmacological treatment for BPSD indicates that some technique and more particularly residential care staff training program appear to have promising results, even if the level of evidence of efficacy remains moderate partly because of the paucity of scientific quality research in this area.

The most of them comes from Anglo-Saxon country. In France, the TNM en EHPAD study demonstrated the staff training program efficacy regarding to the management of behavioral positive symptoms such as agitation or aggressiveness compared to a control group

Aims of the study :

The aims of the study is to evaluate the short and medium term effectiveness of staff training program to manage and stimulate patients with a diagnosis of Alzheimer's disease or associated disorders and presenting BPSD of the apathy type and living in nursing homes.

Description :

A Randomized controlled trial (randomization by nursing home) presents as a routine clinical procedure according to the French regulation. Raters and our statistician are unaware and blind to the randomization. The trial takes place in 4 nursing homes.

To be included, patients are older than 65 years with a diagnosis of Alzheimer's disease or associated disorder and present the diagnostic criteria of apathy, within a moderate to severe stage of the disease.

Data are collected at baseline, month 1 and at month 4, namely 3 months after the end of the training programme thanks to the Apathy Inventory Clinician version (AI-C), the Neuropsychiatric Inventory for the staff members (NPI-ES), the AD QOL, an Observation Scale and a qualitative analysis of the official caregiver's knowledge and perception about BPSD especially apathy and their expectations concerning the training program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease
* MMSE score between 12 and 24
* Patient involved in organized activities in nursing home

Exclusion Criteria:

Patients:

* Who are not able to understand and answer to questions for the study
* \< 60 years of age
* Who are not able to sit
* Aphasic
Desflurane Versus Propofol in the Sitting Position

The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.

The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Forty patients,
* ASA class I or II,
* undergoing shoulder arthroscopy

Exclusion Criteria:

* Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.
Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice.

Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. ginseng root extract supplementation may promote fat oxidation, increase hepatic glycogen levels and produce a glycogen-sparing and antifatigue effect during exercise in swimming rats. Notwithstanding, although there is some evidence of P. ginseng effects in humans, no evidence has been obtained respect to its supplementation in human sport performance. The aim of this study is to assess the effect of P ginseng extract supplementation on the lipid metabolism and sport performance in male endurance runners. For this purpose, the effect of supplementation for 2 weeks of 500 mg/day of P. ginseng will be evaluated in a sub-maximal physical stress test. Variables of lipid metabolism, energy consumption, fatigue, and endurance will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Athletic men of aerobic type, who participate in a supervised training as a previous step to the accomplishment of competitions
* Which their age is older than 18 years
* Training superior or equal to 3 days per week and that these workouts are stable during the intervention.

Exclusion Criteria:

* Athletes with high blood pressure, with pharmacological treatment for hypercholesterolemia, diabetes, any psychiatric illness
* Athletes who practice sports without having the objective of increasing sports performance
* Athletes who use some type of ergogenic sport supplementation looking to optimize any aspect related to the sport.
Patient Navigation for Medicaid Frequent ED Users

A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.


Eligibility Criteria:
Inclusion Criteria:

* 4-18 ED visits per year
* Frequent ED users
* age 18 to 62
* Medicaid insurance only
* Those living in the greater New Haven area (i.e. having a zip code that matches that)

Exclusion Criteria:

* the current visit for primary psychiatric or substance abuse
* more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.
Effects of Ribavirin on Zidovudine or Stavudine

The purpose of this study is to see how treatment of hepatitis C (HCV) patients with ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV).

Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little information about the way these drugs interact in the body. This study will examine how the drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV therapy.

RBV, a nucleoside analogue, is used for the treatment of hepatitis C virus (HCV) in alliance with interferon-alfa 2a/2b in patients with HIV-1. The mechanism of action of RBV has led to in vitro studies examining the agonism/antagonism in efficacy occurring when used in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective of the pharmacology component of this current study will be the evaluation of the effect of RBV on the intracellular activation of ZDV or d4T owing to the reported antagonism observed in vitro.

Pharmacokinetic (PK) evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and measurements of their triphosphate anabolites are performed before initial RBV dosing (within 2 weeks of visit) and 8 weeks after RBV administration. Thymidine triphosphate (TTP) concentrations also are quantitated to permit estimation of the ratio of active drug to endogenous triphosphate concentrations.

For entry, prior to RBV dosing, blood samples are collected within 2 hours prior to the ZDV or d4T dose and then at Hours 1, 4, and 8 post dosing. Following the entry PK blood draws, patients initiate RBV treatment within 2 weeks of the first PK study day.

For the Week 8 evaluation (measured as 8 weeks following initiation of RBV), blood samples are collected prior to the ZDV or d4T dose and then at Hours 1, 4, and 8 post dosing.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years of age.
* Have written consent from parent or guardian if under 18 years of age.
* Have HIV infection.
* Have been receiving ZDV or d4T for at least 4 weeks prior to study entry.
* Are planning to receive RBV-containing hepatitis treatment through their doctor or through coenrollment in another ACTG protocol within 2 weeks following entry into the study.
* Have not received RBV for at least 6 months prior to study entry if they were previously treated with RBV.
* Weigh more than 110 pounds (50 kg).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant.
* Use rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 14 days of study entry.
* Abuse alcohol or drugs. Patients in methadone programs may participate.
Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study

P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants.

The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.


Eligibility Criteria:
Inclusion Criteria:

- Only participants of FinHealth 2017 -study are eligible for the study

Exclusion Criteria:

- Participants not part of FinHealth 2017 -study are not eligible
Proximal Femur Locking Compression Plates Versus Trochanteric Nails

The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.

"Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith \& Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with closed or type 1 open reverse oblique intertrochanteric fractures (AO 31 - A3) or subtrochanteric fractures (transverse fracture line, main fracture line maximum 5 cm distal from the lesser trochanter; proximal extension of fracture allowed)
* Definitive fracture fixation with either a proximal femur locking plate or an intertrochanteric nail within 4 days after accident
* Signed written informed consent (by the subject or legal guardian) and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level

Exclusion Criteria:

* Pathologic fracture
* Polytrauma
* Any displacement of a femoral neck fracture
* Additional fracture of one of the lower extremities that significantly affects the functional outcome
* Additional injury of the lower limb that significantly affects the functional outcome
* Fractures of the upper extremity if it affects the mobility of the patient
* Type 2 or 3 open fracture
* Drug or alcohol abuse
* Active malignancy
* ASA class V and VI
* Inability to walk independently prior to injury
* Neurological and psychiatric disorders that would preclude reliable assessment
* Patient is not able to come to the regular FUs
* Patients who have participated in any other device or drug related clinical trial within the previous month
* Pregnancy (tested with a urine pregnancy test) or women planning to conceive within the study period
Treatment of Formerly Abducted Children (FAC) in Uganda

In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
* member of the group of formerly abducted people or former child soldiers

Exclusion Criteria:

* current substance dependence
* mental retardation
* psychotic disorder
The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.

The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.

The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4.
2. Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
3. Subjects must speak English.
4. Subject must be willing and able to sign an informed consent document.
5. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.

Exclusion Criteria:

1. Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus.
2. Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease.
3. Subjects who have had an injury to the index knee within 6 months of starting treatment.
4. Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
5. Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
6. Subjects who plan to have surgery on the target knee within the study period.
7. Subjects with surgical metallic hardware in the target knee.
8. Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
9. Subjects who are pregnant.
Prophylactic Treatment With Oseltamivir

The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* exposure to influenza during hospitalization
* risk factors for influenza complications
* consent for participation obtained

Exclusion Criteria:

* younger than 18 years
* hematological malignancy
* hospitalized in intensive care unit
* refusal to participate
EFFECT of PYRAMIDAL TRAINING on EPICARDIAL FAT for CORONARY ARTERY DISEASE PREVENTION

To show the effect of pyramidal training for coronary artery disease prevention on:

-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.

Back Ground: Coronary heart disease (CHD) is a type of ischemic heart disease characterized by atherosclerotic plaque accumulation in the coronary arteries.Obesity leads to coronary artery disease (CAD) in part through an inflammatory process that accelerates atherosclerotic plaque formation which may start as early as childhood. Epicardial adipose tissue (EAT) is the Visceral adipose tissue (VAT) of the heart .EAT has unique embryologic, anatomic, and histologic features, including smaller adipocytes and higher prevalence of immune cells when compared to subcutaneous adipose tissue (SAT).

Purpose: To show the effect of pyramidal training for coronary artery disease prevention on:

-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.

Methods: This study is Randomize Control Trail that will be carried out on 50 females' patients and will be selected from the Outpatient clinics at Pharos University. Patient will be randomly assigned to two groups.

Experimental group:

This group will include 25 patients who will receive pyramidal aerobic training by treadmill for 40 minutes per session (three sessions per week) for (12 weeks) in addition to Mediterranean diet.

Control group:

This group will include 25 patients who will receive Mediterranean diet for (12 weeks).

Results: Data analysis with Independent t-test will be used to compare the baseline parameters between the intervention and control groups. Repeated measures ANOVA will be used to compare the changes in EATT, anthropometrics and lipid levels at the baseline and after 12 weeks between the two groups.

Keywords: Pyramidal Training, Epicardial Fat, Coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Fifty females' patients with class I obesity (BMI 30 to 34.9 kg/m2, Waist circumference \> 88 cm).

  * Their age ranges from 30-40 years old.
  * Dyslipidemia and lipid profile as follow (total cholesterol high: 240 mg/dl, HDL less than 40 mg/dl, LDL high: 160-189 mg/dL and triglycerides high: 200-499 mg/dl).
  * All patients will be clinically and medically stable when attending the study.

Exclusion Criteria:

* Patients with conditions will be excluded such as:

  * Musculoskeletal problems.
  * Chronic pulmonary disease.
  * Missed more than two weeks of the program or want to terminate the program.
  * Unstable angina.
  * Acute illness.
  * Uncontrolled cardiac arrhythmia.
  * Decompensated heart failure.
  * Cognitive impairment or mental disorders.
  * Systolic blood pressure higher than 180, and/or diastolic blood pressure over 100mmHg.
  * DVT.
  * Multiple food allergies/intolerances or gastrointestinal difficulties of the prescribed diet.
  * Cancer (have special nutritional and training needs).
7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI.

7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with SSc:

  - ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital, without clinical signs of digital arthrose
* Control subjects:

  - Hospitalized patients in the department of internal medicine of Poitiers University Hospital, without Raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study
* For both:

  * Age ≥ 18 years-old
  * Written informatory consent

Exclusion Criteria:

* Patients with SSc:

  - SSc associated with other define autoimmune disease (overlap syndrome)
* For both:

  * Absolute contraindication to 7.0 T RMI: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 T RMI ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips
  * Individuals with current health condition not allowing realization of the 7.0 T RMI in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia)
  * Individuals under tutorship or guardianship
  * Individuals with reinforced protection: minors, judiciary or administrative decision
  * No affiliation to social insurance
  * Pregnancy or breastfeeding