cyrilzakka/clinical-trials huggingface dataset:
Development of a Money Advice Intervention Within IAPT

This study is the second study of a larger project and will begin the process of testing and the development of an integrated intervention on a series of case studies. The combined intervention provides psychological therapy and debt advice in tandem. The treatment pathway is based on interviews and focus groups with service users and staff and the themes that emerged. It will be trialled in the NHS' Improving Access to Psychological Therapies (IAPT) service. Participants routinely accessing this service who have debt issues affecting their mental health will be asked if they'd like to also take up support for their money worries, which will be provided by Citizen's Advice (CA). Researchers will take exit interviews with both service users and staff at the end of the treatment to develop the protocol further. Researchers will also assess measures of mental health and wellbeing that are routinely taken by IAPT to review the intervention.


Eligibility Criteria:
Inclusion Criteria:

* IAPT clients referred for 'high-intensity' one-to-one treatment in the South London and Maudsley NHS Trust (SLaM)
* Have mental health problems and experience of money problems that are effecting these
* Can access technology

Exclusion Criteria:

* Inability to give informed consent due to mental incapacity (as assessed by IAPT therapists)
* Participants whose care team specify concerns regarding taking part in the study.
Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment

This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.

This study is a single-blind, randomized, controlled, two-period crossover trial. The intervention is done twice a week for 6 weeks. There are two arms. During the first period, participants were randomized to receive either VR-based cognitive training or usual care. After a 2-week washout period, the groups were crossed over to receive the alternative treatment for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 50-85
2. A memory complaint by a participant or caregiver
3. Objective memory decline as defined by a delayed recall score of verbal learning test or logical memory worse than 1.0 standard deviations (SD) below age and education-adjusted normative mean
4. MMSE score better than1.5 SD below age and education-adjusted normative means
5. Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1
6. Preserved activities of daily living (ADL), as defined by Korean Instrumental Activities of Daily Living \< 0.4
7. Not demented
8. Hachinski Ischemic Score ≤ 4
9. Can read and write Korean
10. brain MRI or CT showing no other diseases capable of producing cognitive impairment
11. Having a reliable informant who could provide investigators with the requested information.
12. Provide written informed consent

Exclusion Criteria:

1. Participated in another clinical trial within the past 4 weeks
2. Other serious or unstable medical disease such as acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease, or severe renal disease
3. A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology
4. A primary other neurodegenerative disorder
5. Major psychiatric illness such as major depressive disorders
6. Drug or alcohol addiction during the past 10 years
7. Severe loss of vision, hearing, or communicative disability
8. Malignancy within 5 years
9. Any conditions preventing cooperation as judged by the study physician
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives


Eligibility Criteria:
Inclusion Criteria:

* • Male or female age between 18-80 years of age, inclusive

  * Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP \>= 95 and =\< 109 mmHg for non treated patients.
  * Previously treated patients should have a MSDBP =\< 109 mmHg at visit 1 and a MSDBP \>= 95 and =\< 109 mmHg at visit 2.
  * Written informed consent to participate in the study prior to any study procedures
  * Ability to communicate and comply with all study requirements

Exclusion Criteria:

* Severe hypertension (grade 3 of WHO classification; \>= 110 mmHg diastolic and/or \>= 180 mmHg systolic).
* Malignant hypertension
* Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
* Known history of proteinuria (greater than 0.3 gram per day)
* Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
* Transient ischemic cerebral attack during the last 12 months prior to Visit 1.
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.

Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel

Eligibility Criteria:
Inclusion Criteria:

* The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
* The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) \> 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment

Exclusion Criteria:

* The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
* The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry
Use of the KASPARD System for Fall Prevention in Nursing Homes

Falls are a frequent cause of admission to nursing homes \[2\]. It is also the most frequently reported adverse event in these institutions.

The prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \[21\].

Home automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors.

KASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).

We wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female resident of an EHPAD
* Person aged ≥ 65 years
* Elderly person at high risk of falling (fell at least 1 time in the 6 months prior to inclusion)
* Resident or his/her legal representative who has given free, written, informed consent to participate in the trial
* Socially insured resident
* Resident willing to comply with all study procedures and duration. The questionnaires used will be validated questionnaires for the target population (QoL-AD questionnaire for residents and their carers).

Exclusion Criteria:

* Refusal to participate in the study
* Elderly resident who has a fall and for whom the use of a restraint is deemed essential by the coordinating doctor of the EHPAD
* Persons under legal protection are not excluded.
Xeltis Hemodialysis Access Graft (aXess) US Study

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
2. At least 18 years of age at screening.
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
4. The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent.
5. The patient has been informed and agrees to pre- and post-procedure follow-up.
6. Life expectancy of at least 12 months.

Exclusion Criteria:

1. History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
2. Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level \<8% / 183 mg/dl / 10.2 eAG.
3. Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) \<4,000/mm³ and/or anemia with Hemoglobin \<8g/dL and/or thrombocytopenia \<100,000/mm³) that could influence patient recovery and or/ graft hemostasis.
4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds.
5. Any active local or systemic infection.
6. Known heparin-induced thrombocytopenia.
7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease.
8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically.
9. Anticipated renal transplant within 6 months.
10. Known or suspected central vein obstruction on the side of planned graft implantation.
11. Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
12. Previous enrollment in this study.
13. Subject is participating in another study.
14. A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
15. Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia

The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.

Inappropriate sinus tachycardia (IST) is a non-paroxysmal arrhythmia, characterized by a persistently high sinus heart rate (HR) and/or an exaggerated HR response to minimal exertion, and can be responsible for palpitations, asthenia, chest pain, dizziness and syncope, which can be highly invalidating. Conventional treatment of IST, targeted to symptoms control, mainly consists on β-blockers. However, these drugs are often insufficient or not well tolerated because of side effects (mostly hypotension) that usually limit the administered dose. Ivabradine, a sinus rate lowering agent currently employed in Europe in the treatment of stable angina and chronic heart failure, has recently been demonstrated to be effective and safe in the treatment of IST by a few case reports and clinical trials. A randomized clinical trial comparing ivabradine to β-blockers has not be performed yet.

Eligibility Criteria:
Inclusion Criteria:

* Inappropriate sinus tachycardia (HR \>100 bpm at rest ECG and/or medium Holter ECG HR \>90 bpm)
* Age \> 18 years;

Exclusion Criteria:

* Secondary causes of sinus tachycardia;
* Structural heart diseases,
* Postural orthostatic tachycardia syndrome;
* Sinus nodal reentrant tachycardia;
* Contraindications to beta-blockers;
* Administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class I and III anti-arrhythmic drugs or digitalis at the time of enrollment;
* Age \< 18 years;
* Inability of giving informed consent;
Metabolic Adaptations to Weight Loss With and Without Exercise

Study Purpose:

The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.

Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained

Study Summary:

10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:

1. Moderate Intensity Continuous Training (MICT) exercise group
2. No exercise (control) group

Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.

Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).


Eligibility Criteria:
Inclusion criteria

* Age: 18-40
* Body Mass Index: 30-40 kg/m2
* Weight stable (±3kg for greater than or equal to about 2 months)
* No regularly planned exercise/physical activity
* Women must have regularly occurring menses and must be premenopausal

Exclusion criteria

* EKG abnormalities
* Evidence/history of cardiovascular disease, diabetes or other metabolic disease
* Medications known to affect lipid or glucose metabolism
* Pregnant or lactating
* Tobacco or e-cigarette use
* Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.
* Allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine)
* History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)
* Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.
The Injury and Its Consequences in the Sports Lower Limb Amputee

This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact.

It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used


Eligibility Criteria:
Inclusion Criteria:

* Lower limb amputee or lower limb agenes
* Amputee before 55 years old
* Amputee for more than 2 years
* Willing to participate in the study
* Practicing a regular physical activity (at least 1x/week)
* Patient affiliated or beneficiary of a health insurance plan.
* Patient aged 18-65 years

Exclusion Criteria:

* None
Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine

Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years

Sample Size: 90

Study duration: 21 months

Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery.

Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial

Co Primary objectives

* To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants
* To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age

Secondary objectives

* To assess the cellular immune response during the follow-up period
* To assess the incidence of clinical malaria on study participants
* To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.

It is a long-term observational study comparing the immunology trend of 3 groups of women:

* Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso
* Women of the same age and nulligravid who did not participate in the phase 1b trial
* Women of the same age and primigravid who did not participate in the phase 1b trial

The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.

Eligibility Criteria:
Inclusion Criteria:

* Any participant of the previous PRIMVAC vaccine phase Ib trial
* Nulligravid and primigravid women aged 18-35 years
* Residing in study region and environs
* Available and willing to participate in follow-up for the duration of study
* Participant who accept blood sample collection
* Appear to be in generally good health based on clinical and laboratory investigation
* Signed informed consent

Exclusion Criteria:

* Participants who refused to sign informed consent
* Use of an investigational or non-registered drug or vaccine other than the previous study vaccine
* Chronic administration of immunosuppressants or other immune-modifying drugs
* Confirmed or suspected immunosuppressive or immunodeficient condition
* Confirmed or suspected autoimmune disease
* Simultaneous participation in any interventional clinical trial
* Women of control groups with positif pregnancy test at the enrolment