cyrilzakka/clinical-trials huggingface dataset:
A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities

This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.

White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* With and without with matter hyperintensities
* MRI data available or accept to perform one
* No engagement in other cognitive intervention program

Exclusion Criteria:

* Psychiatric and neurological disorders
* History of alcohol or other substance consumption
* Sensory and or motor deficit that could interfere with the use of computer tool
* Refusal MRI.
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female, between and including 15-21 months of age at the time of visit 1.
* For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
* Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Administration of any pneumococcal vaccine since the end of study NCT00678301.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
* Major congenital defects or serious chronic illness.
* History of any progressive neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
* Child in care.
A Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic

The purpose of this study is to investigate if a brief online-delivered cognitive-behavioral intervention can reduce the degree of dysfunctional worry related to the Covid-19 pandemic, compared to a wait-list control condition.

Worries about the immediate and long-term consequences of the ongoing Covid-19 pandemic are largely justified in the current climate of uncertainty. However, dysfunctional worry, that is, pervasive worry that is disproportionate in its intensity or duration, and that significantly interferes with every-day problem-solving or goal-driven behavior, is clearly counterproductive. Research has also indicated that repeated media exposure to a community crisis can lead to increased anxiety and heightened stress responses, that can give a downstream effect on health, and misplaced health-protective and help-seeking behaviors which, in turn, may overburden health care facilities. There is an urgent need to develop a brief, scalable intervention to target such dysfunctional worry in the general population.

The current randomized controlled trial will evaluate the feasibility and efficacy of a brief online-delivered cognitive behavioral intervention designed to target dysfunctional worry related to the Covid-19 pandemic. 670 individuals are randomized to intervention or to waiting-list. The hypothesis is that the brief self-guided intervention will show significant within-group reductions in self-rated worry from baseline (week 0) to post-treatment (week 3), and that these improvements will be larger than those seen in the wait-list control group. The wait-list group will be crossed over to receive the intervention after three weeks (post-treatment). All participants will be followed-up one month and one year after the end of the intervention.

Eligibility Criteria:
INCLUSION CRITERIA

* The following 2 criteria must be met:

  * Worrying about Covid-19 and its possible consequences (e.g. risk of getting ill, fear of death, economy, family, etc.) every day, often several times a day
  * The worry about Covid-19 is perceived as difficult to control
* In addition, at least one of the following negative consequences of worrying:

  * The worry about Covid-19 takes so much time and energy that it is difficult to concentrate on anything else (work, family, hobbies, etc.)
  * Trouble sleeping due to Covid-19 worries
  * Constantly checking the news and social media to follow developments about Covid-19
  * Marked loss of work productivity due to worries about Covid-19
  * Difficulties finding joy in everyday situations because of worry about Covid-19
* ≥ 18 years of age
* Resident in Sweden
* Daily access to a computer or other device with internet connection

EXCLUSION CRITERIA

* Non Swedish speaking
* Severe depression, defined as \>28 points on the MADRS-S
* Suicidal risk defined as 5 points or above on item 9 on the MADRS-S
* Family member in the same household who is included in the study
Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD

Exclusion Criteria:

* Patients who weigh less than 20kg at visit 1
* Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
* Judged to be at suicidal risk
* Taking psychotropic medication on a regular basis
* Hypertension
Providing Healthy Food Access and Physical Activity Opportunities at Boy Scouts of America Summer Camp

To measure impact of improved healthy food access and physical activity opportunities at summer Boy Scout camp, a four-week intervention to address nutrition and physical activity with youth (n=911) and adults (n=247) was conducted at Bashore Scout Reservation in Jonestown, Pennsylvania between June and July of 2016. Intervention components included dining hall menu modifications, healthy messaging, introduction of nutritious snacks available for purchase, and a physical activity challenge.

Menu modifications resulted in improved satisfaction scores related to portion sizes (+28%) and variety (+14%), decreased plate waste, and consistent food costs. Introduction of nutritious snacks at Trading Post resulted in increased satisfaction (+13%) and increased sales per person (+20%). Physical activity increased (+22%) as a result of a step competition between troops. Small changes towards a healthier camp were widely accepted and successful, indicating potential for translation to other camps within the organization.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years
2. Sex: Male or female
3. Fluent in written and spoken English
4. Boy Scout staff, troop leader or parent of Boy Scout camper

Exclusion Criteria:

1. Not Fluent in written and spoken English
2. Non Boy Scout stafftroop leader or not a parent of a Boy Scout camper
3. Decisional impairment
RJBC-APP and Breast Cancer Treatment Compliance

The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Participants assigned to the Ruijin Breast Cancer APP (RJBC-APP) group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group.

Adjuvant treatments has significantly improved the prognosis of early breast cancer patients. However, previous studies suggested the existence of noncompliance to adjuvant therapies, which might cause detriments to disease outcomes. The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Patients diagnosed with invasive breast cancers after surgery will be randomly assigned to the Ruijin Breast Cancer APP (RJBC-APP) group or the Control group. Those in the RJBC-APP group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group. The primary endpoint is the rate of adjuvant therapy compliance at 12 months after randomization. Secondary endpoints consist of compliance rates at 3, 6, 24 months after randomization, QoL and cancer-related symptoms scores at 3, 6, 12, 24 months, disease-free survival (DFS) and overall survival (OS) at 60 months.

Eligibility Criteria:
Inclusion Criteria:

1. Females aged 18-70
2. Eastern Cooperative Oncology Group Performance Status Score 0-2
3. Breast cancer by pathology
4. Adjuvant therapy by multidisciplinary team
5. Written informed consent form

Exclusion Criteria:

1. Distant metastases at diagnosis
2. Unable to use a smartphone
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)

The purpose of this research study is to:

test the usability and performance of the medical device Surgify Halo ™ in revision spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).

This medical device is available for its indications for atraumatic shaping and removal of hard tissue and bone in neurosurgical (Cranial, Craniofacial), spinal, ear, and general surgical procedures. The target is to enroll 30 participants in this study.


Eligibility Criteria:
Inclusion Criteria:

* Disease of the spine or head requiring surgery with bone removal

  * Ability to understand the purpose and risks of the study and to give written informed consent
  * Age 21-85 years

Exclusion Criteria:

* Previous surgery in the same area

  * Abnormalities of bone tissue
  * Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
  * Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
  * Problems with blood clotting
Effects of Sesamin on Sleep Quality and Antioxidative Status

Sesame recognized as a common healthy food. Sesamin is extracted from sesame and has high antioxidant capacity which is commonly added in functional foods. Present studies had found sesamin supplementation could improve self-reported fatigue but more evidence should be clarify. The purpose of this study is to evaluate the effects of sesame extract on the quality of life and antioxidative status on sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea and assess the potential product development.

30-50 subjects aged from 20 to 80 years old without sleep apnea or with low arousal threshold obstructive sleep apnea will be enrolled in this randomized, double-blind, cross-over, and placebo-controlled 8-week period experiment.

At the treatment period (0th to 8th week of the experiment), subjects will receive 2 placebo or capsules of sesame complex (37-56mg sesamin per capsule). The 9th to 11th week will be the washout period. The control and sesamin group will be cross-over at 11th week to 12th week of the experiment. Sleep quality, life quality examination and anti-oxidative functions will be carried out in this study. The basic anthropometric examination will be carried out at the beginning, 4th, 8th, 11th, 15th, and 19th week of the study. Routine laboratory parameters including liver function, kidney function, blood sugar, lipid profile, and anti-oxidative status will be investigated at the beginning, 8th, 11th and 19th week of the study. The questionnaire evaluation including the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Beck Depression Inventory-II, Beck Anxiety Inventory, and Short form-12 items health survey will be investigated at the beginning, 8th, 11th, and 19th week of the study. We expect that sesame complex including 37-56mg sesamin may improve oxidative status which in turn ameliorates the sleep quality, life quality, and anti-oxidative functions in patients with sleep disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-80 years old
2. Sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea that were diagnosed by the doctor after PSG examination.

Exclusion Criteria:

1. Chronic diseases: liver, renal, gastrointestinal, cardiovascular diseases
2. Cancer
3. Pregnant
4. Be allergy to the intervention materials or having supplements /drugs which might affect the study outcome.
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
* Age of at least 45 and at most 55 years.
* Performance status (Karnofsky-Index) \>80%
* Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures).
* No clinical evidence of local recurrence or distant metastases.
* Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
* Patients have taken the SERMs as endocrine therapy for 2-4 years.
* Patients who have had amenorrhea for at least half a year.
* Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
* Patients must be available for and compliant to treatment and follow-up.
* Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

* Known hypersensitivity reaction to the investigational compounds or incorporated substances.
* Hormone receptor-negative breast cancer.
* Local recurrence and/or metastasis of breast cancer.
* History of hysterectomy.
* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
* History of osteoporosis and/or fractures due to osteoporosis.
* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
* Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
* Males.
The Families Addressing Cancer Together Intervention for Parents With Cancer

The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer Together) intervention designed to improve parents' confidence and ability to talk about their cancer with their minor children. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition.

Parents with cancer are encouraged to be "honest and open" with their minor children about their illness. However, many lack access to professional support for their communication needs. Without this support, parents with cancer and their children experience avoidable psychosocial distress. In order to better support parental communication needs in cancer, psychosocial interventions that can be implemented across clinical practice settings are needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer Together) - a theory-guided, web-based psycho-educational intervention to help parents with cancer talk about their illness with their children in a developmentally appropriate way.

The proposed pilot randomized controlled trial will test the feasibility and acceptability of the FACT intervention. We will enroll 40 patients with cancer who have a minor child to participate in this single site, 6-week study. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible and acceptable when compared with a wait-list control condition. We will also explore preliminary effects of the intervention on parental communication and psychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent reviewed and signed;
* Age equal to or above 18 years;
* Ability to understand and comply with study procedures;
* Able to complete all study measures and visits in English;
* Be a parent (defined as biological, adoptive, foster, or step-parent), kin caregiver (defined as a relative or someone with a significant emotional relationship who provides full-time care and nurturing of a child), or legal guardian of a child age 3 to 17 years of age who can speak and understand English;
* Have a diagnosis of Stage II-IV (or equivalent) invasive solid tumor not in surveillance or survivorship

Exclusion Criteria:

* Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
* Prior participation in the pilot trial or development and user testing protocol preliminary to this study;
* No current or expected contact with their child; or
* Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol.
Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients

Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients

The proposed synopsis aims to compare the effectiveness of Alexander Technique nd Feldenkrais Technique in alleviating non spicific neck pain. Both AT and FT are somatic education methods focusing on improving body awareness and movement patterns. The study will involve non - specificc neck pain paytients randomly assigned to either AT Or FT intervention groups Outcome measures will include pain intensity, posture, functional ability and quality of sleep. Data will be collected at baseline, post - interventrion and on follow up to assess the short term and long term effects. Statistical analysis will be conducted to determine differences in outcomes between the two groups. Understanding the comparitive effectiveness of AT and FT could provide valuable insights for healthcare professionals in choosing appropriate intervention for non - specific neck pain patients management.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients
* Patients who have compromised activity of daily living due to neck pain
* Patients with non - specific neck pain
* Patients aging from 20 to 25 years

Exclusion Criteria:

* Patients with diagnose dneck pathologysuch as cervical disc herniation and spondylosis etc.
* Patients who are unable to participate in any physical activity
* Patients with recent neck injury or trauma
* Patients with cognitive impairment