cyrilzakka/clinical-trials huggingface dataset:
Rural Dementia Caregiver Project

These caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers.

Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia.

The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depression symptoms. The investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations.

If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Caring for person with dementia
* Able to read and write in English
* Able to access the internet
* Providing care for ≥ 10 hours per week
* Reporting a minimum stress level of 4 or more on a 10-point scale
* Living in rural area of United States (self-identify or zip code is a Rural Urban Commuting Area Codes (RUCA) defined rural area)

Exclusion Criteria:

* Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture

The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.

Fractures of the proximal femur and hip are relatively common injuries in adults.

According to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.

Biomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.

For fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith\&Nephew (Trochanteric Antegrade Nail = InterTan).

Each of these nails allow compression over the Nail\\Blade with the intramedullary stability.

There are 3 main complications in the treatment of intramedullary devices : (1) varus collapse of the head/neck, (2) uncontrolled shortening of the neck, and (3)femoral shaft fractures at the tip of the nail The InterTan, unlike other devices, allows for immediate intraoperative compression of the principal fracture fragments through linear compression combined with rotational stability secondary to its unique geometry and mechanism of action.

The mechanical stability of the fracture after the fixation is reflected by the weight bearing the patient can hold . In order to find weather there is a mechanical difference between the two devices we would like to perform a test measuring the weight bearing after fixation of intertrochanteric fractures comparing the pain and impression of mechanical stability in the two devices.

The method to test the amount of weight bearing would be using the "SmartStep gait system" TM (Andante Medical Devices Ltd), an innovative biofeedback and monitoring system that records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.

Eligibility Criteria:
Inclusion Criteria:

* pertrochanteric fracture ao 2.2 and above
* ambulatory patient, without support prior to the fall
* minor trauma mechanism
* without other injuries
* operated 3 days from the injury

Exclusion Criteria:

* dementia
* s/p hip or knee arthroplasty
* known osteoarthritis
Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford Clinical Category 2-4
* At least 18 years of age
* Is able and willing to provide written informed consent prior to study specific procedures

Exclusion Criteria:

* Has a life expectancy of less than 24 months
* Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
* Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs
Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes

Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.

Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.

The investigators will observed fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of the patients preoperation, 14 days postoperation 3 month and 6month postoperation. The investigators will observed the effect of blood glucose to different digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old,gastric cancer ,can be performed operation
2. with type 2 diabetes,fasting blood glucose \> 6.1mmol/L
3. without serious underlying diseases which may affect the metabolism and nutrient uptake
4. without serious underlying diseases which may affect anesthesia and operation
5. can be performed subtotal or total gastrectomy, predicted survival period \> 6months
6. no other abdominal operation
7. preoperation consultation
8. informed consent

Exclusion Criteria:

1. recurrent,metastasis or die
2. patient requests for quit
3. pregnancy
Enhancing Universal Health Coverage and Maternal, Newborn and Child Health in Kenya Through Digital Innovations

This study aims at providing insights into Universal Health Coverage and evaluates the impact of I-PUSH program on maternal healthcare utilization, financial protection and women's empowerment, as well as to evaluate the impact of the LEAP training tool on community health volunteers and women's health literacy including their knowledge, behavior and uptake of respective services.

The study will use a three-pronged approach: year-long weekly Financial and Health Diaries, Baseline and Endline surveys, and qualitative interviews. The Diaries and the Surveys will be carried out in two Counties, Kakamega and Kisumu (Kenya). The qualitative interviews will be carried out in the two counties and in Nairobi as an additional county. The study will use a cluster randomized control trial design in Kakamega to evaluate the impact of I-PUSH program. In Kisumu, selected households will be followed-up to capture the health-seeking behavior, health insurance, and health expenditure pattern of households over time. The study will be initially for 17 months and will continue for three years subject to additional funding.

Eligibility Criteria:
Inclusion Criteria:

* Targets for the intervention

Exclusion Criteria:

* Non-targets for the intervention
Treatment of Pregnant Women With OUD

The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)

The investigators are proposing a cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with an OUD: 1) a collaborative care (CC) approach based upon the Massachusetts Office-Based-Opioid Treatment (OBOT) Model that would provide onsite training, and support to providers and participants through the use of care managers (CMs) vs 2) a telesupport approach modeled on the Project Extension for Community Healthcare Outcomes (ECHO), a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Females age 18 or older
* Documented pregnancy in the medical record at less than 34 weeks gestation
* Delivery date no later than July 1, 2024
* Willingness to adhere to the study schedule
* Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
* Ability to communicate in English
* No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks

Exclusion Criteria:

* Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
* Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
* Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM

This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.

A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of T2DM for \> 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
* Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
* Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
* Patients who agree to participate in the study and give their written informed consent

Exclusion Criteria:

* Patients with type 1 diabetes
* Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
* Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
* Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
* Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
* Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical
Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. In conjunction with this high disease incidence, there have also been reports of Covid-19 related sleep disordered breathing, with up 18% in a Chinese study and 57% in an Italian study of individuals with Covid-19 reporting sleep disturbance.

Obstructive Sleep Apnea (OSA) is a common, chronic condition due to partial or complete upper airway collapse during sleep. OSA is more common in males \& obese individuals, both of which are more adversely affected by SARS-CoV-2 infection. Furthermore, inflammation of the upper airway, or nasal passages leading to congestion could lead to a compromised upper airway during sleep and subsequently, obstructive sleep apnea.

We believe that's SARS -CoV-2 infection, and subsequent Covid-19 will lead to an altered microbiome in the upper airway. This is turn will lead to worsening nasal inflammation and congestion, which could predispose individual with previous Covid-19 disease to OSA.

Additionally, OSA is treated with Continuous Positive Airway Pressure (CPAP) a machine which delivers pressurized air into the upper airway via a face mask. This keeps the upper airway open during sleep. When CPAP is well tolerated by individuals, it works well to reduce the symptoms of OSA. Unfortunately, many patients find it difficult to tolerate CPAP. One reason often reported for poor tolerance is nasal congestion. We believe that an altered upper airway microbiome, due to previous SARS-CoV-2 infection, will affect treatment adherence to CPAP therapy. Secondly, we will investigate if treatment with CPAP therapy causes any change in the upper airway microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of sleepiness, fatigue, loud snoring

Exclusion Criteria:

1. Gross skeletal alterations affecting the upper airway (eg.micrognathia)
2. Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.
3. Pregnancy or intent to become pregnant within the period of the protocol
4. Inability to sign informed consent form
5. Habitual snorer or previous diagnosis of OSA.
6. Less than 18 years of age.
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis

Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* Infants with bronchiolitis \< 6 months who need to be hospitalized and are not able to eat per os.

Exclusion Criteria:

* Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Prevelance of Dental Caries in Agroup of Egyption Children Using Caries Assessment Spectrum and Treatment

To explore the prevalence of dental caries in Egyptian children aged from 6 to 9 years oldusing CAST index and DMFT index

To explore the prevalence of dental caries in Egyptian children aged from 6 to 9 years oldusing CAST index and DMFT index. from MUST university outpatient clinic

Eligibility Criteria:
Inclusion Criteria:

* - Parental or guardian acceptance for participation in the study.
* Children who are medically free from any systemic diseases.
* Children with mixed dentition aging from 6-9 years old.
* Both genders.

Exclusion Criteria:

* uncooperative patient
Brain STimulation for Arm Recovery After Stroke 2

Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.

Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.

Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.

Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.

Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.

Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke


Eligibility Criteria:
Inclusion Criteria:

* Age, 18 years or older
* First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;
* Unilateral upper limb paresis with a motricity index between 9 and 99;
* Possibility to start cTBS treatment within 21 days after stroke onset;
* Signed informed consent.

Exclusion Criteria:

* Upper limb paresis prior to stroke onset;
* Absolute contra-indication to TMS
* Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips);
* History of epilepsy;
* Other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
* Severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
* Life expectancy shorter than one year.
Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

The investigator will retrospect the data of operative patients with limb fracture in Pediatric Orthopedics Unit of Shanghai Xinhua Hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. Then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. According to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. Finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Eligibility Criteria:
Inclusion Criteria:

* Age from 0 to 14 years;
* Children with limb fractures diagnosed by X-ray film;
* The surgical method is open reduction and wire-pin fixation or steel plate internal fixation;
* Children with postoperative plaster fixation;
* Children whose guardian signed informed written consent.

Exclusion Criteria:

* Children with nerve damage which have caused dysfunction such as sensory and motor;
* Children with fracture in other parts or organic diseases.