cyrilzakka/clinical-trials huggingface dataset:
Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot

The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk interventions. The DASH program of diet and exercise based lifestyle change is the most well-established, evidence-based behavioral intervention to control HTN. Its recommendations are central to HTN control national guidelines and consumer health products aimed at behavioral management of HTN. However, translating these recommendations into population-wide, inexpensive, sustainable programs have to date proven largely unrealized. The objective of the proposed study is to determine the efficacy of a HTN intervention behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about the DASH diet, physical activity and HTN related behaviors from health coaches trained in evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity and 2) a web-based coaching portal through which health coaches view and respond to patients' behavioral data and assist them in setting goals for changing behaviors consistent with their HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine improvement from baseline to 3-month follow-up in physiological (blood pressure, weight); behavioral (diet \& physical activity); and psychological (e.g., quality of life) measures over a 3-month intervention. Completing this research will result in preliminary feasibility and efficacy data for a larger randomized efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* hypertension
* prehypertension
* smartphone
* english speaking

Exclusion Criteria:

* on more than 1 medicine for hypertension
* live outside Boston metro area
Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

The purpose of the study was to investigate the effects of etomidate or sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles.

Twenty-five patients will be a total of 150 ECT treatments in this prospective, double-blinded, crossover study. Each patient will receive either 0.2 mg/kg etomidate (Group 1) or 8% sevoflurane (Group 2) in 100% oxygen at 6 L/min fresh gas flow until loss of consciousness for their initial electroconvulsive therapy session. In subsequent sessions, patients will receive the alternative sevoflurane concentration and then alternated between doses until the sixth session. Muscle paralysis will achieve with 1 mg/kg succinylcholine. Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times will recorde.

Eligibility Criteria:
Inclusion Criteria:

* Study include 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who schedule for ECT sessions under general anesthesia

Exclusion Criteria:

* Pregnancy
* Cerebrovascular disease
* Epilepsy
* Unstable cardiovascular disease
* Chronic obstructive pulmonary disease; and
* Renal or hepatic failure
Telerehabilitation Based on Otago Exercises for Older Adults

This study is a single-blind, randomized controlled, prospective clinical trial. At least 62 older adults aged 65 and over were included in the study. Evaluations were made twice, before starting the study and after completion. Otago Exercise Program based on telerehabilitation was applied to the intervention group for a total of 21 sessions, 7 days a week for 3 weeks. The control group did not participate in any exercise program during the study period; however, it was reported that they could be included in the Otago Exercise Program at the end of the study.

Sociodemographic data and information about falling were recorded. Edmonton Frail Scale, Modified Fall Efficiency Scale, Five-Dimensional European Quality of Life Scale-5D-3L, Timed Up and Go Test, Four-Step Balance Test and 30 sec Sit to StandTest were applied to all older adults. Evaluations were applied at the beginning and end of the study. A total of 21 sessions of Otago Exercise Program were applied to the intervention group, 30 minutes/session, 7 days/week for 3 weeks. A printed physical activity recommendation brochure prepared for the older adults by the Ministry of Health of the Republic of Turkey was distributed to both groups. The older adults in the control group did not participate in any exercise program during the study period.

Eligibility Criteria:
Inclusion Criteria for Intervention Group:

* Sedentary and sedentary older adults who do not have any neurological, cognitive, or communication problems that may affect assessments, and who volunteer to participate in the study.

Inclusion Criteria for Control Group:

* Not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.

Exclusion Criteria for Intervention Group:

* Participants who have communication problems, are younger than 65 years old, have any neurological diagnosis and have orthopedic, mental and communication problems that prevent evaluations, and do not consent to participate in the study.

Exclusion Criteria for Control Group:

* Those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.
Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study

Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.

Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.

Eligibility Criteria:
INCLUSION CRITERIA

For inclusion in the study subjects had to meet all of the following criteria:

1. Aged 18-80 years at inclusion.
2. Signed informed consent.
3. In need of full-arch restoration of the maxilla.

   The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
4. Maxilla: totally edentulous, fulfilling all of the following criteria:

   1. History of edentulism: ≥ 6 months and,
   2. Minimum bone height: ≥ 7 mm and,
   3. Minimum bone width: ≥ 5.5 mm.
5. Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw.

EXCLUSION CRITERIA

Any of the following was regarded as a criterion for exclusion from the study:

1. Unlikely to be able to comply with study procedures according to Investigator's judgement.
2. History of bone augmentation in the maxilla within 6 months prior to surgery.
3. Uncontrolled pathologic processes in the oral cavity.
4. Bruxism.
5. Smoking \>10 cigarettes per day.
6. Present alcohol or drug abuse.
7. History of radiation therapy in head and neck region.
8. History of chemotherapy within 5 years prior to surgery.
9. Condition that would compromise post-operative tissue healing or osseointegration.
10. Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
11. Known pregnancy at time of inclusion.
12. Current or former participation in a clinical study that may interfere with the present study.
13. Involvement in the planning and conduct of the study.
Nutrition and Metabolic Prehabilitation in HSCT Patients UK and ROI. BSBMT Multi-centre Survey.

To explore current practices of nutrition and metabolic screening, assessment and management prior to Haematopoietic Stem Cell Transplant (HSCT) in UK and ROI transplant centres.

Nutrition and metabolic parameters assessed in the survey include glycaemic control, lipid function, liver function, nutritional screening, nutritional assessment, nutrition intervention (tube feeding, diet, micronutrient) and exercise.

This work will be used to inform the design of a UK dual centre feasibility study of personalised nutrition and metabolic care for HSCT patients prior to transplantation.


Eligibility Criteria:
Inclusion Criteria:

* BSBMT registered adult HSCT centres (including TYA services where patients have opted to be treated in an adult service pathways)
* Centres delivering either autologous or allogeneic stem cell transplants

Exclusion Criteria:

* All paediatric HSCT services
Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.

The intervention of 16 weeks will include exercise programmes of 48 sessions conducted three times per week for two of the three study groups. These groups will be: a group participating in a conventional training programme, based on a preplanned intensity progression; and, a group of participants involved in an exercise programme which will vary the exercise intensity regarding patients' daily Heart Rate Variability. Each session will include a warm-up, the main part of cardiovascular and strength training and a cool-down including stretching exercises.

All the participants will be evaluated before and after the intervention measuring clinical, physical and psychosocial assessments. The clinical variables will be evaluated in patients' reference hospital and will involve medical history registers, cardiotoxicity variables, blood analysis and inflammatory factors measures. Physical and psychosocial variables measurement will be carried out in a sports centre and will include the assessment of: body composition, heart rate variability, cardiorespiratory capacity, upper and lower extremities' strength and flexibility, agility and balance, quality of life, fatigue, functionality, life satisfaction, self-esteem, anxiety and depression, shoulder mobility perception, kinesiophobia, physical activity level and exercise motivation.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18 and 65 years
* Being a breast cancer patient with luminal or triple-negative
* Having completed the radiotherapy treatment, after chemotherapy, approximately one month ago.
* Be able to perform the proposed tests safely

Exclusion Criteria:

* Being undergoing radiotherapy treatment or scheduled for surgery
* Having metastasic cancer
* Not having any serious psychiatric illness
Physical Therapy for Functional Constipation in Children

Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment


Eligibility Criteria:
Inclusion Criteria:

* children diagnosed as functional constipation.
* aged from 4 to 18 years old
* from both sex

Exclusion Criteria:

* children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.
Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption

In France, patients with benign viral infections (ie: gastro enteritis and/or rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although there is evidence that these medicines are not efficient.

We hypothesize that patients could be reassured by health advices, especially if they are written. In addition, we believe that doctors would feel less guilty for not prescribing drugs if they could hand written consultation reports to patients, in these situations.

We aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

In France, 90% of General practitioners' (GPs) consultations end with prescription of drugs (versus only 43,2% in Netherlands). A french medical thesis published in 2013 showed that drugs prescriptions were not a priority for patients. Rather than medicine's prescription, patients preferred attentive listening associated with personalized advices from their GPs. Several studies also showed that a commercial relationship exists between doctors and patients. The prescription is like an exchange currency against the patient money.

We aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients with \>18 ans Diagnosis of gastroenteritis or rhinopharyngitis by the physician Written consent by patient

Exclusion Criteria:

Patients who have already visited the doctor in the last 15 days A given patient can only be included once Diagnostic uncertainty or need of laboratory tests Cognitive impairment Only one patient by family or visit
Antipsychotic Discontinuation in High-risk Subjects

* Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
* What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
* What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?

After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as a clinical High Risk
* Treated with antipsychotic drugs
* PSP1-5 (from SIPS criteria) \<3 (severity index)for more than 6 months
* Had not experienced a symptomatic relapse in the 6 months

Exclusion Criteria:

* Significant abnormality in laboratory tests
* History of head trauma
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder.

The safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be male and female subjects between the ages of 18 to 65 meeting the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder with a Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) score of \>14 at the Screening and Baseline Visits.
* Female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the Screening Visit.

Exclusion Criteria:

* Subjects with any other psychiatric Axis-I disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
* Subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
* Subjects with clinically significant abnormalities on any Screening or Baseline assessments, including laboratory tests, are excluded.
* Subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
* Subjects who have used selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of Screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. Concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c

The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Self-Management Program on A1c levels for individuals with uncontrolled Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Humana Medicare Advantage member
* Type 2 diabetes diagnosis
* HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria:

* Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
* Not fluent in English
* Humana membership is part of a Full or Global risk arrangement
* Enrolled in Humana at Home Care Management
Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).

Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also \&#34;systemic damage\&#34; (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.

This is a protocol in which we seek to identify those patients with alterations incipient renal failure by determining the albumin/creatinine ratio in urine, test that is currently performed routinely in different groups of patients. By For this reason, the implementation of the non-dialysis objective protocol hopes to be implemented standardized form in patients who go to their primary attention doctor in the province of Burgos to later be extended to the entire Castilla y Leon community.

.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years

Exclusion Criteria:

* Age less than 18 years
ORCHARD- Optimising Home Assessment of Rural Patients

This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.


Eligibility Criteria:
Inclusion Criteria:

* ● Solid organ transplant recipient

  * On the COVID-19 shielding list
  * People with specific cancers

    * People with cancer who had chemotherapy within the last 2 years
    * People with lung cancer that have had radical radiotherapy within the last two years
    * People with cancer of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at end stage treatment
    * People that have had immunotherapy or other continuing antibody treatments for cancer within the last two years
    * People that had other targeted cancer treatment which can affect the immune system, such as protein kinase inhibitors or PARP inhibitors within the last two years
    * People who had bone marrow or stem cell transplants in the last 6 months, or who are still taking immunosuppression drugs
  * People with severe respiratory conditions including all cystic fibrosis, severe asthma, and severe COPD
  * People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as SCID, homozygous sickle cell anaemia)
  * People in immunosuppression therapies sufficient to significantly increase risk of infection

Inclusion criteria for GPs:

* A GP working at the pilot study practice and carried out telemedicine consultations with participants
* A GP who can provide informed consent

Exclusion Criteria:

* People whose GP feels they are not able to participate in the research. People unable to consent to participate. Non-English speakers

Exclusion criteria for GPs:

A GP that cannot provide informed consent