cyrilzakka/clinical-trials huggingface dataset:
4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years old
* Pregnant women with gestational diabetes mellitus on diet modification
* Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
* Gestational age at recruitment 20-34 week

Exclusion Criteria:

* bad obstetrics history.
* Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
* fetal anomaly.
* Women planning to deliver in other centres
* Women who refuse to participate
Vacuumtherapy After Venous Hybrid Procedures

All patients with deep venous obstruction below the sapheno-femoral junction elective for hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral junction) who present with occluded stents which need an additional AVF after thrombolysis will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be performed afterwards.


Eligibility Criteria:
Inclusion Criteria:

* All patients with deep venous obstruction below the sapheno-femoral junction primary elective for hybrid procedure with creation of an AV-fistula in the MUMC
* Be able to communicate in Dutch
* Life expectancy \>1 year

Exclusion Criteria:

* Patients with allergies for the components of the used negative pressure incision management system (Prevena)
Gene Therapy for WAS

This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.

This clinical trial is an ex vivo gene therapy trial. The investigational product corresponds to autologous CD34+ cells transduced with a lentiviral vector harboring the human WASP gene.

Eligibility Criteria:
Inclusion Criteria:

* males of all ages
* severe WAS (clinical score 3-5) or absence of WAS protein in peripheral blood mononuclear cells determined by Western blotting and flow cytometry
* molecular confirmation by WAS gene DNA sequencing
* lack of HLA-genotypically identical bone marrow after 3 month search
* lack of a 10/10 or 9/10 antigen HLA-matched unrelated donor after 3 month search
* lack of a HLA-matched cord blood after 3 month search
* parental, guardian, patient signed informed consent/assent
* willing to return for follow-up
* only for patients who have received previous allogenic hematopoietic stem cell transplant:
* failed allogenic hematopoietic stem cell transplant
* contraindication to repeat transplantation

Exclusion Criteria:

* patient with HLA-genotypically identical bone marrow
* patient with 10/10 or 9/10 antigen HLA-matched unrelated donor or with HLA-matched cord blood
* contraindication to leukapheresis
* contraindication to bone marrow harvest
* contraindication to administration of conditioning medication
* HIV positive patient
Store Safely: Rural Firearm Injury Prevention for Families

The researchers are testing a firearm safety prevention strategy tailored for families with children who reside in a rural area. Researchers hypothesize that the intervention will lead to improvements in household firearm storage.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* English-speaking
* Have a child under 18 living at home
* Own at least one firearm
* Reside in Michigan's Upper Peninsula (UP)
* Access to a computer/mobile device and wifi
* Have sufficient information about household storage to complete surveys

Exclusion Criteria:

* Unable to be consented in English
* Lack of firearm in the home
* No child in the home
* Residence outside the UP
* No access to technology
* Previously enrolled in 2020 pilot project
Interventions in Nutrition Education and Skills

Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability

Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.

Eligibility Criteria:
Inclusion Criteria:

• People who live in one of six rural Kentucky food desert counties

Exclusion Criteria:

* \<16 years old
* Unable to read/write English
* Any GI malabsorption disorder that prevents high fiber consumption
Prevalence, Awareness and Management of Hypertension in Acute Care Personnel

The primary purpose of this study is to identify the percentage of health care workers working in an acute care hospital who have high blood pressure, to determine the awareness of their blood pressure status, and to see how well it is managed. Study participants will come from the following three distinctly different types of departments: telemetry (clinical), non-telemetry (clinical), and non-direct patient care staff. All study participants are offered educational information surrounding high blood pressure and review the recommendation for their primary care engagement. Study participants with high blood pressure will be asked to continue in the study for up to 6 months. It is intended that each study participant who continues will take their blood pressure three times a day and record the results in a study provided diary. Each study participant should also make some of the suggested changes that promote a healthier lifestyle including exercising, improving their diet, and seeing their primary care provider. It is the thought that these changes will reduce the study participant's blood pressure. The secondary purpose is to determine the effect shift work has on these hospital employees and the potential positive effects of the three interventions.

Research on hypertension (HTN) in hospital personnel during work hours is limited yet research has been published on the relationship of job strain and the risk of cardiovascular disease. HTN can be caused by sympathoadrenal activation brought on by long-term exposure to stressors and an inherent biomarker that is associated with an increased risk of cardiovascular disease.

The primary purpose of this study is to quantify differences in HTN prevalence, awareness and management in three distinctly different areas and shifts within an acute hospital. Blood pressure (BP) will be taken during working hours along with pre and post sleep hours. The secondary purpose is to identify the effect of shift work within an acute care hospital and effectiveness of: BP monitoring, increases in physical activity, positive nutritional changes, and the correlation between a primary care provider visits and lowering BP.

Eligibility Criteria:
Inclusion Criteria:

* Providence Health System's Southwest Washington Service Area (SWSA) employees
* Subjects who will be included in the intervention part of the study will have two consecutive BP readings of \> 140/90
* Has or is willing to have collaborative PCP
* Understand and sign the informed consent form

Exclusion Criteria:

* Under the age of 18
* Has a severe systemic illness with life expectancy judged less than three years
* Has a severe vascular event such as Myocardial Infarction or Cerebral Vascular Event in the past 90 days
* Is enrolled in another therapeutic program or similar study, and
* Has a condition which, in the opinion of the investigators, may prevent the subject from participating in the study
Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients

The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.

Temporomandibular disorders (TMD) is a complex and multifactorial disease. Therapeutic modalities, as PBM and MT, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. Fifty-one TMD patients were randomly allocated to three groups: PBM group (n=18) using 808 nm, 100 milliwatt (mW), 13.3 J ∕cm2, 4 J per point), MT group (n=16) with 21 minutes sessions of MT of the masticatory muscles and TMJ and Combined Therapy group (CT) (n=17) applying the 2 protocol described above. All treatments were done three times a week for four consecutive weeks. Evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). Visual analogue scale (VAS), Research Diagnostic Criteria (RDC/TMD) Axis I and II, Beck anxiety inventory (BAI) were used in different moments of evaluation time.

Eligibility Criteria:
Inclusion Criteria:

* TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
* Pain in temporomandibular joint (TMJ)
* Limitation in mouth opening.

Exclusion Criteria:

* Current dental or physical treatment
* Polyarthritis and other rheumatic diseases
* Use of anti-inflammatory and muscle relaxant
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost.

Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 patients with intact colon and rectum

Exclusion Criteria:

* prior finding of severe colorectal stricture
* without the requirement of reaching cecum
* suspected colonic stricture or perforation
* use of prokinetic agents or purgatives within 7 days
* toxic colitis or megacolon
* pregnant women
* hemodynamically unstable
* patients who cannot give informed consent
Physical Activity Promotion in Primary Health Care Settings

A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area

There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering programs of physical activity becomes a convenient option to increase the physical activity level of the population and promote aging process more active and healthy over the life. There is need for greater depth in relation to the operation of programs to promote physical activity and the effects of these programs on different biopsychosocial aspects, especially those offered in primary care settings. This research aims to evaluate a walking program geared to adults and seniors on the following aspects:

1. Characteristics and operation of the intervention,
2. effects of behavior change to physical activity, and
3. biopsychosocial effects of physical activity.

It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and control group (n = 71). The intervention will last for six months, with a subsequent follow-up period of six months after the intervention. The program will offer supervised exercise twice a week, lasting an hour. The classes will consist of recreational activities, walking and educational strategies of behavior change for physical activity. Variables will be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over 40 years, low levels of education, income and varied biopsychosocial characteristics are expected. After the intervention, it is expected that the program present characteristics of low adhesion and retention, especially because of the barrier "lack of time". Still, the promotion of supervised walking increase levels of physical activity beyond the time provided by the program and it will improve the biopsychosocial conditions of the participants.

Eligibility Criteria:
Inclusion Criteria:

* To be insufficiently active
* To accept the intervention invitation
* Living around the selected primary health care
* To sign the Term os Consent
* To have 18 years or more

Exclusion Criteria:

* To participate only in one day of intervention
* To have less than 75% of presence in the intervention
* To give up of the intervention
Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding

Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. A challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. This data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. This information may also give us insight onto why DIVA patients might refuse randomization.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* fluent in English
* hemodynamically stable emergency department patient

Exclusion Criteria:

* history of or current status of difficult intravenous access
The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.


Eligibility Criteria:
Inclusion criteria:

* \>18 y old
* Admitted to the ICU
* Known liver cirrhosis with ascites on clinical examination and/or ultrasound
* Sedated and mechanically ventilated
* Paracentesis deemed necessary by treating physician
* Arterial and central venous catheter in place
* Urinary catheter in place

Exclusion criteria:

* Previous inclusion in the same study
* Renal replacement therapy in place
* Urinary catheter contra-indicated
* Use of radiocontrast media within 72h before paracentesis
Combined Effects of Blow Bottle Technique and Percussion Technique in COPD Patients

It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.

Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life (QoL) is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, a lung function exercise bottle is designed, which is capable of adjusting the pressure according to the patient's needs. The exercise bottle is composed of three components, including bottle body, threaded round cap and air blow pipe. Furthermore, manual chest percussion is the rhythmic clapping on the chest wall with relaxed wrist and cupped hand, creating an energy wave that is transmitted to the airways. It is applied with a frequency of approximately 3-6 Hz. To reduce any adverse consequences, the technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises.

It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.

Eligibility Criteria:
Inclusion Criteria:

* Mild-to-Moderate COPD (according to GOLD criteria)
* Both gender (male and female)
* Aged between 35 and 80 years

Exclusion Criteria:

* Clinically unstable
* cardiovascular impairment,
* musculoskeletal dysfunction
* neurological disease
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.


Eligibility Criteria:
Inclusion Criteria:

* Completed the treatment period of Study ALK9072-003EXT
* Continues to require chronic treatment with an antipsychotic medication
* Continues to reside in a stable living situation
* Continues to have an identified reliable informant

Exclusion Criteria:

* Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
* Has a significant or unstable medical condition that would preclude safe completion of the current study
* Subject is pregnant or breastfeeding
* Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures
Tracking Intervention Effects With Eye Tracking

This pilot study examines concurrent and predictive relationships between eye tracking and clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking system) as well as home-based measures (using tablet-based eye tracking systems). The major goals of this study are both to improve our understanding of the potential role of eye tracking in clinical trials and to advance technologies that may further improve the sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ages 4-7 years diagnosed previously with ASD and meet criteria for ASD when characterized by our research team, English is a language spoken in the family, and Full-scale IQ\>50. Participants must also complete laboratory and home-based eye tracking sessions, with success determined by the Principal Investigator.

Exclusion Criteria:

* Individuals will be excluded from participation based on the presence of

  1. a physical or neurological disorder (e.g., cerebral palsy) which is likely to impact development and learning, as intervention procedures for these individuals may need to be modified beyond the standard approach to address more complex developmental needs,
  2. hearing loss or other severe sensory impairment,
  3. history of significant head trauma or serious brain or psychiatric illness,
  4. parents/caregivers who do not speak fluent English,
  5. parents/caregivers who have previous training in PRT
  6. individuals who must be excluded from eye tracking. These families will be offered the treatment clinically (i.e., fee-based), and they will be given referrals to outside agencies offering the treatment as well.