louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05752292: Study to Understand Risk Information to Support and Empower
Official title: Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes, Gestational
Diabetes Mellitus, Type 2
Keywords: Gestational Diabetes
Diabetes Mellitus, Type 2 Prevention
Preventive Health Services
Health Communication
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-03-02
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.


Eligibility criteria: Inclusion Criteria:

* Current pregnancy complicated by gestational diabetes mellitus (GDM)
* Age: 18 years and older
* Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center
* Able to communicate in English

Exclusion Criteria:

* Diagnosis of diabetes before pregnancy
* Maternal or infant current hospitalization
* Pregnancy loss
* History of eating disorder
* Previously requested not to receive research invitations

Primary outcomes:
measure: Completion of recommended postpartum diabetes screening.
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Completion of any recommended postpartum diabetes screening test.
timeFrame: 4-52 weeks postpartum
measure: Uptake of a lifestyle program for diabetes prevention.
timeFrame: 4-52 weeks postpartum
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: University of California, Davis
name: Susan D Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109792: Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques
Official title: Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques of the Locator Retentive Caps for Two Implant-supported Mandibular Overdentures: A Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.

Group II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.

Group III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.

Group IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture


Eligibility criteria: Inclusion Criteria:

* 1. All selected patients will have two implants placed in the mandibular interforaminal region.

  2. All selected patients have a healthy mucosa and have no clinical complications.

  3. All patients are cooperative and approve of the proposed treatment protocol

Exclusion Criteria:

* 1. Patients who refuse to participate in the study 2.Patients who need implant placement as a result of previous implant failure

Primary outcomes:
measure: patient satisfaction
timeFrame: One year
measure: oral health related quality of life
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University ,Faculty of dentistry
Study officials:
References:
Clinical trial NCT03413592: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2
Official title: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nagoya University
First posted: 2018-01-29
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Routinely drink alcohol before bedtime
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: 60 min
Secondary outcomes:
measure: Distance Coefficient of Variation (DCV)
timeFrame: 5 min
measure: Brake Reaction Time (BRT)
timeFrame: 5 min
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
Clinical trial NCT00540189: Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Official title: Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Perforated Appendicitis
Keywords: appendicitis, perforated, children
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.


Eligibility criteria: Inclusion Criteria:children

* Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

* Age \<2 and \>18
* Pregnancy
* Immunocompromise

Primary outcomes:
measure: cost effectiveness
timeFrame: 3 months post entry into the study
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Mott Childrens Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Steven W Bruch, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04836689: Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Official title: Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Lung; Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate
Primary purpose: TREATMENT

Brief summary: Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

Detailed description: This will be a prospective, crossover observational study that will be performed at Rambam NICU.

Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.

NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

Eligibility criteria: Inclusion Criteria:

* Gestational age 240 to 336.
* At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
* At least 6 hours from surfactant administration.
* Parental consent

Exclusion Criteria:

* If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is\<40mmHg.
* If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is\>60mmHg.
* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.

Primary outcomes:
measure: Trans cutaneous CO2 (TCCO2)
timeFrame: During the 3 hours of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT03293589: Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease
Official title: Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Critical Limb Ischemia
Keywords: end-stage renal disease
critical limb ischemia
surgical revascularisation
endovascular therapy
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study Population comprises of all dialysis patients treated for critical limb ischemia by means of surgical or endiovascular Intervention at University Hospital Erlangen between 2009 and 2017

Brief summary: Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these patients.

Most optimal vascular therapy mode has not been finally decided in these patients.

Therefore retrospective analysis of patients receiving open surgical and endovascular revascularisation was performed.

Detailed description: Query of internal clinical database for identification of patients (2009-2017)with end-stage renal disease and critical limb ischemia, receiving either open surgical (Group I "OR") or endovascular revascularisation (Group II "EVT").

Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral run-off, plantar arch) and comorbidities.

Prospective follow-up of identified patients by means of telephone contacts and/or clinical examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free survival, wound healing)

Eligibility criteria: Inclusion Criteria:

* presence of end-stage renal disease
* presence of critical limb ischemia (Ankle-brachial-index \> 0.4 or presence of rest pain or ischemic ulcers or gangrene)
* revascularisation by means of Bypass or endovascular therapy

Exclusion Criteria:

* conservative Treatment
* non-atherosclerotic lesions
* coagulation disorders

Primary outcomes:
measure: Amputation free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Major Amputation
timeFrame: 24 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen, Department of Vascular Sugery
name: Alexander Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164489: Health Promotion of People With Disabilities
Official title: Intervention Research Grants to Promote the Health of People With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid and Osteoarthritis
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis

Detailed description: Park Nicollet Clinic and the Institute for Clinical Systems Integration (ICSI) have developed evidence-based care guidelines and intervention strategies including degenerative joint disease. Included in these guidelines are risk factors for increased limitations, obesity and physical activity.

The aims of this research are to modify well-established weight management techniques and physical activity promotion interventions according to ICSI recommendations, implement the interventions in a diverse patient population, demonstrate the short and long term impact of the interventions.

The approach will be an individual randomized controlled trial of 400 patients, 200 each in a coach-supported intervention, 200 in a self-directed intervention.

Eligibility criteria: Inclusion Criteria:

* clinical visit 11/1/2003 to april 30/2004 diagnosis code rheumatoid arthritis or lower extremity osteoarthritis saw a provider that consented to have patients invited to participate consented to being contacted for research

Exclusion Criteria:

-

Primary outcomes:
measure: height weight: BMI
measure: Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
Secondary outcomes:
measure: improved weight status
measure: improved diet
measure: decreased pain
measure: reduced depression
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Park Nicollet Institute
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Barbara Braun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05411289: The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Official title: The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the effect of acupressure on labor pain and anxiety levels during labor in primiparas women


Eligibility criteria: Inclusion Criteria:

* Primiparas women aged from 20 to 30 years old,
* gestational age of between 37 and 40 weeks according to ultrasonography.
* A fetal weight of between 2500 and 3500 g according to ultrasonography or clinical examination .
* They are transferred to labor room if active labor is in progress (defined as cervical dilatation 3 cm and the presence of regular uterine contraction,
* having a single and healthy fetus in the vertex position

Exclusion Criteria:

* who were needing an emergency C-section.
* Women having a current or previous high-risk pregnancy
* who have experienced pregnancy complications
* Women with a systemic disease during pregnancy . Women with a psychological disorder

Primary outcomes:
measure: Anxiety level
timeFrame: about one hour
measure: labor pain
timeFrame: about one hour
Secondary outcomes:
measure: pulse rate response
timeFrame: about one hour
measure: blood pressure response
timeFrame: about one hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT00333489: Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
Official title: A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: valsartan
amlodipine
hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 551
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.

Patients should have mild to moderate essential hypertension \[grades 1 and 2 of WHO classification (8)\]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.

For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg) during the open-label treatment phase will be discontinued from the study.


Eligibility criteria: Incl- Patients with mild to moderate essential hypertension (grade 1 and 2 of WHO classification).

- Patients with essential diastolic hypertension measured by a standard aneroid or mercury column sphygmomanometer showing MSDBP \> 95 mmHg and \< 110 mmHg and MSSBP \<180 mmHg.

Exclusion Criteria:

* Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
* Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
* Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.

Primary outcomes:
measure: Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
measure: Adverse events after 8 weeks
measure: Change from baseline in standing blood pressure and heart rate after 8 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT00720889: Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.
Official title: Sleep, Energy Metabolism and Diabetes Risk.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Insulin Resistance
Type 2 Diabetes
Keywords: short sleep duration
glucose clamp technique
insulin secretion
insulin action
lipid turnover
free fatty acids
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes

Brief summary: The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that individual differences in habitual sleep duration may be related to differences in the carbohydrate metabolism of people who have a history of type 2 diabetes in their family.

Detailed description: On two consecutive inpatient days, the participants in this study will undergo two different tests. The first test will determine how much insulin can their body produce in response to an intravenous glucose infusion over a period of several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Eligibility criteria: Inclusion Criteria:

* regular sleep habits
* BMI 20 to 27 kg/m2
* at least one parent, sibling or grandparent with type 2 diabetes
* no regular exercise habits

Exclusion Criteria:

* active smoker
* night or shift work
* have highly variable sleep habits
* have a hormonal disorder
* have a sleep disorder
* have an active medical problem
* women only: use of birth control pills
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep

Primary outcomes:
measure: Total body insulin sensitivity
timeFrame: at the end of a 4-hour hyperinsulinemic clamp
Secondary outcomes:
measure: First and second phase insulin secretion
timeFrame: during a 3-hour hyperglycemic clamp
measure: Endogenous glucose production
timeFrame: before and during a 4-hour hyperinsulinemic clamp
measure: Glycerol turnover and free fatty acid concentration
timeFrame: before and during a 4-hour hyperinsulinemic clamp
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Plamen D Penev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: