louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01539759: Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Official title: Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Devices
Cesarean Section
Keywords: Postpartum Contraception
Intrauterine Devices
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-02-27
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.


Eligibility criteria: Inclusion Criteria:

* Women ages 18-45
* Pregnant and greater than or equal to 24 weeks of estimated gestational age
* Live Pregnancy
* States a plan to use an Intrauterine Device (IUD) postpartum for contraception
* Plan for cesarean delivery
* Intend to stay in the Chapel Hill area for at least 6 months after birth
* Fluent in English or Spanish

Exclusion Criteria:

* known uterine anomalies
* allergies to any component of the IUD of their choosing
* known or suspected carcinoma of the breast
* known acute liver disease or liver tumor (benign or malignant)
* known or suspected uterine or cervical neoplasia
* active pelvic inflammatory disease
* genital bleeding of unknown etiology
* history of solid organ transplantation
* positive test for gonorrhea or chlamydia during this pregnancy

Primary outcomes:
measure: IUD Use
timeFrame: 6 months postpartum
Secondary outcomes:
measure: IUD Expulsion
timeFrame: 0-6 months postpartum
measure: Women's Satisfaction With IUDs
timeFrame: 0-6 months postpartum
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erika Levi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.
Clinical trial NCT00872859: The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Official title: The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Reconstructive Surgery
Keywords: Breast Cancer
Cancer of Breast
Reconstructive Surgery
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Hypothesis:

1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction

Secondary hypotheses:

1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
2. Compare the complication rates between the two types of acellular dermal matrix
3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation


Eligibility criteria: Inclusion Criteria:

* Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
* Female gender
* Age between 18 and 80
* Consent to participate in the study

Exclusion Criteria:

* Patients not undergoing breast reconstruction following mastectomy
* Patients undergoing delayed breast reconstruction following mastectomy
* Patients undergoing immediate definitive breast reconstruction after mastectomy
* Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
* Medical debility precluding surgical treatment
* Prior breast or chest wall irradiation
* Pregnant patients
* Male gender

Primary outcomes:
measure: Effects of radiation on acellular dermal matrix
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital/ Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah Hospital
name: Jayant Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408459: Adherence Dynamics for Whole Food Interventions in African-American Men
Official title: Adherence Dynamics for Whole Food Interventions in African-American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Prostate cancer prevention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 37
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.

Detailed description: African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.

Although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (\< 25%) often provide insufficient numbers to evaluate adherence issues separately.

Tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.

Eligibility criteria: Inclusion Criteria:

* African-American men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (PSA) concentrations of \>2.5 ng/mL with negative prostate biopsy for prostate cancer.
* English literacy
* willing to consume tomato products on a regular basis.

Exclusion Criteria:

* prostate cancer diagnosis
* other cancers \< 5 yrs postdiagnosis except for melanoma
* already consuming four 1/2 cup servings of tomato products/wk.

Primary outcomes:
measure: Tomato Product Intake Between Different Groups
timeFrame: 3 months
Secondary outcomes:
measure: Diet Adherence to Tomato Product Consumption Between Different Groups
timeFrame: 3 months
measure: Consumption of Tomato Products Between Different Groups
timeFrame: 3 months
measure: Differences in Dietary Lycopene Intake Between Different Groups
timeFrame: 3 months
measure: Plasma Lycopene Concentration Between Different Groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Eunyoung Park, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park E, Stacewicz-Sapuntzakis M, Sharifi R, Wu Z, Freeman VL, Bowen PE. Diet adherence dynamics and physiological responses to a tomato product whole-food intervention in African-American men. Br J Nutr. 2013 Jun 28;109(12):2219-30. doi: 10.1017/S0007114512004436. Epub 2012 Nov 19.
Clinical trial NCT05737459: Sedation and Postoperative Cognitive Functions
Official title: The Effect of Sedation on Postoperative Cognitive Functions in Patients Operated for Hip Fracture Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Femoral Fractures
Keywords: Cognitive Impairment
Mini mental status test
Hip fractures
Ketamine
dexmedetomidine
Lead sponsor: Izmir Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients sedated with ketamine and dexmedetomidine during spinal anesthesia for hip fracture

Brief summary: Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.

Detailed description: Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.

Sedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture
* Volunteered to participate in the study

Exclusion Criteria:

* Patients who are under the age of 65
* Patients with known histories of dementia
* Patients with Alzheimer's disease
* Patients with central nervous system disease
* Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)
* Patients who underwent surgery under general anesthesia
* Patients who refused to voluntarily participate in the study

Primary outcomes:
measure: Mini-Mental Status Test
timeFrame: 6 months
Secondary outcomes:
measure: noninvasive mean arterial pressure
timeFrame: 6 months
measure: The heart rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Çelebi University Atatürk Training and Research Hospital
Study officials:
affiliation: Izmir Katip Celebi University Atatürk Training and Research Hospital
name: Derya A Yurtlu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669759: The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis
Official title: The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis in Chinese Medicine.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poststroke Fatigue
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with post-stroke fatigue were enrolled from the departments of neurological, neurosurgical, and rehabilitation in China Medical University Hospital (Taichung, Taiwan), their Brief Fatigue Inventory-Taiwan form score ≥ 4, and stroke onset more than 3 months.

Brief summary: The purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

Detailed description: According to the reports of department of Health, stroke has been the top three ranking in leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review, fatigue symptom is not only common on post-stroke patient and it also has highly correlation with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis became to the main stream for stroke until now. Therefore, the purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

Eligibility criteria: Inclusion Criteria:

1. Gender: men or women
2. Age:40\~80 years old
3. Stroke history at least 3 months
4. Hemorrhage or ischemic stoke
5. Conscious clear and can communicate
6. Brief Fatigue Inventory-Taiwan form score ≥ 4
7. Sign informed consent

Exclusion Criteria:

1. Patient with psychotic diagnosis and can't cooperate with researcher
2. Major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis
3. Pregnant women
4. Breastfeeding women

Primary outcomes:
measure: Frome Fatigue severity level scale to evaluate fatigue severity score.
timeFrame: about 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT04138459: Recovery - a Collaborative Project
Official title: Development of Recovery Oriented Practices, Knowledge and Collaboration in a Norwegian Municipality. An Explorative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Impairment
Substance Abuse
Lead sponsor: University College of Southeast Norway
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
First posted: 2019-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have received community mental health and / or substance abuse services for the past year or longer, due to moderate or severe mental health and / or substance abuse problems.

Brief summary: In Norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal.

This collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and substance abuse services in the municipality of New Drammen develop over a three-year period.

Using qualitative methods, the main aim of the study is to explore what recovery orientation of services in mental health and substance abuse presupposes and involves related to roles, collaboration and knowledge.

To explore these issues, service users will be interviewed together with their primary mental health professional.

The study will also apply observational fieldwork in order to observe recovery oriented practices between service users and professionals and between professionals.

An advisory group consisting of people with background as service users, mental health clinicians and service leaders will contribute throughout the project.

.


Eligibility criteria: 1. Adults who have received community mental health and / or substance abuse services for the past year or longer, due to moderate or severe mental health and / or substance abuse problems.

   Inclusion Criteria:
   * receives community mental health services due to mental health and /or substance abuse related problems
   * Above 18 years old

   Exclusion Criteria:
   * Under the age of 18
2. Mental health workers in the municipality, working in mental health and substance abuse services

Primary outcomes:
measure: Contribute to the knowledge base on what recovery orientation of services involves
timeFrame: The aims of the study will be explored through interviews and fieldwork over an anticipated period of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Trude G Klevan
Study officials:
affiliation: University of South-Eastern Norway
name: Heidi c Kapstad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03071159: An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System
Official title: A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flash Glucose Monitoring
Metabolic Control
Keywords: Flash Glucose Monitoring
Usability
Metabolic control
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitis
* Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

Exclusion Criteria:

-

Primary outcomes:
measure: Usability of the FreeStyle Flash Libre glucose monitoring system
timeFrame: 6-12 months follow up
Secondary outcomes:
measure: Problems associated with the FreeStyle Flash Libre glucose monitoring system
timeFrame: 6-12 months follow up
measure: The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients
timeFrame: 6-12 months follow up
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500
name: Guy Massa, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00935259: Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Official title: A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia, Dyslipidemia
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 31
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.


Eligibility criteria: Inclusion Criteria:

* Participant is a Caucasian (including Hispanic) male
* Participant has a maximum waist size of 40 inches
* Participant does not currently use any lipid-altering medications
* Participant is in good health other than the diagnosis of dyslipidemia

Exclusion Criteria:

* Participant has had stomach ulcers within the last 3 months
* Participant has had a heart attack in the last 6 months or has angina
* Participant has chronic heart failure
* Participant has a history of stroke, seizures, or major neurological disorder
* Participant has a history of cancer
* Participant has a gastrointestinal condition that affects bowel movements
* Participant has type 1 or 2 diabetes

Primary outcomes:
measure: Arachidonic Acid Level After 2 Weeks of Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
timeFrame: 2 weeks
measure: Blood Linoleic Acid Levels
timeFrame: 2 weeks
measure: Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Chen F, Maridakis V, O'Neill EA, Hubbard BK, Strack A, Beals C, Herman GA, Wong P. The effects of simvastatin treatment on plasma lipid-related biomarkers in men with dyslipidaemia. Biomarkers. 2011 Jun;16(4):321-33. doi: 10.3109/1354750X.2011.561367. Epub 2011 Mar 21.
Clinical trial NCT06828159: Dietary Wild Blueberries and Joint Health
Official title: Effects of Dietary Wild Blueberries on Gut Health and Inflammation and Joint Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gut -Microbiota
Inflammation Biomarkers
Pain Assessment
Joint Pain
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Oklahoma Medical Research Foundation
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. Each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.


Eligibility criteria: Inclusion Criteria:

* Adults with documented multi-joint/knee arthritis

Exclusion Criteria:

* inability to give informed consent
* pregnancy or lactation
* planned knee replacement surgery
* allergy or contraindication to berries
* recent trauma of the knee responsible of the symptomatic knee
* intra-articular injection in the target knee/hip in the last 3 months
* oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline
* use of berry extracts in the last 3 months
* special diets
* cancer treatment
* bone diseases

Primary outcomes:
measure: Serum biomarkers of joint function
timeFrame: 12 weeks
Secondary outcomes:
measure: Gut microbiome
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: