louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01342380: Pioglitazone and Quetiapine XR Pharmacogenetic Study
Official title: Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Major Depressive Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Research Resources (NCRR)
First posted: 2011-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 310 subjects between the ages of 18 and 70 will be targeted for enrollment. We anticipate a low enrollment rate of 200 from the targeted 310 participants. Eligible participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise specified) or DSM-IV major depressive disorder, as determined by extensive clinical interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus). Participants will be approached for enrollment if they are currently enrolled in one of four studies: IRB protocol numbers 10-06-19, 12-07-29, 07-07-20, and 07-08-24. Please see these protocols for additional study specific information.

Brief summary: Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.


Eligibility criteria: Inclusion Criteria:

* Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24
* Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study
* Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder
* Patient must be at least 18 years old
* Patient must be willing to give a blood sample

Exclusion Criteria:

* Patient lacks the capacity to provide informed consent

Primary outcomes:
measure: Genetic markers associated with treatment response
timeFrame: Up to 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Jinbo Fan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168480: A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperhidrosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a three year open-label study in subjects with axillary hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* Marked axillary hyperhidrosis

Exclusion Criteria:

* Previous use of botulinum toxin for hyperhidrosis

Primary outcomes:
measure: Assessment of axillary sweat production
timeFrame: Every 4 Months
Secondary outcomes:
measure: Patient reported health outcome measures
timeFrame: 1 Month Post-Treatment Visit
Other outcomes:
Locations:
city: Portland
country: United States
state: Oregon
city: Pinneberg
country: Germany
city: Goteborg
country: Sweden
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04830280: Effect Posterior QLB on Atelectasis
Official title: The Effect of Ultrasound-guided Posterior Quadratus Lumborum Block on Atelectasis in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atelectasis
Block
Pediatrics
Quadratus Lumborum Block
Keywords: postoperative atelectasis
ultrasound
lung ultrasound score
posterior QLB
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 2
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* under 2 years old,
* ASA I-II risk group
* Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method
* Patients whose informed consent was read and approval was obtained from him and his guardian

Exclusion Criteria:

* who do not want to participate in the study,
* ASA III-IV-V patients

Primary outcomes:
measure: lung ultrasound score
timeFrame: up to 1 hour after surgery
Secondary outcomes:
measure: pain scores
timeFrame: up to 6 hour after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT06190080: Outcome of Children With Eosinophilic Esophagitis
Official title: Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophagitis, Eosinophilic
Keywords: children
eosinophilic esophagitis
life quality
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.

This study would also enable us to investigate the quality of life of these chronically ill patients

Detailed description: The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.

Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).

If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
* Due to start treatment.
* informed consent from one of the 2 parents or the representative of parental authority.
* Membership of a social security scheme.

Exclusion Criteria:

-

Primary outcomes:
measure: Determine the rate of complete remission
timeFrame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.
Secondary outcomes:
measure: Description at inclusion of a cohort of pediatric patients with OE
timeFrame: throught a 24 months follow-up
measure: evolution of quality of life
timeFrame: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux pédiatriques de Nice CHU Lenval
Study officials:
References:
Clinical trial NCT05562180: FOOD PRESCRIPTION APP
Official title: FOOD PRESCRIPTION APP TO EXTEND AND CUSTOMIZE HEALTHY MEALS FOR A BETTER DIET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diet, Healthy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will develop and test and app that will create meal plans to improve diet quality and support weight loss. This app will allow participants to customize their meal plans and substitute recipes for nutritionally equivalent options that they find more appealing, thus potentially increasing adherence.

Detailed description: We are specifically planning app to create meal plans that are affordable, meet the recommended dietary allowances (RDAs) and adhere to sustainability guidelines to reduce the food-related carbon footprint. The app will enable participants to customize their weekly meal plans. We hypothesize that having the ability to customize the weekly menus through a FoodRx app will improve outcomes, as the lack of customization appeared to be a barrier for some families to improve their diet quality and achieve weight loss goals. (eg, some families did not like tofu or oatmeal, and would have preferred a substitute). We will be able to test the impact of the Food Rx app by comparing participants who use it to our control group that does not currently have access to the standard menus/grocery delivery or FoodRx app.

Eligibility criteria: Inclusion Criteria:

Already enrolled in FoodRx study \>18 years BMI\>27 and wants to lose weight -

Exclusion Criteria:

Not enrolled in Food Rx

-

Primary outcomes:
measure: Dietary Quality
timeFrame: 1 month
Secondary outcomes:
measure: weight loss
timeFrame: 1 month
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente
state: California
Study officials:
References:
Clinical trial NCT03570580: Inter Scorers Agreement for OSA Screening Scores.
Official title: Inter Scorers Agreement for OSA Screening Scores.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea, Obstructive, Mass Screening
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For all the patients include in the study, the four scores (STOP-Bang, P-SAP, OSA50, and DES-OSA) will be performed several times by various scorers.

The agreement between scorers will be statistically evaluated.

Brief summary: Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed.

Detailed description: Four scores are usually performed to detect OSA (Obstructive Sleep Apnea) patients. These four scores are: STOP-Bang, P-SAP, OSA50 and DES-OSA. These scores have been previously validated. However, a comparison between scorers in the realization of these scores has never been performed. The aim of this study was to evaluate this agreement using statistical methods.

Eligibility criteria: Inclusion Criteria:

* All preoperative patients in the Cabinet Medical ASTES

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: OSA Scoring
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04258280: Improving Genetic Counseling for BRCA+ Mothers
Official title: Parent Communication Study IV: Improving Genetic Counseling for BRCA+ Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes biological children, both male and female. We do not yet know the best ways to educate mothers who have a risk gene (are BRCA+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.


Eligibility criteria: Inclusion Criteria:

* Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old.
* Participating in genetic testing for hereditary breast cancer.
* Adequately speak/read English.

Exclusion Criteria:

- Does not meet inclusion criteria.

Primary outcomes:
measure: Communication
timeFrame: 1- and 6-months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT00346580: The Effects of HIV Protease Inhibitors in Severe Sepsis
Official title: The Effects of HIV Protease Inhibitors in Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sepsis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sepsis is the leading cause of death in critically ill patients in the United States. It develops in approximately 750,000 Americans annually, and more than 210,000 of them die. Despite improvements in supportive treatment, mortality has changed very little, and until recently, no sepsis-specific treatments were available. Protease inhibitors have seemed to have an immune benefit that extends beyond their ability to prevent HIV replication. T cells in those patients treated with protease inhibitors have reduced rates of death than in those patients not receiving therapy.

Detailed description: Our hypothesis is that protease inhibitor therapy will prevent apoptosis associated with sepsis, and this will be manifested as improved clinical outcome, as assessed by 28-day mortality, APACHE II and III, and SOFA scores. All patients enrolled in the study will receive the standard of care for sepsis at Mayo Clinic Rochester. Patients will receive 1250 mg of Nelfinavir/placebo twice each day for seven days with regularly scheduled blood draws (Days 0, 4, and 7).

Eligibility criteria: Infection criteria:known or suspected infection, as evidenced by one or more of the following: WBC in normally sterile body fluid, radiographic evidence of pneumonia, a syndrome associated with a high risk of infection.

Modified SIRS criteria: must meet three or more of the following four criteria: a temperature higher than 38C or lower than 36C, heart rate of more than 90 beats/minute, respiratory rate of more than 20 breaths/minute (or on a mechanical ventilator), WBC more than 12,000/mm(3) or less than 4,000/mm(3).

Dysfunctional organs criteria:must meet one or more of the following five criteria:cardiovascular system dysfunction, kidney dysfunction, respiratory dysfunction, hematological dysfunction, unexplained metabolic acidosis.

Primary outcomes:
measure: Death from any cause at 28 days and 3 months
measure: Daily APACHE II and III scores
measure: Daily SOFA scores
Secondary outcomes:
measure: Change in CD4 and CD8 T-cell apoptosis, as determined by flow cytomerty, at the time of enrollment, on Day 4 of therapy, and upon completion of therapy.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrew D. Badley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091180: Mannitol Improves Cerebral Oxygen Saturation
Official title: Effect of Preoperative Mannitol Infusion on Cerebral Oxygen Saturation and Patients' Recovery After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Anesthesia
Recovery
laparoscopy
cholecystectomy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease in cerebral perfusion pressure.

Detailed description: Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M) or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2. Secondary outcome variables include extubation time, clinical assessment of consciousness recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the mini-mental state examination (MMSE) for cognitive evaluation after recovery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II
* aged between 25 and 50 years
* with a body mass index (BMI) 22-34 kg/m2

Exclusion Criteria:

* obstructive or restrictive pulmonary disease
* cardiac dysfunction

Primary outcomes:
measure: rSO2
timeFrame: participants will be followed for the duration of surgery, an expected average of 1 hour
Secondary outcomes:
measure: extubation time
timeFrame: intraoperative
Other outcomes:
measure: OAA/S
timeFrame: after surgery 30 minutes.
Locations:
city: Al-Khobar
country: Saudi Arabia
facility: Anesthesia Department, University of Dammam
state: EP
city: Al-Khobar
country: Saudi Arabia
facility: King Fahd Hosital of the University
state: EP
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Hany A Mowafi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00650780: Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment
Official title: Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Status
Keywords: Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include thirty males and females who took part in a previous study of a single oral dose of vitamin D.

Brief summary: We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a single dose at the beginning of winter. We found a wide range of responses to the dose. This study proposes that genetic differences account for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Detailed description: We suspect that the wide range of response is effected by other factors such as variation in Vitamin D binding protein (the major transporter of Vitamin D metabolites).

Gc, also known as Vitamin D binding protein (DBP), group specific component, or Gc globulin, is a 52-58 kDa multifunctional plasma protein, synthesized in the liver. The gene encoding for Gc is located on chromosome 4, and three common co-dominant alleles give rise to three phenotypes (Gc1s, Gc1f, and Gc2). Gc binds actin, recruits neutrophil leukocytes and converts into a macrophage- and osteoclast- activating factor. It also is the major transporter of Vitamin D and its' metabolites. Lauridsen et al. showed that Gc phenotype correlates with 25(OH)D levels in a group of postmenopausal women.

This study proposes that Gc phenotype accounts for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Eligibility criteria: Inclusion Criteria:

* Must be willing to participate with an additional blood draw.
* Must have been in the previous study.

Exclusion Criteria:

* Will not be eligible if not a part of the previous study

Primary outcomes:
measure: Gc concentration and phenotype
timeFrame: at 1st visit
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura Armas, MD
role: PRINCIPAL_INVESTIGATOR
References: