louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05113667: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
Official title: Impact of Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program on Hospitalized Older Patients: A Non-Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients.

Detailed description: This prospective, nonrandomized controlled study was conducted in older patients who ordered proton pump inhibitor (PPI) at admission in an internal medicine service of tertiary training and research hospital. In the intervention group, clinical pharmacist-led services (including medication reconciliation and medication review) were conducted during hospitalization and at discharge by using the guidelines and potentially inappropriate medications (PIM) criteria \[American Geriatric Society-AGS Beers Criteria©, 2019\]. Medication Appropriateness Index (MAI), inappropriate PPI cost, and hospitalization for gastrointestinal bleeding within 1 year after discharge were calculated in both groups

Eligibility criteria: Inclusion Criteria:

* 65 years old or greater
* Admitted to the hospital with any reason
* Ordered at least one PPI dose within 48 hours of admission

Exclusion Criteria:

* Transferred to another ward (including an intensive care unit)
* Having active gastrointestinal bleeding
* Having active malignity

Primary outcomes:
measure: Appropriateness of Proton Pump Inhibitors Usage
timeFrame: during hospital stay, an average of 14 days
measure: Potentially Inappropriate Proton Pump Inhibitors Usage
timeFrame: at discharge, an average of 14 days after admission to hospital
Secondary outcomes:
measure: Clinical outcome
timeFrame: 1 year
measure: Cost saving during hospital stay
timeFrame: during hospital stay, an average of 14 days
measure: Medication Appropriateness Index for Proton Pump Inhibitors at hospital stay
timeFrame: during hospital stay, an average of 14 days
measure: Cost saving after discharge
timeFrame: a month
measure: Medication Appropriateness Index for Proton Pump Inhibitors at discharge
timeFrame: at discharge, an average of 14 days after admission to hospital
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Betul Okuyan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dumlu HI, Sancar M, Ozdemir A, Okuyan B. Impact of a clinical pharmacist-led stewardship program for the appropriate use of acid suppression therapy in older hospitalized patients: a non-randomized controlled study. Int J Clin Pharm. 2022 Aug;44(4):914-921. doi: 10.1007/s11096-022-01394-8. Epub 2022 Apr 21.
Clinical trial NCT01822067: Effects of Maternal Body Composition on Offspring Brain Structure and Function
Official title: Effects of Maternal Body Composition on Offspring Brain Structure and Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Function
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)

Brief summary: The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.


Eligibility criteria: Inclusion Criteria:

* the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days

Exclusion Criteria:

* none specified

Primary outcomes:
measure: Brain Structure
timeFrame: Age 2 weeks
Secondary outcomes:
measure: Brain Function
timeFrame: Age 2 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Xiawei Ou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425567: Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
Official title: Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Liver Disease
Keywords: cholestasis
parenteral nutrition
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2011-08-30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

Detailed description: Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).

Eligibility criteria: Inclusion Criteria :

- \>14 days \<24 months\* Anatomic short gut (\< 50 % bowel removed) with total bilirubin \> or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin \> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days \* Patients with direct bilirubin \> or = 6 mg/dL who do not meet criteria above but meet criteria with \* If infants qualify for high risk ARM (gastroschisis, ileal atresia, \<750 grams and stage III NEC) d bilirubin \>1 mg/dL but less than 4 mg/dL.

Exclusion Criteria:

Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health System
state: Texas
Study officials:
affiliation: University of Texas
name: Cynthia Blanco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorrell M, Moreira A, Green K, Jacob R, Tragus R, Keller L, Quinn A, McCurnin D, Gong A, El Sakka A, Mittal N, Blanco C. Favorable Outcomes of Preterm Infants With Parenteral Nutrition-associated Liver Disease Treated With Intravenous Fish Oil-based Lipid Emulsion. J Pediatr Gastroenterol Nutr. 2017 May;64(5):783-788. doi: 10.1097/MPG.0000000000001397.
Clinical trial NCT04705467: 3DUS Imaging of Needles in Gynecological Brachytherapy
Official title: A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: 3D Ultrasound
Intervention
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who are assigned to gynecological brachytherapy
Primary purpose: OTHER

Brief summary: Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.


Eligibility criteria: Inclusion Criteria:

* Females of age eighteen (18) or greater.
* Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas

Exclusion Criteria:

• Above patients who are not offered interstitial brachytherapy as a treatment modality

Primary outcomes:
measure: Needle Localization Accuracy
timeFrame: 16 Months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program, Victoria Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01369667: Vitamin D Supplementation in Adult Crohn's Disease
Official title: Vitamin D and Immunomodulation: Effects in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
First posted: 2011-06-09
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.
* Subjects must have inactive CD as defined by CDAI \< 150
* CRP \</=10 mg/L.

Exclusion Criteria:

* Pregnant and lactating women.
* Known hypersensitivity to vitamin D.
* Hypercalcaemia
* Current supplemental intake of vitamin D3 \>800 IU/D.
* Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.
* Participation in a concurrent clinical trial.

Primary outcomes:
measure: Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin 24
country: Ireland
facility: Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,
Study officials:
affiliation: TCD
name: Maria O'Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12.
Clinical trial NCT04624867: Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch
Official title: A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cumulative Irritation and Sensitization
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.

Detailed description: This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Eligibility criteria: Inclusion Criteria:

* Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;
* Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;
* Subjects who are willing to stop using any current contraceptives for the duration of the study;

Exclusion Criteria:

* Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;
* Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;
* Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;

Primary outcomes:
measure: Skin Irritation Evaluation
timeFrame: 21 days
measure: Sensitization Evaluation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: QPS Missouri
state: Missouri
Study officials:
References:
Clinical trial NCT06693167: Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy
Official title: Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chirurgical Intervention
Auriculotherapy
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated

Brief summary: Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery

Detailed description: the project consists of a retrospective analysis of data from the medical records of patients followed by Doctor, between 2016 and 2017, at the Bizet Clinic. This study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. For comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. The objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 84 years.
* Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated

Exclusion Criteria:

* Have already benefited from an auriculotherapy session.
* Presence of cryoglobulinemia.
* Presence of Raynaud's syndrome.
* Presence of hemoglobinopathy (hemoglobin and capillary abnormalities).
* Allergy to cold.
* Presence of dermatological lesions on the auricle of one of the two ears

Primary outcomes:
measure: demonstrate the effectiveness of auriculotherapy in the management of postoperative pain
timeFrame: Day1, Day2 and Day 3
Secondary outcomes:
measure: reducing the consumption of painkillers
timeFrame: Day1, Day2 and Day 3
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06353867: The Effect of Group Exercise in Children With Special Needs
Official title: The Effect of Group Exercise on Balance and Attention Level in Children With Special Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Child Autism
Keywords: developmental disability
balance
attention
group exercise
Lead sponsor: Istanbul Gedik University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Children aged 6-15 years with special needs
* Able to walk independently

Exclusion Criteria:

* Children with visual problems,
* Any orthopaedic, rheumatic or neurological problems affecting balance,
* Any contraindication to exercise

Primary outcomes:
measure: Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)
timeFrame: Baseline and after the interventions (4th week)
measure: Paediatric Balance Scale
timeFrame: Baseline and after the interventions (4th week)
measure: Functional Reach Test
timeFrame: Baseline and after the interventions (4th week)
measure: Timed Up and Go Test
timeFrame: Baseline and after the interventions (4th week)
measure: Stroop Test
timeFrame: Baseline and after the interventions (4th week)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Gokce Kartal, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697567: Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Official title: Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prophylaxis Herpes Simplex
Keywords: Herpes simplex
Herpes simplex vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years of age
* Written informed consent
* Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
* Good clinical condition as evidenced by history taking and physical examination

Exclusion Criteria:

* History of persistent hepatic, renal, cardiac or respiratory diseases.
* Clinical signs of acute illness at the time of entry into the study.
* Seropositive for antibodies against the human immunodeficiency virus (HIV).
* Pregnancy, lactation.
* Treatment with corticosteroids or immunomodulating drugs.
* Simultaneous participation in another clinical trial.
* Any previous history of allergy.
* Any concomitant vaccination or administration of immunoglobulin during the study period.
* Any abnormal laboratory value among the tests performed at screening

Primary outcomes:
measure: To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
timeFrame: Days 0, 30, 60, 180 and 365 after vaccination
measure: To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
timeFrame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01799967: Minimally Invasive Surgery of the Gastro-esophageal Junction
Official title: Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achalasia
Paraesophageal Hernia
GERD
Epiphrenic Diverticula
Zenker's Diverticulum
Keywords: gastro-esophageal junction
minimally invasive
Achalasia
Paraesophageal hernia
GERD
Epiphrenic diverticula
Zenker's diverticulum
All minimally invasive surgeries of the gastro-esophageal junction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.

Brief summary: This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.


Eligibility criteria: Inclusion Criteria:

* All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ

Exclusion Criteria:

* Less than 18 years of age.

Primary outcomes:
measure: MISGEJ symptoms (subjective)
timeFrame: 8 years
measure: Achalasia Disease Severity (subjective)
timeFrame: 8 years
measure: Diagnostic imaging
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Andrew JE Seely, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: