louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00729495: Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Official title: Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I,
Healthy
Volunteer
Study
Lead sponsor: POZEN
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2008-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria:

* Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

Primary outcomes:
measure: Pharmacokinetics
timeFrame: pre-dose, baseline and multiple times post-dose
Secondary outcomes:
measure: Safety
timeFrame: Throughout study
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Research
state: Missouri
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Bio-Kinetic Clinical Applications, LLC
name: Christopher Billings, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573195: Merck IISP Stewardship Grant for Antibiotic Best Practices
Official title: Implementation of Antimicrobial Stewardship and Decision Support Into the EPIC Electronic Medical Record
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Resistant Infection
Keywords: deescalation
best practice alert
antimicrobial stewardship
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 1285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1285 consecutive patients issued BPA for de-escalation of antibiotics in EPIC

Brief summary: The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC.

Detailed description: The purpose of this study is to pilot the use of best practices to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Screening information technology tools via SETNET/Safety SUrveyor(Premier) and the electronic anti-infective order form would allow for sufficient medical record review to create best practices alerts for the purpose of appropriate de-escalation of anti-invectives.

Eligibility criteria: Inclusion Criteria:

* Physicians with prescribing privileges at the UWHC

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of best practice alerts(BPA) that were completely accepted, partially accepted, or rejected within 72 hours of issuing the BPA
timeFrame: One Year
Secondary outcomes:
measure: The number and type of antiinfectives that were administered before and after(11days) the best practice alert is issued.
timeFrame: One year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Barry C Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulz L, Osterby K, Fox B. The use of best practice alerts with the development of an antimicrobial stewardship navigator to promote antibiotic de-escalation in the electronic medical record. Infect Control Hosp Epidemiol. 2013 Dec;34(12):1259-65. doi: 10.1086/673977. Epub 2013 Oct 28.
Clinical trial NCT02968095: Text Message Support to Prevent Smoking Relapse
Official title: Text Message Support to Prevent Smoking Relapse in Community Treatment Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: Miami University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Cincinnati
First posted: 2016-11-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. The intervention seeks to teach people to think about their cravings to smoke in more helpful ways. The investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million.
* Have a mobile phone and use text messaging at least monthly
* Be planning to quit smoking without pharmacological help.

Exclusion Criteria:

* Significant cognitive impairment
* Current therapy or pharmacological intervention for smoking or nicotine cravings
* Inability to read English

Primary outcomes:
measure: 7-Day Point Prevalence Abstinence
timeFrame: End of Treatment (6-week) Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Miami University
state: Ohio
Study officials:
References:
Clinical trial NCT06103695: Vtama in Psoriasis Patients Being Treated With Biologics.
Official title: Open Label, Observational Study, Evaluating VTAMA® (Tapinarof) Cream, 1% QD in Psoriasis Patients Being Treated With Biologic Agents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Patient with ≥3% BSA
4. Patient has been treated with biologic for a minimum of 24 weeks
5. Able and willing to give written informed consent prior to performance of any study-related procedures.

Exclusion Criteria:

1. ≤3% BSA
2. Patient not receiving biologic agent, or receiving biologic agent \<24weeks

Primary outcomes:
measure: Body surface area ≤1%
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Schweiger Derm Group
state: New Jersey
Study officials:
References:
Clinical trial NCT02931695: Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration
Official title: Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: post partum
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: INSERM 1166 ICAN UPMC
name: CIC1901-Centre d'Investigation Clinique Paris-Est
First posted: 2016-10-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.

The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy

Detailed description: Sex steroid hormones are known to influence heart repolarization. Overall, estradiol is considered to promote QTc lengthening while progesterone and testosterone shorten QTc. New findings suggest more complex regulation of QTc by sex steroid hormones involving also follicle-stimulating hormone, which is associated to prolongation of QTc. Another important aim of this study is to study the influence of sex hormones on QTc duration.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 yo) pregnant women in their third trimester
* Able to give her consent

Exclusion Criteria:

* Concomitant intake of QTcF prolonging drugs
* Past medical history of cardiovascular or endocrino-metabolic conditions (except hypertension or diabetes)
* QRS \>120 msec on electrocardiogram

Primary outcomes:
measure: Difference in QTcF duration (Corrected for heart rate according to Fridericia method) between third trimester of pregnancy and post-partum.
timeFrame: third trimester of pregnancy and 3 to 6 months delivery
Secondary outcomes:
measure: Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).
timeFrame: third trimester of pregnancy and 3 to 6 months delivery
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'investigation Clinique - Paris est
Study officials:
affiliation: Centre d'investigation Clinique - Paris est
name: Joe-Elie SALEM, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846895: Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
Official title: The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder (OAB)
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
* Overactive bladder syndrome (OAB)

  * ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h
  * At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.

Exclusion Criteria:

* Participants with:

  * Pelvic Organ Prolapse (POP) \> stage II of the pelvic organ prolapse quantitation system (POP-Q)
  * Post void residual volume \> 200 ml (measured by ultrasound)
  * Use of moisturizers or lubricants the last month
  * Use of vaginal estrogen in the last 6 months
  * Use of drugs for urinary incontinence
  * Use of psychotropic drugs
  * Symptomatic urinary tract infection
  * Active genital infection
  * Kidney or liver disease
  * Abnormal cardiac conduction, rate or rythm disorders
  * Diabetic neuropathy
  * Myasthenia gravis
  * History of malignant disease
  * Previous radio-chemo therapy

Primary outcomes:
measure: Overactive Bladder questionaire (OAB-q)
timeFrame: 24 months
measure: 3 days voiding diary
timeFrame: 24 months
Secondary outcomes:
measure: King's Health Questionnaire (KHQ)
timeFrame: 24 months
measure: Patients Global Impression of Improvement (PGI-I)
timeFrame: 24 months
measure: Urogenital Distress Inventory questionaire (UDI-6)
timeFrame: 24 months
measure: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
timeFrame: 24 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Themos Grigoriadis, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900195: The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Official title: The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease


Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD
* Stable Disease

Exclusion Criteria:

* Neuromuscular disease
* Recent pneumothorax
* Major surgery in the last 6 months

Primary outcomes:
measure: Forced expiratory volume in the first minute
timeFrame: 6 months after intervention
Secondary outcomes:
measure: 6 minute walking test
timeFrame: 6 months after intervention
measure: St. George's Quality of Life Score
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT05692895: PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
Official title: Immunohistochemical Expression of PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PDL1- Colorectal Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective study will be carried out on 60 colorectal carcinoma specimens that were collected randomly from archives of Pathology Department, Faculty of Medicine, Sohag University

Brief summary: Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .

Programmed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .

Cancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Both endoscopic and excisional biopsy specimens.
2. All the studied cases include sufficient materials for the immunohistochemical study.
3. Complete clinical data

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
3. Insufficient or tiny tissue biopsies

Primary outcomes:
measure: Diagnosis and prognosis of colorectal carcinoma
timeFrame: Two or three days after staining tissue sections with PDL1 antibody
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of medicine ,Sohag university
name: Amira A Abdelnaby, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02072395: Gastric Plication and Banding
Official title: Treatment of Morbid Obesity With Gastric Plication and Gastric Banding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Morbid Obesity
Keywords: morbid obesity
bariatric surgery
gastric banding
gastric plication
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.


Eligibility criteria: Inclusion Criteria:

* Age 18-70
* BMI \> or = to 30 and co-morbid conditions or BMI \> or = to 40
* Ability to provide informed consent
* Willingness to commit to long-term follow-up

Exclusion Criteria:

* Inability to provide informed consent
* Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
* Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
* Pregnancy
* Plan to become pregnant within two years post-surgery
* Current addiction to drugs or alcohol
* Previous history of any type of bariatric surgery (de novo group only)
* Hiatal hernia \> 3 cm

Primary outcomes:
measure: Weight loss
timeFrame: Two years
measure: Complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Bradley J Needleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaudhry UI, Osayi SN, Suzo AJ, Noria SF, Mikami DJ, Needleman BJ. Laparoscopic adjustable gastric banded plication: case-matched study from a single U.S. center. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):119-24. doi: 10.1016/j.soard.2014.05.030. Epub 2014 Jun 4.
Clinical trial NCT03788395: The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Official title: The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.

In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.

The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.


Eligibility criteria: Inclusion Criteria:

- uncontrolled mild or moderate persistent asthma;

Exclusion Criteria:

* acute upper respiratory infections;
* immunological or metabolic systemic disease;
* major malformations of the upper airways;
* active smokers.

Primary outcomes:
measure: Medication Adherence Rating Scale (MARS)
timeFrame: 3 months
Secondary outcomes:
measure: Childhood Asthma Control Test (C-ACT)
timeFrame: 3 months
measure: Asthma Control Test (ACT)
timeFrame: 3 months
measure: Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References:
citation: Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.