louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01251419: The Impact of Social Proximity on Conversion to Generic Prescription Medications
Official title: The Impact of Social Proximity on Conversion to Generic Prescription Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conversion From Brand Name to Generic Medication
Keywords: Generic Medication
Brand Name Medication
Conversion Rates
Social Proximity
Behavioral Economics
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-12-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to understand the effects of receiving peer information on individuals' conversion rates from brand name prescription medication to generic prescription medication.

Detailed description: At companies where employees are predominantly union members, we will compare the efficacy of a peer information intervention using a testimonial from a union identified employee to an intervention using a testimonial with no union identification, as well as to a no-testimonial intervention.

The control arm will receive a letter signed by our partner company's Chief Medical Officer, explaining the health and monetary benefits of switching from brand name prescription medication to generic prescription medication. The testimonial treatment arm will receive the exact same letter, but the letter will feature an employee's testimonial along with the first name, last initial, city and state of the employee giving the testimonial. The testimonial and union arm will receive the same letter as the testimonial treatment arm but with the addition of the union affiliation of the employee giving the testimonial.

Eligibility criteria: Inclusion Criteria:

* Employee of a company that uses Express Scripts as its pharmacy benefits manager.
* Employee at a company with predominantly union employees.
* Currently taking a brand name medication with an exact generic equivalent.

Exclusion Criteria:

* Employees on any psychological prescription medication.

Primary outcomes:
measure: Conversion from Brand Name to Generic Prescription Medication
timeFrame: One month to one year after the intervention.
Secondary outcomes:
measure: Union Status and Conversation to Generic Medication
timeFrame: One month to one year after the intervention.
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Express Scripts
state: Missouri
Study officials:
affiliation: National Bureau of Economic Research
name: David Laibson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05999019: Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer
Official title: Appraisal of Surgical Outcomes and Oncological Efficiency of Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included 366 patients who underwent robotic gastrectomy at the Department of Gastrointestinal Surgery, Fujian Medical University Union Hospital, between August 2016 and September 2019, where over 800 gastrectomies were performed annually for patients with GC.

Brief summary: Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery for gastric cancer (GC).

Detailed description: Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is a significant lack of research on iAE compared with postoperative complications. Owing to the influence of reporting and cultural acceptance, there have been issues of inadequate reporting and non-standardized practices regarding iAE reporting.

The previously reported laparoscopic results showed that the ClassIntra grade is an effective prognostic and surgical quality control index for laparoscopic radical surgery for gastric cancer therefore it could be included in routine hospital care and surgical quality control. (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical gastrectomy significantly correlated with the occurrence of postoperative complications and a poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a crucial surgical quality control and prognostic indicator in the routine surgical quality evaluation system are recommended.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with gastric adenocarcinoma through pathology;
* Preoperative chest radiograph, abdominal ultrasonogram, and full abdominal CT examination showed no distant metastasis to the liver, lungs, or abdominal cavity;
* Patients who underwent robotic radical gastrectomy.

Exclusion Criteria:

* Intraoperatively existing distant metastases
* Neoadjuvant chemotherapy
* Missing general and video data.

Primary outcomes:
measure: ClassIntra grade
timeFrame: 1 months
Secondary outcomes:
measure: Objective Structured Assessment of Technical Skill (OSATS)
timeFrame: 1 months
measure: 3-year overall survival
timeFrame: 36 months
measure: 3-year disease-free survival
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02678819: Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
Official title: Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aids
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

Detailed description: " Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.

The investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.

Eligibility criteria: Inclusion Criteria:

* Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)

Exclusion Criteria:

* All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)

Primary outcomes:
measure: Technical Performance as compared to a Reference Task List
timeFrame: Time 0-30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Lyonnais d'Enseignement par la Simulation en Santé
Study officials:
affiliation: Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
name: Jean-Christophe CEJKA, MD PhD mEng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.
Clinical trial NCT03561519: FMT in the Treatment of IBS
Official title: FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: University of Helsinki
First posted: 2018-06-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Primary purpose: TREATMENT

Brief summary: 52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.

Detailed description: 52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBS based on Rome III criteria
* Having received traditional treatment for at least 1 month
* Availability of consecutive fecal samples over one year.
* Compliance to attend ileocolonoscopy and FMT procedure.
* 18-75 years

Exclusion Criteria:

* Unable to provide informed consent
* Antibiotic therapy in past 3 months
* Inflammatory bowel disease (IBD)

Primary outcomes:
measure: IBS symptom relieve
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: +358 9 4711
name: Perttu Arkkila, Adj. Prof.
role: STUDY_CHAIR
References:
citation: Lahtinen P, Jalanka J, Hartikainen A, Mattila E, Hillila M, Punkkinen J, Koskenpato J, Anttila VJ, Tillonen J, Satokari R, Arkkila P. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. 2020 Jun;51(12):1321-1331. doi: 10.1111/apt.15740. Epub 2020 Apr 28.
Clinical trial NCT04693819: Exploratory Study on the Role of Somatic Modulation in Hyperacusis
Official title: Exploratory Study on the Role of Somatic Modulation in Hyperacusis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperacusis
Keywords: Hyperacusis
Somatic
Modulation
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be aimed at adults experiencing a primary complaint of hyperacusis (i.e. abnormally reduced tolerance to sound).

Brief summary: This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound' and is commonly associated with tinnitus. The effects of somatic modulation upon tinnitus have been studied, but not so for hyperacusis.. The effect of 9 somatic modulations (i.e. 3 jaw modulations and 6 cervical spine modulations) and 1 control movement (i.e. without any somatic modulation effect) in random order on the sound tolerance of a 1 kilohertz (kHz) broadband noise sound and the tinnitus experience will be investigated. More specifically, the perceived loudness and intrusiveness of this sound and the tinnitus sound will be evaluated before somatic modulation and during the somatic modulation.


Eligibility criteria: Inclusion Criteria:

* Primary complaint of hyperacusis

Exclusion Criteria:

* Primary complaint of tinnitus

Primary outcomes:
measure: Change in rating of hyperacusis (loudness and intrusiveness) after modulation
timeFrame: Baseline (Before modulation), Immediately after modulation
Secondary outcomes:
measure: Change in rating of tinnitus (loudness and intrusiveness) after modulation
timeFrame: Baseline (Before modulation), Immediately after modulation
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: University Hospital Antwerp
Study officials:
References:
citation: Shore SE. Plasticity of somatosensory inputs to the cochlear nucleus--implications for tinnitus. Hear Res. 2011 Nov;281(1-2):38-46. doi: 10.1016/j.heares.2011.05.001. Epub 2011 May 18.
citation: Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3.
citation: Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
citation: Demoen S, Michiels S, Gilles A, Vermeersch H, Joossen I, Vanderveken OM, Lammers MJW, Timmermans A, Van Rompaey V, Baguley D, Jacquemin L. Pilot study on the role of somatic modulation in hyperacusis. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1425-1435. doi: 10.1007/s00405-022-07695-y. Epub 2022 Oct 13.
Clinical trial NCT05576519: Immunohistochemical Expression of Epithelial Cell Adhesion Molecule (EpCAM) in Epithelial Ovarian Carcinoma
Official title: Immunohistochemical Expression of Epithelial Cell Adhesion Molecule (EpCAM) in Epithelial Ovarian Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Carcinoma
Keywords: Ovarian carcinoma
CSCs
EpCAM
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty paraffin blocks of EOC collected from the archive of Pathology Department of Sohag Faculty of Medicine during the time period from June 2017 to June 2022.

Brief summary: Cancer stem cells (CSCs) can undergo self-renewal and differentiation. EpCAM is a 40-kDa type I transmembrane glycoprotein composed of a large extracellular domain, one transmembrane region, and a small intracellular domain of 26 amino acids. Recent insights revealed that it is involved in promoting cancer cell proliferation, migration, and invasiveness. It is used as a diagnostic and prognostic marker. EpCAM has also recently been identified as a marker for CSCs.

Detailed description: Ovarian carcinoma is one of most frequent cancer in women worldwide. Epithelial ovarian carcinoma is a group of neoplasms with different histologic pictures. Serous carcinoma is the most common type.

Cancer stem cells (CSCs) can undergo self-renewal and differentiation. EpCAM is a 40-kDa type I transmembrane glycoprotein composed of a large extracellular domain, one transmembrane region, and a small intracellular domain of 26 amino acids. It is abundantly expressed by the majority of human epithelial carcinomas, including colorectal, breast, lung, prostate, ovarian, and endometrial cancers. it is overexpressed in various neoplasms. Recent insights revealed that it is involved in promoting cancer cell proliferation, migration, and invasiveness. It is used as a diagnostic and prognostic marker. EpCAM has also recently been identified as a marker for CSCs.

Eligibility criteria: Inclusion Criteria:

* Patients with epithelial ovarian carcinoma and underwent surgery

Exclusion Criteria:

* - Cases received pre-operative chemotherapy or radiotherapy.
* Cases with insufficient clinical data.

Primary outcomes:
measure: evaluate EpCAM expression in ovarian carcinoma
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
city: Sohag
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT01702519: A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Official title: A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.


Eligibility criteria: Inclusion Criteria:

* BMI 19-27 kg/m2
* smokes \>10 cigarettes per day for preceeding 6 months

Exclusion Criteria:

* inability to stop smoking during study

Primary outcomes:
measure: Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)
timeFrame: Baseline to 32 hours
measure: Maximum Measured Plasma Concentration (Cmax)
timeFrame: Baseline to 32 hours
Secondary outcomes:
measure: Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)
timeFrame: Baseline to 32 hours
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Baseline to 32 hours
measure: Plasma Half-life (t1/2)
timeFrame: Baseline to 32 hours
measure: Rate of Elimination (Kel)
timeFrame: Baseline to 32 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06793319: The Effect of Education Given to Patients with Atrial Fibrillation on Anxiety Levels
Official title: Atriyal Fibrilasyonu Olan Hastalara Verilen Eğitimin Anksiyete Düzeyleri Üzerine Etkisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation (AF)
Atrial Fibrillation New Onset
Keywords: Anxiety
Atrial Fibrillation
Patient education
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a study that does not involve drugs or biological products. It was examined how the education given to patients affected anxiety. The operating model is parallel.
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effect of a structured training program on state anxiety levels in patients diagnosed with Atrial Fibrillation (AF). AF is a chronic heart rhythm disorder that negatively affects patients' quality of life with both physical and psychological symptoms. Lack of information and uncertainty in AF patients cause increased anxiety levels, making compliance with treatment difficult. This study aims to determine whether an educational intervention for AF patients can reduce their anxiety levels and increase their awareness of the disease. This is a randomized controlled trial. A two-session individual training program containing detailed information about AF will be applied to the training group and no training will be given to the control group. Data will be collected through a personal information form and the Situationality Anxiety Inventory (STAI).

Hypotheses of the Research H0: Training regarding Atrial Fibrillation has no effect on the anxiety level of patients.

H1: Education regarding Atrial Fibrillation reduces the anxiety level of patients.


Eligibility criteria: Inclusion criteria:

* Newly diagnosed with AF,
* Able to speak and understand Turkish,
* Does not have a physical or psychological disorder that would cause communication problems,
* Patients between the ages of 18 and 65 who are oriented to place and time, -Agreeing to participate in the study

Exclusion criteria:

\* Using any psychotropic medication (antidepressant, anxiolytic, antipsychotic)

Primary outcomes:
measure: Anxiety Levels of Patients Given Atrial Fibrillation Training
timeFrame: Within 2-3 hours after training
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Uskudar University
Study officials:
affiliation: Uskudar University
name: Sebahat B Ateş
role: STUDY_DIRECTOR
References:
Clinical trial NCT00367419: Use of Erythromycin in Mustard-Induced Bronchiolitis
Official title: Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiolitis Obliterans
Acute Obliterating Bronchiolitis
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2006-08-22
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans


Eligibility criteria: Inclusion Criteria:

* Documented chemical exposure
* Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
* Non-responsiveness to high dose bronchodilator therapy

Exclusion Criteria:

* Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
* History of cigarette smoking and occupational exposure to toxic agents of hypersensitivity to macrolides
* History of treatment with a systemic antibiotic within 7 days before the start of the study
* Any investigational medicine within 4 weeks of the study
* History of antibiotic injection within 6 weeks before the study
* Concomitant Theophylline or Carbamazepine, unless their serum concentrations were regularly monitored
* Patients who were in the exacerbation phase of their respiratory complications
* Need to use medications interact with macrolides such as Digoxin, Theophylline and Carbamazepine
* Systemic antibiotics
* Systemic Corticosteroids
* Admission to the hospital
* Abnormal kidney or liver function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqiyatallah Medical Sciences University
Study officials:
affiliation: Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
name: Mostafa Ghanei, Professor
role: STUDY_DIRECTOR
References: