louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04007211: Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
Official title: A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Adhesion of Uterus
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 192
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.


Eligibility criteria: Inclusion Criteria:

* Female patients aged from 19 to 70
* Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.

Exclusion Criteria:

* Those who will apply other intrauterine device rather than investigational device during the study period.

Primary outcomes:
measure: Incidence of intrauterine adhesion
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Lee DY, Lee SR, Kim SK, Joo JK, Lee WS, Shin JH, Cho S, Park JC, Kim SH. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Med J. 2020 Oct;61(10):868-874. doi: 10.3349/ymj.2020.61.10.868.
Clinical trial NCT00229411: Simulation Training as a Tool for Teamwork Improvement in Multidisciplinary Intensive Care Team
Official title: Experimental Like Observational Study of Teamwork Improvement in Multidisciplinary Intensive Care Team Before and After Simulation Training.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Education, Health
Keywords: intensive care
teamwork
medical errors
education
simulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: The purpose of the study is to check whether training mixed teams of physicians and nurses from intensive care units on patient simulators improves teamwork within the teams.

Detailed description: Patient safety and the prevention of medical error are primary goals of healthcare organizations. One of the means of reducing such errors is teamwork improvement. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses. We intend to compare simulation training of a mixed team of physicians and nurses, using specifically designed scenarios based on real life experience, to frontal teaching sessions designed to enhance teamwork, by assessing teamwork, using accepted behavioral scales, during routine work, before and after both interventions.

Eligibility criteria: Inclusion Criteria:

* intensive care physicians and nurses working in respiratory ICU willing to participate in the study

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: improvement in teamwork parameters as measured by previously published tools
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center and Medical Simulation Center
name: Asaph E Nini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578811: Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erosive Gastritis
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.


Eligibility criteria: Inclusion Criteria:

1. Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
2. Patients who voluntarily signed written informed consent may participate in the study.

Exclusion Criteria:

1. Pregnant or lactating female.
2. Patients have gastric ulcer, duodenal ulcer and GERD.
3. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
4. Patients requiring corticosteroid therapy
5. Severe neurological or psychological disease
6. History of allergic reaction to the medications used in this study
7. Use of other investigational drugs within 30 days prior to the study.
8. Patients that investigators consider ineligible for this study

Primary outcomes:
measure: Improvement rates of erosive gastritis according to the sydney classification
timeFrame: Change from Baseline in the grade of erosive gastritis at 2 weeks
Secondary outcomes:
measure: Healing rates of erosive gastritis according to the sydney classification
timeFrame: Change from Baseline in the grade of gastric erosions at 2 weeks
measure: Improvement rates of erosive gastritis by estimated the number of erosion
timeFrame: Change from Baseline in the number of gastric erosions at 2 weeks
measure: Healing rates of edema according to the sydney classification
timeFrame: Change from Baseline in the grade of edema at 2 weeks
measure: Improvement rates of erythema according to the sydney classification
timeFrame: Change from Baseline in the grade of erythema at 2 weeks
measure: Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement
timeFrame: Change from Baseline in the grade of hemorrhage at 2 weeks
measure: Improvement rates of symptoms using Korean NDI
timeFrame: Questionaire at baseline and then week 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SKChemicals
Study officials:
References:
Clinical trial NCT02700711: Methylphenidate-Duloxetine Combinations for Cocaine Dependence
Official title: Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use
* Seeking treatment for cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation
* Females not currently using effective birth control
* Contraindications to cocaine, methylphenidate or duloxetine
* Currently using opioids for pain or who are currently maintained on methadone or buprenorphine for opioid use disorder will be excluded from participation
* Body weight less than 50 kg

Primary outcomes:
measure: Number of Cocaine Positive Urines
timeFrame: Six weeks
Secondary outcomes:
measure: Self-Reported Cocaine Use
timeFrame: Six weeks
measure: Blood Pressure
timeFrame: Six weeks
measure: Heart Rate
timeFrame: Six weeks
measure: Side effects
timeFrame: Six weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
References:
Clinical trial NCT02135211: Healthy Directions After Lung Surgery Pilot
Official title: Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non Small Cell Lung
Keywords: non-small cell lung cancer (NSCLC)
multiple risk factor
lifestyle intervention
health behavior
lifestyle risk reduction
health related quality of life
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: University of Massachusetts, Boston
First posted: 2014-05-09
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.


Eligibility criteria: Patient Inclusion Criteria:

* \> 21 years of age
* English speaking
* MD approval to participate in study
* Meets one of the inclusions below:
* 1. a histological diagnosis of NSCLC undergoing potentially curative treatment
* 2. OR those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules
* 3.OR patients who have had a surgical procedure for lung cancer within the last six months.
* May invite a buddy to join study with them defined as a friend, partner, adult child or sibling

Buddy Inclusion Criteria:

* ≥ 21 years of age,
* English speaking, who is invited by the subject to join as a support person (e.g., friend, partner, adult child or sibling)

Primary outcomes:
measure: Feasibility and acceptability
timeFrame: at end of study (4 months post intervention)
measure: Feasibility and acceptability
timeFrame: at end of study (4 months post intervention)
measure: Feasibility and acceptability
timeFrame: at end of study (4 months post intervention
measure: Feasibility and acceptability
timeFrame: at end of study (4 months post intervention)
Secondary outcomes:
measure: Interest for this study
timeFrame: baseline, 1 month, & 4 month
measure: Interest for this study
timeFrame: baseline, 1 month, & 4 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Woman's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana Farber Cancer Insitute
name: Mary E. Cooley, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01552811: Studies of Pancreatic Islet Mass by Positron Emission Tomography (PET)
Official title: Open Study to Investigate Pancreatic Islet Mass by Positron Emission Tomography Using the Tracer [11C]5-hydroxytryptophane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult, type 1 diabetic patients Healthy controls

Brief summary: This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer \[11C\]5-hydroxytryptophane.


Eligibility criteria: Inclusion Criteria:

* Adult patients with type 1 diabetes
* Adult, healthy controls

Exclusion Criteria:

* Pregnancy
* Impaired renal function

Primary outcomes:
measure: Difference in pancreatic uptake of % injected dose (ID) [11]5-hydroxy tryptophan between healthy volunteers and patients with long-standing type 1 diabetes
timeFrame: To be measured at Positron emission tomography investigation for all study persons.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Per-Ola Carlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson O, Espes D, Selvaraju RK, Jansson E, Antoni G, Sorensen J, Lubberink M, Biglarnia AR, Eriksson JW, Sundin A, Ahlstrom H, Eriksson B, Johansson L, Carlsson PO, Korsgren O. Positron emission tomography ligand [11C]5-hydroxy-tryptophan can be used as a surrogate marker for the human endocrine pancreas. Diabetes. 2014 Oct;63(10):3428-37. doi: 10.2337/db13-1877. Epub 2014 May 21.
Clinical trial NCT04969211: Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers
Official title: An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Iloperidone
VHX-896
Bioequivalence
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
* Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
* Pregnant or nursing (lactating) women.

Primary outcomes:
measure: Bioequivalence between VHX-896 tablets relative to iloperidone tablets
timeFrame: 96 hours
measure: Assessment of Safety and Tolerability of a single dose of VHX-896
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Vanda Investigational Site
state: Missouri
Study officials:
References:
Clinical trial NCT06247111: Monitoring Blood Pressure at Home
Official title: Post-Emergency Department Discharge Clinic Telehealth Program for Patients With Uncontrolled Hypertension: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-02-07
Enrollment: 24
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 overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months.

Detailed description: For all participants:

1. Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure.
2. Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs.
3. Participants will come in for one research clinic visit to get blood pressure measured 3 months after enrollment in this study.

For participants asked to measure blood pressure at home:

1. Measure blood pressure twice a day at home, following the instructions provided. The study will provide participants with the device and send text message reminders each week day. Participants will return the device at study visit 3 months from now.
2. Following the instructions provided, participants will talk to a pharmacist over the phone weekly to discuss blood pressure and medications. All medication changes will be discussed with a collaborating physician.
3. Participants will complete questionnaires on satisfaction with the program.

Eligibility criteria: Inclusion Criteria:

* Patients seen at the Emergency Department Post-Discharge Clinic
* \>=18 years
* Blood pressure \>=130/80 mmHg and \<=160/100 mmHg
* English speakers
* Have a smartphone

Exclusion Criteria:

* Patients with blood pressure \>=160 mmHg

Primary outcomes:
measure: Total number of recruited participants
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Lama Ghazi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00430911: Radiotherapy for Malignant Astrocytomas in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Brain Tumor
Anaplastic Astrocytoma
Glioblastoma Multiforme
Keywords: malignant gliomas
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-02-02
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status \> 70.


Eligibility criteria: Inclusion Criteria:

* Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed
* Brain CT scan or MRI within 28 days before surgery
* Age: 70 years or older
* Karnofsky performance status, 70 or more.
* Life expectancy over 12 weeks
* Informed consent

Exclusion Criteria:

* Brain radiotherapy
* Chemotherapy
* Severe systemic disease

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Progression free survival
measure: Quality of life
measure: Cognitive functions
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Salpêtrière
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: jean-yves Delattre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assitance Publique-Hôpitaux de Paris
name: Florence Keime-Guibert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
Clinical trial NCT04052711: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-12
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design


Eligibility criteria: Inclusion Criteria:

1. Male or female age 18 and older who was healthy
2. Was of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema

Exclusion Criteria:

-

Primary outcomes:
measure: Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: