louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02583022: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis
Official title: A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 20 and 65 years old
* Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
* SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion Criteria:

* Patients presenting symptoms of systemic infection at screening
* Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
* Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
* Pregnant women or breastfeeding women
* Women of childbearing potential or women who are planning a pregnancy during the study

Primary outcomes:
measure: SCORing Atopic Dermatitis (SCORAD) index
timeFrame: Change from baseline at Day 28
Secondary outcomes:
measure: Visual Analogue Scale (VAS) score
timeFrame: Change from baseline at Day 7, 14 and 28
measure: Success rate to pruritus treatment
timeFrame: Change from baseline at Day 7, 14 and 28
measure: Eczema Area and Severity Index (EASI) score
timeFrame: Change from baseline at Day 7, 14 and 28
measure: Each SCORAD index
timeFrame: Change from baseline at Day 7, 14 and 28
measure: Transepidermal Water Loss (TEWL) level
timeFrame: Change from baseline at Day 7, 14 and 28
measure: Skin Hydration level
timeFrame: Change from baseline at Day 7, 14 and 28
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology, Chungang University Hospital
name: BeomJoon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00649922: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Official title: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Vaccines with adalimumab dosing
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 226
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo


Eligibility criteria: Inclusion Criteria:

* Male/Females at least 20 years of age.
* Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
* Females have a negative pregnancy test at screening.
* Diagnosis of RA and met ACR criteria.
* Must discontinue any TNF at least 2 months prior to baseline.
* In condition of general good health.

Exclusion Criteria:

* History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
* History of current acute inflammatory joint disease.
* Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
* Recent (3 month) history of influenza or pneumococcal bacterial infection.
* Known positive human immunodeficiency virus (HIV) status.
* Positive hepatitis B or hepatitis C virus.
* Positive PPD \>5 mm.
* Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.

Primary outcomes:
measure: Blood samples for Influenza A & B antibody Assay
timeFrame: Baseline (Day 1), Day 36 or premature discontinuation
measure: Blood Samples for Pneumococcal Antibody Assay
timeFrame: Baseline (Day 1), Day 36 or premature discontinuation
Secondary outcomes:
measure: Laboratory assessments
timeFrame: Screening, Week 15, Day 36, Month 3 and Month 6
measure: Vitals signs
timeFrame: Screening - Month 6
measure: Adverse events
timeFrame: Screening - Month 6
Other outcomes:
Locations:
Study officials:
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Clinical trial NCT05302622: Detecting the Most Efficient Residency Time for Laparoscopic Simulators
Official title: Determination of the Most Efficacious Period for the Use of Laparoscopic Simulators in Obstetrics and Gynecology Specialty Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy
Simulation Training
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There is three group based on the surgical skills and ob/gyn residency years.
Primary purpose: OTHER

Brief summary: Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators.

This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.


Eligibility criteria: Inclusion Criteria:

* Should be an ob/gyn resident
* Should except to participate study

Exclusion Criteria:

* Not to complete all simulations

Primary outcomes:
measure: Laparoscopic surgical procedures time
timeFrame: 6 months
Secondary outcomes:
measure: Movement number for laparoscopic procedures
timeFrame: 6 months
measure: Complication during laparoscopic surgery simulations
timeFrame: 6 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Education and Research Hospital
Study officials:
References:
Clinical trial NCT00037622: Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
Official title: An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.

Detailed description: Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.

Eligibility criteria: Inclusion Criteria:

* Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies.
* Adults ? 18 years of age
* Chronic HBV infection, known to be HbsAg positive ? 6 months
* Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study
* Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment
* HIV negative
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
* No need for excluded medications
* Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal)

Exclusion Criteria

* HIV infection
* Active Hepatitis C co-infection
* Concurrent systemic antiviral treatment
* Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
* Alcohol abuse
* Pregnancy or breast-feeding
* Inability to tolerate oral medication
* AST\>10.0 times the upper limit of normal
* ALT\>10.0 times the upper limit of normal
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
* Use of investigational drug not approved by Medical Monitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00337922: Pharmacokinetic Study Of EPZICOM Tablet
Official title: Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: EPZICOM
Lamivudine
Abacavir
pharmacokinetics
Japanese
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to explore the drug levels in the blood in Japanese HIV-infected patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total of 8 subjects.


Eligibility criteria: Inclusion criteria:

* A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug.
* A patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis.

Exclusion criteria:

* A patient developing AIDS (Patients who developed AIDS in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.)
* A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug

Primary outcomes:
measure: The following pharmacokinetic parameters of plasma lamivudine and abacavir Maximum plasma concentration(Cmax), Time to the maximum plasma concentration(tmax), Elimination half-life(t1/2), Area under the plasma concentration-time curve(AUC)
Secondary outcomes:
measure: Safety (adverse events occurring during the study period)
Other outcomes:
Locations:
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02923622: Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Colorectal Cancer
Traditional Chinese Medicine
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2016-10-04
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients with advanced colorectal cancer and the tumor progressed after conventional chemotherapy

Brief summary: Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease. The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed adenocarcinoma of the colon or rectum
* TNM classification of stage IV disease according to American Joint Committee on Cancer
* Between 18 and 80 years old
* Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before)
* Expected survival time is over 3 months
* Signed informed consent

Exclusion Criteria:

* serious non-malignant diseases such as heart, renal, and hepatic illnesses
* the presence of other types of malignancies
* The patients can not take medicine for intestinal obstruction

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Progress free survival
timeFrame: 3 years
measure: Quality of life as assessed by FACT-C v4.0
timeFrame: 3 years
measure: Tumor control rate
timeFrame: 3 years
measure: TCM syndrome score
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References:
citation: Hao TT, Xu Y, Cui N, Qu Q, Liang BY, Yuan JH, Zhao Y, Li QN, Lu F, Wu Y. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study. Chin J Integr Med. 2021 Sep;27(9):674-679. doi: 10.1007/s11655-020-3420-0. Epub 2020 Aug 19.
Clinical trial NCT03264222: Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices
Official title: Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromagnetic Interference
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Bayerisches Staatsministerium für Wirtschaft
name: R & S GmbH und Co KG
First posted: 2017-08-29
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study.
Primary purpose: PREVENTION

Brief summary: Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Detailed description: Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.

Eligibility criteria: Inclusion Criteria:

* implantable pacemaker or defibrillator in situ

Exclusion Criteria:

* malfunction of implantable pacemaker or defibrillator
* low battery voltage of implanted cardiac electronic device

Primary outcomes:
measure: Electromagnetic interference
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München
name: Christof Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lennerz C, O'Connor MJ, Blazek P, Weigand S, Grebmer C, Reif S, Friedrich L, Reents T, Bourier F, Schunkert H, Deisenhofer I, Kolb C. Modern Security Screening and Electromagnetic Interference With Cardiac Implantable Electronic Devices. J Am Coll Cardiol. 2020 Mar 17;75(10):1238-1239. doi: 10.1016/j.jacc.2020.01.012. No abstract available.
Clinical trial NCT03616522: A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced non-small cell lung cancer

Brief summary: Symptoms are common among patients with advanced malignancy undergoing treatment, and yet often go unrecognized by treatment providers. In addition to contributing to morbidity, poorly controlled symptoms drive emergency room utilization and hospital admission in this population, representing significant cost to patients, families, and the health care system. Systematic collection of patient-reported outcomes (PROs) has been proposed as a way to arm providers with the information necessary to intervene early, intensify symptom management, and improve symptom control. Recent research suggests that a standardized, web-based program of weekly patient-reported symptom monitoring leads to improved health-related quality of life and reduced acute care utilization; it may also prolong overall survival. Despite mounting evidence supporting its use among oncology patients, systematic PRO collection is lacking at most cancer centers, and optimal models for collection of PROs are poorly understood. The objective of this study is to evaluate prospectively the feasibility of a novel mobile phone-based intervention of weekly symptom reporting, among patients undergoing treatment for advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age ≥ 18 years) with advanced (metastatic) non-small cell lung cancer, initiating a new line of palliative-intent treatment at Abramson Cancer Center
* Ability to read and respond to questions in English
* Ability to provide informed consent to participate in the study
* Access to a smart phone capable of SMS-text messaging and internet access

Exclusion Criteria:

* Inability to read and respond to questions in English
* Inability or unwillingness to provide informed consent to participate in the study
* Inability to engage with SMS-text based platform
* Current enrollment in a clinical trial

Primary outcomes:
measure: Number of subjects who will adhere to the mobile phone-based intervention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lawrence Shulman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05285722: Testing of Cognitive Behavioral Therapy Resource of Turkish Version
Official title: Adaptation and Testing of Cognitive Behavioral Therapy Resource of Turkish Version of ''Message to Dentist'' to Reduce Dental Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
cognitive behavioral therapy
pediatric dentistry
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 262
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings.

Detailed description: Children aged 5-16 years attending a dental faculty clinic and a private dental office were invited to complete the MTD form. Children were asked to report how worried they felt, their level of pain they anticipated and the actual level of pain they experienced on a scale of 1-10 (with 1 being the best outcome).

Eligibility criteria: Inclusion Criteria:

Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence

* Without any systemical and mental diasabilities
* Who volunteered to participate in the study and whose parental consent was obtained.

Exclusion Criteria:

* not have dental anxiety
* having any systemical or mental disability
* having negative experiences during dental treatment in childhood or adolescence
* and who did not volunteer to participate in the study and did not have parental consent for the study were excluded.

Primary outcomes:
measure: clinic differences and dental anxiety
timeFrame: 6 month
measure: worry type of participants
timeFrame: 6 month
measure: Gender anxiety differences
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Altinbas University, Faculty of Dentistry
state: Bakirkoy
city: Istanbul
country: Turkey
facility: Altinba University Faculty of Dentistry
Study officials:
References:
citation: Porritt J, Rodd H, Morgan A, Williams C, Gupta E, Kirby J, Creswell C, Newton T, Stevens K, Baker S, Prasad S, Marshman Z. Development and Testing of a Cognitive Behavioral Therapy Resource for Children's Dental Anxiety. JDR Clin Trans Res. 2017 Jan;2(1):23-37. doi: 10.1177/2380084416673798. Epub 2016 Nov 1.