louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02039440: 6-year Antibody Check After Third Vaccination Against Japanese Encephalitis
Official title: Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Other Specified Vaccination Encephalitis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.

Detailed description: Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.

The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

Eligibility criteria: Inclusion Criteria:

* Subjects who received a booster dose of JE-VC in study IC51-311
* Subjects who are willing to give written informed consent to participate in the trial

Exclusion Criteria:

* Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311
* Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy
* simultaneous participation in another clinical study

Primary outcomes:
measure: Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT
timeFrame: 1.5 years
Secondary outcomes:
measure: Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT
timeFrame: 1.5 years
Other outcomes:
measure: Projected mean duration of protection after a booster dose of JE-VC
timeFrame: 1.5 years
Locations:
city: Vienna
country: Austria
facility: Institute for Specific Prophylaxis and Tropical Medicine
state: Kinderspitalgasse 15
Study officials:
affiliation: Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15
name: Herwig Kollaritsch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02460640: The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy:
Official title: The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Chronic Pain
Keywords: Minimally invasive surgery
Partial nephrectomy
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 96
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: Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.


Eligibility criteria: Inclusion Criteria:

* asa score I,II,II
* patients scheduled for robot assisted partial nephrectomy

Exclusion Criteria:

* previous abdominal surgery
* inability to provide informed consent
* allergy to the anesthetic drugs

Primary outcomes:
measure: Morphine consuption 24 hr after surgery
timeFrame: 24 hours
measure: Acute pain after surgery measured with Numerical Rating Scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena CI
Study officials:
References:
citation: Covotta M, Claroni C, Costantini M, Torregiani G, Pelagalli L, Zinilli A, Forastiere E. The Effects of Ultrasound-Guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy: A Prospective Randomized Clinical Trial. Pain Med. 2020 Feb 1;21(2):378-386. doi: 10.1093/pm/pnz214.
Clinical trial NCT03585140: Low Glycemic Index and Load Diet for the Treatment of Acne
Official title: Effect of Adding a Diet With Low Glycemic Index and Load During 12 Weeks for the Treatment of Moderate Acne in Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Diet Modification
Keywords: Acne Vulgaris
Low Glycemic Diet
Doxycycline
Adapalene
Lead sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, two-arm
Primary purpose: TREATMENT

Brief summary: Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.

Detailed description: Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.

Eligibility criteria: Inclusion Criteria:

* Having moderate inflammatory acne
* 18 to 25 years old
* Male
* Stable weight during the last 3 months

Exclusion Criteria:

* Previous or actual isotretinoin therapy
* Antibiotic therapy or during the last 3 months
* Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
* Endocrine disorders
* Drug and alcohol consumption during the last 6 months
* Tabacco use during the last 6 months
* Lactose intolerance
* Have eating disorders or gastrointestinal disorders
* Actual nutrition therapy
* Have chronic diseases that requires pharmacologic therapy
* Severe acne that requires isotretinoin therapy

Primary outcomes:
measure: Count of inflammatory acne lesions
timeFrame: 12 weeks
Secondary outcomes:
measure: Count of non-inflammatory acne lesions
timeFrame: 12 weeks
measure: Changes in quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Centro Dermatológico Dr. Ladislao de la Pascua
name: Martha A Morales-Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164840: Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Official title: Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.

On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.

The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.


Eligibility criteria: Inclusion Criteria:

* Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months

Exclusion Criteria:

* Erosive esophagitis
* Concomitant peptic ulcer disease
* Use of NSAID in recent 4 weeks (Low dose aspirin \< 300 mg is allowed)
* Pregnant or lactating female
* Illiterate patient (who cannot administer questionnaire)
* Known hypersensitivity to PPI

Primary outcomes:
measure: Treatment failure
timeFrame: 26 Weeks
Secondary outcomes:
measure: Symptom score
timeFrame: 26 weeks
measure: Quality of Life
timeFrame: 1 year
measure: Number of days off treatment
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Justin CY WU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085940: Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Official title: Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 37
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: Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction. Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some metabolic effects. The investigators intend to find the role of HCQ to improve endothelial dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL (oxidized-LDL) level change, with endothelial dysfunction improvement.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis patients (2010 ACR/EULAR criteria)
* Being or will be treated with methotrexate (monotherapy)
* Agree to join the study

Exclusion Criteria:

* Autoimmune diseases other than RA
* Acute severe infection, acute coronary syndrome, heart failure, stroke
* Malignancy or chronic inflammatory diseases
* Eye disease involving the retina and visual field defects
* G6PD (glucose 6-phosphate dehydrogenase) deficiency
* History of smoking within last 5 years
* Lipid lowering, insulin resistance lowering, antidiabetic, insulin, ACE(angiotensin converting enzyme)-inhibitor or ARB(angiotensin receptor blocker) drugs

Primary outcomes:
measure: Endothelial dysfunction marker
timeFrame: 3 months
measure: Endothelial dysfunction marker
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Ciptomangunkusumo Hospital
Study officials:
References:
Clinical trial NCT01991340: H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
Official title: H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 657
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: Patients with HER2-positive breast cancer eligible for treatment with Herceptin

Brief summary: This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed HER2-positive breast cancer
* Eligible to receive Herceptin as per Summary of Product Characteristics

Exclusion Criteria:

* Contra-indications according to Summary of Product Characteristics

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to approximately 4.5 years
Secondary outcomes:
measure: Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)
timeFrame: up to approximately 4.5 years
measure: Incidence of asymptomatic LVEF decline
timeFrame: up to approximately 4.5 years
measure: Frequency of treatment discontinuations/interruptions
timeFrame: up to approximately 4.5 years
Other outcomes:
Locations:
city: Algiers
country: Algeria
city: Annaba
country: Algeria
city: Blida
country: Algeria
city: Mascara
country: Algeria
city: Oran
country: Algeria
city: Sidi Belabes
country: Algeria
city: Tizi Ouzou
country: Algeria
city: Agadir
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Fes
country: Morocco
city: Marrakech
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05376540: Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
Official title: Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gall Stone
Cholecystitis
Keywords: Cholecystectomy
Flourescent cholangiography
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2022-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.


Eligibility criteria: Inclusion Criteria:

* Indication for laparoscopic cholecystectomy
* Signed informed consent

Exclusion Criteria:

* Allergy to indocyanine green or iodine
* Pregnancy or breast feeding

Primary outcomes:
measure: A questionnaire will be used to evaluate the surgeons experience.
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moss
country: Norway
facility: Østfold Hospital trust
Study officials:
affiliation: Ostfold Hospital Trust, Norway
name: Tom Nordby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184040: Extending Contingency Management's Benefits With Progressively Increasing Variable Interval Prize Reinforcement
Official title: Extending Contingency Management's Benefits With Progressively Increasing Variable Interval Prize Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Addictive Behaviors
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-18
Enrollment: 61
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: Contingency Management (CM) is highly effective in promoting recovery from substance use disorders, but benefits tend to attenuate over time when CM is discontinued. Identifying modifications of CM delivery that can extend its benefits is an important goal. The goal of this study is to evaluate the use of reinforcements to increase physical activity, specifically walking. The study provides a standard CM intervention to promote walking for three weeks. After three weeks, a progressively increasing variable interval schedule of reinforcement will be evaluated for increasing the durability of effects of the initial CM intervention. We hypothesize that Variable Interval Prize Contingency Management will result in greater adherence to a walking goal of 10,000 steps per day at Week 15 and Week 24 compared to the Control Condition.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* currently not physically active
* Physically able and willing to walk 10,000 steps per day

Exclusion Criteria:

* psychiatric or physical illness that could interfere with participation

Primary outcomes:
measure: number of steps walked in seven days prior to follow up assessment, as verified by the pedometer
timeFrame: week 15
measure: number of steps walked in seven days prior to follow up assessment, as verified by the pedometer
timeFrame: week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Heatlh Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00211640: Identification and Treatment of Men With BPH in the Primary Care Setting
Official title: A Proactive Approach to the Identification and Treatment of Men With BPH Inthe Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No Conditions for This Study. All Male Patients 18 Years of Age or Older Were Administered the LUTS, MSHQ, and Patient Demographics Questionnaire
Lead sponsor: Mid Michigan Health Centers
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 1100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Male patients between the ages of 18 to 100 years of age who entered the Mid Michigan Health Center were administered a patient demographic questionnaire, a Lower Urinary Tract Symptom (LUTS) questionnaire, and the Men's Sexual Health Questionnaire (MSHQ) without exception. The purpose of this study was to better identify symptoms of benign prostatic hyperplasia (BPH) with the intent to prescribe better and more helpful treatment options for patients demonstrating these symptoms.


Eligibility criteria: Inclusion Criteria:

* All male patients between the ages of 18 to 100 years

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mid Michigan Health Centers
state: Michigan
Study officials:
affiliation: Mid Michigan HC Partner
name: Matt T Rosenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04291040: Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies
Official title: Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy, High Risk
Contraception
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-03-02
Enrollment: 380
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.

Detailed description: This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum.

The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.

Eligibility criteria: Inclusion Criteria:

* Aged 13-50 years old
* High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications

Exclusion Criteria:

* Planned cesarean hysterectomy
* Unable to provide informed consent in either English or Spanish
* Unable to provide reliable cell phone access for the study duration
* Not willing to provide follow-up for two years

Primary outcomes:
measure: Rate of initial LARC utilization
timeFrame: 12 weeks postpartum (12 weeks)
Secondary outcomes:
measure: Number of patients who keep the LARC after placement
timeFrame: 12 months
measure: Number of patients who keep the LARC after placement
timeFrame: 24 months
measure: rates of short interval pregnancy
timeFrame: 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
citation: Qureshey EJ, Chauhan SP, Wagner SM, Batiste O, Chen HY, Ashimi S, Ross PJ, Blackwell SC, Sibai BM. Educational Multimedia Tool Compared With Routine Care for the Uptake of Postpartum Long-Acting Reversible Contraception in Individuals With High-Risk Pregnancies: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):571-578. doi: 10.1097/AOG.0000000000004718. Epub 2022 Mar 10.