louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00433004: Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Official title: A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Partum
Keywords: Teen
Plan B
Post Partum
Emergency Contraception
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2007-02-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.


Eligibility criteria: Inclusion Criteria:

1. Female
2. English speaking
3. Aged 14-19 at enrollment
4. Immediately postpartum of a live infant
5. Planning to parent the baby
6. Desiring to delay another pregnancy for at least one year
7. General good health
8. Willing and able to follow the study protocol

Exclusion Criteria

1. Allergy to levonorgestrel
2. Current substance abuse
3. Plans for relocation outside of Philadelphia

Primary outcomes:
measure: ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
timeFrame: 1 year
measure: PREGNANCY RATES
timeFrame: 1 year
measure: PLAN B USE
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Courtney Schreiber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824004: Postoperative Chemoradiotherapy With S-1 in Gastric Cancer
Official title: A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric cancer
Adjuvant
Chemoradiotherapy
S-1
Cisplatin
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Detailed description: Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Histologically proven gastric adenocarcinoma which is complete resected
* ECOG performance status of 1 or lower
* Adequate bone marrow function

  * absolute neutrophil count \[ANC\] ≥1,500µL, and platelets ≥100,000/µL
* Adequate kidney function (serum creatinine \< 1.5 mg/dL)
* Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL) serum transaminases levels \<2 times UNL
* No prior chemotherapy

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Evidence of distant metastasis
* Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Uncontrolled infection
* Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
* Symptoms of gastrointestinal obstruction
* concomitant drug medication: The following drugs cause drug interaction with S-1.

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 3 year
Other outcomes:
measure: Health -related quality of life
timeFrame: 6 months after enrollment
Locations:
city: Hwasun-Eup
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
Study officials:
affiliation: CNUHH
name: Sang-Hee Cho, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354504: Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment
Official title: Gingival Crevicular Fluid (GCF) Bactericidal/Permeability-increasing Protein (BPI) and Interleukin (IL)-1beta in Periodontitis Patients: Non-surgical Periodontal Treatment Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).

Detailed description: Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.

Objective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.

Method: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples

Eligibility criteria: Inclusion Criteria

Systemically healthy,

* Stage II or III, Grade A periodontitis
* Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).

Exclusion Criteria:

Smoking,

* use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
* having received periodontal treatment within the last 6 months

Primary outcomes:
measure: Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Gingival crevicular fluid interleukin-1Beta levels
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz Üniversity
city: Antalya
country: Turkey
facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi
Study officials:
References:
Clinical trial NCT01972204: Intensive Instruction on the Use of Aricept
Official title: A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Type Dementia
Lead sponsor: Mirai Iryo Research Center, Inc.
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 125
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 examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.

Detailed description: To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.

Eligibility criteria: Inclusion Criteria:

* Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV.
* Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
* Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.
* Outpatients in their own home.

Exclusion Criteria:

* Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment.
* Known hypersensitivity to donepezil or piperidine derivatives.
* Involvement in any other investigational drug clinical trail during the preceding 12 weeks.

Primary outcomes:
measure: Number of Participants With Medication Continuation
timeFrame: 48 weeks
Secondary outcomes:
measure: Reasons for Discontinuation
timeFrame: 48 weeks
measure: Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics
timeFrame: 48 weeks
measure: Adverse Events
timeFrame: Week 2, 12, 24, 48
Other outcomes:
Locations:
city: Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
state: Kanagawa
Study officials:
affiliation: Shonan Fujisawa Tokushukai Hospital
name: Tetsumasa Kamei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252404: FranceLEVO - Zimino Registry (FZR)
Official title: FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: low cardiac output syndrome
cardiogenic shock
Lead sponsor: Arcothova
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cardiac dysfunction receiving levosimendan (Zimino®)

Brief summary: The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

Detailed description: This is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving Zimino® in France.

The patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. The follow-up can be a phone call or a visit to the hospital. Patients who meet the eligibility criteria will be identified consecutively at each hospital. The participating hospitals will vary in size and medical activities, depending on their location and the population size they serve.

The physician will determine the patient's treatment strategy. Drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians.

The estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months.

Eligibility criteria: Inclusion Criteria:

* Patients receiving Zimino® treatment
* Patients or patient's families not objecting to the patient's participation in the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Indication for levosimendan (Zimino)
timeFrame: from January 28, 2020 until January 28, 2021
measure: Dose of levosimendan (Zimino) (in µg/kg/min)
timeFrame: from January 28, 2020 until January 28, 2021
measure: Duration of levosimendan (Zimino) infusion
timeFrame: from January 28, 2020 until January 28, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou, AP-HP
state: Ile De France
Study officials:
affiliation: Arcothova
name: Bernard CHOLLEY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00994604: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Official title: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
COPD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Detailed description: Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

Eligibility criteria: Inclusion Criteria:

* asthma
* COPD

Exclusion Criteria:

* currently on chronic oral steroid medications
* current respiratory symptoms
* pregnant
* FEV1 less than 40% predicted at baseline
* extreme degrees of bronchial hyperreactivity
* recent respiratory infection (\<3 weeks)
* unstable symptoms in the prior month
* a history of intubation for respiratory symptoms within the past year
* any history of cardiac disease.

Primary outcomes:
measure: The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract
timeFrame: baseline and two weeks
Secondary outcomes:
measure: Changes in Airway Size by Computed Tomography
timeFrame: baseline and after two weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695404: Contribution of 3D Printing in Anatomical Lung Segmentectomies.
Official title: Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Keywords: Segmentectomy
Thoracic surgery
3D printed model
Mental workload
3D reconstruction
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
name: Paris cite university, 75006 Paris, France
First posted: 2023-01-25
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all anatomic segmentectomies performed by full thoracoscopy in our department.

Brief summary: The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.

Detailed description: Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

We performed a prospective randomized controlled pilot trial on 2 parallel arms:

* The "Digital" arm
* The "Digital+Object" arm.

Eligibility criteria: Inclusion Criteria:

* all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

Exclusion Criteria:

* S6 segmentectomies
* S4+5 left bisegmentectomy
* Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

Primary outcomes:
measure: Surgeon's mental workload.
timeFrame: 1 day
Secondary outcomes:
measure: The surgeon's stress during surgery
timeFrame: 1 day
measure: Surgeon's attention to work by d2-R test
timeFrame: 1 day
measure: Surgeon's attention to work by EncephalApp Stroop test.
timeFrame: 1 day
measure: The surgeon's overall satisfaction at the end of the surgery.
timeFrame: 1 day
measure: Duration of the surgical procedure
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris (thoracic surgery department)
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Madalina Grigoroiu, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02588404: The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient
Official title: The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient with Biochemical Failure Status Post Salvage or Radical Radiation Therapy (PCS VIII)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The original slides of 65 patients with informed consent will be reviewed. Assuming 50% Gene-fusion carrier rate, patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index. The block must be clearly labeled with the protocol and case number. A tissue microarray (TMA) containing cores representing clinically localized prostate cancers will be constructed from 60 men who underwent radical radiation therapy. Three cores (0.6mm in diameter) will be taken from each representative tissue block to construct the TMA. Detailed clinical, pathological, and TMA data will be maintained on a secure database.

Brief summary: The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

Detailed description: The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in prostate patients who have been treated with hormonal and radiation treatment after biochemical failure

Original biopsy slides of 65 patients will be collected and reviewed. A tissue used to test and map DNA fragments will be constructed from patients who underwent radiation therapy. RNA and DNA will be extracted from each slide. This study, if positive, will establish the predictive value of TMPRSS2-ERG gene fusion in prostate cancer patients. It can lead to believe that high-risk prostate cancer patients will benefit from a more aggressive treatment.

An endpoint of this study is to evaluate the relation between the Gleason score and the TMPRSS2-ERG gene fusion. Another is to evaluate the relation between the T-stage and TMPRSS2-ERG gene fusion.

Eligibility criteria: Inclusion Criteria: One of the following

* T3a +
* PSA \> 20
* Gleason 8 or higher
* Karnofsky performance status ≥ 70.
* Signed study-specific informed consent

Primary outcomes:
measure: Number of patients with biochemical failure showing presence of TMPRSS2-ERG gene fusion.
timeFrame: recruitment over 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: