louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04489524: Smoking Cessation in NYC
Official title: A Feasibility Study of Culturally Tailored Smoking Cessation for Chinese Smokers in New York City
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-28
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators tested the feasibility of a culturally and linguistically sensitive smoking cessation program with combined counseling and pharmacological components for Chinese smokers in New York City; identified factors and techniques that enhance the administration and appropriateness of the intervention program; and examined the effectiveness of this program on quit attempts, quit rates, and overall smoking reduction.


Eligibility criteria: Inclusion Criteria:

* Primary eligibility criterion for inclusion in the study cohort was current smoking status. Other inclusion criteria were:

  1. self-identification as ethnic Chinese,
  2. aged 18 years and older,
  3. having smoked or puffed on a cigarette during the previous week,
  4. willingness to participate in the smoking cessation study,
  5. access to a functional telephone,
  6. expected presence in the study geographic area for a year or more, and
  7. not having been enrolled in the past or at the current time in any smoking cessation treatment programs.

Exclusion Criteria:

1. being currently pregnant and
2. having had a recent diagnosis of cardiovascular disease.

Primary outcomes:
measure: change in smoking behavior
timeFrame: baseline, 1 week, 1, 3, and 6-month
measure: change in Carbon monoxide (CO) concentration
timeFrame: baseline, 6-month follow-up
measure: change in the stages of smoking cessation
timeFrame: baseline, 1 week, 1, 3, and 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Asian Health, Lewis Katz School of Medicine, Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Grace X Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13.
Clinical trial NCT06426524: Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study
Official title: Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.

Detailed description: In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.

In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.

Eligibility criteria: Inclusion Criteria:

Systemically healthy male and female patients of age \>18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm.

Exclusion Criteria:

Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded

Primary outcomes:
measure: Bone Regeneration
timeFrame: 3 months and 6 months
measure: clinical attachment level
timeFrame: 3 months and 6 months
measure: Probig depth
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Telangana
Study officials:
References:
Clinical trial NCT01970124: A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinocerebellar Degeneration
Keywords: Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Spinocerebellar Ataxia (SCA)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: SARA (Scale for the Assessment and Rating of Ataxia)
timeFrame: 52 weeks
Secondary outcomes:
measure: SF-8 (QOL)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese Cities
country: Japan
Study officials:
References:
Clinical trial NCT02832024: Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
In-stent Arterial Restenosis
Keywords: stents
atherectomy
femoral artery
popliteal artery
In-stent Restenosis
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 120
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: This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

Detailed description: This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

Eligibility criteria: Inclusion Criteria:

Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with \>50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion Criteria:

They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Primary outcomes:
measure: Primary Patency Rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: freedom from clinically-driven TLR
timeFrame: 12 months
measure: Major Adverse Events
timeFrame: 12 months
measure: Limb Salvage Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gu Yong Quan
state: Beijing
Study officials:
References:
citation: Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.
Clinical trial NCT06581224: Implementation of a Primary Hospital Provider (PHP) Team
Official title: Implementation of a Primary Hospitalist Provider Team to Enhance the Care for High-Need High-Complexity Patients Requiring Hospitalization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-need, High-complexity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pragmatic clinical trial is to learn if it is possible to implement a Primary Hospital Provider (PHP) team that aims to improve continuity of care for patients who are frequently hospitalized. The main question it aims to answer is: Are patients assigned to the PHP team more likely to be assigned to this team during a follow up hospitalization? Researchers will compare this to similar patients assigned to receive usual care. Some participants from both the PHP team and usual care groups will be asked to participate in interviews to help researchers understand the needs of patients who are frequently admitted and the care they receive.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 at the time of index admission
* Two or more hospitalizations to a general medicine service at UW Health (University Hospital or East Madison Hospital) within the past 12 months AND an EPIC Readmission Risk Score of greater than a predetermined value

Exclusion Criteria:

* Outpatient primary care provider is part of the UW Health Family Medicine service that currently admits their own patients to a separate service at University Hospital
* Patients with an oncologic diagnosis for which they are actively receiving chemotherapy or immunotherapy
* Prisoners
* Pregnant women

Primary outcomes:
measure: Number of patients readmitted to the PHP team
timeFrame: 11.5 months
measure: Number of patients readmitted to usual care team
timeFrame: 11.5 months
measure: Percentage of patients readmitted to the PHP team
timeFrame: 11.5 months
measure: Percentage of patients readmitted to usual care team
timeFrame: 11.5 months
Secondary outcomes:
Other outcomes:
measure: Themes that emerge as barriers from the patient perspective
timeFrame: 6 months
measure: Themes that emerge as facilitators from the patient perspective
timeFrame: 6 months
measure: Acceptability as assessed from the patient perspective
timeFrame: 6 months
measure: Themes that emerge as barriers from the hospitalist perspective
timeFrame: 4 months
measure: Themes that emerge as facilitators from the hospitalist perspective
timeFrame: 4 months
measure: Acceptability as assessed from the hospitalist perspective
timeFrame: 6 months
Locations:
city: Madison
country: United States
facility: UW Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sara Westergaard, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871724: Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Official title: A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
* Clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals

Primary outcomes:
measure: Cmax of EDP-938 with and without coadministration with fluconazole
timeFrame: Up to 19 days
measure: AUC of EDP-938 with and without coadministration with fluconazole
timeFrame: Up to 19 days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 25 Days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Utah
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00863824: Clearance of NNAL and Cotinine From Second-hand Smoke in Hair and Urine
Official title: Elimination of NNAL and Cotinine From Hair and Urine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: NNAL
Cotinine
Second hand smoke
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2009-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Caucasians and African Americans who are ready to quit smoking.

Brief summary: This study will investigate how long it takes for NNAL and cotinine, markers of second hand smoke, to clear the human body.

Detailed description: The purpose of the study is to investigate how long it takes for NNAL and cotinine, both specific markers of second hand tobacco smoke exposure to clear the human body.

Eligibility criteria: Inclusion Criteria:

* Healthy Caucasians and African-Americans 19 years of age or above, how are ready to quit smoking

Exclusion Criteria:

* Anyone who is not a Caucasian or an African-American, below 19 years of age, and is currently taken prescription medication.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Chandran Achuatn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06328634: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital
Official title: Bacillus Cereus : a Retrospective Study of Patients Diagnosed at Nîmes University Hospital With a Positive Culture for B. Cereus From January 1, 2008 and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacillus Cereus Infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with a B. cereus infection who were hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012.

Brief summary: OBJECTIVES:

We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.

METHODS:

We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with a B. cereus infection
* patients adult (\>18)

Exclusion Criteria:

* patientn diagnosed without infection by B. Cereus

Primary outcomes:
measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Veysseyre F, Fourcade C, Lavigne JP, Sotto A. Bacillus cereus infection: 57 case patients and a literature review. Med Mal Infect. 2015 Nov-Dec;45(11-12):436-40. doi: 10.1016/j.medmal.2015.09.011. Epub 2015 Oct 31.
Clinical trial NCT01655134: Biomarkers and Therapeutic Modelisation in Heart Failure
Official title: Home-based Assessment of Plasma Volume, Serum Potassium and Renal Function Variations in Patients With Heart Failure and Low Left Ventricular Ejection Fraction: Pilot Study BIOMIC. Biomarkers and Therapeutic Modelisation in Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Telemonitoring systems for congestive HF
Biomarkers
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial encouraging results. Decongestion is one of the main objectives in Congestive HF, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. These three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive HF.

Main objective :

To assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated HF, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (ABOTT iSTAT).

Secondary objectives :

1. to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by Istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations.
2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis


Eligibility criteria: Inclusion Criteria:

* 18 years old or over
* Patients with heart failure and FE ≤ 45% hospitalized for decompensated heart failure

Exclusion Criteria:

* GFR \< 30 ml/min/1.73 m2 as estimated by the abbreviated MDRD formula
* Pregnancy and lactation
* Participation in other investigational trials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Brabois hospital
Study officials:
affiliation: Brabois Hospital
name: Patrick Rossignol
role: STUDY_DIRECTOR
References:
citation: Rossignol P, Fay R, Girerd N, Zannad F. Daily home monitoring of potassium, creatinine, and estimated plasma volume in heart failure post-discharge. ESC Heart Fail. 2020 Jun;7(3):1257-1263. doi: 10.1002/ehf2.12642. Epub 2020 Apr 10.
Clinical trial NCT04961034: Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Atresia
Keywords: biliary atresia
kasai portoenterostomy
modified
cholangitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 26
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation

Detailed description: To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival.

Methods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.

Eligibility criteria: Inclusion Criteria:

* infants with biliary atresia diagnosed and treated before 60th day of age

Exclusion Criteria:

* infants older than 60 days

Primary outcomes:
measure: the total number of cholangitis
timeFrame: two years
measure: number of native liver survivors
timeFrame: two years
Secondary outcomes:
measure: early improvement of liver functions
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbeya
city: Tanta
country: Egypt
facility: Tantra Universiy
Study officials:
References: