louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01315626: Bronchiectasis: Evaluation of an Educational Intervention
Official title: Identification of Patients With a Diagnosis of Bronchiectasis: Evaluation of an Educational Intervention
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bronchiectasis
Keywords: Bronchiectasis
pulmonary exacerbations
pulmonary infections
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present, or who have been seen in the above time periods, to the participating primary care physician with the following inclusion / exclusion criteria will be enrolled.

Brief summary: A study of an educational intervention of primary care practice physicians to assist in the identification of patients who have Bronchiectasis and to assess the effectiveness of the specific didactic educational intervention targeting primary care physicians in the recognition of Bronchiectasis.

Detailed description: A pilot study will be conducted for the purpose of evaluating an educational intervention (Description in Appendix A). As part of the educational intervention, primary care physician(s) will be trained in the use of an algorithm to guide assessment of patients seen with a respiratory chief complaint, and who have not previously been identified as having a diagnosis of BE. We propose an evaluation of three primary care practice(s) to compare the number of patients identified in three three-month periods as having a diagnosis of BE.

The evaluation periods will be as follows: Period 1) the three-month period immediately following the intervention, Period 2) the three-month period immediately preceding the intervention, Period 3) the three month period starting one year prior to the intervention.

Eligibility criteria: Inclusion Criteria:

1. Respiratory is the chief complaint
2. Patient \> 35 years of age
3. Seen in practice for \> 12 months

Exclusion Criteria:

1) Prior diagnosis with bronchiectasis

Primary outcomes:
measure: Number / Percent of BE patients
timeFrame: 18 months
Secondary outcomes:
measure: HRCT patients
timeFrame: 18 months
Other outcomes:
Locations:
city: Shelbyville
country: United States
facility: Howard Rupard, MD Primary Care Practice
state: Tennessee
Study officials:
References:
Clinical trial NCT01671826: Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years
Official title: Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newly Diagnosed Myeloma Patient Above 65 Years Old
Keywords: Multiple Myeloma
Autologous Stem Cell Transplantation
Elderly Patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed myeloma patients over 65 years of age and a measurable disease.

Brief summary: Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.

Detailed description: Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed MM,
* age over 65,
* measurable disease

Exclusion Criteria:

* Patients less than 65 and/or not proceeding to autologous PBSC transplantation

Primary outcomes:
measure: Progression Free survival
timeFrame: 2 years
Secondary outcomes:
measure: Response
timeFrame: after induction, 3 months post transplant, 2 months post consolidation
measure: Time To Progression
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Lyon
country: France
facility: CHU
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique
name: Laurent Garderet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garderet L, Beohou E, Caillot D, Stoppa AM, Touzeau C, Chretien ML, Karlin L, Moreau P, Fontan J, Blaise D, Polge E, Gueye MS, Ikhlef S, Marjanovic Z, Labopin M, Mohty M. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016 Nov;101(11):1390-1397. doi: 10.3324/haematol.2016.150334. Epub 2016 Sep 9.
Clinical trial NCT00361426: EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients
Official title: EarlySense Monitoring Device Evaluation on Patients in Med / Surg
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COPD Patients
Keywords: COPD
Respiration Rate
Monitoring
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Chaim Sheba Medical Center
First posted: 2006-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in Med/Surg unit

Brief summary: Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.

Detailed description: Study's participants are CHF, COPD and Pneumonia patients or patients who are otherwise hospitalized in internal medicine department. During the study the patients' breathing patterns, heart rate, restlessness and cough in sleep will be measured by the EarlySense ES 16 device, which is placed in the patients' bed.

Patients' clinical status are followed. The patient's clinical condition is followed and analyzed in comparison to the EarlySense system output in order to determine the capability of the EarlySense system to predict COPD, CHF or Pneumonia deteriorations.

Eligibility criteria: Inclusion Criteria:

* CHF, COPD and Pneumonia Patients or control group non respiratory patients
* 18 years old and up
* Able to perform spirometry test or connect to ECG, respiratory belt, SPO2
* Willing to sign consent form
* Home close to Tel Aviv

Exclusion Criteria:

* hospitalization within the passing year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Haim Sheba Medical Center, Israel
name: Martine Szyper-Kravitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06294626: Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
Official title: Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniosynostosis, Sagittal
Scaphocephaly
Developmental Delay
Keywords: scaphocephaly
neuromotor development
alberta infant motor scale
denver II developmental screening test
pediatric rehabilitation
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 21 cases diagnosed with scaphocephaly aged 2-17 monts were included.

Brief summary: It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.

21 infants diagnosed with scaphocephaly aged 2-17 months were included.

* Is there any delay in the neuromotor development of scaphocephaly cases?
* If delay is observed, in which area is it most common?

Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.

Detailed description: Scaphocephaly (sagittal synostosis) is the most common single-suture craniosynostosis. It occurs as a result of premature ossification of the fibrous connective tissue extending between two parietal bones (sagittal suture). Phenotypically, a long and narrow head shape occurs. It occurs in 2-3 per 10,000 live births and is more common in men.

Premature ossification of the sagittal suture can lead to cranial deformity, potentially cranial growth restriction, and resulting increased intracranial pressure. In these cases, increased intracranial pressure and compression of the sagittal sinus cause increased venous pressure, which may cause developmental delays. These delays most commonly include cognitive impairments, language disorders, motor delays, learning disabilities, executive dysfunction, and behavioral problems.

When looking at the literature, it was seen that the studies were mostly on neurocognitive development in cases with craniosynostosis. There are relatively fewer studies focusing on the neuromotor development of these cases.

This study aims to evaluate the neuromotor development of scaphocephaly cases.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with scaphocephaly
* Being between 0-18 months

Exclusion Criteria:

* Be over 18 months
* Having a diagnosed disease other than scaphocephaly

Primary outcomes:
measure: Denver-II Developmental Screening Test
timeFrame: baseline
measure: Alberta Infant Motor Scale
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
state: Uskudar
Study officials:
References:
Clinical trial NCT04785326: Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Meiji Seika Pharma Co., Ltd.
First posted: 2021-03-05
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

Exclusion Criteria:

* Patients with hypersensitivity to ustekinumab or any of the product excipients.

Primary outcomes:
measure: • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
timeFrame: Week 8 (For EMA) and 12 (For FDA)
Secondary outcomes:
Other outcomes:
Locations:
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
Study officials:
References:
Clinical trial NCT01543126: IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer
Official title: A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: metastatic breast cancer patients with pleural effusion

Brief summary: Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

Detailed description: To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Eligibility criteria: Inclusion Criteria:

* Female between 18 and 70 years old;
* Patients with histologic proved metastatic breast cancer;
* Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
* There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
* With at least one measurable disease according to RECIST criteria,
* Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB\<UNL (\<1.5 x UNL in patients with liver mets),ALT/AST\< 1.5 x UNL (\<2.5x UNL in patients with liver mets),AKP\<5 x UNL(except bone mets),Cr\<UNL;
* Normal functions with heart, liver,renal and bone marrow;
* Got ICF before enrollment;
* Life expectancy more than 12 weeks.

Exclusion Criteria:

* Pregnant or breast-feeding women or positive serum pregnancy test;
* Uncontrolled brain metastases;
* No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
* Participation in any investigational drug study within 4 weeks preceding treatment start;
* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
* Serious uncontrolled intercurrent infections;
* Poor compliance.

Primary outcomes:
measure: level of IL-6 and IL-8
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05090826: A Real-World Study for the TECNIS Synergy™ Intraocular Lens
Official title: A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Synergy™ Intraocular Lens Model ZFR00V
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 42
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Synergy™ IOL. The study will enroll up to 100 subjects from a single site in China. All implanted subjects will be followed for 12 months postoperatively.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients at least 22 years of age
2. Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Synergy intraocular lens
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian

Exclusion Criteria:

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Planned monovision correction (one eye designated for near correction).
3. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Primary outcomes:
measure: mean monocular postoperative DCNVA
timeFrame: 6 months
measure: percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCNVA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6
state: Hainan
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02796326: Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Official title: Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Stenosis
Keywords: tracheal stenosis
tracheal dilatation
ventilation
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

Detailed description: The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Symptoms of tracheal or laryngeal stenosis or airway narrowing
* Endoscopic evidence of subglottic or tracheal stenosis
* Able to provide informed consent

Exclusion Criteria:

* Refractory stenosis not amenable to balloon dilatation
* Contraindication to balloon dilatation
* Lack of informed consent

Primary outcomes:
measure: Incidence of peripheral arterial desaturation
timeFrame: During procedure (up to 60 minutes duration)
measure: Time to desaturation
timeFrame: During procedure (up to 60 minutes duration)
Secondary outcomes:
measure: Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading
timeFrame: During procedure (up to 60 minutes duration)
measure: Incidence of major adverse events
timeFrame: During and within 24 hours of procedure
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
References:
Clinical trial NCT01652326: Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Official title: Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Withdrawal Syndrome
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2012-07-30
Enrollment: 792
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: hospitalized inpatients

Brief summary: The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.


Eligibility criteria: Inclusion Criteria:

either

1. a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
2. \> 40mg of diazepam (or diazepam equivalents) in 1 hr; or
3. an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

Exclusion Criteria:

* if \< 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen

Primary outcomes:
measure: Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome
timeFrame: up to 38 months
Secondary outcomes:
measure: Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome
timeFrame: Up to 38 months
measure: Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
timeFrame: Up to 38 months
measure: Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
timeFrame: Up to 38 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00377026: FirstWIND: Weight Loss Interventions After Delivery
Official title: FirstWIND: Weight Loss Interventions After Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: weight loss
postpartum
weight retention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2006-09-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care.

Detailed description: Overweight and obesity affect over 15 million adult women in the United States. Postpartum weight retention has been shown to be one factor contributing to weight retention, obesity and possible development of type 2 diabetes. African-American women and other minority women are at especially high risk for the development of obesity and type 2 diabetes. We propose to pilot a six-month postpartum-specific lifestyle intervention among urban-based, postpartum African-American women.

Eligibility criteria: Inclusion Criteria:

* Postpartum women with a pre-pregnancy or first trimester body mass index of 28 or greater or a history of gestational diabetes in the most recent pregnancy.

Exclusion Criteria:

* Current cardiac disease or serious chronic disease, including cancer.

Primary outcomes:
measure: weight loss
timeFrame: baseline, 3 months, and 6 months
Secondary outcomes:
measure: health status
timeFrame: baseline and six months
measure: body mass index
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Wanda Nicholson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: