louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03025217: Total Lifestyle Coaching Pilot Study (TLC)
Official title: Total Lifestyle Coaching Pilot Study (TLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Telemedicine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.

Detailed description: This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.

Eligibility criteria: Inclusion Criteria:

1. age 21 and older
2. body mass index (BMI) exceeds 25
3. speaks English
4. has access to a telephone
5. able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
6. overweight (BMI exceeds 25)

Primary outcomes:
measure: Change in Weight
timeFrame: 26 weeks
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Chad-Friedman E, Pearsall M, Miller KM, Wheeler AE, Denninger JW, Mehta DH, Dossett ML. Total Lifestyle Coaching: A Pilot Study Evaluating the Effectiveness of a Mind-Body and Nutrition Telephone Coaching Program for Obese Adults at a Community Health Center. Glob Adv Health Med. 2018 Jul 4;7:2164956118784902. doi: 10.1177/2164956118784902. eCollection 2018.
Clinical trial NCT03943017: The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident
Official title: The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident: Medical vs. Regulatory Relevance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Knowledge, Attitudes, Practice
Safety Issues
Health, Subjective
Keywords: safety dysfunctions
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the 30 sites of Ile de France region fully authorized to perform phase I/II trials

Brief summary: Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all Authorized Research Centers (ARC) conducting phase I/II clinical trials of experimental drugs.

Detailed description: Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all research sites conducting phase I/II clinical trials of experimental drugs.

All 30 sites of Île-de-France region fully authorized to perform phase I/II trials will be inspected by a physician and a public health pharmacist. Their reported list of observations will be submitted to three physicians with longstanding experience of early pharmacology studies performed in academic or private research facilities. These physicians will be asked to adjudicate each observation according to their perceived medical importance regarding safety. Adjudications will be first performed separately and disagreements will be later settled during a final adjudication meeting.

Eligibility criteria: Inclusion Criteria:

* Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of observations which have potentially serious medical consequences after experts adjudication
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number on disagreements occuring initially among the 3 adjudicators before adjudication
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
affiliation: INSERM, CIC-1421 and UMR ICAN 1166, Sorbonne Université, Faculty of Medicine, AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology and Clinical Investigation Center
name: Christian Funck-Brentano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894917: Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Official title: Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Hepatocellular
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 84
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: Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.

Brief summary: This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants.

Detailed description: The results from this study will allow us to identify unique disease characteristics of older participants and to study treatment patterns that may be barriers to treatment and risk factors for increased morbidity. Characteristics of Comprehensive Geriatric Assessment will be obtained prior to standard interventional treatment for participants that are 65 years or older. Observations will be made of treatment toxicities and cellular senescence with treatment outcomes. Findings from this study will result in the development of R01 intervention studies that develop and validate a treatment algorithm based on these associations to provide older adults with a personalized treatment plan.

Eligibility criteria: Inclusion Criteria:

* Histologically or radiographically (CT or MRI) confirmed newly diagnosed hepatocellular carcinoma.
* Age 18 years and older.
* Patients with advanced, unresectable HCC as determined by the treating physician.

Exclusion Criteria:

* Patients with resectable HCC who are still candidates for locoregional therapy
* Patients receiving prior systemic or locoregional therapy

Primary outcomes:
measure: Characterize the Change in disease and treatment patterns of advanced hepatocellular carcinoma (HCC) in older patients in the US.
timeFrame: will be collected at time points: at screening, Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
Study officials:
affiliation: Mays Cancer Center
name: Sukeshi Patel Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03126617: Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Official title: Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-04-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.

When contacted by a treating physician, BMS will consider requests for providing early patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium, Thailand, Turkey, Argentina, and Colombia.

Detailed description: Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to participate in an early patient access program.

To learn more about early patient access programs, your doctor may contact BMS using the information provided below.

Eligibility criteria: Specific eligibility criteria must be met for access outside of a clinical trial.

These inclusion criteria include:

* The illness must be serious or life threatening
* There are no other viable options (including approved products or active clinical trials)
* There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
* Other defined inclusion/exclusion criteria could be applicable.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02429817: Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pulmonary aerosol distribution
SPECT-CT analysis
High flow nasal cannula
Vibrating-mesh nebulizer
Jet nebulizer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers.

On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased using a vibrating-mesh nebulizer as compared to a jet nebulizer.

Lung distribution of nebulized particles delivered through a HFNC has never been investigated in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers through a HFNC by SPECT-CT.


Eligibility criteria: Inclusion Criteria:

* Healthy respiratory function

Exclusion Criteria:

* Pulmonary disease

Primary outcomes:
measure: Pulmonary deposition
timeFrame: Immediately after nebulization by imaging technique, expected average of 15 minutes
Secondary outcomes:
measure: Three-dimensional penetration index
timeFrame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
Other outcomes:
measure: Spirometry
timeFrame: Baseline
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT03322917: Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma
Official title: A Prospective Interventional Non-randomized and Non-comparative Series of Cases of Patiens Suffering Ocular Surface Syndrome Post-LASIK: Outcomes After the Treatment With Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye After LASIK-Laser in Situ Keratomileusis
Keywords: dry eye
PRP
autologous
after LASIK
ocular surface
Lead sponsor: Vissum, Instituto Oftalmológico de Alicante
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective interventional non-comparative consecutive case series.
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).

Detailed description: Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.

Eligibility criteria: Inclusion Criteria:

* Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK.
* Tear break-up time (TBUT) between 4 and 9 seconds.

Exclusion Criteria:

* Ocular pathology needing topical treatments different than dry eye syndrome
* Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES).
* Ocular tumours, corneal distrophies, history of ocular herpes.
* Pregnant or nursering women.

Primary outcomes:
measure: Corneal fluorescein staining (CFS)
timeFrame: Before LASIK surgery and after the 6 weeks of treatment
Secondary outcomes:
measure: Dry eye symptoms
timeFrame: Before LASIK surgery and after the 6 weeks of treatment
measure: Corrected distance visual acuity (CDVA)
timeFrame: Before LASIK surgery and after the 6 weeks of treatment
measure: Conjunctival hyperemia
timeFrame: Before LASIK surgery and after the 6 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Vissum, Instituto Oftalmológico de Alicante
name: JORGE L ALIO, DR.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alio JL, Rodriguez AE, Abdelghany AA, Oliveira RF. Autologous Platelet-Rich Plasma Eye Drops for the Treatment of Post-LASIK Chronic Ocular Surface Syndrome. J Ophthalmol. 2017;2017:2457620. doi: 10.1155/2017/2457620. Epub 2017 Dec 12.
Clinical trial NCT02542241: Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control
Official title: Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Abdominal Injuries
Keywords: Open abdomen
hypertonic saline solution
intensive care
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.

Detailed description: A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.

Eligibility criteria: Inclusion Criteria:

* Abdominal trauma requiring damage control surgery.
* Acceptance by the patient or by a proxy to be included in the trial.

Exclusion Criteria:

* Concomitant severe head trauma, defined by a Glasgow score \<9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a CT-scan.
* Pregnancy
* Patient not included 4 hours or more after damage control surgery.
* Damage control laparotomy performed for other indications other than trauma.
* Not index damage control laparotomy
* No acceptance to participate in the study.

Primary outcomes:
measure: Abdominal wall closure
timeFrame: 7 days
Secondary outcomes:
measure: Fluid Balance measured in cm3
timeFrame: 72 hours
measure: Incidence of Abdominal compartment syndrome
timeFrame: 7 days
measure: Incidence of Organ Failure
timeFrame: 7 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundacion Clinica Valle del Lili
state: Valle Del Cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Alberto F García, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051817: POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Official title: A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-remitting Multiple Sclerosis
RRMS
Keywords: relapsing-remitting multiple sclerosis
RRMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
timeFrame: weeks 4,8,12,16,20,24,28
Secondary outcomes:
measure: Raw Number of Cumulative New Gd-T1 Lesions
timeFrame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
measure: Raw Number of Cumulative New Gd-T2 Lesions
timeFrame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava-Moravska Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 10
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 2
country: Czech Republic
facility: Novartis Investigative Site
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Odessa
country: Ukraine
facility: Novartis Investigative Site
city: Vinnitsya
country: Ukraine
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01442441: Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria
Official title: How Pathologic Features of Chronic Pancreatitis Corelate With Endoscopic Ultrasound (EUS) Criteria for Diagnosing Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective surgery cases who had chronic pancreatitis

Brief summary: In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis.

This will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.


Eligibility criteria: Inclusion Criteria:

* will include all patients who consented to have both EUS and had biopsy taken for tissue diagnosis.

Exclusion Criteria:

* Will exclude patients who are less than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00566241: IGF-1 Therapy in Patients With Cystic Fibrosis
Official title: An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Body weight
Body composition
Pulmonary function
Carbohydrate tolerance
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.

Detailed description: 28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight and body composition in patients with cystic fibrosis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis.
* Age \>= 18 yr.
* Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5

Exclusion criteria:

* Hemoglobin A1C \> 8.5 %
* Diabetic retinopathy
* Obstructive sleep apnea
* Respiratory failure requiring mechanical ventilation.
* Status post pulmonary transplantation.
* Concurrent or recent (within past 6 months) receipt of human growth hormone.
* History of adverse side effects to growth hormone other than carbohydrate intolerance.
* Pregnancy or attempting pregnancy.
* Women who are breast feeding.
* Sexually active women who refuse to use or are incapable of responsibly using reliable contraception.
* Proven non compliance with medical regimens.
* Inability or refusal to take subcutaneous injections.
* Known allergy to components in the IGF-I preparation.

Primary outcomes:
measure: Body weight and body composition
timeFrame: 28 weeks
Secondary outcomes:
measure: Pulmonary function
timeFrame: 28 weeks
measure: Carbohydrate tolerance
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: State University of New York
state: New York
Study officials:
affiliation: State Univeristy of New York, Stony Brook, NY
name: Thomas A Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: