louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01982708: A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen
Official title: A Prospective Study of a Haptic Device Evaluation of the Acute Abdomen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Abdomen
Keywords: Evaluation
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 20
Sex: ALL
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: Emergency department and inpatient referrals for general surgery evaluation for acute abdominal presentation

Brief summary: The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen. Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are assessing the ability of a non invasive, optical device that is placed on a patients abdomen (much like an ultrasound transducer) to evaluate a patient with an acute abdominal presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel obstruction will be examined with the haptic device. Data will be collected by the device and later compared to the abdominal findings recorded from an examination conducted by the principle investigator who is a surgeon. The surgeon will not have acess to data collected by the haptic sensor and therefore it will have no impact on the decision making process in the care of the patient. The impact on the individual patient will require obtaining a consent to participate in the study, a few minutes to place the device gently on the abdomen and collect the sensor data. There is no direct benefit to the patient by participating in the study. The potential for such a study may be to develop the technology to have a device that non-medical staff can use to collect patient data and transmit that data to a healthcare provider at another location.


Eligibility criteria: Inclusion Criteria:

* All patients referred to the MSU Acute Care Surgery service for the evaluation of abdominal pain.

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Hardness of the abdominal wall
timeFrame: At intial presentation with abdominal pain
Secondary outcomes:
measure: temperature of the abdominal wall
timeFrame: At initial presentation
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
Study officials:
affiliation: MichiaganSU
name: Robert Osmer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Marc Basson, M.D., PhD, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT01153308: Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry
Official title: Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Obesity
Weight Loss
Bariatric Surgery
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 4785
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UMMMC Bariatric Surgery Patients

Brief summary: The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

Detailed description: See brief Summary

Eligibility criteria: Inclusion Criteria:

* Must be scheduled for Bariatric Surgery @ UMMMC

Exclusion Criteria:

* Not scheduled for Bariatric Surgery @ UMMMC

Primary outcomes:
measure: Weight Loss after surgery
timeFrame: Preop, Postop, Six Months, and Annually
Secondary outcomes:
measure: Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension
timeFrame: Preop, Postop, Six Months, Annually
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Medical School and UMass Memorial Medical Center
name: John J Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892008: A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
Official title: Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: pregabalin
neuropathic pain
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 2278
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: Male or female, 18 years and above diagnosed with neuropathic pain.

Brief summary: This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion Criteria:

* Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Primary outcomes:
measure: Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
timeFrame: Baseline through Final Visit (Week 4)
measure: Discontinuations Due to Adverse Events
timeFrame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Secondary outcomes:
measure: Change From Baseline in Visual Analogue Scale (VAS) Score
timeFrame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: VAS Pain Score at Baseline (BL) and Second Visit
timeFrame: Baseline, Second Visit (Week ≥ 2)
measure: VAS Pain Score at Baseline and Final Visit
timeFrame: Baseline, Final Visit (Week 4)
measure: Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
measure: Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
timeFrame: Second Visit (Week ≥ 2), Final Visit (Week 4)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04654208: Swedish Ibrance Registries Insights (SIRI)
Official title: Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm of Breast
Keywords: metastatic breast cancer (MBC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all adult (age ≥18 years) patients (male and female) with at least one filled prescription of palbociclib (ATC code: L01XE33) registered in the Swedish Prescribed Drug Register between January 1st, 2017 and June 30th 2020.

Brief summary: The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
2. Age ≥18 years at index date

Exclusion Criteria:

There are no exclusion criteria

Primary outcomes:
measure: Proportion of patients on treatment
timeFrame: 01 January 2017 until 30 September 2020
Secondary outcomes:
measure: Proportion of patients alive
timeFrame: 01 January 2017 until 30 September 2020
measure: Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment
timeFrame: 01 January 2017 until 30 September 2020
Other outcomes:
Locations:
city: Sollentuna
country: Sweden
facility: Pfizer AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00521508: Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy
Official title: Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glomerulonephritis, IGA
Keywords: IgA
kidney
Berger'disease
regulatory T cells
pathogenesis of Berger's disease
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.


Eligibility criteria: Inclusion Criteria:

* Patients with pathogenesis of Berger's disease confirmed by renal biopsy
* Glomerular filtration \> 60 ml/min/1,73m2
* Written informed consent
* Patient affiliated to social insurance

Exclusion Criteria:

* Immunosuppressor treatment within 6 months before the study inclusion
* Clinical infection within 2 months before the study inclusion
* C-reactive protein (CRP) \> 10 mgL-1

Primary outcomes:
measure: proportion averages of cells CD4+CD25+CD127 low T in peripheral blood
timeFrame: inclusion
Secondary outcomes:
measure: average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3
timeFrame: inclusion
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Nephrology Unit Hôpital Nord CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christophe MARIAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004 Aug;19(8):1947-51. doi: 10.1093/ndt/gfh309. Epub 2004 May 25. No abstract available.
citation: Mariat C, Sanchez-Fueyo A, Alexopoulos SP, Kenny J, Strom TB, Zheng XX. Regulation of T cell dependent immune responses by TIM family members. Philos Trans R Soc Lond B Biol Sci. 2005 Sep 29;360(1461):1681-5. doi: 10.1098/rstb.2005.1706.
citation: Mariat C Degauque N et al. TIM-1 strengthens Th-1 polarization and weakens CD4+CD25 T cells. Am J Transplant 6(suppl 2): 557, 2006
Clinical trial NCT00975208: Osteogenesis and Dental Eruption Through Electrical Stimuli
Official title: Osteogenesis and Dental Eruption Through Electrical Stimuli Following Periosteoplasty for Alveolar Clefts in Patients With Cleft Lip and Palate Deformities. A Preliminary Report.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cleft Lip
Keywords: Osteogenesis [G07.700.320.500.325.377.625.100.729]
Tooth Eruption [G10.549.235.726]
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of the Institute of Reconstructive Surgery of Jalisco, México

Brief summary: The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure that, to this date, still demands great efforts from plastic surgeons. The feasibility of periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical stimulation in order to increase osteoneogenesis have been proven in the past. The present study attempts to combine both procedures that have only been reported separately worldwide. The objective of this study is to increase the osteogenic capacity and hence, dental eruption.


Eligibility criteria: Inclusion Criteria:

* Patients with unilateral cleft lip and palate deformities and alveolar defects

Exclusion Criteria:

* Patients without alveolar cleft
* Patients with syndromes that did not require periosteoplastic procedures as well as patients with systemic illnesses that may affect the result of the study (for instance diabetes)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Jalisciense de Cirugía Reconstructiva "Dr. Guerrerosantos"
name: José Guerrerosantos, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04702308: Non-Interruptive Alerts for Improving Use of Clinical Decision Rules
Official title: The Use of Non-Interruptive Alerts for Improving the Use of Clinical Decision Rules in the Emergency Department: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Minor Head Injury
Chest Pain
Neck Trauma
Keywords: clinical decision support
clinical decision rules
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: This study is an extension of a planned quality improvement project that aims to promote standard of care by increasing the use of evidence-based clinical decision rules amongst emergency medicine providers in the University of Utah Emergency Department. Patient-specific information from the EHR will be used to recommend the use of relevant clinical decision rules to emergency medicine providers at the point-of-care. These recommendations will be in the form of non-interruptive alerts with one-click access to the suggested decision rules through the MDCalc Connect EHR add-on application. Specific aims of the study are to determine if 1) patient-specific non-interruptive alerts increase the use of clinical decision rules amongst emergency medicine providers and 2) an increase in the use of clinical decision rules affects provider ordering habits.


Eligibility criteria: Patient Inclusion Criteria:

* 16 years of age or older
* Qualifying chief complaint\*

Patient Exclusion Criteria:

* None

  * A full list of the qualifying chief complaints is provided in Appendix A of the full research protocol.

Primary outcomes:
measure: Total clinical decision rule usage
timeFrame: During the intervention
Secondary outcomes:
measure: Individual clinical decision rule usage
timeFrame: During the intervention
measure: Computed tomography pulmonary angiography studies
timeFrame: During the intervention
measure: Computed tomography head studies
timeFrame: During the intervention
measure: Computed tomography c-spine studies
timeFrame: During the intervention
measure: Lower extremity ultrasound
timeFrame: During the intervention
measure: d-dimer tests
timeFrame: During the intervention
measure: Delta troponin tests
timeFrame: During the intervention
measure: Emergency department bounceback rate.
timeFrame: Up to 30 days after the intervention
measure: Admission rate
timeFrame: During the intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT02896608: Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome
Official title: Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dravet Syndrome
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 92
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Dravet syndrome and control patients with and without epilepsy.

Brief summary: This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.


Eligibility criteria: Inclusion Criteria:

* early infantile epileptic encephalopathy with HCN1 channel mutation
* control patients with no neurologic pathology (age, gender and body temperature matched)
* epileptic patients (age, gender and body temperature matched)

Exclusion Criteria:

* pregnant or breast feeding patient

Primary outcomes:
measure: hyperpolarizing electrotonus
timeFrame: baseline
measure: hyperpolarizing threshold current
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT01613508: A Randomized Study of Approaches in Total Hip Arthroplasty
Official title: A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table.


Eligibility criteria: Inclusion Criteria

1. Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty
2. Study participants must be able to give informed consent.

Exclusion Criteria

1. Significant proximal femoral deformity (post SCFE, Perthes, DDH), acetabular dysplasia (ANY CROWE), inflammatory arthritis, septic arthritis, osteomyelitis, prior infection of hip joint, significant leg length discrepancy (\> 4cm), osteoporosis, arthrodesis of the affected hip.
2. The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis.
3. Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
4. Presence of previous prosthetic hip replacement device (any type).
5. Active Metastatic disease
6. Active major Psychiatric illness
7. Active Drug or alcohol abuse
8. BMI \> 40.
9. Patients that are known to be pregnant
10. Actively failing contralateral hip replacement.

Primary outcomes:
measure: Activity monitors will be worn
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Taunton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203008: A Survey Study to See if Patients Diagnosed With Parkinson's Disease Have Higher Incidence of Melanoma
Official title: A Survey to Assess the Incidence and Characteristics of Melanoma in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Malignant Melanoma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 2106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients known to have Parkinson's Disease will be invited to join the study by their treating physicians as long as they are not taking investigational product.

Brief summary: Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.


Eligibility criteria: Inclusion Criteria:

Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment

Exclusion Criteria:

unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Bruce Schwartz, Ph.D.
role: STUDY_DIRECTOR
References: