louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00372164: Retrospective Evaluation of ASIPP Guidelines Implementation
Official title: Evaluation of the Effectiveness of Implementation of American Society of Interventional Pain Physician Guidelines for Interventional Techniques: A Retrospective Evaluation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Guideline Implementation
Keywords: ASIPP
Guidelines
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: current patients

Brief summary: To demonstrate clinically significant improvements in the patients treated following ASIPP guidelines compared to the patients who were treated prior to the establishment of ASIPP guidelines.

Detailed description: We have performed one study in the past showing that the implementation of guidelines improved outcomes by reducing the number of procedures and also the cost. However,, no large scale study has been performed thus far.

Eligibility criteria: Inclusion Criteria:

Evaluate all patients undergoing the following interventional techniques during 1999 and 2000 compared to patients undergoing interventional techniques during 2004 and 2005

* Cervical facet joint nerve blocks
* Thoracic facet joint nerve blocks
* Lumbar facet joint nerve blocks
* Lumbar interlaminar epidural steroid injections
* Cervical interlaminar epidural steroid injections

Exclusion Criteria:

Non-availability of appropriate data

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Ambulatory Surgery Center
state: Kentucky
Study officials:
affiliation: Ambulatory Surgery Center
name: Laxmaiah Manchikanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00095264: A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
Official title: A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndrome
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-11-03
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).


Eligibility criteria: Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed

Primary outcomes:
measure: The proportion of subjects achieving an erythroid response during the 13-week test period
Secondary outcomes:
measure: The proportion of subjects achieving an erythroid response during the 28-week treatment period
measure: The change in Hb from baseline
measure: The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit)
measure: The change in FACT-F from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gabrilove J, Paquette R, Lyons RM, Mushtaq C, Sekeres MA, Tomita D, Dreiling L. Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes. Br J Haematol. 2008 Jul;142(3):379-93. doi: 10.1111/j.1365-2141.2008.07181.x. Epub 2008 Jun 6.
Clinical trial NCT03486964: Use of Incretins in Diabetic Patients
Official title: Observational Study on the Use of Incretins in Diabetic Patients: Evaluation of Metabolic Effects and Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 2234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in therapy with DPP-4 inhibitors in addition to sulfonylureas and/or biguanides and/or thiazolidinediones and/or insulin

Brief summary: Observational, retrospective study, conducted in diabetic patients aimed to evaluate the effects on the glyco-metabolic control and on cardiovascular events of different DPP-4 inhibitors. Patients will be stratified in patients taking different DPP-4 in addition to sulfonylureas, biguanides, thiazolidinediones, insulin, compared to those in therapy with other hypoglycemic classes, such as sulphonylureas, biguanides, thiazolidinediones, insulin, alone or in combination, in primary and secondary prevention.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients
* On oral hypoglycemic agents ± basal insulin
* In primary and secondary prevention

Exclusion Criteria:

- Patients with a follow-up of less than 8 years

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 8 years
measure: Fasting plasma glucose
timeFrame: 8 years
measure: Post-prandial plasma glucose
timeFrame: 8 years
Secondary outcomes:
measure: Angina pectoris
timeFrame: 8 years
measure: Extrasystoles
timeFrame: 8 years
measure: Atrial fibrillation
timeFrame: 8 years
measure: Fatal myocardial infarction
timeFrame: 8 years
measure: Non-fatal myocardial infarction
timeFrame: 8 years
measure: Heart failure
timeFrame: 8 years
measure: Cardiovascular death
timeFrame: 8 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Foundation
state: Lombardy
Study officials:
References:
Clinical trial NCT05018364: Serum Erythropoietin Level in Perinatal Asphyxia
Official title: Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatal Hypoxia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from full-term neonates (first 28 days of life) with perinatal hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males \& females) .

Brief summary: This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).

Detailed description: Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.

Eligibility criteria: Inclusion Criteria:

Cases group:

1. The presence of a sentinel hypoxic event immediately before or during delivery
2. History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
3. Need for neonatal resuscitation at delivery
4. One-min Apgar score \<3 or 5-minApgar score\<7
5. Metabolic acidosis (BE \> 10 in cord blood)
6. Cardiocirculatory instability (CCI), clinical indications of hypoxic-ischemic encephalopathy (HIE) and multiple organ involvement (MOI).

Control group:

Newborns who were delivered normally after uncomplicated pregnancy. None of them have clinical nor biochemical signs of asphyxia.

Exclusion Criteria:

* Newborns who do not fulfill the above criteria.
* Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
* Whose parents refuse to participate in the study.
* Cases above 4 days old.
* Preterm neonates (less than 37 weeks).

Primary outcomes:
measure: correlation between serum erythropoietin level and brain injury
timeFrame: first 4 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Cairo university
Study officials:
affiliation: Dryosra86@hotmail.com
name: Yosra Aboelnaga
role: STUDY_CHAIR
affiliation: docnermoo@gmail.com
name: Nermine Riad
role: STUDY_CHAIR
References:
citation: Sweetman DU, Onwuneme C, Watson WR, Murphy JF, Molloy EJ. Perinatal Asphyxia and Erythropoietin and VEGF: Serial Serum and Cerebrospinal Fluid Responses. Neonatology. 2017;111(3):253-259. doi: 10.1159/000448702. Epub 2016 Dec 1.
Clinical trial NCT03249064: Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
Official title: Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: VITILIGO
Keywords: TREGS
CD91
LRP1
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 65 years-old both sex

Brief summary: This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease.

These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist.

Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.

Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study.

In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation.

Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention .

This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.


Eligibility criteria: Inclusion Criteria:

- Patient with vitiligo without treatment

Exclusion Criteria:

* Patient with inmunosupressive disease
* Patient receiving vitiligo treatment

Primary outcomes:
measure: Tregs levels
timeFrame: Baseline
measure: Tregs levels
timeFrame: 16 weeks
Secondary outcomes:
measure: LRP1 (CD91) levels
timeFrame: Baseline
measure: LRP1 (CD91) levels
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Piquero-Casals J, Martinez-Martinez L, Alomar A, Rozas-Munoz E, Juarez C, Puig L. LRP1/CD91 is highly expressed in monocytes from patients with vitiligo - even after repigmentation. Exp Dermatol. 2021 Mar;30(3):390-395. doi: 10.1111/exd.14249. Epub 2020 Dec 14.
Clinical trial NCT00645164: Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Official title: Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: wound healing
photoallergenicity
Healthy subjects
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The product is being tested to see if exposure to light causes photoallergic reactions on the skin.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Less than 18 years

Primary outcomes:
measure: Frequency Distribution of Skin Irritation Scores
timeFrame: 48-hours post irradiation
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Suncare Research Laboratories
state: North Carolina
Study officials:
affiliation: Suncare Research Laboratories
name: Joe Stanfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05254964: Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
Official title: Effect of Intensive Cognitive Rehabilitation on Cognitive, Motor, and Language Functional Networks in Subacute Stroke Patient
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Altered brain networks, including cognitive, motor, and language networks, are investigated by intensive cognitive rehabilitation in subacute stroke patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 to 80 years
* Patients with subacute stroke within 2 weeks of onset
* First-ever stroke
* Supratentorial stroke
* Less than 8 SAFE (shoulder abduction, finger extension) points
* Less than 35 FMA Upper scores
* MEP (motor evoked potential) negative
* Not more than 24 K-MMSE (Korean Mini-Mental State Examination) score

Exclusion Criteria:

* Difficult to communicate due to severe language impairment.
* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
* If there are difficulties in conducting the research
* Any patients who are judged by the investigator to be difficult to participate in this study
* Patients with contraindicated MRI scans

Primary outcomes:
measure: Strength of connectivity in brain network obtained from MRI neuroimaging data
timeFrame: Change in strength of connectivity after intensive cognitive rehabilitation for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00550264: Study of Physician Awareness of and Communication About Patient Readmissions to the Hospital
Official title: Physician Awareness of and Communication About Hospital Readmissions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Readmission
Keywords: Hospital Readmission
Continuity of Care
Quality of Health Care
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Risk Management Foundation
First posted: 2007-10-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Patients admitted to inpatient medicine services often require early hospital readmission, and often they are readmitted to different physician or team, potentially without the knowledge of the prior physician or team. Thus, physicians may lose the opportunity to share valuable information about readmitted patients, which may be detrimental to continuity of care and patient safety. The purpose of this study is to determine baseline awareness and communication rates among physicians regarding readmissions, and then measure the effect of automatic notification on these rates.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the general medicine service at two academic medical centers, and unexpectedly readmitted within 14 days.

Exclusion Criteria:

* Patients readmitted to the same physician(s), or those whose readmission was planned

Primary outcomes:
measure: Physician Awareness and Communication Rates
timeFrame: Within 24 hours of readmission time
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher L Roy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy CL, Kachalia A, Woolf S, Burdick E, Karson A, Gandhi TK. Hospital readmissions: physician awareness and communication practices. J Gen Intern Med. 2009 Mar;24(3):374-80. doi: 10.1007/s11606-008-0848-x. Epub 2008 Nov 4.
Clinical trial NCT02947802: Sugar Sweetened Beverage Labeling Support
Official title: Sugar Sweetened Beverage Labeling Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consumer Behavior
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an online survey assessing consumer support for different labeling policies related to sugar sweetened beverages. The investigators will present consumers with three labels that are being considered for sugar sweetened beverages: a calorie label, a text warning label that says "Warning drinking beverages with added sugar(s) can lead to health problems like obesity, diabetes and tooth decay" and a graphic warning label that includes graphic images to correspond with each of the health problems listed with the text warning. The investigators will ask participants their support for each label. The investigators will also see if support for the labels change after learning of the effectiveness of these labels. The investigators will share the results of a recent field study that suggested calorie and textual warning labels had no influence on the purchasing of sugar sweetened beverages while the graphic label decreased purchasing by 11 percent.


Eligibility criteria: Inclusion Criteria:

* The investigators will recruit a nationally representative sample using ClearVoice, a company that recruits online survey takers.

Exclusion Criteria:

-

Primary outcomes:
measure: Rate Support of a Label on a 1 (not at all) to 7 (a great deal) Scale.
timeFrame: Immediately following the presentation of the labels.
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
References:
citation: Donnelly GE, Zatz LY, Svirsky D, John LK. The Effect of Graphic Warnings on Sugary-Drink Purchasing. Psychol Sci. 2018 Aug;29(8):1321-1333. doi: 10.1177/0956797618766361. Epub 2018 Jun 18.
Clinical trial NCT05679102: Atorvastatin as an Antihypertensive Agent
Official title: Effect of Atorvastatin in the Management of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atorvastatin Antihypertensive Effect
Lead sponsor: Shaqra University
Sponsor class: OTHER
Collaborators: name: Ayub Teaching Hospital
name: Khyber Medical University Peshawar
First posted: 2023-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to see the antihypertensive effect of statin (Atorvastatin) as certain animal models have shown that statins have the voltage-gated calcium channel blocking effect. It will be a randomized controlled trial that will be done in Ayub Hospital Complex Abbottabad. After ethical approval, 120 patients with newly diagnosed hypertension belonging to either gender and aged 35 and above will be enrolled in the trial. They will randomly be grouped into two groups with each group comprising 60 patients. One group will be administered Amlodipine 5 mg PO once a day, while the other one will be given 5mg Amlodipine plus 10 mg Atorvastatin. The patients will be examined on a follow-up visit 14 days later and blood pressure will be recorded as per protocols.


Eligibility criteria: Inclusion Criteria:

- The inclusion criteria for the study were all newly diagnosed hypertensive patients aged 35 years and above with normal lipid profile

Exclusion Criteria:

* Patients with a history of dyslipidemias, diabetes mellites, chronic kidney disease, and ischemic heart disease

Primary outcomes:
measure: Antihypertensive effect of atorvastatin
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shaqra
country: Saudi Arabia
facility: Shaqra University
state: Riyadh
Study officials:
References: