louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01566994: Comparing Population Cessation Services
Official title: Comparing Population Cessation Services With Emphasis on Unmotivated Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: smoking cessation
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.

Detailed description: This proposal addresses major gaps in research for nicotine addiction treatments for entire populations of smokers and for the 80% who are not motivated to quit. Nicotine addiction is just like other drug addictions in terms of breaking the addiction cycle. Researchers and providers differ on whether treatment emphasis should be on clinician-based counseling, biologically-based medications, computer-based tailored communications or a combination of these. There is a lack of comparative research on population treatments to compare effectiveness, cost-effectiveness and enhancement of quality of life. Such comparative research would provide health care systems and providers with evidence on how to best serve entire populations of smokers, especially unmotivated smokers who are seriously underserved. This research will compare the four most highly recommended treatments: 1. Motivation Enhancement Therapy (MET) plus NRT; 2.Tailored communications based on the Transtheoretical Model (TTM), and 3. The combination of these treatments.

Eligibility criteria: Inclusion Criteria:

* smoker

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Smoking cessation (quit) rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: Univeristy of Rhode Island
name: James O Prochaska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111994: Efficacy & Safety of Clindamycin and Tretinoin in Acne
Official title: Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acne
Keywords: hyperpigmentation
Lead sponsor: Callender Center for Clinical Research
Sponsor class: OTHER
Collaborators: name: Society Hill Dermatology
First posted: 2010-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is ascertain the efficacy and safety of Clindamycin

Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post

Inflammatory Hyperpigmentation in patients with skin of color.

Detailed description: Acne is a chronic disorder of the pilosebaceous glands characterized by

inflammatory papules, pustules, opened and closed comedones, cysts and

nodules. Post inflammatory hyperpigmentation is a condition in which an

inflammation from a disease such as acne, trauma, or abrasion results in areas

of the skin with increased melanin content compared to the surrounding skin.

There are several treatments available for acne, which include benzoyl

peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,

tazarotene, adapalene). Combination therapy, such as topical retinoid and

clindamycin, has been shown to be more effective than monotherapy in

addressing all pathogenic factors of acne.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
* Photo skin types IV - VI
* Ages 12 and older
* Both sexes
* Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
* Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives

Exclusion Criteria:

* Seborrheic dermatitis
* PIH of solely dermal origin
* Acne vulfaris known to be resistant to oral antibiotics
* Use of erythromycin-containing products
* Use of neuromuscular blocking agents
* Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).

Primary outcomes:
measure: Improvement of acne and post inflammatory hyperpigmentation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mitchellville
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Philadelphia
country: United States
facility: Society Hill Dermatology
state: Pennsylvania
Study officials:
affiliation: Callender Center for Clinical Research
name: Valerie Callender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05191394: IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.
Official title: IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Plasma Exchange
Keywords: Therapeutic plasma exchange
anti-SARS-CoV-2 antibodies
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Context:

Therapeutic plasma exchange is an extracorporeal blood purification technique that removes pathogenic substances (including antibodies) from plasma. This technique also combines an immunomodulatory effect. The impact on the anti-SARS-CoV-2 titre and the humoral and cellular responses in the general population benefiting from therapeutic plasma exchanges is not known at this time.

The purpose of this study is to evaluate the evolution of anti-SARS-CoV-2 antibodies' titre over time in vaccinated adult patients treated with therapeutic plasma exchange.

Research question and associated variables:

Prospective non-drug interventional study on the possible variation of anti-SARS-CoV-2 antibody titre in adult patients regularly treated with therapeutic plasma exchange.

Study population: any adult patient vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc in Brussels, Belgium.

Number of subjects expected to be enrolled: 10-15

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

* Adult patients vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc.

Exclusion Criteria:

* Patients treated with therapeutic plasma exchange for an acute condition at the intensive care unit
* Patients unable to sign the ICF or unwilling to participate to the study

Primary outcomes:
measure: Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: International
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Catherine Lambert, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00673894: Effects of Glutamine on GLP-1 and Insulin Secretion in Man
Official title: Study of the Effects of Glutamine on Glycemia, Glucagon-like Peptide-1 (GLP-1) and Insulin Secretion in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.

Detailed description: In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, on metformin or diet alone (not sulphonylureas or insulin)

Exclusion Criteria:

* Malabsorption, renal or liver disease, treatment with steroids

Primary outcomes:
measure: Postprandial Glucose Area Under the Curve (AUC)
timeFrame: 0 to 180 minutes
Secondary outcomes:
measure: Fructosamine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Clinical Research Facility
state: New South Wales
Study officials:
affiliation: Garvan Institute of Medical Research
name: Jerry R Greenfield, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samocha-Bonet D, Wong O, Synnott EL, Piyaratna N, Douglas A, Gribble FM, Holst JJ, Chisholm DJ, Greenfield JR. Glutamine reduces postprandial glycemia and augments the glucagon-like peptide-1 response in type 2 diabetes patients. J Nutr. 2011 Jul;141(7):1233-8. doi: 10.3945/jn.111.139824. Epub 2011 May 18.
citation: Samocha-Bonet D, Chisholm DJ, Holst JJ, Greenfield JR. L-glutamine and whole protein restore first-phase insulin response and increase glucagon-like peptide-1 in type 2 diabetes patients. Nutrients. 2015 Mar 24;7(4):2101-8. doi: 10.3390/nu7042101.
citation: Samocha-Bonet D, Chisholm DJ, Gribble FM, Coster AC, Carpenter KH, Jones GR, Holst JJ, Greenfield JR. Glycemic effects and safety of L-Glutamine supplementation with or without sitagliptin in type 2 diabetes patients-a randomized study. PLoS One. 2014 Nov 20;9(11):e113366. doi: 10.1371/journal.pone.0113366. eCollection 2014.
Clinical trial NCT05219994: Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
Official title: Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After screening, participants will complete two study visits.
Primary purpose: BASIC_SCIENCE

Brief summary: Our overall goal is to advance our understanding of the contribution of the carotid body chemoreceptors in glucose regulation and the development of type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* healthy,
* type 2 diabetes
* BMI 18-40 kg/m2,
* non-pregnant,
* non-breastfeeding,
* non-nicotine users.

Exclusion Criteria:

* cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke;
* renal or hepatic diseases;
* active cancer;
* autoimmune diseases;
* immunosuppressant therapy;
* excessive alcohol consumption (\>14 drinks/week);
* current nicotine use;
* foot ulcers;
* diabetic neuropathy;
* medication directly influencing sympathetic nervous system activity

Primary outcomes:
measure: Glucose change in response to OGTT
timeFrame: 2 hours post glucose ingestion
measure: Insulin change in response to OGTT
timeFrame: 2 hours post glucose ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820391: KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami
Official title: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Keywords: Post-traumatic Stress disorder (PTSD)
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: NGO vivo e.V.
name: GTZ-German Technical Cooperation, rmany
name: German Research Foundation
name: Ein Herz für Kinder
First posted: 2009-01-12
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.


Eligibility criteria: Inclusion Criteria:

* Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster.

Exclusion Criteria:

* Mental retardation, psychosis, any neurological disorder

Primary outcomes:
measure: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder
timeFrame: pre-treatment, 1 month post, 6 months follow up
Secondary outcomes:
measure: Functioning, Somatic Problems, School grades
timeFrame: pre, 1 month post, 6 months follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: Catani C, Kohiladevy M, Ruf M, Schauer E, Elbert T, Neuner F. Treating children traumatized by war and Tsunami: a comparison between exposure therapy and meditation-relaxation in North-East Sri Lanka. BMC Psychiatry. 2009 May 13;9:22. doi: 10.1186/1471-244X-9-22.
Clinical trial NCT01029691: Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
Official title: Use of PAP in Women With Pre-eclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Hypertension
Keywords: Sleep disordered breathing
Preeclampsia
Positive Airway Pressure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-12-10
Enrollment: 125
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

Detailed description: Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.

Eligibility criteria: Inclusion Criteria:

* Women with preeclampsia who receive care at the University of Michigan Hospitals
* No current use of PAP therapy.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Current PAP therapy
* Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
* Cognitively impaired and unable to understand informed consent.

Primary outcomes:
measure: Nocturnal Blood Pressure
timeFrame: baseline and 1 week after PAP treatment.
measure: Number of Participants With Worsening of Hypertension
timeFrame: 1-6 months after enrollment.
measure: Severity of Sleep Disordered Breathing
timeFrame: at baseline
measure: Number of Participants With Sleep-disordered Breathing (SDB)
timeFrame: Baseline night 1
Secondary outcomes:
measure: Gestational Age at Delivery
timeFrame: At delivery (within 6 months of enrollment).
measure: Birth Weight
timeFrame: At delivery (within 6 months of enrollment)
measure: NICU Admission
timeFrame: at delivery (within 6 months of enrollment)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Louise M O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-0528.12885. Epub 2014 May 30.
Clinical trial NCT02060591: Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2014-02-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.


Eligibility criteria: Inclusion Criteria:

All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) score of 4 or higher
* Hepatic disease (contraindication for acetaminophen)
* Renal disease (contraindication for NSAIDs)
* Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol
* Fibromyalgia
* Any contraindication for intrathecal opioid injection
* History of substance abuse during the last 2 years
* History of allergy to amide compounds
* Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications
* Allergy to metabisulfite compounds
* Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia)
* Body weight\<50 Kg, BMI\>40 Kg/m2
* History of hypotension
* Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure

Primary outcomes:
measure: 2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method
timeFrame: Within first 30 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
citation: Alijanipour P, Tan TL, Matthews CN, Viola JR, Purtill JJ, Rothman RH, Parvizi J, Austin MS. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. J Arthroplasty. 2017 Feb;32(2):628-634. doi: 10.1016/j.arth.2016.07.023. Epub 2016 Aug 9.
Clinical trial NCT03454191: Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
Official title: Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for thoracoscopy
* physical status I-III

Exclusion Criteria:

* allergy to local anaesthetics
* other contraindications to peripheral nerve blocks
* patients suffering from chronic pain condition

Primary outcomes:
measure: IV morphine consumption
timeFrame: 24 postoperative hours
Secondary outcomes:
measure: IV morphine consumption
timeFrame: 2 postoperative hours
measure: IV morphine consumption
timeFrame: 48 postoperative hours
measure: Pain scores
timeFrame: 2, 24, 24 postoperative hours
measure: Chronic pain scores
timeFrame: 3 and 6 postoperative months
measure: Forced vital capacity
timeFrame: 24 and 48 postoperative hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
References: