louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01405365: The Impact of Obesity on Nonsurgical Periodontal Therapy
Official title: The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Obesity
Keywords: Periodontitis
Periodontal diseases
Obesity
Metronidazole
Prognosis
Probing depth
Periodontal attachment loss
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Augusta University
First posted: 2011-07-29
Enrollment: 96
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

Detailed description: Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI \>30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments:

1. scaling and root planing + placebo
2. scaling and root planing + metronidazole

Eligibility criteria: Inclusion Criteria:

* Normal weight or obese (according to BMI)
* nonsmokers or former smokers (3 or more years)
* no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
* have 10 teeth present
* have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm

Exclusion Criteria:

* Pregnancy
* Development of diabetes or other conditions that may impair periodontal healing

Primary outcomes:
measure: Probing depth
timeFrame: 12 months
Secondary outcomes:
measure: Attachment level
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Cassiano K Rosing, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Georgia School of Dentistry
name: Cristiano Susin, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121665: Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
Official title: Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: CD Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Government Dental College and Hospital, India
First posted: 2014-04-23
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.

Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.


Eligibility criteria: Inclusion Criteria:

* Subject of both sexes
* Age group of 25-65 years
* Subjects with generalized moderate to severe chronic periodontitis
* Signed informed Consent

Exclusion Criteria:

* Any known history of systemic diseases
* Patients already on anti-inflammatory drugs or antibiotics
* Patients allergic to any material used in the study
* Pregnant and lactating women
* Periodontal therapy in past 6 months
* Current smoker or smoker in the past

Primary outcomes:
measure: Improvement in Periodontal Clinical indices
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement in biochemical indices
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aurangabad
country: India
facility: Department of Periodontics, Government Dental College & Hospital
state: Maharashtra
Study officials:
affiliation: Government Dental College & Hospital, Aurangabad
name: Rohan Sethi, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276065: Effectiveness of Laser Hair Removal in Pilonidal Disease
Official title: Randomized Controlled Trial of Laser Hair Depilation in Adolescents With Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 302
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after initial incision and drainage and after resection have been reported to be 16% and 11% respectively. Furthermore, wound issues after resection with primary closure have been reported to be as high as 30%. In several retrospective studies and small prospective studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent infections and decrease the need for repeat surgery in adults and older adolescents. We are performing a randomized control trial of laser hair depilation plus chemical/mechanical depilation to examine outcomes related to recurrence of pilonidal disease.


Eligibility criteria: Inclusion Criteria:

* All Fitzpatrick skin types
* 11-21 years of age
* Diagnosis of pilonidal disease

Exclusion Criteria:

* History of photosensitivity
* Actively inflamed pilonidal sinus. These patients are invited to participate upon resolution of their inflamed sinus.

Primary outcomes:
measure: Recurrence of pilonidal disease
timeFrame: 12 months
Secondary outcomes:
measure: Disability Days
timeFrame: 12 months
measure: Health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Peter C Minneci, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Katherine J Deans, MD, MHSc
role: STUDY_DIRECTOR
References:
citation: Minneci PC, Halleran DR, Lawrence AE, Fischer BA, Cooper JN, Deans KJ. Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial. Trials. 2018 Nov 1;19(1):599. doi: 10.1186/s13063-018-2987-7.
Clinical trial NCT04080765: Antiretroviral Therapy Selection: Comparing HIV Clinical Guidelines With HIV-ASSIST, an Online Decision-support Tool
Official title: Prospective Validation Study of a Antiretroviral Therapy (ARV) Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: decision analysis
HIV
education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: HIV-ASSIST is an online decision support tool created by Johns Hopkins faculty that utilizes standard patient variables, and provides treatment recommendations and tailored educational content to assist providers learn HIV treatment principles and support decision-making.

The research goal is to determine the difference in percentage of appropriate antiretroviral therapy (ART) selection (based upon a reference standard of HIV experts and guidelines) for a set of hypothetical patient scenarios, comparing a group of trainees with access to current national DHHS guidelines (control), and a group using HIV-ASSIST (intervention) in addition to guidelines.

The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 10 HIV case vignettes are presented to study participants. Medical and nursing students and internal medicine residents will be eligible to participate.

Participants providing informed consent will be randomized to receiving access to either online Department of Health and Human Services (DHHS) HIV guidelines, or the HIV-ASSIST online tool to support participants' decision making. Participants will be asked to indicate participants' ART regimen of choice for each case scenario. The proportion of appropriate ART selections will be evaluated comparing the intervention and control arms. The investigators will additionally report the time required for trainees to complete ART selections for the presented clinical vignettes.


Eligibility criteria: Inclusion Criteria:

* Students in the Johns Hopkins Schools of Medicine or Nursing, and/or internal medicine residents

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of appropriate ARV selections
timeFrame: Up to one hour
Secondary outcomes:
measure: Time to ARV selection
timeFrame: Up to one hour
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maunank Shah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez JA, Maddali MV, Nematollahi S, Li JZ, Shah M. New Strategies in Clinical Guideline Delivery: Randomized Trial of Online, Interactive Decision Support Versus Guidelines for Human Immunodeficiency Virus Treatment Selection by Trainees. Clin Infect Dis. 2021 May 4;72(9):1608-1614. doi: 10.1093/cid/ciaa299.
Clinical trial NCT05889065: Effects of Scapular Proprioceptive Neuromuscular Facilitation on Pain and Range of Motion in Patients With Adhesive Capsulitis
Official title: Effects of Scapular Proprioceptive Neuromuscular Facilitation on Pain and Range of Motion in Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the other group will receive scapular PNF with conventional physical therapy. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: The term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (ROM) in all directions, including flexion, abduction, and rotation.The objective of the study is to determine the effects of Scapular proprioceptive neuromuscular facilitation and conventional physical therapy among patients with adhesive capsulitis.The study will be a randomized controlled trial (single-blinded parallel study), consisting of 2 groups- interventional group A and interventional group B.Group A will be given conventional physical therapy and group B will be given conventional physical therapy alongwith scapular PNF.Scapular PNF exercises are not included in our routine PT treatment programs and there is limited literature related to the PNF techniques. These techniques help develop muscular strength and endurance, joint stability, mobility, neuromuscular control and coordination all of which are aimed at improving the overall functional ability of patients.


Eligibility criteria: Inclusion Criteria:

* Cases diagnosed with adhesive capsulitis, both primary and secondary origin.
* Stage two and stage three of adhesive capsulitis.
* Unilateral adhesive capsulitis.
* Both males and females of the age group 40 years and above.

Exclusion Criteria:

* History of shoulder surgery or manipulation under anesthesia,
* Local corticosteroid injection administration to the affected shoulder within the last 3 months.
* Severe musculoskeletal, neurological and cardiovascular conditions.

Primary outcomes:
measure: Shoulder Pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Shoulder range of motion (ROM)
timeFrame: 2 weeks
measure: Scapular mobility
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Maryum Fatima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06523465: Statin Combined with Amlodipine Treats Primary Aldosteronism
Official title: A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Aldosteronism
Statin
Mineralocorticoid Receptor Antagonist
Hypertension
Keywords: primary aldosteronism
hypertension
Statin
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary aldosteronism

Exclusion Criteria:

* Allergy to drugs in this study
* Pregnancy
* Severe liver and kidney dysfunction
* Mental illness

Primary outcomes:
measure: changes in plasma aldosterone levels
timeFrame: 6 month
measure: changes in 24-hour urinary aldosterone levels
timeFrame: 6 month
Secondary outcomes:
measure: changes in office blood pressure and home blood pressure
timeFrame: 6 month
measure: changes in serum potassium levels
timeFrame: 6 month
measure: changes in serum renin level
timeFrame: 6 month
measure: changes in plasma cholesterol levels
timeFrame: 6 month
measure: changes in blood glucose
timeFrame: 6 month
Other outcomes:
Locations:
city: Chongqing
country: China
facility: No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China
state: Chongqing
Study officials:
References:
Clinical trial NCT05435365: Investigating The Experiences of Patients In Immunotherapy Clinical Trials
Official title: An Observational Study Investigating The Experiences of Patients In Immunotherapy Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immunotherapy
Cancer
Keywords: Immunotherapy
Cancer
Diversity In Immunotherapy Clinical Trials
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer who are actively considering enrolling in an immunotherapy interventional clinical trials, but have not yet completed enrollment and randomization in said clinical trial.

Brief summary: It has been observed before that participation in medical trials has been in favor of specific demographic groups. But research pointing out which trial attributes impact participation positively or negatively is sparse.

This study invites various participants to collect more data on their immunotherapy clinical experiences. The goal is to know which factors always limit how patients participate or complete the medical study they are first interested in.

The data obtained in the trial will be assessed through a variety of demographic lenses to discover patterns that might improve the experience of immunotherapy patients in the future.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to participate in an interventional clinical trial using immunotherapy
* Patient has been diagnosed with a type of cancer
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital reporting as per study requirements
* Patient does not complete Informed Consent Form

Primary outcomes:
measure: Number of patients who decide to enroll in an immunotherapy clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in immunotherapy clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Loree JM, Anand S, Dasari A, Unger JM, Gothwal A, Ellis LM, Varadhachary G, Kopetz S, Overman MJ, Raghav K. Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol. 2019 Oct 1;5(10):e191870. doi: 10.1001/jamaoncol.2019.1870. Epub 2019 Oct 10.
citation: Hussain-Gambles M. Ethnic minority under-representation in clinical trials. Whose responsibility is it anyway? J Health Organ Manag. 2003;17(2):138-43. doi: 10.1108/14777260310476177.
citation: Ma MA, Gutierrez DE, Frausto JM, Al-Delaimy WK. Minority Representation in Clinical Trials in the United States: Trends Over the Past 25 Years. Mayo Clin Proc. 2021 Jan;96(1):264-266. doi: 10.1016/j.mayocp.2020.10.027. No abstract available.
Clinical trial NCT01050465: MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use
Official title: MedlinePlus Health Prescriptions: Developing a Real World Approach for Clinic Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Allergic Rhinitis
Anxiety
Asthma
Back Pain
Prostatic Hyperplasia
Bursitis
Chronic Obstructive Pulmonary Disease
Cough
Coronary Artery Disease
Depression
Diabetes Mellitus
Diarrhea
Gastroesophageal Reflux
Fibromyalgia
Headache
HIV Infections
Hypothyroidism
Hyperlipidemia
Hypertension
Influenza
Sleep Initiation and Maintenance Disorders
Irritable Bowel Syndrome
Migraine Disorders
Obesity
Obstructive Sleep Apnea
Osteoarthritis
Senile Osteoporosis
Shoulder Pain
Sinusitis
Smoking Cessation
Tobacco Use Cessation
Menopause
Urinary Incontinence
Urinary Tract Infection
Vaginitis
Vertigo
Keywords: HIV
Knee pain
Colonoscopy
Mammography
Vaccination
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2010-01-15
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.

Detailed description: The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.

Primary Hypothesis. Individuals in the paper prescription group will be just as likely to seek information using MedlinePlus compared with individuals in the group who receive the same customized information through an email prescription.

Secondary Hypothesis. Individuals in the paper prescription group will be just as likely to have successful behavioral outcome measures as those in the group who receive the same customized information through an email prescription.

Eligibility criteria: Inclusion Criteria:

* one of the 40 target health conditions.

Exclusion Criteria

- absence of at least one of the target 40 conditions

Primary outcomes:
measure: seeking information using MedlinePlus
timeFrame: clicks will be tracked on the website when they occur
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Robert Hodge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coberly E, Boren SA, Mittal M, Davis JW, Scoville C, Chitima-Matsiga R, Ge B, Cullina A, Logan RA, Steinmann WC, Hodge RH. MedlinePlus-based health information prescriptions: a comparison of email vs paper delivery. Inform Prim Care. 2012;20(3):197-205. doi: 10.14236/jhi.v20i3.25.
Clinical trial NCT01601665: Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9
Official title: Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataracts
Astigmatism
Keywords: Intraocular lens
Cataracts
Astigmatism
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 477
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be selected from up to 80 clinical investigative sites.

Brief summary: The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

Detailed description: In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with bilateral cataracts and in the targeted astigmatism range.
* Planned cataract removal by phacoemulsification.
* Pupil size greater than or equal to 6 mm after dilation.
* Able to undergo second eye surgery within 30 days of first eye surgery.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Irregular corneal astigmatism.
* Any inflammation or swelling of the cornea.
* Any corneal abnormality other than regular corneal astigmatism.
* Previous corneal refractive surgery.
* Amblyopia.
* Diabetic retinopathy.
* Uncontrolled glaucoma.
* Currently participating in another investigational drug or device study that may confound the results of this investigation.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Rate of Severe Visual Distortions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Gina Calderon, CM, Surgical
role: STUDY_DIRECTOR
References:
citation: Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.