louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04697199: The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
Official title: The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

Detailed description: The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).

Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.

Eligibility criteria: Inclusion Criteria:

1. Patients with good systemic health.
2. Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
3. Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
4. No gingival recession.

Exclusion Criteria:

1. Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
2. Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
3. Patients who are allergic to lactate products.

Primary outcomes:
measure: Change in Probing pocket depth
timeFrame: Baseline. 3 months. 6 months
Secondary outcomes:
measure: Change in Plaque index
timeFrame: Baseline, 3 and 6 months
measure: Change in Bleeding on probing
timeFrame: Baseline, 3 and 6 months
measure: Change in Clinical attachment level
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ghadeer
Study officials:
affiliation: Tanta University
name: Elbagoory
role: STUDY_DIRECTOR
References:
Clinical trial NCT03177642: Orthopaedic Hand and Upper Extremity Data Repository
Official title: Orthopaedic Hand and Upper Extremity Data Repository
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-traumatic and Traumatic Orthopaedic Issues
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients presenting to the orthopaedic hand and upper extremity service for a traumatic or non-traumatic issue

Brief summary: The purpose of this research is to investigate multiple facets of non-traumatic and traumatic orthopaedic health issues. Studies under this protocol will investigate a variety of research questions concerning traumatic and non-traumatic health issues in the Orthopaedic Hand and Upper Extremity Service.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Patients presenting to the Orthopaedic Hand and Upper Extremity Service for traumatic or non-traumatic issues
* English speaking

Exclusion Criteria:

* Under 18 years
* Vulnerable population

Primary outcomes:
measure: Quick-DASH (Disabilities of the Arm, Shoulder and Hand Quick Questionnaire)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03094442: Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?
Official title: Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Quality of Life
Pelvic Organ Prolapse
Prolapses, Vaginal Vault
Keywords: Quality of Recovery
Minimally Invasive Sacrocolpopexy
Dexamethasone
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

Detailed description: There has been a public outcry regarding the continuing rise of health care expenditures. In 1997, the estimated costs of surgery for pelvic organ prolapse (POP) were $ 100.1 million. It is important to identify interventions that would improve the QoR in this patient population and to speed-up postoperative recovery. As most of these surgeries are performed in an outpatient manner as a 23 hour observation, improved recovery may also speed discharge and free-up valuable hospital resources.

Patients will receive either Dexamethasone or placebo ( normal saline) at the time of induction of general anesthesia. QoR questionnaires, Pain scale and postoperative nausea and vomiting scale (PONV).

Eligibility criteria: Inclusion Criteria:

1. Women over the age of 18
2. Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
3. American Society of Anesthesiologists (ASA) class 1-2

Exclusion Criteria:

1. Daily use of steroids, antiemetics in the month prior to surgery
2. Chronic pain requiring daily opioid treatment
3. History of allergy/intolerance to Dexamethasone
4. ASA class 3
5. Numerical Pain score (NPS) of more than 4 at baseline
6. Renal/Liver disease
7. Diabetes mellitus
8. Pregnancy
9. Inability to answer questionnaires
10. Any systemic infections
11. Immuno compromised status

Primary outcomes:
measure: Quality of recovery 40 (QoR-40)
timeFrame: baseline, 24 hours, 6 weeks
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: baseline, 24 hours, 6 weeks
measure: Postoperative Nausea Vomiting Scale
timeFrame: 6 weeks
Other outcomes:
measure: postoperative urinary retention
timeFrame: 6 weeks
measure: Infections
timeFrame: 6 weeks
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: David Ossin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06488742: The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis
Official title: Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in the Treatment of Patients With Mild Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dermatitis, Atopic
Pruritus
Lead sponsor: Nexgen Dermatologics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atopic dermatitis is a common disease affecting millions worldwide. A common associated symptom in this population is pruritus. We seek to investigate the use of an natural, over-the-counter cosmeceutical to help this population

Detailed description: There are many treatment options available for atopic dermatitis yet many patients still suffer from the underlying symptomatology. It is important to explore other treatment alternatives to help this population.

Eligibility criteria: Inclusion Criteria:

* age greater than 12 years, diagnosis of atopic dermatitis for longer than 2 years, investigator's static global assessment score of either 2 or 3, and initial worst itch numerical rating scale (WI-NRS) for itch greater than 4.

Exclusion Criteria:

* the use of topical or systemic corticosteroids within 28 days of entering the study, the use of any other non-emollient therapy within 28 days of entering the study,nursing, and pregnancy

Primary outcomes:
measure: ISGA
timeFrame: 28 days
measure: WI-NRS
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Berlin Center
state: Florida
Study officials:
References:
citation: Shortt N, Martin A, Kerse K, Shortt G, Vakalalabure I, Barker L, Singer J, Black B, Liu A, Eathorne A, Weatherall M, Rademaker M, Armour M, Beasley R, Semprini A; Medical Research Institute of New Zealand's Pharmacy Research Network. Efficacy of a 3% Kanuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial. EClinicalMedicine. 2022 Jul 15;51:101561. doi: 10.1016/j.eclinm.2022.101561. eCollection 2022 Sep.
Clinical trial NCT06664606: Impact of a Pain Neuroscience Education Program on Primary Students with and Without Intellectual Disabilities
Official title: Satisfaction and Knowledge Acquisition Following a Pain Neuroscience Education Program in Primary Students with and Without Intellectual Disabilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain (back / Neck)
Keywords: Pain Management
Health Education
Students
Neuroscience
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 413
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of fifth and sixth grade primary school students enrolled in the Autonomous Community of Extremadura, Spain. The participants include students from both regular and special education schools, encompassing both urban and rural areas. The sample represents a diverse group with variations in intellectual abilities, aiming to assess the impact of a neuroscience education program on understanding pain and promoting health knowledge.

Brief summary: This observational study evaluates the impact of a Pain Neuroscience Education (PNE) program on primary school students in Extremadura, Spain. The study examines satisfaction levels and knowledge acquisition regarding pain neuroscience among students with and without intellectual disabilities. Conducted across both rural and urban educational centers, as well as special and regular education schools, this study aims to identify the effectiveness of PNE in enhancing pain-related knowledge and addressing Sustainable Development Goals (SDGs) awareness. Additionally, the program includes interactive educational activities tailored for accessibility, using resources such as easy-to-read questionnaires and hands-on models, to support inclusive health education. Data collection involves pre- and post-intervention questionnaires to assess satisfaction and knowledge gains, with statistical analysis exploring differences between demographic and school-type groups.


Eligibility criteria: Inclusion Criteria:

* Students enrolled in the fifth or sixth grade of primary education in schools within the Autonomous Community of Extremadura.
* Students who regularly attend academic activities and complete the educational intervention.

Exclusion Criteria:

* Students who do not attend school regularly or who are not expected to complete the intervention.
* Students with severe cognitive or behavioral impairments that may interfere with participation in the educational activities.

Primary outcomes:
measure: Satisfaction Level and Knowledge Acquisition in Pain Neuroscience Education
timeFrame: Immediately after completion of the educational intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Universidad de Extremadura
Study officials:
affiliation: University of Extremadura
name: Luis Espejo-Antúnez, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004406: Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: disease-related problem/condition
osteoporosis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 36
Sex: MALE
Minimum age (years): 29
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.

Patients are followed regularly for unacceptable toxicities.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)

No family history of male osteoporosis

No other metabolic bone disease

--Prior/Concurrent Therapy--

Endocrine therapy:

* No concurrent glucocorticoid therapy
* No prior steroid use

Surgery: No prior gastrointestinal tract surgery

Other: No prior or concurrent anticonvulsant therapy

--Patient Characteristics--

Hematopoietic: Normal CBC

Hepatic: Normal liver function

Renal: Normal renal function

Other:

* Normal thyroid function
* Normal adrenal function
* Normal gonadal status
* No myeloma or other malignancy
* No alcoholism, hypercortisolism or diabetes mellitus
* No gastrointestinal tract disease or disorder associated with malabsorption

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: John Paul Bilezikian
role: STUDY_CHAIR
References:
Clinical trial NCT00570206: An Evaluation of Motivational Interviewing to Increase Compliance in a Probation Setting
Official title: An Evaluation of Motivational Interviewing to Increase Compliance in a Probation Setting (Enhancing Communication and Officer Responsivity; ENCORE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance With Terms of Probation Sentence
Keywords: Probation
Motivational
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2007-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Motivational Interviewing (MI) on probationer progress over a 6-month period, using probation officers as the MI providers.


Eligibility criteria: Inclusion Criteria:

1. Participants must be on felony probation.
2. Participants must be English speaking.
3. Participants must be classified as medium or high-risk.
4. Participants must be placed on a non-specialized caseload.
5. Participants must be at least 18 years of age.

Exclusion Criteria:

1. Does not speak English.
2. Is less than 18 years old.
3. Is not on felony probation.
4. Is not classified as medium or high-risk.
5. Is placed on a specialized caseload.

Primary outcomes:
measure: Revocations
timeFrame: 6 months
measure: Absconder Status
timeFrame: 6 months
measure: Urinalysis (UA) Data
timeFrame: 6 months
measure: Arrest Data
timeFrame: 6 months
Secondary outcomes:
measure: Officer Responses Questionnaire
timeFrame: 9 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas County Community Supervision and Corrections
state: Texas
city: Dallas
country: United States
facility: University of Texas School of Public Health Dallas Regional Campus
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Scott T Walters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419206: The Relationship Between CMV* Reactivation and Anti-cytokine Treatment in Critical COVID-19 Patients
Official title: Department of Infectious Disease and Clinical Microbiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The mean age of the patients was 59.2 (26-91 years), 63.7 years for women, and 58.6 years for men. The study included 167 critical and/or intensive care patients, 24 of whom were female (14%), and 143 of whom were men.

Brief summary: The risk of secondary infection is high in critical patients hospitalized with the diagnosis of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients, and immune dysfunction and CMV reactivation can be unnoticed in these patients.

Detailed description: The records of critical patients were reviewed retrospectively. Whether these patients used tocilizumab and/or anakinra and their relationship with CMV reactivation were examined. Furthermore, the relationship between CMV reactivation and mortality and anti-cytokine treatment in patients was also examined. A total of 167 critical COVID-19 patients were included in the study, of which 38 (22.7%) were found to be CMV DNA positive. CMV positivity in patients treated with anti-cytokines (31.11%) was found to be significantly higher than in patients who were not treated with it (16.88%) (p:0.033). There was no significant difference in viral load levels (p:0.513). Furthermore, it was determined that anti-cytokine treatment significantly decreased mortality (p: 0.003) and that there was no significant relationship between CMV reactivation and mortality (p: 0.399). Even though CMV reactivation was high in critical COVID-19 patients who received anti-cytokine treatment, positive developments in morbidity and mortality were observed with early diagnosis and effective treatment.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients over the age of 18 diagnosed with COVID-19 and patients followed in the intensive care unit.

Exclusion Criteria:

* Patients under the age of 18 with a mild/moderate course of COVID-19,
* CMV PCR positive before anti-cytokine treatment,
* patients who underwent hematopoietic stem cell transplantation

Primary outcomes:
measure: The relationship between CMV reactivation and anti-cytokine treatment
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Hospital Intercontinental
Study officials:
References:
Clinical trial NCT03462706: Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
Official title: A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Colon Polyp
Colon Adenoma
Keywords: Polyp Resection
Cold Snare
Hot Snare
Cold Endoscopic Mucosal Resection (EMR)
Hot Endoscopic Mucosal Resection (EMR)
Colonoscopy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: John D. Dingell VA Medical Center
name: White River Junction Veterans Affairs Medical Center
First posted: 2018-03-12
Enrollment: 238
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.

Detailed description: The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.

Eligibility criteria: Inclusion Criteria:

* Aged 40 years or older
* Ability to provide informed consent

Exclusion Criteria:

* Subjects with a history of Inflammatory Bowel Disease
* Lesions less than 6mm or greater than 15mm in largest dimension

Primary outcomes:
measure: Efficacy of Resection (Central Post-Resection Biopsies)
timeFrame: 1 day
measure: Efficacy of Resection (Peripheral Post-Resection Biopsies)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.