louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06654063: Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients
Official title: Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

Detailed description: This randomized clinical trial evaluates the effect of Omega- 3 versus Vitamin D regarding Clinical evaluation

1. Clinical attachment loss (CAL)
2. Probing pocket depth (PPD)
3. Modified sulcus bleeding index (mSBI)

Eligibility criteria: Inclusion Criteria:

* • Systemic healthy patients

  * Patients aged \> 25 years
  * Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
  * Patients with interdental clinical attachment loss (CAL) of 3-4 mm
  * No history of previous periodontal therapy.
  * No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
  * No previous periodontal surgery at involved sites.
  * Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
  * Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
  * Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
  * Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.

Exclusion Criteria:

* • Patients taking Omega- 3 or Vitamin D as a nutritional supplement were excluded from the study

  * Smoking habits
  * Pregnant and lactating mothers
  * Patients who have been received periodontal surgery in the study area during the last 6 months.

Primary outcomes:
measure: clinical attachment loss (CAL)
timeFrame: Day 0 - Week 6
Secondary outcomes:
measure: probing pocket depth (PPD)
timeFrame: Day 0 - Week 6
measure: modified sulcus bleeding index (mSBI)
timeFrame: Day 0- Week 6
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Helal
Study officials:
References:
Clinical trial NCT04954963: CT Mar Technology and MR Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation
Official title: Objective to Explore the Clinical Application Value of Spectral CT Mar Technology and Magnetic Resonance Mavric, Semac Sequence in Removing Artifacts of Orthopedic Metal Internal Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From December 2019 to October 2020, patients who were reexamined after spinal internal fixation or knee and hip replacement in Peking University Third Hospital.

Brief summary: 1. Objective to compare the effect of single energy imaging and mar technology in reducing artifacts of knee and hip replacement, and to explore the appropriate keV range of Mar technology in removing metal artifacts.,2. Objective to compare the effects of different MRI sequences (mavric / semac, stir, ideal, FSE) in removing artifacts of spinal internal fixation, knee and hip replacement.

Detailed description: Conventional spiral CT \[4\] examination will form black-and-white stripe artifacts around the metal implant, making the display of adjacent important structures unclear. In routine MRI examination \[5\], metal will interfere with the uniformity of local magnetic field, resulting in signal loss, and the artifacts will seriously affect the observation of bone and its surrounding structures.

The purpose of this study was to comprehensively evaluate the effect of Mar technology on reducing metal artifacts after internal fixation and joint replacement, and then to explore the appropriate keV range of Mar technology to reduce metal artifacts. We also aim to compare the reduction effect of different sequences of MRI on internal fixation artifacts after internal fixation and joint replacement, and to explore the sequence suitable for clinical diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Patients after spinal internal fixation or knee or hip replacement

Exclusion Criteria:

* Patients with poor image quality caused by their own factors such as patients' movement can not meet the diagnostic requirements

Primary outcomes:
measure: Artifact index
timeFrame: 2020.10.15-2020.10.30
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Huishu Yuan
role: STUDY_CHAIR
References:
Clinical trial NCT01157663: The Effect of Balance Training in People With Functional Ankle Instability (FAI)
Official title: The Effect of Balance Training in People With Functional Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Ankle Instability
Keywords: Functional ankle instability
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who sustain such an injury display residual symptoms under the general denominator functional ankle instability (FAI). In literature, there is already given a lot of attention to extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the possible interventions which may be able to reduce the chance of developing chronic instability. At this moment there is a lack of unequivocality.

In this study the investigators address the question of what is the effect of a balance training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure measurements and muscle activity are taken in consideration The purpose of this study is a better insight in the effect of treatment on the residual symptoms related to FAI.


Eligibility criteria: Inclusion Criteria:

* a history of more than 1 unilateral ankle sprain
* presence of feeling of 'giving way'
* a feeling of weakness around the ankle
* a decreased functional participation

Exclusion Criteria:

* ankle fracture
* ankle surgery
* lower limb pain (not related to an ankle sprain)
* ankle distortion in the last 3 months
* currently receiving treatment
* disturbance of equilibrium

Primary outcomes:
measure: effect of balance training on movement strategy
timeFrame: after 8 weeks of treatment
Secondary outcomes:
measure: self-assessed complaints registration using questionnaires
timeFrame: after 8 weeks
measure: self-assessed complaints registration using questionnaires
timeFrame: after 1 year
measure: self-assessed complaints registration using questionnaires
timeFrame: at baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Ghent
name: Philip Roosen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304863: Addition of Lactobacillus to Metronidazole in Treatment of CDAD
Official title: Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Enterocolitis
Pseudomembranous Colitis
Antibiotic-associated Colitis
Keywords: CDAD
Clostridium difficile Associated Diarrhea
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: Baylor College of Medicine
First posted: 2006-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.

Detailed description: Clostridium difficile associated disease (CDAD), which nearly always follows antibiotic therapy, has become increasingly common and important in American hospitals, causing substantial morbidity and mortality. Metronidazole is the recommended treatment for this condition. We have recently reported (Clin Infect Dis, June 2005) that treatment with metronidazole is associated with a 22% rate of failure and 28% rate of relapse. No other medication has been shown to be more effective. There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients. Lactobacillus GG is the best-standardized and the most extensively studied of these agents.

Eligibility criteria: Inclusion Criteria:

* Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin

Exclusion Criteria:

* Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded.
* Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus.

Primary outcomes:
measure: Response to Treatment
timeFrame: less than 10 days
measure: Stool sample C. diff toxin assay
timeFrame: 30 days after start of medication
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Houston VA Medical Center
name: Daniel M Musher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898063: 90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure
Official title: An Experimental Investigation of the Effects of an Entertainment Education Short Film on Internalized HIV-related Stigma, Sexual Partner Status Disclosure, and Medical Adherence Intentions Among Black HIV-positive Women in Miami-Dade County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This investigation seeks to understand if and how, the 90 Days film can be used as an intervention to address HIV-related stigmas, intimate partner status disclosure and HIV ART medical adherence among Black HIV positive women.


Eligibility criteria: Inclusion Criteria:

* Black women ages 18-50
* clinically diagnosed with HIV/AIDS
* Speak and comprehend English

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: HIV Self-stigmatization as Assessed Via Self Stigmatization Questionnaire
timeFrame: Day 1 post test
measure: HIV Disclosure Intentions as Assessed by Disclosure Intentions Scale
timeFrame: Day 1 post-test
measure: Medical Adherence Intentions as Measured by the Medical Adherence Scale
timeFrame: Day 1 post-test
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Medical Campus
state: Florida
Study officials:
affiliation: University of Miami
name: Nicholas Carcioppolo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583863: Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission
Official title: Parasitic Infection Flares up the Activity of Ulcerative Colitis; However, Combined Immunomodulatory Therapy With Anti-parasitic Treatment Could Proceed Toward Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to explore the link between parasitic infections and the severity of ulcerative colitis (UC). 120 UC patients were divided into three groups: those without infection, those with Giardia lamblia infection treated with metronidazole, and those with Giardia infection treated with a combination of metronidazole and E. purpurea. The results revealed that patients with Giardia infections exhibited more severe UC symptoms. All groups experienced improved symptoms following treatment, but the combination therapy group demonstrated the most significant improvement. Remission rates were highest in the group without infection and the group receiving combination therapy. Additionally, the study identified E. purpurea therapy and a substantial reduction in SCCAI score as significant predictors of higher remission rates.


Eligibility criteria: Inclusion Criteria:

* Ulcerative Colitis patients had active disease,
* Patients had parasitic infection by G. lambellia,
* Patients free of parasitic infection,
* Patients free of exclusion criteria..

Exclusion Criteria:

* Patients had Inflammatory Bowel Disease other than Ulcerative Colitis,
* Patients had multiple parasitic infections,
* Patients had infection by parasites other than G. lambellia,
* Patients who were maintained on immunosuppressant therapy,
* Patients who were in remission and patients refused to sign the written consent to participate in the study.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% increase in the remission rate of parasitic infection (measured by changes in Serum CRP, Fecal calprotectin, and on the Simple Clinical Colitis Activity Index[SCCAI]) in patients with Ulcerative colitis.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha faculty of Medicine
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT04548063: Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Official title: Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.

Detailed description: This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.

Eligibility criteria: Inclusion Criteria:

* Patient-reported history of cancer
* Patient is able to read English
* Patient-reported age of 18 years or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Decision to enroll
timeFrame: Through study completion, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14.
citation: Wieland J, Satele D, Almodallal Y, Novotny P, Pritzl SL, Mandrekar SJ, Jatoi A. Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study. J Patient Exp. 2022 Jun 22;9:23743735221107242. doi: 10.1177/23743735221107242. eCollection 2022.
Clinical trial NCT05989763: Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Official title: Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Sclerosis
Constipation
Gastrointestinal Motility Disorder
Autonomic Dysfunction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-08-14
Enrollment: 60
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 purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.


Eligibility criteria: Inclusion Criteria

* Patients with SSc-constipation from Aim 1 of the study
* Patients with SCT (\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
* Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Exclusion Criteria

-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Primary outcomes:
measure: Change in slow colonic transit (SCT)
timeFrame: baseline, week 4 (visit 2)
Secondary outcomes:
measure: Change in rectal hyposensitivity as assessed by the anorectal manometry
timeFrame: baseline, week 4 (visit 2)
measure: Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
timeFrame: baseline, week 4 (visit 2)
measure: Change in autonomic dysfunction as assessed by the COMPASS-31 measures
timeFrame: baseline, week 4 (visit 2)
measure: Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
timeFrame: baseline, week 4 (visit 2)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Zsuzsanna H McMahan, MD, MHS (M-PI)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010763: A Study on M2a Magnum Total Hip Arthroplasty
Official title: A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Joint Disease
Avascular Necrosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.

Detailed description: There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for primary Total Hip Replacement
* Patients aged over 20
* Patients with limited co-morbidity- ASA I-III
* Patients must be able to understand instructions and be willing to return for follow-up
* Patients willing to provide blood and urine samples for metal ion analysis at follow-up

Exclusion Criteria:

* Pre-existing metal implants
* Infection, sepsis, and osteomyelitis
* Uncooperative patient or pt with neurologic disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* osteomalacia
* distant foci of infections which may spread to the implant site
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* vascular insufficiency, muscular atrophy, or neuromuscular disease
* pregnancy

Primary outcomes:
measure: Range of Motion
timeFrame: 1 year
Secondary outcomes:
measure: Metal Ion
timeFrame: 3 month
measure: UCLA Activity Score
timeFrame: 5 year
measure: Radiographic Assessment
timeFrame: 5 year
measure: Harris Hip Score
timeFrame: 5 year
measure: Metal Ion
timeFrame: 6 month
measure: Metal Ion
timeFrame: 1 year
measure: Metal Ion
timeFrame: 2 year
measure: Metal Ion
timeFrame: 3 year
measure: Metal Ion
timeFrame: 4 year
measure: Metal Ion
timeFrame: 5 year
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo Pref.
Study officials:
affiliation: Kansai Rosai Hospital
name: Kenji Ozono, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ando W, Yamamoto K, Atsumi T, Tamaoki S, Oinuma K, Shiratsuchi H, Tokunaga H, Inaba Y, Kobayashi N, Aihara M, Ohzono K. Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study. J Orthop. 2015 Jun 10;12(4):228-36. doi: 10.1016/j.jor.2015.05.008. eCollection 2015 Dec.