louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00662194: Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
Official title: A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-hepatitis Co-infection
HIV Infections
Keywords: HIV
HBV
HCV
co-infection
innate immunity
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Monash Medical Centre
name: National Institutes of Health (NIH)
First posted: 2008-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinics

Brief summary: Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.

Detailed description: It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.

The aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.

The study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.

Eligibility criteria: Inclusion Criteria:

* HIV and either HBV or HCV co-infection
* 18 years and older
* able to give informed consent

Exclusion Criteria:

* HIV-HBV-HCV triple infection

Primary outcomes:
measure: TLR change with HIV co-infection therapy
timeFrame: 6 months
Secondary outcomes:
measure: TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting
timeFrame: 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Joe Sasadeusz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06722794: Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture
Official title: Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Ahmed glaucoma valve, prolene, glaucoma drainage device
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: Magrabi Eye & Ear Hospital
First posted: 2024-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma

Detailed description: This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty

Eligibility criteria: Inclusion Criteria:

* Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.

Exclusion Criteria:

* The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.

Primary outcomes:
measure: long term stability and plate migration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jedda
country: Saudi Arabia
facility: Maghrabi Eye Hospitals
Study officials:
affiliation: ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS
name: AHMED SAMIR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05446194: Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Official title: Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2022-07-06
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.

Detailed description: Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.

Eligibility criteria: Inclusion Criteria:

1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4

Exclusion Criteria:

1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
2. Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
3. Evidence of a stroke or mass lesion on structural brain imaging (MRI).
4. Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
5. Severe claustrophobia precluding MR or PET imaging.
6. Subjects limited by participation in research procedures involving ionizing radiation.
7. Pregnancy (test within 48 hours of each PET session) or breastfeeding.
8. Subjects with active and unstable mood or anxiety disorders
9. Subjects with active ear infections or perforated eardrums

Primary outcomes:
measure: Freezing of Gait
timeFrame: after a week of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chatkaew Pongmala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05205694: Oral Health in Covid-19 Survivors
Official title: Biomarkers of Oral Health in Covid-19 Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Periodontitis
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Groups I and III will include COVID-19 survivors in late convalescent stage (one to six months post onset of symptoms accompanied by SARS-CoV-2- positive nasopharyngeal swab result) who had non-severe COVID-19 (no or mild pneumonia - less than 50 percent lung involvement on imaging within 24 to 48 hours, absence of dyspnea and hypoxia). Groups II and IV will include participants who report to had no symptoms of COVID-19 and had no SARS-CoV-2- positive nasopharyngeal swab result

Brief summary: Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors

Detailed description: There are lack of data concerning oral health in COVID-19 survivors, nevertheless, many middle-aged patients with oral symptoms of Post-acute COVID-19 report xerostomia and taste impairment and suffer from oral hypofunction, thus may be susceptible to periodontitis and oral frailty. Post-acute or long COVID-19 is/would be the health hallmark of post-COVID-19 era, manifested as a multiplicity of clinical problems and requiring conceptual framework aiming at multidisciplinary health preserving activities. There are various factors which may affect oral and periodontal health in post-COVID-19 era, such as disruption of dental professional care due to the fear of infection, virus-induced disturbance of oral homeostasis and, as a common denominator- COVID-19-induced psychological stress. Expected results would not just offer epidemiological data but also, mechanistic background for defining risks and modified measures aiming to preserve oral health in post-COVID-19 era.

Eligibility criteria: Inclusion Criteria:

* self-reported good general health, ≥ 14 erupted teeth excluding third molars. For periodontally healthy: Bleeding on probing score ≤10%, without attachment loss and radiographic bone loss and probing depth ≤ 3 mm in every site (Trombelli L et al., 2018). For periodontitis patients: periodontitis in stages II-IV.

Exclusion Criteria:

* history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day

Primary outcomes:
measure: Periodontal disease stage and COVID 19
timeFrame: one to six months after COVID-19
Secondary outcomes:
measure: Oral frailty
timeFrame: one to six months after COVID-19
measure: psychological stress
timeFrame: one to six months after COVID-19
measure: salivary stress/immunity mediators
timeFrame: one to six months after COVID-19
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine University of Belgrade
Study officials:
References:
Clinical trial NCT05100394: Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
Official title: Effectiveness of High Power Laser Therapy on Pain and Isokinetic Power in Athletes With Proximal Hamstring Tendinopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Lasers
Keywords: Proximal hamstring tendinopathy
laser therapy
Pain
Muscle power
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel-groups
Primary purpose: TREATMENT

Brief summary: Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. To the best of the investigator's knowledge, no study has compared the effects of high-power LASER therapy with conventional physiotherapy programs in proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy patients.

Detailed description: 2 arms comparative pretest-posttest experimental research design with random allocation of subjects into groups (experimental and control group) using the lottery method. A total of thirty-six participants aged between 18-35 (mean age) years, were recruited in the present study. The selected participants were randomly allocated into experimental and control groups using the lottery method and website randomization.com with eighteen participants in each group. The participants and outcome assessor were kept blinded to the allocation. In the experimental group, the high-power laser was given whereas in the control group conventional physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included the US, moist heat pack, and home exercises. Home exercises include nordic hamstring exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Athletes
* pain located deep in the buttock/posterior thigh region
* tenderness of ischial tuberosity
* hamstring muscle tightness.

Exclusion Criteria:

* Recent trauma to the posterior thigh
* Musculoskeletal disorder of ipsilateral lower extremity
* taking pain medication daily
* hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 3 weeks.
measure: Isokinetic peak torque
timeFrame: 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00009594: Alternative Medicine Approaches for Women With Temporomandibular Disorders
Official title: Alternative Medicine Approaches for Women With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-02
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: Temporomandibular disorders (TMD) are characterized by pain and tenderness in the muscles of mastication and/or the temporomandibular joint (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds.

TMD is often found in association with other problems: depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infections, etc. This project proposes to holistically address patient symptoms through three different approaches, Naturopathic Medicine (NM), Traditional Chinese Medicine (TCM), and usual care at KPNW. We will conduct a pilot test and Phase II trial to evaluate the two alternative healing approaches, TCM (n=50) and NM (n=50) delivered by TCM and NM practitioners, are as effective as usual TMD care (n=50) provided by dental clinicians in the KPNW TMD Clinic. Subjects will be females 25-55 years of age with multiple health problems (defined as patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD). Subjects will be evaluated at baseline, 6 and 12 months after start of treatment. The primary endpoint is change from baseline in the Axis II Pain Related Disability and Psychological Status Scale. Clinical examinations, saliva samples to assess salivary cortisol levels, and responses to a series of questionnaires to assess pain, chronic pain, psychosocial functioning, and other physical symptoms will be used to assess outcomes. We will passively monitor health care utilization within KPNW using clinical, research, and administrative databases to determine whether the interventions have an impact on overall health care utilization. If either of these alternative interventions is shown to merit Phase III trial, our goal is to design and implement such a clinical trial to further evaluate the health consequences and costs of these alternative healing paradigms.

Detailed description: See brief summary

Eligibility criteria: - Patients who have had at least 4 organ system-grouped diagnoses in the past year, not including TMD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Health Research, Kaiser Foundation Hospitals
state: Oregon
Study officials:
affiliation: Center for Health Research (CHR), Kaiser Foundation Hospitals
name: Alexander White
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079494: Clinical Pharmacists Role in the Management of Hypertension in Jordan
Official title: Clinical Pharmacists Role in the Management of Hypertension in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Uncontrolled blood pressure
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Jordan Hospital
First posted: 2010-03-03
Enrollment: 266
Sex: ALL
Minimum age (years): 21
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: studies have demonstrated the crucial role of clinical pharmacists as integrated part of heath care team. Not only in Jordan but also in the Middle East region, clinical pharmacy practice is not well established. This current study is the first to evaluate physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and the Middle East.

Detailed description: Objective: this study aimed to evaluate clinical pharmacists' role in the management of uncontrolled hypertensive patients in Jordan. Design: single blinded randomized controlled clinical trial. Patients: 253 patients with uncontrolled hypertension specified as higher blood pressure readings than the recommended goals by the seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure (JNC VII) at the time of enrollment.

Interventions: patients were randomly allocated to an intervention or control group: 130 and 123 patients, respectively. Patients in both arms were followed up for 6 months. In the intervention group, patients were managed by physician-clinical pharmacist team. In the control group, patients were managed by physician(s) only and were not provided pharmaceutical care services.

Eligibility criteria: Inclusion Criteria:

* Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.

Exclusion Criteria:

* Patients with hypertensive urgency or emergency with BP more than (180/110).
* Patients with recent stroke or myocardial infraction (within past 6 months).
* Patients with Class III or IV Chronic heart Failure (CHF).
* Patients with Unstable angina.
* Patients with Serious renal or hepatic disease.
* Pregnant patients.
* Patients with Dementia or cognitive impairment.
* If the patient is unable to provide informed written consent.

Primary outcomes:
measure: percentage of patients who achieved blood pressure goals specified by the JNC VII at each group
timeFrame: 6 month
Secondary outcomes:
measure: mean reductions in both systolic and diastolic blood pressure readings
timeFrame: 6 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: family medicine clinic JUH
Study officials:
affiliation: University of Jordan/ Faculty of Pharmacy
name: Eman Hammad, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jordan/ Faculty of Pharmacy
name: Abla Al bsoul, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00155194: Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice
Official title: Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Atresia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Detailed description: Biliary atresia patients with cholestatic jaundice were noted to have increased incidence of infectious complications. Previous animal models of bile duct ligation with acute jaundice ever demonstrated impairment of both humoral and cellular immune function. We performed the immunity study in biliary atresia patients due to the lack of comprehensive systemic immunity study in pediatric cholestatic model. Systemic humoral immunity (total serum IgG, IgA, IgM, C3 and C4), specific cellular immunity (lymphocyte classification, mitogen response, cytokines level after PHA stimulation test), and non-specific cellular immunity (absolute neutrophil count, PMN CD11b/CD18 expression level, PMN superoxide release function, and PMN phagocytosis function) were tested. Association with serum bilirubin level, nutritional status and blood biochemical values were tested to see the relation between systemic immune function and cholestatic jaundice.

Eligibility criteria: Inclusion Criteria:

Biliary patients older than 1-year-old status post Kasai operation.

Exclusion Criteria:

Received liver transplantation, immunosuppresant, systemic immunoglobulin (within 6 months) and obvious infectious episode (within 2 weeks).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Pediatrics, National Taiwan University Hospital
Study officials:
affiliation: Department of Pediatrics, Natonal Taiwan University Hospital
name: Mei-Hwei Chang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00445094: A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
Official title: A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Pneumonia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 120
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 primary objective of this study is a comparison between MK0787B and standard therapy.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Patient is diagnosed with nosocomial pneumonia

Exclusion Criteria:

* Immunological deficient patients
* Pregnant women and nursing mothers
* A fungus is identified before the study enrollment
* Received vancomycin or imipenem for more than 5 days before icu admission

Primary outcomes:
measure: A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: