louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06015412: Physical Parameters in Osteoarthritis Stages
Official title: Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Pain
Quality of Life
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed with the same grade of knee OA in both knees by the responsible physician in the hospital

Brief summary: To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.


Eligibility criteria: Inclusion Criteria:

* having the same OA grade in both knees
* volunteering to participate in the study
* not having undergone previous lower extremity surgery

Exclusion Criteria:

* neurological disorders;
* those with a history of surgery related to the lower extremities;
* those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis;
* those who had neurological, orthopedic, or cognitive disorders that would prevent walking;
* those with a diagnosis of diabetes, obesity, or rheumatological disorders;
* those who had received intra-articular injection therapy within the last three months;
* and those with malignancy or perception problems.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 2 minutes
measure: two-minute walk test (2MWT)
timeFrame: 2 minutes
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 10 minutes
measure: Nottingham Health Profile (NHP)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selçuklu
Study officials:
References:
Clinical trial NCT00733512: Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)
Official title: Surgeon Experience ReSTOR Aspheric +4 Intraocular Lens (IOL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: ReSTOR Aspheric +4 IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were selected from primary care clinics.

Brief summary: To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.


Eligibility criteria: Inclusion Criteria:

* operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion Criteria:

* ocular comorbidities confounding study outcomes

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 week to 10 months
Secondary outcomes:
measure: Contrast Sensitivity
timeFrame: 1 week to 10 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT00214812: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Official title: An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV Seronegativity
HIV
Lead sponsor: Biosyn
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-09-22
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.


Eligibility criteria: Inclusion Criteria:

* 18 -45 year old women
* normal Pap smear
* not pregnant

Exclusion Criteria:

* abnormal pelvic exam
* history of claustrophobia
* allergy to product formulation
* pregnant or breastfeeding

Primary outcomes:
measure: Presence or absence of bare spots with and without Gd.
measure: Quantification and location of bare spots.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Reproductive Research Unit, U of Penn Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt Barnhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633412: A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSAID Associated Gastric Ulcers
Keywords: NSAID
Nexium
esomeprazole
Gastric Ulcers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 400
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: Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
* A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy.
* Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
* Many other conditions and criteria, as specified in the protocol.

Primary outcomes:
measure: The proportion of patients with no gastric ulcers after 8 weeks of treatment.
timeFrame: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
Secondary outcomes:
measure: The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N
timeFrame: Assessments at Week 0, Week 4 and Week 8
measure: To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.
timeFrame: Assessments at Week 0, Week 4 and Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT01872312: Spiration IBV® Valve System and Spiration Airway Sizing Kit
Official title: The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Management of BPF (Bronchopleural Fistulae)
Keywords: BPF(Bronchopleural fistulae)
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Olympus Corporation of the Americas
First posted: 2013-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

Detailed description: IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.

Eligibility criteria: Inclusion Criteria:

* Unresolved BPF
* Not candidate for surgical repair

Primary outcomes:
measure: resolution of BPF (Bronchopleural Fistulae)
timeFrame: 6 weeks
measure: resolutin of BPF
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSUMC
state: Ohio
Study officials:
affiliation: Ohio State University
name: shaheen Islam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715412: Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients
Official title: Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplant;Failure,Kidney
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2021-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data


Eligibility criteria: Inclusion Criteria:

\>18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training \& data collection.

Exclusion Criteria:

* Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer patients.

Primary outcomes:
measure: Specified clinical and educational outcome
timeFrame: 6 months
Secondary outcomes:
measure: Renal function
timeFrame: 6 months
measure: Renal function
timeFrame: 6 months
measure: Renal function
timeFrame: 6 months
measure: Serum trough Immunosuppressant level (C0)
timeFrame: 6 months
measure: CBC
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Transplantation Clinic Nasser Institute
Study officials:
References:
Clinical trial NCT03637712: Deep-Learning for Automatic Polyp Detection During Colonoscopy
Official title: Deep-Learning for Automatic Polyp Detection During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Colonoscopy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

* People with diminished cognitive capacity.
* The subject is pregnant or planning a pregnancy during the study period.
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients with any polypoid/ulcerated lesion \> 20mm concerning for invasive cancer on endoscopy.

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Seth Gross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190512: Periodontal Treatment and Psychology
Official title: The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gum Disease
Keywords: Periodontal disease
depression
body image
self-esteem
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Detailed description: Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.

Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.

Eligibility criteria: Inclusion Criteria:

* the presence of periodontal diseases,
* the presence of diagnosed minor depression
* being under maintenance therapy regarding the depression

Exclusion Criteria:

* any hormonal condition such as pregnancy or lactation
* received any periodontal treatment within six months

Primary outcomes:
measure: Depression level
timeFrame: Baseline and after 6 weeks
Secondary outcomes:
measure: Body image level
timeFrame: Baseline and after 6 weeks
measure: Anxiety level
timeFrame: Baseline and after 6 weeks
measure: Self-esteem level
timeFrame: Baseline and after 6 weeks
measure: Probing pocket depth
timeFrame: Baseline and after 6 weeks
measure: Clinical attachment level
timeFrame: Baseline and after 6 weeks
measure: Gingival index
timeFrame: Baseline and after 6 weeks
measure: Plaque index
timeFrame: Baseline and after 6 weeks
measure: Bleeding on probing
timeFrame: Baseline and after 6 weeks
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa Universty
name: Ozge Gokturk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01587612: Study of Quantification of Hyperpronation
Official title: Study of Quantification of Hyperpronation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Pain Chronic
Keywords: Pain
Foot
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hyperpronation of foot

Brief summary: Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited functional ability cause problems with work-related activities, sport activities and leisure activities.

There are only few studies of the frequency of pain related to hyperpronation in foot and the effect of exercises. Medics and physiotherapists need sufficient evidence-based knowledge to treat these patients correctly.

Therefore, the investigators want to study the effect of exercises and inner soles for treatment of patients with chronic pain and hyperpronation of foot.


Eligibility criteria: Inclusion Criteria:

* Hyperpronation of foot
* Consent of information

Exclusion Criteria:

* Normal gait
* Lack of consent of information
* Unable to speak and read Danish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Mogens B Laursen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01941212: Effect of Music Therapy Intervention on Pain After Gynecological Surgery
Official title: Effect of Music Therapy Intervention on Pain After Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Music therapy
pain
gynecological surgeries
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery.

The hypothesis is that musical therapy is effective in pain relief following surgical procedures.

Detailed description: The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design.

The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.

Eligibility criteria: Inclusion Criteria:

* Women are schedule to undergo gynecological surgeries

Exclusion Criteria:

* Neuropathy
* Neurological conditions
* Diabetes

Primary outcomes:
measure: Pain level following surgery
timeFrame: 48 hours following suegery
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Lior Lowenstein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047146: The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt
Official title: The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCC cases from a single tertiary center eligible for pathological analysis as a primary tool

Brief summary: This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications


Eligibility criteria: Inclusion Criteria:

* All pathologically proven Hepatocellular Carcinoma

Exclusion Criteria:

* Other malignant tumors than Hepatocellular Carcinoma
* Benign tumor

Primary outcomes:
measure: Clinicopathological factors of Hepatocellular Carcinoma
timeFrame: 10 years
measure: Clinicopathological factors of Hepatocellular Carcinoma
timeFrame: 10 years
measure: Clinicopathological factors of Hepatocellular Carcinoma
timeFrame: 10 years
measure: Clinicopathological factors of Hepatocellular Carcinoma
timeFrame: 10 years
measure: Clinicopathological factors of Hepatocellular Carcinoma
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: National Liver Intitute
state: Menoufia
Study officials:
References:
citation: Sweed D, Sweed E, Moaz I, Mosbeh A, Fayed Y, Elhamed SMA, Sweed E, Macshut M, Abdelsattar S, Kilany S, Saied SA, Badr R, Abdallah MS, Ehsan N. The clinicopathological and prognostic factors of hepatocellular carcinoma: a 10-year tertiary center experience in Egypt. World J Surg Oncol. 2022 Sep 19;20(1):298. doi: 10.1186/s12957-022-02764-2.