louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00459563: Vitamin D and Blood Pressure
Official title: A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: vitamin D
blood pressure
hypertension
Vitamin D insufficient
Systolic blood pressure between 130 and 150 mmHg
Lead sponsor: Atlanta VA Medical Center
Sponsor class: FED
Collaborators: name: Emory University
First posted: 2007-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.


Eligibility criteria: Inclusion Criteria:

* Participants must be over the age of 18
* Vitamin D levels between 10 and 30 ng/ml
* Systolic blood pressure between 130 and 150 mmHg

Exclusion Criteria:

* Current use of anti-hypertensive medication
* Inability to understand the consent form
* Inability to return ABP monitor within 24-48 hours after visit
* Alcohol dependence
* Diagnosis of chronic kidney disease
* History of heart disease
* History of stroke
* Inability to comply with study protocol
* Current treatment for cancer
* Narcotic dependence
* Current use of greater than 2000 IU of vitamin D
* Pregnant

Primary outcomes:
measure: Blood pressure
timeFrame: 3 Weeks
measure: 25(OH)D
timeFrame: 3 weeks
Secondary outcomes:
measure: Parathyroid hormone
timeFrame: 3 weeks
measure: Renin
timeFrame: 3 weeks
measure: Aldosterone
timeFrame: 3 weeks
measure: Angiotensin II
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: VAMC
state: Georgia
Study officials:
affiliation: Emory University/VAMC
name: Vin Tangpricha, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Suzanne E Judd, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06053463: Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
Official title: Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: contact lenses
Multifocal contact lenses
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2023-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 38
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

Detailed description: The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent.
* Any gender.
* Any racial or ethnic origin.
* At least 38 years of age or older.
* Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
* Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
* Spectacle sphere power range between +6.00 to -10.00.
* Previously dropped out of contact lens wear due to vision or vision and discomfort.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI

Exclusion Criteria:

* Current or active ocular inflammation or infection as determined by the Investigator.
* Astigmatism ≥ 1.00 D in either eye.
* History of previous eye surgery.
* Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
* Demonstration or history of corneal ectasia or keratoconus.
* Pregnant or lactating

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 month
measure: Quality of Life Survey
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jennifer Fogt, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04104763: Osteofibrous Dysplasia (Kempson-Campanacci's Disease)
Official title: Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteofibrous Dysplasia
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is single institution cases series review of histological and clinical data

Brief summary: The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.


Eligibility criteria: Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1943 to 31 Dic 2011
* Diagnosis of osteofibrous dysplasia pathologically confirmed
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

* Patients with histological diagnosis different from osteofibrous dysplasia

Primary outcomes:
measure: Osteofibrous Dysplasia (Kempson-Campanacci's disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship with Adamantinoma
timeFrame: BASELINE
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Benassi MS, Campanacci L, Gamberi G, Ferrari C, Picci P, Sangiorgi L, Campanacci M. Cytokeratin expression and distribution in adamantinoma of the long bones and osteofibrous dysplasia of tibia and fibula. An immunohistochemical study correlated to histogenesis. Histopathology. 1994 Jul;25(1):71-6. doi: 10.1111/j.1365-2559.1994.tb00600.x.
citation: Scholfield DW, Sadozai Z, Ghali C, Sumathi V, Douis H, Gaston L, Grimer RJ, Jeys L. Does osteofibrous dysplasia progress to adamantinoma and how should they be treated? Bone Joint J. 2017 Mar;99-B(3):409-416. doi: 10.1302/0301-620X.99B3.38050.
citation: Gleason BC, Liegl-Atzwanger B, Kozakewich HP, Connolly S, Gebhardt MC, Fletcher JA, Perez-Atayde AR. Osteofibrous dysplasia and adamantinoma in children and adolescents: a clinicopathologic reappraisal. Am J Surg Pathol. 2008 Mar;32(3):363-76. doi: 10.1097/PAS.0b013e318150d53e.
Clinical trial NCT03483363: Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
Official title: Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.


Eligibility criteria: Inclusion Criteria:

* patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
* patients who are admitted to Memorial Hermann hospital at Texas Medical Center
* able to sign their own consent

Exclusion Criteria:

* infected surgical sites
* allergies to bacitracin

Primary outcomes:
measure: Number of Participants With Surgical Site Infection (SSI)
timeFrame: 8 weeks
Secondary outcomes:
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: Nagi Demian, MDDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770063: Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
Official title: Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amino Acid Deficiency
Malnutrition
Lung Cancer
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* NRS2002 \>=3 scores
* lung cancer patients
* low albumin or hemoglobin
* informed consent

Exclusion Criteria:

* Acute and critical patients;
* Severe liver and kidney dysfunction;
* Patients with gastrointestinal bleeding or intestinal obstruction;
* Pregnant women, lactating women, people with mental illness, and people without independent behavior ability.

Primary outcomes:
measure: Concentration of albumin
timeFrame: after 42 days after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06118463: Study on AUNIP as a Novel Tumor Marker for Cervical Cancer
Official title: Study on AUNIP as a Novel Tumor Marker for Cervical Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, 150 patients with cervical cancer in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group. 150 healthy women are taken as control group during the same period.

Brief summary: To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.

Detailed description: Blood of all study participants of cervical cancer patients are collected to detect the expression of AUNIP, analyze the statistical correlation between the expression of cervical cancer AUNIP and clinicopathological parameters of patients, and preliminarily understand the expression of AUNIP in cervical cancer tumor tissues and its clinical diagnostic and progniostic value.

Eligibility criteria: Inclusion Criteria:

Study group inclusion criteria:

* Women aged 20-60
* There is a definite pathological diagnosis of cervical cancer

Healthy control group:

* Women aged 20-60
* No tumors in the uterus or other parts of the body
* No inflammatory disease
* Blood routine and blood biochemical tests are normal

Exclusion Criteria:

Exclusion criteria of the study group:

* There are other lesions in the uterus and uterine adnexa

Exclusion criteria of healthy control group:

* Pregnant, lactating or menarche women
* Women who are undergoing human papillomavirus (HPV) vaccination

Primary outcomes:
measure: AUNIP expression in serum
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Lin Yuan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang Z, Liang X, Fu Y, Liu Y, Zheng L, Liu F, Li T, Yin X, Qiao X, Xu X. Identification of AUNIP as a candidate diagnostic and prognostic biomarker for oral squamous cell carcinoma. EBioMedicine. 2019 Sep;47:44-57. doi: 10.1016/j.ebiom.2019.08.013. Epub 2019 Aug 10.
citation: Ma C, Kang W, Yu L, Yang Z, Ding T. AUNIP Expression Is Correlated With Immune Infiltration and Is a Candidate Diagnostic and Prognostic Biomarker for Hepatocellular Carcinoma and Lung Adenocarcinoma. Front Oncol. 2020 Dec 9;10:590006. doi: 10.3389/fonc.2020.590006. eCollection 2020.
Clinical trial NCT02761863: Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma
Official title: Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Receiving Pemetrexed/Platinum Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Mesothelioma
Keywords: Mesothelioma
CD 74
VEGF
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from Malignant Pleural Mesothelioma

Brief summary: This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before starting treatment using IHC and the results will be correlated with the outcome of treatment during evaluation.


Eligibility criteria: Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant pleural Mesothelioma
2. No prior chemotherapy.
3. ECOG less than or equal to 2 .
4. Measurable disease according to the requirements of SWOG criteria.
5. Age ≥ 19 years .
6. Estimated life expectancy of at least 12 weeks .
7. Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Presence of central nervous system metastases.
2. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
3. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
4. Serious concomitant systemic disorder incompatible with the study.
5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
6. Pregnancy

Primary outcomes:
measure: CD 74 and VEGF detection effect on response to treatment
timeFrame: Essay done before starting treatment and correlated with the response
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02131363: A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
Official title: A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis of Toenails
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.


Eligibility criteria: Inclusion Criteria:

* Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
* Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
* Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.

Exclusion Criteria:

* Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
* Subjects suspected to be immunocompromised.
* Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
* Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
* Subjects with known sensitivity/allergies to any component of the investigational device.
* Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire).
* Use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. Regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit.
* Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
* Pregnancy or lactating mother.

Primary outcomes:
measure: The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
timeFrame: At Day 42 from Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: CPS Research Ltd.
state: Scotland
Study officials:
References:
Clinical trial NCT02833363: Difference of Gastric Microbiota in the Process of Correa's Model.
Official title: Difference of Gastric Microbiota in the Process of Correa's Model.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Microbiota
Non-atrophic Gastritis
Atrophic Gastritis
Intestinal Metaplasia
Intraepithelial Neoplasia
Gastric Cancer
Helicobacter Pylori
Keywords: gastric microbiota
Helicobacter pylori
Non-atrophic Gasrititis
Atrophic gastritis
Intestinal metaplasia
intraepithelial neoplasia
Gastric cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.

Brief summary: Helicobater pylori plays an important role in the development of gastric cancer. Eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. Prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted in the development of gastric cancer. The pathological change makes a more suitable environment for bacteria to overgrowth. This study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.
2. Did not take any antibiotics,PPI,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination.
3. Sign the informed consent.

Exclusion Criteria:

1. Had been taken Helicobacter pylori eradication therapy before.
2. Previous gastrointestinal surgery.
3. During the pregnancy and lactation period.
4. With any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result.
5. With any mental problems.

Primary outcomes:
measure: Difference of Gastric Microbiota in the Process of Correa's Model.
timeFrame: 5 months
Secondary outcomes:
measure: Difference of Gastric Microbiota in the Process of Correa's Model.
timeFrame: 5 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: