louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00300079: Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension
Official title: A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Ocular Hypertension Patients
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2006-03-08
Enrollment: 30
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: This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

* Women of childbearing potential
* History of bronchial asthma, or severe chronic obstructive pulmonary disease
* Presence of acute glaucoma

Primary outcomes:
measure: IOP-lowering at 8 and 16 weeks
Secondary outcomes:
measure: Safety throughout the 16 weeks of the study
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: University of California, San Diego
name: John Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu JH, Medeiros FA, Slight JR, Weinreb RN. Comparing diurnal and nocturnal effects of brinzolamide and timolol on intraocular pressure in patients receiving latanoprost monotherapy. Ophthalmology. 2009 Mar;116(3):449-54. doi: 10.1016/j.ophtha.2008.09.054. Epub 2009 Jan 20.
Clinical trial NCT02577679: Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease
Official title: Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis, Rheumatoid Arthritis, Autoimmunity,
Keywords: Dentistry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 47
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physically healthy persons, especially free of any autoimmune diseases, DM, CVD. No history of periodontal treatment.

Brief summary: The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.

Detailed description: In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.


Primary outcomes:
measure: Serum level of anti-cyclic citrullinated peptide/protein antibody
timeFrame: Base line
measure: Periodontal pocket depth and clinical attachment level
timeFrame: Baseline
Secondary outcomes:
measure: Serum level of tumor necrotic factor alpha
timeFrame: Baseline
measure: Serum level of anti-mutated citrullinated vimentin
timeFrame: Baseline
measure: Serum level of interleukin 6
timeFrame: Baseline
measure: Serum level of interleukin 17
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Assistant professor
name: Yi-Wen Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06000579: The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students
Official title: The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Emotional Regulation, Premenstrual Syndrome
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: EMEL EGE
name: KAMİLE ALTUNTUĞ
name: Merve YAZAR
First posted: 2023-08-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and 14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions.


Eligibility criteria: Inclusion Criteria:

* Persons with amenorrhea,
* pregnancy,
* menstrual irregularity,
* chronic disease,
* mental disorders,
* psychiatric disorders,
* polycystic ovarian syndrome,
* those who have received training on EFT before and those who have communication problems will not be included in the study.

Exclusion Criteria:

* Female students between the ages of 18-25,
* who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)
* participated in the study voluntarily will be included in the study.

Primary outcomes:
measure: premenstrual syndrome and emotional freedom technique
timeFrame: 3 month Wıll Be Followed.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: merve.yazar@karatay.edu.tr
name: MERVE YAZAR
role: STUDY_CHAIR
References:
Clinical trial NCT02933879: Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability Patients With Mild to Moderate Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Detailed description: Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).

Exclusion Criteria:

* Females who are pregnant, lactating or likely to become pregnant during the study.

Primary outcomes:
measure: Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
timeFrame: Day 365
measure: Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
timeFrame: Day 141
Secondary outcomes:
measure: Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
timeFrame: Day 365
measure: Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
timeFrame: Day 141
measure: Number of Patients in Each Treatment Group With a Mycological Cure
timeFrame: day 365
measure: Number of Patients in Each Treatment Group With a Mycological Cure
timeFrame: Day 141
measure: Number of Patients in Each Treatment Group With a Complete Clinical Cure
timeFrame: day 365
measure: Number of Patients in Each Treatment Group With a Complete Clinical Cure
timeFrame: Day 281
measure: Number of Patients in Each Treatment Group With a Complete Clinical Cure
timeFrame: Day 141
measure: Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
timeFrame: day 365
measure: Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
timeFrame: Day 281
measure: Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
timeFrame: Day 141
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Novum Pharmaceutical Research Services (Novum)
state: Pennsylvania
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT04235179: Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer
Official title: Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 30
Sex: FEMALE
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: TREATMENT

Brief summary: Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Patient with histologically confirmed endometrial adenocarcinoma
* Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1.
* Age ≥18 years.
* Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.

Exclusion Criteria:

* Patient has had prior pelvic radiotherapy.
* Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
* Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
* Patient has a contraindication to CT contrast.
* Patient has a hip prosthesis.

Primary outcomes:
measure: Acute Treatment-Related Adverse Events
timeFrame: 3 months after accrual is completed
Secondary outcomes:
measure: Late Treatment-Related Adverse Events
timeFrame: 5 years after accrual is completed
measure: Disease Local-Regional Failure Rate
timeFrame: 5 years after accrual is completed
measure: Quality of Life
timeFrame: 5 years after accrual is completed
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City
Study officials:
References:
Clinical trial NCT01046279: Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
Official title: Hypertension Monitoring in Glioma Patients Treated With Bevacizumab
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioma Patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glioma patients receiving bevacizumab

Brief summary: Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist Patients should be on a stable or decreasing dose of steroids Willingness and ability to comply with the protocol Patient should present with a KPS of \>=70 Signed informed consent

Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or hypersensitivity against bevacizumab Contraindications to bevacizumab according to the Summary of Product of Characteristics Unwillingness to comply with regular assessments of response and performance of study-related procedures Any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator

Primary outcomes:
measure: Incidence of Hypertension
timeFrame: Hypertension under treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Internal Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Internal Medicine
name: Lukas Zimmerli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745379: Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation
Official title: Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Maxillary Sinus Augmentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Alveolar Bone Loss
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.

Detailed description: The buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissues. The BFPSCs will be loaded on freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea). Furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (GAC medical) for 14 minutes at 2800 rpm (approximately 400 g). Following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (PRF) clot in the middle and red blood cells at the bottom of the tube. The PRF clot is separated by a sterile pincette.

The patients in the test group receives BFPSCs loaded on DFDBA with PRF for sinus augmentation and the control group receives combination of PRF and DFDBA (lacking any cells).The results will be evaluated by cone beam computed tomography (CBCT) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining.

Eligibility criteria: Inclusion Criteria:

1. patients with posterior maxillary edentulism
2. pneumatized sinus
3. less than 5mm bone height between the alveolar crest and sinus membrane

Exclusion Criteria:

1. smoking
2. history of malignancy
3. radiation
4. chemotherapy
5. pregnancy
6. systemic diseases contradicting dental and surgical treatments
7. conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
8. allergy to collagen

Primary outcomes:
measure: amount of regenerated bone
timeFrame: 6 months
measure: amount of regenerated bone
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: School of Dentristry at Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Arash Khojasteh, DMD, OMFS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882479: Formalizing a Conceptual Framework of Work Domain Knowledge
Official title: Formalizing a Conceptual Framework of Work Domain Knowledge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge Representation
Knowledge Modeling
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

1. Subjects must be over 21 years old
2. Subjects must be a student or employee in University of Texas
3. Subjects must be able to read and write in English
4. Subjects must be able to give signed informed consent

Brief summary: The purpose of this study is to learn the daily activities of nutrition management software users through an improved informed consent process and develop a conceptual model to describe these activities. The investigators will gather information from nutrition management software users, and design and test a new prototype of nutrition management software.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be over 21 years old
2. Subjects must be a student or employee in University of Texas
3. Subjects must be able to read and write in English
4. Subjects must be able to give signed informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Cognitive Informatics Lab
state: Texas
Study officials:
affiliation: UTHSC-Houston
name: Min Zhu, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177879: Usability of a Website for People With Schizophrenia
Official title: Schizophrenia Website Usability
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cognitive Deficits Related to Internet Use
Keywords: website
comparison
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will determine the usability of a website for people with schizophrenia versus other websites designed for the same purpose.

Detailed description: The objective of this study is to test and compare the usability of a website developed as part of a NIMH-funded project (see IRB #0208128), versus four other online websites in a effort to continue to improve website design elements and maximize usability by those identified with schizophrenia, a disease that produces cognitive impairments.

Prior usability testing done to evaluate a website developed as part of a NIMH-funded project (see IRB #0208128) was used to develop a website designed specifically to meet the needs of those with cognitive deficits. Generally, the website was well received. However, an implicit component of this project was to make quantitative statements comparing the website developed in this project to other existing websites for individuals with schizophrenia, in order to maintain and improve the usability of the website. As such, it is important to test the usability of this website versus other websites to continue to improve design elements and ease of use for those with serious mental illness.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia

Exclusion Criteria:

-

Primary outcomes:
measure: Subject task performance data will be analyzed to determine what website properties influenced subject's performance of various assigned website search-related tasks.
Secondary outcomes:
measure: Website properties, such as reading level, font size, and amount of content on the homepage, etc will be used to determine what factors influence subject's performance, and thus the usability of the various websites.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Armando J Rotondi, PhD
role: PRINCIPAL_INVESTIGATOR
References: