louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00300443: Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-03-09
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of glaucoma or ocular hypertension in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Ocular seasonal allergies within the past 2 years

Primary outcomes:
measure: Lowering intraocular pressure (IOP)
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
References:
citation: Katz LJ, Cohen JS, Batoosingh AL, Felix C, Shu V, Schiffman RM. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol. 2010 Apr;149(4):661-671.e1. doi: 10.1016/j.ajo.2009.12.003.
Clinical trial NCT00457990: Neurodevelopment After Early Iron Supplementation
Official title: Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Anemia of Prematurity
Neurodevelopmental Delay
Keywords: Neurocognitive outcome
preterm infant
very low birth weight
iron deficiency
iron supplementation
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2007-04-09
Enrollment: 204
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Iron deficiency in early childhood may impair neurodevelopment.

Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.

Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.

Detailed description: Children with a birth weight of \< 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.

Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS\>1), severe cognitive impairment (mental processing composite (MPC) \<51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC\>85) and the absence of any severe hearing and visual impairment.

Eligibility criteria: Inclusion Criteria:

* inborn infants with a birth weight of \<1301g admitted between June 1996 and June 1999

Exclusion Criteria:

* major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent

Primary outcomes:
measure: ferritin at 61 days of life
measure: the number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary outcomes:
measure: Neurological Status
measure: Mental Processing Composite (Kaufmann Assessment Battery for Children)
measure: Disability Status
measure: Behavioural Problems
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University of Ulm
name: Axel R Franz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinmacher J, Pohlandt F, Bode H, Sander S, Kron M, Franz AR. Randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams: neurocognitive development at 5.3 years' corrected age. Pediatrics. 2007 Sep;120(3):538-46. doi: 10.1542/peds.2007-0495.
Clinical trial NCT00259090: Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
Official title: A Double-blind, Randomized, Multicentre Trial to Compare the Anti-tumour Effects and Tolerability of a 500 mg Dose of Faslodex (Fulvestrant) Plus Arimidex (Anastrozole) With a 500 mg Dose of Faslodex(Fulvestrant) Alone and With Arimidex(Anastrozole) Alone, in Postmenopausal Women Prior to Surgery for Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women.
* Biopsy confirmation of primary breast cancer.
* Oestrogen receptor positive tumour.
* Fit for surgery within one month.
* Written informed consent to participate in the study

Exclusion Criteria:

* Previous treatment with any anti-hormonal therapy for breast cancer.
* Previous radiotherapy to the primary tumour.
* Previous chemotherapy for the primary tumour.

Primary outcomes:
measure: Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.
timeFrame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)
measure: Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.
timeFrame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)
measure: Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.
timeFrame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Faslodex Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Robertson JF, Dixon JM, Sibbering DM, Jahan A, Ellis IO, Channon E, Hyman-Taylor P, Nicholson RI, Gee JM. A randomized trial to assess the biological activity of short-term (pre-surgical) fulvestrant 500 mg plus anastrozole versus fulvestrant 500 mg alone or anastrozole alone on primary breast cancer. Breast Cancer Res. 2013 Mar 5;15(2):R18. doi: 10.1186/bcr3393.
Clinical trial NCT00002090: An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)
Official title: An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Azithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Medications allowed under a Treatment IND program.

Patients must have:

* HIV infection.
* Disseminated Mycobacterium avium Complex.
* Fever (\> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
* Life expectancy of at least the duration of the study.
* Consent of parent or guardian if below the legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy).

Prior Medication:

Excluded:

* Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
* Any other antibiotic with known activity against M. avium within 7 days prior to study entry.

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Hosp
state: Massachusetts
city: Bronx
country: United States
facility: Bronx Veterans Affairs Med Ctr
state: New York
city: Syracuse
country: United States
facility: SUNY / Health Sciences Ctr at Syracuse
state: New York
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Lackland Air Force Base
country: United States
facility: United States Air Force Med Ctr
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
Study officials:
References:
Clinical trial NCT04910490: Stereotactic Aspiration for Primary Brainstem Hemorrhage Based on 'Zhe-er Classification'
Official title: A Descriptive Research on the Effect of Primary Brainstem Hemorrhage Stereotactic Aspiration Based on 'Zhe-er Classification'
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Brainstem Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with primary brainstem hemorrhage who receive stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Brief summary: The purpose of this study is to determine the benefit of stereotaxic aspiration for patients with primary brainstem hemorrhage with the guidance of 'Zhe-er Classification'

Detailed description: This is a retrospective study aiming to analyze the clinical record of patients from March 2014 to October 2020. This study is indicated for primary brainstem hemorrhage.

Eligibility criteria: no new patients will be enrolled within this project

Inclusion Criteria:

* Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Exclusion Criteria:

* patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies

Primary outcomes:
measure: Survival events
timeFrame: 1 year after hemorrhage
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmin Zhang
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Jianmin Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151190: Community Diabetes Education Program Evaluation "Code Evaluation"
Official title: Community Diabetes Education Program Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Institute for Faith Health Research of Dallas
First posted: 2005-09-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.


Eligibility criteria: Inclusion Criteria:

* people with no health insurance

Exclusion Criteria:

* people with any type of health insurance coverage

Primary outcomes:
measure: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
Secondary outcomes:
measure: Patients' attitudes and knowledge about diabetes self-management, American Diabetes Association standards of care.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Central Dallas Ministries Community Health Services Clinic
state: Texas
Study officials:
affiliation: UTHSC School Public Health at Houston
name: DAN CULICA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prezio EA, Balasubramanian BA, Shuval K, Cheng D, Kendzor DE, Culica D. Evaluation of quality improvement performance in the Community Diabetes Education (CoDE) program for uninsured Mexican Americans: results of a randomized controlled trial. Am J Med Qual. 2014 Mar-Apr;29(2):124-34. doi: 10.1177/1062860613489165. Epub 2013 Jun 7.
citation: Prezio EA, Cheng D, Balasubramanian BA, Shuval K, Kendzor DE, Culica D. Community Diabetes Education (CoDE) for uninsured Mexican Americans: a randomized controlled trial of a culturally tailored diabetes education and management program led by a community health worker. Diabetes Res Clin Pract. 2013 Apr;100(1):19-28. doi: 10.1016/j.diabres.2013.01.027. Epub 2013 Feb 28.
Clinical trial NCT02665390: Percutaneous Cryoablation Peripheral Lung Cancer
Official title: Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
Percutaneous cryoablation
treatment of medically inoperable
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 30
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 study is focus on percutaneous cryoablation,which was for the treatment of medically inoperable Peripheral lung cancer.The patients who were agreed to attend the study will accept the operation. After the operations,they will follow up according to the plan.

Detailed description: The patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.

Eligibility criteria: Inclusion Criteria:

medically inoperable peripheral lung cancer Diameter no more than 3cm

Exclusion Criteria:

1. Refusal of participation
2. tendency to bleed to that can't receive percutaneous cryoablation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Chest Hospital
name: Sun jiayuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang X, Tian J, Zhao L, Wu B, Kacher DS, Ma X, Liu S, Ren C, Xiao YY. CT-guided conformal cryoablation for peripheral NSCLC: initial experience. Eur J Radiol. 2012 Nov;81(11):3354-62. doi: 10.1016/j.ejrad.2012.04.035. Epub 2012 May 23.
citation: Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051.
citation: Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.
citation: Yamauchi Y, Izumi Y, Hashimoto K, Yashiro H, Inoue M, Nakatsuka S, Goto T, Anraku M, Ohtsuka T, Kohno M, Kawamura M, Nomori H. Percutaneous cryoablation for the treatment of medically inoperable stage I non-small cell lung cancer. PLoS One. 2012;7(3):e33223. doi: 10.1371/journal.pone.0033223. Epub 2012 Mar 8.
Clinical trial NCT05264090: Possibilities of Interpreting the Night-to-Day Ratio Specified by 24-hour Blood Pressure Monitoring
Official title: Seven-day Ambulatory Blood Pressure Monitoring and CAVI in the Prevention of Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: ambulatory blood pressure monitoring
hypertension
night-to-day ratio
exercise
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk University
name: University of Minnesota
First posted: 2022-03-03
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocenter, non-randomized, controlled study
Primary purpose: DIAGNOSTIC

Brief summary: Specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring

Detailed description: The subjects in the study are divided into 4 groups:

group 1 (40 healthy men and women without exercise); group 2 (40 healthy exercise-training men and women); group 3 (40 patients with ischemic coronary artery disease without exercise); and group 4 (51 patients with ischemic coronary artery disease following cardiovascular rehabilitation).

The subject of the evaluation is the percentage rate of incorrect subject classification (dipper, non-dipper, extreme dipper, and risers) based on the mean blood pressure values for 7 days and from seven independent 24-hour cycles (the mean value mode).

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (without any disease, including the cardiovascular ones, and without any kind of treatment)
* Patients with chronic ischemic coronary artery disease
* Patients treated with ACE inhibitors, beta-blockers or statins.
* To visit routinely in the health centres where the study is carried out

Exclusion Criteria:

* Age under 18 years,
* Pregnant, or breast-feeding,
* Patients on dialysis or being followed by nephrology,
* Severe physical or cognitive limitations,
* Intolerance to the method of measurement

Primary outcomes:
measure: The risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h ABPM in comparison to the results of 7-day ABPM monitoring.
timeFrame: 1 - 7 days
Secondary outcomes:
measure: Optimalization of the blood pressure diagnostic through comparing of 24 hours and 7 days monitoring.
timeFrame: 1 - 7 days
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: St. Anne´s University Hospital Brno
Study officials:
References:
Clinical trial NCT06500390: Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
Official title: Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Levonorgestrel Adverse Reaction
Temporomandibular Joint Disorders
Temporomandibular Disorder
Keywords: Mirena
Levonorgestrel
Intrauterine system
Temporomandibular disorder
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to investigate the possible role of levonorgestrel intrauterine system use(LIU) in the pathogenesis of temporomandibular joint disorder (TMD). In this clinical trial, levonorgestrel intrauterine system patients (n=30) aged 25-50 and control group patients (n=30) with the same demographics and age range are used. The main questions it aims to answer are:

To compare the frequency of temporomandibular dysfunction in women using the levonorgestrel intrauterine system with the control group of the same demographic and age range.

The levonorgestrel intrauterine system use group consisted of 50 women who had previously a mirena implanted by a gynecologist at least 3 months ago due to menstrual bleeding and pelvic pain.

The control group included 50 randomised healthy women who had regular menstrual cycles and were not taking any medication.


Eligibility criteria: Inclusion Criteria:

* Being a woman
* Having used an intrauterine device for at least 3 months
* Being between the ages of 18-50
* Being in American Society of Anesthesiologists-1 and American Society of Anesthesiologists-2 systemic status

Exclusion Criteria:

* Patients with craniofacial syndrome
* Patients with a history of head and neck trauma
* Isolated muscle tenderness or previous surgery on TMJ
* Patients with rheumatological disorders
* Patients with an additional gynecological disease other than endometriosis
* Lack of cooperation with the patient.

Primary outcomes:
measure: Evaluation of temporomandibular joint disorder and masticator muscle pain
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Maltepe
Study officials:
References: