louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01427751: Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Vein Occlusion
Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 307
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 study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of branch retinal vein occlusion in at least one eye
* Visual acuity between 20/400 to 20/40

Exclusion Criteria:

* Active eye infection
* Ocular hypertension which is not controlled on monotherapy (one medication)
* Anticipated need for eye surgery during the study
* Cataract surgery in either eye within 3 months
* Eye surgery including laser of any type within 6 months
* Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
* Use of ocular steroids within 3 months
* Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
timeFrame: Baseline, Month 12
measure: Percentage of Patients With 15-or-More Letter Improvement in BCVA
timeFrame: Baseline, Month 12
measure: Percentage of Patients With a 15-or-More Letter Decrease in BCVA
timeFrame: Baseline, Month 12
measure: Time to BCVA Improvement of 15-or-More Letters
timeFrame: 12 Months
measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
timeFrame: Baseline, Month 12
measure: Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
timeFrame: 12 Months
Other outcomes:
Locations:
city: Paris
country: France
city: Munich
country: Germany
city: Tel Aviv
country: Israel
city: Milan
country: Italy
city: Madrid
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.
Clinical trial NCT02792751: Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?
Official title: Effects of Bispectral Index on Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: Depth of anesthesia
BIS
ERCP
Positive Regulation
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.

Detailed description: 50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status I-II
* Patients undergoing ERCP procedures

Exclusion Criteria:

* uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure)
* difficulty in communication (language problems, such as deafness)
* who are allergic to the drugs used
* pregnant women

Primary outcomes:
measure: Effects of BIS on oxidative stress
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05634551: Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status
Official title: Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2022-12-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer

Brief summary: To better understand your feelings and expectations about immunotherapy

Detailed description: Primary Objective:

1. To compare expectations of survival benefit from immunotherapy between advanced cancer patients with poor performance status (PS) and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of survival beyond 2 years.

Secondary Objectives:

1. To compare expectations of therapeutic benefit of immunotherapy between advanced cancer patients with poor PS and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of cure, quality of life improvement, and lower likelihood of adverse events.
2. To qualitatively describe the priorities and preferences for information of advanced cancer patients with poor PS when considering immunotherapy treatment.
3. To evaluate the associations between discrepant expectations with patients' sociodemographic and clinical characteristics.
4. To compare patient and oncologist expectations with actual treatment outcomes and survival.

Eligibility criteria: Inclusion Criteria:

1. Patients being considered for or within 2 months of starting immunotherapy for advanced cancer
2. Patient ≥18 years of age
3. ECOG ≥2
4. Cognitively able to understand consent and complete questionnaire as determined by the interviewer at the time of study enrollment
5. English speaking
6. Willing to participate in the study and sign informed consent
7. The study will include medical oncologists that treat advanced cancers

Exclusion Criteria:

1. Treatment for curative intent
2. Presence of Delirium (as determined by score \>13 on MDAS 46, appendix A)

Primary outcomes:
measure: Discrepancy in expectation of survival for 2 years or more between the patient and oncologist
timeFrame: through study completion; an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sriram Yennu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266351: EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
Official title: EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Normal Tension Glaucoma
Lead sponsor: Intuor Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 198
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:

* At least 22 years of age and undergone LASIK treatment
* Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form

Brief summary: The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.


Eligibility criteria: Inclusion Criteria:

Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:

* At least 22 years of age and undergone LASIK treatment
* Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form

Exclusion Criteria:

* Subjects will be excluded from participation if they meet the following criteria:

  * Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months
  * Pregnant or nursing women
  * Those who have had previous corneal surgery excluding LASIK
  * Keratoconus
  * Corneal scarring
  * Microphthalmos
  * Buphthalmos
  * Dry eyes with clinical epithelial breakdown upon exam
  * Lid squeezers - blepharospasm
  * Nystagmus
  * Corneal or conjunctival infection.

Primary outcomes:
measure: IOP measurement difference between CATS and GAT in LASIK patients
timeFrame: single measurement 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Eye Consultants
state: Arizona
city: Memphis
country: United States
facility: Eye Specialty Group
state: Tennessee
Study officials:
References:
Clinical trial NCT03769051: Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Official title: Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Protein Allergy
Keywords: Cow's Milk Protein allergy
Open Food Challenge test
Immune Tolerance
Amino Acid Formula
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cow's milk protein allergy infants in 0\~6 months

Brief summary: The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.

Detailed description: This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).

Eligibility criteria: Inclusion Criteria:

* Age: 0 to 6 months;
* Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
* Unable to breastfeed;
* Vital signs are stable;
* Legal guardian has signed the informed consent.

Exclusion Criteria:

* Subject with congenital and hereditary metabolic diseases;
* Digestive tract obstruction;
* Subject with immunodeficiency diseases;
* Subject who is allergic to known components of amino acid formula powder;
* The investigator judges it is not suitable for the subject to participate in this study.

Primary outcomes:
measure: Negative rate of open food challenge test
timeFrame: From baseline to AAF feeding for 6 months
Secondary outcomes:
measure: WAZ(weight for age Z score)
timeFrame: From baseline to AAF feeding for 6 months
measure: HAZ(height for age Z score)
timeFrame: From baseline until AAF feeding for 6 months
measure: HCAZ(head circumference for age Z score)
timeFrame: From baseline to AAF feeding for 6 months
measure: SCORAD score
timeFrame: From baseline to AAF feeding for 6 months
measure: Gastrointestinal symptom score
timeFrame: From baseline to AAF feeding for 6 months
measure: Respiratory symptom score
timeFrame: From baseline to AAF feeding for 6 months
measure: Comfort symptom score
timeFrame: From baseline to AAF feeding for 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Colleague
name: Juan Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03431051: The Impact of Workplace Food and Beverage Choices on Health and Wellness
Official title: The Impact of Workplace Food and Beverage Choices on Health and Wellness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health and Wellness
Keywords: Healthy Beverage Initiative, Sugar Sweetened Beverages
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: Laura and John Arnold Foundation
name: University of California, San Francisco
First posted: 2018-02-13
Enrollment: 648
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is designed to determine if instituting a Healthy Beverage Initiative (HBI) at hospitals influences health and wellness of employees over a 12 month period.

Detailed description: To examine whether HBI is associated with decreased adiposity over a 12-month time period, in comparison to individuals identically assessed but not exposed to a HBI. Specifically, do those exposed to the HBI decrease in measures of adiposity, BMI, and sugar sweetened beverage (SSB) intake? Do they decrease more in those measures as compared to those not exposed to the HBI?

Eligibility criteria: Inclusion Criteria:

* The participant speaks and reads English.
* The participant consumes three or more sugar-sweetened beverages a week.
* The participant expects to be able to participate for all 3 visits (baseline, 6 months, and 12 months).

Exclusion Criteria:

The participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.

Primary outcomes:
measure: Abdominal adiposity
timeFrame: About one year.
measure: Abdominal adiposity
timeFrame: About one year.
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: About one year.
measure: Sugar Sweetened Beverage Intake
timeFrame: About one year.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: Sutter Health-California Pacific Medical Center Research Institute
name: Greg Tranah, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05106751: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
Official title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Correction of Nasolabial Folds
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.

Detailed description: This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.

Eligibility criteria: Inclusion Criteria:

* Male or female 21 years or above age.
* 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
* Agree to use proper contraception as guided in the protocol.
* Signed for Informed Consent.

Exclusion Criteria:

* have received permanent facial implants anywhere in the face or neck or planning during the investigation.
* have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
* have undergone semi-permanent filler in lower face
* have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
* Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
* Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
* have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days

Primary outcomes:
measure: Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.
timeFrame: 24 weeks from baseline
measure: Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
timeFrame: 24 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: LG Chem investigational site 01
Study officials:
References:
Clinical trial NCT00623454: Non Cardiac Chest Pain and Benign Palpitations
Official title: A Randomized Controlled Trial of Cognitive Behavioural Therapy for Non-cardiac Chest Pain and Palpitations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety/Depression in Cardiological Unit
Keywords: anxiety
panic disorder
chest pain
palpitations
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms.

The coping course consist of three sessions of cognitive behaviour therapy.


Eligibility criteria: Inclusion Criteria:

* investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital
* suffer of chest pain or palpitations

Exclusion Criteria:

* do not speak norwegian properly
* mentally retarded
* psychosis last 6 month
* current alcohol or drug misuse

Primary outcomes:
measure: Body sensation questionnaire (BSQ)
timeFrame: end of treatment, after 3 month and after 12 month
measure: Beck Depression Inventory (BDI)
timeFrame: end of treatment, after 3 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Cardiological Out-patient Clinic
Study officials:
affiliation: Norwegian University of Science and Technology
name: Egil Jonsbu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonsbu E, Dammen T, Morken G, Martinsen EW. Patients with noncardiac chest pain and benign palpitations referred for cardiac outpatient investigation: a 6-month follow-up. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):406-12. doi: 10.1016/j.genhosppsych.2010.03.003. Epub 2010 Apr 13.
Clinical trial NCT00674154: Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Official title: Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitamin D Deficiency
Primary Hyperparathyroidism
Hypercalcemia
Keywords: Vitamin D
Primary hyperparathyroidism
hypercalcemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Detailed description: The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Eligibility criteria: Inclusion Criteria:

* P-Ca-ion \> 1,30 mmol/l
* P-PTH \> 5 pmol/l
* P-OH25-vitamin D \< 80 nmol/l

Exclusion Criteria:

* P-creatinin \> 120 mumol/l
* usage of Etalpha, Mimpara
* Cancer
* Sarcoidosis
* malabsorption
* pancreatitis
* alcohol abuse
* pregnancy

Primary outcomes:
measure: Decrease in Preoperative P-PTH
timeFrame: 25 weeks
Secondary outcomes:
measure: Improved Muscular Function
timeFrame: One Year
measure: Reduced Postoperative Hypocalcemia
timeFrame: Postoperative week
measure: Increase in Quality of Life
timeFrame: One year
measure: Increased Bone Mineral Density
timeFrame: One year
measure: Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
timeFrame: one year
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Osteoporoseklinikken, Aarhus University Hospital, THG
Study officials:
name: Lars Rolighed, MD
role: PRINCIPAL_INVESTIGATOR
name: Lars Rejnmark, MD,PhD,DrMed
role: STUDY_DIRECTOR
References:
citation: Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.