louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00855491: Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL
Official title: Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Keywords: PCO
POCO
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Detailed description: We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Eligibility criteria: Inclusion Criteria:

* local residency and presence of a cataract in an otherwise normal eye.
* Patients older than 50 years
* a dilated pupil after mydriasis
* Patients with retinochoroidal atrophy, retinal laser prophylaxis,
* hypertension

Exclusion Criteria:

* nondilating pupil after maximal dilation;
* pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
* previous intraocular surgery;
* previous surgery for glaucoma;
* uveitis
* diabetes mellitus
* Patients who did not give consent preoperatively

Primary outcomes:
measure: the percentage area of PCO with posterior capsule opacity (POCO) software
timeFrame: 4 years
Secondary outcomes:
measure: the presence of PCO within the central 3-mm zone were noted
timeFrame: 4 years
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Raghudeep Eye Clinic
state: gUJARAT
Study officials:
affiliation: Iladevi Cataract and IOL Research Center
name: ALPESH SHAH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716091: The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery
Official title: The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery on Maternal Morbidity and Gastrointestinal System Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Enfectious Morbidity
Postoperative GİS Functionally Recovery
Keywords: focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2012-10-29
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all pregnant women between 18 years or older and who requıred cesarean delivery.

Brief summary: The investigators hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will increase Gastrointestinal System Disfunction without maternal infectious morbidity(especially febril morbidity).


Eligibility criteria: Inclusion Criteria:

1. Elective cesarean delivery
2. Gestational age greater 38 weeks

Exclusion Criteria:

1. chorioamnıonıtıs
2. type 1 diabetes mellitus
3. placenta previa and acreata
4. prior severe gastrointestional disease
5. emergency cesarean delivery

Primary outcomes:
measure: postoperative gastrointestinal system disturbance
timeFrame: postoperativeone weeks
Secondary outcomes:
measure: postoperative febril morbidity
timeFrame: postoperative six weeks
Other outcomes:
Locations:
city: Halkalı/İstanbul
country: Turkey
facility: T.C. Kanuni Sultan Süleyman Teaching Hospital
state: Küçükçekmece
Study officials:
affiliation: T.C. Kanuni Sultan Süleyman Teaching Hospital
name: Osman Aşıcıoğlu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191291: Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors
Official title: Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Constraints During School Meals
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Recent peer-reviewed observational evidence suggests that school children receive anywhere from 10-33 minutes of seated lunch time and that students with less time to eat discard higher amounts of milk, entrée (i.e. protein items), grains, and vegetables. This waste is a missed nutritional and food security opportunity and also negatively impacts the environment. The purpose of this study is to estimate the impact that lunch time constraints have on child food selection, consumption and waste behaviors using a crossover trial design, where the duration of seated lunch times are randomly allocated to be either 10 minutes or 20 minutes each day.


Eligibility criteria: Inclusion Criteria:

* Must be enrolled in local summer camp

Exclusion Criteria:

* None

Primary outcomes:
measure: Food item selection
timeFrame: Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp
measure: Food item consumption
timeFrame: Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp
measure: Food item waste
timeFrame: Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References:
citation: Burg X, Metcalfe JJ, Ellison B, Prescott MP. Effects of Longer Seated Lunch Time on Food Consumption and Waste in Elementary and Middle School-age Children: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2114148. doi: 10.1001/jamanetworkopen.2021.14148.
Clinical trial NCT03038191: Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home
Official title: Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epilepsy
Lead sponsor: Medial Research Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult epilepsy patients who are admitted to the video EEG unit and are expected to experience seizures during hospitalization

Brief summary: Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication.

In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Known diagnosis of Epilepsy
* Expected to experience seizures during the period of the study as determined by the PI.
* Able to meet with the Sponsor representative at home

Exclusion Criteria:

* Trauma/broken skin on forehead.
* Patient can not follow or comply with instructions
* Patients who are unable to independently provide an informed consent
* Patients with major psychiatric co-morbidities
* Patients with psychogenic non-epileptic seizures

Primary outcomes:
measure: Successful data collection during hospitalization
timeFrame: 12 hours daily for up to 5 days
measure: Successful data collection during at home monitoring
timeFrame: 12 hours daily for up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01150591: Microaspiration in Pulmonary Fibrosis
Official title: The Role of Microaspiration in Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IPF

Brief summary: Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common in patients with IPF.

Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with IPF.

Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in IPF.

Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary function.

Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF
* Ability ot provide informed consent

Exclusion Criteria:

* History of fundoplication or other gastroesophageal surgery
* Too ill to undergo bronchoscopy in the opinion of the investigator

Primary outcomes:
measure: BAL pepsin level
timeFrame: Cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT02896491: RF-EMF Effects on the CNS in Elderly Men
Official title: Radiofrequency Electromagnetic Fields (RF-EMF) Effects on Brain Activity During Wake and Sleep in Healthy Elderly Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Ionizing Radiation
Lead sponsor: The Federal Office for Radiation Protection, Germany
Sponsor class: OTHER_GOV
Collaborators: name: Seibersdorf Labor GmbH
First posted: 2016-09-12
Enrollment: 30
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

Detailed description: To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h during the night and for the whole duration of the test session during the day. Exposures will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure three times in addition to an adaptation/screening night and day to learn the test.

The results have to be discussed in the context of possible health risks resulting from RF-EMF exposure.

Eligibility criteria: Inclusion Criteria:

* healthy male subjects (age 60 - 80 years)
* right handedness
* alpha EEG as resting state EEG
* non-smokers

Exclusion Criteria:

* acute illness
* severe neurological, psychiatric or internal disease
* CNS active medication
* sleep disorders
* drug abuse

Primary outcomes:
measure: sleep EEG (power)
timeFrame: during exposure for 8 hours
Secondary outcomes:
measure: resting state Waking EEG (power)
timeFrame: during exposure 4 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Competence Center Sleep Medicine
Study officials:
affiliation: Federal Office of Radiation Protection
name: Blanka Pophof, Ph.D
role: STUDY_CHAIR
References:
citation: Eggert T, Dorn H, Sauter C, Schmid G, Danker-Hopfe H. RF-EMF exposure effects on sleep - Age doesn't matter in men! Environ Res. 2020 Dec;191:110173. doi: 10.1016/j.envres.2020.110173. Epub 2020 Sep 12.
citation: Danker-Hopfe H, Dorn H, Sauter C, Schmid G, Eggert T. An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters! Environ Res. 2020 Apr;183:109181. doi: 10.1016/j.envres.2020.109181. Epub 2020 Jan 24.
Clinical trial NCT01855191: SDC for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation
Official title: Standardized Data Collection (SDC) for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SDC Lung).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for curatively intended radiotherapy or postoperative radiotherapy.

Brief summary: Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

Detailed description: All patients planned for curative primary or postoperative radiotherapy can be included. Patients will be treated according to the institutional protocol. It is optional to collect a saliva sample for genetic profiling.

Follow up at five time points:

* 2 weeks after RT
* 3 months after RT
* 6 months after RT
* 12 months after RT
* 24 months after RT

At these time points, toxicity will be assessed. In addition, patients will receive a short questionnaire by mail at eight time points.

Eligibility criteria: Inclusion Criteria:

* All patients planned for curatively intended radiotherapy or postoperative radiotherapy
* Recurrent disease

Exclusion Criteria:

* All patients planned for palliative radiotherapy

Primary outcomes:
measure: Two-year survival rate
timeFrame: 24 months after RT
Secondary outcomes:
measure: Change in dyspnea
timeFrame: during 24 months after RT
measure: Change in cough
timeFrame: During 24 months after RT
measure: Change in dysphagia
timeFrame: During 24 months after RT
measure: Patient-rated generic quality of life
timeFrame: During 24 months after RT
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Dirk De Ruysscher, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07007091: A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants
Official title: A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight between 40 kg and 100 kg, inclusive, at the time of screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
* Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Time to Cmax (Tmax) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Terminal Phase Elimination Half-life (t1/2) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
timeFrame: Up to Approximately 113 days
measure: Number of Anti-drug antibodies (ADA)
timeFrame: Up to Approximately 113 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to Approximately 113 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Cpmi /Id# 276490
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 276043
state: Illinois
city: Las Vegas
country: United States
facility: Ppd - Las Vegas Research Unit /ID# 276565
state: Nevada
city: Austin
country: United States
facility: PPD Phase I Clinic /ID# 276525
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05747391: Assessment of Rosacea Patients' Clinical Trial Experiences
Official title: An Evaluation of Medical Study Experiences of Patients With Rosacea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Rosacea who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Rosacea patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Rosacea patients.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of Rosacea
* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Women who are pregnant, intend to become pregnant, or are lactating
* Enrolled in another research study

Primary outcomes:
measure: Rate of patients who decide to join in an Rosacea clinical study
timeFrame: 3 months
measure: Number of Rosacea patients who remain in clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Hopkinson D, Moradi Tuchayi S, Alinia H, Feldman SR. Assessment of rosacea severity: A review of evaluation methods used in clinical trials. J Am Acad Dermatol. 2015 Jul;73(1):138-143.e4. doi: 10.1016/j.jaad.2015.02.1121. Epub 2015 Mar 19.
citation: Yang JH, Hwang EJ, Moon J, Yoon JY, Kim JW, Choi S, Cho SI, Suh DH. Clinical efficacy of herbal extracts in treatment of mild to moderate acne vulgaris: an 8-week, double-blinded, randomized, controlled trial. J Dermatolog Treat. 2021 May;32(3):297-301. doi: 10.1080/09546634.2019.1657792. Epub 2019 Oct 16.
citation: Egeberg A, Weinstock LB, Thyssen EP, Gislason GH, Thyssen JP. Rosacea and gastrointestinal disorders: a population-based cohort study. Br J Dermatol. 2017 Jan;176(1):100-106. doi: 10.1111/bjd.14930. Epub 2016 Oct 31.
Clinical trial NCT01786291: PAP Therapy Sleep Apnea and Exercise
Official title: Effects of Positive Airway Pressure Therapy on Exercise Parameters in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
continuous positive airway pressure
cardiopulmonary exercise test
VE/VCO2
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients newly diasgnosed with obstructive sleep apnea in whom CPAP therapy was indicated

Brief summary: Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.


Eligibility criteria: Inclusion Criteria:

* obstructive sleep apnea diagnosed by polysomnography
* CPAP therapy indicated

Exclusion Criteria:

* obstructive or restrictive lung disease
* cardiac failure
* acute coronary syndrome
* inability to cycle

Primary outcomes:
measure: peak oxygen uptake
timeFrame: 30-60 days
Secondary outcomes:
measure: ventilatory equivalent for carbon dioxide at anaerobic threshold
timeFrame: 30-60 days
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: University of Gaziantep, Faculty of Medicine, Dept. of Pulmonary Diseases
Study officials:
affiliation: University of Gaziantep
name: Meral Uyar, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Gaziantep
name: Nazan Bayram, Assis Prof
role: PRINCIPAL_INVESTIGATOR
References: