louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01028872: Spherical Aberration and Contrast Sensitivity Function in Eyes Implanted With Spherical and Aspheric Intraocular Lenses: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: higher-order aberrations, contrast sensitivity
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-12-09
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Senile cataract

Exclusion Criteria:

* Glaucoma, corneal opacity, retinal abnormality, previous history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad Medical Center
Study officials:
References:
Clinical trial NCT06565572: Antisense Oligonucleotide Treatment for PCARP Disease Due to Mutation in FLVCR1
Official title: An Open-label Single Center, Single Participant Study of an Experimental Antisense Oligonucleotide Treatment for PCARP (Posterior Column Ataxia with Retinitis Pigmentosa) Disease Due to Mutations in FLVCR1
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Posterior Column Ataxia with Retinitis Pigmentosa
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate a specific antisense oligonucleotide medication in one patient with posterior column ataxia with retinitis pigmentosa. The main question it aims to answer is: what is the safety and tolerability of this medication in a single participant.


Eligibility criteria: Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Genetically confirmed FLVCR1-related disease.
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.

Exclusion Criteria:

* Allergy to any of the ASO components
* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Over 12 months
measure: We will measure visual acuity, retinal thickness, examine changes in fundus photos and biomicroscopic exam post nL-FLVC-001 administration in a participant with FLVCR1 gene mutation
timeFrame: Over 12 months
Secondary outcomes:
measure: Measure any changes in the Cardiff Visual Ability Questionnaire for Children (CVAQC-25) in one patient with PCARP after nL-FLVC-001 intravitreal injection.
timeFrame: Over 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT06141772: Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy
Official title: Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Diffuse Large B Celle Lymphoma
Circulating tumor DNA
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

Detailed description: ctDNA in diffuse large B cell lymphoma (DLBCL) has become an essential dynamic biomarker. Due to its short half-life, ctDNA is a real-time reflection of tumoral evolution and is a non-invasive biomarker that can be used for patient evaluation and follow-up. The quantity of ctDNA before treatment is correlated with tumoral mass, international prognostic index (IPI) and prognosis. The principal mechanism of ctDNA release is tumor cell apoptosis and it is well established that tumor cell apoptosis is observed in the hours following immuno-chemotherapy. However, the kinetics of ctDNA concentration in the hours following immuno-chemotherapy administration is unknown.

Modelizing the kinetics of ctDNA during this early timeframe could help to better predict chemo-sensitivity and better reflect genetic heterogeneity of the tumor, through release of a larger quantity of ctDNA compared to baseline.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diffuse Large B Cell Lymphoma
* TEP-TDM at diagnosis
* Inform Consent form signed
* Performance status 0 or 1
* Hospitalized on clinician decision for first cycle of R-CHOP or R-miniCHOP

Exclusion Criteria:

* Histology other than Diffuse Large B Cell
* Patient under guardianship or curatorship
* Incapacity to understand the study or conform to the constraints of the study (language barrier, psychological barrier, geographic barrier...)

Primary outcomes:
measure: Analysis of circulating tumor DNA kinetics
timeFrame: 21 days
Secondary outcomes:
measure: Correlation between circulating tumor DNA concentration and metabolic volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Fabrice Jardin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06338072: Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).
Official title: Impact of the Menstrual Cycle on the Control of Type 1 Diabetes in Reproductive Aged Women Using an Advanced Closed Loop System.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, close loop system, women
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
First posted: 2024-03-29
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both genders, aged 18 or older, with type 1 diabetes and in their reproductive years, receiving care at the Endocrinology and Nutrition Department of Ramón y Cajal University Hospital in Madrid, and undergoing treatment with the Medtronic© MinimedTM 780G closed loop advanced system.

Brief summary: The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.


Eligibility criteria: Inclusion Criteria:

* Diagnostic criteria for DM1 according to ADA
* Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system.
* Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year.
* Men under 50 years old.
* Acceptance of participation in the study and signing of the informed consent

Exclusion Criteria:

* Gestation
* Use of hormonal contraceptives (including intrauterine devices)
* Institutionalization, serious or terminal illness or renal replacement therapy.
* Refusal to participate in the study or to sign the informed consent

Primary outcomes:
measure: Time in range
timeFrame: 1 month
Secondary outcomes:
measure: Time below range
timeFrame: 1 month
measure: Time above range
timeFrame: 1 month
measure: Caloric intake
timeFrame: 1 month
measure: Temperature
timeFrame: 1 month
measure: Photoplethysmography
timeFrame: 1 month
measure: Accelerometry
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Lía Nattero-Chávez
Study officials:
affiliation: Diabetes, Obesity and Human Reproduction Research Group (IRYCIS)
name: Lía Nattero, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02950272: Chinese Adolescent Registry for Diabetes (CARD) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chinese Adolescents With Diabetes
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adolescents with diabetes aged 14-30.

Brief summary: The CARD study is a observational study which includes Chinese adolescents with diabetes aged 18-30. The study aims to explore the status of disease treatment, self-management, the relationship between disease treatment and disease outcome in Chinese adolescents with diabetes.


Eligibility criteria: Inclusion Criteria:

* diagnosed diabetes
* aged 14-30
* signed the informed consent

Exclusion Criteria:

* taking part in other drug research
* gestational diabetes
* diagnosed with tumor or cardiovascular disease

Primary outcomes:
measure: cardiovascular events
timeFrame: six year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan Shi
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02729272: Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy
Official title: Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy During Total Laparoscopic Hysterectomy in Terms of Surgical Smoke and Lateral Thermal Damage: a Randomized Controlled Trial (ULMOST Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Diseases
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

Detailed description: According to previous studies performed in porcine and bovine tissues, ultrasonic energy based surgical devices (ESDs) created less surgical smoke, involved less visual obstruction, and produced less lateral thermal damage than monopolar ESDs. However, there was no study comparing ultrasonic ESD and monopolar ESD in laparoscopic colpotomy in terms of surgical smoke and lateral thermal damage. Therefore, the aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

Eligibility criteria: Inclusion Criteria:

* women with gynecologic diseases, such as uterine myoma, adenomyosis, and ovarian tumor;
* women who were planning to undergo TLH;
* women between 19 and 75 years of age.

Exclusion Criteria:

* women with any suggestion of malignant cervical or vaginal pathologies
* women with uncontrolled medical comorbidities or psychiatric illness, which could affect follow-up and/or compliance
* women who refused to participate or give consent to the procedures.

Primary outcomes:
measure: Degree of surgical smoke obstructing vision
timeFrame: Day of surgery
measure: Degree of lateral thermal damage
timeFrame: Day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: NJ
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331472: The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome (Pilot Study)
Official title: The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Interstitial Cystitis
Keywords: interstitial cystitis
biomarker
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Interstitial cystitis

Brief summary: This study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome


Eligibility criteria: Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
2. Pain VAS \>4
3. PUF score \>13
4. ICQ score \>12

4) cystoscopic record within 2years

Exclusion Criteria:

1. Patients who are pregnancy or, childbearing age without no contraception
2. Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination
3. patients with urine culture showing evidence of urinary tract infection 1month prior to the study
4. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, Prostate cancer
   * Recurrent cystitis
   * Anatomical disorder
5. Patients had prior surgery (bladder augmentation, cystectomy)
6. Patients with neurologic disorder
7. Patients with indwelling catheter or intermittent self-catheterization
8. Patients with psychological problem

Primary outcomes:
measure: Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups
timeFrame: 1day
Secondary outcomes:
measure: Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups
timeFrame: 1day
measure: Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale
timeFrame: 1day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan medical center Institutional review board
Study officials:
affiliation: Asan Medical Center
name: Myung-Soo Choo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934672: KineSpring® System Patient Preference Study
Official title: KineSpring® System Patient Preference Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of the Knee
Lead sponsor: Moximed
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 323
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee

Brief summary: The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.

Detailed description: Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 25 - 80 years
* Diagnosed with osteoarthritis in the knee
* Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
* Experience knee pain at least once a week
* Previously failed non-surgical treatments for knee OA pain
* Pass a security screen

Exclusion Criteria:

* Do not suffer or has not been diagnosed with knee osteoarthritis
* Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)

Primary outcomes:
measure: Patient preferences for knee osteoarthritis surgical procedures
timeFrame: At time of survey
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Moximed
name: Tessa Yamut
role: STUDY_DIRECTOR
References:
citation: Moorman CT 3rd, Kirwan T, Share J, Vannabouathong C. Patient Preferences Regarding Surgical Interventions for Knee Osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Sep 20;10:1179544117732039. doi: 10.1177/1179544117732039. eCollection 2017.
Clinical trial NCT03449472: Bariatric Surgery and Pharmacokinetics of Quetiapine
Official title: Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Quetiapine fumarate
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on quetiapine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Quetiapine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453972: Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese
Official title: Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Exercise
High-intensity
Interval training
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of our study is to examine the physiological adaptations in oxygen transport chain for high-intensity exercise and moderate exercise in overweight and obese humans. The main goals are:

1. To investigate the most effective short-and long-interval training in terms of VO2max, pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.
2. How these physiological adaptations affect the aerobic endurance and performance, and how this training can reduce the risk of cardiovascular diseases related to overweight and obesity.


Eligibility criteria: Inclusion Criteria:

* BMI \> 25

Exclusion Criteria:

* Exclusion criteria will be cardiovascular disease or another disease that is not consistent with high physical activity. Subjects should not have exercised regularly before the study.

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Medical Faculty, Norwegian University of Science and Technology
state: Sør-Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øivind Rognmo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baekkerud FH, Solberg F, Leinan IM, Wisloff U, Karlsen T, Rognmo O. Comparison of Three Popular Exercise Modalities on V O2max in Overweight and Obese. Med Sci Sports Exerc. 2016 Mar;48(3):491-8. doi: 10.1249/MSS.0000000000000777.