louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06159881: Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus
Official title: Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus Corneas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keratoconus
Keywords: Progression
Customized
Cross-Linking
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 20
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: The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:

* Is it effective while using personalized (reduced) energy?
* Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults


Eligibility criteria: Inclusion Criteria:

* Keratoconus diagnosed with corneal tomography/topography
* Thinnest point pachymetry below 400 microns

Exclusion Criteria:

* Previous corneal cross linking history
* Corneal scars not allowing best corrected visual acuity of 20/100 or better
* Previous corneal hydrops history
* Psychomotor retardation history

Primary outcomes:
measure: Keratometry stability
timeFrame: Baseline and 6 months
measure: Pachymetry stability
timeFrame: Baseline and 6 months
measure: Uncorrected visual acuity stability
timeFrame: Baseline, 72 hours, 1 week, 3 months and 6 months
measure: Corneal endothelium safety
timeFrame: Baseline, 72 hours, 1 week, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología Conde de Valenciana
Study officials:
affiliation: Instituto de Oftalmología Conde de Valenciana
name: Enrique Graue, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA. Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30.
citation: Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB. Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878.
citation: Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG. Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28.
Clinical trial NCT03763981: Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
Official title: Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perianal Fistula
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes and aged 20 years and above with high perianal fistula

Exclusion Criteria:

* Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma

Primary outcomes:
measure: fistula healing
timeFrame: 8 to 12 weeks
Secondary outcomes:
measure: Fistula recurrence
timeFrame: 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT05751681: Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI
Official title: Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovary Cyst
Fertility Issues
Keywords: IVF,ICSI,success rate
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-03-02
Enrollment: 79
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

Detailed description: Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations

Eligibility criteria: Inclusion Criteria:

1. All patients should be candidates for ICSI.
2. Age between 20-40 years.
3. Body mass index 18-35 kg/m2.
4. Diagnosis of PCOS according to modified Rotterdam's criteria

Exclusion Criteria:

* 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.

Primary outcomes:
measure: Efficacy (Number of MII oocytes retrieved)
timeFrame: 3 months
measure: Efficacy (Maturation index)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: zagazig
name: mostafa fahmy, mcs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030781: Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
Official title: Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx
Oxygen
Intubation
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2017-01-25
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study evaluated CT images of the chest of children less than 8 years of age. The database search of the electronic medical records identified 110 patients of which 40 patients qualified for the study.

Brief summary: Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. The primary aims of this study were to define the relationship between cricoid and mainstem bronchi (right and left) in children of various ages and to determine the effects of age, height and weight.

Detailed description: Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.

Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.

Eligibility criteria: Inclusion Criteria:

* Children 1 month to 8 years of age

Exclusion Criteria:

* Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants

Primary outcomes:
measure: comparison between cricoid and mainstem borncchi
timeFrame: 1 month to 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06184581: Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Official title: Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bipolar II Disorder
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded two-armed, parallel randomized trial
Primary purpose: TREATMENT

Brief summary: The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.

Detailed description: Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.

Eligibility criteria: Inclusion Criteria:

* Bipolar disorder, type II with diagnosis confirmed by SCAN interview
* Age 18-65 years
* Habile (i.e., able to give informed consent)
* Speaks Danish

Exclusion Criteria:

* Past non-response or intolerance to lamotrigine or lithium with \> 6 weeks treatment at an adequate dosage
* Currently taking mood stabilizers at enrollment in CADIC
* Severe chronic kidney disease
* Severe cardiac insufficiency
* Brugadas syndrome
* Severe hypothyroidism despite treatment
* Women who are pregnant, breastfeeding or planning pregnancy in near future.

Primary outcomes:
measure: Mood stabilization
timeFrame: 6 (possibility of 12) months follow-up
Secondary outcomes:
measure: Non-response
timeFrame: 6 (possibility of 12) months follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
Study officials:
References:
Clinical trial NCT01157481: Diastolic Heart Failure Management by Nifedipine
Official title: Diastolic Heart Failure Management by Nifedipine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastolic Heart Failure
Keywords: Diastolic Heart Failure
Heart failure with preserved ejection fraction
nifedipine
Lead sponsor: Demand Investigators
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 226
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with heart failure with preserved ejection fraction have a equally high risk for mortality and re-hospitalization as those with reduced ejection fraction. Effective management strategies are critically needed to be established for this type of heart failure. These patients have more hypertensive and ischemic etiology than those with reduced ejection fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the heart failure clinical composite response endpoint compared with the conventional treatment in patients with heart failure with hypertension and/or coronary artery disease and preserved ejection fraction (\>=50%) by echocardiography. This study is multi-center, prospective, randomized, open-label, and blinded-endpoint design.


Eligibility criteria: Inclusion Criteria:

1. 20 years and older
2. Heart failure with history of hypertension and/or coronary artery disease
3. LVEF \> or = 50% on echocardiography

Exclusion Criteria:

1. Valvular heart diseases with significant regurgitation and/or stenosis
2. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
3. Constrictive pericarditis
4. Cardiogenic shock
5. Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
6. History of acute coronary syndrome or stroke within 3 months
7. Pregnancy or breastfeeding
8. Hypersensitivity or contraindication to nifedipine
9. Inability to obtain informed consent
10. Any conditions not suitable for the participation in this trial judged by the investigator

Primary outcomes:
measure: Heart failure clinical composite response endpoint
timeFrame: up to 53 months
Secondary outcomes:
measure: Death
timeFrame: up to 53 months
measure: Cardiovascular death
timeFrame: up to 53 months
measure: Hospital admission
timeFrame: up to 53 months
measure: Hospital admission for cardiovascular disease
timeFrame: up to 53 months
measure: Hospital admission for worsening heart failure
timeFrame: up to 53 months
measure: Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
timeFrame: up to 53 months
measure: Stroke
timeFrame: up to 53 months
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido Univestity Hospital
Study officials:
References:
Clinical trial NCT05932381: Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
Official title: Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Keywords: complete decongestive therapy
carpal tunnel syndrome
upper limb lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: complete decongestive therapy and routine medical treatment
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.

Detailed description: lymphedema is a chronic condition characterized by lymphatic vessel ectasia and valve dysfunction, followed by the reflux of lymphatic fluid into the interstitial space. Lymph stasis may lead to a chronic inflammatory process, resulting in adipose tissue differentiation and fibro adipose tissue deposition. One consequence of post-mastectomy lymphedema may be the development of nerve entrapments. One example is median nerve entrapment in the carpal canal, or carpal tunnel syndrome (CTS). many studies assessed the relationship of CTS as a risk factor for developing lymphedema, other studies stated the possibility of lymphedema as a potential contributor to CTS development. Complex decongestive treatment of breast cancer-related lymphoedema is an accepted strategy and is considered as an international standard for treatment. A previous review concluded that complex decongestive therapy has a positive impact on the volume of arm and quality of life in different stages of lymphedema.sixty females will be allocated randomly to two groups; first one will receive decongestive therapy and the second one will receive the routine medical treatment for ten weeks

Eligibility criteria: Inclusion Criteria:

* Age will range between 20- 40 years.
* Only females will participate in the study.
* All patients have carpal tunnel syndrome post upper limb lymphedema.

Exclusion Criteria:

* Diabetes mellitus.
* Individuals with cardiopulmonary conditions.
* Individuals undergoing radiation therapy or chemotherapy.
* Hepatic or pancreatic diseases.
* Sensory impairment.

Primary outcomes:
measure: hand strength
timeFrame: up to ten weeks
measure: median nerve conduction velocity
timeFrame: up to ten weeks
Secondary outcomes:
measure: pain intensity
timeFrame: up to ten weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02271581: Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer
Official title: INSYNC: Leo Jenkins Cancer Center (LJCC) - Symptom Management Service (SMS) Protocol -Phase II Trial Regarding The Effect Of Comprehensive Symptom Management On Inflammation And Survival In Metastatic Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Leo W. Jenkins Cancer Center
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with metastatic (stage IV) non-small cell lung cancer

Brief summary: There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of stage IV non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Able to read and respond to questions in English

Exclusion Criteria:

* Small Cell Lung Cancer

Primary outcomes:
measure: Overall Survival
timeFrame: Patients will be followed for 5 years after enrolling last patient
Secondary outcomes:
measure: Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)
timeFrame: 10 months
measure: Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups
timeFrame: 10 months
measure: Change in VeriStrat status
timeFrame: 10 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center
state: North Carolina
Study officials:
affiliation: Brody School of Medicine at ECU
name: Geoffrey Stroud, PharmD, BCOP, CPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05283681: A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
Official title: A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male and female healthy volunteers between 18 and 55 years of age.
* Body weight less than 110.00 kg inclusive at Screening.

Exclusion Criteria:

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 140 Days
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 113 Days
measure: Time to Cmax (Tmax)
timeFrame: Up to 113 Days
measure: Terminal phase elimination rate constant (β)
timeFrame: Up to 113 Days
measure: Terminal phase elimination half-life (t1/2)
timeFrame: Up to 113 Days
measure: Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)
timeFrame: Up to 113 Days
measure: AUC from time 0 to infinity (AUCinf)
timeFrame: Up to 113 Days
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Up to 113 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 210844
state: Illinois
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 211456
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: