louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00474695: Study Evaluating Genotypes Using Lucentis
Official title: VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age-Related Maculopathy
Keywords: Exudative age-related macular degeneration
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-05-17
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moran Eye Center Clinic

Brief summary: The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Detailed description: Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Eligibility criteria: Inclusion Criteria:

* Treatment naive AMD patients;
* At least 50 years of age;
* Visual acuity between 20/40 and 20/320

Exclusion Criteria:

* Pregnancy;
* Prior enrollment in a ranibizumab clinical trial;
* Previous therapy in either eye for AMD;
* Concurrent eye disease that could compromise visual acuity

Primary outcomes:
measure: To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
timeFrame: 4 months
Secondary outcomes:
measure: Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Salt Lake City
country: United States
facility: University of Utah, Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Paul Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.
Clinical trial NCT05475795: Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials
Official title: Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

Detailed description: The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

Eligibility criteria: Inclusion Criteria:

* 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:

Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

Radiographic:

1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.

Exclusion Criteria:

* A child's tooth with any of the following criteria:

Clinical findings:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.

Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.

Primary outcomes:
measure: postoperative pain.
timeFrame: after one day and after one week .
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Nada Mohamed Hassan Saied
Study officials:
affiliation: Pediatric Dentistry Department, Faculty of Dentistry, Minia University
name: Osama S Gad El-Hak, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03241095: The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing
Official title: The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Swing Via Objective Data From Golf Simulator Swing Analysis and Subjective Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manipulation, Osteopathic
Keywords: Osteopathic Manipulation Treatment
Golf
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. One group will receive no intervention other than a 10-minute break between the pre and post measurements. A second group will receive a sham intervention where the doctor will pretend to give the participant OTM. The third group will receive real OTM.

Participants will perform a sample of 10 golf swings pre and post intervention which will be measured by a golf simulator. They will also complete a brief health history and pre/post self-evaluation of their swing.


Eligibility criteria: Inclusion Criteria: Adult golfers (18 years old or over) -

Exclusion Criteria: Anyone under 18 years, people that do not golf.

-

Primary outcomes:
measure: Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mankato
country: United States
facility: Mayo Clinic Health System - Family Medicine Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Angela Buffington, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03563495: Tissue Engineered Constructs for Alveolar Cleft Repair
Official title: Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: tissue engineering.
stem cells.
autogenous grafts.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Description of the research question

In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting?

Objective of the study:

• Research hypothesis

The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction.

* The objectives

The primary objective:

Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

The secondary objective:

Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.


Eligibility criteria: Inclusion Criteria:

* Children with maxillary unilateral alveolar clefts requiring reconstruction
* Children free from any systemic disease that may affect normal healing of bone
* Children in an age range (8-14) year.

Exclusion criteria

* Bilateral alveolar clefts.
* Cleft lip or palate not including the alveolus.
* Immunocompromized patients.
* Children who undergone previous bone grafting procedure for the alveolar cleft

Primary outcomes:
measure: Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
timeFrame: Immediate postoperative and after 6 months
Secondary outcomes:
measure: Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months
timeFrame: Immediate postoperative and after 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05987995: Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial
Official title: Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Endometrial injury
ICSI
infertility
pregnancy rate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial injury is one of the interventions suggested to improve the endometrial receptivity by enhancing the decidualization process, and so increasing the pregnancy rate

Detailed description: In assisted reproductive techniques , specially ICSI, several approaches have been put forward to improve the endometrium, including endometrial injection of granulocyte colony-stimulating factor or platelet-rich plasma. Endometrial injury is one of the interventions suggested to improve the endometrial receptivity.

Endometrial injury, also known as endometrial scratching, is the intentional damage of the endometrium, usually using a pipelle, aiming at increasing the implantation rate. The exact mechanism of action is still vague ,many hypotheses have been advocated, including enhanced decidualization, which is stimulated by the local injury. Moreover, endometrial injury stimulates an inflammatory response, which in turn adjusts gene expression.

The value of endometrial injury is a controversial issue, there is no agreement on the exact time to perform endometrial scratching, so in the current study, we investigated the safety and efficacy of performing endometrial injury in the follicular phase of the same ICSI cycle.

Eligibility criteria: Inclusion Criteria:

* Age \<40 year.
* BMI 20-35 kg/m2.

Exclusion Criteria:

* Age \>40 year
* BMI \> 35
* Uterine cavity abnormalities
* poor quality embryos
* Poor responders
* Diagnosed sever endometriosis
* Sever male factor
* Declined to participate

Primary outcomes:
measure: pregnancy rate
timeFrame: 15 days after HCG administration
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Tamer
Study officials:
References:
Clinical trial NCT02886195: EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Official title: EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: EGFR Gene Mutation
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
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 study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

Detailed description: This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).

Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.

The endpoint of this study included clinical efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* Stage Ⅳ EGFR mutation-positive NSCLC
* Initial therapy
* ECOG performance status 0-1

Exclusion Criteria:

* EGFR mutation-negative
* Previous systemic antitumour treatment

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: Response Rate (RR)
timeFrame: 2 months
measure: Overall Survival (OS)
timeFrame: 6 months
measure: Adverse Event (AE)
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Fujian province cancer hospital
name: zhiyong he he, master
role: STUDY_CHAIR
References:
citation: Lin J, Li M, Chen S, Weng L, He Z. Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naive Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial. J Inflamm Res. 2021 Jun 16;14:2557-2567. doi: 10.2147/JIR.S313056. eCollection 2021.
Clinical trial NCT04110795: Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs
Official title: Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atypical Femur Fracture
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-10-01
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based population in Ontario and British Columbia Canada

Brief summary: The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.

Detailed description: Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

Eligibility criteria: Inclusion Criteria:

* Cases: Have experienced a confirmed, documented Atypical femur fracture
* Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use

Exclusion Criteria:

-

Primary outcomes:
measure: Associations between AFF and clinical Risk Factor
timeFrame: baseline
measure: Associations between AFF and common genetic variants
timeFrame: baseline
measure: Validation of top genetic variants
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Adachi Medical Centre
state: Ontario
city: Oakville
country: Canada
facility: Bone Research & Education Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, TGH
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Angela M Cheung, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04214795: Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants
Official title: The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidity;Newborn
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 710
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants admitted with less than 6 hours after birth in the Gregorio Marañón Neonatal Department born with less than 32 weeks GA.

Brief summary: The aim is to evaluate the impact of a complete course of antenatal steroids treatment on mortality and main morbidities in a current population of preterm infants.

Detailed description: All infants admitted in the Neonatal Department born with less than 32 weeks of gestational age are included.

Data are prospectively recorded. Perinatal variables (Gestational age, materna condition at admission, antenatal steroids treatment, gender and results of histological analysis of the placenta) are recorded as well as respiratory status during hospitalization and morbidities at discharge. Results of neurodevelopment test performed at 24 months of corrected age are also included.

Eligibility criteria: Inclusion Criteria:

* All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).

Exclusion Criteria:

* Congenital malformations.
* premature infants in whom active resuscitation measures are not established.

Primary outcomes:
measure: Mortality
timeFrame: at hospital discharge, an average of 2-4 months.
Secondary outcomes:
measure: Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.
timeFrame: 36 weeks postmenstrual age
measure: Number of participants requiring Surfactant administration
timeFrame: in the first 3 days after birth
measure: Number of participants that requires Mechanical ventilation.
timeFrame: during hospitalization, and average of 2-4 months
measure: Number of participants with Neurodevelopment disability
timeFrame: performed at 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cristina Ramos-Navarro
Study officials:
affiliation: Gregorio Marañón Hospital
name: Manuel Sánchez-Luna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02334995: The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY
Official title: The Biofeedback Therapy in Solitery Rectal Ulser Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Ulcer
Keywords: solitery rectal ulcer
biofeedback
dissynergy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solitary rectal ulser

Brief summary: Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.

Detailed description: dyssynergia treating ulcers caused by treatment with biofeedback

Eligibility criteria: Inclusion Criteria:

* solitary rectal ulcer in rectosigmoidoscopy
* type 1 or 3 dissynergic defecation
* to accept to participate to study and sign informed consent

Exclusion Criteria:

* previously applied biofeedback
* serious psychiatric disorder
* previous anorectal surgery
* the presence of active malignancy

Primary outcomes:
measure: ulcer diameter shrinkage
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
name: Serhat Bor
role: PRINCIPAL_INVESTIGATOR
References: