louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00453440: Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701
Official title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Human Immunodeficiency Virus
Keywords: HIV
HLA-B*5701
Abacavir hypersensitivity reaction
HIV Infection
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-03-29
Enrollment: 1502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B\*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.

The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin.

They will be asked to give two samples to test for the presence of the genetic marker HLA-B\*5701. The two samples are:

* A cheek swab
* A blood sample

In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B\*5701 testing.


Eligibility criteria: Inclusion criteria:

* HIV-1 infected patients over 18 years of age
* Patient willing \& able to understand and provide written informed consent

Exclusion criteria:

* None

Primary outcomes:
measure: Prevalence of HLA-B*5701 in the UK population via central labs
timeFrame: 2 Hours
Secondary outcomes:
measure: Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
timeFrame: 2 Hours
measure: Description of HLA-B*5701 in the UK population via local labs.
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Woolwich, London
country: United Kingdom
facility: GSK Investigational Site
state: London
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Orkin C, Sadiq ST, Rice L, Jackson F; UK EPI team. Prospective epidemiological study of the prevalence of human leukocyte antigen (HLA)-B*5701 in HIV-1-infected UK subjects. HIV Med. 2010 Mar;11(3):187-92. doi: 10.1111/j.1468-1293.2009.00762.x. Epub 2009 Sep 24.
Clinical trial NCT03496740: Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias
Official title: Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Ultrasound
Dorsal Penile Nerve Block
Pudendal Block
Hypospadias
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 36
Sex: MALE
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.


Eligibility criteria: Inclusion Criteria:

* 1 to 10 years of age
* ASA I-II
* Undergoing elective hypospadias surgery

Exclusion Criteria:

* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* ASA III-IV
* Patients with neurological disorders

Primary outcomes:
measure: Time to first analgesic
timeFrame: postoperative 7 day
Secondary outcomes:
measure: Pain Scores
timeFrame: postoperative 48 hour
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
References:
Clinical trial NCT01564940: Human Factors Usability Study of Ib2C Conception System
Official title: Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cap Insemination
Keywords: Cervical cap insemination
Usability Study
Lead sponsor: Rinovum Women's Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Females between the ages of 20 and 45.

Brief summary: The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Detailed description: The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Eligibility criteria: Inclusion Criteria:

* Female, any ethnicity
* 20 - 45 years of age
* Sexually active
* Signed Informed Consent

Exclusion Criteria:

* Prior surgery to the cervix or vaginal tract
* Vaginal prolapse
* Cervical cancer
* Hysterectomy
* History of Toxic Shock Syndrome (TSS)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Forbes Regional Hospital
state: Pennsylvania
Study officials:
affiliation: Forbes Regional Hospital (West Penn Allegheny Health System)
name: Michael J Pelekanos, OB-GYN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03608540: Endomina as an Aid for Endoscopic Full Thickness Resection
Official title: A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Full Thickness Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Submucosal Tumor of Intestine
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection.

Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.


Eligibility criteria: Inclusion Criteria:

1. Lesion untreatable with standard technique.
2. Age between 18-65 years;
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders (for upper GI lesion)
2. Severe esophagitis (for upper GI lesion)
3. Gastro-duodenal ulcer (for upper GI lesion)
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction;
6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
7. Anticoagulant therapy;
8. Impending gastric surgery 60 days post intervention (Upper GI);
9. Currently participating in other study

Primary outcomes:
measure: Incidence of all Adverse Device Effects
timeFrame: one year from procedure
Secondary outcomes:
measure: R0 resection
timeFrame: 1 month after resection
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Gastroenterology Department Erasme Hospital
Study officials:
References:
Clinical trial NCT02123940: Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy
Official title: Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Patients Ventilated More Than 48 h
Keywords: Weaning from mechanical ventilation
Lung ultrasound
Nasal humidified high flow therapy
Weaning failure
Postextubation distress
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
name: University Hospital, Grenoble
name: Hospices Civils de Lyon
name: Centre Hospitalier Universitaire de Saint Etienne
name: University Hospital, Marseille
First posted: 2014-04-28
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

Detailed description: Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Eligibility criteria: Inclusion Criteria:

* Adult patients ventilated more than 48 h
* Stable respiratory and hemodynamic conditions for SBT
* Consent of patients
* Arterial line

Exclusion Criteria:

* severe COBP
* Laryngeal dyspnea
* Tracheostomy
* Arrhythmia
* No echogenicity
* Paraplegia \>T8

Primary outcomes:
measure: Incidence of postextubation distress
timeFrame: during 48 hour (at day 1)
Secondary outcomes:
measure: Number of ventilator-free-days
timeFrame: at day 1 (after extubation)
measure: Length of stay in ICU
timeFrame: at day 1
measure: Mortality in ICU
timeFrame: at day 1
measure: Extubation failure
timeFrame: at day 7
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02511340: A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients
Official title: Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Myelogenous Leukemia
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Detailed description: Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.

Eligibility criteria: Inclusion Criteria:

* Male or female patients age 18-75 year-old;
* ECOG 0 - 2;
* Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;
* Adequate organ function;
* Written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Patients in Chronic and Blastic Phases;
* Previously treated with Flumatinib;
* Previously documented T315I mutations;
* Previous therapy within protocol defined timeframe, including:

  * hydroxyurea within 24 hr,
  * Imatinib or Nilotinib or Dasatinib within 28 days)
* Cardiac dysfunction ;
* History of congenital or acquired bleeding disorders unrelated to CML;
* Central nervous system leukemia;
* Previous malignancy except CML;
* Acute or chronic liver or severe kidney disease unrelated to CML;
* Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

Primary outcomes:
measure: Confirmed overall hematologic response（OHR）at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and technology
state: Hubei
Study officials:
affiliation: Peking University People's Hospital
name: Kaiyan Liu
role: STUDY_CHAIR
References:
Clinical trial NCT00097240: An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)
Official title: The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Pregnancy
Keywords: FOLLOW
Psoriasis
Pregnancy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-22
Enrollment: 18
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women solicited through advertising, physician and patient awareness, and other programs.

Brief summary: The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.


Eligibility criteria: Any patient who has used Raptiva within 6 weeks prior to conception or during her pregnancy may be included in the Registry. Enrollment is based on Raptiva exposure, whether inadvertent or deliberate, in relation to pregnancy. Enrollment should occur as early as possible during the pregnancy and must occur prior to knowledge of pregnancy outcome.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: FOLLOW Raptiva Pregnancy Registry
state: North Carolina
Study officials:
affiliation: Genentech, Inc.
name: Ivor Caro, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02974140: Cataract Refractive Suite Study
Official title: A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 39
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative


Eligibility criteria: Inclusion Criteria:

* Diagnosed with bilateral cataracts;
* Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
* Clear intraocular media, other than cataract, in study eye(s);
* Willing and able to complete all required postoperative visits;
* Able to comprehend and sign a statement of informed consent;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Significant irregular corneal astigmatism;
* History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
* Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
* Any inflammation or edema (swelling) of the cornea;
* Pregnant;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
timeFrame: Day 20-40 from second implantation
Secondary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day 0 (operative day), each eye
measure: Estimated Aspiration Fluid Used During Surgery
timeFrame: Day 0 (operative day), each eye
measure: Phaco Aspiration Time Spent During Surgery
timeFrame: Day 0 (operative day), each eye
Other outcomes:
Locations:
city: Panama City
country: United States
facility: Alcon Investigative Site
state: Florida
city: Stillwater
country: United States
facility: Alcon Investigative Site
state: Minnesota
city: Hurst
country: United States
facility: Alcon Investigative Site
state: Texas
Study officials:
affiliation: Alcon, A Novartis Division
name: Sr. Clinical Manager, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06338540: Relation of Caries Color to Caries Severity and Its Microbial Load
Official title: Relation of Caries Color to Caries Severity and Its Microbial Load in Primary Molars. A Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Relation of Caries Color
Keywords: Relation of Caries Color
History of pain
Caries severity
ICDAS
Microbial load
Radiograph
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color
Primary purpose: OTHER

Brief summary: This study is to find the relation of caries color to caries severity and its microbial load in primary molars.

Detailed description: This study is to investigate the relationship between the caries color to caries severity and its microbial load.

Eligibility criteria: Inclusion Criteria:

1. Their ages ranged from (4 to 7) years.
2. They were healthy, free from any chronic disease and had no previous anxiety disorder or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism.
3. Primary molars with class 1 caries, normal furcation and normal periapical bone structure
4. They were indicated for restorative treatment under local anesthesia.
5. They were not indicated for pharmacological management

Exclusion Criteria:

1. Primary molars with class 2 caries
2. Teeth with mobility
3. Periapical abscess
4. Fistula

Primary outcomes:
measure: Caries color related to history of pain
timeFrame: Up to 12 weeks
measure: Caries color related to ICDAS
timeFrame: Up to 12 weeks
measure: Caries color related to pulp exposed
timeFrame: Up to 12 weeks
measure: Caries color related to microbial load
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlia
Study officials:
affiliation: Researcher of Pediatric Dentistry , Faculty of Dentistry Mansoura University
name: Khaled A Habbal, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
name: Salwa M Awad, Prof
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Hossam E Hammouda, PhD
role: STUDY_DIRECTOR
References: