louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05585736: Cycloplegia and Refractive Status
Official title: Effect of Cycloplegia on the Refractive Status of Egyptian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cycloplegia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 388
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Myopia is a public health problem, affecting the general population worldwide. The common modalities for correcting myopia include spectacles, contact lenses, and surgical procedures. Cycloplegic refraction is considered the gold standard for measuring refractive errors, especially in children. It has been well-established that generally myopia could be overestimated and hyperopia be underestimated if refraction was performed without cycloplegia.


Eligibility criteria: Inclusion Criteria:

* Myopia or Hyperopia or compound myopic astigmatism.
* Normal intra ocular pressure (IOP≤21 mmHg.
* Age \> 2 years and \< 10 years

Exclusion Criteria:

* Unwilling to participate in the study.
* Previous ocular surgery
* Any diagnosed ocular disease
* History of ocular trauma
* Irregular astigmatism on corneal topography.

Primary outcomes:
measure: Sphere of the eye
timeFrame: Baseline
measure: Sphere of the eye
timeFrame: Immediate after 30 minutes of cycloplegic addition
measure: cylinder of the eye
timeFrame: Baseline
measure: cylinder
timeFrame: Immediate after 30 minutes after cycloplegia
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT01250236: Effect of Brimonidine on Corneal Thickness
Official title: Effect of Brimonidine on Corneal Thickness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impact of Brimonidine on the Cornea
Keywords: brimonidine
alpha-2 adrenoceptor
cornea
corneal thickness
Lead sponsor: Augenarztpraxis Breisach
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive

Brief summary: Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is widely used in glaucoma treatment. Although it is known that it is quickly taken up by the cornea following topical administration and that the cornea has alpha-2 adrenoceptors there are only few studies available on the impact brimonidine has on the cornea. The aim of the study is to find out

1. whether topical administration of brimonidine results in interaction with corneal alpha-2 adrenoceptors in terms of an increase in corneal thickness and
2. whether there are any differences between the response corneal epithelium, stroma and endothelium show to alpha-2 adrenoceptor stimulation.


Eligibility criteria: Inclusion Criteria:

* healthy, 18-99 years, normal ophthalmologic history, consent to participate in the study

Exclusion Criteria:

* any serious medical or neurologic conditions and/or regular use of local or systemic medications

Primary outcomes:
measure: corneal thickness
timeFrame: 5 days
Secondary outcomes:
measure: intraocular pressure
timeFrame: 5 days
Other outcomes:
Locations:
city: Breisach
country: Germany
facility: Augenarztpraxis
state: Baden-Wuerttemberg
Study officials:
affiliation: Augenarztpraxis Breisach
name: Matthias Grueb, Priv. Doz. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03107936: Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Official title: Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.

Detailed description: The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs. For this sub-study we will further develop, expand, and refine the smokeSCREEN game and increase the game's reach on a national platform. The study will conduct the proposed evaluation by: working with game developers to develop a web- based version of the game, creating a pre-post survey to measure the effect of the game and building that into the smokeSCREEN game to anonymously collect information on players' knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.

Eligibility criteria: Inclusion Criteria:

* must be able and willing to sit at a computer or mobile device for 45-60 minutes per session to play the game and answer questions before and after playing video game.
* be enrolled in a youth program that we have a partnership with

Exclusion Criteria:

* up to the discretion of the study team

Primary outcomes:
measure: Beliefs about smoking pre-test survey
timeFrame: Baseline
measure: Beliefs about smoking post-test survey
timeFrame: immediately after game play is completed
measure: Knowledge about smoking pre-test survey
timeFrame: Baseline
measure: Knowledge about smoking post-test survey.
timeFrame: immediately after game play is completed
measure: Game experience satisfaction post-test survey
timeFrame: immediately after game play is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Hamden Youth Center
state: Connecticut
city: New Haven
country: United States
facility: Leadership, Education, and Athletics Partnership (LEAP) Inc.
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Farnam Neighborhood House
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn E. Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03435536: Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer
Official title: Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resectable Pancreatic Cancer
Keywords: circulating tumor DNA
kinetic
pancreatic cancer
pancreatoduodenectomy
Next Generation Sequencing
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.

Detailed description: The investigators will analyze if the tumor mobilization increases circulating DNA rate in peripheral and portal blood. Moreover, circulating tumor DNA will be measured during 12 months after surgery in peripheral blood. They will use a gene mutation detection technique called Next Generation Sequencing (NGS) which is more specific than a simple Polymerase Chain Reaction (PCR).

Eligibility criteria: Inclusion Criteria:

* Every patient taken care by Toulouse University Hospital for the resection of a non-metastatic pancreatic adenocarcinoma by whipple resection.
* Patient aged over 18 years old
* Patient having given his written consent
* Patient with social insurance coverage

Exclusion Criteria:

* Patients who had surgery, but their pathological examination of the resected specimen does not contain adenocarcinoma.
* Patient for whom the surgery was not realized (exploratory laparotomy)

Primary outcomes:
measure: Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.
timeFrame: Kinetic up to one year
Secondary outcomes:
measure: Overall survival
timeFrame: Kinetic up to one year
measure: Correlation between circulating tumor DNA rate and Ca19.9 dosage
timeFrame: Kinetic up to one year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Emmanuel CUELLAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682136: Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery
Official title: Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: postoperative analgesia
abdominal surgery
ropivacaine
local anaesthesia
tap block
pain management
Lead sponsor: Hunter Colorectal Research
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.

TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.

This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.

Exclusion Criteria:

* History of adverse reaction to Ropivicaine or similar drug.
* Inability or refusal to give consent
* Coagulopathic
* Severe renal impairment
* Aged \<18 years

Primary outcomes:
measure: mg/kg of morphine equivalent used by patients post operatively.
timeFrame: From operation until discharge.
Secondary outcomes:
measure: Lung Function (spirometry), including FVC, FEV1 and PEFR
timeFrame: 24, 48 and 72 hours postoperatively
measure: Visual Analogue Scale for pain at rest, deep breathing and coughing.
timeFrame: 24, 48 and 72 hours postoperatively
Other outcomes:
Locations:
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: Newcastle Private Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: Private Medical Suites
state: New South Wales
city: Waratah
country: Australia
facility: Mater Misericordiae Hospital
state: New South Wales
Study officials:
affiliation: Hunter Colorectal Research
name: Brian Draganic, B.Med.,B.Med.Sci.(Hons),FRACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunter Colorectal Research
name: Stephen Smith, B.Med.,F.R.A.C.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06065436: Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Official title: Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peyronie Disease
Erectile Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.


Eligibility criteria: Inclusion Criteria

• Diagnosed with PD

* Palpable penile plaque
* Dorsal, lateral, or dorsolateral penile curvature
* Penile curvature \> 30 degrees and \< 90 degrees as measured using goniometer during objective curvature assessment
* Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
* "Stable PD symptoms' defined as PD symptom duration \> 6-months or stable symptoms \> 3-months

Exclusion Criteria:

* Prior intralesional injections or surgery for PD.
* Severe baseline penile pain.
* Moderate or severe baseline ED based on IIEF-EF domain.
* History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
* Ventral (downward) or ventrolateral penile curvature.
* Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
* Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Primary outcomes:
measure: Change in symptom bother
timeFrame: Baseline, 6 weeks
measure: Change in penetrative sexual intercourse
timeFrame: Baseline, 6 weeks
measure: Surgical straightening intervention
timeFrame: 6 weeks
measure: Change in erectile function
timeFrame: Baseline, 6 weeks
measure: Change in Erectile Function Domain (IIEF-EF)
timeFrame: Baseline, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tobias Kohler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497236: Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda
Official title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Kaabong, Karamoja, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Infant Morbidity
Lead sponsor: Medecins Sans Frontieres, Spain
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 2202
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

Detailed description: similar to MSF-nutcon 03 : NCT01154803

Eligibility criteria: Inclusion Criteria:

* 6 to 59 months of age
* Not malnourished
* Diagnosis of malaria and/or diarrhoea and/or LRTI
* Intending to remain in area for the duration of the 6 month follow-up
* Living within approximately 60 minutes walking distance from the clinic
* Informed consent from a guardian\*

Exclusion Criteria:

* Child is exclusively breastfeeding
* Child is severely malnourished
* Presence of 'General Danger Signs'
* Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
* Needing hospitalisation for any reason
* Known history of allergy to the nutritional supplementation
* Having a sibling enrolled in the study\*

Primary outcomes:
measure: "negative nutritional outcome" of a child
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Number of new events of a study disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaabong
country: Uganda
facility: Kaabong Hospital
state: Karamoja district
Study officials:
affiliation: MSF Spain
name: Nuria Salse
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Kam S, Roll S, Swarthout T, Edyegu-Otelu G, Matsumoto A, Kasujja FX, Casademont C, Shanks L, Salse-Ubach N. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda. PLoS Med. 2016 Feb 9;13(2):e1001951. doi: 10.1371/journal.pmed.1001951. eCollection 2016 Feb.
Clinical trial NCT00005936: Collection of Liver Tissue for Virologic Studies
Official title: Collection of Liver Tissue for Virologic Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Virus Disease
Keywords: Fulminant Hepatitis
Parvovirus
Hepatitis
Biopsy
Control
Liver Biopsy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2000-07-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure.

All patients who are undergoing liver biopsy or liver transplantation may participate in this study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from the sample collected during the scheduled biopsy. For patients undergoing liver transplantation, a small piece of tissue will be collected from the diseased liver that is to be removed.

Detailed description: Our laboratory has a long-standing interest in viruses that affect the bone marrow. Many such viruses also may cause hepatitis. One specific syndrome, post-hepatitis aplastic anemia, suggests that the same agent is responsible for both severe and sometimes fulminant hepatitis as well as profound bone marrow failure. In investigating the role of viruses in these diseases, we require small amounts of liver tissue for molecular studies. We request permission to obtain samples from patients undergoing 1) liver transplantation or 2) liver biopsy at the time of surgery for purpose of virus discovery, including obtaining control samples. For liver transplant samples, tissue will be obtained from the removed organ; in other surgical circumstances, small amounts of tissue will be obtained when the liver is biopsied for other medical indications. No additional risk to the patient should result from either procedure.

Eligibility criteria: All patients undergoing open liver biopsy or the removal of liver for purposes of hepatic transplantation are eligible for participation.

There are no exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Naides SJ, Karetnyi YV, Cooling LL, Mark RS, Langnas AN. Human parvovirus B19 infection and hepatitis. Lancet. 1996 Jun 1;347(9014):1563-4. doi: 10.1016/s0140-6736(96)90720-5. No abstract available.
citation: Tzakis AG, Arditi M, Whitington PF, Yanaga K, Esquivel C, Andrews WA, Makowka L, Malatak J, Freese DK, Stock PG, et al. Aplastic anemia complicating orthotopic liver transplantation for non-A, non-B hepatitis. N Engl J Med. 1988 Aug 18;319(7):393-6. doi: 10.1056/NEJM198808183190702.
citation: Brown KE, Tisdale J, Barrett AJ, Dunbar CE, Young NS. Hepatitis-associated aplastic anemia. N Engl J Med. 1997 Apr 10;336(15):1059-64. doi: 10.1056/NEJM199704103361504.
Clinical trial NCT01490736: Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
Official title: Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne
Keywords: Acne
Sebum gland disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.

Detailed description: This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.

Eligibility criteria: Inclusion Criteria:

* Stage 1 only: healthy subjects
* Stage 1-4: male or female subjects age 18 years or older
* Stage 2: subjects with sebum excretion rate of 4 or higher on forehead
* Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead
* Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead

Exclusion Criteria:

* Poor skin condition on back (Stage 1) or face (Stage 2 \& 3)
* Severe facial acne, acne fluminans/conglobata, or nodulocystic acne
* Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0
* Stage 2-4: previous treatment of isotretinoin or other oral retinoids

Primary outcomes:
measure: Change in sebum excretion rate
timeFrame: Baseline to Day 14
Secondary outcomes:
measure: Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)
timeFrame: Baseline to Day 14
measure: Change in acne lesion count
timeFrame: Baseline to Day 14
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research, Inc
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: