louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02078856: Double-blind, Randomised Study of A3384 in BAM/BAD
Official title: A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bile Acid Malabsorption
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).


Eligibility criteria: Inclusion Criteria:

* Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable

Exclusion Criteria:

* Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
* Patient needs medications prohibited as specified in the protocol

Primary outcomes:
measure: The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).
timeFrame: 2 weeks
Secondary outcomes:
measure: Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Academy
city: Skövde
country: Sweden
facility: Kärnsjukhuset
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02466256: Intra and Postoperative Outcomes With 3 Injectors
Official title: Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular lens implantation
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors :

Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.

Detailed description: In this randomized, clinical trial, three types of injectors were compared :

1. Manual, screw type injector (Monarch III)
2. Manual, plunger type injector (Royale, ASICO)
3. Motorized injector (Autosert, Alcon)

Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion.

The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied.

further, the surgeon was asked to subjectively grade the ease of implantation with each injector

Eligibility criteria: Inclusion Criteria:

* Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
* Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)

Exclusion Criteria:

* Glaucoma,
* uveitis,
* shallow anterior chamber (depth \<2.1mm),
* prior ocular trauma or surgery,
* maximal pupillary dilatation \<6mm,
* high myopia (axial length \>25mm),
* posterior polar cataracts,
* dense cataracts, and
* an IOL power \<19.0 D or \>25.0 D

Primary outcomes:
measure: Incision enlargement in mm
timeFrame: 1 minute after surgery
Secondary outcomes:
measure: Trypan Blue ingress into the anterior chamber in log units
timeFrame: 1 minute after surgery
measure: Incision morphology - qualitative
timeFrame: 1 day, 1 week and 1 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: iladevi cataract & iol research centre
name: abhay r vasavada, ms, frcs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894356: The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation
Official title: The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 4250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients presenting for infertility evaluation from all ages, ethnicities, and medical histories.

Brief summary: Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects.

Recent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.


Eligibility criteria: Inclusion Criteria:

* Male of at least 18 years of age

Primary outcomes:
measure: Investigate the impact of advanced paternal age on sperm DNA fragmentation
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05223556: Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
Official title: Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 167
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from Shaoguan diabetic cohort

Brief summary: This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional CRP imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist.

Within one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.


Eligibility criteria: Inclusion Criteria:

1. who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up
2. who are diagnosed with diabetes and aged between 30 years and 80 years
3. be able to sit for an imaging device for image acquisition
4. be capable of giving their own consent

Exclusion Criteria:

1. who are pregnant or nursing women

Primary outcomes:
measure: Accuracy in the diagnosis of referral retinal lesions
timeFrame: 1 week
Secondary outcomes:
measure: The agreement between the two modalities
timeFrame: 1 week
measure: Feasibility of self-testing diagnosis imaging model
timeFrame: 1 week
measure: Feasibility of self-testing diagnosis imaging model
timeFrame: 1 week
measure: Satisfaction of participants as measured by questionnaire
timeFrame: 1 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04892056: Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics
Official title: Evaluation of the Rate of Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bimaxillary Protrusion
Keywords: T loops
Friction
Frictionless
power chains
digital models
anterior segment retraction
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.

Detailed description: Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.

Eligibility criteria: Inclusion Criteria:

* Female Subjects.
* Age 13-25 y of age.
* Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
* Fully erupted permanent dentition without crowding.
* Good oral and general health.

Exclusion Criteria:

* Systemic Diseases or syndromes or on anti-inflammatory medication.
* Extracted or missing permanent teeth.
* History of previous Orthodontic Treatment.
* Parafunctional Habits.
* Badly decayed teeth.

Primary outcomes:
measure: Rate of Anterior Segment Retraction
timeFrame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Secondary outcomes:
measure: Anchorage Loss
timeFrame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
measure: Pain experienced after each activation of the two mechanics
timeFrame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future Univeristy in Egypt
Study officials:
affiliation: Future Univeristy in Egypt
name: Yehia Mostafa, Chairman
role: STUDY_CHAIR
References:
Clinical trial NCT03780556: Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Official title: Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Colic
Keywords: Renal pain
lornoxicam
pethidine
emergency room
ketamine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and Group P administered pethidine and VAS was recorded for both groups.

Detailed description: Prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. They were randomly assigned to one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.

Eligibility criteria: Inclusion Criteria:

* Patients, who did not administer any analgesics at least within the last two hours. - -
* Patients aged between 20-60 years.

Exclusion Criteria:

* Patients with previous renal surgery
* liver and renal failure
* hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,
* gastrointestinal bleeding and perforation,
* hypertensive and history of cardiac diseases
* pregnancy and lactation and
* urine examination showing more than 5 leukocytes suggestive of pyuria.
* patients with hyperthyroidism are excluded

Primary outcomes:
measure: Change in pain feeling
timeFrame: 0hours, 1hour,2hours,3hours,4hours after drug administration in both groups
measure: No need for more analgesics
timeFrame: Registration of analgesic needed for 12h after the attack
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: ِAin Shams University hospitals
Study officials:
References:
Clinical trial NCT02019056: Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled,Phase 2 Study to Evaluate the Efficacy, Safety of MG in Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholic Fatty Liver Disease
Alcoholic Hepatitis
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.


Eligibility criteria: Inclusion Criteria:

* •Patients over 18, under 70 years of age

  * The chronic alcohol intake patients

    * Current the heavy drinker over 3month, Day the average alcohol consumption Male\>=60g, Female\>=40mg y-GTP increase Male\>=75, Female\>=35
  * Over 1.5 ratio of AST to ALT
  * Patients who have chronoc alcohol disease

Exclusion Criteria:

* Patients who have liver disease with the cause different with the alcohol except
* Patients who have pyridoxine allergy or history
* Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
* Patients taking other investigational product within 90 days prior to the participation in the study.
* Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(\>=2.5g/day)
* Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
* Patient who considered ineligible for participation in the study as Investigator's judgment

Primary outcomes:
measure: Change from Baseline in AST at 14weeks
timeFrame: 14Weeks
measure: Number of Participants with Adverse Events (Safety)
timeFrame: 14weeks
measure: To evaluate ALT normalization
timeFrame: 14weeks
measure: To evaluate AST normalization
timeFrame: 14weeks
measure: change in AST, ALT, total lab billirubin lab value
timeFrame: 14weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guri city
country: Korea, Republic of
facility: Hanyang university Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04888156: Impact of Self-tonometry on Glaucoma Treatment Decision.
Official title: Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Glaucoma, Open-Angle
OHT - Ocular Hypertension
Glaucoma Capsulare
Keywords: glaucoma
self-tonometry
treatment
IOP peaks
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All glaucoma patients who obtained an IOP curve using an iCare Home® self-tonometer between January 2018 and December 2020 and who fulfill all the inclusion criteria and none of the exclusion criteria.

Brief summary: Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.

Detailed description: Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.

As the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)
* Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline
* Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline
* Monitoring over at least two days

Exclusion Criteria:

* More than one measurement with iCare Home® tonometer below 5 mmHg
* Missing more than one daily measurement with iCare Home® tonometer

Primary outcomes:
measure: Clinician's choice of glaucoma treatment
timeFrame: One month
Secondary outcomes:
measure: Occurence of IOP peaks
timeFrame: Three days of self-tonometry
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Erik Eye Hospital
Study officials:
affiliation: St. Erik Eye Hospital
name: Enping Chen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726556: A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Official title: A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleurisy With Effusion
Keywords: Pleural effusion
Semirigid thoracoscopy
Rigid thoracoscopy
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2012-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.


Eligibility criteria: Inclusion Criteria:

* Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination

Exclusion Criteria:

* Significant hypoxemia on room air
* Hemodynamic instability
* Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
* Refractory cough
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy

Primary outcomes:
measure: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
timeFrame: 3 months
Secondary outcomes:
measure: Yield of biopsies successfully completed
timeFrame: 3 months
measure: Complications
timeFrame: 3 months
measure: Scar size
timeFrame: At the end of the procedure
measure: Biopsy size
timeFrame: At the end of the procedure
Other outcomes:
measure: Use of sedation and analgesia during the procedure
timeFrame: At the end of procedure
measure: Operators' experience characteristics
timeFrame: At the end of the procedure
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: PGIMER, Chandigarh
name: Ritesh Agarwal, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8.