louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02937376: Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Official title: Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: G6PD Deficiency
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of N-acetyl Cystein (NAC) supplementation on redox status, physiological and biochemical parameters in G6PD deficient individuals after acute exercise.

Detailed description: In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of both sexes will be supplemented with either 10 mg/kg of NAC (experimental condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2max test will be performed.

Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion) before and after each condition. Blood samples will be collected before, immediately after and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and physiological parameters will be performed before and after each condition. There will be a washout period of at 4 weeks between conditions.

Eligibility criteria: Inclusion Criteria:

* G6PD deficiency

Exclusion Criteria:

* Any uncontrolled health condition for which exercise is contraindicated
* Current use of dietary supplements or drugs
* Pregnant, pregnancy intention or breast feeding

Primary outcomes:
measure: Change in redox status after exercise
timeFrame: Before, immediately after and 1 hour after each trial of exercise
Secondary outcomes:
measure: Body composition
timeFrame: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
measure: Blood pressure
timeFrame: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Department of Physical Education & Sport Science of the University of Thessaly
state: Karyes
Study officials:
affiliation: University of Thessaly
name: Athanasios Z Jamurtas, PhD
role: STUDY_DIRECTOR
References:
citation: Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. Alpha-lipoic acid supplementation up-regulates antioxidant capacity in adults with G6PD deficiency. Food Chem Toxicol. 2013 Nov;61:69-73. doi: 10.1016/j.fct.2013.01.055. Epub 2013 Feb 14.
Clinical trial NCT03878576: The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
Official title: The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Keywords: Glycemic Index
glycemic response
bread
barley
beta-glucans
glucose level
continous glucose monitoring
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: Community Health Centre Ljubljana
name: Slovenian Research Agency
name: Valens Int. d.o.o., Slovenija
First posted: 2019-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of content of barley beta-glucans in bread on postprandial blood sugar will be measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult subjects who will test three barley beta-glucan containing bread formulations (food) in comparison with a reference white bread. Objective of the study is to investigate the influence of the content of barley beta-glucan in bread on glycaemic index (incremental area under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing breads in comparison to reference white bread.


Eligibility criteria: Inclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged above 18 years at the time of the signature of ICF
* No known food allergy or intolerance
* No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
* Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
* Body mass index (BMI) \> 25

Exclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged above 18 years at the time of the signature of ICF
* No known food allergy or intolerance
* No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
* Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
* Body mass index (BMI) \> 25

Primary outcomes:
measure: Change in glycaemic response (capillary blood glucose)
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
measure: Glucose level as measured with continuous glucose monitor (CGM)
timeFrame: up to 3 hours
Locations:
city: Ljubljana
country: Slovenia
facility: Nutrition Institite
Study officials:
affiliation: Institut za nutricionistiko
name: Igor Pravst, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06967376: The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis
Official title: The Role of Adjuvant Cross Linking in the Management of Infective Keratitis - an OCT Based Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infective Keratitis
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Methods

Study Design:

A prospective, single centre, randomised controlled study of forty eyes of forty patients was conducted. The study was approved by local institutional review board (Approval number 109) and adhered to the Declaration of Helsinki. All patients provided informed consent before enrolling and participating in the study.

Selection:

All patients presenting with infective keratitis were explained about the study and informed consent was sought (CONSORT Diagram). Fifty-three patients were screened against the exclusion criteria and 13 were excluded. The remaining total of 40 patients were allocated equally to two groups (A and B) by process of simple randomisation. Group A patients were to be offered standard targeted anti-microbial therapy whilst group B were offered CXL in addition to the standard targeted anti-microbial therapy.
Primary purpose: TREATMENT

Brief summary: This was a prospective, single centre, randomised controlled study to evaluate the clinical effectiveness of corneal collagen crosslinking as an adjuvant to antimicrobial therapy.

Detailed description: This randomised controlled study of forty eyes of forty patients was conducted to assess the impact of corneal collagen crosslinking in addition to antimicrobial therapy.

All forty patients presenting with infective keratitis of various aetiologies (bacterial, fungal, acanthamoeba) were screened and then randomly allocated equally to two groups (A and B). Group A patients were to be offered standard targeted anti-microbial therapy whilst group B were offered CXL in addition to the standard targeted anti-microbial therapy.

Patients were evaluated clinically for visual acuity; infection parameters and dimensions were measured on slit lamp and optical coherence tomography. Evaluations were noted at the baseline visit and subsequently on days 7, 14, and day 30 of treatment

Eligibility criteria: Inclusion Criteria:

• Patients presenting with infectious keratitis

Exclusion Criteria:

* Infective keratitis \< 1mm from limbus
* Corneal thickness \< 350μm
* Previous herpetic eye disease
* Expectant and nursing women

Primary outcomes:
measure: clinical response
timeFrame: At presentation; and then on day 7, day 14 and day 30 of commencing treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmology
Study officials:
References:
Clinical trial NCT06455176: Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial
Official title: Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Facial Bone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest


Eligibility criteria: Inclusion Criteria:

* cleft alveolus patients of both genders after eruption of all permanent dentition

Exclusion Criteria:

* previous failed repairs of alveolar clefts and bone metabolic diseases

Primary outcomes:
measure: bone volume in the reconstructed cleft site
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05812976: Novel Index (PIMR) in PAH
Official title: Impact of the Pulmonary Index of Microcirculatory Resistance in Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Pulmonary Index of Microcirculatory Resistance
Pulmonary Arterial Hypertension
Index of Microcirculatory Resistance
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2023-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult PAH patients

Brief summary: The chief regulator of resistance in pulmonary arterial hypertension (PAH) is the small arteries. In the heart, the invasive measurement of the resistance of the small arteries has been shownto be safe, easy, reliable, and prognostic. This study is intended to translate prior work in heart arteries to the PAH space and invasively measure the resistance of the small arteries of the lung (pulmonary index of microcirculatory resistance \[PIMR\]) and the coronary artery supplying the right ventricle (acute marginal of the RCA; RV-IMR). Importantly, these measurements will be made during standard of care cardiac catheterizations (right heart catheterization \[RHC\] +/- left heart catheterization). The correlation between these new indices and the standard ones measured during RHC typically used to determine the severity of pulmonary hypertension will be analyzed. In addition, among newly diagnosed patients, the study will evaluate how these indices change 6 months after starting treatment. Finally, the association of these indices with clinical outcomes at 1 year will be assessed. The findings from this study may deliver an immediate impact to patient care by identifying a new metric to help better identify those who may benefit from a more intensive, personalized treatment regimen.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Group 1 PAH with invasive pulmonary hypertension defined as: Mean pulmonary arterial pressure ≥ 20 mmHg, pulmonary capillary wedge pressure \< 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units.
* Serum creatinine \< 2.0 mg/dL
* Able to provide informed written consent

Exclusion Criteria:

* Other groups/forms of pulmonary hypertension (i.e. groups 2-5)
* Contraindicated to undergo fluoroscopy and/or coronary angiography
* Pregnancy

Primary outcomes:
measure: PAH hospitalization or all-cause mortality at 1 year
timeFrame: 1 year
measure: PIMR change from baseline
timeFrame: Baseline, 6 months only if repeat RHC as standard of care
measure: RV-IMR
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rushi Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658876: Predictors of Response to Iron and Erythropoietin Stimulating Agents
Official title: Predictors of Response to Iron and Erythropoietin Stimulating Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure Chronic
Anemia
Keywords: Hemodialysis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.


Eligibility criteria: Inclusion Criteria:

* All prevalent haemodialysis patients, established for greater than 3 months

Exclusion Criteria:

Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin

Primary outcomes:
measure: Hemoglobin Incrementation
timeFrame: Within 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Damien Ashby, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419076: A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
Official title: A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lung Cancer Metastatic
Brain Metastases
Brain Metastases, Adult
Small-cell Lung Cancer
Small Cell Lung Carcinoma
Keywords: Stereotactic Radiosurgery
small cell lung cancer
small cell lung carcinoma
lung cancer
lung cancer metastatic
brain metastases
22-133
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of small cell lung cancer
* Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced MRI
* Age 18 and above
* Performance status KPS 60-100/ECOG 0-2
* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment
* The patient or legally authorized representative is able to provide informed consent

Exclusion Criteria:

* Unable to undergo contrast-enhanced MRI brain or spine
* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine
* Pregnant or lactating women
* Prior brain-directed radiotherapy
* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET/CT imaging, no more than 3 months before study enrollment

Primary outcomes:
measure: Overall survival
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare (Data Collection Only)
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Luke Pike, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05641376: Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
Official title: Nebulized Versus Intravenous Dexmedetomidine for Managing Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergence Agitation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.

Exclusion Criteria:

* Patient's guardian refusal to participate in the study.
* Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
* Children on sedative or anticonvulsant medication.
* history of sleep apnea
* significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
* Known allergy to the study drugs.

Primary outcomes:
measure: postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
timeFrame: 60 minutes
Secondary outcomes:
measure: Postoperative pain
timeFrame: 60 minutes
measure: emergence agitation (EA) onset
timeFrame: 60 minutes
measure: Emergence Agitation duration
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT02326376: Kineret CAPS Post Authorisation Study
Official title: Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryopyrin-Associated Periodic Syndromes
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Pediatric Rheumatology International Trials Organization
First posted: 2014-12-29
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All CAPS patients treated with Kineret at the selected sites.

Brief summary: A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.


Eligibility criteria: Inclusion Criteria:

* Informed consent by the patient and/or caregiver
* Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of serious infections
timeFrame: 3 years
measure: Rate of new malignancies
timeFrame: 3 years
measure: Rate of injection site reactions
timeFrame: 3 years
measure: Rate of allergic reactions
timeFrame: 3 years
measure: Rate of medication errors including re-use of syringe
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Swedish Orphan Biovitrum Investigational Site
city: London
country: United Kingdom
facility: Swedish Orphan Biovitrum Investigational Site
Study officials:
affiliation: IRCCS Istituto Giannina Gaslini
name: Marco Gattorno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Orphan Biovitrum AB (publ)
name: Torbjörn Kullenberg, MD
role: STUDY_DIRECTOR
References: