louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01680055: Collection of Blood and Bone Marrow From Patients With Aplastic Anemia for Analysis of Adhesion Molecules, Chemokines and Their Receptors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aplastic Anemia
Healthy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients With Aplastic Anemia

Brief summary: This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine


Eligibility criteria: Inclusion Criteria:

* patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70 years

Exclusion Criteria:

* Patients complicated with diabetes, tumor, pregnancy, active infection, or connective tissue diseases, such as systemic lupus erythematosus.

Primary outcomes:
measure: hematologic response
timeFrame: 6 months following antithymocyte globulin plus cyclosporine treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06557655: Caffeinate Chewing Gum on Ice Hockey Performance
Official title: The Effect of Caffeinate Chewing Gum on Ice Hockey Performance After Partial Sleep Deprivation: a Double-blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Placebo
Keywords: exercise performance
fatigue index
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine the impact of caffeinated chewing gum on the physical performance of elite ice hockey players in a partial sleep deprivation state.

Detailed description: This study used a randomisation crossover design with a single-blind, double-blind experimental design. The participants were randomly assigned to either a caffeinated chewing gum trial (CAF) or a placebo trial (PL).

Eligibility criteria: Inclusion Criteria:

* 1. 6 years of professional ice hockey training,
* 2. 6 months of continuous training,
* 3. 3 months of recovery from sports injuries such as strains and sprains

Exclusion Criteria:

* 1. non-specialised ice hockey player.
* 2. has not trained regularly for the past 6 months.
* 3. has recovered from an athletic injury.
* 4. have been recovering from a sports injury for less than 3 months, or have epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.

Primary outcomes:
measure: counter-movement jump
timeFrame: 15 minutes after intervention
Secondary outcomes:
measure: 35-metre sprint
timeFrame: 15 minutes after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
affiliation: National Taiwan University of Sport
name: ChihHui Chiu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00803855: Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: single dose
pharmacokinetics
safety
healthy volunteers
food interaction
AZD1446
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.


Eligibility criteria: Inclusion Criteria:

* physical healthy volunteers
* weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder.
* History of severe allergy/hypersensitivity reactions

Primary outcomes:
measure: Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
timeFrame: From first to last visit
Secondary outcomes:
measure: Determine the single ascending dose pharmacokinetics of AZD1446
timeFrame: PK sampling taken at defined timepoints during residential period
measure: Determine the single dose of AZD1446 on food interaction
timeFrame: From first to last visit
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Research site
Study officials:
affiliation: AstraZeneca Södertälje
name: Didier Meulien, MD, PhD, MSD
role: STUDY_DIRECTOR
affiliation: AstraZeneca CPU Huddinge
name: Ingemar Bylesjö, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03201055: Snore Positive Airway Pressure Trial
Official title: Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Apnoeic Snorers
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Eden Sleep
First posted: 2017-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will aim to assess the acceptance of the Snore PAP system as a treatment concept for snore. The study will subjectively assess participant and bed partner acceptability and usability of the Snore PAP system and objectively assess participant compliance with the Snore PAP system.


Eligibility criteria: Inclusion Criteria

* Participants willing to provide written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are ≥ 18 years of age
* Participants are CPAP naïve
* Participants who are self/ partner reported snorers
* Participants whose ApneaLink study results demonstrate snore
* Participants who are willing to use Nice system in place of current non prescribed methods for alleviating snore
* Participants have a bed partner
* Participant's bed partner willing to answer assessment questionnaire

Exclusion Criteria

* Participants previously diagnosed with obstructive or central sleep apnoea
* Participants whose ApneaLink home study indicates AHI ≥6
* Participants who are pregnant or breastfeeding
* Participants who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
* Participants with severe bullous lung disease, history of pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery or trauma.
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants currently using a prescribed medication/ device to alleviate snore
* Participants who are physically unable to comply with the protocol- no access to internet to conduct online visits with researcher or unable to attend clinic for visit

Primary outcomes:
measure: Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system
timeFrame: 28 Nights
Secondary outcomes:
measure: Subjectively assess the performance of the Snore PAP system in relieving: self-reported and bed partner reported snore in non-apnoeic participants.
timeFrame: 28 Nights
measure: Objectively assess participant compliance with the Snore PAP system
timeFrame: 28 Nights
Other outcomes:
Locations:
city: New Plymouth
country: New Zealand
facility: EdenSleep
Study officials:
References:
Clinical trial NCT00571155: Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery
Official title: Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Brain Tumor
Epilepsy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* suspected primary brain tumor by imaging
* planned bioptical or cytoreductive surgery of the tumor
* symptomatic epilepsy
* Karnofsky performance score ≥ 70%
* women with child bearing potential must perform sufficient contraception
* sufficient haematologic, hepatic and renal function by laboratory testing

Exclusion Criteria:

* treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
* known allergic reaction to levetiracetam or other serious side effects
* known, not tumor-induced, epilepsy
* previous brain surgery
* dementia
* participation in another clinical trial
* addiction to drugs or alcohol
* pregnant or breast feeding women

Primary outcomes:
measure: Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
timeFrame: 1 year
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of General Neurology
state: Baden-Wuerttemberg
Study officials:
affiliation: University-Hospital of Tuebingen, Department of General Neurology
name: Michael Weller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bahr O, Hermisson M, Rona S, Rieger J, Nussbaum S, Kortvelyessy P, Franz K, Tatagiba M, Seifert V, Weller M, Steinbach JP. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial. Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10.
Clinical trial NCT04070755: Dermal Photo Allergic Skin Reaction
Official title: A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 56
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: A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design


Eligibility criteria: Inclusion Criteria:

* Healthy male or female who were 18 years of age or older
* Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

* Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
* Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfigurations of the test site

Primary outcomes:
measure: Assessment of photoallergic skin reactions (numerical equivalent scoring of erythema and edema) after periodic exposure to IP on irradiated and non-irradiated skin
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02851355: Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 2
Sex: ALL
Minimum age (years): 5
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those children and adolescents who were younger than 18 years of age and who recived treatement for medulloblastoma or CNS-PNET in southern part of Norway between 1974 and 2013.

Brief summary: Clinical follow-up survey of the Norwegian material of paediatric patients who received therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life, education, work, family and children, delayed effects of tumour disease and treatment, endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.


Eligibility criteria: Inclusion Criteria:

* Whose who has been treated for medulloblastoma og CNS-PNET between 1974 and 2013

Exclusion Criteria:

* Other brain tumours

Primary outcomes:
measure: SF 36 for those older than 18 years
timeFrame: 1 year
measure: PedsQL for those younger than 18 years
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Einar Stensvold
Study officials:
References:
Clinical trial NCT02708355: Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Official title: A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 55
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
* Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
* When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.

Exclusion Criteria:

* A history (past or present) of erosive esophagitis verified by endoscopy.
* The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
* Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).

Primary outcomes:
measure: Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
timeFrame: Day 8 up to Day 14
measure: Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
timeFrame: Baseline, Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: St. Anthony Hospital - Conference Rooms
state: Oklahoma
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Miner PB, Johnson DA, Katz PO, Li J, Gatoulis SC, Pollack C. Pilot, Randomized, Blinded, Placebo-Controlled Trial Investigating the Correlation Between Acid Control and Heartburn Relief with 14 Days of Esomeprazole Treatment. Adv Ther. 2018 Nov;35(11):2024-2040. doi: 10.1007/s12325-018-0792-z. Epub 2018 Sep 25.
Clinical trial NCT07006155: Biograph Vision 600 Versus Biograph Vision.X PET/CT
Official title: Intra-individual Comparison of PET Scans on the Biograph Vision 600 With the New Biograph Vision.X PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Alzheimer Disease
Keywords: PET/CT
Vision
image quality
diagnostic performance
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose is to evaluate initial clinical experiences and to explore whether the Vision.X system yields improved image quality and diagnostic performance compared to Vision 600.


Eligibility criteria: Inclusion Criteria:

* Written Inform Consent to participating.
* 18 to 85 years of age
* Willing and able to comply with the requirements of the study, as judged by the investigator

Exclusion Criteria:

* Women in pregnancy
* Patients unable to lie still for the duration of the examination

Primary outcomes:
measure: change of physician's diagnostic confidence
timeFrame: through study completion , an average of 1 year
Secondary outcomes:
measure: lowering of the radiotracer activity
timeFrame: through study completion , an average of 1 year
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Hopitaux Universitaires de Genève
Study officials:
References:
Clinical trial NCT06181955: Extracorporeal Shock Wave Therapy in Osteoarthritis
Official title: Effectiveness of Extracorporeal Shock Wave Therapy on Improving Functional Ability in Knee Osteoarthritis (Grade iv)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Physical therapy
Lower Extremity Functional Scale score
Ultrasound therapy
Exercises
Quadriceps
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group experimental-control design
Primary purpose: TREATMENT

Brief summary: The present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade IV knee osteoarthritis. Intervention program was performed for four weeks. Conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (SLR) and isometric hip adductor strengthening exercises. Functional ability was assessed using the Lower Extremity Functional Scale (LEFS) score.


Eligibility criteria: Inclusion Criteria:

* Grade IV primary knee Osteoarthritis (OA) diagnosed by an orthopaedic surgeon based on the Kellgren-Lawrence score

Exclusion Criteria:

* Secondary knee OA,
* rheumatoid arthritis,
* psoriatic arthritis,
* the presence of any red flags (metastatic growth, thrombophlebitis),
* neurologic or psychiatric impairments,
* tissue injuries of the knee joint,
* previous knee joint replacement or other surgeries in the knee joint,
* already received ESWT,
* Intra articular injection
* unable to walk independently

Primary outcomes:
measure: Lower Extremity Functional Scale (LEFS) score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944255: Pharmacogenetics of Antifolate Drugs in Autoimmune Diseases in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: National Chung Hsing University
Sponsor class: OTHER
First posted: 2009-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A cross-sectional study involving 150 patients with RA were enrolled from TCVGH.

Brief summary: BACKGROUND. Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.

OBJECTIVE. The goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying anti-rheumatic drug in Taiwan.

DESIGN. A cross-sectional study involving patients with RA were enrolled from TCVGH. Disease activity, drug efficacy and associated side-effects were assessed.

Genotypes in folylpoly-gamma-glutamate synthetase and reduced folate carrier were determined by RFLP or pyrosequencing.


Eligibility criteria: Inclusion Criteria:

* Male/female age \>18
* RA diagnosed

Exclusion Criteria:

* Must not be pregnant/breastfeeding
* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: