louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01552564: The Microcirculation in Acute Myocardial Infarction (Micro-AMI)
Official title: The Microcirculation in Acute Myocardial Infarction (Micro-AMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI attending Bristol Heart Institute via the primary PCI service

Brief summary: This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Cardiac symptoms of \> 20 mins chest pain or equivalent.
* ECG criteria consistent with STEMI (STEMI)
* Proceeding with percutaneous angioplasty
* Assent/ consent to the study

Exclusion Criteria:

* Known allergy to adenosine or gadolinium
* Chronic atrial fibrillation
* Renal impairment with eGFR \<30
* Contraindication to angiography
* Contraindication to CMR (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
* Cardiogenic shock
* Patients with special communication needs or altered consciousness.
* Patients who do not give assent/consent to the study

Primary outcomes:
measure: Microvascular obstruction
timeFrame: DAy 2-4
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
Study officials:
References:
citation: McAlindon E, Pufulete M, Harris J, Lawton C, Johnson T, Strange J, Baumbach A, Bucciarelli-Ducci C. Microvascular dysfunction determines infarct characteristics in patients with reperfused ST-segment elevation myocardial infarction: The MICROcirculation in Acute Myocardial Infarction (MICRO-AMI) study. PLoS One. 2018 Nov 13;13(11):e0203750. doi: 10.1371/journal.pone.0203750. eCollection 2018.
Clinical trial NCT05499364: TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth
Official title: TinCat Tobacco Cessation Protocol for LGBTQ+ Austinites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use Disorder
Tobacco Use Cessation
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the control or intervention groups randomly.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among LGBTQ+ people.

Detailed description: After being informed about potential risks and screened into the study, patients will be randomized into the treatment or control group. Control group participants will complete 7 sessions based on quit.gov smoking cessation planning. Intervention participants will complete 7 sessions of individualized asynchronous telehealth sessions.

Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Live in Greater Austin
* Identify as LGBTQ+
* Current smokers
* High speed internet access

Exclusion Criteria:

* Exceed screener cutoff for suicide risk
* Exceed screener cutoff for borderline personality disorder
* Report current active substance use other than tobacco that interferes with functioning

Primary outcomes:
measure: Tobacco use
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Teah GE, Conner TS. Psychological and Demographic Predictors of Vaping and Vaping Susceptibility in Young Adults. Front Psychol. 2021 Aug 17;12:659206. doi: 10.3389/fpsyg.2021.659206. eCollection 2021.
Clinical trial NCT00379964: A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED)
Official title: A Noncomparative, Multicenter, Open-Label, Study to Evaluate the Safety, Tolerability and Efficacy of MK0991 as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 50
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 evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.


Eligibility criteria: Inclusion Criteria:

* Patient has a low white cell count (less than 500/mm3) for at least 96 hours
* Patient is indian and is greater than 18 years of age
* Patient received chemotherapy for blood disorders and blood cancers

Exclusion Criteria:

* Patient has an invasive fungal infection
* Patient has a bacterial infection that is not controlled
* Patient has allergy to the class of antifungals of study drug
* Patient is not expected to survive at least 5 days
* Patient is pregnant or breast-feeding

Primary outcomes:
measure: Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
timeFrame: during the study drug therapy period plus 14 days posttherapy
Secondary outcomes:
measure: Survival for at least 7 days following study therapy reduce fever during period of low white blood cell counts fungal infection no longer present following study therapy
timeFrame: 7 days following study therapy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03568864: High Nucleotide Meal Consumption in Uric Acid and Metabolic Health
Official title: The Acute Effect of a High Nucleotide Mycoprotein Meal in Uric Acid Concentrations and Other Markers of Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health.

Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers.

The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30

Primary outcomes:
measure: Changes in serum uric acid concentrations over a 24 h period
timeFrame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal
Secondary outcomes:
measure: Blood glucose
timeFrame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 24 hours after meal
measure: Serum insulin
timeFrame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
measure: Branched chained amino-acids
timeFrame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: St Luke's Campus - University of Exeter
state: Devon
Study officials:
References:
Clinical trial NCT05990764: Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Official title: Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: IBS
Gastrointestinal diseases
Probiotic
Prebiotic
Plant extract
Polyphenol-rich Extracts
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.

Detailed description: The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed Irritable Bowel Syndrome.
* Women and men, 18-55 years old.
* Signed informed consent.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics.
* Participation in another clinical trial.
* Inability to swallow an oral study drug/placebo.
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding,

Primary outcomes:
measure: IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index
timeFrame: Baseline, 2 months
measure: Stool consistency
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Zonulin
timeFrame: Baseline, 2 months
measure: Short-chain fatty acids
timeFrame: Baseline, 2 months
measure: IL-6
timeFrame: Baseline, 2 months
measure: IL-8
timeFrame: Baseline, 2 months
measure: I-FABP
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Study officials:
References:
Clinical trial NCT06050564: Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score
Official title: Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clubfoot
Keywords: PBS-score
PEVA
Treatment clubfoot
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 children with idiopathic clubfoot will be included from four different countries

Brief summary: Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

Detailed description: In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.

Exclusion Criteria:

* syndromic clubfoot

Primary outcomes:
measure: Treatment recommendations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children´s Hospital
state: Region Stockholm
Study officials:
affiliation: Astrid Lindgren Children´s Hospital
name: Eva W Broström, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00181064: Atkins Diet for Difficult-to-Control Headaches in Teenagers
Official title: Use of the Atkins Diet for Adolescents With Chronic Daily Headache.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Daily Headache
Keywords: headache
Atkins
ketosis
intractable
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache improvement.

Detailed description: Patients are placed on the diet and followed with various measures for 3 months. If the diet is helpful it is continued. Patients are still being enrolled as of 9/6/06.

Eligibility criteria: Inclusion Criteria:

* Ages 12-19
* Minimum 15 headaches/month for at least 3 months
* Tried 2 preventative medications previously

Exclusion Criteria:

* Prior use of the Atkins diet for more than 1 week
* Pregnancy
* Significant heart or kidney disease
* Dangerously underweight
* Using acute pain medications more than 11 days in the past month
* Medications being changed

Primary outcomes:
measure: Headaches
timeFrame: 3 months
Secondary outcomes:
measure: Ketosis
timeFrame: 3 months
measure: Diet duration
timeFrame: as long as tolerated
measure: Quality of life (PedsMIDAS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric H Kossoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. doi: 10.1111/j.1526-4610.2006.00321_5.x. No abstract available.
Clinical trial NCT05094921: Halliwick Concept on Motor Functions in Spastic CP
Official title: Effect of Hydrotherapy (Halliwick Concept)on Motor Function in Spastic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Spastic Hemiplegic Cerebral Palsy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will investigate the effect of hydrotherapy (halliwick concept) on motor functions in children with spastic cerebral palsy (CP). Minimum of 30 Spastic CP children will be recruited for this study. Children will be randomly assigned into control group who will receive conventional selected exercise treatment or study group who will receive the same conventional program in addition to underwater exercise program. Motor function will be evaluated at baseline and after 3 months of treatment. No potential harms are expected during this study.


Eligibility criteria: Inclusion Criteria:

* Children from both sexes diagnosed with spastic CP according to a pediatrician
* The degree of spasticity will be determined as grade two or less according to modified Ashworth scale
* Their age will range from five to nine years
* Intelligence quotient score \> 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales
* No severe psychosocial or behavioral problems, such high aggression or risk of self-harm.

Exclusion Criteria:

* Initiation of oral antispastic medication
* botulinum toxin injections or surgery performed less than 90 days before enrollment
* severe visual or auditory impairment
* uncontrollable epilepsy (defined as the occurrence of seizures despite the use of at least one antiepileptic drug)
* open wounds
* children with a psychiatric disorder
* cognitive disorders evaluated by the pediatric evaluation of disability inventory
* uncontrolled epilepsy
* active infection
* severe cardiopulmonary disorders.

Primary outcomes:
measure: Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]
timeFrame: Baseline and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
References:
Clinical trial NCT04738721: Physical Activity and Physical Fitness Parameters in COVID-19 Lockdown
Official title: Comparison of Physical Activity and Physical Fitness Parameters Pre and Post COVID-19 Lockdown in Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment, Self
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Students of university

Brief summary: In this study; it was aimed to compare the physical activity levels of students who continued their university education face-to-face before the COVID-19 lockdown, and the values of physical activity levels related to health, physical activity levels and health-related physical fitness parameters in the post-lockdown period.

Detailed description: Within the scope of the course, the demographic information of the students will be recorded and physical activity status, physical fitness parameters, muscle endurance, cardiovascular endurance, flexibility and body composition will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Before the quarantine period, those who completed the physical activity level and physical fitness tests within the scope of Physical Activity I course
* Students who do not have any physical or mental problems for the tests and measurements to be applied

Exclusion Criteria:

* No internet access,
* Students who have an obstacle to taking tests and measurements

Primary outcomes:
measure: Physical activity
timeFrame: 2 days
Secondary outcomes:
measure: Physical fitness
timeFrame: 2 days
measure: Flexibility
timeFrame: 2 days
measure: Body composition
timeFrame: 2 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Pınar Kaya Ciddi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05877521: Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief
Official title: Adapting Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief: The MORE Relief Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Cancer Pain
Keywords: chronic pain
cancer pain
Mindfulness-oriented Recovery Enhancement
MORE
mindfulness-based interventions
MBIs
Memorial Sloan Kettering Cancer Center
23-082
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether or not mindfulness-based interventions/MBIs may help reduce chronic pain in participants who have cancer-related chronic pain. MBIs are therapeutic programs that use mindfulness meditation practices to help people focus on the present moment, as well as encourage acceptance of thoughts, emotions, and body sensations. The researchers think that an MBI treatment called Mindfulness-oriented Recovery Enhancement (MORE) may help people who are experiencing cancer-related chronic pain.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Age ≥ 18 years or older
* A history of cancer with no restrictions placed on type of cancer
* Determined to be either no-evidence of disease or stable oncological disease by referring or study physicians/advanced practice providers
* Having a pain (musculoskeletal, generalized, or neuropathic) rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week
* Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days
* Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC
* Ability to attend video-call session and a quiet/private location

Exclusion Criteria:

* Active suicidality or schizophrenia
* Plan to initiate palliative radiation or interventional pain procedure within the next 12 weeks
* Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians

Primary outcomes:
measure: Rate of participant enrollment to the study
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: