louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06311552: Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.
Official title: Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Either a clinical diagnosis of HFpEF, be at risk of or pre-HFpEF

Brief summary: The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.


Eligibility criteria: Inclusion Criteria:

* Males or females aged \>18 years
* Either a clinical diagnosis of HFpEF, be at risk of or pre- HFpEF

Exclusion Criteria:

* Absolute contraindication to MRI
* Unable to read/understand English sufficiently to provide informed consent
* Pregnancy
* Unable to consent due to lack of mental capacity
* Current cancer diagnosis and actively undergoing treatment
* Inability to exercise on the MRI ergometer
* Severe claustrophobia

Primary outcomes:
measure: To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper).
timeFrame: By end of study - 30/04/2023
Secondary outcomes:
measure: To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study
timeFrame: By end of study - 30/04/2023
measure: To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group.
timeFrame: By end of study - 30/04/2023
measure: To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study
timeFrame: By end of study - 30/04/2023
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
Study officials:
References:
Clinical trial NCT04963452: Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
Official title: Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Labor Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.

Detailed description: Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.

Eligibility criteria: Inclusion Criteria:

1. 18 - 45 years old,
2. Physical status American society of anesthesiology (ASA) II,
3. Singleton,
4. Vertex fetuses at 37-41 weeks' gestation,
5. Nulliparous and multiparous women,
6. Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included
7. Cervical dilatation \< 5 cm

Exclusion Criteria:

1. Contraindications to regional anesthesia
2. Refuse to participate
3. No pain
4. Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
5. Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery

Primary outcomes:
measure: Incidence of adequate analgesia
timeFrame: 5 minutes
Secondary outcomes:
measure: Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )
timeFrame: 6 hours
measure: Sensory level of DPE by pricking by blunt head of a pin
timeFrame: 6 hours
measure: Motor block Bromage score (1 being complete motor block and 6 being no motor block)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT03226652: Heart Function in Patients Assessed for Sleep Apnoea
Official title: Heart Function in Patients Assessed for Sleep Disordered Breathing (SDB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Sleep Disordered Breathing
Heart Failure With Normal Ejection Fraction
Obstructive Sleep Apnea
Central Sleep Apnea
Heart Failure
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2017-07-24
Enrollment: 101
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred from primary and secondary care for SDB assessment.

Brief summary: This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).

Detailed description: Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.

Eligibility criteria: Inclusion Criteria:

* Aged ≥40 years and referred for respiratory polygraphy

Exclusion Criteria:

* Previous diagnosis of Heart Failure
* Treated sleep disordered breathing

Primary outcomes:
measure: Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Martin R Cowie, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050452: Safety and Efficacy of Drug Combinations Against Trichuris Trichiura
Official title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parasitic Diseases
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 750
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.


Eligibility criteria: Inclusion Criteria:

* Those who are enrolled in class one to six
* Are infected with T. trichiura
* Whose parent consent and who are willing to participate

Exclusion Criteria:

* Those with acute and chronic diseases other than T. trichiura
* Those with a history of any serious adverse drug reactions

Primary outcomes:
measure: Record adverse reactions
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy of treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Vector Control Division
Study officials:
References:
citation: Namwanje H, Kabatereine NB, Olsen A. Efficacy of single and double doses of albendazole and mebendazole alone and in combination in the treatment of Trichuris trichiura in school-age children in Uganda. Trans R Soc Trop Med Hyg. 2011 Oct;105(10):586-90. doi: 10.1016/j.trstmh.2011.07.009. Epub 2011 Aug 31.
Clinical trial NCT06757452: The Effect of Supplementation with Curcuminoids for the Improvement of Musculoskeletal Conditions in Sedentary Adults
Official title: The Effect of Supplementation with Curcuminoids for the Improvement of Musculoskeletal Conditions in Sedentary Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedentariness and Well-being
Keywords: curcuminoid
sedentarism
recovery
inflammation
antioxidants
Lead sponsor: Inbiotech
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Caldas
First posted: 2025-01-03
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the effect of a supplementation with curcuminoids, called Cal LX, prior to physical exercise, on the improvement of musculoskeletal conditions in sedentary people, which would lead to more physical exercise regularly.


Eligibility criteria: Inclusion Criteria:

* To be over 25 years old
* To have not exercised systematically during the last 3 months, or do not do physical exercise daily for more than 25 minutes per day for a maximum of 3 days per week
* Sitting for at least 4 hours continuously
* Type 2 diabetes patients.

Exclusion Criteria:

* To have a history or diagnoses of cardiopulmonary, osteoarticular, type 1 diabetes or autoimmune disorders
* Pregnancy
* Smokers.

Primary outcomes:
measure: RMSSD
timeFrame: Twice a week, prior and after the physical activity, during the three monts of intervention
Secondary outcomes:
measure: Creatinine
timeFrame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
measure: CK
timeFrame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
measure: LDH
timeFrame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
measure: Urea
timeFrame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
measure: SOD
timeFrame: Every 30 days, begining the first day physical activity, during the three monts of intervention.
Other outcomes:
Locations:
city: Manizales
country: Colombia
facility: Universidad de Caldas
state: Caldas
Study officials:
References:
Clinical trial NCT00081952: Amino Acid Therapy for Hot Flashes in Postmenopausal Women
Official title: Amino Acid Therapy for Hot Flashes/Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hot Flashes
Keywords: Postmenopause
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-04-28
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.

Detailed description: Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future.

Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Experience over 5 hot flashes per day

Exclusion Criteria:

* Hormone Replacement Therapy (HRT) in the past 2 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Women's Health Initiative
state: New York
Study officials:
affiliation: Women's Health Initiative
name: Thomas Guttuso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guttuso T, McDermott MP, Su H, Kieburtz K. Effects of L-isoleucine and L-valine on hot flushes and serum homocysteine: a randomized controlled trial. Obstet Gynecol. 2008 Jul;112(1):109-15. doi: 10.1097/AOG.0b013e31817d53b6.
Clinical trial NCT01976052: Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Biomarkers
Genomics
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OSA patients will be recruited from an outpatient sleep clinic

Brief summary: Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by polygraphy.

Detailed description: This project includes two parts:

* Genomic screening
* Biomarkers

Eligibility criteria: OSA-patients with moderate and severe OSA (n=15+15)

1. Adult, 18-75 years of age
2. Moderate (AHI 15-30) or Severe (AHI \>30) OSA that are currently untreated and planned for CPAP-treatment
3. Otherwise healthy except for well controlled hypertension since 3 month, Max BP 140/90
4. Non-smokers
5. Not pregnant
6. No medications with antioxidants
7. BMI of \<40

Controls (AHI\<5) Two groups of controls

1. Matched controls The same age, sex and BMI ± 3 and eventual hypertension. These controls should also fulfill criteria 4-6 above.
2. Healthy controls with normal BMI (19-25) These controls should also fulfill criteria 1., 4-6 above.

Exclusion Criteria:

* If they no not fulfil the inclusion criteria

Primary outcomes:
measure: Biomarker
timeFrame: Comparison between 0, 3 and 12 month
Secondary outcomes:
measure: Genomics
timeFrame: Comparison between 0, 3, 12 month
measure: Apnea hypopnea index
timeFrame: Comparision between 0, 3 and 12 month
measure: Exhaled nitric oxide
timeFrame: Comparision at 0, 3 and 12 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256852: Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer
Official title: Open Label,Single Arm,Exploratory Study to Evaluate the Safety,Tolerability,Compliance and MOA,of QBKPN SSI in Subjects With 2 or More Second Primary Pre-invasive/Invasive Adenocarcinoma Following Surgical Resection of Stage I NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Qu Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 6
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 this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.

Detailed description: Please refer to summary above.

Eligibility criteria: Inclusion Criteria:

* Male or female who is at or above the age of consent
* Histologically confirmed original diagnosis of lung cancer
* Life expectancy greater than 12 months
* ECOG performance status 0, 1, or 2 at screening
* Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
* Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug

Exclusion Criteria:

* Extra-thoracic lung cancer progression
* Any active malignancies
* Any uncontrolled or major organ dysfunction
* Any past or current radiation or systemic therapies for the treatment of lung cancer
* Known HIV infection or other immunosuppressive disorder
* Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening

Primary outcomes:
measure: Safety, tolerability and compliance variables
timeFrame: 16 weeks
Secondary outcomes:
measure: Exploratory variables
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Research Centre
Study officials:
affiliation: British Columbia Cancer Agency
name: Dr. Stephen Lam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04631952: Online Exercise Intervention for Psychosis Patients Receiving Residential Care
Official title: A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this randomised controlled trial (RCT) is to investigate the immediate and long-term effectiveness of 8-week online exercise intervention for people with psychosis receiving residential care.

Detailed description: The effect will also be evaluated after 6-month and 12-month, anticipate seeing the maintenance of physical activity throughout a year of time.

The secondary objective of this RCT is to investigate if the exercise intervention will be effective in improving the clinical symptoms, cognitive functioning and social functioning of the subjects, and to see if the improvement can be maintained (or improve) over a longer period of time (i.e., 6-month and 12-month).

Eligibility criteria: Inclusion Criteria:

* Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders
* Have the ability to understand Chinese
* Able to give informed consent

Exclusion Criteria:

* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders.
* Comorbid substance dependence
* Unstable psychotic symptoms
* Any history of brain trauma or organic brain disease
* Known history of intellectual disability or special school attendance
* Other mental conditions that requires other treatment priorities, e.g., suicidal risk.
* Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.

Primary outcomes:
measure: Exercise level
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Severity of psychotic symptoms
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Yi Nam Suen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277052: Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders
Official title: Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Joint Disorders
Ultrasonography
Cross sectional
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to examine masseter and temporal muscle sections with Ultrasonography in this individuals depending on the origin of Temporomandibular Disorders.

Detailed description: Multidirectional evaluations are needed to examine the symptoms of Temporomandibular Disorders (TMD). Physical examination, questionnaires towards symptoms, and imaging techniques provide objective data on pathology. The chewing muscles should also be evaluated in this way and the approaches to be followed in subsequent processes should be determined. It is known that muscle sections are changed in TMD, which develops due to muscle disorders. However, regardless of the origin of TMD chewing muscles are affected depending on the condition.

Eligibility criteria: Inclusion Criteria:

* Having a temporomandibular disorder,
* Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria:

* Pregnant,
* Canser,
* Trauma,
* Neurologic disorder,
* Infection,
* Trigeminal or postherpatic neuralgia

Primary outcomes:
measure: Determination of the thickness of the masseter and temporalis muscles sections by Ultrasonography and the changes in the biomechanical properties of the masticatory muscles in individuals with temporomandibular disorders.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Halime ARIKAN
state: Yenimahalle
Study officials:
References: