louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05299450: Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
Official title: Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure
Pre-conception
Hypertension
Exercise
Beetroot
Wearable
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study proposes to evaluate the feasibility of a preconception intervention comprising two proven interventions for reducing blood pressure; Beetroot juice; a source of dietary nitrate which reduces BP by 8/4mmHg after 4 weeks(6); Personalised resistance and endurance exercise programme (as per CMO recommendations) which reduces BP by \~10/5mm Hg over 8-12 weeks (7).

Detailed description: A feasibility study will be conducted for a randomised, controlled trial of preconception interventions.

The study will advertise using posters, social media and on departmental emails at Imperial College Healthcare NHS Trust or Imperial College for women aged 18-45 planning a pregnancy at any time in the future.

The study will randomise women to 1 of 4 arms Arm 1: Exercise intervention for weeks 1-12 Arm 2: Beetroot juice for weeks 1-12 Arm 3. Exercise and Beetroot juice for weeks 1-12 Arm 4: Control group

Women will be provided with daily Beetroot juice shots (as per study arm), membership to an Everybody Active centre close to their home, personal training sessions to tailor an exercise program to them (2 initial sessions then monthly), a wearable to track their physical activity and a home BP monitor.

Eligibility criteria: Inclusion Criteria:

* Aged 18-45
* considering pregnancy at some time in the future
* no health contra-indications to moderate-vigorous exercise
* employed by ICHT NHS Trust or Imperial College.

Exclusion Criteria:

* Currently pregnant
* planning pregnancy during the study period, or becoming pregnant during the study period.

Primary outcomes:
measure: Adherence to intervention
timeFrame: Over 12 week study period
measure: Adherence to intervention
timeFrame: Over 12 week study period
Secondary outcomes:
measure: Effect of interventions on physical activity
timeFrame: Week 12
measure: Effect of interventions on cardiac output
timeFrame: Week 12
measure: Effect of interventions on total peripheral resistance
timeFrame: Week 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Edward WS Mullins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College Healthcare NHS Trust
name: Cristoph C Lees, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06647550: To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

Detailed description: This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.

This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.

Exclusion Criteria:

* Type 1 diabetes or another immune-mediated diabetes syndrome
* BMI: \> 40 kg/m2
* C-peptide: \< 0.5ng/mL

Primary outcomes:
measure: change in HbA1c at weeks 12 from baseline
timeFrame: at weeks 12 from baseline
Secondary outcomes:
measure: change in HbA1c at weeks 6 from baseline
timeFrame: at weeks 6 from baseline
measure: percentage of subjects with HbA1c level below 7.0% at weeks 12
timeFrame: at weeks 12
measure: percentage of subjects with HbA1c level below 6.5% at weeks 12
timeFrame: at weeks 12
measure: change in Glycoalbumin at weeks 6 and 12 from baseline
timeFrame: at weeks 6 and 12 from baseline
Other outcomes:
measure: change in body weight at weeks 6 and 12 from baseline
timeFrame: at weeks 6 and 12 from baseline
measure: change in GA/HbA1c at weeks 6 and 12 from baseline
timeFrame: at weeks 6 and 12 from baseline
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT02908438: Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
Official title: Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: GnRHa;LPS
Lead sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to investigate the effect of luteal-phase administration of gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro fertilization-embryo transfer.


Eligibility criteria: Inclusion Criteria:

1. Age \< 37 years;
2. One or more high quality embryos have been got in IVF/ICSI treatment;
3. To transfer at lest 2 fresh embryos;
4. Uterine endometrial thickness ≥ 7mm;
5. Patients have signed informed consents.

Exclusion Criteria:

1. ≥3 IVF/ICSI/FET cycles and no pregnancy;
2. Polycystic ovary syndrome(PCOS);
3. uterine malformation;
4. endometriosis
5. patients with a history of recurrent pregnancy loss.

Primary outcomes:
measure: pregnancy rate
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06968338: A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-213 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 weeks.


Eligibility criteria: Inclusion Criteria:

* Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
* Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
* Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m\^2, inclusive

Exclusion Criteria:

* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction

Primary outcomes:
measure: Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
timeFrame: Up to 17 weeks
Secondary outcomes:
measure: ARGX-213 serum concentrations
timeFrame: Up to 17 weeks
measure: Percent change from baseline in total IgG concentrations in serum
timeFrame: Up to 17 weeks
measure: Incidence of antidrug antibodies against ARGX-213 in serum
timeFrame: Up to 17 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Altasciences
Study officials:
References:
Clinical trial NCT06688838: Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome
Official title: Exploring the Clinical Features and Factors Related to Efficacy in Blau Syndrome: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Blau Syndrome
Keywords: Blau syndrome
retrospective
Janus kinase inhibitors
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Affiliated Hospital of Yunnan University
First posted: 2024-11-14
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrieve patients diagnosed with Blau syndrome from the medical record system between January 2017 and December 2023.

Brief summary: To investigate the effectiveness of the JAK 1/3 inhibitor tofacitinib in treating Blau syndrome and explore the association between various clinical and genetic features and therapeutic responses within the cohort.

Detailed description: Blau Syndrome (BS) is a monogenic systemic autoinflammatory disease characterized by dominantly inherited granulomatous inflammation due to mutations in nucleotide-binding oligomerization domain 2 gene (NOD2). Traditionally associated with a clinical trial of arthritis, dermatitis, and uveitis, recent observations have expanded its recognized manifestations to include systemic inflammatory features, skin or cutaneous vasculitis, and multi-organ involvement. Despite the rarity of BS, significant advances have been made through multi-center collaborations. Current studies, primarily retrospective, highlight the clinical diversity of BS, including cases with disease-causing NOD2 mutations but lacking the typical clinical trial . In response to gaps in understanding of BS's pathogenic mechanisms, the investigators initiated a retrospective observational study to collect detailed clinical data and perform whole exome sequencing, specifically targeting NOD2 mutations and STAT3 rs2293152 phenotypic variations to explore their relationships with therapeutic responses.

Eligibility criteria: Inclusion Criteria:

1. The patient must conform to the characteristic triad of granulomatous arthritis, uveitis, and dermatitis, or the characteristic non-caseous granuloma of BS indicated by skin or synovial biopsy;
2. Whole exon detection indicated characteristic mutations of NOD2 gene

Exclusion Criteria:

1. Patients with autoimmune diseases, including but not limited to lupus erythematosus, Sjogren's syndrome, vasculitis, ankylosing spondylitis, myositis, dermatomyositis, rheumatoid arthritis, etc.;
2. combined with other neoplastic diseases, such as lymphoma, leukemia, etc.

Primary outcomes:
measure: clinical responses
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Yikai YU
state: Hubei
Study officials:
References:
Clinical trial NCT01570738: Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Official title: Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: sleep disorders
sleep apnea
ambulatory device
polysomnography
WatchPAT
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 274
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with and without sleep disorders, referred to Carmel Medical Center clinical sleep laboratory for an overnight sleep study

Brief summary: Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".


Eligibility criteria: Inclusion Criteria:

1. Age between 5-90
2. Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

Exclusion Criteria:

1. Permanent pacemaker.
2. Severe lung disease.
3. Peripheral neuropathy.
4. Finger deformity that precludes adequate sensor appliance.
5. Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Primary outcomes:
measure: Compare sleep data collected from the Watch-PAT device to PSG data
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
References:
Clinical trial NCT02658838: The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
Official title: The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: LOVASTATIN/TICAGRELOR [VA Drug Interaction]
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.

Detailed description: Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old and ≤75 years ;
2. unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
3. voluntary participation in clinical trials, and informed consent;

Exclusion Criteria:

1. acute ST segment elevation myocardial infarction, stable angina pectoris;
2. aspirin allergy or resistance;
3. consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
4. patients have coagulopathy;
5. can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
6. can not complete revascularization;
7. NYHA ≥Ⅲ level or left ventricular ejection fraction \<40%;
8. severe liver and kidney dysfunction (ALT and AST were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: Nonfatal myocardial infarction
timeFrame: one year
measure: Non-fatal stroke
timeFrame: one year
measure: Revascularization again
timeFrame: one year
measure: Rehospitalization for ACS or heart failure
timeFrame: one year
measure: Bleeding events
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hosipital
state: Beijing
Study officials:
affiliation: Beijing Anzhen hosipital
name: jinghua Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT00619138: Treatment of Social Phobia and Panic Disorder in Adults
Official title: A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Phobia
Panic Disorder
Keywords: Cognitive therapy
Stepped care
Self-help
Internet
Anxiety
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnoses of panic disorder or social phobia
* Informed consent

Exclusion Criteria:

* Alcohol/drug dependency
* Major depressive disorder
* Psychosis
* Unstable medication

Primary outcomes:
measure: Clinical Severity Ratings
timeFrame: End of treatment and 12 months follow-up
Secondary outcomes:
measure: Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale
timeFrame: End of treatment and 12 months follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: haukelandUH
Study officials:
affiliation: University of Bergen
name: odd e havik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haug T, Nordgreen T, Ost LG, Tangen T, Kvale G, Hovland OJ, Heiervang ER, Havik OE. Working alliance and competence as predictors of outcome in cognitive behavioral therapy for social anxiety and panic disorder in adults. Behav Res Ther. 2016 Feb;77:40-51. doi: 10.1016/j.brat.2015.12.004. Epub 2015 Dec 11.
citation: Haug T, Nordgreen T, Ost LG, Kvale G, Tangen T, Andersson G, Carlbring P, Heiervang ER, Havik OE. Stepped care versus face-to-face cognitive behavior therapy for panic disorder and social anxiety disorder: Predictors and moderators of outcome. Behav Res Ther. 2015 Aug;71:76-89. doi: 10.1016/j.brat.2015.06.002. Epub 2015 Jun 9.
Clinical trial NCT01241838: The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy
Official title: The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Left Ventricular Hypertrophy
Diastolic Dysfunction
Heart Failure
Heart Rate
Keywords: Heart failure
Left ventricular hypertrophy
Diastolic dysfunction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effect of heart rate on cardiac index in patients with or without left ventricular hypertrophy. The study will be conducted in postoperative heart surgery patients with a pacemaker.


Eligibility criteria: Inclusion Criteria:

* Scheduled heart surgery including thoracotomy
* Ejection fraction \> 45%
* Duration of QRS complex \< 120 milliseconds
* Sinus rhythm
* Planned perioperative temporary pacemaker

Group: Left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall \>11 mm.

Group: No left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall \<11 mm.

Exclusion Criteria:

* Active endocarditis
* Severe mitral insufficiency
* No patient consent

Primary outcomes:
measure: Cardiac index
timeFrame: At heart rates 65-80-95-110-125
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: At heart rates 65-80-95-110-125
measure: Ejection fraction
timeFrame: Heart rates of 65-80-95-110-120
measure: Strain
timeFrame: Heart rates of 65-80-95-110-125
measure: S-max
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: E/E'
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: E/A ratio
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: E'/A' ratio
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: Isovolumetric relaxation index
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: IVRT/IVRT'
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: End diastolic volume
timeFrame: Heart rates of 65-80-95-110-125 beats per second
measure: End systolic volume
timeFrame: Heart rates of 65-80-95-110-125 beats per second
Other outcomes:
Locations:
city: Århus N
country: Denmark
facility: Department of Anaesthesiology, Århus University Hospital
Study officials:
affiliation: Department of Anaesthesiology, Århus University Hospital
name: Peter Juhl-Olsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: