louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00063362: Combination Therapy for the Treatment of Bipolar Disorders
Official title: Combination Therapy in Bipolar Rapid Cycling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Depression
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-06-27
Enrollment: 49
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

Detailed description: Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Eligibility criteria: Inclusion Criteria:

* Bipolar I or II Disorder
* Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
* Meet criteria for a major depressive episode

Exclusion Criteria:

* History of intolerability of lithium, divalproex, or lamotrigine

Primary outcomes:
measure: The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response
timeFrame: Baseline and Week 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University / University Hospitals of Cleveland
name: Keming Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00987662: Irbesartan Versus Amlodipine: The OBI Study
Official title: Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Hypertension
Keywords: irbesartan
amlodipine
obesity
ambulatory blood pressure monitoring
new onset diabetes
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Objective:

1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
2. To study the drug specific effect in arterial stiffness
3. To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)

Detailed description: Study Objectives

1. Primary:

   * Reduction of 24h BP in obese hypertensives
   * Reduction in arterial stiffness
2. Secondary

   * Drug specific effect on new onset of diabetes
   * Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio

Study design

Study drugs: Irbesartan 300mg vs. amlodipine 10mg

Tx duration and follow-up: 12 months

Collected data:

* 24h SBP and DBP in time 0, 1, 12.
* Pulse wave velocity in time 0,1,12.
* Central obesity (total, visceral, abdominal fat) in time 0,1,12.
* Leptin/adiponectin in time 0,1,12.
* BMI, waist/hip ratio in time 0,1, 12.
* Glu, HbA1c, insulin in time 0, 1,12.
* K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula)

Number of centers: 1

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 60 years.
2. All patients are going to give their informed consent to participate in the study.
3. Stage I hypertension.
4. BMI \> 30.

Exclusion Criteria:

1. Known oversensitiveness,
2. Chronic renal disease (GFR \< 50 ml/min) or ESRD,
3. Heart or respiratory failure, OR
4. Recent MI, shock, liver deficiency (ALT or AST \> 3 times normal and pregnancy or lactation.

Primary outcomes:
measure: Reduction of 24h BP and arterial stiffness in obese hypertensives
timeFrame: 12
Secondary outcomes:
measure: New onset of diabetes
timeFrame: 12
measure: Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
timeFrame: 12
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hypertension-24h ABPM Center Papageorgiou Hospital
Study officials:
affiliation: AUTH
name: Vasilios Kotsis, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02373462: Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Artery Disease With Intermittent Claudication
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 85 years at visit 1
* Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months
* Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)
* Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment

Exclusion Criteria:

* Blood pressure of more than 180/110 mmHg
* Patients taking ARBs or ACE inhibitors treatment for at least 6 months before
* Patients taking aldosterone receptor antagonists at least 6 months before
* Patients with serum creatinine of more than 3 mg/dL
* serum potassium (K+) \> 5.5mg/dl
* History of bilateral renal artery stenosis
* History of acute coronary syndrome or heart failure hospitalization within 6 months
* Peripheral arterial revascularization planned within 1 month
* Critical limb ischemia
* Patients with impaired cognition (e.g. dementia)
* pregnancy or women at age of childbearing potential

Primary outcomes:
measure: Pain free maximum walking distance and time
timeFrame: 12th week
Secondary outcomes:
measure: Quality of life as measured by questionnaires
timeFrame: 24th week
Other outcomes:
measure: Pulse wave analysis as measured by PWV
timeFrame: 24th week
measure: Blood pressure by measured by 24hr ABPM
timeFrame: 24th week
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Severance Hospital
Study officials:
References:
Clinical trial NCT01187862: Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
Official title: Single-center, Randomized, Five-way Crossover Study to Investigate Low-dose Combinations of Caffeine, Efavirenz, Losartan, Omeprazole, Metoprolol, Chlorzoxazone and Midazolam ("Basel Cocktail") for Simultaneous Phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytochrome
Pharmacokinetics
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male aged between 18 and 45 years
* No clinically significant findings on the physical examination
* Body mass index (BMI) between 18 and 28 kg/m2
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (inclusive)
* 12-lead electrocardiogram (ECG) without clinically relevant abnormalities
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent
* Negative results from urine drug screen
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study

Exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulations
* Treatment with another investigational drug within 30 days prior to screening
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
* Excessive caffeine consumption, defined as mor than 800 mg per day
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Smoking within the last 3 months prior to screening
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening
* Loss of 250 ml or more of blood within 3 months prior to screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Legal incapacity or limited legal capacity at screening

Primary outcomes:
measure: Assessment of phenotyping measures of seven drugs used as a cocktail
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Manuel Haschke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01189162: High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study
Official title: High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Primary treatment of RDS and treatment of RDS post extubation
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-26
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that while the extremely low birthweight (ELBW) infants (\<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with HFNC while getting coparable respiratory support to NIMV.


Eligibility criteria: Inclusion Criteria:

1. Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight \>1000 g for the initial treatment of RDS or \<35 weeks post extubation or for apnea of prematurity
2. Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.

Exclusion Criteria:

1. Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus \[PDA\]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH),
2. Parents refuse consent.
3. Unavailability of suitable ventilator.

Primary outcomes:
measure: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.
timeFrame: 1 year
Secondary outcomes:
measure: Clinical features on both methods
timeFrame: 1 year
measure: % of infants with neonatal morbidities on both methods
timeFrame: 1 year
measure: % of infants with possible side effects on both methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center, Neonatal department
Study officials:
affiliation: Bnai Zion Medical Cente
name: Amir Kugelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032.
citation: Kugelman A, Riskin A, Said W, Shoris I, Mor F, Bader D. A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS. Pediatr Pulmonol. 2015 Jun;50(6):576-83. doi: 10.1002/ppul.23022. Epub 2014 Mar 12.
Clinical trial NCT04996862: A Survey Exploring Health and Screening Tests in People Treated for Hodgkin Lymphoma
Official title: A Study of Health Beliefs and Cancer Screening Behaviours and Intentions in Hodgkin Lymphoma Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Lymphoma
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of Hodgkin lymphoma survivors registered in a clinical follow-up database at The Christie Hospital

Brief summary: A survey of health beliefs and cancer screening behaviour and intentions in Hodgkin lymphoma survivors

Detailed description: A survey of Hodgkin lymphoma survivors registered in a follow-up database, examining health beliefs (using Health Belief Model) around breast, bowel and lung cancer screening, previous screening uptake and future uptake intentions

Eligibility criteria: Inclusion Criteria:

* Details held in the ADAPT database at The Christie NHS Foundation trust
* Aged 18-80
* Previously treated for Hodgkin lymphoma without evidence of relapse for at least 5 years
* Treated with radiotherapy and/or alkylating agent containing chemotherapy

Exclusion Criteria:

\* Have previously stated they do not wish to be contacted for research

Primary outcomes:
measure: The psychosocial factors predictive of uptake of breast, bowel and lung cancer screening in HL survivors
timeFrame: At baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05492162: An Intervention to Promote Health Students' Well-being
Official title: An Intervention to Promote Health Students' Well-being : a Protocol of a Quasi-experimental Interventional Study in Le Havre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Students Wellbeing
Keywords: health promotion
wellness program
health occupations students
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before/after study using a quasi-experimental design
Primary purpose: OTHER

Brief summary: The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life.

This study aims to evaluate a well-being promotion intervention among paramedic students.

This is a before/after study using a quasi-experimental design. This study aims to compare well-being, resilience, and self-esteem before and after the intervention.

Students' satisfaction will be assessed through a questionnaire.

Detailed description: Health students' well-being is a big issue today. We need to increase the number of interventions designed to improve quality of life and well-being among this population of students.

The investigators aim to evaluate a well-being promotion intervention among paramedic students through a before/after study using a quasi-experimental design by comparing the scores of validated scales of well-being, resilience, and self-esteem of participating students before and after the intervention.

A satisfaction questionnaire will allow to assess the content and the organization of this intervention.

The first edition will be implemented in September 2022 in Le Havre. The questionnaires will be distributed before and eight months after the intervention.

The investigators will describe the study population, then they will compare the average scores.

The results of satisfaction questionnaire will allow to improve the intervention to best meet the needs of students.

The main benefit expected from this study is the improvement of paramedic students' well-being by adopting a healthy lifestyle.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* paramedic students enrolled at IFP Mary Thieullent in september 2022

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: Well-being
timeFrame: Month 1 and Month 8
Secondary outcomes:
measure: Resilience
timeFrame: Month 1 and Month 8
measure: Self-esteem
timeFrame: Month 1 and Month 8
measure: Students' Satisfaction
timeFrame: Month 1
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
Study officials:
References:
Clinical trial NCT01731262: Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis
Official title: Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Neovascularization, Pathologic
Synovitis
Keywords: Arthritis, Rheumatoid
Sonic hedgehog protein, human
Neovascularization, Pathologic
Synovitis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2012-11-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of south China

Brief summary: Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.

Detailed description: 4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected

* peripheral blood mononuclear cells will be detached
* messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in both groups will be detected

Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need to carry out knee joint replacement operation will be collected

* inflammatory feature of synovial tissue will be observed
* the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by immunohistochemistry assay
* fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients

Eligibility criteria: Inclusion Criteria:

* definitely diagnosed
* the disease is active (DAS28\>3.2)

Exclusion Criteria:

* combined with severe organ dysfunction
* combined with other rheumatic diseases

Primary outcomes:
measure: mRNA expression
timeFrame: 1 day (December 15, 2012)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jianlin Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05788562: The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants
Official title: The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Hemoglobin
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 92
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants with gestational age \<32 weeks or birth weight \<1500g

Brief summary: A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants


Eligibility criteria: Inclusion Criteria:

1. Preterm infants with gestational age \<32 weeks or birth weight \<1500g
2. Parents agree to attend

Exclusion Criteria:

1. serious functional or organic diseases
2. severe congenital deformity
3. parents reject to attend

Primary outcomes:
measure: Occurrence and severity of early complications in premature infants
timeFrame: 2022.1-2023.1
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: First hospital of Jilin University
state: Jilin
Study officials:
References: