louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00170027: Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease
Official title: Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Ischemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CardioMag Imaging
First posted: 2005-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A magnetocardiograph (MCG) is a medical device capable of recording the magnetic fields that arise from the electrical activity of the heart. It was developed for the general purpose as a noninvasive, non-contact diagnostic tool of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart (as in an Heart attack) in patients presenting with chest pain.

Detailed description: The CMI-2409 magnetocardiograph (MCG) is an FDA-approved medical device capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart. This system was developed by CMI for the general purpose of noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device and of the associated MCG method for the detection and diagnosis of ischemia in chest pain patients.

The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology. In this study the rest MCG data will be analyzed and compared to the results of a rest ECG.

Eligibility criteria: Subjects with chest pain syndrome or angina equivalent

Primary outcomes:
measure: Primary endpoint will be final clinical diagnosis of ischemia by the primary treating physician. This decision will be based upon evaluation of symptoms, clinical presentation, 12-lead ECG, cardiac enzymes (Troponin I or CKMB).
Secondary outcomes:
measure: 1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography
measure: 2. Correlation of MCG with functional and laboratory tests
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter A. Smars, M.D. EM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753427: Perception of Symptom Variability in COPD
Official title: Perception of Symptom Variability in Chinese COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD,
symptoms,
Non-Interventional study,
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 1058
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patient, male or female aged 40 years and over and Clinical diagnosis of COPD at least 6 months

Brief summary: The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.


Eligibility criteria: Inclusion Criteria:

* Provision of subject informed consent
* Out-patient
* Clinical diagnosis of COPD at least 6 months
* Lung function based on data available within 3 months in medical records confirming FEV1\<80% normal predicted (post-bronchodilator) and FEV1/FVC\<0.7 (post-bronchodilator)

Exclusion Criteria:

* Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire
* Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency
* History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis

Primary outcomes:
measure: The variability of symptoms due to COPD throughout the day
timeFrame: Day 1
Secondary outcomes:
measure: The impact of COPD symptoms on patient's daily living activities and sleep quality
timeFrame: Day 1
measure: The impact of COPD symptoms on morning activities
timeFrame: Day 1
measure: Total CAT score
timeFrame: Day 1
measure: Total MMRC score
timeFrame: Day 1
measure: Patient's perception on COPD and COPD treatments
timeFrame: Day 1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
Study officials:
References:
Clinical trial NCT02855060: Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Official title: Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Pelvic Fracture
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.

Detailed description: The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.

Eligibility criteria: Inclusion Criteria:

* Traumatic injury other than ground-level fall, and
* Complaint of pelvic groin or hip pain, or
* Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or
* Hemodynamic instability

Exclusion Criteria:

* Ground level fall
* Penetrating pelvis injury without frank evidence of fracture
* Obviously pregnant patients
* Patients who are too small or too big for the binder
* Priority 2 or 3 Trauma

Primary outcomes:
measure: Mortality Rate
timeFrame: 30 day
Secondary outcomes:
measure: Pain Scores - Visual Analog Scale
timeFrame: At time of arrival to Emergency Department
measure: Number of Participants With Skin Complications After Pelvic Binder Application
timeFrame: From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
measure: Length of Stay in Hospital
timeFrame: From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
measure: Number of Patients With Blood Transfusions
timeFrame: 48 hours
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph R Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604260: FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Official title: FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IBD (Inflammatory Bowel Disease)
Crohn Disease (CD)
Ulcerative Colitis (UC)
Keywords: FAPI
fibroblast activation protein
FAP
FAPi-scan
68Ga-FAPi PET-CT
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.


Eligibility criteria: Inclusion Criteria:

Group 1

- Adults ≥18 years with confirmed diagnosis of Crohn's disease

AND one of the following:

* Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
* Increased CRP (\&gt;5 mg/L) and/or fecal calprotectin levels (\&gt;250 mg/kg)
* Active disease confiremed by endoscopy ( endoscopic SES-CD score \&gt;3)
* Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2
* Adults ≥18 years with confirmed diagnosis of ulcerative colitis

AND one of the following:

* Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
* Active disease confirmed by intestinal ultrasound (BWT \&gt; 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
* Increased CRP (\&gt;5 mg/L) and/or fecal calprotectin levels (\&gt;250 mg/kg)

Exclusion Criteria:

* Pregnancy
* Unable to provide informed consent
* IBD-related surgeries \&lt; 5 years in medical history
* Colorectal carcinoma

Primary outcomes:
measure: Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
timeFrame: At baseline up to week 12 of study enrolment
measure: Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients
timeFrame: At baseline up to week 12 of study enrolment
Secondary outcomes:
measure: Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi
timeFrame: At baseline up to week 12 of study enrolment
measure: Protocol optimisation
timeFrame: At baseline up to week 12 of study enrolment
measure: Minimal tracer injection dose
timeFrame: At baseline up to week 12 of study enrolment
Other outcomes:
measure: Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP
timeFrame: At baseline up to week 12 of study enrolment
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC
name: Mark Lowenberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04116060: Dietary Nitrate and Erectile Dysfunction
Official title: Impact of Dietary Nitrate on Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment to intervention vs. control
Primary purpose: BASIC_SCIENCE

Brief summary: An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet. Nitrate improves vascular functions in old adults and improves ischemia reperfusion injury in experimental models.

Whether dietary nitrate improves erectile dysfunction is not known and will be investigated in the present study.


Eligibility criteria: Inclusion Criteria:

Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years

Exclusion Criteria:

* Spinal cord disease
* Insulin dependent Diabetes mellitus
* Prostate cancer after operation, radiotherapy and hormone therapy
* Treatment with NO-Donators or sGC-Activators
* Chronic kidney disease (Stage IV-V)
* Advanced liver dysfunction

Primary outcomes:
measure: The changes of erectile function according to the international index of erectile function (IIEF5) score
timeFrame: 4 Weeks
Secondary outcomes:
measure: Change in oral microbiome
timeFrame: 4 Weeks
measure: Change in cardiac diastolic function,
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Tienush Rassaf, Prof
role: STUDY_DIRECTOR
affiliation: University Hospital, Essen
name: Christos Rammos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435160: The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Fecal Microbiota Transplantation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.


Eligibility criteria: Inclusion Criteria:

* mild to moderate UC patients
* male
* volunteered to our FMT trial

Exclusion Criteria:

* severe UC
* Hb \< 6g/dL

Primary outcomes:
measure: Change of mayo criteria in UC patients after FMT.
timeFrame: one year
measure: Number of patients with adverse events after FMT.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Huang C, Huang Z, Ding L, Fu Y, Fan J, Mei Q, Lou L, Wang J, Yin N, Lu Y, Guo S, Zeng Y. Fecal microbiota transplantation versus glucocorticoids for the induction of remission in mild to moderate ulcerative colitis. J Transl Med. 2022 Aug 12;20(1):354. doi: 10.1186/s12967-022-03569-3.
Clinical trial NCT04227860: Balance and Strength Exercise in Knee Osteoarthritis Patients
Official title: The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

Detailed description: The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):

Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA

* Patients will undergo pre-exercise and post- exercise assessment with:

  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
  2. Modified Stare Excursion Balance test
  3. Timed up and Go test
* Exercise program includes:

  1. Lower extremity kinesthesia and balance exercise program
  2. Strength exercise program

Eligibility criteria: Inclusion Criteria:

* Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
* Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)

Exclusion Criteria:

* Patients that cannot complete at least stage 1 of balance and exercise program
* Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
* Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
* Patients with secondary KOA.
* Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.

Primary outcomes:
measure: Assessment of pain
timeFrame: 2-6 weeks
measure: Assessment of stiffness
timeFrame: 2-6 weeks
measure: Assessment of physical function
timeFrame: 2-6 weeks
Secondary outcomes:
measure: Dynamic Balance
timeFrame: 2-6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
affiliation: Alexandria University Faculty of Medicine
name: Yousra H Abdel Fattah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001060: Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.
Official title: 1. Study Design 2. Sample Collection 3. Microbial DNA Extraction in Faecal Samples 4. PCR Amplification： 5. Sequencing： 6. HCY Test Principle: 7. Statistical Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Miscarriage
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients or healthy individuals who visited Hangzhou First People's Hospital

Brief summary: The goal of this observational study is to test the alterations of gut microbiota composition among women of reproductive age with elevated homocysteine levels. The main question it aims to answer is:

• the relationship between gut microbiota composition and recurrent abortion. Participants will provide their stool samples to be detected the composition of gut microbiota. .

Researchers will compare women of reproductive age with normal homocysteine levels to see if any bacteria were involved in recurrent miscarriages.


Eligibility criteria: Inclusion Criteria:

* No recent antibiotic treatment

Exclusion Criteria:

* Recently received antibiotics

Primary outcomes:
measure: homocysteine levels
timeFrame: The first day of the trail
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
Study officials:
References:
Clinical trial NCT04636060: Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women
Official title: Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (Without Anemia)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Female gender
* Premenopausal
* Age \> 18 years
* Regular menstrual cycle
* BMI in normal range (18-25 kg/m²)
* Serum-ferritin \<30ng/ml
* No anaemia
* symptomatic iron deficiency in the past
* No intake of dietary supplements

Exclusion Criteria

* Intake of dietary supplements
* Pregnancy
* Hypermenorrhea
* Anaemia
* Serum-ferritin \>30ng/ml
* BMI \<18 kg/m² or \>25 kg/m²
* chronic inflammatory diseases (e.g. colitis)
* Hypersensitivity to iron-supplements
* psychiatric disorder

Primary outcomes:
measure: Increase of serum ferritin concentration under iron supplementation
timeFrame: 8 weeks
Secondary outcomes:
measure: Side-effects of treatment
timeFrame: 8 weeks
measure: Serum hepcidin concentration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: University of Zurich
name: Pierre-Alexandre Krayenbühl
role: PRINCIPAL_INVESTIGATOR
References: