louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05242172: THE RELATIONSHIP OF CRP/ALBUMIN RATIO LEVEL AND PROGNOSIS IN PREGNANT COVID-19 PATIENTS
Official title: THE RELATIONSHIP OF CRP/ALBUMIN RATIO LEVEL AND PROGNOSIS IN PREGNANT COVID-19 PATIENTS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corona Virus Infection
Pregnancy; Infection
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalised Covid PCR test positive pregnant patient

Brief summary: The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.

Detailed description: Pregnant women are more susceptible to viral infections affecting the respiratory tract than non-pregnant women. Similar to non-pregnant patients, Covid-19 infection occurs with non-specific symptoms in pregnant patients. A computed tomography (CT) scan of lungs and several laboratory parameters are used to predict the prognosis of this infection, which starts with non-specific findings. Although it has been demonstrated that low-dose lung CT can be used safely in pregnant women, both clinicians and pregnant women tend to avoid tomography imaging due to its teratogenic effects

The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. It is an indicator of both the inflammatory state and the nutritional state, simultaneously. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.

Eligibility criteria: Inclusion Criteria:

* Covid PCR test positive patients
* Pregnant

Exclusion Criteria:

* Covid PCR test negative
* Missed data

Primary outcomes:
measure: CRP/Albumin ratio
timeFrame: First day of hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00840372: Semi-blunt Needles: is Outcome Better?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hemodialysis Patients
Vascular Abord: Native Arterio-venous Fistula
Buttonhole Cannulation
Keywords: Blunt needles
Semi-blunt needles
Buttonhole cannulation method
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hemodialysis patients dialyzed in Cliniques Universitaires Saint-Luc by a native arterio-venous fistula

Brief summary: The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent.

Inclusion criteria and study design are detailed below.


Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patients
* Aged 18 years or more
* Dialyzed by a native arterio-venous fistula
* Cannuled by buttonhole method with blunt needles

Exclusion Criteria:

* Acute hemodialysis
* Puncture with 14G needles
* Puncture with a sole needle
* Arterio-venous grafts
* Patients transferred from another centre

Primary outcomes:
measure: Incidence of AVF hematomes
timeFrame: Two months
measure: Incidence of use of sharp needles
timeFrame: Two months
Secondary outcomes:
measure: Incidence of trampoline-effect
timeFrame: Two months
measure: Incidence of AVF infections
timeFrame: Two months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Laura Labriola, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368172: Physical Activity Guidelines for People With Spinal Cord Injury (SCI)
Official title: Implementation and Evaluation of the New Physical Activity Guidelines for People With Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
physical activity
physical fitness
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Rick Hansen Foundation
First posted: 2011-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The first evidence-based physical activity guidelines for people with spinal cord injury were released in March, 2011. This project will evaluate the implementation of the new physical activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators hypothesize that persons who follow the guidelines will experience increased aerobic fitness and muscle strength. The investigators also hypothesize that participants will find the guidelines easy to follow and that their self-efficacy for participating in physical activity will be improved following the study period.


Eligibility criteria: Inclusion Criteria:

* adults with spinal cord injury who have been given clearance to exercise by their primary care physician (or healthcare team)

Exclusion Criteria:

* ventilatory support
* inability to voluntarily participate in upper body exercises
* inability to communicate in English
* ongoing infection
* unstable autonomic dysreflexia

Primary outcomes:
measure: Physical Fitness
timeFrame: 4 months
Secondary outcomes:
measure: Self-efficacy for achieving the physical activity guidelines
timeFrame: 4 months
measure: Adherence to physical activity guidelines
timeFrame: 4 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Centre for Health Promotion and Rehabilitation, McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Audrey Hicks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800172: The Possible Effects of Roflumilast on Obesity Related Disorders
Official title: The Possible Effects of Roflumilast on Obesity Related Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
PreDiabetes
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.


Eligibility criteria: Inclusion Criteria:

1. Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
2. Obese subjects (BMI ≥30 kg/m2 and \<40 kg/m2).

Exclusion Criteria:

1. Patients with morbid obesity (BMI \> 40 kg/m2).
2. Patients already on weight lowering agents or weight loss program.
3. History or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant.
4. Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
5. Women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study.
6. Patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity.
7. Diabetic patients and patients with any inflammatory disease.
8. Smokers.
9. Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)

Primary outcomes:
measure: Change in patients body weight
timeFrame: baseline and 3 months later
measure: Change in blood glucose
timeFrame: baseline and 3 months later
measure: Change in plasma insulin level
timeFrame: baseline and 3 months later
measure: Change in HOMA-IR index
timeFrame: baseline and 3 months later
measure: Change in blood lipid levels
timeFrame: baseline and 3 months later
Secondary outcomes:
measure: Changes in TNF-alfa serum level
timeFrame: baseline and 3 months later
measure: Changes in malondialdehyde serum level (MDA)
timeFrame: baseline and 3 months later
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sara Mohammad Zayed
Study officials:
affiliation: Tanta University
name: Sara M Zayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04161872: Nutraceutical on Hyperuricemia
Official title: Evaluation of the Effects of a Supplement Composed by Quercetin, Rutin, Bromelain and L-carnosine in Patients With Hyperuricemia, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperuricemia
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 116
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 aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy.

Detailed description: The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and \< 7 mg/dl after 3 months of therapy.

Patients will be randomized to Uricemin® or placebo for three months. We will evaluate body weight, fasting plasma glucose (FPG), lipid profile, uricemia (UA), high-sensitivity C-reactive protein (Hs-CRP) at baseline and after 3 months since the study start. Treatment tolerability will be assessed evaluating transaminases, and creatinine, and all adverse events will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with uric acid levels between ≥ 6 and \< 7 mg/dl
* Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with previous gout attack
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with history of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypouricemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, antidepressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.

Primary outcomes:
measure: Variation of Hyperuricemia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lombardia
Study officials:
References:
Clinical trial NCT07001072: Smartshoes for Freezing of Gait in Parkinson's Disease
Official title: Mitigating Freezing of Gait (FoG) in Parkinson's Disease With Spatiotemporal Haptic Feedback Delivered by Smartshoes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: freezing of gait
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot research study aimed at evaluating whether an FDA listed wearable shoe with capability to deliver vibration feedback can be safe and tolerable for patients with Parkinson disease and control participants and explore whether such a feedback can be useful for treating freezing of gait (FOG) in patients with Parkinson disease.


Eligibility criteria: Inclusion Criteria:

For patients with Parkinson disease:

* diagnosis of PD according to the UK Brain Bank criteria
* Hoehn and Yahr stages 2 to 3 during the ON phase of PD medication
* Self-report episodes of FoG based on item 1 of the NFOG-Q, and score of 3 on item 2, part II

For patients with Parkinson disease withOUT freezing of gait:

* diagnosis of PD according to the UK Brain Bank criteria
* Hoehn and Yahr stages 2 to 3 during the ON phase of PD medication

For all participants (PD with or without freezing, or age-matched controls):

* adult age 40-80
* able to walk 10 minutes at baseline
* able to provide consent
* able to read and write in English at an 8th grade level.

Exclusion Criteria:

For all participants (PD with or without freezing, or age-matched controls)

* moderate to severe peripheral neuropathy (based on self report or clinical exam using vibration tuning fork) which may limit ability to sense the vibratory feedback
* use of orthotics incompatible with the haptic wearable shoes
* severe balance deficits or daily falls at baseline
* patients with dementia (MoCA\<18) who are not able to appropriately provide consent for the study
* pregnant persons

Primary outcomes:
measure: Participant device tolerance survey score
timeFrame: immediately after completion of walking tasks on day 1
measure: Total duration of freezing episodes
timeFrame: Baseline, and day 1 during each walking task (2 min per assessment)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Hengameh Zahed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060172: A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
Official title: A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.

The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age ≥ 32 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand Dutch or English
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* Plurality higher than 1
* History of allergies to skin adhesives
* Contraindication to the use of the CTG

Primary outcomes:
measure: Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate
timeFrame: 1 hour
measure: Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Gyselaers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00415272: Pulmonary Rehabilitation in Patients With Fibrotic Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibrotic Interstitial Lung Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2006-12-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our study aims to investigate the benefits of an outpatient pulmonary rehabilitation program in a population of subjects with fibrotic interstitial lung disease. Our hypothesis is that pulmonary rehabilitation will lead to improvements in quality of life, breathlessness, exercise capacity and pulmonary function in this patient population.


Eligibility criteria: Inclusion Criteria:

1. Restriction on pulmonary function testing (TLC \<80%, FEV1/FVC ratio \> predicted or DLCO \< 80%)
2. Evidence of fibrosis on high resolution computed tomography of the chest.
3. Fibrosis on surgical lung biopsy if performed
4. Referral for pulmonary rehabilitation

Exclusion Criteria:

1. Participation in pulmonary rehabilitation in the past 24 months
2. Inability to complete 6 minute walk test or study questionnaires
3. Limitations other than dyspnea (e.g. arthritis) that affect ability to participate in pulmonary rehabilitation
4. Baseline 6 minute walk distance \> 400 meters
5. Planned change in medication treatment for lung disease during the course of pulmonary rehabilitation
6. Ejection fraction known to be \< 25%
7. Contraindications to pulmonary rehabilitation (clinically unstable, uncontrolled arrhythmia or hypertension, symptomatic or uncontrolled hypotension with systolic blood pressure of \< 95, active angina, unexplained syncope or worsening dizziness, limiting orthopedic or neurological disorders, psychiatric impairment that inhibits cooperation in the program)
8. FEV1/FVC \< 65%
9. Unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
Study officials:
affiliation: University of California at San Francisco
name: Harold R Collard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597972: Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
Official title: Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 &Amp; 4-Part Proximal Humerus Fractures: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Closed Fracture Proximal Humerus, Four Part
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 3
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?

Detailed description: The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.

Eligibility criteria: Inclusion

* Neer 3 and 4-part proximal humerus fractures.
* Age greater than and equal to 70 years old.
* Functional deltoid musculature (axillary nerve intact).

Exclusion

* Less than 70 years old.
* Dementia or inability to provide adequate follow up.
* Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

Primary outcomes:
measure: To measure the change using the chi-square tests for lowering the pain score of the patients
timeFrame: base line to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joaquin Sanchez-Sotelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00339872: Study Evaluating IMA-638 in Asthma
Official title: Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-638 Administered Subcutaneously and Intravenously to Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma subjects.


Eligibility criteria: Inclusion Criteria:

* Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted.
* Well controlled asthma, as exhibited by completion of asthma questionnaire.
* Otherwise healthy, except for asthma.

Primary outcomes:
measure: Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
Secondary outcomes:
measure: Drug levels in the blood and associated biomarkers will be evaluated.
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: