louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01491776: Evaluation of the IND One Step Strep A Rapid Test vs. Culture
Official title: Evaluation of the IND One Step Strep A Rapid Test Versus Culture Using Clinical Throat Swab Samples From Patients With Suspected Strep A Infections, CLIA Waiver Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Strep Throat
Keywords: Group A Streptococcus
Strep A
Rapid Test
Pharyngitis
Lead sponsor: IND Diagnostic Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 315
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.

Brief summary: The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Streptococcus (Strep A) when compared to culture.

Detailed description: Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.

Eligibility criteria: Inclusion Criteria:

* Male and Female subjects three (3) years of age or older
* Patients exhibiting at least 3 of the following symptoms:

  * fever
  * sore throat
  * swollen lymph nodes in the neck
  * redness of the throat and tonsils
  * white or yellow patches on the tonsils
* Must be able to collect 2 throat swab samples from patient

Exclusion Criteria:

* Patients currently undergoing antibiotic treatment will be excluded from study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Pioneer Clinical Research, LLC
state: Nebraska
city: Franklin
country: United States
facility: HCCA Clinical Research
state: Tennessee
city: Smyrna
country: United States
facility: HCCA Clinical Research
state: Tennessee
Study officials:
affiliation: Pioneer Clinical Research
name: Darin M. Gregory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCCA Clinical Research
name: Sadia Dar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCCA Clinical Research
name: Sreedhar (Steve) Samudrala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820676: iUni G2+ Prospective Study
Official title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 28
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: Patients with knee osteoarthritis

Brief summary: This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Detailed description: The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Eligibility criteria: Inclusion Criteria:

* Clinical condition included in the approved Indications For Use
* Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
* Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
* \> 18 years of age

Exclusion Criteria:

* Simultaneous bilateral procedure required
* BMI \> 35
* Treatment for cancer within the past 5 years, with the exception of skin cancer
* Poorly controlled diabetes
* Neuromuscular conditions which prevent patient from participating in study activities
* Active local or systemic infection
* Immunocompromised
* Fibromyalgia or other general body pain related condition
* Advanced tricompartmental osteoarthritis
* Symptomatic patellofemoral disease
* Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
* Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
* Advanced loss of osteochondral structure on the affected femoral condyle
* Compromised ACL, PCL or collateral ligament
* Severe (\>15º) fixed valgus or varus deformity
* Extension deficit \> 15 º
* Prior history of failed implant surgery of the joint to be treated
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results

Primary outcomes:
measure: 2011 Knee Society Score
timeFrame: 1 Year
measure: KOOS Score
timeFrame: 1 Year
measure: Oxford Knee Score
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The London Clinic
Study officials:
affiliation: The London Clinic
name: Dinesh Nathwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05161676: Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)
Official title: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and \>50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.

Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure with NYHA II-III
* Left ventricular ejection fraction ≤40%
* Negative urine-HCG for women with childbearing potential

Exclusion Criteria:

* Known diabetes or HbA1c ≥48 mmol/mol
* Significant cardiac valve disease
* Severe stable angina pectoris
* Age \<18 years

Primary outcomes:
measure: Differences in lipolysis rate
timeFrame: 14 days of dietary supplement
Secondary outcomes:
measure: Changes in protein metabolism
timeFrame: 14 days of dietary supplement
measure: Changes in glucose kinetic
timeFrame: 14 days of dietary supplement
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT02245776: Stem Cell Therapy in Incurable Neurological Disorders
Official title: Autologous Bone Marrow Mononuclear Cell Therapy for Incurable Neurological Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neurological; Disorder, Nervous System
Keywords: Incurable Neurological Disorders
Autologous mononuclear cell therapy
Stem cells
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.


Eligibility criteria: Inclusion Criteria:

* diagnosed cases of incurable neurological disorders
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
* pregnancy
* lactation

Primary outcomes:
measure: Change in various clinical symptoms of neurological disorders
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
Clinical trial NCT02873676: Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia
Official title: Prevalence and the Effect of Lifestyle Modification Project (LMP) on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia in Chinese Adults and Elderly: a Multicenter Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: prevalence; lifestyle modification; clinical outcomes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purposes of this study were to investigate the prevalence and risk factors for sarcopenia in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.


Eligibility criteria: Inclusion Criteria:

* age\>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent

Exclusion Criteria:

* age\<18 year Concurrent severe cardiac disease, unstable diabetes mellitus,uncontrolled chronic disease,liver and renal failer, which may significantly interfere with study compliance.

Participants received any drugs or supplements known to influence effcet size,such as protein powder, calcium, or vitamin D before the 3 months preceding the study. Participants with electronic or mental device

Primary outcomes:
measure: relative skeletal muscle index
timeFrame: 3 months
Secondary outcomes:
measure: Hand grip
timeFrame: 3 months
measure: gait speed
timeFrame: 3 months
measure: quality of life on EQ-5D scale
timeFrame: 3 months
measure: The rate of fracture
timeFrame: 3 months
measure: the change of physical function on frail index
timeFrame: 3 months
measure: the rate of infection complication
timeFrame: 3 months
measure: mortality rate
timeFrame: 3 months
measure: medical cost on cost-effectiveness ratio
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Kang Yu
role: STUDY_CHAIR
References:
citation: Li Z, Cui M, Yu K, Zhang XW, Li CW, Nie XD, Wang F. Effects of nutrition supplementation and physical exercise on muscle mass, muscle strength and fat mass among sarcopenic elderly: a randomized controlled trial. Appl Physiol Nutr Metab. 2021 May;46(5):494-500. doi: 10.1139/apnm-2020-0643. Epub 2020 Nov 20.
citation: Li CW, Yu K, Shyh-Chang N, Li GX, Jiang LJ, Yu SL, Xu LY, Liu RJ, Guo ZJ, Xie HY, Li RR, Ying J, Li K, Li DJ. Circulating factors associated with sarcopenia during ageing and after intensive lifestyle intervention. J Cachexia Sarcopenia Muscle. 2019 Jun;10(3):586-600. doi: 10.1002/jcsm.12417. Epub 2019 Apr 10.
Clinical trial NCT01538927: Effect of Fibrin Sealant on Early Wound Healing
Official title: Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: fibrin sealant
tissue adhesive
wound healing
interleukin 1 beta
interleukin 8
Lead sponsor: Chhattisgarh Dental College and Research Institute
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-02-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.

Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.


Eligibility criteria: Inclusion Criteria:

1. A subject has to be between the ages of 18 and 60 years.
2. Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery.
3. Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
4. Good oral hygiene: Full-mouth plaque score (FMPS) \< 25%.
5. Low levels of residual infection: Full-mouth bleeding score (FMBS) \< 25%.
6. Endodontic status: Teeth had to be vital or properly treated with root canal therapy

Exclusion Criteria:

1. History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
2. Current or former smokers.
3. Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
4. Mobility of selected teeth.
5. Pregnant or lactating women.

Primary outcomes:
measure: Concentration of cytokines.
timeFrame: 7 days
Secondary outcomes:
measure: Clinical inflammation
timeFrame: 7, 14 and 21 days
Other outcomes:
Locations:
city: Raj Nandgaon
country: India
facility: Chhattisgarh Dental College and Research Institute
state: Chhattisgarh
Study officials:
affiliation: Chhattisgarh Dental College and Research Institute
name: Shaju P Jacob, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443027: Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Official title: Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sexual Dysfunction, Physiological
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data is collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

Detailed description: Medical Device Development

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
* Subjects must be void of Female Sexual Disorder.

Exclusion Criteria:

* Pregnant or lactating women
* Postmenopausal subjects
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.

Primary outcomes:
measure: To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
timeFrame: 28d
measure: To assess the safety and toleration of the heat washout device.
timeFrame: 28d
Secondary outcomes:
measure: To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
timeFrame: 28d
Other outcomes:
Locations:
city: Dulwich
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03787576: Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens
Official title: Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Multifocal intraocular lens
Trifocal intraocular lens
Extended Depth of Focus Lens
Lead sponsor: Clínica Rementería
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone bilateral cataract surgery with bilateral implantation of a multifocal intraocular lens and who are willing to participate in the study.

Brief summary: Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.


Eligibility criteria: Inclusion Criteria:

* Previous bilateral cataract surgery
* Bilateral implantation of multifocal intraocular lens

Exclusion Criteria:

* Presence of ocular pathologies
* Intra- or postoperative complications

Primary outcomes:
measure: Patient satisfaction
timeFrame: Three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Rementería
Study officials:
affiliation: Clinina Rementería
name: Inés Contreras
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.
Clinical trial NCT03429127: Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery
Official title: Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Neoplasms
Vascular Malformations, Brain
Keywords: balanced fluids, neurosurgery, plasma osmolality
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
Collaborators: name: Sisters of Mercy University Hospital
First posted: 2018-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.

Brief summary: The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.

Detailed description: Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.

Eligibility criteria: Inclusion Criteria:

* Patients with brain tumor, meningeomas and vascular malformation.

Exclusion Criteria:

* Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease

Primary outcomes:
measure: Changes in acid base pH status
timeFrame: During operation and immediately after operation
Secondary outcomes:
measure: Changes in electrolytes (sodium and chloride)
timeFrame: During operation and immediately after operation
Other outcomes:
measure: Plasma osmolality
timeFrame: Immediately after operation
Locations:
city: Zagreb
country: Croatia
facility: UHC Zgagreb
Study officials:
affiliation: UHC Zagreb
name: Natasa Kovac, M.D.
role: PRINCIPAL_INVESTIGATOR
References: