louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02430584: Whole Blood Specimen Collection From Pregnant Subjects
Official title: Whole Blood Specimen Collection From Pregnant Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Edwards Syndrome
Patau Syndrome
Klinefelter Syndrome
Turner Syndrome
DiGeorge Syndrome
Perinatal Infections
Lead sponsor: Progenity, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older

Brief summary: To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Detailed description: This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:

1. be at an increased risk for fetal genetic abnormalities
2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.
3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Eligibility criteria: Inclusion Criteria:

* Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
* Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
* Subject is 18 years of age or older
* Subject is at an increased risk for one or more of the following:

  * fetal gene and chromosome abnormalities
  * congenital fetal infection
  * known to possess irregular blood group antigens (subject or father of the baby)
  * known to have some other condition amenable to noninvasive prenatal testing

Exclusion Criteria:

* Pregnancy is non-viable

Primary outcomes:
measure: Whole blood collection
timeFrame: One or more monthly clinic visits (≥25 days apart) over 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
Study officials:
References:
Clinical trial NCT03415984: Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA
Official title: Evaluation of the Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA (AMD-PARK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Age Related Macular Degeneration
Keywords: Parkinson Disease
Age Related Macular Degeneration
L-DOPA
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-01-30
Enrollment: 133
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease, treated or not treated with L-DOPA

Brief summary: Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population.

Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.


Eligibility criteria: Inclusion Criteria:

* Patients aged of 50 years old and more
* Parkinson's disease

Exclusion Criteria:

* Patient under a measure of legal protection

Primary outcomes:
measure: Prevalence of ARMD
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Martine MAUGET FAYSSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04991584: Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection
Official title: Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Concomitant Therapy
Rescue treatment
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Detailed description: Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with persistent H. pylori infection.
* Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

* Patients unable or unwilling to receive gastroscopy.
* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
* History of allergy to any of the drugs used in the study.
* Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
* Currently pregnant or lactating.
* Severe neurologic or psychiatric disorders.
* Alcohol abuse or drug addiction.
* Patients with compliance lower than 90% in any previous treatment are not included.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates
timeFrame: 6 month
Secondary outcomes:
measure: The rate of adverse events happening
timeFrame: 6 month
measure: Compliance of patients
timeFrame: 6 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
References:
Clinical trial NCT03926884: Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients
Official title: Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Lead sponsor: Veterans Affairs Medical Center, Miami
Sponsor class: FED
Collaborators: name: Dr. Robert Jackson
First posted: 2019-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in COPD patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.


Eligibility criteria: Inclusion Criteria:

1. Males or females ages 50-80 at the time of entry
2. Non-smoker for at least 1 year
3. Chronic bronchitis with Fev1 \<80% and Fev1/ Fvc \<0.7 and daily sputum production
4. Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study.
5. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation

-

Primary outcomes:
measure: Sputum and cough score
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03189784: Ankle Instability Treatment in Patients With Chronic Ankle Instability
Official title: Mobilization With Movement Treatment in Patients With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Ankle joint self mobilization.

Detailed description: The intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program

Eligibility criteria: Inclusion Criteria:

* ankle range of motion limitation respect the contralateral ankle.
* At least two episodes of giving way on the affected ankle.
* Scores of at least 24 in the cumberland ankle instability tool.

Exclusion Criteria:

* recent fractures of the involved limb.
* Vestibular or balance dysfunction.
* Acute ankle sprain.

Primary outcomes:
measure: range of motion
timeFrame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Secondary outcomes:
measure: dynamic balance
timeFrame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
measure: Self reported instability
timeFrame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Other outcomes:
Locations:
city: Jaen
country: Spain
facility: University of Jaen campus
city: Jaen
country: Spain
facility: University of Jaen
Study officials:
References:
Clinical trial NCT03336684: Evaluation of Rheumatoid Arthritis Disease Education Literature
Official title: Evaluation of Rheumatoid Arthritis Disease Education Literature: The ERADEL Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Patient education
Rheumatoid arthritis
Knowledge
Attitudes
Practice
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rheumatoid arthritis is an inflammatory disease that results in joint inflammation, pain and swelling. It may progress to advance stages that render patients unable to carry out their daily activities. It also results in joints deformity and is a leading cause of disability globally.

Patient education plays an important role in the management of disease. Adequate patient knowledge and awareness about disease may help in incorporating the ailment in daily life. The purpose of this study is to evaluate the benefit of a disease education literature in Urdu language and with culturally relevant illustration for rheumatoid arthritis patients.


Eligibility criteria: Inclusion Criteria:

1. Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
2. Participants who are willing to participate in the study.

Exclusion Criteria:

1. Patients with no rheumatoid arthritis.
2. Patients currently undergoing surgery or had previous history of surgery.
3. Patients who are not willing to participate.
4. In-patients.

Primary outcomes:
measure: Patient knowledge about rheumatoid arthritis
timeFrame: 3 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Clifton Central Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Liaqat National Hospital
state: Sindh
Study officials:
affiliation: Liaqat National Hospital Karachi
name: Mehfooz Alam, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamdard University
name: Baqir S Naqvi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03198884: A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Official title: A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Lead sponsor: Southern Illinois Healthcare Foundation
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2017-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult HIV positive patients

Brief summary: A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
* Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
* Resistance data (if applicable)

Exclusion Criteria:

* Received a regimen of darunavir/ritonavir in combination with dolutegravir for \<24 weeks duration
* Patients receiving darunavir/ritonavir + DTG+NRTI's
* Missing laboratory data in ≥2 study time points
* Patients missing more than five doses over two weeks prior study visit

Primary outcomes:
measure: Number of Participants With RNA <50 Copies/mL at 48 Weeks
timeFrame: 48 weeks
measure: The Change in Serum Creatinine From Baseline to 48 Weeks.
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in Mean CD4+ Cell Count From Baseline.
timeFrame: 48 weeks
measure: Incidence of Adverse Events.
timeFrame: 48 weeks
measure: Number of Grade 1 Adverse Events Reported
timeFrame: 48 weeks
measure: Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks
timeFrame: 48 weeks
measure: Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02884284: Prospective and Retrospective Breast Cancer Database
Official title: Creation of a Prospective and Retrospective Breast Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
database
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patient with breast cancer of any stage

Brief summary: In order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. All data are from patients treated in Toulouse Centre.

The scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Female patient
* Histologically confirmed breast cancer of any stage
* Affiliated to a social security system in france
* Who signed the informed consent

Exclusion Criteria:

* Any psychiatric or medical condition that would make the patient unable to give a signed informed consent

Primary outcomes:
measure: Database of patients with breast cancer
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut claudius regaud IUCT ONCOPOLE
Study officials:
affiliation: Institut claudius regaud Toulouse ONCOPOLE
name: Florence DALENC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756284: Evaluation of the PhageTech Virus BioResistor
Official title: A Pilot Study to Evaluate the PhageTech Virus BioResistor inDetecting Combinations of Bladder Cancer Biomarkers inPatients Under Active BCa Surveillance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: PhageTech, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort or samples will be required from the patients. Results from this study will not be used for any of the normal physician diagnostic process. Patients will have a suspected bladder tumor undergoing cystoscopy or a history of bladder cancer undergoing surveillance cystoscopy. Patients who have had a positive diagnosis of bladder cancer, but have not yet had a tumor resection (known BCa positive patients) are highly desirable for this study. It is anticipated that the majority of samples collected will be negative. In the case of a known BCa positive patient, the sponsor is requested

Brief summary: To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

Detailed description: This study will sample urine provided by bladder cancer patients as part of their normal routine surveillance screening. No additional effort will be required from the patients and only modest additional effort from the study staff. Some de-identified patient medical information may also be requested, including concominant medications, relevant current or previous diseases, prior bladder cancer interventions and other relevant information to ensure there are no interfering substances or other confounders that could affect study results. There is no risk to patients as the normal diagnostics for bladder cancer will be followed.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients ≥ 18 years
2. Previous bladder cancer diagnosis; any stage and histological type, undergoing cystoscopy
3. Patients with suspected bladder tumor undergoing surveillance cystoscopy
4. Patients must provide written Informed Consent.

Exclusion Criteria:

1. Patients unable or unwilling to sign the informed consent
2. Age \< 18 years
3. Known HIV/HCV/HBV (information from clinical history).

Primary outcomes:
measure: Successful identification of bladder tumor biomarkersBiomarkers in Patients Under Active BCa Surveillance
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center and the Saint John's Cancer Institute
state: California
Study officials:
References:
Clinical trial NCT05230784: The PURI-HF (Air Purifiers on Heart Failure) Trial
Official title: Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Indoor Air Purifier
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Indoor air pollution and fine mode particulate matter with an aerodynamic diameter smaller than 2.5 micrometers (PM2.5) is a major contributor to global morbidity and mortality, particularly due to cardiovascular disease. This project aims to demonstrate the efficacy, feasibility and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India. The findings from the project will add to existing knowledge of innovative and scalable strategies to improve environmental and cardiovascular health worldwide.

The overall objective of this study is to demonstrate the efficacy, feasibility, and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age diagnosed with HF with a reduced ejection fraction of ≤ 40% within the last six months in NYHA class II-IV.

Exclusion Criteria:

* listed for a cardiac transplant
* history of CRT device implantation in last 3 months
* on oxygen therapy
* with severe pulmonary disease
* participants unable to ambulate

Primary outcomes:
measure: Change in Distance Walked
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline, 12 months
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 12 months
measure: Change in Heart Rate
timeFrame: Baseline, 12 months
measure: Change in pro B-type natriuretic peptide (Pro-BNP) Levels
timeFrame: Baseline, 12 months
measure: Change in Number of Hospitalizations
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Thiruvananthapuram
country: India
facility: Centre for Chronic Disease Control (CCDC)
state: Kerala
city: Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Punjab
city: Ludhiāna
country: India
facility: Public Health Foundation of India (PHFI)
state: Punjab
Study officials:
affiliation: NYU Langone Health
name: Rajesh Vedanthan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: