louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02510677: Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 21
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: The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.

Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.


Eligibility criteria: Inclusion Criteria:

* Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
* Age over 18 years
* Clinically stable (without hospitalization for heart failure in the last month)
* Sinus rhythm
* Social security insurance
* Signed consent form

Exclusion Criteria:

* Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
* Recent history (less than 1 month) of acute heart failure;
* Right bundle branch block;
* Irregular heart rate;
* Double-chamber cardiac pacemaker
* Patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated QRS.
* Countraindication to dobutamine therapy;
* Valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy;
* Significant Ventricular arrhythmias;
* Hypertension (upper than 160/100 mmHg);
* Pregnant, breastfeeding or guardianship

Primary outcomes:
measure: measures of dyssynchrony parameters
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Médecine Nucléaire du CHU de Caen
Study officials:
References:
Clinical trial NCT02678377: The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Official title: The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mixed Urinary Incontinence
Stress Urinary Incontinence
Urgency Incontinence
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Friends of Prentice
First posted: 2016-02-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.


Eligibility criteria: Inclusion Criteria:

* Undergoing mid-urethral sling surgery
* Have symptoms of both stress and urgency urinary incontinence
* Able to consent, fill out study documents, and complete all study procedures and follow-up visits
* At least 18 years of age
* English speaking
* Be able and willing to learn clean intermittent self catheterization technique

Exclusion Criteria:

* History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
* Systemic neuromuscular disease known to affect the lower urinary tract
* Undergoing concomitant prolapse surgery
* Previous incontinence surgery
* Treatment with anticholinergic medication in the last 2 months
* Previous bladder injection with onabotulinumtoxinA
* Prisoner Status
* Pregnancy

Primary outcomes:
measure: Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Incontinence Episode Frequency
timeFrame: 3 months after surgery
measure: Urinary Incontinence Symptoms and Quality of Life
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Integrated Pelvic Health Clinic
state: Illinois
Study officials:
affiliation: Professor, Departments of Obstetrics and Gynecology, Urology
name: Kimberly Kenton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198.
Clinical trial NCT02500277: Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy
Official title: A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Pleurisy
Tuberculosis
Metastatic Malignancy
Keywords: thoracoscopy
pleuroscopy
semirigid thoracoscopy
flexible cryoprobe
cryobiopsy
pleural biopsy
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2015-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Detailed description: Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:

Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Eligibility criteria: Inclusion Criteria:

* Age ≥12 years
* Semirigid thoracoscopy being performed for diagnosis of the pleural effusion

Exclusion Criteria:

* Age ≥80 years
* SpO2 \<88% on room air
* Hemodynamic instability
* Myocardial infarction or unstable angina in the last 6 wk
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy
* Failure to provide informed consent

Primary outcomes:
measure: Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
timeFrame: One week
Secondary outcomes:
measure: Biopsy size
timeFrame: One day
measure: Duration of procedure
timeFrame: One day
measure: Ease of biopsy VAS
timeFrame: One day
measure: Artifacts
timeFrame: One day
measure: Tissue depth
timeFrame: One day
measure: Bleeding
timeFrame: One day
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
Clinical trial NCT02521077: Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
Official title: Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Fatigue
Keywords: Ascorbic Acid
Breast Neoplasms
Fatigue
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
* Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
* Willing to receive either intravenous ascorbic acid or normal saline;
* Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
* Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
* Willing to complete all evaluation tools;
* Able to give informed consent to participate in the study; and
* Agree to avoid any additional supplemental ascorbic acid throughout the study.

Exclusion Criteria:

* Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
* Renal insufficiency (Blood Urea Nitrogen \>30 mg/dL, or Creatinine \>1.5 mg/dL);
* Unwillingness or mental incapacity to complete self-reported questionnaires;
* Active smoker; and
* Male sex

Primary outcomes:
measure: Fatigue by self reported fatigue inventory questionnaire
timeFrame: Day 8 of each 4-week treatment cycle.
Secondary outcomes:
measure: Fatigue ( EORTC QLQ-FA13)
timeFrame: Day 1 of each 4-week treatment cycle.
measure: Fatigue ( EORTC QLQ-FA13)
timeFrame: Day 8 of each 4-week treatment cycle.
measure: Fatigue ( EORTC QLQ-FA13)
timeFrame: Day 15 of each 4-week treatment cycle.
measure: Fatigue by self reported fatigue inventory questionnaire
timeFrame: Day 1 of each 4-week treatment cycle.
measure: Fatigue by self reported fatigue inventory questionnaire
timeFrame: Day 15 of each 4-week treatment cycle.
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern Regional Medical Center
name: Dennis Citrin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615277: The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood
Official title: The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood of Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Young adults
Long-chain polyunsaturated fatty acids
Cognitive function
Mood
Supply with omega-3 fatty acids
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
name: Cognitive Drug Research Ltd
First posted: 2008-02-14
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.

Detailed description: The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel.

The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.

Eligibility criteria: Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* Coagulation disorder

Primary outcomes:
measure: Cognition
timeFrame: Before intervention and after 16 weeks of intervention
Secondary outcomes:
measure: Mood
timeFrame: Before intervention and after 16 weeks of intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Ulm
name: Katharina A Widenhorn-Mueller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulm
name: Ulrike Weiland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02870777: MRD-directed Therapy for Low-risk and Intermediate-risk AML.
Official title: Minimal Residual Disease-directed Therapy for Low-risk and Intermediate-risk Acute Myeloid Leukemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Minimal Residual Disease
Keywords: MRD
Acute myeloid leukemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
name: Zhujiang Hospital
name: Peking University People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2016-08-17
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MRD-directed therapy
Primary purpose: TREATMENT

Brief summary: Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.


Eligibility criteria: Inclusion Criteria:

Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: 3 year
Secondary outcomes:
measure: leukemia relapse rate
timeFrame: 3 year
measure: disease-free survival (DFS)
timeFrame: 3 year
measure: overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00097747: Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Official title: A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Chronic Kidney Disease
Chronic Renal Failure
Cancer
Keywords: anemia
chronic kidney disease
CKD
chronic renal failure
CRF
erythropoietin
EPO
erythropoiesis stimulating agent
ESA
Hematide™
hemoglobin
Hb
Hgb
Omontys
peginesatide
red blood cell
red blood cell production
Lead sponsor: Affymax
Sponsor class: INDUSTRY
First posted: 2004-12-01
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

Detailed description: This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.

Eligibility criteria: Main eligibility criteria:

* Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m\^2), and weight ≥ 50 and ≤ 95 kilograms (kg)
* Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry
* Participant has normal iron stores

Primary outcomes:
measure: Adverse events
timeFrame: 28 Days
Secondary outcomes:
measure: PK parameters
timeFrame: 28 Days
measure: Pharmacodynamic (PD) parameters
timeFrame: 28 Days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Facility
Study officials:
affiliation: Affymax, Inc.
name: Affymax
role: STUDY_DIRECTOR
References:
Clinical trial NCT04716647: Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research
Official title: A Community-Based Participatory Research to Assess the Feasibility of Ayurveda Intervention in Patients With Mild-to-Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Ayurveda Intervention, Community Based Participatory Research
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: University of Warwick
name: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
First posted: 2021-01-20
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Community Based Participatory Research
Primary purpose: SUPPORTIVE_CARE

Brief summary: Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19.


Eligibility criteria: Inclusion Criteria:

* With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
* With mild or moderate manifestations of COVID-19
* Willing to participate, and consent by signing the informed consent and
* not involved in another clinical trial during the study

Exclusion Criteria:

* Patients suffering from severe COVID-19 Disease as per World Health Organisation criteria (REF)
* Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
* Patients with ongoing immunosuppressive therapy for any reasons
* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
* Pregnancy and lactation
* Ayurveda practitioner decision that involvement in the study is not in the patient's best interest

Primary outcomes:
measure: Time to clinical recovery
timeFrame: Up to 14-days
measure: Proportion of patient with negative conversion in nasopharyngeal swab
timeFrame: Up to 14 days
Secondary outcomes:
measure: Clinical Outcome
timeFrame: Up to 14-days
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam UK
state: Leicestershire
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma
role: STUDY_DIRECTOR
affiliation: East Park Medical Centre, NHS trust, Leicester
name: Dipa Modi
role: STUDY_CHAIR
affiliation: University of Warwick
name: Vishwesh Kulkarni
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
name: Abhimanyu Kumar
role: STUDY_DIRECTOR
References:
Clinical trial NCT00733447: SynCardia Freedom Driver System Study
Official title: SynCardia Freedom Driver System Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Biventricular Failure
Keywords: Biventricular failure
Lead sponsor: SynCardia Systems. LLC
Sponsor class: INDUSTRY
First posted: 2008-08-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.


Eligibility criteria: Inclusion Criteria:

* Patients who are implanted with the TAH-t and are clinically stable.

Exclusion Criteria:

* Patients who are implanted with the TAH-t and are not clinically stable.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
References: