louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00906126: Oral Misoprostol for Labor Augmentation: A Pilot Study
Official title: Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arrest of Dilation in Labor
Keywords: oral misoprostol
labor augmentation
arrest of dilation
nulliparous
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.


Eligibility criteria: Inclusion Criteria:

* nulliparous
* gestational age of at least 36 weeks
* singleton gestation
* cephalic presentation
* reassuring fetal heart rate
* 4 cm or greater cervical dilation
* ruptured membranes with clear amnionic fluid
* intrauterine pressure catheter in place
* less than 200 MVU's

Exclusion Criteria:

* non-reassuring fetal heart rate
* meconium-stained amnionic fluid
* previous uterine incision
* maternal fever
* pregnancy-induced hypertension or other pregnancy-related complications
* known fetal anomalies
* placenta previa or unexplained vaginal bleeding
* estimated fetal weight of 4,500 grams or greater
* evidence of cephalopelvic disproportion
* any moderate or severe preexisting disease
* contraindication to the use of prostaglandins

Primary outcomes:
measure: uterine hyperstimulation
Secondary outcomes:
measure: adequate uterine activity
measure: need for oxytocin augmentation
measure: time from administration of study drug to delivery
measure: route of delivery and indications
measure: maternal and neonatal infectious morbidity
measure: neonatal outcomes
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Kathryn S Villano, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304226: Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
Official title: A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Valsartan,
amlodipine,
hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 1288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.

The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.


Eligibility criteria: Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2

Exclusion criteria Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Blood pressure less than 140/90 mmHg after 14 weeks
Secondary outcomes:
measure: Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks
measure: Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks
measure: Time when blood pressure reaches less than 140/90 mmHg
measure: Change in blood pressure at baseline, week 4, 8, 11, and 14
measure: Adverse events and serious adverse events at each study visit for 14 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novatis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Zappe D, Papst CC, Ferber P; PROMPT Investigators. Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control. Vasc Health Risk Manag. 2009;5:883-92. doi: 10.2147/vhrm.s8062. Epub 2009 Nov 2.
Clinical trial NCT06113926: Racial Discrimination, Pain, and the Buffering Influences of Acknowledgment
Official title: Racial Discrimination, Pain, and the Buffering Influences of Acknowledgment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: discrimination
racism
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Psi Chi
name: Society for the Psychological Study of Social Issues
name: D.C. Psychological Association
First posted: 2023-11-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three independent groups
Primary purpose: BASIC_SCIENCE

Brief summary: Black young adults (aged 18-30; N = 92) were racially included (i.e., received the ball an equal number of times) or excluded (i.e., received the ball only once) by other White players in a ball-tossing computer game called Cyberball; White experimenters acknowledged the exclusion for half of the excluded participants. Participants completed a cold-pressor task twice to measure pain sensitivity (threshold, tolerance, and unpleasantness): immediately prior, and after the Cyberball (and acknowledgment) manipulation. Participants also completed a post-manipulation survey examining the psychological effects of racial exclusion and acknowledgment (i.e., psychological needs satisfaction, negative affect, control).


Eligibility criteria: Inclusion Criteria:

* Participants identify as Black/African American
* Age 18-30

Exclusion Criteria:

* Past 30-day persistent pain
* Cardiovascular or circulatory disorders
* Diabetes
* Current pregnancy
* Open sores/frostbite on nondominant hand

Primary outcomes:
measure: Pain Threshold measured with a cold pressor task
timeFrame: Measured immediately after the manipulation (within minutes).
measure: Pain Tolerance
timeFrame: Measured immediately after the manipulation (within minutes).
measure: Pain unpleasantness
timeFrame: Measured immediately after the manipulation (within minutes).
Secondary outcomes:
measure: Psychological Needs Satisfaction; Self Control subscale
timeFrame: Measured immediately after the manipulation (within minutes).
measure: Psychological Needs Satisfaction; Belongingness subscale
timeFrame: Measured immediately after the manipulation (within minutes).
measure: Psychological Needs Satisfaction; Meaningful Existence subscale
timeFrame: Measured immediately after the manipulation (within minutes).
measure: Psychological Needs Satisfaction; Self esteem subscale
timeFrame: Measured immediately after the manipulation (within minutes).
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
Study officials:
References:
Clinical trial NCT03727126: Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer
Official title: Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophagectomy
Robotic esophagectomy
Laparoscopic esophagectomy
Minimally invasive esophagectomy
Ivor Lewis esophagectomy
McKeown's esophagectomy
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.


Eligibility criteria: Inclusion Criteria:

* Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class 4 and above
* Esophagectomy for other non-malignant conditions

Primary outcomes:
measure: Lymph node yield
timeFrame: 7 days after Index Surgery
Secondary outcomes:
measure: Surgical margin status
timeFrame: 7 days after Index Surgery
measure: Complications
timeFrame: Up to 90 days after surgery
measure: ICU stay
timeFrame: During index admission or within 30 days after surgery
measure: Hospital stay
timeFrame: During index admission or re admission within 30 days
measure: Mortality
timeFrame: During index admission or within 90 days following surgery
measure: Duration of surgery
timeFrame: 1 day after surgery
measure: Blood loss
timeFrame: During surgery and up to 24 hours after index surgery
measure: Conversion rate
timeFrame: 1 day after surgery
Other outcomes:
Locations:
city: Chennai
country: India
facility: GEM Hospital & Research Center
state: Tamil Nadu
city: Coimbatore
country: India
facility: GEM Hospital & Research Center
state: Tamil Nadu
Study officials:
affiliation: GEM Hospital & Research Center
name: Chinnusamy Palanivelu, MS, MCh
role: PRINCIPAL_INVESTIGATOR
affiliation: GEM Hospital & Research Center
name: Shankar Balasubramanian, MS, MRCS
role: STUDY_DIRECTOR
affiliation: GEM Hospital & Research Center
name: Sandeep Sabnis, MS, DNB
role: STUDY_DIRECTOR
References:
Clinical trial NCT05838326: 'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula
Official title: Physiological Effects of High Flow Oxygen Therapy Using 'Optiflow + Duet' Interface vs 'Standard' High Flow Nasal Cannula for Acute Respiratory Failure After Extubation. The OPTIMARF Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: asymmetrical nasal cannula
hypoxemia
DUET
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.

Detailed description: A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.

Eligibility criteria: Inclusion Criteria:

* age \>18 years old;
* invasive mechanical ventilation \> 24h;
* acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio \< 300;
* absence of Sars-Cov-2 positivity;
* absence of cardiological or long-term respiratory disease

Exclusion Criteria:

* pregnancy
* tracheostomy
* non-invasive ventilation after extubation
* second tracheal intubation
* contraindications for EIT belt
* facial or nose abnormalities

Primary outcomes:
measure: Breathing effort
timeFrame: Last 10 minutes of 1 hour-trial
measure: Lung aeration
timeFrame: Last 10 minutes of 1 hour-trial
Secondary outcomes:
measure: Minute ventilation (MV) (L/min)
timeFrame: Last 10 minutes of 1 hour-trial
measure: corrected MV (L/min)
timeFrame: Last 10 minutes of 1 hour-trial
measure: Breathing heterogeneity
timeFrame: Last 10 minutes of 1 hour-trial
measure: Comfort
timeFrame: Last 10 minutes of 1h-trial
measure: Dyspnea
timeFrame: Last 10 minutes of 1h-trial
measure: Gas exchange
timeFrame: Last 10 minutes of 1h-trial
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Institute of Anaesthesia and Intensive Care, Padua University hospital
Study officials:
affiliation: AOUP, DIMED
name: Annalisa Boscolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625257: COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)
Official title: COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronavirus Infectious Disease 2019 (COVID-19)
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay
point of care tests (POCT)
next-generation sequencing (NGS) method
contact tracing
transmission chains
crude RNA extraction from saliva
loop mediated amplification (LAMP) assay
viral nucleic acid analysis platform
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: ETH Zurich Department for Biosystems, Science and Engineering
name: Kanton Basel- Landschaft
First posted: 2020-11-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic patients arriving at the COVID-19 test center Feldreben in Muttenz, Basel Land and at Swiss TPH in Basel, Basel Stadt to get tested for COVID-19.

Brief summary: This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.


Eligibility criteria: Inclusion Criteria:

* symptomatic patients getting tested for COVID-19

Exclusion Criteria:

* mentally incompetent adults

Primary outcomes:
measure: qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)
timeFrame: single point assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
Study officials:
affiliation: Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
name: Miodrag Savic, Dr. med. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956657: Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial
Official title: Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Randomised Controlled Trial
Adherence
Patient Participation
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Patients who attend such a programme have been shown to have reduced health problems. Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class. A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness. For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control. Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes. Increased adherence to CR could improve health outcomes for patients with cardiac illnesses. The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment group. It is hoped that those who receive the treatment session will attend more CR classes.


Eligibility criteria: Inclusion Criteria:

* Attending first cardiac rehabilitation class at one of three hospital sites
* Participants had to be over 18

Exclusion Criteria:

* Unable to read and understand English information sheet and consent form

Primary outcomes:
measure: CR Adherence
timeFrame: Approximately 3-months after recruitment
Secondary outcomes:
measure: Illness Perceptions Questionnaire-Revised Scores
timeFrame: 3-months after consent
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Glasgow
country: United Kingdom
facility: Stobhill Infirmary
city: Glasgow
country: United Kingdom
facility: Victoria Infirmary
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Gavin H Taylor, MA (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02689557: VEINEX : Venous Investigations During Exercise
Official title: VEINEX : Venous Investigations During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Successfully develop and confirm with the Higher School of Electronics West Plethysmographic a multichannel recorder to perform measurements staggered volume of the lower limbs at rest, walking and recovery (6 storied measures on members lower).

Detailed description: Validate the measurement made by EAP (Electroactive polymer) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.

Eligibility criteria: Inclusion Criteria:

* present or not venous pathology

Exclusion Criteria:

* amputation of a lower limb
* heart failure
* Severe respiratory disease
* Unstable angina or myocardial infarction
* Parkinson's disease, hemiplegia and paraplegia

Primary outcomes:
measure: plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
timeFrame: Maximum 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: UH ANGERS
name: ANTOINE BRUNEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: