louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04186975: Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy
Official title: Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotocography
Keywords: FETAL MONITORING, CARDIOTOCOGRAPHY
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2019-12-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low risk and High risk pregnancies. Low risk post date patients. High risk intra uterine growth restricted fetuses.

Brief summary: The long term aim of this research is to evaluate a portable NI-FECG (Non-invasive fetal ECG) monitor (Holter NI-FECG) which can be used for regular remote assessment of fetal health in pregnancies at risk or to follow-up on treatments. The elaboration of a NI-FECG Holter device will offer new opportunities for fetal diagnosis and remote monitoring of problematic pregnancies because of its low-cost, non-invasiveness, portability and minimal set-up requirements.

Detailed description: Pregnant patients that are of gestational age in which fetal heart rate monitoring is recommended and feasible will be enrolled to this cohort study. Each patient will be monitored via conventional fetal heart rate monitoring in addition to the NI-FECG method and both methods will be directly compared. Each patient will be her own control. NI-FECG is a non-invasive method of fetal monitoring' thus no ethical issues are relevant. Nevertheless, each patient will sign informed consent before participating in the study.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies.
* low-risk pregnancy: women from the post-date clinic (after 40 weeks' gestation) in which we perform routinely Non stress test and ultrasound.
* High-risk pregnancy: women who are hospitalized for different indications: IUGR, diabetes, hypertension, non-reassuring fetal heart rate, Decreased fetal movements

Exclusion Criteria:

* Non singleton pregnancies.
* Do not want to participate in the study

Primary outcomes:
measure: Identification of abnormal fetal heart rate from NI-FECG
timeFrame: 2 years
measure: Computerized NI-FECG for the prediction of abnormal FHR traces
timeFrame: 2 years
measure: Comparison between computerized CTG and NI-FECG
timeFrame: 4 years
measure: Develop a portable NI-FECG monitor for remote fetal monitoring.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Oren Grunwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04417075: Mobile Smoking Treatment for Spanish-speaking Latinx Smokers
Official title: Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Mobile App
Anxiety Sensitivity
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-06-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.

Detailed description: A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be recruited for this project. Eight (8) participants will complete user interviews in Spanish and thirty (30) participants will participate in a randomized controlled trial (RCT) for smoking cessation. Participants will be randomized to receive either the Impacto mobile app or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar Asistente).

Eligibility criteria: Inclusion Criteria:

1) 18 to 55 year of age, 2) current smoker (i.e., at least 6 cigarettes/day), 3) not currently engaged in smoking cessation treatment, 4), high anxiety sensitivity (AS) score defined as an ASI-III score of ≥ 23, 5) motivation to quit \> 5 on a 10 pt. scale, 6) Spanish speaking, and 7) currently own an Android-compatible mobile phone.

Exclusion Criteria:

1) use of other tobacco products (including e-cigarettes), 2) current non-nicotine substance dependence and/or current or intended participation in a concurrent substance abuse treatment, 3) ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, or 4) active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis

Primary outcomes:
measure: 7-Day Point Prevalence Smoking Abstinence
timeFrame: End of treatment (Week 8)
measure: Change in Smoking Rate (# cigarettes per day)
timeFrame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Secondary outcomes:
measure: Change in Anxiety Sensitivity
timeFrame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
measure: Change in Mood and Anxiety Symptoms
timeFrame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
measure: Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)
timeFrame: Daily over the course of the 8 weeks of participant study involvement
measure: User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
timeFrame: Weeks 2, 4, 6, and 8
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
state: Texas
Study officials:
References:
Clinical trial NCT01861275: Ischaemic Stroke and Sleep Apnea in Northern Part of Finland
Official title: Obstructive Sleep Apnea as a Risk Factor for Ischaemic Stroke , a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnoea
Cerebral Palsy
Keywords: osa
cerebral palsy
thrombolysis in cerebral palsy
sleep registration
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 256
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: residents of Oulu university hospital area. consecutive patient sampling

Brief summary: Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In prospective study the investigators want to know how many ischaemic stroke patients have sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.

Detailed description: In prospective study the investigators include all over 18 years old patients who came to emergency room for ischaemic stroke. Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have ischaemic stroke and no thrombolysis and 100 study patients who will have thrombolysis. The investigators do sleep registration during hospital staying within 2 days after patients have felt ill.Follow-up registration will be done after 6 months at home.

Eligibility criteria: Inclusion Criteria:

* over 18 years old patients that have cerebral palsy and are able to participate to the study.

Exclusion Criteria:

* no co-operation and need for intensive care unit

Primary outcomes:
measure: cerebral palsy events and severity of osa
timeFrame: from six months to twenty four months
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu university hospital,department of neurology
state: northern Finland
Study officials:
affiliation: University hospital of Turku
name: Tarja Saaresranta, Md PhD
role: STUDY_DIRECTOR
References:
citation: Huhtakangas JK, Saaresranta T, Vahanikkila H, Huhtakangas J. Nocturnal hypoxemia and central apneas increase mortality, but not recurrent ischemic events after ischemic stroke. Sleep Med. 2022 Sep;97:1-9. doi: 10.1016/j.sleep.2022.05.014. Epub 2022 May 23.
citation: Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Unattended sleep study in screening for sleep apnea in the acute phase of ischemic stroke. Sleep Med. 2020 Jan;65:121-126. doi: 10.1016/j.sleep.2019.08.002. Epub 2019 Aug 8.
citation: Huhtakangas JK, Saaresranta T, Bloigu R, Huhtakangas J. The Evolution of Sleep Apnea Six Months After Acute Ischemic Stroke and Thrombolysis. J Clin Sleep Med. 2018 Dec 15;14(12):2005-2011. doi: 10.5664/jcsm.7524.
citation: Huhtakangas JK, Huhtakangas J, Bloigu R, Saaresranta T. Prevalence of sleep apnea at the acute phase of ischemic stroke with or without thrombolysis. Sleep Med. 2017 Dec;40:40-46. doi: 10.1016/j.sleep.2017.08.018. Epub 2017 Oct 7.
Clinical trial NCT01957475: Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
Official title: Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma - Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
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: The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ileostomy for at least 3 months.
4. Have used a 2-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have an ileostomy with a diameter of 30 mm or less.
7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444275: Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
Official title: A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD
Keywords: Gastroesophageal Reflux Disease
Acid Reflux
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 3029
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.


Eligibility criteria: Inclusion Criteria:

* Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).

Exclusion Criteria:

* Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
* A history of severe esophagitis or known other complications, with alarm symptoms

Primary outcomes:
measure: Efficacy of Three Strategies of Long-term Treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).
timeFrame: 4 weeks
measure: Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase
timeFrame: 4 weeks
measure: Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)
timeFrame: 4 to 16 weeks
measure: Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment
timeFrame: 16 weeks
measure: Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study
timeFrame: 12 weeks - maintenance treatment phase
measure: Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
timeFrame: Day 0
measure: Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire
timeFrame: Day 0
measure: Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)
timeFrame: Week 4
Other outcomes:
Locations:
city: Rouen
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00559975: Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Official title: A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Infection
Keywords: Adjuvanted Influenza Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18 to ≤40 years

Exclusion Criteria:

* Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.
* Abnormal TSH from blood samples collected during the screening visit;

Primary outcomes:
measure: Measures of humoral immunogenicity for each antigen
timeFrame: 22 days
Secondary outcomes:
measure: Measures of vaccine-induced B and T cell immune responses
timeFrame: 72 hours
measure: Measure of alterated biomarkers and measure of safety
timeFrame: 72 hours
Other outcomes:
Locations:
city: Ligornetto
country: Switzerland
facility: Institute for Pharmacokinetic and Analytical Studies
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT02779075: Exendin-9,39 and Satiety After Bariatric Surgery
Official title: Exendin-9,39 and Satiety After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Sleeve Gastrectomy
Roux-en-Y Gastric Bypass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: The Obesity Society
First posted: 2016-05-20
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

Detailed description: Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider that the postprandial rise in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the increase in GLP-1 is less marked.

Eligibility criteria: Inclusion Criteria:

* Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
* Healthy, with no active systemic illness

Exclusion Criteria:

* Pregnancy
* Functional or organic bowel symptoms
* Systemic illness
* Diabetes
* Bariatric surgery \> 2 years

Primary outcomes:
measure: Caloric Intake
timeFrame: 5 hours
Secondary outcomes:
measure: Gastrointestinal Transit Measured Using Scintigraphy
timeFrame: 4 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kittah E, Camilleri M, Jensen MD, Vella A. A Pilot Study Examining the Effects of GLP-1 Receptor Blockade Using Exendin-(9,39) on Gastric Emptying and Caloric Intake in Subjects With and Without Bariatric Surgery. Metab Syndr Relat Disord. 2020 Nov;18(9):406-412. doi: 10.1089/met.2020.0049. Epub 2020 Aug 20.
Clinical trial NCT01576575: Buprenorphine Disposition and CYP3A
Official title: Influence of CYP3A Modulation on Buprenorphine Disposition and Clinical Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: buprenorphine CYP3A
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: To evaluate role of CYP3A in buprenorphine disposition and effect

Detailed description: Subjects will be studied during a maximum of seven occasions.

Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.

Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine

Eligibility criteria: Inclusion Criteria:

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old
2. Good general health with no known major medical conditions
3. BMI \< 33
4. Provide informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease
2. Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).
3. Females who are pregnant or nursing
4. Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)
5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)

Primary outcomes:
measure: Plasma Cmax of Buprenorphine
timeFrame: 96 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heel RC, Brogden RN, Speight TM, Avery GS. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979 Feb;17(2):81-110. doi: 10.2165/00003495-197917020-00001.
citation: Pickworth WB, Johnson RE, Holicky BA, Cone EJ. Subjective and physiologic effects of intravenous buprenorphine in humans. Clin Pharmacol Ther. 1993 May;53(5):570-6. doi: 10.1038/clpt.1993.72.
citation: Walsh SL, Preston KL, Bigelow GE, Stitzer ML. Acute administration of buprenorphine in humans: partial agonist and blockade effects. J Pharmacol Exp Ther. 1995 Jul;274(1):361-72.