louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02805114: Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
Official title: Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Capnography
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Rabin Medical Center
First posted: 2016-06-17
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: PROBABILITY_SAMPLE
Study population: Asthma and COPD patients

Brief summary: This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

Detailed description: This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adult asthma and COPD patients (age \>18). Patients will be enrolled on a continuous basis and will be monitored by capnograph and oximeter before and after lung function assessment and also during and after medical treatment.

Eligibility criteria: Inclusion Criteria:

1. Age \>18
2. Ability and willingness to participate the study and sign informed consent form
3. Asthma / COPD patients

Exclusion Criteria:

1. Pregnant women
2. Asthma or COPD patients with FEV1 \> 80%
3. Disability or unwillingness to undergo capnography measurement
4. Cannot be assessed for FEV1
5. Oxygen supply \>5 L/min
6. 6. Subjects that gone through LOBECTOMY OF LUNG in the last 5 years.

Primary outcomes:
measure: Correlation between capnography parameters and severity of asthma
timeFrame: 1/2 hour to 48 hours from enrollment of subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute Rabin Medical center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center
name: Mordechai M Kremer, Prof.; M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pertzov B, Ronen M, Rosengarten D, Shitenberg D, Heching M, Shostak Y, Kramer MR. Use of capnography for prediction of obstruction severity in non-intubated COPD and asthma patients. Respir Res. 2021 May 21;22(1):154. doi: 10.1186/s12931-021-01747-3.
Clinical trial NCT01486914: Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process
Official title: A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Caucasian
* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Fasting blood glucose below or equal to 6 mmol/L
* Body mass index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Participated in another clinical study with an investigational drug within the last 4 weeks
* Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
* Known or suspected allergy to the trial product or related products
* Family history of type 2 diabetes

Primary outcomes:
measure: Area under the Curve (AUC) (insulin aspart)
Secondary outcomes:
measure: Cmax (maximum plasma concentration)
measure: Terminal half life (t½)
measure: Incident of hypoglycaemic episodes
measure: Adverse events
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004314: Phase II Pilot Study of Aminoimidazole Carboxamide Riboside (AICAR), a Precursor of Purine Synthesis, for Lesch-Nyhan Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lesch-Nyhan Syndrome
Keywords: Lesch-Nyhan syndrome
inborn errors of metabolism
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 1999-10-19
Enrollment: 2
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the effects of aminoimidazole carboxamide riboside (AICAR) on hematologic manifestations of Lesch-Nyhan disease.

II. Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan disease.

III. Examine the effect of AICAR on purine production.

Detailed description: PROTOCOL OUTLINE:

After a 3-day baseline, patients are treated with aminoimidazole carboxamide riboside (AICAR) by continuous infusion for 12 days. Concurrent allopurinol and folate are allowed.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Men with Lesch-Nyhan syndrome Moderate erythrocyte macrocytosis No active urinary tract disease or impaired renal function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Bruce Barshop
role: STUDY_CHAIR
References:
citation: Page T, Barshop BA, Yu A, et al.: Treatment of Lesch-Nyhan syndrome with AICAR. In: Sahota A, Tayor M, eds.: Purine and Pyrimidine Metabolism in Man VIII. Plenum Press, New York, NY: 1995, pp 353-356.
citation: Page T, Barshop B, Yu AL, Nyhan WL. Treatment of Lesch-Nyhan syndrome with AICAR. Adv Exp Med Biol. 1994;370:353-6. doi: 10.1007/978-1-4615-2584-4_76. No abstract available.
Clinical trial NCT03002714: Blood Pressure Reactivity After Resistance Exercise in Older Women
Official title: BLOOD PRESSURE REACTIVITY TO MENTAL STRESS IS ATTENUATED FOLLOWING RESISTANCE EXERCISE IN ELDERLY HYPERTENSIVE WOMEN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Exercise Pressor and Neural Responses in Older Women
Keywords: Resistance Training
Psychological Stress
Aging
Hypertension
Autonomic Nervous System
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-12-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine and compare the effects of two sessions of resistance exercise in blood pressure reactivity to a mental stress test in older hypertensive women.


Eligibility criteria: Inclusion Criteria:older hypertensive women -

Exclusion Criteria:subjects taking hormonal therapy; those with a history of metabolic, neurologic, or cardiovascular diseases other than HTN, those with a history of cardiovascular events; subjects with physical limitations; those with non-treated HTN; obesity (BMI ≥ 30.0); and subjects taking adrenergic inhibitors or non-dihydropyridinic calcium channel blockers.

-

Primary outcomes:
measure: Blood pressure reactivity to mental stress
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01804114: Continuous Local Anesthetic Infusion Following Hernia Repair
Official title: Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Kimberly-Clark Corporation
First posted: 2013-03-05
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.

Detailed description: Patients will be screened to determine study eligibility using inclusion/exclusion criteria. Following the consent process, subjects will be randomly assigned to a treatment arm (anesthetic or placebo group). Baseline data will be collected prior surgical implantation of the pain pump delivery system. Both study and control groups will be able to receive supplemental medication for breakthrough pain as determined by the surgeon. Post-operative data will be collected up to three weeks following surgery.

Eligibility criteria: Inclusion Criteria:

\>18 years

* ASA I,II,III
* Scheduled for Laparoscopic Ventral Hernia Repair

Exclusion Criteria:

* ASA IV or greater
* Needing emergency surgery
* Known history of drug abuse
* GI, liver, kidney or other condition which, per the surgeon's opinion, could interfere with the absorption, distribution, metabolism or excretion of any drug used during the duration of the study
* Patients with a prior allergic reaction or dependency to morphine, demerol, dilaudid, fentanyl, marcaine(bupivicaine), lidocaine, or ropivicaine.

Primary outcomes:
measure: Post-Operative Pain
timeFrame: Verbal Rating Scale used twice a day, up to 7 days postoperatively
Secondary outcomes:
measure: Number of Days With Post-Operative Narcotic Analgesic Use
timeFrame: Up to 3 weeks post surgery
Other outcomes:
measure: Satisfaction With PostOperative Pain Management
timeFrame: Satisfaction scores reported twice daily for up to the 7th day postoperatively
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Michael Ujiki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730114: Monitoring Antiplatelet Drugs in Cardiac Arrest Patients
Official title: Platelet Aggregation in Patients Treated With P2Y12 Inhibitors and V-A ECMO for Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Myocardial Infarction
Extracorporeal Membrane Oxygenation
Platelet Dysfunction
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
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: Patient admitted to ICU for Acute Coronary Syndrome and treated with oral P2Y12 inhibitors during primary PCI.

Brief summary: Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). There is evidence for an increased risk of stent thrombosis after PCI despite administration of DAPT in patients resuscitated from a cardiac arrest with STEMI/NSTEMI who undergo primary PCI, in particular for those treated with hypothermia. Point of Care Aggregometry represents an emerging tool to measure platelet reactivity in patient treated with antiplatelets drugs. Among patients with Acute Coronary Syndrome (ACS), those requiring Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory Cardiogenic Shock or Cardiac Arrest represent a growing population burdened by more profound metabolic, pharmacokinetic, hemostatic and physiological alterations due to increased clinical severity and ECMO itself. In addition, profound platelet inhibition can result in a higher risk of bleeding complication, since these patients have to be simultaneously anticoagulated with unfractioned heparin (UFH) and ECMO itself can cause coagulopathy. We aimed to perform an observational prospective cohort study to investigate platelet reactivity in a population of ACS patients with different clinical severity.


Eligibility criteria: Inclusion Criteria:

* Patients P2Y12 naive
* Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs

Exclusion Criteria:

* Known liver or hematological disease
* Anticoagulant therapy
* Active bleeding needing blood transfusions.

Primary outcomes:
measure: HRPR risk
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: IRCCS San Gerardo dei Tintori
state: MB
Study officials:
References:
Clinical trial NCT05651295: A Precision Medicine Approach to Target Engagement for Emotion Regulation
Official title: A Precision Medicine Approach to Target Engagement for Emotion Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Regulation
Depression
Anxiety
Borderline Personality Disorder
Obsessive-Compulsive Disorder
Posttraumatic Stress Disorder
Eating Disorders
Keywords: cognitive-behavior therapy
mechanism
ecological momentary assessment
personalization
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-12-15
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.


Eligibility criteria: Inclusion Criteria:

* Elevated emotion dysregulation

Exclusion Criteria:

* Lack of proficiency in English
* No access to smartphone
* Conditions requiring greater than outpatient care

Primary outcomes:
measure: Changes in Positive and Negative Affect Schedule-Short Form
timeFrame: 7 times per day for 42 days
Secondary outcomes:
measure: Changes in Hamilton Depression Rating Scale
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in Hamilton Anxiety Rating Scale
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in Five-Factor Model Score Sheet
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in Ways of Responding Scale
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in Opposite to Emotion Action Task
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in Breath-Counting Task
timeFrame: Once every 2 weeks for 6 weeks (4 times total)
measure: Changes in emotion regulation effectiveness
timeFrame: 7 times per day for 48 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Matthew W Southward, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349995: Amplatzer PFO Occluder Post-marketing Surveillance Study
Official title: Amplatzer PFO Occluder Post-marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: PFO - Patent Foramen Ovale
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body

Brief summary: The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Detailed description: Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").

Eligibility criteria: Inclusion Criteria:

* Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

* Refer to Amplatzer PFO occluder IFU

Primary outcomes:
measure: device- or procedure related SAE rate
timeFrame: up to 30 Days
measure: PE, DVT and ischemic stroke and atrial fibrillation rate
timeFrame: beyond 30 days through 3 years
measure: Effective PFO closure
timeFrame: At 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mita
country: Japan
facility: Abbott Medical Japan LLC
state: Minato
Study officials:
References:
Clinical trial NCT05616195: Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors
Official title: Application of 3D Printed Bone Prosthesis in Limb Salvage Surgery for Bone Tumors: a Single-center, Real-world Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malignant Tumor
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing 3D-printed bone prosthesis replacement surgery

Brief summary: To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients.

Detailed description: To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. The basic data, treatment methods, postoperative complications and limb function of these patients were collected.

Eligibility criteria: Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received 3D printed bone prosthesis replacement in our hospital.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: complications
timeFrame: From surgery to 24 months after surgery
measure: Limb function
timeFrame: Patients were enrolled until 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Bone and Soft Tissue ,Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT03208595: Endometrial Flora in Women Undergoing IVF Treatments
Official title: Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Flora Characterization in Infertile Women
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing transfer of a single euploid blastocyst .The specimen will be obtaine from the embryo transfer catheter.

Brief summary: Characterization of the female genital tract microbiome in women undergoing IVF treatment

Detailed description: The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .

Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.

The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.

Eligibility criteria: Inclusion Criteria:

* All undergoning IVF treatment
* Embryo transfer of one Blastocyst

Exclusion Criteria:

* More then one Embryo Transfer
* Recent antibacterial treatment

Primary outcomes:
measure: To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification
timeFrame: 2017-2020
measure: To identify specific endometrial flora in association to faliure of IVF treatment
timeFrame: 2017-2020
measure: to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher
timeFrame: 2017-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: