louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00964444: Demonstration of a New Device to Measure the Force of Delivering a Baby
Official title: Demonstration of a New Device to Measure the Force of Delivering a Baby
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Term Singleton Pregnancy
Keywords: Labor and delivery
Vaginal delivery
Lead sponsor: Pinnacle Health System
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an uncomplicated singleton pregnancy at term in active labor, who are anticipated to have a vaginal delivery.

Brief summary: This study is an observational study to prove that a new device, which measures the force of delivering a baby, (US patent 6,684,165) functions as described in the patent. This is the first time this has been used with patients.

Detailed description: Currently, there is no way to measure how hard a doctor or midwife pulls when a baby is delivered. This device is a platform with special sensors. The doctor or midwife stands/sits on the platform while delivering the baby, and using a simple physical principle: for every action, there is an equal an opposite reaction. Prior to building the prototype and starting the study, the system and concept has been patented (US patent 6,684,165). In reality, this is not really a medical device since it does not touch the patient and does not have any effect on the delivery itself. It is merely a new type of external observation of the delivery of a baby that happens to produce useful information (the force that is exerted when the baby is delivered).

Eligibility criteria: Inclusion Criteria:

* Pregnancy at term
* Singleton gestation
* Vertex presentation

Exclusion Criteria:

* Non-reassuring fetal heart rate tracing

Primary outcomes:
measure: Force Exerted on a Fetus as the Delivery Occurs
timeFrame: Assessment was done after the delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Harrisburg Hospital
state: Pennsylvania
Study officials:
affiliation: Pinnacle Health System
name: David B Peisner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peisner DB. A device that measures the pulling force and vector of delivering a baby. Am J Obstet Gynecol. 2011 Sep;205(3):221.e1-7. doi: 10.1016/j.ajog.2011.04.029. Epub 2011 Apr 24.
Clinical trial NCT00310544: Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
Official title: Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* At least 8 weeks post-documented myocardial infarction (heart attack)

Exclusion Criteria:

* History of radiation therapy to the chest
* Clinically unstable
* Any contraindication for MRI

Primary outcomes:
measure: Quantitative measurement of the total area of delayed enhancement
timeFrame: 30 min post injection
Secondary outcomes:
measure: Quantitative measures of area of delayed enhancement and signal intensities
timeFrame: At 5, 10 and 20 minutes post injection
measure: Semiquantitative measures of area of delayed enhancement
timeFrame: At 5, 10, 20 and 30 minutes post injection
measure: Presence of delayed enhancement
timeFrame: At 5,10 and 20 minutes post injection
measure: Wall motion endpoints
timeFrame: Pre-injection
measure: Safety
timeFrame: From baseline to 24h follow-up of second imaging
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Winston-Salem
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Buenos Aires
country: Argentina
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02928744: Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Keywords: Resistance
Forced oscillations
Dyspnea
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 23
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: Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc...) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.


Eligibility criteria: Inclusion Criteria:

* COPD with dyspnoea with Medical Research Council scale (MRC) \>1,
* No exacerbation for 6 weeks
* No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.
* Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit
* Having given a written consent

Exclusion Criteria:

* Patient Under 18
* Other respiratory illness
* Clinically significant left cardiac failure
* Obesity with BMI \> 35 kg / m2)
* Unable to perform respiratory evaluations
* Contraindication to the salbutamol or to the ipratropium bromide or to one of its components
* Pregnant or breast-feeding woman
* Unable to agree
* No social security scheme

Primary outcomes:
measure: Percentage of obstruction reversibility
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Hélène Neveu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05185544: Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma
Official title: Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensitivity
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma

Brief summary: Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma


Eligibility criteria: Inclusion Criteria:

* 1. Aged between 18 and 75 years;
* 2. Lung adenocarcinoma;
* 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy
* 4 .The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

* 1. Patients with a history of lung surgery;
* 2. Postoperative pathology showed non-primary lung cancer;
* 3. Patients with a history of other tumors;
* 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
* 5. Unable to cooperate with the researchers because of dementia or cognitive decline
* 6. Other situations that are not in conformity with the standards and requirements of this trial.

Primary outcomes:
measure: Tumor Regression Grade
timeFrame: 1-2 Weeks after enrollment (after Surgery)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05393544: Digitally Assisted Recovery Coach
Official title: Digitally Assisted Virtual Recovery Coach to Improve Inpatient Alcohol Withdrawal Management: A Proof-of-concept Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Withdrawal
Keywords: alcohol use disorder
peer recovery coach
smartphone app
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65
* Diagnosis of DSM-5 alcohol use disorder
* Admitted to Brigham and Women's Faulkner Hospital (BWF) inpatient Addiction Recovery Program to treat alcohol withdrawal
* Own either an iOS or Android smartphone device
* Have an active email address
* English speaking

Exclusion Criteria:

* Inability to provide informed consent due to delirium or other cognitive impairments
* Current psychosis, suicidality or homicidality

Primary outcomes:
measure: Feasibility of coach engagement
timeFrame: 30 days
Secondary outcomes:
measure: Feasibility of monitoring clinical status
timeFrame: 30 days
measure: Linkage to care
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02893644: Optical Coherence Pachymetry to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis
Official title: Optical Coherence Pachymetry (OCP) to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis (LASIK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing refractive surgery with LASIK

Brief summary: Prospective study aiming to measure central ablation depth during excimer laser surgery in myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP, before and after laser ablation. This measurement will be compared with pre and 1 month postoperative topography differential pachymetric measurements.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* undergoing refractive surgery with LASIK
* with myopic or compound myopic astigmatism ametropia
* without irregular cornea and topographical sign of keratoconus
* preoperative corneal thickness compatible with LASIK

Exclusion Criteria:

* hyperopia
* opposition to participate in the study
* no health insurance coverage
* patient under legal protection
* pregnant or breastfeeding patient

Primary outcomes:
measure: depth of central corneal ablation
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: SALOMON
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Jean-Luc FEBBRARO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718744: Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
Official title: Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Keywords: Allergen-extract
Standardization
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

Detailed description: The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Eligibility criteria: Inclusion Criteria:

* Voluntarily signed informed consent form by the patient
* Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.
* Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil the inclusion criteria.
* A positive case history with inhalant allergy related to exposure to the allergen to be tested.
* A positive prick test (mean wheal diameter \> 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.
* A mean wheal diameter \> 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
* Age: 18-50 years.
* Both genders

Exclusion Criteria:

* Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
* Use of drugs that may interfere with the skin reactions.
* Pregnancy
* Dermographism
* Atopic dermatitis (locally at the test site)
* Urticaria.

Primary outcomes:
measure: Wheal size area (mm2) of the immediate phase reaction.
timeFrame: 30 minutes per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Calde
country: Spain
facility: Hospital "Xeral de Calde"
state: Lugo
Study officials:
name: Manuel Boquete, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026544: Effect of Low Frequency Ultrasound on Kidney Function
Official title: Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: low frequency ultrasound
glomerular filtration rate
Lead sponsor: Sonogenix
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Must be \>/= 18 years of age
* Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease
* Females with childbearing potential must not be pregnant at the time of study
* Subject must provide written informed consent

Exclusion Criteria:

* Unable or unwilling to cooperate with study procedures
* Currently enrolled in another clinical study for which the follow-up period is not complete

Primary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: Baseline and 15 minutes after start of Intervention
Secondary outcomes:
measure: Percent change in GFR
timeFrame: Baseline and 15 minutes after start of Intervention
measure: Blood Pressure
timeFrame: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention
Other outcomes:
measure: Cutaneous Injury
timeFrame: 5 minutes after LOTUS intervention
measure: Heart rate
timeFrame: Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention.
Locations:
city: San Francisco
country: United States
facility: Department of Radiology and Biomedical Imaging, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Randall A Hawkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dae MW, Liu KD, Solomon RJ, Gao DW, Stillson CA. Effect of Low-Frequency Therapeutic Ultrasound on Induction of Nitric Oxide in CKD: Potential to Prevent Acute Kidney Injury. Kidney Dis (Basel). 2020 Nov;6(6):453-460. doi: 10.1159/000509819. Epub 2020 Aug 21.
Clinical trial NCT02500992: Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy
Official title: Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diverticular Disease
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 40
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: Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.

Brief summary: Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.

Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.

In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.


Eligibility criteria: Inclusion Criteria:

* Status post several episodes of diverticulitis
* Status post contained diverticulitis

Exclusion Criteria:

* not able to give informed consent
* \<18 years of age
* pregnancy
* emergency operation
* acute diverticulitis

Primary outcomes:
measure: Peritoneal bacterial contamination
timeFrame: during surgery
measure: Contamination in the rectal stump after wash-out
timeFrame: during surgery
Secondary outcomes:
measure: septic complications
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland Bruderholz
Study officials:
References:
Clinical trial NCT01065792: Stocrin Re-examination Study (0831-028)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 728
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HIV-1 infection treated with STOCRIN

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* HIV-1 Infected Patient
* Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)

Exclusion Criteria:

* Patient Who Has A Contraindication To Stocrin According To The Local Label

Primary outcomes:
measure: Percent of patients with any adverse experience
timeFrame: Up to 14 days following cessation of treatment
measure: Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment
timeFrame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
measure: Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)
timeFrame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: