louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00775983: Dilapan Versus Laminaria
Official title: Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Preparation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.

Hypothesis:

Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.

Primary objective:

Determine differences in procedure times

Secondary objectives:

Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria


Eligibility criteria: Inclusion Criteria:

* Pregnancy between fourteen and eighteen weeks gestation
* Request for elective abortion and certainty of decision to proceed

Exclusion Criteria:

* Incarceration
* Minor status (women younger than eighteen years)
* Allergy to Dilapan or laminaria
* Inability to speak and understand Spanish or English

Primary outcomes:
measure: Procedure Time
timeFrame: Day of procedure
Secondary outcomes:
measure: Participants Who Experienced Complications or Need for Additional Dilation
timeFrame: Day of procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
References:
citation: Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.
Clinical trial NCT05674097: Blood Flow Path Reconstruction in Rectal Cancer
Official title: Blood Flow Path Reconstruction in Rectal Cancer After High IMA Ligation Through Preoperative and Postoperative Comparison by Manual Subtraction CTA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Surgery
Image
Lead sponsor: Shandong First Medical University
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
First posted: 2023-01-06
Enrollment: 89
Sex: ALL
Minimum age (years): 39
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with distal sigmoid colon or rectal cancer and they were received routine laparoscopic surgery.

Brief summary: 89 patients with distal sigmoid and rectal cancer were referred in our observation and underwent MS-CTA between June 2020 and March 2022. We classified the distribution of LCA and confirmed whether there exists AMCA (accessory middle colic artery). Then we planned blood flow path based on the classification of LCA branches before operation. High ligation was applied in regular radical surgery. During operation, we carefully protect the bifurcation of ascending and descending LCA. Then we compared the planned blood flow path with the actual postoperative blood flow path to verify the mechanism we proposed previously.


Eligibility criteria: Inclusion Criteria:

* (1) patients with distal sigmoid colon and rectal cancer; (2) cTNM stage was confirmed to be I-III on MRI or CT; (3) Laparoscopic anterior resection (LAR) was performed.

Exclusion Criteria:

* (1) The starting time of arterial phase scanning is earlier； (2) The anatomic structure is not clear; (3) No enhanced CT after operation (only 5 cases).

Primary outcomes:
measure: Six pattens of blood flow and AMCA based on the preoperative observation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Guoqin LIU
state: Shandong
Study officials:
References:
Clinical trial NCT02968797: Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
Official title: SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apnea
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to perform endoscopy procedures under sedation

Brief summary: SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.

Detailed description: Patients performing endoscopy procedures under sedation at the gastro clinic will be monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist. All patients will be monitored using the same two techniques (SafeSed and Capnography). No clinical decisions will be made based upon the data generated by the SafeSed system.

The data from all sources will be compared (post factum) to validate SafeSed performance.

The data collected on the SafeSed prototype will not be used for treatment of the patient.

The comparative analysis will be free vto be used by the sponsor.

Eligibility criteria: Inclusion Criteria:

* class 1-3 per American Society Anesthesiologists Physical Status Classification
* Subject signed Informed Concent Form

Exclusion Criteria:

* Pregnancy
* Unresolved pulmonary infection requiring active treatment
* Chronic pulmonary disease
* Any othe medical condition, that treating physician determines participating in the study is unadvisable

Primary outcomes:
measure: Comparative data of monitoring respiratory by 2 technologies
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Israel: Clalit Health bServices
name: Brian Fredman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845897: Botulinum Toxin Effects on Plantar Ulcer Recurrence
Official title: Botulinum Toxin Effects on Plantar Ulcer Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Peripheral Neuropathy
Plantar Ulcers
Keywords: Diabetes mellitus
plantar ulcers
peripheral neuropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-02-18
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The decrease in plantar pressure will provide temporary protection to the new tissue as it gains tolerance to high stress with the long term potential outcome as a decrease in the ulcer recurrence rate.

Detailed description: Please read "Brief Summary"

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
* A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
* Ambulatory

Exclusion Criteria:

* Active infection in the involved foot
* Previous botulinum toxin injections
* Ulcers on the dorsal surface of the foot
* Ankle-brachial index \<0.45
* History of cerebral vascular accident or other neurological problems complicating their rehabilitation
* Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
* Current drug therapy that includes an anticoagulant
* History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus

Primary outcomes:
measure: Plantar Flexor Muscle Strength
timeFrame: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing
Secondary outcomes:
measure: Barefoot Plantar Pressure
timeFrame: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary K Hastings, PT, DPT, ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641297: White Matter Plasticity in Schizophrenia
Official title: White Matter Plasticity in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia Disorders
Keywords: music
training
plasticity
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Schizophrenia spectrum disorders are associated with impairment in the microstructure of white matter, the key brain tissue responsible for fast communication between different brain regions necessary for any complex task. This white matter impairment is linked to problems with cognition in schizophrenia, especially slower processing speed. This project aims to study the potential for correcting white matter deficits in schizophrenia by examining mechanisms underlying white matter structure changes in response to training on playing a mock musical instrument.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis NOS
* age 15-45
* able to provide informed consent

Exclusion Criteria:

* contraindications to MRI (metal implants, claustrophobia)
* medical condition that limits use of hands (ie, arthritis)
* Active or recent (within 6 months) substance use disorder other than nicotine

Primary outcomes:
measure: White matter microstructure
timeFrame: 3 weeks
Secondary outcomes:
measure: Brain level of N-acetylaspartate
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
city: Catonsville
country: United States
facility: University of Maryland Baltimore - Maryland Psychiatric Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT00518297: DDI HV (ATV - Merck)
Official title: Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Antivirals / HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-08-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
* Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
* Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
* Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Primary outcomes:
measure: Safety Assessments
timeFrame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
measure: Pharmacokinetic Assessments
timeFrame: Days 5, 12, and 26
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Bristol-Myers Squibb Clinical Pharmacology Unit
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06568497: Dairy and Vegan Cheese: Effect on Satiety and Blood Glucose
Official title: Sensory, Satiating and Glycaemic Characteristics of Cheese and Non-dairy Alternative Products to Cheese
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Glucose
Satiety Response
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
Collaborators: name: Dairy Farmers of Canada
First posted: 2024-08-23
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The project will consist of two studies. One study will explore the satiating properties of dairy cheese and its dairy-free substitute when consumed ad libidum, and another study will investigate their effects on postprandial glycemia. Both studies will involve healthy young adults. The secondary outcomes of these studies will be food sensory characteristics, diet-induced thermogenesis, subjective feeling of fatigue and energy, gastrointestinal comfort level, and food intake. The proposed project results will help to better understand the health properties of the cheese and its dairy-free substitute.


Eligibility criteria: Inclusion Criteria:

* Young healthy adults

Exclusion Criteria:

* Breakfast skipper
* Smoker (including e-cigarettes) / cannabis consumer
* Be underweight, overweight or obese
* Have chronic diseases, including diabetes
* Taking certain medication
* Have lactose intolerance, food allergies or gastrointestinal disorders (e.g., irritable bowel syndrome, or others).

Primary outcomes:
measure: Blood glucose
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
measure: Satiety
timeFrame: 0-120 minutes
measure: Food intake
timeFrame: 0 minutes, 120 minutes
Secondary outcomes:
measure: Energy and Fatigue
timeFrame: 0-120 minutes
measure: Gastrointestinal comfort
timeFrame: 0-120 minutes
measure: Diet-induced thermogenesis
timeFrame: 0-120 minutes
measure: Sensory characteristics
timeFrame: 0 minutes, 120 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
References:
Clinical trial NCT00477997: Effect of Growth Hormone on Insulin Signaling in Muscle Tissue
Official title: The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Growth Hormone
Insulin Signaling
GH signaling
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2007-05-24
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.


Eligibility criteria: Inclusion Criteria:

* Male
* Healthy
* Age between 18 and 30 years
* BMI ≤ 26

Exclusion Criteria:

* Known present disease including diabetes mellitus
* BMI \> 26
* Uses any medication
* Consumes \> 21 units of alcohol per week

Primary outcomes:
measure: PI3-kinase activity i muscle tissue
timeFrame: 2 hours
Secondary outcomes:
measure: Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
timeFrame: 2 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department M (endocrinology and diabetes)
Study officials:
affiliation: Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark
name: Jens Otto L Jørgensen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krusenstjerna-Hafstrom T, Madsen M, Vendelbo MH, Pedersen SB, Christiansen JS, Moller N, Jessen N, Jorgensen JO. Insulin and GH signaling in human skeletal muscle in vivo following exogenous GH exposure: impact of an oral glucose load. PLoS One. 2011 May 3;6(5):e19392. doi: 10.1371/journal.pone.0019392.
Clinical trial NCT02641197: Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study
Official title: Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: flow-mediated dilation
AngioDefender
device precision
repeatability
reproducibility
cardiovascular diseases
Lead sponsor: Everist Genomics, Inc
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 20
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: The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.

Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.

Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.


Eligibility criteria: Inclusion Criteria:

1. Men and women, ≥18 years old
2. Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm
3. Sinus arrhythmia, atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting muscle tremor or inability to remain still for the duration of the testing period
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Diabetic subjects - Type I or II
8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Primary outcomes:
measure: Change from baseline %flow-mediation dilation (%FMD) at 1 hour
timeFrame: Daily x 4 consecutive days
Secondary outcomes:
measure: Reproducibility of multiple %FMD determinations by AngioDefender
timeFrame: Daily x 4 consecutive days
measure: Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03
timeFrame: 4 consecutive days (maximum 5 days)
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Windsor
country: Canada
facility: Hotel-Dieu Grace Healthcare
state: Ontario
Study officials:
affiliation: Everist Genomics, Inc
name: Peter F Lenehan, MD PhD
role: STUDY_DIRECTOR
References: