louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02090062: Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection
Official title: Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Gastric Cancer
Keywords: endoscopic resection
H. pylori infection
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with early gastric lesions

Brief summary: Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.

Detailed description: Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection（ER） is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis，which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.

Eligibility criteria: Inclusion Criteria:

* high grade dysplasia(HGD) and EGC patients treated by endoscopic resection(including EMR and ESD) in Ren Ji hospital

Exclusion Criteria:

* Suspect of advanced gastric cancer
* Lesions with light grade dysplasia
* History of gastric surgery
* Poor gastrointestinal preparation
* Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Primary outcomes:
measure: difference in H. pylori infection rate before and after ER
timeFrame: in two weeks after endoscopic resection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai,China
name: Xiaobo Li, MD.Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261362: Impact of Branched-chain Amino Acids in the Development of Insulin Resistance
Official title: Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

Detailed description: The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.

The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

Eligibility criteria: Inclusion Criteria:

* Diabetes type 2
* Non smokers
* Untrained
* Willingness to adhere to a diet intervention

Exclusion Criteria:

* Chronic disease
* Pregnancy
* Cancer
* Antibiotic therapy
* Drug/alcohol abuse
* Competitive athletes

Primary outcomes:
measure: Clamp test
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Mixed Meal Test
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Centre
Study officials:
affiliation: Deutsches Diabetes Zentrum
name: Michael Roden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karusheva Y, Koessler T, Strassburger K, Markgraf D, Mastrototaro L, Jelenik T, Simon MC, Pesta D, Zaharia OP, Bodis K, Barenz F, Schmoll D, Wolkersdorfer M, Tura A, Pacini G, Burkart V, Mussig K, Szendroedi J, Roden M. Short-term dietary reduction of branched-chain amino acids reduces meal-induced insulin secretion and modifies microbiome composition in type 2 diabetes: a randomized controlled crossover trial. Am J Clin Nutr. 2019 Nov 1;110(5):1098-1107. doi: 10.1093/ajcn/nqz191.
Clinical trial NCT01804062: Respiration Rate V2.0 in Healthy Volunteers
Official title: Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of the Study is Measuring Respiratory Rate
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer subjects with no significant medical problems

Brief summary: The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).

Detailed description: Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.

The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects.
* 18 years or older.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Subject is younger than 18.
* Subject is pregnant or lactating
* Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
* Subject has an abnormality that may prevent proper application of the device.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
* Subject has an implanted pacemaker.
* Subject is unwilling or unable to sign informed consent.

Primary outcomes:
measure: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
timeFrame: up to 40 minutes of continous monitoring
Secondary outcomes:
measure: ME +/- 1 Breath Per Minute, Max-N Sensor
timeFrame: up to 40 minutes of continuous monitoring
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder In-House Clinical Laboratory
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Scott D Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449862: Key Information Can Influence Clinician Ordering of Brain CTs
Official title: Effect of Clinical Decision Rules, Patient Cost and Malpractice Information on Clinician Brain CT Image Ordering: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Decision-Making
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
name: Emory University
First posted: 2018-02-28
Enrollment: 167
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, double-blinded simulation-based randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns. Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians. Using simulation, we explored whether the presentation of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems.

Detailed description: Multi-center, double-blinded simulation-based randomized controlled trial. Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient. This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order. The malpractice and cost information differed by assigned group to test the any temporal relationship. The simulation closed with a second vignette and an imaging decision.

Eligibility criteria: Inclusion Criteria:

* Clinician (physician, nurse practitioner, physician assistant) licensed to deliver health care.
* Actively employed to deliver health care in the emergency department of Greenville health System (South Carolina) or Emory University (Georgia)

Exclusion Criteria:

* None

Primary outcomes:
measure: brain CT medical image order
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clemson University
name: Ronald W. Gimbel, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gimbel RW, Pirrallo RG, Lowe SC, Wright DW, Zhang L, Woo MJ, Fontelo P, Liu F, Connor Z. Effect of clinical decision rules, patient cost and malpractice information on clinician brain CT image ordering: a randomized controlled trial. BMC Med Inform Decis Mak. 2018 Mar 12;18(1):20. doi: 10.1186/s12911-018-0602-1.
Clinical trial NCT01479062: Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
Official title: Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Diabetes
Obesity
Keywords: behavior change
pre-diabetes
prevention
diabetes prevention
Hemoglobin A1c
glucose
physical activity
nutrition
email
web
obesity
Lead sponsor: Berkeley Analytics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Palo Alto Medical Foundation
First posted: 2011-11-24
Enrollment: 339
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.


Eligibility criteria: Inclusion Criteria:

* at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
* at least one measurement of body mass index (BMI) \>=27 in the past two years
* age 40-79
* no use of diabetes medications within the past two years
* member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
* live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA

Exclusion Criteria:

* comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension

Primary outcomes:
measure: Change from baseline in body weight
timeFrame: at 3 months, 6 months and one year
measure: Change from baseline in diabetes risk markers
timeFrame: at 3 months, 6 months and one year
Secondary outcomes:
measure: Change from baseline in physical activity and dietary factors
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
Study officials:
affiliation: Berkeley Analytics, Inc.
name: Gladys Block, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.
citation: Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.
Clinical trial NCT06261762: Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone
Official title: Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone: A Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Wound Heal
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for consecutive (two) teeth extraction in the anterior maxilla.

Brief summary: The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:

* Is significant alveolar ridge resorption observed at center sites after consecutive extractions
* Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
* Is a thick or thin wall phenotype associated with the amount of bone resorption
* Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
* Is the interdental papilla height significantly affected after extractions.

Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks.


Eligibility criteria: Inclusion Criteria:

* 18+ years old
* Require consecutive (two) teeth replacement in the anterior maxilla
* Signed informed consent
* No significant medical conditions
* Patients with healthy periodontal conditions or previously treated to controlled and stable conditions

Exclusion Criteria:

* General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
* Pregnancy or nursing
* Any interfering medication such as steroid therapy or bisphosphonate therapy
* Uncontrolled diabetes
* Autoimmune diseases or inflammatory diseases affecting the intraoral tissues
* Radiation therapy to head or neck region

Primary outcomes:
measure: Bone level change from baseline
timeFrame: Baseline and at 8 weeks
measure: Soft tissue change from baseline
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum.
timeFrame: Baseline and at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Feng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06029062: tACS for Sensory Motor Recovery After Stroke
Official title: tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Recovery
Keywords: tACS
Motor recovery
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.


Eligibility criteria: Inclusion/exclusion criteria for stroke subjects

Inclusion criteria:

1. Age between 18\~75 years old
2. ≥ 6 months post stroke, medically stable;
3. Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
4. Visible finger flexor activation/movement
5. The ability to give consent

Exclusion criteria:

1. Patients with visual deficit/neglect; hearing or cognitive impairment;
2. Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
3. Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \<2 years;
4. Patients with pacemaker, metal implants or supplemental oxygen;
5. Patients who have musculoskeletal disorders, including pain in the affected side
6. Women who are pregnant.

Primary outcomes:
measure: Block and Box Test (BBT) of Motor functional test
timeFrame: Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured.
measure: EEG alpha band and Beta band
timeFrame: Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651962: Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
Official title: Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor Pain
Keywords: Labor Pain
Analgesia, Epidural
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.


Eligibility criteria: Inclusion Criteria:

* in labor
* labor pain \>3 on visual analog scale (VAS)

Exclusion Criteria:

* cardiovascular disease
* preeclampsia
* diabetes mel-litus
* thyroid disease
* current (outpatient) opioid medication
* recent and / or current use of cocaine
* seizure disorder
* psychiatric disease
* body mass index \>35
* preterm labor (\<37 weeks pregnant)
* known allergies to any of the three study substances

Primary outcomes:
measure: reduction of pain score on a visual analog scale (VAS) of 1-10
timeFrame: 0-30 minutes
Secondary outcomes:
measure: movement during epidural placement
timeFrame: 0-30 minutes
measure: position during epidural placement
timeFrame: 0-30 minutes
Other outcomes:
measure: hemodynamic and oxygenation assessment of parturient and fetus, side effects
timeFrame: 0-30 minutes
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Kai Schoenhage, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375062: Obtaining Undifferentiated Cells From Testis Biopsy
Official title: Isolation, Culture and Characterization Stem Cells From Testis Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Azoospermia
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.

Detailed description: Testicular biopsies were obtained from azoospermic patients as part of their diagnosis and work-up after obtaining a signed informed consent. A portion of each sample was mechanically dissected in PBS with 1% Pen/Strep. For enzymatic digestion samples were incubated with 0.5g/ml Collagenase type 1A for 20min and TripLE Select for 15min at 37ºC on a shaker and then filtered with 30µm and centrifuged at 1,000rpm. The pellets were seeded and incubated in embryonic stem cell media (hESC) with glial cell line-derived neurotrophic factor (GDNF 4ng/mL) for 5-7 days at 37ºC (1st culture). To identify and isolate SSCs they were marked with CD49f antibody and FACS sorted. Positive cells were cultured in gelatine plates containing hESC media with leukaemia inhibitory factor (LIF1000U/mL) (2nd culture).

Eligibility criteria: Inclusion Criteria:

-azoospermic patients

Primary outcomes:
measure: Assessment of potential germinal and pluripotent of the isolated cultures.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Carlos Simon, MDPhD
role: STUDY_DIRECTOR
affiliation: Fundación IVI
name: Marcia Riboldi, PhD
role: PRINCIPAL_INVESTIGATOR
References: