louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01602042: Adaptive Portable Essential Tremor Monitor
Official title: Phase II Study: Adaptive Portable Essential Tremor Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Keywords: essential tremor
motion sensors
tremor
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
name: Baylor College of Medicine
name: National Institute on Aging (NIA)
First posted: 2012-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Essential tremor

Brief summary: The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Clinical diagnosis of essential tremor
* Able to provide informed consent

Exclusion Criteria:

* Significant medical or psychiatric illness
* Not capable of following the required clinical instructions
* Serious medical conditions that compromise safety

Primary outcomes:
measure: Tremor ratings during activities of daily living versus standardized tasks.
timeFrame: 10 hours each day the sensor is worn.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: CleveMed Inc. also dba Great Lakes NeuroTechnologies
name: Dustin A Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03875742: Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
Official title: Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: simulation
interfascial blocks
TAP block
needles
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 70 anesthesia residents with low experience in interfascial blocks ( less than 15 interfascial blocks)will be asked to execute a Trasversus Abdominis Plane Block on "Trasversus Abdominis Plane Block Ultrasound Training Model" (BluePhantom) two times and they will be randomized in two groups.

First group will execute the first Trasversus Abdominis Plane Block using UltraPlex 360(Braun) and the second Trasversus Abdominis Plane Block using STIMUPLEX D SH, 30°(Braun).

Second group will execute the first Trasversus Abdominis Plane Block using STIMUPLEX D SH, 30°(Braun) and the second Trasversus Abdominis Plane Block using Ultraplex(Braun).
Primary purpose: OTHER

Brief summary: This study will compare two different needles for interfascial blocks. All participants will execute the block on simulator with both needles. The participants will be randomized in two groups to choose the starting needle.

Detailed description: Interfascial blocks are an emerging field of anesthesia. They are executed injecting local anesthetics inside a fascia plane using a needle.

Actually no evidence supports the use of a needle upon one other. Investigators would like to compare "Ultraplex 360®" (Braun) needle with " STIMUPLEX D SH, 30°"(Braun) while performing a Trasversus Abdominis Plane Block on BluePhantom simulator.

Ultraplex 360® (Braun) has an innovative surface pattern and clear coating that could result in better ultrasound visualization and tip identification.

Eligibility criteria: Inclusion Criteria:

* Novice interfascial block operators (\< 15 interfascial blocks executed)
* informed consent

Exclusion Criteria:

* Exper Interfascial blocks operators

Primary outcomes:
measure: Time to correct block execution
timeFrame: baseline
Secondary outcomes:
measure: Needle tip visualization
timeFrame: baseline
measure: Participant Overall Satisfaction
timeFrame: baseline
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
state: Veneto
Study officials:
References:
Clinical trial NCT03402542: Eligibility Criteria for Cholecystectomy in Ambulatory Surgery
Official title: Eligibility Criteria for Cholecystectomy in Ambulatory Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other). Hospitalisation within the CHU Brugmann Hospital between May 2016 and November 2017.

Brief summary: Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety.

"Minor" surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more "heavy" interventions, such as cholecystectomy.

The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.


Eligibility criteria: Inclusion Criteria:

* Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)

Exclusion Criteria:

* Pregnant women
* Diabetic patients under insulin treatment
* History of major abdominal surgery
* Acute cholecystitis as per anatomo-pathological examination

Primary outcomes:
measure: Surgery duration
timeFrame: Up to 4h
measure: Post surgical pain
timeFrame: Up to 1 day after surgery
measure: Nausea
timeFrame: Up to 1 day after surgery
measure: Post surgery hospitalization duration
timeFrame: Up to 10 days after surgery
measure: Medical complications after surgery
timeFrame: Up to 1 year after surgery
Secondary outcomes:
measure: Data extraction from medical files: medical history
timeFrame: 5 min
measure: Physical status score
timeFrame: 5 min
measure: Body mass index
timeFrame: 5 min
measure: Hospitalisation type
timeFrame: Up to 10 days after surgery
measure: Type of surgery
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Levon HAKOBYAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02255942: The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
Official title: The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: PATH
First posted: 2014-10-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.

Detailed description: Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.

Eligibility criteria: Inclusion Criteria:

* Female
* Serum Ferritin Level \< 15 µg/L
* Body weight \<65 kg
* Signed informed consent 4. Body Mass Index in the range of 18.5 to 25

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: baseline, 2 weeks
measure: Change from week 2 in the isotopic ratio of iron in blood at week 4
timeFrame: 2 weeks, 4 weeks
measure: Change from week 4 in the isotopic ratio of iron in blood at week 6
timeFrame: 4 weeks, 6 weeks
Secondary outcomes:
measure: Haemoglobin
timeFrame: baseline, 16th, 30th and 44th day
measure: Plasma Ferritin
timeFrame: baseline, 16th, 30th and 44th day
measure: C reactive protein
timeFrame: baseline, 16th, 30th and 44th day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH Zürich, Laboratory of Human Nutrition
state: ZH
Study officials:
affiliation: ETH Zürich
name: Michael Zimmermann, Prof.Dr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hackl L, Zimmermann MB, Zeder C, Parker M, Johns PW, Hurrell RF, Moretti D. Iron Bioavailability from Ferric Pyrophosphate in Extruded Rice Cofortified with Zinc Sulfate Is Greater than When Cofortified with Zinc Oxide in a Human Stable Isotope Study. J Nutr. 2017 Mar;147(3):377-383. doi: 10.3945/jn.116.241778. Epub 2017 Feb 1.
Clinical trial NCT00729742: Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)
Official title: A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-small Cell Lung
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).


Eligibility criteria: Inclusion Criteria:

* Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
* Patient has measurable disease
* Patient has accessible tumor and consents to undergo a tumor biopsy \[Part II only\]
* Patient is 18 years of age or older
* Patient has a performance status of 0-2 on ECOG scale
* Women of childbearing potential have a negative pregnancy test
* Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
* Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion Criteria:

* Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
* Patient has not recovered from adverse events from previous therapy within 4 weeks
* Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
* Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
* Patient has untreated brain metastases
* Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
* Patient is taking part in another clinical study
* Patient abuses drugs or alcohol
* Patient is pregnant or breastfeeding
* Subject is HIV positive
* Patient has active hepatitis
* Patient is using growth hormone or growth hormone inhibitors
* Patient has poorly controlled diabetes mellitus

Primary outcomes:
measure: Validate imaging platform and molecular markers
timeFrame: FDG response at Weeks 1 and 3 following chemotherapy
Secondary outcomes:
measure: Progression-free survival, overall survival
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00655642: Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED
Official title: A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nausea
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.


Eligibility criteria: Inclusion Criteria:

* All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.

Exclusion Criteria:

* Patients less than 18 years of age
* Unstable patients with SBP \< 90
* Patients with a stated or documented allergy to any of the study medications
* Patients whose nausea rating if \< 40 on the pretreatment VAS scale
* Patients who have received a commonly accepted antiemetic within the previous 24 hours
* Patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
timeFrame: Baseline and 30 minute assessments
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Tyler W Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.
Clinical trial NCT06170242: A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
Official title: A Randomized, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: RSV Infection
Keywords: challenge study
RSV
antiviral
RSV-A Memphis 37b
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: hVIVO Services Limited
First posted: 2023-12-14
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Age 18 to 55 years, inclusive.
* In good health with no history of major medical conditions.
* A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2.

Exclusion Criteria:

* Pregnant or nursing females
* Acute or chronic medical illness
* History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
* Abnormal lung function
* Positive for HIV, active hepatitis B or C test
* Nose or nasopharynx abnormalities
* Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Primary outcomes:
measure: Change in viral load measurements
timeFrame: Post initial dose of EDP-323 up to Day 12
Secondary outcomes:
measure: Change in Total Symptom Score (TSS)
timeFrame: Innoculation through Day 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: hVIVO Services Limited
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05819242: The Reliability And Validity Of A Smartphone App
Official title: The Reliability And Validity Of A Smartphone App For Measuring Wrist And Metacarpophalangeal Joint Motion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Carpal Tunnel Syndrome
Keywords: reliability
validity
range of motion
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy

Brief summary: The goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is:

• Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?

Participants will be evaluated by goniometers which is a gold standart for range of motion assessment.


Eligibility criteria: Inclusion Criteria:

* a history of previous traumatic hand or wrist injury in the upper extremity,
* pain in the hand and wrist during evaluation
* orthopedic, neurologic, or rheumatologic disease

Exclusion Criteria:

* not to understand the command that the therapist give

Primary outcomes:
measure: Range of Motions
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
Study officials:
References:
Clinical trial NCT00724542: Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
Official title: Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Impaired Glucose Tolerance
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Takeda
First posted: 2008-07-29
Enrollment: 1600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary heart disease
* Impaired Glucose Tolerance

Exclusion Criteria:

* Age \< 40yr or \> 75yr
* Diabetes Mellitus
* Scr \> 2.0 mg/dL（176 μmol/L）
* ALT or AST \> 2.5 ULN
* Hb \< 90g/L
* Heart Failure
* Infection
* Undergo other interventional clinical trial

Primary outcomes:
measure: TypeⅡDiabetes Mellitus
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of Cardiovascular Events
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Wenhui Ding, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05134142: Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy
Official title: Quality of Life and Function of Patients After Hemipelvectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Primary Pelvic Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients within the institution who have undergone or will undergo a hemipelvectomy.

Brief summary: This study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. Learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.

Detailed description: PRIMARY OBJECTIVE:

I. To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.

SECONDARY OBJECTIVES:

I. To determine factors that influence the functional outcomes of these patients following surgery.

II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.

III. Determine whether type of surgery influences long-term sexual and urinary function.

OUTLINE:

Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.

Eligibility criteria: Inclusion Criteria:

* Patients within the institution who have undergone or will undergo a hemipelvectomy

Exclusion Criteria:

- None

Primary outcomes:
measure: Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy
timeFrame: Through study completion, average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Valerae O Lewis
role: PRINCIPAL_INVESTIGATOR
References: