louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377415: Continuous Subacromial Bupivacaine
Official title: The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthroscopy
Keywords: arthroscopy
shoulder surgery
subacromial
continuous bupivacaine
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-06-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after shoulder arthroscopy with standard surgical techniques, including rotator cuff operations. The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.

Detailed description: Shoulder surgery has become a routine outpatient procedure. Previously shoulder surgery was associated with intense, occasionally severe postoperative pain and hence considerable use of opioids. Also arthroscopic shoulder surgery, especially rotator cuff procedures, may cause significant pain resulting sometimes in inpatient admission. Subacromial local anaesthetic infusion as a part of a multimodal approach is one commonly used modality to pain relief after shoulder surgery. Nevertheless, it has been criticized recently for its poor benefits and possible adverse effects. On the whole, the scientific evidence of the advantages of local anaesthetic infusions is inconclusive.

Eligibility criteria: Inclusion Criteria:

* subacromial impingement disease
* scheduled for an elective arthroscopic surgery

Exclusion Criteria:

* liver disease
* renal impairment
* psychiatric disorder
* alcohol abuse
* obesity (a body mass index of \> 35 kg/m2)
* allergies to the drugs used in the study

Primary outcomes:
measure: The consumption of analgesics (oxycodone)
timeFrame: It was recorded on a daily basis during the first three days
Secondary outcomes:
measure: The intensity of pain
timeFrame: During the study the pain assessments were recorded 15 min before operation, 15 min, 6, 12 and 18 h after the beginning of the operation and on the first and third postoperative day
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital and University of Turku
Study officials:
References:
Clinical trial NCT05120115: Optimization of Hip-exoskeleton Weight Attributes
Official title: Evaluating Optimal Weight Design Parameters of a Hip Exoskeleton Designed for Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Gait, Frontal
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are examining how weight distribution affects the way people walk, in terms of joint kinematics, kinetics, and muscle activity. The investigators are measuring these quantities while people walk while wearing a weighted belt. The investigators distribute the weights and walk for specified periods. They hypothesize that greater weight will have a greater effect on walking.

Detailed description: The purpose of this study is to examine how the amount and distribution of weight on the pelvis affects how people walk. The investigators two factors, weight and placement. They are examining how these factors affect muscle activation, joint motions and foot forces. The investigators plan to recruit 40 healthy adult individuals. Each of the 20 experimental conditions (3x3 factorial and one control condition with no weight) will be recorded immediately in a single session. The investigators hypothesize that weight amount, gait speed and weight distribution will all affect how people walk, which will lead towards optimized design of hip exoskeletons.

Eligibility criteria: Inclusion Criteria:

* Willing to commit to the full experimental session

Exclusion Criteria:

* Functionally relevant lower limb musculoskeletal injury

  * Functionally relevant osteoarthritis and weight bearing restrictions
  * Severe respiratory problems that restrict the wearer from using a metabolic rate apparatus
* Patients with cardiac issues may be included, but the cardiac issue will be noted in the health history questionnaire

Primary outcomes:
measure: Pelvic Obliquity
timeFrame: One day
Secondary outcomes:
measure: Knee Flexion Angle During Swing Phase
timeFrame: One Day
measure: Integrated Gastrocnemius Muscle Activity During Preswing Phase of Walking
timeFrame: One day
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT02742415: Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study
Official title: Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: Since there is a limited amount of evidence on the feasibility and outcomes on the use of hand massage in patients undergoing cancer treatment, the purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.


Eligibility criteria: Inclusion Criteria:

1. Patients age 18 - 80
2. Patient receiving treatment on Mayo Clinic's Chemotherapy Outpatient Clinic
3. Able to speak English and complete surveys
4. Able to read, understand and sign inform consent.

Exclusion Criteria:

1. Patient has rash, sores, wounds, incision or other skin conditions on hands
2. Unable to give consent or complete the surveys
3. Already having received previous hand massage
4. Pregnant women. (As verbalized by participant)

Primary outcomes:
measure: Comparison of symptom scores
timeFrame: baseline to 45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Susanne M Cutshall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04758715: Diet and Microbiome Longitudinal Monitoring With Food Intervention
Official title: Diet and Microbiome Longitudinal Monitoring With Food Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Microbiome, Human
Gastrointestinal Tract
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.


Eligibility criteria: Inclusion Criteria:

* willing to sign consent and have samples collected,
* able to read and speak English,
* participants must be willing to use an electronic food diary and consume study provided foods,
* only individuals able to provide a US address will be included.

Exclusion Criteria:

* Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative \[LAR\]),
* Current parenteral nutrition,
* Received cancer treatment within past 6 months prior to signing consent,
* Taken antibiotic treatment within the past 1 month prior to signing consent,
* Received oral x-ray contrast within the past 1 month prior to signing consent,
* Received any type of gastrointestinal bowel preparation in the past 1 month prior to signing consent,
* History of organ transplant,
* Shellfish allergy,
* Insect allergy,
* Cacti allergy,
* Carmine allergy,
* Dragon fruit (pitaya) allergy,

Primary outcomes:
measure: Microbiota variation
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska - Lincoln
state: Nebraska
Study officials:
affiliation: Univeristy of Nebraska-Lincoln
name: Jacques Izard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004315: Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cystic Fibrosis
Gastrointestinal Diseases
Cholestasis
Keywords: cardiovascular and respiratory diseases
cholestasis
cystic fibrosis
gastrointestinal disorders
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.

II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

Detailed description: PROTOCOL OUTLINE:

Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic cholestatic liver disease

Cystic fibrosis-associated liver disease

--Prior/Concurrent Therapy--

Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil

--Patient Characteristics--

Pulmonary: No serious respiratory deficiency

No acute illness

No inability to swallow

No fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: William Balistreri
role: STUDY_CHAIR
References:
Clinical trial NCT02693015: Impact of Time to Coronary Angiography on Survival for NSTEMI
Official title: Impact of Time to Coronary Angiography on Survival for NSTEMI: an Observation Study Using a Nationwide Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non ST-elevation Myocardial Infarction
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 235986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.

Brief summary: This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.

Detailed description: The use of an invasive strategy for the management of NSTEMI according to estimated risk of 6 month mortality is recommended by international guidelines. NSTEMI appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with NSTEMI who are medically managed. Whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (\<24, 24-72, 72-96 and \<96 hours) is based upon estimated clinical risk (using the GRACE risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. Moreover, the investigators recent research has shown that in the UK, may NSTEMI (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death.

This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. It will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. The investigators anticipate that this observational study will provide Level B evidence for the benefits of the timing of an invasive strategy according to the GRACE risk score. The investigators are aware that the NICE guidelines for the management of acute chest pain are to be updated in 2016.

Eligibility criteria: Inclusion Criteria:

* The target population will be all patients aged 18 to 100 years recorded within MINAP from 2004 to 2013 who have been hospitalised with NSTEMI and received coronary angiography.

Exclusion Criteria:

* Age below 18 or above 100 or age missing
* Diagnosis not NSTEMI
* Patients who did not receive coronary angiography - as this is the investigators explanatory variable

Primary outcomes:
measure: All-cause mortality
timeFrame: 30-day mortality since hospitalisation
measure: Mortality
timeFrame: 1-year mortality since hospitalisation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03237715: Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
Official title: Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Jaundice
Lead sponsor: Rutgers University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and late preterm infants admitted to regular care nursery

Brief summary: Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life.

Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels.

Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.


Eligibility criteria: Inclusion Criteria:

* Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study

Exclusion Criteria:

* Infants suffering from genetic, chromosomal or surgical conditions will be excluded.

Primary outcomes:
measure: Unbound bilirubin levels in term and late preterm infants
timeFrame: Two years
measure: Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants
timeFrame: Two years
measure: Effect of phototherapy on unbound bilirubin levels
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT05122715: Demonstration Of A Next Generation PET CT System
Official title: Demonstration Of A Next Generation PET CT System (OMNI dBGO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncology
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).


Eligibility criteria: Inclusion Criteria:

1. Adult, who is at least 18 years of age;
2. A clinical indication for PET/CT examination according to current clinical practice standards;
3. Able and willing to provide informed consent for participation in this study

Exclusion Criteria:

1. Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
2. Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
3. Previously enrolled in this study.

Primary outcomes:
measure: Evaluation- Likert Scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Data Collection
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
Study officials:
affiliation: GE Healthcare
name: Brian W Thomsen
role: STUDY_DIRECTOR
References:
Clinical trial NCT03948815: Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth
Official title: Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Birth
Keywords: Birthing room
labour
randomised controlled trial
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Chalmers University of Technology
name: University of Dublin, Trinity College
First posted: 2019-05-14
Enrollment: 1268
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Decreased stress, increased parasympathisuc, increased physiological oxytocin promotes a normal healthy Labour and birth.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This study will measure and compare effects and experiences of two types of birthing rooms.

Detailed description: Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This RCT project measures and compares effects and experiences of two types of birthing rooms at one Labour ward in Sweden. A qualitative ethnografic studu will assess how women interact with the birthing rooms and its physical objects.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* Robson 1 classified, i.e. nulliparous, single Pregnancy \>37 weeks, cephalic presentation, sponatanous Labour start
* speak, understand Swedish, English, arabic or somali or have an interpreter present
* Active phase of Labour: 2 of these 3 criteria fulfilled: sponatanous rupture of membranes, 2-3 painful contractions in 10 minutes; cervix dilated \>3-4 cm or effaced and open \>1cm

Exclusion Criteria:

* induced Labour
* planned caesarean section
* multiple gestation
* lack of informed written consent
* not Speaking Swedish, Egmnlish, Arabic or Somali

Primary outcomes:
measure: Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience
timeFrame: within 2 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: Berg M, Goldkuhl L, Nilsson C, Wijk H, Gyllensten H, Lindahl G, Uvnas Moberg K, Begley C. Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden. Trials. 2019 Nov 19;20(1):629. doi: 10.1186/s13063-019-3765-x.