louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00456209: Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact on Occupations
Official title: Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact of Occupations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Keywords: Lived Experiences
Adolescents
Cancer Treatment
Occupations
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 4
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents being treating for cancer and the impact of their lived experience on engagement in occupations and social participation.

Brief summary: The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. The focus area of interest lies in the impact side-effects (psychological and physical) which these treatments may have on an individual's ability to participate with peers, maintain social activities, and be involved in daily occupation(s).

Detailed description: This study will explore the following research questions: 1. How do adolescent patients in the treatment process of cancer perceive and describe their experience of engaging in occupational routines? 2. What effect does the treatment process of cancer have on an adolescent's ability to participate in life situations such as creating and maintaining relationships with family, friends, peers, students, or people with similar backgrounds?

By doing this study, researchers hope to gain information so that occupational therapists can increase the profession's present body of knowledge and better understand these individuals at a transitional period in their lives.

Eligibility criteria: Inclusion Criteria:

* Pediatric cancer patients

Primary outcomes:
measure: Lifestyle changes
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
name: Gary Grimaldi, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068756: Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
Official title: Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-02-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body Mass Index (BMI) of 18 to 32 inclusive
* Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
* Glucosuria
* Abnormal liver function tests

Primary outcomes:
measure: AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data
timeFrame: Days 1 to 3 and Days 9 to 11
Secondary outcomes:
measure: Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data
timeFrame: Days 1 to 3 and Days 9 to 11
measure: Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data
timeFrame: Days 1 to 3 and Days 9 to 11
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00677209: The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite
Official title: Frankfurt Investigator-initiated Autovaccine-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergens, House Dust Mites
Keywords: house dust mite
asthma
autovaccine
allergy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* informed consent
* age 18-35 years
* known allergy on house-dust mite
* GINA 0-1

Exclusion Criteria:

* anamnestic incompatibility to parts of autovaccine
* asthma \> GINA I°
* chronic disease conditions or infections
* pregnancy
* inhalative or systemic steroid use
* any immunosuppressive therapy
* intake of any other probiotic medication (e.g. E.coli nissle 1917)
* participation in any other study at the same time
* substance abuse
* Incapability of understanding the study's purpose and performance
* smoker

Primary outcomes:
measure: Patients' clinical parameters and behaviour, laboratory values
timeFrame: jul 2006 - august 2008
measure: laboratory testing reflecting function of bone marrow, liver, kidney
timeFrame: jul 2006- august 2008
Secondary outcomes:
measure: Lung function,exhalative NO
timeFrame: jul 2006 - oct 2007
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University, Department of Pulmonology
state: Hessen
Study officials:
affiliation: Goethe University, Department of pulmonology
name: Stefan Zielen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halasa J. [Justification of treatment with autovaccine]. Med Dosw Mikrobiol. 1994;46(1-2 Suppl):5-9. No abstract available. Polish.
citation: Schulze J, Voss S, Zissler U, Rose MA, Zielen S, Schubert R. Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge. Respir Res. 2012 Sep 19;13(1):78. doi: 10.1186/1465-9921-13-78.
citation: Rose MA, Weigand B, Schubert R, Schulze J, Zielen S. Safety, tolerability, and impact on allergic inflammation of autologous E.coli autovaccine in the treatment of house dust mite asthma--a prospective open clinical trial. BMC Complement Altern Med. 2011 Jun 3;11:45. doi: 10.1186/1472-6882-11-45.
Clinical trial NCT05051709: Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus
Official title: Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Keywords: Hallux valgus
First ray hypermobility
Fusion
Corrective osteotomy
Functional outcome
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.


Eligibility criteria: Inclusion Criteria:

* Hallux Valgus with 1st ray hypermobility

Exclusion Criteria:

1. Generalized Ligament laxity
2. Previous foot and ankle surgery
3. Diabetes Mellitus

Primary outcomes:
measure: American foot and ankle score
timeFrame: This score was assessed one year after surgery
measure: Foot and Ankle Disability Index
timeFrame: This score was assessed one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medica University
Study officials:
References:
Clinical trial NCT01686009: Intra-nasal Ketamine for Analgesia in the Emergency Department
Official title: Intra-nasal Ketamine for Analgesia in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
analgesia
ketamine
intranasal
emergency
Lead sponsor: Lions Gate Hospital
Sponsor class: OTHER
Collaborators: name: North Shore Health Research Foundation
First posted: 2012-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route.

The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.


Eligibility criteria: Inclusion Criteria:

* age 6 years or greater
* moderate or severe pain (VAS \>=50mm)

Exclusion Criteria:

* history of allergy or intolerance to ketamine
* structural or functional nasal occlusion
* inability to understand the VAS
* Glasgow Coma Scale \< 15
* Systolic BP \> 180
* History of schizophrenia
* Clinical necessity for immediate IV access as judged by the treating physician

Primary outcomes:
measure: Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.
timeFrame: 30 minutes
Secondary outcomes:
measure: Median maximum reduction in VAS pain score achieved within 30 minutes
timeFrame: 30 minutes
measure: Median time required to achieve a 13-mm reduction in VAS pain score
timeFrame: 1 hour
measure: Vital signs changes (ETCO2, O2sat, HR, RR, BP)
timeFrame: 1 hour
measure: Adverse effects as defined by SERSDA
timeFrame: 1 hour
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
Study officials:
affiliation: UBC Dept of EM; Lions Gate Hospital
name: Gary Andolfatto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354609: DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease
Official title: Assessment of Intestinal Inflammatory Activity in the Follow-up of Patients With Crohn's Disease: Diffusion-weighted MR-enterography, Without or With Bowel Cleansing, Compared With Standard MR-enterography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Bowel Cleansing
Apparent Diffusion Coefficient
Keywords: Crohn Disease
diffusion-weighted imaging
MR-enterography
bowel cleansing
apparent diffusion coefficient
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 140
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: Since 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis).

The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI.

However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation.

Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and


Eligibility criteria: Inclusion Criteria:

* Any patient diagnosed with Crohn's disease with bowel involvement for whom a MR-enterography was ordered as part of their follow-up
* Age ≥ 18
* Subject's ability to understand and express opposition
* Affiliation to French social security system

Exclusion Criteria:

* Any contraindication to MRI
* Allergy to gadolinium chelates
* Claustrophobia
* Major obesity that does not allow the patient to enter the machine's tunnel (whose diameter is 70 cm)
* Pregnant woman
* Person under curators or guardianship

Primary outcomes:
measure: variation of inflammatory activity localisation number in the main bowel
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02028156: Feeding Intolerance in Formula-Fed Infants
Official title: Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feeding Intolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 3
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for Stage 1:

* Singleton full term birth with birth weight of \> 2500g.
* Infant between 0 and 60 days of age.
* Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
* Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.

Inclusion Criteria for Stage 2:

* Infant was fed according to protocol in Stage 1 of the study.
* Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.

Exclusion Criteria:

Exclusion Criteria for Stage 1:

* Chromosomal or major congenital anomalies.
* Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Hospitalization, other than for delivery, prior to enrollment.
* Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
* More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
* Use of a prokinetic drug within 7 days before enrollment.

Exclusion Criteria for Stage 2:

* Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
* Infant has immunization(s) within 3 days of enrollment in Stage 2.

Primary outcomes:
measure: Improvement in Fussiness
timeFrame: 0 to 15 days
Secondary outcomes:
measure: Diarrhea
timeFrame: 0 to 4 weeks
measure: Constipation
timeFrame: 0 to 4 weeks
measure: Spit-up
timeFrame: 0 to 4 weeks
measure: Gassiness
timeFrame: 0 to 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Women and Children Hospital
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Xin Hua Hospital
Study officials:
affiliation: Abbott Nutrition China
name: Shirley Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05968209: The Impact of Probiotic Supplementation on General Well Being
Official title: The Impact of Probiotic Supplementation on General Well Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-Being, Psychological
Keywords: Probiotic
Well-being
Absenteeism
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: Welsh Ambulance Service NHS Trust
name: Cultech Ltd
First posted: 2023-08-01
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The health and wellbeing of any workforce is a core priority and taking steps to ensure the wellbeing of employees is an important part of everyday working life. Winter is a time of particular challenge and is linked to increased absenteeism. There is a growing awareness that probiotics (similar to the bacteria found in yogurts) can play a role in boosting general wellbeing. Probiotics are known as 'good' or 'friendly' bacteria and are living organisms that are found naturally in yogurt and fermented foods. They can be capsules, tablets or powders in sachets that are taken daily to help to keep the gut in peak condition. Everyone has trillions of bacteria in their guts living together happily and they are needed to boost our wellbeing but the stresses and strains of everyday life can often disturb their balance, probiotics can help to restore the balance. Over the winter of 2022, a small exploratory study with employees based in South Wales who were offered the opportunity to 'try out' a probiotic manufactured by Cultech Limited (a company based in Port Talbot specialising in the production of nutritional supplements). The results were very promising with significant improvements in wellbeing and reduced absenteeism among those who opted to take the product. This project is designed as a follow-up on last year's exploratory study to further assess effectiveness of the same probiotic nutritional supplement over the winter


Eligibility criteria: Inclusion Criteria:

1. Aged 18 - 60 (at the time of consent)
2. Working in an NHS healthcare setting
3. Willing to use the Trialflare app on personal phone to record data securely
4. Able to understand and communicate using the English language
5. Normal or corrected to normal vision 6 Happy to take no other probiotics during study

7. Able to continue with normal lifestyle throughout 8. Able to consent to take part in the study

Exclusion Criteria:

1. Immunodeficient
2. Taking probiotics or have taken within the last month
3. Allergic or suspected allergy to zinc

Primary outcomes:
measure: Quality of Life changes
timeFrame: 60 days
measure: Change in Absenteeism
timeFrame: 60 days
measure: Changes in gut symptoms and overall health
timeFrame: 60 days
Secondary outcomes:
measure: Feasibility of app-based probiotic studies
timeFrame: 60 days
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: Cwm Taf Morgannwg Health Board
state: Mid Glamorgan
Study officials:
References:
Clinical trial NCT00734409: Combining Objective and Subjective Sedation Assessment Tools
Official title: Combining Objective and Subjective Sedation Assessment Tools - Second Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Mechanical ventilation
Human
conscious sedation
bispectral index
monitoring
critical care
propofol
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2008-08-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

Detailed description: Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.

Eligibility criteria: Inclusion Criteria:

* patient in the ICU
* continuous IV sedation with propofol midazolam or dexmedetomidine
* age \> 18
* expected to require mechanical ventilation for \>=48 hours

Exclusion Criteria:

* prisoners
* no available space on forehead
* continuous electroencephalography(EEG) monitoring
* bifrontal brain injury
* barbiturate coma therapy
* known hypersensitivity to study medications
* high risk for ethanol (ETOH) withdrawal
* resuscitation from cardiac arrest without recovery of mental status
* moribund clinical state (death expected within 48 hours)

Primary outcomes:
measure: Mean Sedative Use
timeFrame: Intensive Care Unit (ICU) stay through discharge
Secondary outcomes:
measure: Unplanned Self-device Removal Events
timeFrame: ICU stay through discharge
measure: Mean Days on Mechanical Ventilation
timeFrame: ICU stay- through discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: DaiWai M Olson, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: