louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05453149: Piloting an Online Integrated Behaviour Change and Physical Activity Program
Official title: Piloting an Online Integrated Behaviour Change and Physical Activity Program for Those With Neurological Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurological Disorder
Behavioural Change Intervention
Physical Activity
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a significant disparity in access to physical activity programs for people with mobility impairments, which greatly impacts mobility, function and long-term wellbeing. This study will test an online, group-based intervention consisting of exercise and behaviour activation strategies targeting these and other outcomes. Importantly, this programming will be applied to patient groups across several clinical programs at Parkwood Institute.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and over
* Neurological condition (i.e., brain injury, stroke)
* Completed rehabilitation and living in the community
* Participants must have some upper limb function permitting arm movement against gravity
* Physician clearance to participate in the study.

Exclusion Criteria:

* Not cleared by a physician.
* Not able to move upper limbs against gravity.
* No internet access.

Primary outcomes:
measure: Change in Self Efficacy
timeFrame: baseline, 10 weeks, 3 months
measure: Change in Physical Activity
timeFrame: baseline, 10 weeks, 3 months
measure: Change in Life Participation
timeFrame: baseline, 10 weeks, 3 months
measure: Change in health behaviour
timeFrame: baseline, 10 weeks, 3 months
measure: Change in fear of falls
timeFrame: baseline, 10 weeks, 3 months
measure: Change in exercise expectations
timeFrame: baseline, 10 weeks, 3 months
measure: Change in Mood
timeFrame: baseline, 10 weeks, 3 months
measure: Change in Anxiety
timeFrame: baseline, 10 weeks, 3 months
measure: Change in personality
timeFrame: baseline, 10 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Swati Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000349: Infusion Laboratory: Protocol 5 (Flupenthixol) - 14
Official title: Infusion Laboratory: Protocol 5 (Flupenthixol)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol, to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol modifies the subjective as well as physiological effects of cocaine. Taken together, these relatively D-1 selective agents can help determine the extent to which DA-1 binding affects the reinforcing effects of stimulants.


Eligibility criteria: Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Degree of drug craving
measure: History, incidence and amount of drug use
measure: Type and severity of stimulant withdrawal symptoms
measure: Characterization of study population
measure: Population incidence of symptoms of depression, po
measure: Frequency and intensity of drug use and sexual beh
measure: Evidence of change in neurophysiology and brain ac
measure: Evidence of change in subjective responses to coca
measure: Clinical physiological response to cocaine challen
measure: Degree to which study medication influences change
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00263549: Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis
Official title: Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: House Dust Mite Allergy
Keywords: House dust mite,
Allergy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis


Eligibility criteria: Inclusion Criteria:

* Positive skin prick test to house dust mite,
* Positive RAST test to house dust mite,
* Positive provocation test result to house dust mite,

Exclusion Criteria:

* Serious chronic diseases,
* Other perennial allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01979549: Adverse Events During Upper Gastrointestinal Endoscopy
Official title: Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Need Upper Gastrointestinal Endoscopy
Peptic Ulcer
Gastric Cancer
Esophagus Cancer
Oesophagitis
Keywords: Adverse events
Upper gastrointestinal endoscopy
Sedation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong New Area People's Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2013-11-08
Enrollment: 6000
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: Patients who will undergo the upper gastrointestinal endoscopy

Brief summary: The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population


Eligibility criteria: Inclusion Criteria:

* Patients will undergo upper gastrointestinal endoscopy
* Age \> 18 years old
* Signed informed consent form

Exclusion Criteria:

* Pregnant
* Allergy to propofol or soybean or albumen

Primary outcomes:
measure: Adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Diansan Su, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765749: Empirical Antibiotic and Outcome in Community-onset Bacteremia
Official title: Empirical Antibiotic and Outcome in Community-onset Bacteremia Caused by Third Generation Cephalosporin Resistant Enterobacteriaceae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 108
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: Patient with community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae. Age \> 18 years

Brief summary: Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae

Detailed description: Prospective cohort study is conducted for monitoring outcomes and risk factors among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.

Primary endpoint is mortality rate among those who received initially inappropriate antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial susceptibility test reported among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae.

Eligibility criteria: Inclusion Criteria:

* Patient with Community-onset Bacteremia Caused by third generation cephalosporin resistant Enterobacteriaceae. Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Polymicrobial infection

Primary outcomes:
measure: Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae
timeFrame: January 2018 - march 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Worapong Nasomsong
Study officials:
References:
Clinical trial NCT00591149: Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
Official title: Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Carcinoma, Squamous
Keywords: cancer
head and neck cancer
squamous cell cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-01-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed description: This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed recurrent SCCHN
* 18 years or older
* Tumor site accessible by biopsy
* Measurable disease
* Receiving no other therapy
* ECOG performance status 0-1
* Adequate bone marrow, renal function and hepatic function

Exclusion Criteria:

* Active infection or fever within 3 days of treatment
* Active CNS metastases
* Prior malignancy within 5 years
* Hypersensitivity to study drugs
* Chemotherapy within 30 days of treatment
* Concurrent investigational therapy within 30 days
* Radiotherapy of more than 25% of bone marrow
* Peripheral neuropathy of grade 2 or greater
* Pregnant or lactating patients
* History of allogeneic transplant
* Active or previously treated HIV or Hepatitis B or C
* Patients with a tracheostomy

Primary outcomes:
measure: Efficacy Measured by Response Rate in Participants
timeFrame: 12 Weeks, 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Chao Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644549: Natural History Study of Batten Disease
Official title: Natural History Study of Batten Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Batten Disease
Neuronal Ceroid Lipofuscinosis CLN6
Neuronal Ceroid Lipofuscinosis CLN3
Keywords: Neuronal ceroid lipofuscinosis (NCL)
CLN6
vLINCL6
CLN6 Batten Disease
Batten Disease
CLN3
CLN3 Batten Disease
variant late infantile
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 10
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: Subjects diagnosed with CLN3 or CLN6 and their parents/legal guardians are eligible to take part in this study.

Brief summary: This is a multicenter, international, study to assess the natural history data from people with Batten disease by collecting both retrospective and prospective information about the motor, behavioral and functional capabilities of patients. The study initially has 2 cohorts. Cohort 1 (n ≈ 75) includes subjects with CLN6 Batten disease. Cohort 2 (n ≈ 120) includes subjects with juvenile CLN3 Batten disease. Additional cohorts for other Batten disease subtypes may be added in the future.


Eligibility criteria: Inclusion Criteria:

* Subject has or had a diagnosis of CLN6 or CLN3 Batten disease that has been confirmed by genotyping (documented presence of a variant on both gene alleles). Confirmation of genotyping will be performed prior to enrollment.
* Subject (or legally authorized representative) has provided written informed consent (or assent) and authorization for use and disclosure of personal health information or research related health information
* Subjects may enroll starting from birth

Exclusion Criteria:

* Subject has or had experienced another illness that is known to cause cognitive decline (eg, trauma, meningitis, hemorrhage)
* Subject received or receives an investigational gene therapy

Primary outcomes:
measure: Assess the change over time in rating as determined using the Unified Batten Disease Rating Scale (UBDRS).
timeFrame: 10 years
measure: Assess the change over time in rating as determined using the Hamburg Scale.
timeFrame: 10 years
measure: Assess the change over time in cognitive function using Mullen Scales of Early Learning (for children up to 60 months old).
timeFrame: 10 years
measure: Assess the change over time in cognitive function using WPPSI-IV (for children up to 7 years 7 months old).
timeFrame: 10 years
measure: Assess the change over time in cognitive function using WISC-V (for patients older than 6 years old).
timeFrame: 10 years
measure: Characterize the age of onset of disease, including the timing of both the loss of capacities and the emergence of disease-related signs and symptoms
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT06578949: Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title: A Phase 3, Single-arm, Open-label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Paroxysmal Nocturnal Hemoglobinuria
PNH
Keywords: Paroxysmal Nocturnal Hemoglobinuria
PNH
Ravulizumab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.


Eligibility criteria: Inclusion Criteria:

* Adult C5 inhibitor naive PNH patients (age\>=18), which is confirmed by flow cytometry evaluation.
* Must be vaccinated againast N meningitidis.

Exclusion Criteria

* Meningitidis infection or unresolved meningococcal disease
* History of bone marrow transplantation
* Other significant systemic diseases that might have impact on efficacy and safety assessment

Primary outcomes:
measure: Percentage Change in Lactate Dehydrogenase (LDH) From Baseline to Day 183 (Week 26)
timeFrame: Baseline, Day 183 (Week 26)
Secondary outcomes:
measure: Number of Participants Achieving LDH <1.5 × Upper Limit of Normal (ULN) at Day 183 (Week 26)
timeFrame: Day 183 (Week 26)
measure: Number of Participants Achieving Transfusion Avoidance (TA) Through Day 183 (Week 26)
timeFrame: Day 183 (Week 26)
measure: Number of Participants Experiencing Breakthrough Hemolysis Through Day 183 (Week 26)
timeFrame: Day 183 (Week 26)
measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score From Baseline to Day 183 (Week 26)
timeFrame: Day 183 (Week 26)
measure: Change in Hemoglobin (Hgb) From Baseline to Day 183 (Week 26)
timeFrame: Baseline, Day 183 (Week 26)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
Study officials:
References:
Clinical trial NCT01515449: Predictors of Poor Outcomes in 1038 Sigma Knees
Official title: Predictors of Poor Outcomes in 1038 Sigma Knees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
Collaborators: name: DePuy International
First posted: 2012-01-24
Enrollment: 1038
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: All patients undergoing total knee replacement in Fife

Brief summary: The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

Detailed description: It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it

Eligibility criteria: Inclusion Criteria:

All patients undergoing total knee replacement in Fife

Primary outcomes:
measure: Predictors of poor outcomes using 3 measures
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kirkcaldy
country: United Kingdom
facility: NHS Fife
state: Fife
Study officials:
References:
Clinical trial NCT05433649: Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Official title: Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Exercise Therapy
Women
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study consists of an intervention of 16 therapeutic exercise sessions during 8 weeks with a frequency of two sessions per week. All sessions had a practical focus (strength and stretching exercises) with the help of elastic bands. In addition, they had an initial session and another at the end of the intervention in which measurements of the different variables (cervical pain, cervical flexor strength, cervical extensor strength and strength of the scapular stabilising musculature) were taken on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

Nonspecific neck pain has a higher incidence in women than in men. Female sex is a risk factor for this pathology. Clinical practice guidelines highlight the importance of preventing neck pain through exercise. There are previous studies on the effects of strength programmes on patients with non-specific neck pain, but none have used elastic bands as an implement, despite the fact that it is one of the most commonly used implements in physiotherapy clinics. Therefore, the aim of this study is to investigate the effects of an elastic band therapeutic exercise intervention in women with non-specific neck pain. It was previously hypothesised that this intervention would have positive effects on pain and strength in the cervical and scapular region.


Eligibility criteria: Inclusion Criteria:

* Women.
* 18-65 years of age.
* With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

* Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder.
* Missing more than sessions.
* Not being able to attend the measurement sessions.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Through study completion, an average of 2 months
measure: Neck flexor muscle endurance.
timeFrame: Through study completion, an average of 2 months
measure: Neck extensor muscle endurance.
timeFrame: Through study completion, an average of 2 months
measure: Scapular stabiliser endurance.
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Pablo Hernández Lucas
Study officials:
References: