louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02618889: OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Official title: OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Torticollis, Dystonia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

Detailed description: Specific Aim 1: To investigate the effect of BoNT on PsyD severity and disability.

We will measure the changes in severity, duration, and incapacitation scores of the Rating Scale for Psychogenic Movement Disorders (RSPMD)10 in adult patients with clinically definite PsyD one month after intramuscular injections with onabotulinumtoxinA in selected muscles of the affected limb(s).

H1: PsyD patients treated with onabotulinumtoxinA injections will demonstrate lower severity and disability at one month than those having received placebo injections.

Specific Aim 2: To investigate the effect of CBT on PsyD severity and disability with and without BoNT pretreatment.

We will examine the extent to which any changes in severity and disability of PsyD, as measured by the RSPMD, after 12 weekly CBT sessions, can be influenced by pre-CBT injections with onabotulinumtoxinA.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet standard criteria for clinically definite PsyD;17
* PsyD severity and disability score ≥ 10 as measured by the RSPMD (Appendix 1);10
* Dystonic posturing must have been present without remission for a period longer than 1 year.
* Between the ages of 18 and 75, inclusive

Exclusion Criteria:

* Prior treatment with any BoNT
* Presence of clinically unstable medical condition other than the condition under evaluation
* Concurrent participation in another investigational drug or device study within 30 days prior to study enrollment.
* We will also exclude subjects with medical disorders deemed at increased risk when exposed to BoNT, including myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or other neuromuscular disorders.

Primary outcomes:
measure: Rating Scale for Psychogenic Movement Disorders (RSPMD)
timeFrame: 4 months
Secondary outcomes:
measure: Clinical Global Impression (CGI) of change
timeFrame: 4 months
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 4 months
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 4 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Alberto Espay
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Alberto Espay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169189: The Effect of Education Given to Nursing Students on Their Environmental Attitudes: A Randomized Controlled Study
Official title: The Effect of Education Given to Nursing Students on Their Environmental Attitudes: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Student
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is conducted to examine the effect of climate change and global warming-based education given to nursing students on their environmental attitudes. The research was planned as a randomized controlled experimental. According to the posthoc power analysis, it was determined that the type one error amount was 0.05 with a medium effect size and the power of the study was 94% when 110 participants were taken. The data were included from the 2nd, 3rd and 4th grades of a nursing faculty in eastern Turkey. Assignments were made to experimental and control groups by randomization. Personal information form and environmental attitude scale were used to collect data.

Detailed description: Climate change and global warming are a global public health problem. This situation, which affects all masses, also deeply affects human life. Future nurses need to have high awareness of this situation and educate and inform the society about this situation. Nurse students' environmental attitudes, knowledge and behavior towards the environment need to be increased. The aim of this research is to determine the effect of global warming and climate change-based education given to nursing students on their environmental attitudes.The research was planned as a randomized controlled experimental. According to the posthoc power analysis, it was determined that the type one error amount was 0.05 with a medium effect size and the power of the study was 94% when 110 participants were taken. The data were included from the 2nd, 3rd and 4th grades of a nursing faculty in eastern Turkey. Assignments were made to experimental and control groups by randomization. Personal information form and environmental attitude scale were used to collect data.

Eligibility criteria: Inclusion Criteria:

* volunteering to participate in research
* have verbal communication skills

Exclusion Criteria:

-

Primary outcomes:
measure: change of environmental attitude scale
timeFrame: baseline to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Alparslan University
Study officials:
References:
Clinical trial NCT01318889: Dexpanthenol Mouthwash to Treat Oral Mucositis
Official title: Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Mucositis (Ulcerative) Due to Radiation
Keywords: Dexpanthenol
Radiotherapy
chemotherapy
Mucositis
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.

Detailed description: Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.

Eligibility criteria: Inclusion Criteria:

1. without any systemic disease
2. estimated survival of at least 6 months
3. without any mental disorders
4. grade 1 to 3 WHO mucositis

Exclusion Criteria:

1. development of grade 4 WHO mucositis
2. Brachytherapy
3. allergy to the drug
4. dissatisfaction of the patient

Primary outcomes:
measure: reduction of intensity of mucositis
timeFrame: first week (week one)
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: ShaheedBeheshti medical university
Study officials:
affiliation: dental faculty of shaheed Beheshti medical university
name: Fahimeh Anbari, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03037489: A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Official title: An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).


Eligibility criteria: Inclusion Criteria:

- Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

* Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
* Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

Exclusion Criteria:

* The presence of any inflammatory arthritis
* Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
* Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
* Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

Primary outcomes:
measure: Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
timeFrame: Group A: 0-56 weeks; Group B: 0-30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: MC Comac Medical
city: Tbilisi
country: Georgia
facility: LCC ARENSIA Exploratory Medicine
city: Berlin
country: Germany
facility: PAREXEL Berlin Early Phase Clinical Unit
city: Chisinau
country: Moldova, Republic of
facility: LCC ARENSIA Exploratory Medicine
Study officials:
affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine
name: Philip Conaghan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276029: TNF Alpha in Refractory Asthma
Official title: The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Refractory
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways

Detailed description: Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending.

This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.

Eligibility criteria: Inclusion Criteria:

* Symptomatic asthma Methacholine PC20\<8mg/ml

Exclusion Criteria:

* History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding

Primary outcomes:
measure: Methacholine PC20
measure: Juniper asthma quality of life
Secondary outcomes:
measure: Net change in post-bronchodilator FEV1
measure: FEF25-75
measure: FVC
measure: symptom visual analogue score
measure: exhaled nitric oxide concentration
measure: computed alveolar nitric oxide concentration
measure: sputum differential inflammatory cell counts
measure: sputum supernatant mediator concentration.
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Institute for Lung Health
state: Leicestershire
Study officials:
affiliation: Institute for Lung Health
name: Michael A Berry, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berry MA, Hargadon B, Shelley M, Parker D, Shaw DE, Green RH, Bradding P, Brightling CE, Wardlaw AJ, Pavord ID. Evidence of a role of tumor necrosis factor alpha in refractory asthma. N Engl J Med. 2006 Feb 16;354(7):697-708. doi: 10.1056/NEJMoa050580.
Clinical trial NCT05531929: Role of Anxio-depressive History on Return to Work and Sport After Rotator Cuff Surgery
Official title: Study of the Role of Anxiety-related Antecedents on the Resumption of Work and Sport in a Series of Patients Operated on for Rotator Cuff Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Depression Disorder
Keywords: Anxiety Depression Disorder
Rotator cuff repair
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥ 18 years) operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture

Brief summary: Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.).

And it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). These 2 pathologies are therefore responsible for significant economic expenses.

It is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.


Eligibility criteria: Inclusion criteria:

* Major subject (≥ 18 years)
* Operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture, retracted in zone 1, resistant to medical treatment with a mobile shoulder, fatty degeneration of stage 2 or less with also a preserved subacromial space
* Subject not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

- Subject having expressed his opposition to the reuse of his data for scientific research purposes.

Primary outcomes:
measure: Measurement of the duration of complete sports cessation after rotator cuff repair surgery
timeFrame: 6 months after rotator cuff repair surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie orthopédique de l'épaule et du coude - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03253029: Study of Branched-chain Amino Acids in Cancer Cachexia
Official title: Use of Branched-chain Amino Acids in Cancer Cachexia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer Cachexia
Keywords: oncology, cancer cachexia, cachexia anorexia,
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 0
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: Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment (BIA).


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 and a life expectancy \>3 months
3. Participants must have evaluable disease by RECIST 1.1 criteria17
4. At least four (4) weeks from prior major surgery
5. Participants must be cachectic as defined by the guidelines below18

   * \>5% weight loss over the past 6 months (in absence of simple starvation); OR
   * BMI \<20 and any degree of weight loss \>2%; OR
   * Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \<14.6 kg/m²; women \<11.4 kg/m²) and weight loss \>2%
6. Participants must be anorexic as defined by reporting one of the following symptoms below3

   * Early satiety
   * Nausea/vomiting
   * Taste alterations
   * Smell alterations
   * Meat aversion

Exclusion Criteria:

1. Patients taking Levadopa
2. Patients with amyotrophic lateral sclerosis (ALS)
3. Patients utilizing a percutaneous gastrostomy tube for drainage
4. Patients unable to consume food or beverage orally
5. Patients on any form of parenteral nutrition which contains BCAA.
6. Serious non-healing wound, ulcer, or burn
7. Patients who are pregnant or lactating
8. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
9. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Primary outcomes:
measure: Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and LBM based on body weight in kg
timeFrame: 12 weeks
measure: Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
timeFrame: 12 weeks
Secondary outcomes:
measure: Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04781829: Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Official title: Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Community-acquired Pneumonia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physician-specific Step Wedge
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.

Detailed description: The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
2. Meets one of the following:

   1. Have or plan to obtain a bronchoalveolar lavage (BAL)
   2. Have or plan to obtain a quantitative endotracheal aspirate sample
   3. Have already produced a high-quality sputum sample if not intubated
3. Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT

Exclusion Criteria:

1. Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
2. Neutropenic fever, defined as absolute neutrophil count \<1000/mm3 and absence of infiltrate on available chest imaging
3. Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
4. Patient/surrogate refusal
5. Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission

Primary outcomes:
measure: Narrow-spectrum Antibiotic Treatment
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: