louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02161107: Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Grass-SPIRE in Subjects With Asthma and Grass-Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Asthma
Keywords: Grass
Allergy
rhinoconjunctivitis
rhinitis
asthma
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2014-06-11
Enrollment: 54
Sex: ALL
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 purpose of this study is to determine whether it is safe to administer Grass-SPIRE to subjects suffering from both grass allergy and asthma


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years.
* Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
* A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to grass for at least the previous two grass seasons.
* Positive skin prick test to grass.
* Grass-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.

Exclusion Criteria:

* History of life-threatening asthma.
* Uncontrolled asthma according to GINA.
* FEV1 of \<70 % of predicted, regardless of the cause.
* Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease).
* History of severe drug allergy or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 15 weeks
Secondary outcomes:
measure: Number of subjects with asthma exacerbations as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 15 weeks
measure: Evaluation of change in lung function as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 15 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: Inflamax Research
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Appliquée en Allergie de Québec
Study officials:
References:
Clinical trial NCT06327607: Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
Official title: Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is for women who have had breast cancer and are currently undergoing hormonal therapies.

Brief summary: Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months.

The study is randomized in the two following arms:

Control arm (standard care pathway) Psychosexual intervention arm

Detailed description: The aim of the study is to evaluate the effectiveness of a psychosexual intervention on sexual functioning, mood (levels of depression and anxiety), sleep, and quality of life, compared to standard care pathway. Considering the high incidence of sexual dysfunction in breast cancer patients, this study will focus on this population of patients.

The psychosexual intervention aims to improve female sexual functionality and satisfaction by facilitating the understanding of disorders, enabling adequate assessment of possible interventions, and adopting specific treatment exercises.

Patients will be randomized in one of the following two arms:

Control arm (standard care pathway) Psychosexual intervention arm

Eligibility criteria: Inclusion Criteria:

* Women with age \>=18 years;
* Breast cancer patients undergoing hormonal therapy for at least 6 months in accordance with clinical practice and scientific evidence;
* Pre-menopausal patients (regular menstrual cycles in the last year) before the start of oncological treatments;
* Presence of one or more criteria of sexual dysfunction as per DSM-5;
* Acceptance and signature of the Informed Consent.

Exclusion Criteria:

* Patients in postmenopausal status;
* Presence of psychiatric or neurological conditions that impair the ability to perform the exercises proposed by the research project;
* Already undergoing psycho-sexual counseling;
* Refusal to sign the informed consent

Primary outcomes:
measure: Evaluation of differences between two arms in female sexual satisfaction and functionality scores
timeFrame: 10 weeks
Secondary outcomes:
measure: Evaluation of differences between two arms in levels of quality of life
timeFrame: 10 weeks
measure: Evaluation of differences between two arms in levels of anxiety and depression
timeFrame: 10 weeks
measure: Evaluation of differences between two arms in levels of sleep quality
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542607: Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Official title: Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.


Eligibility criteria: Inclusion Criteria:

* adults 18 to 55 years both inclusive
* suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
* positive RAST and/or positive skin prick test
* comply with study restrictions

Exclusion Criteria:

* known alcohol or drug addiction or abuse
* known allergy/intolerance to lactose, cellulose, cornstarch
* presence of nasal anatomical deformities leading to \> 50% obstruction
* ENT infection within 30 days of the study
* use of disallowed medication
* ongoing desensitization
* known cardiac, renal or hepatic dysfunction
* presenting allergic bronchial asthma
* use of cimetidine
* intending to donate blood during the trial

Primary outcomes:
measure: Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
Secondary outcomes:
measure: The change from baseline of the mean MSC score over time interval 3
measure: the change from baseline of the mean MSC score over time intervals 1 and 4.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCb Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05082207: Ischemic Preconditioning and Thiol-disulfide Balance
Official title: Effect of Ischemic Preconditioning on Dynamic Thiol-disulfide Balance, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourniquets
Keywords: thiol/disulfide homeostasis
ischemic preconditioning
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.


Eligibility criteria: Inclusion Criteria:

* ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions

Exclusion Criteria:

* emergency operation,
* Underlying neurological disorder,
* Underlying peripheral vascular disease,
* other types of concurrent surgery.

Primary outcomes:
measure: thiol/disulfide homeostasis
timeFrame: 24th hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References:
Clinical trial NCT06039488: Effectiveness of a Cancer Exercise Program
Official title: The Impact of an 8-week Exercise Program on Physical Function in Individuals With Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Keywords: Exercise
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 150
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 investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (\>18 years old) with cancer.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 diagnosed with cancer

Exclusion Criteria:

* unwilling to come to the on-site clinic for exercise sessions
* any neuromuscular, cardiovascular, or psychological condition precluding safe exercise
* unable to read/understand English.

Primary outcomes:
measure: Bellarmine Norton Assessment Tool (2-minute Step Test)
timeFrame: 0 and 8-weeks
measure: Bellarmine Norton Assessment Tool (Timed Arm Curl)
timeFrame: 0 and 8-weeks
measure: Bellarmine Norton Assessment Tool (30 second Chair Stand)
timeFrame: 0 and 8-weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 0 and 8-weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00448188: Bleeding Risk in CVCs
Official title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Keywords: central venous catheter
international normalized ratio
thrombocytes
bleeding risk
all patients in need of central venous line
comparison of patients with normal hemostasis to such with disorders in hemostasis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-03-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Eligibility criteria: Inclusion Criteria:

* All patients acquiring a central venous catheter

Exclusion Criteria:

* Patients pre or post surgery
* Patients with bleeding due to other reason

Primary outcomes:
measure: Bleeding within 24 hours after cvc application
measure: other complications within the first 24 hours
Secondary outcomes:
measure: mortality
measure: long-term complications
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
name: Kilian Weigand, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
name: Jens Encke, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Weigand K, Encke J, Meyer FJ, Hinkel UP, Munder M, Stremmel W, Zahn A. Low levels of prothrombin time (INR) and platelets do not increase the risk of significant bleeding when placing central venous catheters. Med Klin (Munich). 2009 May 15;104(5):331-5. doi: 10.1007/s00063-009-1070-2. Epub 2009 May 16.
Clinical trial NCT05094388: Validation of Prediction Model of Vitamin D Deficiency
Official title: Validation of Prediction Model of Vitamin D Deficiency in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Keywords: critical care
vitamin D
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to intensive care units

Brief summary: Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. The investigators' previous multi-center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. The investigators used the data of that observational study to train a predictive model for predicting vitamin D deficiency. In addition, the association between vitamin D and the immune regulation of critically ill patients in Taiwan has not been investigated. This study aims primarily to validate the performance of the prediction model of vitamin D deficiency. Moreover, this study will investigate the association between vitamin D level and inflammatory cytokine levels.

This multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (ICUs) less than 28 days. After inform consent, blood will be drawn for examination of vitamin D, interleukin 6, and interleukin 10 levels. The main diagnosis of ICU admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. The predictive model will use the required parameters to predict the patient's risk of vitamin D deficiency and vitamin D severe deficiency.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to intensive care units

Exclusion Criteria:

* aged \< 20 years
* admitted to intensive care unit longer than 28 days
* body max index \< 18 kg/m2
* receive vitamin D supplement \> 3000 IU/day
* previously admitted to intensive care unit within 3 months
* have parathyroid disease, rickets, or severe liver cirrhosis \[Child C\]

Primary outcomes:
measure: Area under the receiver operating characteristic
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00851188: Internet Delivered Self-help for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Utrecht University
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility criteria: Inclusion Criteria:

* Insomnia
* Access to the internet

Exclusion Criteria:

* Alcohol or substance abuse
* Severe depression
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder

Primary outcomes:
measure: Sleep Diary
timeFrame: 1 year
Secondary outcomes:
measure: Anxiety rating
timeFrame: 1 year
measure: Depression ratings
timeFrame: 1 year
measure: Sleep medication
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
References:
Clinical trial NCT00205088: The Use of Shunt Tap in Assessing Ventriculoperitoneal (VP) Shunt Malfunction
Official title: The Use of Shunt Tap in Assessing Ventriculoperitoneal (VP) Shunt Malfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Signs or Symptoms of Shunt Failure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of the study is to test the sensitivity and specificity of a shunt tap to predict shunt failure.


Eligibility criteria: Inclusion Criteria:

* The patient has clinically suspected shunt malfunction.
* The patient has had an imaging study of the head.
* The patient needs a shunt revision.

Exclusion Criteria:

* The patient has not had an imaging study of the head.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bermans Iskandar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05304988: Development and Validation of the EFT for Adolescents With Cancer
Official title: Development and Validation of the Exercise Fit Test (EFT) for Adolescents With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Adolescents
Physical Activity
Tool
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of 400 adolescents who meet the eligibility criteria will be invited to participate. Subjects will be recruited in the pediatric oncology unit in Hong Kong Children's Hospital which is the largest hospital in Hong Kong for admitting adolescents with cancer for hospitalization and follow-ups.

Brief summary: There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. These interventions emphasized heavily on interventionists' role to assess adolescents' physical fitness and prescribe exercises. After the intervention, the adolescents were unable to follow the previous exercise prescriptions due to their changing medical conditions. To promote physical activity sustainably, it is vital to develop a patient-based assessment tool to allow adolescents with cancer to self-assess their own appropriate levels of physical activity that they could perform. However, a review of literature indicates a lack of such a tool.

Detailed description: A cross-sectional study design will be used. A convenience sample of 400 adolescents who (1) are aged 13-18; (2) are diagnosed with cancer; (3) can communicate in Cantonese and read Chinese will be recruited in Hong Kong Children's Hospital. The outcome measures will include demographic characteristics, pain scores, cardiopulmonary function measurements, EFT scores and ratings of the oncologist for the fitness of subjects for physical activity.

Eligibility criteria: Inclusion Criteria:

* Aged 13-18
* are diagnosed with cancer
* are able to communicate in Cantonese and read Chinese

Exclusion Criteria:

* with physical or cognitive impairment and learning problems as identified from the medical records

Primary outcomes:
measure: The EFT scores
timeFrame: Just before their scheduled oncologist routine visit
Secondary outcomes:
measure: Numerical Rating Scale (NRS) for pain
timeFrame: Just before their scheduled oncologist routine visit
measure: The oncologists' rating for physical activity
timeFrame: Just before their scheduled oncologist routine visit
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Katherine Lam
state: Hong Kong,China
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Katherine Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: