louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00399438: A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
Official title: A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Diarrhea-predominant irritable bowel syndrome
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)


Eligibility criteria: Inclusion Criteria:

* Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire

Exclusion Criteria:

* Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit

Primary outcomes:
measure: Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
timeFrame: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
Secondary outcomes:
measure: Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
timeFrame: throughout the study
measure: Safety
timeFrame: Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge
measure: Blood pharmacokinetics
timeFrame: PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05587738: Human Papillomavirus in Young People Epidemiological Research 4
Official title: A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 21-25 Years in Australia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Papillomavirus Infection
HPV
HPV Infection
Anal Cancer
Cancer
Men
HPV 16 Infection
Keywords: Vaccination
Vaccine
Public health
Prevention
Men who have sex with men
Gay and bisexual men
Immunisation
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: The Alfred
name: University of Melbourne
First posted: 2022-10-20
Enrollment: 500
Sex: MALE
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.

Brief summary: Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years.

The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program.

Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.


Eligibility criteria: Inclusion Criteria:

* Men aged 21 to 25 years old in 2023-2024
* Same-sex attracted
* Residing in Australia since 2013

Exclusion Criteria:

* Unable to complete all study requirements in English

Primary outcomes:
measure: Prevalence of quadrivalent vaccine HPV types
timeFrame: Baseline
measure: Prevalence of type-specific HPV types
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
Study officials:
References:
Clinical trial NCT06505538: Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery
Official title: Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptom Management
Breast Care Nurse
Mobile App
Mobile Health
Lead sponsor: Gümüşhane Universıty
Sponsor class: OTHER
Collaborators: name: Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
First posted: 2024-07-17
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery.

Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care.

Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.


Eligibility criteria: Inclusion Criteria:

* Speaking the national language,
* The presence of primary breast cancer,
* The utilization of a smartphone for a minimum of one year,
* An age of 20 years

Exclusion Criteria:

* An uncontrollable medical problem,
* Having speech problems,
* Having hearing problems,
* Vision impairment,
* A psychiatric diagnosis/ongoing treatment
* Previous treatment due to a different type of cancer
* Rheumatological diseases,
* Fractures,
* Health problems leading to joint limitation,
* Amputation

Primary outcomes:
measure: Function of the affected arm
timeFrame: three months
measure: Body image and sexual adjustment scale
timeFrame: three months
measure: Pain scale
timeFrame: three months
Secondary outcomes:
measure: Quality of life scale
timeFrame: one year
Other outcomes:
Locations:
city: Gumushane
country: Turkey
facility: Gumushane University
Study officials:
References:
Clinical trial NCT03867838: Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion
Official title: Effects of Post-Stroke Upper Extremity Assistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arm Weakness as a Consequence of Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 6
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: The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.


Eligibility criteria: Inclusion Criteria:

* greater than 6 months post-stroke
* passive abduction to 90 degrees at shoulder
* reduced active (retro)flexion/extension at shoulder when abducted to 90 degrees
* reduced active flexion/extension at elbow

Exclusion Criteria:

* unable to give informed consent
* unable to comprehend and follow instructions
* have a condition (other than stroke) affecting sensorimotor function
* show evidence of unilateral spatial neglect
* unable to sit in a chair without armrests for 2 hours

Primary outcomes:
measure: Percent Change From Baseline in Reachable Workspace
timeFrame: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
Secondary outcomes:
measure: Percent Change From Baseline in Biceps Activation
timeFrame: baseline and while using support device (up to 10 seconds per assessment)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University CHARM Lab
state: California
Study officials:
affiliation: Stanford University
name: Allison Okamura
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simpson CS, Okamura AM, and Hawkes EW. Exomuscle: An inflatable device for shoulder abduction support. 2017 IEEE International Conference on Robotics and Automation (ICRA) 2017; pp. 6651-6657.
citation: Simpson C, Huerta B, Sketch S, Lansberg M, Hawkes E, and Okamura A. Upper Extremity Exomuscle for Shoulder Abduction Support. IEEE Transactions on Medical Robotics and Bionics. 2020; 2(3):474-484.
Clinical trial NCT03614338: A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Official title: A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.


Eligibility criteria: Inclusion Criteria:

1. BMI 25-45 kg/m2
2. Age 18-75
3. Attend one of the West Side partnership churches at least 2 times per month
4. Able to attend in-person meetings
5. Willing to share their experiences on the West Side ALIVE Facebook page

Exclusion Criteria:

1. Blood pressure \> 170/90 (self-report or during the WSA screening)
2. Diabetes treated with insulin
3. History of cancer within the past 5 years
4. Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months

Primary outcomes:
measure: Weight
timeFrame: 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months
measure: Physical activity
timeFrame: 3 months
measure: Weight loss strategies
timeFrame: 3 months
measure: Weight
timeFrame: 6 months
measure: HbA1c
timeFrame: 3 months
Other outcomes:
measure: Program satisfaction
timeFrame: 3 months
measure: Program engagement
timeFrame: 3 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT00165438: Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy
Official title: A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Disease
Keywords: Pulmonary function
Bleomycin-based chemotherapy
mediastinal irradiation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed classic Hodgkin's disease with mediastinal involvement in whom bleomycin-based chemotherapy alone or bleomycin-based chemotherapy and mediastinal irradiation are recommended as initial treatment.

Brief summary: The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given with or without chest radiation therapy, on patients' lung function over time.

Detailed description: * The tests and procedures in this study are part of regular cancer care but this study offers more structured timing of these standard tests.
* Due to the potential lung toxicity associated with bleomycin-based chemotherapy, pulmonary function tests are routinely performed. Pulmonary function tests will be performed by a licensed, registered respiratory therapist and performed prior to the beginning of treatment, between the chemotherapy and radiation therapy (only for patients receiving both chemotherapy and radiation therapy), and at approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
* A CAT scan will be performed prior to the beginning of treatment, and approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
* A self-administered questionnaire will be performed on the days the patient is undergoing pulmonary function tests.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed classical Hodgkin's disease, with mediastinal involvement
* Bleomycin-based chemotherapy alone or in combination with mediastinal irradiation

Exclusion Criteria:

* Prior chest irradiation
* Mediastinal irradiation received at an outside institution
* Refractory or progressive disease on treatment

Primary outcomes:
measure: Pulmonary function
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea K. Ng, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00073138: A Study of ABT-751 in Patients With Colorectal Cancer
Official title: A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility criteria: Inclusion Criteria

* Colorectal cancer.
* Recurrent tumor following treatment with irinotecan and/or oxaliplatin.
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney, and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
* Prior radiation therapy.
* CNS metastasis.

Primary outcomes:
measure: Objective Response Rate in subjects with Recurrent Colorectal Cancer
timeFrame: 1 year
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: 1 year
measure: Survival
timeFrame: 2 years
measure: Toxicities associated with treatment administration
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott
name: Helen Eliopoulos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05092438: QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study 001
Official title: An Observational, Retrospective, Clinical Performance Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis/Encephalitis
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 595
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis

Brief summary: Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Detailed description: This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Eligibility criteria: Inclusion Criteria:

* Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing
* Specimen that had not been centrifuged Adequate residual volume (≥400 μl)

Exclusion Criteria:

* Specimens not fitting criteria outlined above
* CSF obtained from an external ventricular drain or shunt source
* Lack of clear subject identification or label on residual banked CSF specimen
* Obvious physical damage of banked residual specimen
* Repeat specimens from the same subject

Primary outcomes:
measure: sensitivity
timeFrame: 6 weeks
measure: specificity
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Qiagen
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02936908: Respiratory Care in Intensive Care Unit for Neuromuscular Patients
Official title: Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Keywords: Neuromuscular Diseases
Muscular dystrophy
Amyotrophic Lateral Sclerosis
Acute respiratory failure
respiratory care
mechanical ventilation
weaning
Intensive Care Unit
Critical Care
Survival
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles.

Neuromuscular diseases concerned :

Central or Peripheral metabolic, toxic, or inflammatory neuropathies, Central or peripheral neurodegenerative or hereditary disorders Myopathies, amongst them dystrophinopathies, myotonic dystrophies Myasthenia gravis Tetraplegy, consequence of cervical spinal cord injury

Brief summary: Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.

Research of markers associated with long term mortality and ventilatory status.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* First stay in a ICU ward
* Inclusion period : Admission in ICU between 01/01/2007 and 31/12/2015
* Presenting an acute respiratory distress at admission or during ICU stay
* Diagnosis of neuromuscular disease confirmed before Hospital discharge

Exclusion Criteria:

* Absence of respiratory failure during ICU stay (ICU stay for monitoring or for a specialized invasive procedure in the absence of respiratory failure, for example)
* Neuromuscular disease not proven or uncertain diagnosis
* Anterior admission in ICU ward for vital organ failure

Primary outcomes:
measure: Mortality
timeFrame: until 2016.12.31
Secondary outcomes:
measure: Definitive long term invasive ventilatory support
timeFrame: until 2016.12.31
measure: Mortality attributable to a respiratory issue
timeFrame: until 2016.12.31
measure: Re-hospitalization in a ICU-Ward
timeFrame: until 2016.12.31
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: St Etienne
country: France
facility: Hôpital Nord CHU St Etienne
Study officials:
References:
Clinical trial NCT01045408: The Effect of Berry Extract on Helicobacter Pylori Eradication
Official title: The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Increase the Eradication Rate of Helicobacter Pylori
Keywords: Helicobacter pylori
Berry extract
Triple therapy
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 120
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: Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.

Detailed description: One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18

Exclusion Criteria:

* Pregnancy or breastfeeding
* Use of antibiotics 2 weeks prior to inclusion
* Previous eradication treatment

Primary outcomes:
measure: Eradication rate
timeFrame: 4 weeks after Eradication of Helicobacter pylori
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Taipei Medical University
name: Shih-Yi Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: