louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04865328: Impact of OAB Symptoms on Quality of Life in Croatia
Official title: Impact of OAB Symptoms on Work, Quality of Life and Treatment-seeking Behavior in Croatia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with diagnosed overactive bladder without treatment.

Brief summary: Overactive bladder (OAB) has a negative impact on the daily activities of affected individuals. OAB affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. It has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs.

The primary objective of the present study was to evaluate, in a Croatian population reporting symptoms of OAB, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).


Eligibility criteria: Inclusion Criteria:

* consenting adult patients who had an OAB diagnosis by their healthcare practitioner and were about to start mirabegron treatment as part of routine clinical practice were eligible for enrollment.

Exclusion Criteria:

* mixed incontinence where stress incontinence was the predominant symptom (as determined by the investigator)
* severe uncontrolled hypertension (i.e. systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg)
* anxiety and/or depression
* pregnancy
* women who reported having either a current or previous (within one month) urinary tract infection

Primary outcomes:
measure: OAB-V8 score > 8
timeFrame: At the point of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb, Croatia
Study officials:
References:
citation: Mikus M, Ostroski M, Beljan P, Karadza M, Dumancic S, Sprem Goldstajn M, Coric M, Kalafatic D, Oreskovic S. Validation of the Croatian Version of the 8-Item Overactive Bladder Questionnaire (OAB-V8). Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):e687-e690. doi: 10.1097/SPV.0000000000001098.
Clinical trial NCT00103428: Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
Official title: A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: chemotherapy
prostate cancer
cancer
metastatic
hormone refractory
chemotherapy naive
dose escalation
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-02-09
Enrollment: 69
Sex: MALE
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: V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.

All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
* Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
* ECOG performance status 0-1

Exclusion Criteria:

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* History of deep vein thrombosis or pulmonary embolus
* Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
* History of a bleeding disorder or recent clinically significant bleeding
* Seropositive for HIV
* History of Hepatitis B, Hepatitis C, or chronic liver disease
* Prior gene therapy or immunotherapy
* Prior chemotherapy for prostate cancer
* Radiation therapy within 4 weeks of the first treatment.
* History of myocardial infarction within 6 months of the first treatment
* History of cerebrovascular accident
* History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
* Evidence of active prostatitis
* Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80

Primary outcomes:
measure: Metastatic hormone refractory prostate cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
References:
Clinical trial NCT05902728: Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
Official title: Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NSCLC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.

Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements;
2. Male or female subjects aged 18 to 45 (including 18 and 45);
3. Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m2. BMI = weight (kg)/\[height (m)\]2;

Exclusion Criteria:

1. Known history of drug or food allergy;
2. Those who have a positive urine drug screen or have a history of drug abuse;
3. Excessive smoking (≥ 5 cigarettes/day);

Primary outcomes:
measure: Pharmacokinetics parameter Cmax of HLX208
timeFrame: up to 48 hours
measure: Pharmacokinetics parameter AUC0-t of HLX208
timeFrame: up to 48 hours
measure: Pharmacokinetics parameter AUC0-inf of HLX208
timeFrame: up to 48 hours
Secondary outcomes:
measure: other pharmacokinetics parameter Tmax of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter Tlag of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter t1/2 of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter CL/F of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter Vd/F of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter MRT of HLX208
timeFrame: up to 48 hours
measure: other pharmacokinetics parameter %AUCex of HLX208
timeFrame: up to 48 hours
measure: The incidence and severity of adverse events/serious adverse events
timeFrame: up to 17 days after the last dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04245228: Wellness Coaching for Caregivers of Thoracic Transplant Candidates
Official title: Does a Pre-transplant Health Coaching Intervention for Informal Caregivers of Adult Heart or Lung Transplant Candidates Improve Caregiver-Reported Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Caregiver Burden
Keywords: Caregiver
Heart Transplant
Lung Transplant
Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

Detailed description: This is a randomized trial of health coaching compared to usual care. Caregivers for patients on the adult heart or adult lung transplant waiting list at the Mayo Clinic will undergo informed consent. Consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. Questionnaires and demographic information will be collected at baseline and after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and Jacksonville, FL

Exclusion Criteria:

* Individuals younger than 18 years
* Non-English speaking, non-verbal, or extremely hard of hearing

Primary outcomes:
measure: Acceptability
timeFrame: after completion of the 12-week intervention or between 12-16 weeks after enrollment
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: after completion of the 12 week intervention or between 12-16 weeks after enrollment.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cassie Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084328: Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
Official title: Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this study is patients who have fatty liver disease. Patients who have low vitamin D (\<30ng/dL) and patients who have normal vitamin D (\> or = to 30ng/dL) will be followed for six months and observed.

Brief summary: Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with Vitamin D replete status have lowering of Vitamin D over time if not supplemented.

One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will use this to follow patients as is currently done as standard of care. All patients in the Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. We hypothesize that patients with NAFLD with low Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adults of age 18 or greater
* Diagnosis of fatty liver disease with a low Vitamin D level (\< 30 ng/dl) in the past 6 months
* Able to give consent

Exclusion Criteria:

* Those currently receiving Vitamin D supplementation

Primary outcomes:
measure: Change in vitamin D levels
timeFrame: Baseline and 6 months
measure: Change in liver and renal function
timeFrame: Baseline and 6 months
measure: Change in body composition data
timeFrame: Baseline and 6 months
measure: Chang in lipid profile
timeFrame: Baseline and 6 months
measure: Change in insulin resistance
timeFrame: Basline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT05634928: Construction of a Database for TMA
Official title: Construction of a Database for Thrombotic Microangiopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombotic Microangiopathies
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 500 eligible TMA patients are to be collected for this project.

Brief summary: Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Dec 1, 2022, to Nov 31, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical-related data of thrombotic microangiopathy.


Eligibility criteria: Inclusion Criteria:

* The patient has elevated lactate dehydrogenase to more than twice the baseline value, platelets less than 20 or decreased by more than 50% within 24 hours, and more than 2% of schistocytes visible on a peripheral blood smear. Alternatively, pathological sections show extensive micro thrombosis.

Exclusion Criteria:

* The investigator considers the subject unable or unwilling to cooperate with the study procedures.

Primary outcomes:
measure: Number of participants with stroke
timeFrame: 5 years from the time of entering the database.
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00047528: Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41
Official title: Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients (C-02-41).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
POAG
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2002-10-18
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: To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility criteria: Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Clinical Trial Sites
state: Texas
Study officials:
References:
Clinical trial NCT05277428: Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Irritable Bowel Syndrome Symptoms Improving Effect and Safety of Lactobacillus Plantarum APsulloc 331261(GTB1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Diarrhea
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects older than 19 years old
* Diagnosed case of IBS using Rome IV criteria
* Who had type 6 or 7 stools according to the BSFS on at least 2 weeks ≥ 25%
* Who voluntarily agreed to participate in the study and signed an informed consent form

Exclusion Criteria:

* Who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial
* Who had antibiotic agents during the 4 weeks prior to study entry
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
* Who is determined ineligible for study participation by investigators for any other reasons

Primary outcomes:
measure: Changes in a global relief at 4 weeks
timeFrame: Global Relief after 4 weeks of ingestion
measure: Changes in frequency and type of stools at 4 weeks from baseline
timeFrame: Baseline, and 4 weeks of ingestion
measure: Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks
timeFrame: Baseline, and 4 weeks of ingestion
Secondary outcomes:
measure: Changes in Quality of Life at 4 weeks from baseline
timeFrame: Baseline, 1, 2 and 4 weeks of ingestion
measure: Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale
timeFrame: Improvement/worsening assessed after 4 weeks of ingestion
measure: Fecal microbiome
timeFrame: Baseline, 4 weeks of ingestion
Other outcomes:
measure: Changes in a global relief
timeFrame: Global Relief after 1, 2 and 4 weeks of ingestion
measure: Changes in frequency and type of stools
timeFrame: Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
measure: Changes in severity and frequency of IBS-Intestinal discomfort symptoms
timeFrame: Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Amorepacific
state: Gyeonggi-do
Study officials:
affiliation: Amorepacific R&I center
name: Jonghwa Roh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06203028: Cyberbullying Awareness Training for Secondary School Students
Official title: Investigation of the Effectiveness of Cyberbullying Awareness Training Given to Secondary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyberbullying
Keywords: cyberbullying
students
school
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 122
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be conducted with the randomized controlled experimental method. The purpose of this research is to determine the cyberbullying awareness training given to 7th-grade secondary school students' awareness levels of cyberbullying. Students will be randomly assigned to groups by lottery method. After the randomization students in the intervention group will be given 'Cyberbullying Awareness Training'. The cyberbullying awareness level of all students will be determined with the 'Cyberbullying Awareness Scale' before and 3 months after the training. Students in the control group will not be educated. The cyberbullying awareness level of the students in the control group will be determined with the 'Cyberbullying Awareness Scale' when they are included in the research and 3 months later.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 12 and 14,
* No auditory, visual, or mental problems that would affect communication
* Speaking and understanding Turkish at native level

Exclusion Criteria:

* Being younger than 12 years old and older than 14 years old,
* Having auditory, visual, or mental problems that would affect communication
* Not speaking and understanding Turkish at native level

Primary outcomes:
measure: Cyberbullying Awareness Level
timeFrame: Before and 3 months after the Cyberbullying Awareness Training.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Maltepe University
state: İ̇stanbul
Study officials:
affiliation: Maltepe Üniversitesi Hemşirelik Yüksekokulu
name: Zeynep Erkut, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189228: Immune Dysfunction in Allergic Asthma
Official title: Not a Drug Trial. We Are Using Anti-IgE to Examine the Role of Pulmonary Mast Cells in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Detailed description: Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Eligibility criteria: Inclusion Criteria:

Mild asthma, adults -

Exclusion Criteria:

children. on inhaled or systemic steroids

-

Primary outcomes:
measure: Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM HSC
state: New Mexico
Study officials:
affiliation: UNM HSC
name: Mark Schuyler, MD
role: STUDY_DIRECTOR
References: