louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05011409: Prevalence of Depression and Anxiety Among Breast Cancer Patients
Official title: Prevalence of Depression and Anxiety Symptoms Among Newly Diagnosed Breast Cancer Patients in Almaty, Kazakhstan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Breast Cancer
Keywords: depression
anxiety
breast cancer
prevalence
Beck Depression Inventory
Beck Anxiety Inventory
Lead sponsor: Kazakh Medical University of Continuing Education
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2021-08-18
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include breast cancer patients with confirmed diagnosis referred to the treatment to the Kazakh Institute of Oncology and Radiology and the Almaty Oncology Center

Brief summary: Depression and anxiety in patients with breast cancer is serious comorbidity that affects the quality of life for patients, and their survival rates as they have poorer health outcomes. Furthermore, patients' high psychological burden is linked to higher healthcare costs. The investigation of the depression and anxiety symptoms prevalence among newly diagnosed breast cancer patients will help to navigate the health policy adjustment and psycho-social support system requirements. This study aims to investigate the prevalence of depression and anxiety symptoms among newly diagnosed breast cancer patients in Almaty, Kazakhstan, and associated risk factors.


Eligibility criteria: Inclusion Criteria:

* Female adults with confirmed diagnosis of breast cancer within the 6 months study enrollment
* TNM stage I-IV
* Russian or Kazakh language proficiency
* Ability to provide informed consent

Exclusion Criteria:

* Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
* Current active suicidal ideation
* Referral to palliative care

Primary outcomes:
measure: Prevalence of Depression Symptoms
timeFrame: within 6 months of diagnosis
measure: Prevalence of Anxiety Symptoms
timeFrame: within 6 months of diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Almaty Oncology Center
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
Study officials:
affiliation: Kazakh Medical University of Continuing Education
name: Indira A Karibayeva, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03698409: Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.
Official title: Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine. A Randomized, Double-blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Migraine, Headache
Keywords: Migraine
Onabotulinumtoxin A
Botox
Reconstitution
Saline
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chronic migraine.

While reducing discomfort is a desirable target in all procedures, it has a special importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous injection locations each session (31 sites) and the ubiquity of scalp tenderness in this population. In addition, the pain during procedure is a known migraine trigger for many of these patients.

We hypothesize that preserved saline (known as bacteriostatic saline) produces lower procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in individuals with chronic migraine as opposed to using preservative-free saline.

In addition, we hypothesize that reduction of procedure-relate pain during the injections will also result in reduced migraine/headache attacks in the week immediately following the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of chronic migraine receiving FDA-approved treatment with OnabotulinumtoxinA injection as per standard protocol. Standard protocol consists of 31 injection sites, with total dose ranging from 155 u to 195u.

Exclusion Criteria:

* Subjects whom OnabotulinumtoxinA injections deviate from standard protocol for any reason, such as head/neck infection, head deformity, recent surgery...etc.

Primary outcomes:
measure: Verbal Pain Scale
timeFrame: Immediately after intervention, an average of 2 minutes
Secondary outcomes:
measure: Headache-day Frequency
timeFrame: 1 week
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT02930109: A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
Official title: A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Leukemia
Lead sponsor: Prescient Therapeutics, Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

Detailed description: Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.

The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.

Eligibility criteria: Inclusion Criteria:

* Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
* Age ≥ 18 years
* ECOG Performance Status 0-2
* Patients must be able to give adequate informed consent

Exclusion Criteria:

* Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
* Uncontrolled Disseminated Intravascular Coagulation (DIC)
* Uncontrolled diabetes mellitus
* Active, uncontrolled infection

Primary outcomes:
measure: Treatment-related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Phospho-Akt (pAkt) expression within CD34+ leukemic blasts
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Fairway
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: Moffitt Cancer Center
name: Jeffrey Lancet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015209: Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.

Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 45 years
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 dpt.

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Abuse of alcoholic beverages
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia of 6 or more dpt.
* Pregnancy

Primary outcomes:
measure: Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT02403609: An Online Study of the Reliability of the Brain Performance Test (BPT)
Official title: An Online Study of the Reliability of the Brain Performance Test (BPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: cognitive assessment
Brain Performance Test
Lumosity
test-retest reliability
computerized assessment
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 1357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate test-retest reliability of each subtest (correlation coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).

Detailed description: This is an open-label, randomized online study in which participants will be invited to take versions of the Brain Performance Test (BPT) on two consecutive days.

In parallel, all current Lumosity subscribers are invited to take the BPT at the beginning of their premium Lumosity experience and again every 10 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Electronically signed informed consent
* English-speaker
* Current Lumosity free user (test-retest portion) OR current Lumosity subscriber (longitudinal portion)

Exclusion Criteria:

* Visual or physical impairment that impedes computer use or completion
* Under 18 years of age

Primary outcomes:
measure: Correlation coefficients (Pearson's r)
timeFrame: 2 days
Secondary outcomes:
measure: Intercorrelation coefficients (Pearson's r)
timeFrame: 1 day
measure: Principle component analysis
timeFrame: 1 day
measure: Longitudinal BPT Grand Index and Subtest scaled scores
timeFrame: 10 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Lumos Labs, Inc.
state: California
Study officials:
affiliation: Lumos Labs, Inc.
name: Glenn Morrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802009: Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade
Official title: Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: ultrasound-guided regional anesthesia
nerve block
brachial plexus
mepivicaine
dexamethasone
hand wrist surgery
duration
anesthetic duration following brachial plexus/nerve block for hand/wrist surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing surgery of the hand often are treated with a nerve block in the shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last for a few hours after surgery and provide pain relief for this period. It may be possible to extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties. This study will compare the duration of the nerve block when dexamethasone (steroid) is added to the anesthetic injected around the nerve.


Eligibility criteria: Inclusion Criteria:

1. Patients having unilateral hand or forearm surgery under Supraclavicular brachial plexus blockade.
2. ASA I-III
3. Age 18-60
4. BMI \< 35

Exclusion Criteria:

1. Patients with a known history of hypersensitivity to local anesthetics and dexamethasone.
2. Contra-indication to regional anesthesia/ supraclavicular brachial plexus blockade e.g. bleeding diathesis, coagulopathy.
3. Peripheral neuropathy.
4. Peptic ulcer disease.
5. Diabetes Mellitus.
6. Inability to give informed consent.

Primary outcomes:
measure: Duration of anesthesia
timeFrame: hourly for first 24 hours; daily until discharge
Secondary outcomes:
measure: Requirements for pain medications; complications
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT01215409: Real Life Safety and Efficacy of Vardenafil
Official title: Vardenafil in Routine Treatment of Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Erectile Dysfunction
Keywords: Levitra
Erectile dysfunction
Taiwan
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 372
Sex: MALE
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: Primary care clinics

Brief summary: In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.


Eligibility criteria: Inclusion Criteria:

* Any adult patient (\>/=18 years) with erectile dysfunction treated with LEVITRA®.
* Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the product information (Package Insert).

Primary outcomes:
measure: General assessment of patients concerning efficacy and tolerability of vardenafil treatment
timeFrame: 2 months
Secondary outcomes:
measure: Time to first intercourse after intake of vardenafil
timeFrame: 2 months
measure: Percentage of successful second intercourse within 24 hours
timeFrame: 2 months
measure: Percentage of participants who are willing to continue treatment
timeFrame: 2 months
measure: Number of participants with adverse events
timeFrame: 2 months
Other outcomes:
Locations:
city: Many Locations
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03840109: Emotional Support Messages Following a Cancer Diagnosis
Official title: Emotional Support Messages Following a Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stress
Anxiety
Keywords: emotional support
cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: University of Arizona
name: University of Minnesota
First posted: 2019-02-15
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult cancer patients

Brief summary: Cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements. The messages with negative statements also differ based on whether the negative statements occur at the start or end of the message. After viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants with a diagnosis of breast, prostate, thoracic or digestive cancer in the past 3 years
* Participants consented to Moffitt's Total Cancer Care (TCC) protocol and indicating a willingness to be contacted for future research by including an email contact.
* Ability to read and write fluently in English

Primary outcomes:
measure: Message Effectiveness Scale
timeFrame: Through study completion, up to 1 year
measure: Affective Improvement Scale
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Supporter Competence Scale
timeFrame: Through study completion, up to 1 year
measure: Likelihood of Seeking Support Scale
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Maija Reblin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03215485: WAVE~Ripples for Change: Obesity Prevention in Active Youth
Official title: The WAVE~Ripples for Change: Obesity Prevention in Active Youth in Afterschool Programs Using Virtual- and Real-World Experiential Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity Prevention
Keywords: adolescent
sports
nutrition
physical activity
body mass index
virtual world
Lead sponsor: Oregon State University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 498
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There is one intervention group and one comparison group.
Primary purpose: PREVENTION

Brief summary: Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group will be given face to face nutrition lessons and have access to an online immersive learning environment. The comparison group will not. The project will test if the immersive learning environment is effective in preventing unhealthy weight gain.

Detailed description: Active youth are just as likely to develop poor dietary habits that can contribute to obesity later in life, after high school sports has ended. However, youth in sports may provide a key "window of opportunity" to teach them about eating health foods if that information is tied to sport performance. This project will test to see if that is true.

The virtual world is an idea medium for learning for this project. The project will test whether it indeed can result in behavior change more effectively than just more traditional face to face learning.

Eligibility criteria: Inclusion Criteria:

* youth ages 14 - 19 at baseline
* enrolled in a high school soccer program
* living with a parent/caregiver in Oregon
* without medical condition that hinders them from consuming normal healthy diets
* has assess to the internet during the 2-year study
* proficient in English

Exclusion Criteria:

* non-English speakers (youth)
* prisoners

Primary outcomes:
measure: Nutrition: Meet specific good groups dietary recommendation/guideline for fruit, vegetables, fat, and sugar intakes.
timeFrame: Change from baseline at 12 and 24 months later
measure: Physical activity: Meet moderate to vigorous physical activity (MVPA) recommendation.
timeFrame: Change from baseline at 12 and 24 months later
measure: Sleep about 8 hours/day.
timeFrame: Change from baseline at 12 and 24 months later
Secondary outcomes:
measure: Growth-adjusted Body Mass Index (kg/m2)
timeFrame: Change from baseline at 12 and 24 months later
Other outcomes:
Locations:
Study officials:
affiliation: OSU
name: Siew Sun Wong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OSU
name: Melinda M Manore, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01849185: Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 60
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: The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.

The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin


Eligibility criteria: Inclusion Criteria:

1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.

Exclusion Criteria:

1. Patients on chronic antibiotic treatment
2. Patients with immune disorders
3. Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
4. Patients who experienced myocardial infarction within less than two months.
5. Patients who consume probiotics.

Primary outcomes:
measure: LDL-Cholesterol levels.
timeFrame: 8 weeks
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Division of Cardiology Meir MC
Study officials:
affiliation: Division of Cardiology Meir MC
name: Tatiana Berlin, MD
role: PRINCIPAL_INVESTIGATOR
References: