louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01580306: Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Official title: Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.


Eligibility criteria: Inclusion criteria:

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Exclusion criteria:

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

Primary outcomes:
measure: AUC0-∞
timeFrame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
measure: Cmax
timeFrame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration
Secondary outcomes:
measure: Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
timeFrame: from drug administration up to 2 weeks
measure: Number of Participants With Drug Related Adverse Events
timeFrame: drug administration until end-of-study examination (7 to 14 days after drug administration)
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: 1220.58.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01187706: A Controlled Study of Quality of Life and it's Related Factors Among Gynecological Cancer Survivors
Official title: A Controlled Study of Quality of Life and it's Related Factors Among Gynecological Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Ovarian Cancer
Endometrial Cancer
Keywords: gynecological cancer survivors
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues.

Brief summary: To compare quality of life and it's related factors between gynecological cancer survivor and healthy controls.

Detailed description: This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues. The instruments include "Sample characteristics questionnaire," "Short Form-12 (SF-12)," "Medical Outcome Study Sleep Scale (MOS-sleep)," "Beck Depression Inventory-II (BDI)," "State-Trait Anxiety Inventory (STAI)," "Sexual Activity Questionnaire (SAQ), and "The Experiences in Close Relationships-Revised (ECR-R)." The data will be analyzed by descriptive statistical analysis, independent t-test, ANOVA, Scheffe's test, Pearson's correlation, and stepwise regression.

Eligibility criteria: Inclusion Criteria:

* Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment.
* 20-70 years old
* Agreed to participate in this study.

Exclusion Criteria:

* Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Fei-Hsiu Hsiao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100306: The Role of Auditory Feedback in Guiding Upper Extremity Movements
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000 cases per year in Canada. Less than half of stroke patients regain use of their arm and hand. There is currently no intervention regime that is the gold standard, despite the variety of therapeutic techniques used to treat the upper extremity post-stroke. The use of external feedback to improve motor learning is a technique that has been less studied but shows promise. Therefore, the purpose of this proof of principle study it to test whether different auditory feedback frequencies can facilitate reaching ability in people with stroke. In addition brain scans will be collected that will enable us to determine how stroke severity may impact on one's ability to improve with this technique.

We hypothesize that patients who receive less feedback (50% alternate) will have enhanced learning relative to the patients who receive more feedback (100%).


Eligibility criteria: Inclusion Criteria:

* Unilateral first time MCA ischemic stroke
* Stroke patients should have some movement of shoulder/elbow (no movement of hand - e.g. hand, fingers - is OK)
* \> 2 months post
* between 30-85 years

Exclusion Criteria:

* prior stroke
* severe comprehension (or cognitive) deficit that compromises informed consent or understanding of instructions
* contraindications to MRI (e.g. claustrophobia, metal implants)
* neurodegenerative or psychiatric disease
* apraxia
* auditory deficits that would impair testing
* prior musculoskeletal injury to back or upper extremity (including shoulder subluxation from stroke)
* skin conditions that would preclude taping of goniometers

Primary outcomes:
measure: Change in movement error from baseline
timeFrame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
Secondary outcomes:
measure: Change in range of motion
timeFrame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
measure: Change in movement duration
timeFrame: participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Canadian Partnership for Stroke Recovery
name: Joyce Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03137706: Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
Official title: Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colon Carcinoma
Liver and Intrahepatic Bile Duct Carcinoma
Pancreatic Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-03
Enrollment: 8
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 scheduled for surgery to remove primary tumors in the pancreas, liver, or colon

Brief summary: This pilot research trial studies characterization of mechanical tissue properties in patients with pancreatic, liver, or colon cancer. Mechanical properties and stiffness of the cancerous tissue may be correlated with the standard pathology report that describes the stage of the disease.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.

SECONDARY OBJECTIVES:

I. To describe the inter- and intra-tumor heterogeneity of tissue stiffness. II. To determine if the measurements made by the optical polarimeter device are non-destructive.

TERTIARY OBJECTIVES:

I. Perform multi-variable cross-correlation statistical analysis to determine relationships between: tissue stiffness characteristics, molecular level signatures, and cellular level properties, and if numbers permit, response to treatment.

OUTLINE:

Patients undergo fresh tumor tissue collection at the time of surgery. The fresh tumor tissue samples are analyzed for tissue stiffness measurements using an optical polarimeter device and cell viability using an automated cell counter.

Eligibility criteria: Inclusion Criteria:

* Scheduled for surgery to remove primary tumors in the pancreas, liver or colon and have not undergone any prior treatment
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Pregnant women will not be consented
* Patients that are unable to consent for surgery
* Primary liver tumors with cirrhosis will be excluded from this study

Primary outcomes:
measure: Young's modulus (stiffness) on fresh tissue
timeFrame: Up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Shannon Mumenthaler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06930599: Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
Official title: Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Pulmonary vein isolation
Transition Zone Modification
Atrial Fibrillation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.


Eligibility criteria: Inclusion Criteria:

Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent

Exclusion Criteria:

Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy \<12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies

Primary outcomes:
measure: Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
timeFrame: at least 12 months follow up
Secondary outcomes:
measure: Incidence of Peri-procedural Complications
timeFrame: 1 week after patient enrollment
measure: Total procedure time
timeFrame: 1 week after patient enrollment
measure: Total fluoroscopic time
timeFrame: 1 week after patient enrollment
measure: Total RF delivery time
timeFrame: 1 week after patient enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04134949: Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
Official title: Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population. Improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors. The study aim is to asses psychological intervention for insomnia in prisons.


Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age
* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-5 Insomnia Disorder
* Can speak, understand, and write in Persian
* Male

Exclusion Criteria:

* Currently receiving psychological treatment for Insomnia
* presence of a rapidly progressing neurological or medical disorder

Primary outcomes:
measure: sleep hygiene behavior
timeFrame: changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
measure: Sleep Quality
timeFrame: changes in sleep quality baseline , 1 month and 6 months follow-up
measure: Insomnia Severity Index
timeFrame: changes in insomnia baseline , 1 month and 6 months follow-up
measure: Sleep Logs
timeFrame: changes in Sleep Logs , 1 month and 6 months follow-up
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: changes in HADS, 1 month and 6 months follow-up
measure: Perceived Stress Scale (PSS)
timeFrame: changes in PSS, 1 month and 6 months follow-up
measure: Mindful Attention Awareness Scale
timeFrame: changes in MAAS, 1 month and 6 months follow-up
measure: psychological well-being
timeFrame: changes in GHQ-12, 1 month and 6 months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
city: Qazvin
country: Iran, Islamic Republic of
facility: Social Determinants of Health Research Center
Study officials:
References:
Clinical trial NCT02473549: Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation
Official title: Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: motor
rehabilitation
transcranial direct current stimulation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many individuals are often left with problems moving their arm and hand, months to even years after a stroke. Recent progress in research suggests the application of non-invasive brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with rehabilitation exercises can further improve a person's ability to move after stroke. However, the problem is that this doesn't work for everyone, and researchers do not know why. One reason may be that TDCS is currently applied using a one-size-fits-all approach. Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in the same way. But, researchers know this is not the case. For example, each person will likely have different amounts of damage to brain regions that control movements. A better understanding of how the stroke uniquely affects a person's brain will help us to know which is the correct type of TDCS to apply for that person. Therefore, the objective of this research is to determine whether the amount of damage to brain regions that control movements can predict which type of TDCS will be more effective to help a person improve their ability to move. Participants will undergo 1 session of magnetic resonance imaging, and three sessions of TDCS.


Eligibility criteria: Inclusion Criteria:

* unilateral first time stroke in middle cerebral artery territory
* greater 3 months post-stroke
* able to raise arm onto a table from a seated position

Exclusion Criteria:

* severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions
* severe apraxia and neglect
* neurodegenerative or psychiatric disease
* contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)

Primary outcomes:
measure: Change in movement time (seconds) for reaching after 1 session of TDCS
timeFrame: 1 day
measure: Change in accuracy of reaching (root mean square error) after 1 session of TDCS
timeFrame: 1 day
measure: Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Joyce Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06957249: Clinical Study to Evaluate the Tooth Whitening Efficacy
Official title: Clinical Study to Evaluate the Tooth Whitening Efficacy of a Colgate Toothpaste With 5% Hydrogen Peroxide and Fluoride Compared to a Toothpaste With 0% Hydrogen Peroxide and Fluoride Over a One-Week Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Whitening
Keywords: hydrogen peroxide
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2025-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form;
* Male and female subjects 18-70 years old, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* All maxillary natural permanent anterior teeth (6-11) must be present;
* Availability for the duration of the study;
* Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker.

Exclusion Criteria:

* Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
* Obvious signs of periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Concurrent participation in another clinical study;
* Self-reported pregnant and/or lactating women;
* History of allergies or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
* Restorations on the teeth to be scored which may interfere with scoring procedures;
* Have used a professional whitening product within one (1) year and/or had a dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study

Primary outcomes:
measure: Tooth color measurement
timeFrame: baseline, day 1, day 3, day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Consumer Research Consulting, LLC
state: Florida
Study officials:
affiliation: Consumer Research Consulting, LLC
name: John Gallob, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01993849: Use of N-Acetylcysteine (NAC) in Fingernail Biting
Official title: A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychophagia
Keywords: Anxiety
Impulse control
Depression
ADHD
Fingernail Biting
N-Acetylcysteine
NAC
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC) in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy on young adults who bite their fingernails. It is proposed that NAC will help decrease fingernail biting.

Detailed description: This is a proof-of-concept pilot placebo-controlled trial of N-acetylcysteine (NAC) in young people who bite fingernails. The primary interest is in assessing the feasibility of conducting this line of research, while preliminarily exploring potential effects on nail biting, as measured by nail length.

Eligibility criteria: Inclusion Criteria:

* 1. Age 18-30 2. Fingernail biter for ≥5 years

Exclusion Criteria:

* 1. Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g., psychotic disorders, bipolar disorder, major depressive disorder) 2. Current substance dependence in the past month 3. Current unstable major medical disorder or medical condition in the past 6 months (e.g., renal impairment) 4. Current pregnancy or breastfeeding 5. Current seizure disorder or asthma, due to possible elevated risk for adverse effects with NAC in individuals with these conditions 6. Known hypersensitivity to NAC 7. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Primary outcomes:
measure: Number of Participants Enrolled Within One Year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Measurement of Nail Length
timeFrame: End of 8-week treatment
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: