louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04850625: Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
Official title: Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pyrotinib
Lapatinib
Vinorelbine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 224
Sex: FEMALE
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: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Detailed description: This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.

Eligibility criteria: Inclusion Criteria:

* HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
* Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
* Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021.
* Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion Criteria:

* Incomplete medical history

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01963325: S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Official title: Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.

Detailed description: There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of cholangiocarcinoma
* Not eligible for curative surgery
* Progressed after first-line gemcitabine-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
* No serious or uncontrolled concomitant medical illness
* Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: \> or equal to 8 mg/dL, total bilirubin: \< or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).

Exclusion Criteria:

* Uncontrolled infection or severe active comorbid disease
* Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
* Pregnancy or lactating women

Primary outcomes:
measure: Response rates
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 6 months
measure: Number of participants with adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yuhong Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06443125: Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
Official title: Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder
natural psychotherapy
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

Detailed description: 1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
2. Investigate the pathological mechanism of neurotic patients from the aspects of electroencephalic graph/functional magnetic resonance imaging (EEG/fMRI) and biology.
3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of obsessive-compulsive disorder or compulsive behavior
* Duration of symptoms for not less than 12 months
* Age 15-60 years old.
* You can participate in the whole experiment and offline assessment in Beijing

Exclusion Criteria:

* Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma
* Subjects who suffered from alcohol or illegal drug abuse/dependence

Primary outcomes:
measure: Obsessive-compulsive symptoms
timeFrame: Baseline, 12 weeks
measure: Cognitive function
timeFrame: Baseline, 12 weeks
measure: Mood and behavior
timeFrame: Baseline, 12 weeks
measure: ERP components associated with cognitive function
timeFrame: Baseline, 12 weeks
measure: rest fMRI in Obsessive-compulsive patients
timeFrame: Baseline, 12 weeks
measure: Behavioral inhibition
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Mental Health Center
state: Anhui
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Science
name: Xiang-Yang Zhang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844025: Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication
Official title: Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication: a Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Chronic Disease
Keywords: Adverse drug reaction
Inappropriate medication
Pharmacist
Pharmaceutical care
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients aged at least 65 years
* Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication

Exclusion Criteria:

* Patients who refused informed consent
* Discharged before consent could be obtained
* Cognitive impaired

Primary outcomes:
measure: Number of unsolved drug-related problems
timeFrame: 14 days after randomization
Secondary outcomes:
measure: Rate of adverse drug event during hospitalization
timeFrame: 14 days after randomization
measure: Number of potentially inappropriate medication
timeFrame: 14 days after randomization
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wo Ho-Su Memorial Hospital, Department of Pharmacy
Study officials:
affiliation: Shin Kong Wo Ho-Su Memorial Hospital
name: Liu Jen Wei, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
citation: Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008 Nov;37(6):673-9. doi: 10.1093/ageing/afn197. Epub 2008 Oct 1.
citation: Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PR, Downie G, Seymour DG. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Age Ageing. 2001 May;30(3):205-11. doi: 10.1093/ageing/30.3.205.
citation: Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2. Epub 2007 Jun 7.
Clinical trial NCT03054025: Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors
Official title: Facilitating Motivational Readiness and Adoption of Physical Activity by Breast Cancer Survivors With a Smart Phone Application
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies how well a smart phone application works in increasing physical activity in breast cancer survivors. A smart phone application that increases physical activity may help reduce the likelihood of cancer coming back in breast cancer survivors.

Detailed description: PRIMARY OBJECTIVES:

I. To conduct a pilot study to inform the design of a mobile health application for smartphone that is targeted to increase physical activity and reduce risks associated with breast cancer.

Eligibility criteria: Inclusion Criteria:

* A participant is only able to participate in one phase, not both phases, of the research study
* Must have completed breast cancer treatment
* Those on adjuvant hormonal therapy are allowed to participate in the research study (either phase)

Exclusion Criteria:

* Those who currently meet the Centers for Disease Control and Prevention (CDC)'s physical activity guidelines
* Those who do not currently use a smartphone (of any kind)
* Those who do not read and speak English

Primary outcomes:
measure: Features of the mobile application that were most used by participants
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Andrea Barsevick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06054425: A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Official title: A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at the time of screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Up to Day 131
measure: Time to Cmax (Tmax)
timeFrame: Up to Day 131
measure: Apparent Terminal Phase Elimination Rate Constant (β)
timeFrame: Up to Day 131
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: Up to Day 131
measure: Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
timeFrame: Up to Day 131
measure: AUC from Time 0 to Infinity (AUC0-inf)
timeFrame: Up to Day 131
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 141
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 260740
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 260800
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 260864
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01488825: Yoga Intervention Study on Episodic Tension Type Headache
Official title: Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Episodic Tension Type Headache
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 77
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: The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.


Eligibility criteria: Inclusion Criteria:

* aged between 18 to 60 years
* more than 5 but fewer than 15 headache episodes per month
* headache intensity moderate to severe

Exclusion Criteria:

* Patients on anti-psychotic, antidepressant or any prophylactic medication
* pregnancy
* Taking psychotherapy or any other alternative medicine
* migraine headache more than 1 day a month
* pain disorder, psychiatric or medical disorder requiring immediate treatment,
* headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches

Primary outcomes:
measure: Frequency of headache
timeFrame: 3 Months
Secondary outcomes:
measure: Duration of Headache
timeFrame: 3 months
measure: Severity of headache
timeFrame: 3 Months
measure: Analgesic consumption
timeFrame: 3 Months
measure: Anxiety levels
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Stress
timeFrame: 3 months
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Pain Clinic, NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute
name: Neha SHARMA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747422: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
Official title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Wrinkles
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

Detailed description: The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 40 to 70 years
* Subject in good health
* Desire improvement in periorbital wrinkles
* Subject provides informed consent and agrees to attend follow-up visits
* Subject signs a HIPPA authorization

Exclusion Criteria:

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Has significant scarring in test areas
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
* Has a metal stent or implant in the face area
* Is a current smoker or has a history of smoking in last 10 years

Primary outcomes:
measure: reduction of periorbital wrinkles
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology
state: California
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
Study officials:
References:
Clinical trial NCT02116322: Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
Official title: EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.


Eligibility criteria: Inclusion Criteria:

* In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Uncooperative patients
* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
* Refusal to consent form
* Prior negative FNTA
* In situ metallic biliary stents
* Predominantly cystic lesions
* Inaccessible lesions to EUS

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic Yield of the FNA Using Corkscrew Technique
timeFrame: 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mouen A Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References: