louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02133820: A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.
Official title: A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Healthy Volunteer
Pharmacokinetics
Lead sponsor: Mundipharma Research Limited
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

Detailed description: This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.

Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.

Eligibility criteria: Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.

Primary outcomes:
measure: Pharmacokinetics parameters AUC and Cmax
timeFrame: Up to 32 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: 7 to 10 days
measure: Vital Signs
timeFrame: 0 to 32 hours
measure: Clinical Laboratory Tests
timeFrame: Day 0 and Day 7-10
measure: ECG
timeFrame: Screening, 1 our post-dose and Day 7-10
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Limited
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT04824820: Improving Female Sexual Wellness
Official title: Effect of Commercial Genital Vibrators Use on Female Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexuality
Sexual Dysfunction
Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Orgasmic Disorder
Pelvic Organ Prolapse
Urinary Incontinence
Interstitial Cystitis
Pelvic Floor Disorders
Female Sexual Dysfunction
Keywords: sexuality
Sexual Dysfunction
Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Orgasmic Disorder
Pelvic Organ Prolapse
Urinary Incontinence
Interstitial Cystitis
Pelvic Floor Disorders
Wellness
Female Sexual Dysfunction
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of commercially available genital vibrator use on sexual health, female pelvic floor disorders, and overall quality of life among a diverse population of women.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Diagnosis of female sexual dysfunction, pelvic floor dysfunction, genito-urologic issues (stress urinary incontinence, urge urinary incontinence, pelvic organ prolapse, interstitial cystitis, pelvic pain, dyspareunia, lichen sclerosis)
* Manual dexterity to use vibrator

Exclusion Criteria:

* Non English speaking
* Pregnancy or \<12 months postpartum
* Poor manual dexterity

Primary outcomes:
measure: To assess the change from baseline sexual function at 3 month
timeFrame: baseline, post intervention at 3 months
measure: To assess the change from baseline sexual function at 3 month
timeFrame: baseline, post intervention at 3 months
measure: To assess the change from baseline degree of pelvic organ prolapse at 3 month
timeFrame: baseline, post intervention at 3 months
measure: To assess the change from baseline overall health and quality of life at 3 month
timeFrame: baseline, post intervention at 3 months
measure: To assess the change from baseline overall health and quality of life at 3 month
timeFrame: baseline, post intervention at 3 months
measure: To assess the change from baseline overall health and quality of life at 3 month
timeFrame: baseline, post intervention at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Karyn Eilber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886520: Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes
Official title: Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Stress Incontinence
Keywords: Urinary incontinence
Materials
Surgery
Transobturator tape
Polyvinylidene fluoride
Polypropylene
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital de Granollers
name: Hospital Quiron Sagrado Corazon
name: Hospital de Mataró
name: Hospital Riotinto
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Universitari de Bellvitge
name: Hospital de Viladecans
name: Hospital Santa Caterina
First posted: 2016-09-01
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.


Eligibility criteria: Inclusion Criteria:

* Women with stress urinary incontinence.
* Women with stress-predominant mixed urinary incontinence.

Exclusion Criteria:

* Incapacity to understand the information or give their consent.
* Previous anti-incontinence surgery with slings.
* Low pressure urethra (MUCP \< 20cmH2O).
* Neurogenic bladder.

Primary outcomes:
measure: Effectiveness
timeFrame: One year
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to one year.
Other outcomes:
measure: Change in subjective questionnaires of incontinence severity
timeFrame: One year
Locations:
city: Barcelona
country: Spain
facility: Hospital de Mataró
city: Barcelona
country: Spain
facility: Hospital de Viladecans
city: Barcelona
country: Spain
facility: Hospital General de Granollers
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Santa Caterina
city: Huelva
country: Spain
facility: Hospital General Riotinto
city: Sevilla
country: Spain
facility: Hospital Quiron Sagrado Corazon
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
Study officials:
References:
Clinical trial NCT01440920: A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Official title: A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
WT1
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.


Eligibility criteria: Key Inclusion Criteria:

* Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.
* Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy.
* Age: ≥ 60years of age(at the time of signature of the informed consent form)
* Sex: Male and Female
* Patients who are capable of giving informed consent
* Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.
* Patients must be one of the following HLA DRB1 types: HLA-DRB1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01.

Key Exclusion Criteria:

* Patients who are scheduled for a bone marrow transplantation
* Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids.
* Patients with uncontrollable active infectious diseases
* Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases
* Immunocompetent patients
* Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicities
timeFrame: 4 Weeks
Secondary outcomes:
measure: Recurrence Based on the Response Evaluation Criteria by the International Working Group
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center
Study officials:
References:
Clinical trial NCT04477720: Retrospective Analysis of De-identified Deceased HCC Patients
Official title: HCC Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival
Keywords: HCC, AFP, MTD, survival, NLR, PLR, Tumor Aggressiveness
Lead sponsor: Carr, Brian
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for HCC management

Brief summary: De-identified deceased HCC patients who were not surgical candidates were evaluated for their clinical baseline characteristics associated with their survival. Baselines included tumor markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and presence of portal vein thrombosis.


Eligibility criteria: Inclusion Criteria:

* biopsy-proven HCC

Exclusion Criteria:

* none

Primary outcomes:
measure: Survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02653820: Complementary Effect of Reflexology on Chemotherapy-Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Reflexology
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting. This study aims to investigate the clinical effect of reflexology on chemotherapy-induced nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Chemotherapy patients

Exclusion Criteria:

* Myocardial Infarction in previous 6 months
* Mechanical colonic obstruction

Primary outcomes:
measure: Change in Severity of Nausea
timeFrame: Three weeks
measure: Change in Severity of Vomiting
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Katerina Shulman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03206320: Topical Lidocaine for Needle Insertion and Injection Pain
Official title: Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needle Insertion and Injection Pain
Lead sponsor: New York School of Regional Anesthesia
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.


Eligibility criteria: Inclusion Criteria:

* Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
* Age \>18 at the time of informed consent
* ASA I-III physical class
* Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block

Exclusion Criteria:

* History of an allergy or contra-indication to a local anesthetic
* Baseline neurological deficit
* Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
* Presence of preexisting coagulation disorders
* Infection at injection site
* Concomitant opioid therapy
* Recent history (\<3 months) of drug or alcohol abuse
* Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit

Primary outcomes:
measure: Needle insertion pain
timeFrame: Immediately at the time the needle is inserted through the skin
measure: Injection pain
timeFrame: Immediately at the end of the block
Secondary outcomes:
measure: Fearfulness
timeFrame: Just before the nerve block
measure: Overall discomfort
timeFrame: Immediately at the end of the block
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
References:
Clinical trial NCT05023720: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer
Official title: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
regorafenib
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.

Brief summary: Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study

Detailed description: To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Eligibility criteria: 1. Inclusion Criteria:

   1. Must be a pathologically proven colorectal adenocarcinoma
   2. Must have been treated with regorafenib
   3. Regorafenib must be used after two lines of standard antitumor therapy
2. Exclusion Criteria:

   1. Application is less than one course of treatment with regorafenib
   2. First - or second-line treatment with regorafenib
   3. Patients with multiple primary cancers

Primary outcomes:
measure: The difference in overall survival between the two groups calculated by Kaplan-Meier
timeFrame: 2021.7-2022.12
measure: The difference of OS in patients receiving different doses of regorafenib
timeFrame: 2021.11-2022.12
measure: Regorafenib in combination with other drugs
timeFrame: 2021.7-2022.10
Secondary outcomes:
measure: Survival differences among the patients with different clinical phenotypes and genotypes
timeFrame: 2021.7-2022.10
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan cancer hosiptal
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Shujun Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05353920: The Effect of Cognitive Function Training Program for Community Elderly
Official title: The Effect of Cognitive Function Training Program for Community Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function 1, Social
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated.

Objective. The purpose of this study is to construct and evaluate the effects of cognitive function training program on cognitive function for community elderly.

Design. This is a randomized controlled study. Study subjects are elderly living in community. Subjects will be randomized into experimental group or active control group. The evaluation of the program will be evaluated at baseline, immediate after, 3 months, 6 months, and 1 year after the last session. The primary outcome indicators of the training is cognitive function, assessed by MMSE and MoCA.

Expected contribution. With rigorous design and long term follow-up, the effectiveness of cognitive function training program in Chinese population in Taiwan can be evaluated. Results of the current study will determine the value of the cognitive function training program and provide valuable information for future utilization of this protocol.


Eligibility criteria: Inclusion Criteria:

* 65 years old

Exclusion Criteria:

* TBI

Primary outcomes:
measure: MMSE
timeFrame: 12 weeks
measure: MoCA
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TMU
Study officials:
affiliation: Professor
name: Kuei-ru Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581320: Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 201
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Female more than 40 years old in postmenopausal

Exclusion Criteria:

* Subject who has a history of malignant cancer

Primary outcomes:
measure: A ratio of subject whose 25 OHD concentration is less than 15ng/mL
timeFrame: 16weeks
Secondary outcomes:
measure: A ratio of subject whose 25 OHD concentration is less than 9ng/mL
timeFrame: 16 weeks
measure: Safety evaluation (AE, Lab test, Vital sign etc)
timeFrame: 16weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Moo-il Kang, MD, PhD
role: STUDY_CHAIR
References: