louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02278458: Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
Official title: Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
* ECOG Performance Status of 0 to 1.
* Adequate organ function as defined by study-specified laboratory tests.
* Signed informed consent form.
* Willing and able to comply with study procedures.

Exclusion Criteria:

* Previous chemotherapy or target therapy.
* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
* Systemically active steroids.
* Another investigational product within 28 days prior to receiving study drug.
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
* Infection with HIV, hepatitis B or C at screening.
* Pregnant or lactating.
* Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.

Primary outcomes:
measure: The number of patients who suffer adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Tumor response assessed by RECIST 1.1
timeFrame: 3 months
measure: Progression-free survival
timeFrame: 4 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Cancer Hospital of Harbin Medical University
name: Yanqiao Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717558: Bioavailability Pilot Study of Versus W0035 Versus Stromectol
Official title: Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pierre Fabre Dermatology
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
Primary purpose: OTHER

Brief summary: Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.

PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.


Eligibility criteria: Inclusion Criteria:

* 18.5 ≤ BMI ≤ 30.0 kg/m².
* Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
* Agree to use effective contraception method

Exclusion Criteria: most specific out of 30.

* History of or current symptomatic orthostatic hypotension
* Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
* History of or current macroscopic or microscopic hematuria
* Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
* Organic disorder likely to modify, absorption, distribution or elimination of the medication.

Primary outcomes:
measure: Concentration of ivermectin
timeFrame: 5 periods of 3 days each
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Institut de Recherche Pierre Fabre
name: Karim Keddad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00943163: Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method
Official title: Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Cyclorotation Degree
Pupil Shift
Keywords: cyclorotation
pupil
laser refractive surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ninety-three consecutive patients undergoing bilateral wavefront-guided laser refractive surgery in the Department of Ophthalmology of the National Taiwan University Hospital between September 2004 and December 2007.

Brief summary: Cyclorotation of eyes may be affected by motion and orientation of the head and body. An automated alignment method with the technique of iris recognition was used to assess the amount and orientation of position-induced cyclorotation between preoperative wavefront measurement and laser refractive surgery.

Detailed description: Ninety-three consecutive patients undergoing bilateral wavefront-guided laser refractive surgery in the Department of Ophthalmology of the National Taiwan University Hospital between September 2004 and December 2007 were enrolled in this retrospective study. Before laser refractive surgery, all patients were seated in front of the Zyoptix 100 system platform (Bausch \& Lomb, salt lake city, UT, USA) and received Zywave aberrometer measurement on both eyes. When patients were in the supine position for refractive surgery, an infrared camera mounted on the laser system (Technolas 217z100 excimer laser system, Bausch \& Lomb)obtained iris images on undilated pupils before laser ablation. Overall cyclorotation was detected by a comparison between iris images of undilated pupils in the supine position and dilated pupils in the seated position before laser treatment. The degree and direction of position-induced cyclorotation were assessed.

Eligibility criteria: Inclusion Criteria:

* patients undergoing bilateral wavefront-guided laser refractive surgery

Exclusion Criteria:

* patients with strabismus, extraocular muscle palsy, muscle restriction or other diseases interfering normal ocular movement.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: Telephone: 886-2-23123456 Ext. 65025 Email: ychou51@ntu.edu.tw
name: Yu-Chih Hou, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06790563: Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
Official title: Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arousal Disorders, Sexual
Keywords: Neuromodulation
Neurostimulation
Persistent Genital Arousal Disorder
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if neuromodulation of the dorsal genital nerve works to treat symptoms related to Persistent Genital Arousal Disorder in women. The main questions it aims to answer are:

What is the effect of neuromodulation on PGAD symptoms in women?

Participants will:

Use a neurosimulator every day for 3 weeks. Keep a diary of their symptoms and the number of times they used the neurostimulator Fill in questionaires


Eligibility criteria: Inclusion Criteria:

* Women with PGAD

Exclusion Criteria:

* Women \< 18 years
* Women not able to handle the neuromodulator
* Women in whom the anatomy of the genitals precludes proper electrode placement

Primary outcomes:
measure: Symptom severity
timeFrame: 8 weeks
measure: Neuromodulation effect
timeFrame: 3 weeks
measure: Satisfaction device
timeFrame: At the end of the treatment, at week 8
Secondary outcomes:
measure: HADS
timeFrame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
measure: PCS
timeFrame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
measure: QoL
timeFrame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
measure: Patient Global Impression of Improvement
timeFrame: During follow-up (after week 8)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud Unversity Medical Center
Study officials:
References:
Clinical trial NCT01703663: Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Official title: Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Obstructive Sleep Apnea
Keywords: Stroke
Sleep Apnea
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke.

Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night.

Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.


Eligibility criteria: Inclusion Criteria:

* adults with an ischemic stroke (including TIA with infarction) within the prior 14 days

Exclusion Criteria:

1. Current use of any transnasal tube (eg dobhoff tube)
2. Current use of CPAP, mechanical ventilation, or supplemental oxygen
3. Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
4. Severe heart disease (including severe heart failure)
5. Pathologically low blood pressure
6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
7. Sores, abrasions, or skin or mucosal irritation on or around the nose.
8. Known pregnancy
9. Inability to provide informed consent
10. Use of alpha blockers or short acting nitrates
11. Permanent pacemaker
12. Sustained non-sinus cardiac arrhythmia

Primary outcomes:
measure: Apnea-hypopnea Index
timeFrame: night 1 and night 2
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Devin L Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120.
Clinical trial NCT05451563: Double-S: a Wearable Device for Erectile Dysfunction
Official title: Double-S: a Wearable Device for Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

Detailed description: The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse.

The goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.

Eligibility criteria: Inclusion Criteria:

* males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
* having a female partner willing to participate in the study

Exclusion Criteria:

* not willing to attempt sexual vaginal intercourse with their partner
* inability to wear/operate the external penile device for any reason

Primary outcomes:
measure: Change in modified International Index of Erectile Dysfunction score
timeFrame: baseline and up to 1 month post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare, Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Michael Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05191563: A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.
Official title: An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax of Losartan
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: AUClast of Losartan
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: Cmax of EXP3174
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: AUClast of EXP3174
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: Cmax of Chlorthalidone
timeFrame: Day 1, Day 15: pre-dose(0 hour)~144hours
measure: AUClast of Chlorthalidone
timeFrame: Day 1, Day 15:pre-dose(0 hour)~144hours
Secondary outcomes:
measure: AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174
timeFrame: Day 1, Day 15: pre-dose(0 hour)~48hours
measure: AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone
timeFrame: Day 1, Day 15:pre-dose(0 hour)~144hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yangji Hospital
Study officials:
References:
Clinical trial NCT01365663: Multiple Ascending Dose Study of SPC4955 in Healthy Subjects
Official title: A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC4955 Administered to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
LDL
HDL
apoB
hyperlipidemia
LNA-oligonucleotide
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects, age 18-65 years, inclusive.
2. BMI 18-33 kg/m2
3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

   * LDL-C ≥3.24 mmol/L (≥125 mg/dL)
   * Triglycerides (fasted) \<2.7mmol/L (\<239 mg/dL)
   * ALT within normal limits

Exclusion Criteria:

1. Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
2. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
3. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
4. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
5. Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
6. Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

Primary outcomes:
measure: Number of subjects experiencing adverse events
timeFrame: up to 78 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of SPC4955
timeFrame: Up to 78 Days
measure: total Cholesterol
timeFrame: up to 78 days
measure: Area under the plasma concentration versus time curve (AUC) of SPC4955
timeFrame: Up to 78 days
measure: LDL
timeFrame: up to 78 days
measure: HDL
timeFrame: up to 78 days
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Nuvisan GmbH
name: Werner Feuerer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: