louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05424549: A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease
Official title: A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: dry eye disease
reproxalap
Aldeyra
ADX-102
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

1. Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
2. Ability to provide written informed consent
3. Reported history of dry eye for at least 6 months prior to screening
4. Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion Criteria:

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
2. Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
3. Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
4. Women of childbearing potential (WOCBP) who are pregnant and nursing
5. If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
6. Known allergy and/or sensitivity to reproxalap or the drug product vehicle
7. A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
8. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Primary outcomes:
measure: Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
timeFrame: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.
measure: Schirmer Test Mean Change From Baseline
timeFrame: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
Study officials:
References:
Clinical trial NCT03592849: The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Official title: The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Endometrium
Keywords: thin endometrium
infertility
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.


Eligibility criteria: Inclusion Criteria:

1. Infertile patients with clear fertility desires
2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
3. 20-42 years old
4. Normal ovarian function or with frozen embryos
5. Willing to actively cooperate with postoperative follow-up

Exclusion Criteria:

1. With abnormal chromosome karyotype
2. With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
3. Systemic diseases: hypertension, diabetes, and so on
4. Contraindications to pregnancy
5. Contraindications to hormone replacement therapy
6. Medical history of pelvic tumors or receiving pelvic radiotherapy
7. Involved in other clinical studies
8. Unable to adhere to the follow-up

Primary outcomes:
measure: endometrial thickness
timeFrame: 12 months
Secondary outcomes:
measure: ongoing pregnancy rate
timeFrame: 24 months
measure: live birth rate
timeFrame: 24 months
measure: endometrial blood flow
timeFrame: 6 months
Other outcomes:
measure: menstrual blood volume
timeFrame: baseline and 6 month postoperation
measure: adverse event rate
timeFrame: 30 months
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yali Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462836: The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
Official title: The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laparoscopic Colorectal Resection Due to Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects.

This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.


Eligibility criteria: Inclusion Criteria:

1. elective laparoscopic colorectal resection due to colorectal cancer
2. curative, resectable operation
3. ASA classification Ⅰ-Ⅲ

Exclusion Criteria:

1. elective co-operation due to distance metastasis
2. preoperative chemo/radiation therapy
3. drug allergy to opioid, tramadol, local anesthetics
4. MAOi medication (within 14 days of surgery)
5. decreased hepatic/renal function
6. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner
7. pregnant, lactating women
8. palliative surgery

Primary outcomes:
measure: natural killer cell cytotoxicity
timeFrame: postoperative day #3
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Study officials:
References:
Clinical trial NCT02697149: Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
Official title: The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Retrograde Cholangiopancreatography , Gallstone
Keywords: ERCP
nonradiation-to-endoscopist
gallstones
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-90 years old, patients undergoing endoscopic retrograde cholangiopancreatography

Brief summary: Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe when endoscopists were not expose to radiation. This study was to evaluate the effectiveness and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in patients with complexity level I/II.


Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

* 1 Bismuth typy Ⅲ and Ⅳ
* 2 common bile duct stone \> 15mm
* 3 common bile duct stone and distal stenosis

Primary outcomes:
measure: Success of endoscopic retrograde cholangiopancreatography
timeFrame: 6 months
Secondary outcomes:
measure: Overall complications
timeFrame: 6 months
measure: Cannulation success rate
timeFrame: 6 months
measure: ERCP procedure time
timeFrame: 6 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of gastroenterology, Chinese PLA 174 Hospital
state: Fujian
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of gastroenterology, Chinese PLA 174 hospital
name: Wei Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uradomo LT, Goldberg EM, Darwin PE. Time-limited fluoroscopy to reduce radiation exposure during ERCP: a prospective randomized trial. Gastrointest Endosc. 2007 Jul;66(1):84-9. doi: 10.1016/j.gie.2006.10.055.
citation: Liao C, Thosani N, Kothari S, Friedland S, Chen A, Banerjee S. Radiation exposure to patients during ERCP is significantly higher with low-volume endoscopists. Gastrointest Endosc. 2015 Feb;81(2):391-8.e1. doi: 10.1016/j.gie.2014.08.001. Epub 2014 Oct 5.
Clinical trial NCT01601249: Improving IVF Embryo Quality Grading Using Polarized Light
Official title: A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Infertility
Keywords: IVF, embryo selection, polarized light
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Selecting one or two IVF embryos with the highest potential to implant is extremely important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations. The currently used IVF embryo grading method is based solely on embryo morphology (cleavage rate and fragmentation) just before the transfer, which is not very well correlated with the implantation potential of each embryo. Oocyte quality and adequacy are the most important factors determining the biological quality and implantation potential of the embryo. It impossible to grade oocytes using plain optical systems, other than maturity and gross anomalies.

Polscope systems allow to visualize intra ooplasmic structures and determine their retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading embryos using the oocyte's parameters as visualized by polscope is superior to conventional morphology and correlates better with their implantation potential.

Here the investigators will perform a prospective randomized controlled trial to examine this hypothesis.

Detailed description: Each embryo will be graded in accordance to polscope based parameters; the presence of a spindle in the oocyte, its retardance, the distance between the spindle and the PB, and the thickness and retardance of the ZP.

In the experimental group the embryos for transfer will be selected based on these parameters, whereas in the control group they will be selected based on conventional morphologic criteria.

Eligibility criteria: Inclusion Criteria:

* Age 18-38, (near) normal MF, normal uterus, \>4 aspirated oocytes, intent to transfer 1-2 embryos.

Exclusion Criteria:

* Severe MF problems, uterine anomalies, PGD, RIF.

Primary outcomes:
measure: Occurrence of clinical pregnancy
timeFrame: within 2 weeks after ET
Secondary outcomes:
measure: Live birth
timeFrame: up to 40 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: HMO
name: Yoel Shufaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05636449: Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty
Official title: Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.

Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.

Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Total knee arthroplasty

Exclusion Criteria:

* BMI\>35
* liver, kidney, and advanced heart failure,
* routine use of analgesics and
* having used analgesics in the last 24 hours,
* having neuropathic pain,
* refusal to participate in the study

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: first 48 hours
measure: timed up and go test (TUG)
timeFrame: at 24th hour
measure: quadriceps muscle strength
timeFrame: at 24th hour
measure: joint range of motion test (ROM)
timeFrame: at 24th hour
measure: Five Time Sit to Stand Test (FTSST)
timeFrame: at 24th hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ali Ahiskalioglu
Study officials:
affiliation: Ataturk University
name: Elif Oral Ahiskalioglu
role: STUDY_DIRECTOR
References:
citation: Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12.
citation: Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2.
Clinical trial NCT00189449: Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Official title: Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Allergy
Growth
Keywords: Allergic Rhinitis
Allergy
Growth
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS). One of the major long-term safety concerns is whether ICS interferes with normal growth in allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased growth. However, the effect of nasal ICS on long-term growth and the attainment of final adult height is unknown. Another potential systemic adverse effect of ICS use is suppression of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male/Female aged 6-13 years of age
* Diagnosis of SAR/PAR, with symptoms within the past 3 months
* Positive skin test to inhalant allergen with negative saline control
* No previous use of intranasal inhaled, oral, IV or topical steroid use within past 6 months.
* If the subject has asthma, only mild intermittent (per NAPP) guidelines treated with PRN bronchodilator

Exclusion Criteria:

* screening height outside the 5th and 95th percentiles
* History of abnormal growth
* Any other chronic condition beside allergic rhinitis or mild intermittent asthma
* Subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial.
* Subject with a known hypersensitivity to any active ingredients or excipents in the study medications
* Subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum)
* Subjects with a history of substance abuse, mental illness or retardation
* Subjects with a history or presence of glaucoma or posterior subcapsular cataract
* Subjects with nocturnal enuresis.
* Use of Theophylline, Intal/Tilade or leukotriene modifiers.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: David Skoner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622349: Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
Official title: A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Randomised phase III
Chemotherapy
Advanced non-small cell lung carcinoma
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 707
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 purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of non-small cell lung cancer
* Advanced (unresectable or functionally inoperable) stage III or stage IV disease
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Informed consent

Exclusion Criteria:

* Prior treatment with chemotherapy
* Operable patient with resectable tumour
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
* Polynuclear cells \< 2,000/mm³
* Platelet cells \< 100,000/mm³
* Serum bilirubin \>1.5 mg/100 ml
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
* Perception hypoacousia
* Peripheral neuropathy
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
* Uncontrolled infectious disease
* Serious medical or psychological factors which may prevent adherence to the treatment schedule

Primary outcomes:
measure: Survival
timeFrame: Survival will be dated from the first day of registration until death or last follow up
Secondary outcomes:
measure: Response rate
timeFrame: Every 3 courses of chemotherapy
measure: Toxicity
timeFrame: After each course of chemotherapy
measure: Activity of second-line chemotherapy
timeFrame: Every 3 courses of chemotherapy
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Lille
country: France
facility: Pneumology department of CHU Lille
city: Athens
country: Greece
facility: Hellenic Cancer Institute - St Savas Oncology Hospital
city: Valencia
country: Spain
facility: Medical Oncology Hospital de Sagunto
Study officials:
affiliation: European Lung Cancer Working Party
name: Jean-Paul Sculier, MD, PhD
role: STUDY_CHAIR
References: