louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389619: Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars
Official title: Effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection With and Without Microneedling on Tissue Levels of PDGF & CTGF in Hypertrophic Scars: a Randomized Comparative Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Scars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars

Detailed description: In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.

Eligibility criteria: Inclusion Criteria:

* Patients with mature hypertrophic scars.
* Patients with age above 18 years.
* Both males and females.
* Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.

Exclusion Criteria:

* Patients with unrealistic expectations.
* Patients with active skin infections or autoimmune diseases.
* Non-compliant patients.
* Patients who had received any form of treatment for scars during the last six months.
* Recent use of isotretinoin within six months prior to the procedures.
* Patient with known allergy to lidocaine.
* Pregnancy \& Lactation.

Primary outcomes:
measure: Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
timeFrame: 6 months
measure: Photographic documentation will be performed to assess change of hypertrophic scar(s)
timeFrame: 6 months
measure: Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maha Fathy Elmasry
Study officials:
References:
Clinical trial NCT05490719: A Phase II Study of CRT Combined With QL1706 in ESCC Patients
Official title: A Single Arm, Phase II Clinical Study of Chemoradiationtherapy Combined With QL1706 (Anti-CTLA-4 and PD-1 Antibody) in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal Cancer
Concurrent chemoradiation
Immunotherapy
CTLA-4
PD-1
QL1706
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 39
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 is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. age:18-75 years, male or female.
3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

1. Patients who have a history of esophageal cancer surgery.
2. Previous history of fistula caused by primary tumor infiltration.
3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
5. Major surgery or serious trauma within 4 weeks before the first use of the study drug.

Primary outcomes:
measure: PFS assessed by investigators
timeFrame: Up to approximately 2 years.
Secondary outcomes:
measure: OS
timeFrame: 1year and 3years
measure: ORR
timeFrame: Up to approximately 2 years
measure: DoR
timeFrame: Up to approximately 2 years
measure: The rates and severity of Adverse Events, Serious Adverse Events
timeFrame: Through study completion, up to approximately 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin cancer hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01010919: A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
Official title: A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Phytomedics Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Texas, Southwestern Medical Center at Dallas
First posted: 2009-11-10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT

Brief summary: Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.


Eligibility criteria: Inclusion Criteria:

1. Patients must be 50 years of age or older and may be of either gender.
2. Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
3. Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
4. Patients must be able and willing to give informed consent.

Exclusion Criteria:

1. Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
2. Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
3. Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
4. Patients requiring any dose of glucocorticoids within the past 30 days are excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.
Clinical trial NCT00126919: Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound
Official title: Randomized Crossover Trial of Sonication Followed by 5 Minute LMX4 Application Compared With 30 Minute LMX4 Application for Topical Anesthesia Prior to Subcutaneous Port Access in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children ages 3-17 who are undergoing port access receive both standard care, topical medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2 separate visits to the clinic. The child's pain with the access procedure is evaluated.


Eligibility criteria: Inclusion Criteria:

* Children ages 3-17 with subcutaneous port

Exclusion Criteria:

* Emergent need for port access
* Allergy to lidocaine sodium lauryl sulfate

Primary outcomes:
measure: pain
Secondary outcomes:
measure: tolerability
measure: safety-skin effects
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: CT Children's Medical Center
name: William T. Zempsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757419: AZD3355 Dose-escalation Study in Healthy Males
Official title: A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated Doses in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Reflux Disease
Keywords: Safety
tolerability
healthy subjects
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.


Eligibility criteria: Inclusion Criteria:

* Subjects without concurrent diseases who do not require any medical treatments
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
* Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
* History of clinically significant orthostatic reaction or syncope
* Clinically important abnormalities related to the heart function

Primary outcomes:
measure: Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Several occasions during the study days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Research Site
Study officials:
affiliation: CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg
name: Marianne Hartford
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Eva Ersdal
role: STUDY_DIRECTOR
References:
Clinical trial NCT00241319: Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: ocular, allergic conjunctivitis, ophthalmic
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* history of ocular allergies and a positive skin test reaction to cat hair,
* cat dander, grasses, ragweed, and/or trees within the past 24 months;
* calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction

Exclusion Criteria:

* narrow angle glaucoma,
* clinically significant blepharitis, follicular conjunctivitis, iritis
* pterygium or diagnosis of dry eye
* ocular surgical intervention within 3 months
* history of refractive surgery within 6 months
* known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
* presence of active ocular infection positive history of an ocular herpetic infection
* preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis

Primary outcomes:
measure: Ocular itching and conjunctival redness post challenge
Secondary outcomes:
measure: Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Lewiston
country: United States
state: Maine
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Johnson & Johnson
name: Ingerman Avner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01865019: Pressure Controlled Versus Volume Controlled Mechanical Ventilation During Anesthesia for Living Donor Liver Transplantation Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Living Donor Liver Transplantation Recipients
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: living donor liver transplantation recipients

Brief summary: pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for living donor liver transplantation recipients ,improving postoperative graft function and decreasing postoperative pulmonary complications


Eligibility criteria: Inclusion Criteria:

* all living donor liver transplantation recipients scheduled

Exclusion Criteria:

* Moderate to severe restrictive pulmonary functions

Primary outcomes:
measure: oxygen tension
timeFrame: during intraoperative period
Secondary outcomes:
measure: decreased postoperative pulmonary complications
timeFrame: one week postoperative
Other outcomes:
measure: improved intraoperative hemodynamics
timeFrame: intraoperative
Locations:
city: Mansoura
country: Egypt
facility: Gastroenterology center
state: Dakahleya
Study officials:
References:
Clinical trial NCT01420419: Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
Official title: A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: nipple pain
breastfeeding
nipple damage
lanolin
clinical trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 186
Sex: FEMALE
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 evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.


Eligibility criteria: Inclusion Criteria:

* Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
* Infant delivered at, or greater than 37 weeks gestation.
* Singleton birth.
* Speaks and understands English.
* Access to telephone.

Exclusion Criteria:

* Infant not expected to be discharged home with mother.
* Infant with congenital abnormalities that would impair breastfeeding.
* Maternal allergy to lanolin.
* Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.

Primary outcomes:
measure: Nipple pain severity
timeFrame: 4 days post randomization
Secondary outcomes:
measure: Breastfeeding duration
timeFrame: 4 and 12 weeks postpartum
measure: Breastfeeding exclusivity
timeFrame: 4 and 12 weeks postpartum
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Postpartum Unit St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: University of Toronto
name: Cindy-Lee Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305719: Regional Anesthesia for Thoracoscopic Surgery
Official title: Regional Anesthesia for Thoracoscopic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 thoracoscopic surgery ASA 1-3

Brief summary: Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control.

Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

Detailed description: A prospective evaluation of different regional anesthesia regimes for thoracoscopic surgery to elucidate their efficiency in (postoperative) pain control.

A day before surgery the patients gave their written informed consent to the study.

Patients choose their favorite regional anesthesia out of the following: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

In addition a general anesthesia was applied for the surgical procedure. Anesthesia was maintained using propofol and remifentanil. The patients pain score (visual analog scale), consumption of analgesic medication, satisfaction with pain therapy will be obtained one, six, 24 and 48 hours postoperatively.

These prospective evaluation of different regional anesthetic techniques might provide us data to recommend a procedure for thoracoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for thoracoscopic surgery
* ASA 1-3

Exclusion Criteria:

* ASA 4 and 5
* Age under 18 and over 80

Primary outcomes:
measure: Postoperative Pain (visual analog scale)
timeFrame: 48 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich, Marchioninistr. 15
Study officials:
affiliation: Attending
name: Philip M Lang, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917419: Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)
Official title: Prise en Charge infirmière Des Anomalies du Sommeil et du Rythme Circadien Par luminothérapie et/ou un Programme Court de psychoéducation Chez Des Patients Souffrant de Troubles Bipolaires
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.


Eligibility criteria: Main inclusion Criteria:

* Bipolar disorder (type 1 and 2 according to DSM V)
* Mood Disorder Questionnaire MDQ ˂ 7
* Sleeping and Circadian Rhythms Disorders
* Under treatment

Main exclusion Criteria:

* No addiction except for tobacco
* Narcolepsy
* Sleep Apnea
* Psychiatric comorbidities
* Suicidal ideation

Primary outcomes:
measure: Number of days in-hospital
timeFrame: Day 0 to Day 365
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References:
Clinical trial NCT00000219: Buprenorphine Dose Alteration Study - 1
Official title: Buprenorphine Dose Alteration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Opioid withdrawal
measure: Subjective dose estimate
measure: Drug effect characteristics: ARCI
measure: Physiological changes in: pupil diameter
measure: Physiological changes in: blood pressure
measure: Physiological changes in: heart rate
measure: Physiological changes in: respiration
measure: Physiological changes in: skin temperature
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: In preparation. In preparation.