louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00994474: Comparison of Outcome Parameters in Laser Rhytide Treatment
Official title: Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Aging
Keywords: Laser surgery
Profilometry
Fitzpatrick wrinkle score
Patient Benefit Index
Patient satisfaction
Lead sponsor: Laserklinik Karlsruhe
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.


Eligibility criteria: Inclusion Criteria:

* mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)

Exclusion Criteria:

* unrealistic expectations
* inability to meet follow-up criteria
* Fitzpatrick skin phototype \>III
* coagulation disorders or anti-coagulant treatment
* allergy to lidocaine or tetracaine
* oral isotretinoin within the last 6 months
* any active skin disease within the treatment areas (e.g., psoriasis, cancer, or autoimmune disease)
* synthetic implants in the treatment area
* facial cosmetic procedures affecting the treatment area within the last 6 months
* photosensitizing medications (e.g., tetracycline, gold)
* history of keloid formation
* pregnancy

Primary outcomes:
measure: Quantitative measurement of wrinkle depth
timeFrame: Before and after treatment (3 months)
measure: Fitzpatrick wrinkle score
timeFrame: Before and after treatment (3 months)
Secondary outcomes:
measure: Patient benefit index (PBI)
timeFrame: Before and after treatment (3 months)
measure: Patient satisfaction
timeFrame: 1, 3, 6 days and 3 months after treatment
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Laserklinik Karlsruhe
Study officials:
affiliation: Laserklinik Karlsruhe
name: Syrus Karsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797874: Pazopanib Maintenance for SCLC
Official title: Phase II Study of Pazopanib Maintenance for SCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SCLC
Keywords: pazopanib maintenance
efficacy
SCLC
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed SCLC
* no disease progression after 4 cycles of etoposide/platinum 1st-line therapy
* history of 4 cycles of etoposide/platinum 1st-line therapy
* between 21 days and 42 days since C4D1 of etoposide/platinum
* no symptomatic brain meta

Exclusion Criteria:

* poor hepatic, renal function

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01244074: Visual Rehabilitation of Patients With Myopic Maculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopic Maculopathy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-11-19
Sex: ALL
Minimum age (years): 35
Maximum age (years): 57
Standard ages: ADULT

Brief summary: The Visual Pathfinder (LACE inc.) offers a non- invasive, patient- centered visual rehabilitation system based on an acoustic biofeedback. The investigators wanted to evaluate its usefulness in the improvement of visual function in visually impaired patients with high myopia.


Eligibility criteria: Inclusion Criteria:

* high myopia (range 9-15 D) visited at the Outpatient Medical Retina's Hospital A. Fiorini Terracina (LT), University of Rome "La Sapienza", Polo Pontino. The diagnosis of myopic maculopathy was made on the basis of a comprehensive ophthalmological evaluation which included: biomicroscopic examination of anterior and posterior segment, fluorescein angiography (FAG) (Heidelberg HRA-2, FA module Heidelberg, Germany), optical coherence tomography (OCT), Spectral Domain (Heidelberg HRA-2, OCT module Heidelberg, Germany) and microperimetry with microperimeter MP-1 (Nidek Technologies, Padova, Italy).

Exclusion Criteria:

* The investigators have excluded patients with other eye diseases (glaucoma, AMD, retinal detachment, etc.), uncooperative patients and persons with opacity of the dioptric media.

Primary outcomes:
measure: improvement of visual performance
Secondary outcomes:
measure: improvement of visual acuity, retinal sensitivity, fixation stability
Other outcomes:
Locations:
city: Latina
country: Italy
facility: University La Sapienza, Polo Pontino
Study officials:
References:
Clinical trial NCT00985374: A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
Official title: Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
* advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
* measurable disease (Part 2);
* ECOG performance status 0-2.

Exclusion Criteria:

* prior treatment with agents acting via inhibition of IGF-IR pathway;
* prior treatment with agents acting via inhibition of mTOR (Part 2);
* untreated CNS metastases;
* current anti-cancer therapy, or radiotherapy or chemotherapy \<=4 weeks prior to enrollment;
* other known malignancy requiring treatment.

Primary outcomes:
measure: Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
timeFrame: First 3 week cycle of treatment
measure: Progression-free survival (Part 2)
timeFrame: 24 weeks
Secondary outcomes:
measure: Overall objective response rate; duration of response; overall survival
timeFrame: Event driven; monitored throughout study
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
city: Milano
country: Italy
state: Lombardia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03875274: Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
Official title: Postoperative Analgesic Effect of Morphine Added to Ropivacaine for Fascia Iliaca Compartment Block Following Femoral Fracture Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 70
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: TREATMENT

Brief summary: prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective femur surgery under spinal anaesthesia

  * Age group (18-65 years)
  * ASA physical status I and II

Exclusion Criteria:

* • Not willing to participate in the study

  * Other painful co-morbidities (neuropathies)
  * Allergy or any contraindication to study medication
  * Psychiatric disorder
  * Coagulopathy
  * Infection at the site of the block
  * Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.

Primary outcomes:
measure: Duration of Analgesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: BPKIHS
state: Sunsari
Study officials:
References:
Clinical trial NCT05190874: Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Official title: Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Syndesmotic Injuries
Ankle Inversion Sprain
Deltoid Ankle Sprain
Achilles Tendon Rupture
Flexor Hallucis Longus on the Left
Flexor Hallucis Longus on the Right
Flexor Digitorum Longus on the Left
Flexor Digitorum Longus on the Right
Ankle Sprains
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigational population will include a minimum of 23 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria

Brief summary: Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

Detailed description: This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.

Eligibility criteria: Inclusion Criteria:

* The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
* The subject signs a written informed consent form (ICF)

Exclusion Criteria:

* None

Primary outcomes:
measure: Device performance and benefits as related to Foot and Ankle Mobility Measure
timeFrame: 6 months post-operative
measure: Device performance and benefits as related to pain levels based on the Visual Analog Scale
timeFrame: 6 months post-operative
measure: Device performance and benefits as related to pain levels based on Patient satisfaction
timeFrame: 6 months post-operative
Secondary outcomes:
measure: Safety will be assessed by recording the incidence of secondary procedures related to the index device
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Worthington
country: United States
facility: Orthopedic Foot and Ankle
state: Ohio
Study officials:
affiliation: Paragon 28
name: Jacy Legue
role: STUDY_DIRECTOR
References:
Clinical trial NCT01630174: IMRT/Pemetrexed/Cisplatin in Esophageal Cancer
Official title: Phase I Study of Concurrent Selective Lymph Node Late Course Accelerated Hyper-fractionated Radiotherapy and Pemetrexed, Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: IMRT,Pemetrexed,Cisplatin , Esophageal Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: esophagus cancer patients

Brief summary: To evaluate the effect of concomitant late course accelerated hyperfractionation radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent; 2.Acquired pathological diagnosis; 3.Life expectancy≥6 months; 4.Age:18-75 years, male or female; 5.General state of health: ECOG 0-1 grade; 6.Without any chemotherapy or radiotherapy; 7.Subjects meet the following criteria for the clinical laboratory:HG≥100g/L, WBC≥3.5X109 /L, neutrophilic leukocyte≥1.5X109,PLT100X109 /L。CR≤1.5 x N，TB≤2.5XN，AST and ALT≤2.5xN，AKP≤2.5XN.

Exclusion Criteria:

* 1.Serious infection; 2.Uncontrollable diabetes; 3.Other serious diseases, such as myocardial infarction in 6 months; 4. Participated other clinical trials in 4 weeks or at present

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer hospital and institute
state: Shandong
Study officials:
References:
Clinical trial NCT05536674: SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia
Official title: Design, Test and Evaluate Behavioural Insights Interventions to Strengthen Demand for Immunisation in Georgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine
Lead sponsor: The Behavioural Insights Team
Sponsor class: OTHER
Collaborators: name: UNICEF
name: National Center for Disease Control and Public Health, Georgia
name: Information Technology Agency, Georgia
First posted: 2022-09-13
Enrollment: 55176
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is possible that achieving adequate HPV vaccination coverage will allow cervical cancer to be virtually eliminated. This is a priority for Georgia, where the burden of mortality and morbidity from cervical cancer is high and the yearly prevalence of cervical cancer is 14.5 per 100,000 population.

The objective of the intervention evaluated is to increase the uptake of the 1st dose of the HPV vaccination in Georgia. The intervention aims to achieve this by providing a SMS reminder informed by behavioural insights (BI) to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination, share information about the vaccine, and encourage them to book an appointment to receive the vaccination. Four different SMS messages will be compared to no SMS message.

The evaluation will be a 5-arm randomised controlled trial (RCT) which aims to answer the research question: Does each of the designed BI-informed SMS reminders increase the uptake of the first dose of the HPV vaccination among eligible girls in Georgia, compared to no reminder? Our hypothesis is that SMS reminders will increase the uptake of HPV vaccination.


Eligibility criteria: Inclusion Criteria:

* Girls
* Aged 10-12 years
* Not yet received any doses of the HPV vaccine
* With a caregiver's mobile phone number in the e-health system.

Exclusion Criteria:

* Boys
* Girls aged less than 10 or more than 12 years
* Girls with no caregiver phone number in the e-health system
* Girls who have received 1 or 2 doses of the HPV vaccine

Primary outcomes:
measure: HPV vaccination status
timeFrame: At 60 days after receiving the SMS reminder
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Behavioural Insights Team
name: Hannah Behrendt
role: STUDY_DIRECTOR
References:
Clinical trial NCT00181974: Efficacy of a Fibrin Sealant in Burn Surgery
Official title: Efficacy of a Fibrin Sealant in Burn Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burns
hemostasis
skin graft
Surgical Hemostasis
Grafting, Skin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2005-09-16
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.

Detailed description: Burn patients require extensive split-thickness skin grafting operations. These operations necessitate excision of burn wounds and the procurement of autografts. Both of these result in bleeding open wounds. Fibrin sealants may be of benefit in three aspects of burn surgery:

1. as a hemostatic agent on excised burns,
2. as a hemostatic agent on donor sites, and
3. as a method of fixation of skin grafts to wounds.

Skin grafts are routinely secured with surgical staples. Patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. Problems associated with the use of surgical staples include:

1. discomfort upon removal and
2. staples become deeply embedded in the tissue.

If effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process.

Subjects will serve as their own control. They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care. Both areas will be compared for hemostasis, skin graft fixation, wound healing, and cosmetic outcome.

Eligibility criteria: Inclusion Criteria:

* Requires skin grafting of an acute or reconstructive burn wound.

Exclusion Criteria:

* Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.

Primary outcomes:
measure: initial wound hemostasis
measure: initial donor site hemostasis
measure: initial graft fixation
measure: percent graft take at 1 week
measure: outcome and cosmetic appearance at routine intervals up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Burns Hospital
state: Massachusetts
Study officials:
affiliation: Shriners Burns Hospital
name: Robert L Sheridan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607074: Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
Official title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Giardiasis
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 410
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.

Detailed description: A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.

Eligibility criteria: Inclusion Criteria:

* infants living in the study area

Primary outcomes:
measure: nutritional status
timeFrame: 9 months
Secondary outcomes:
measure: intestinal permeability
timeFrame: 9 months
Other outcomes:
Locations:
city: Mohakhali
country: Bangladesh
facility: National Institute of Preventive and Social Medicine
state: Dhaka
Study officials:
affiliation: Department of Biological Anthropology, University of Cambridge
name: Nicholas C Mascie-Taylor, ScD
role: STUDY_CHAIR
References:
citation: Goto R, Mascie-Taylor CG, Lunn PG. Impact of anti-Giardia and anthelminthic treatment on infant growth and intestinal permeability in rural Bangladesh: a randomised double-blind controlled study. Trans R Soc Trop Med Hyg. 2009 May;103(5):520-9. doi: 10.1016/j.trstmh.2008.07.020. Epub 2008 Sep 11.