louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04520997: Restylane Defyne in a Stepwise Treatment Approach
Official title: A Randomized, Evaluator-Blinded Study to Evaluate Facial Harmony and Subject Satisfaction Using Restylane Defyne in a Stepwise Treatment Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Face Folds and Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 62
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.


Eligibility criteria: Inclusion Criteria:

* Subjects willed to comply with the requirements of the study and provided a signed written informed consent
* Subjects willed to undergo augmentation and correction therapy in the studied indications
* Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
* Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
* Participation in any interventional clinical study within 30 days of screening

Primary outcomes:
measure: Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
timeFrame: At Week 3
measure: Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
timeFrame: At Week 6
measure: Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
timeFrame: At Week 9
Secondary outcomes:
measure: Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
timeFrame: At Week 3, 6, and 9
measure: Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
timeFrame: At Week 3, 6 and 9
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Research Site
state: Alabama
city: Chicago
country: United States
facility: Galderma Research Site
state: Illinois
city: Belo Horizonte
country: Brazil
facility: Galderma Research Site
city: São Paulo
country: Brazil
facility: Galderma Research Site
city: Palermo
country: Italy
facility: Galderma Research Site
Study officials:
References:
Clinical trial NCT00786097: Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion inclusion:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00805597: Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Official title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
mastectomy
one to three positive nodes
radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2008-12-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
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 postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Detailed description: Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility criteria: Inclusion Criteria:

* Ipsilateral histologically confirmed invasive breast cancer
* Undergone total mastectomy and axillary dissection
* T1-2 and one to three axillary lymph nodes positive
* A minimum of 10 axillary nodes dissected
* Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
* Written,informed consent

Exclusion Criteria:

* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
* Previous or concurrent malignant other than non-melanomatous skin cancer
* Unable or unwilling to give informed consent

Primary outcomes:
measure: overall survival
timeFrame: 10 years
Secondary outcomes:
measure: loco-regional recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ye-xiong Li, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06676397: Homeostatic Roles of Eosinophils in Asthma
Official title: Characterization of the Homeostatic Functions of Eosinophils in Asthma: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma; Eosinophilic
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with mild asthma with severe asthma (Biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma
* Signature of informed consent
* Affiliation with the French social security system

Exclusion Criteria:

* Non-eosinophilic asthma
* Coexistence of a chronic eosinophilic inflammatory condition other than asthma
* Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)
* Treatment with corticosteroids within 10 days prior to inclusion
* Active smoking or a smoking history of more than 20 pack-years
* Pregnant women
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or with anticipated low cooperation as assessed by the investigator
* Subject without health insurance
* Subject currently in an exclusion period of another study or as indicated by the "national registry of volunteers."

Primary outcomes:
measure: Flow cytometry based eosinophil phenotyping : Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity)
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06898697: Midazolam or Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia
Official title: Midazolam or Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia After Lumbar Spine Fixation: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lumbar Spine Fixation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-03-27
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare better postoperative analgesia after lumbar spine Fixation using either epidural bupivacaine with midazolam or fentanyl with the combination of dexamethasone.

Detailed description: After being informed about the study and potential risks. A computer-generated randomization table will randomize all patients giving written consent into 2 groups, each containing 51 patients. In the Fentanyl Group :.Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone.In Midazolam Group: Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone

Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient.
* Physical status: ASA 1\& II.
* BMI = (25-30 kg/m2).
* Type of operation: elective lumbar spine Fixation.

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Primary outcomes:
measure: the time to first call to rescue analgesia (ketorolac)
timeFrame: day 1
Secondary outcomes:
measure: The Numerical Pain Rating Scale
timeFrame: 24 hours postoperative]
measure: The total postoperative opioid consumption in the first 24 hours. opioid consumption
timeFrame: 24 hours postoperative
measure: the duration of hospital stay
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
Study officials:
References:
Clinical trial NCT02269397: Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
Official title: Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Seizures
Diagnosis
Diagnostic
Inflammation
Lead sponsor: Cognizance Biomarkers, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2014-10-21
Enrollment: 371
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 12 years and older who are attending their first visit to the University of Pennsylvania's Epilepsy Center for diagnostic purposes

Brief summary: The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.


Eligibility criteria: Inclusion Criteria:

* Male/female patients aged 12 and older
* Evaluation in at least one of the following settings:
* Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites
* All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring

Exclusion Criteria:

* Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf
* Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason

Primary outcomes:
measure: Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Cognizance Biomarkers, LLC
name: Peter Crino, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01542697: Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
Official title: Phase IV Recruiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: magnesium sulpahate
postoperative analgesia
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 60
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: intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.

Detailed description: Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.

Eligibility criteria: Inclusion Criteria: ASA I-II

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Exclusion Criteria: history of

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Primary outcomes:
measure: number of analgesic request
timeFrame: 24 hour
Secondary outcomes:
measure: VAS score
timeFrame: first complaint of pain, 6 hrs, 12 hrs, 24 hrs
measure: nausea and vomiting
timeFrame: 24 hrs
measure: respiratory rate
timeFrame: 24 hrs
measure: sedation
timeFrame: 24hrs
Other outcomes:
Locations:
city: Dharan
country: Nepal
facility: routine operation theatre of BPKoirala
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences
name: krishna Pokharel, MD
role: STUDY_DIRECTOR
References:
citation: Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
citation: Abdel - Raouf M, Amer H. Postoperative analgesic effects of intraperitoneal NMDA receptor antagonist (ketamine and magnesium sulphate )in patients undergoing laparoscopic cholecystectomy .Eg J Anaesth. 2004;20: 107-11
Clinical trial NCT01898897: Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions
Official title: Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia; Reaction
Adverse Effect of Other General Anesthetics
Adverse Anesthesia Outcome
Acute Kidney Injury
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.

Detailed description: The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.

Eligibility criteria: Inclusion Criteria:

* signed the informed consent without previous renal function alteration respiratory and hemodynamic stability

Exclusion Criteria:

* refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases

Primary outcomes:
measure: acute kidney injury
timeFrame: 4 days
Secondary outcomes:
measure: postoperative outcome
timeFrame: 10 days
Other outcomes:
Locations:
city: Cluj Napoca
country: Romania
facility: City Clinical Hospital Cluj Urology and ICU Departments
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine
name: Daniela Ionescu, MD, Phd
role: STUDY_DIRECTOR
References:
citation: Kurosawa S, Kato M. Anesthetics, immune cells, and immune responses. J Anesth. 2008;22(3):263-77. doi: 10.1007/s00540-008-0626-2. Epub 2008 Aug 7.
citation: Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: Curatolo M. Adding regional analgesia to general anaesthesia: increase of risk or improved outcome? Eur J Anaesthesiol. 2010 Jul;27(7):586-91. doi: 10.1097/EJA.0b013e32833963c8.
citation: Wolf AR. Effects of regional analgesia on stress responses to pediatric surgery. Paediatr Anaesth. 2012 Jan;22(1):19-24. doi: 10.1111/j.1460-9592.2011.03714.x. Epub 2011 Oct 14.
Clinical trial NCT01251497: ¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos
Official title: ¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education
Lead sponsor: Texas AgriLife Extension Service
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2010-12-02
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program.


Eligibility criteria: Inclusion Criteria: Self-identification as Hispanic/Latino, over the age of 18 years of age, diagnosis of type 2 diabetes and willingness to participate in the diabetes self-management education class.

Exclusion Criteria: non-diabetic persons, non English-speaking Hispanic/Latinos with type 2 diabetes

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: