louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785681: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower
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 dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Sweet Flower.


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 criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression 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 NCT04369781: Critical Limb Ischemia and Transcutaneous Oximetry
Official title: Oximetrie Transcutanee et Ischemie Critique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Keywords: transcutaneous oxygen pressure
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for critical limb ischemia

Brief summary: Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Detailed description: * Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position.
* Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests.
* TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization.
* We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease.

Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..

Eligibility criteria: Inclusion Criteria:

* Referral for suspected critical limb ischemia

Exclusion Criteria:

* Absence of recording, deny to use medical file

Primary outcomes:
measure: Variability of TcpO2
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University and univerity hospital in Angers, FRANCE
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345981: A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Official title: A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Disease
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Detailed description: Background: Intravenous injection of propofol produces pain. Many factors are involved and various techniques have been tried to minimize the propofol-induce pain with variable results.

Objective: To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Design: Randomize controlled trial. Method: Two hundred and ten ASA class I - III patients undergoing elective surgery were blinded and equally allocated into 3 groups. Patients in group N, L1, and L2 received MCT/LCT propofol 10 ml mixed with 0.9% NaCl 2 ml, 1% lidocaine 2 ml, and 2% lidocaine 2 ml respectively. Pain at time of propofol injection was assessed by blinded anesthesiologist on a four point scale ; 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Results: Patient's demographic data of each group were similar. There were significant differences in the incidence of propofol injection without pain among groups (p\<0.001). The numbers of patients who had moderate and severe pain in groups L1 and L2 were significantly less than those in group N (p\<0.001). The mean blood pressure and heart rate were not significant differences in among groups. Conclusion : The amount of 20 mg, and 40 mg lidocaine to MCT/LCT propofol in our study is equally effective in decreasing pain and more effective than MCT/LCT propofol alone group significantly. They were no significant differences in hemodynamics change in among groups.

Eligibility criteria: Inclusion Criteria:

* ASA class I - III patients
* undergoing elective surgery
* age 18-75 years

Exclusion Criteria:

* allergy to propofol and lidocaine
* abnormal liver and renal functions
* has psychological problem or drug abuse
* has recieved analgesic drug 2 weeks prior to surgery
* risk of aspiration

Primary outcomes:
measure: pain on injection
timeFrame: 30 minutes
Secondary outcomes:
measure: hemodynamic change
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
References:
Clinical trial NCT01759381: Incisional Negative Pressure Wound Therapy
Official title: The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Deformity
Keywords: Spinal Deformity
Complex Spinal Surgery
Negative Pressure Wound Therapy
Post-Operative Infection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.

Detailed description: This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age
* \>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion

Exclusion Criteria:

* \< 18 years of age
* \< 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
* Spinal infection at time of surgery
* History of immunosuppression or chronic systemic infection
* Pregnancy
* Inability to provide informed consent

Primary outcomes:
measure: Number of Participants With Post-operative Infection (NPWT)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Carlos A Bagley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911181: Quality Project Malnutrition Intensive Care
Official title: Quality Project Malnutrition Intensive Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: BIVA measurement
SNAQ score
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in the ICU between feb 2016 and may 2016

Brief summary: Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

Detailed description: Malnutrition is a great problem in healthcare, its related to mortality, infections and length of stay. Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

All patients were asked for their nutrition state by SNAQ and the BIVA measurement is done by a trained doctor.

Eligibility criteria: Inclusion Criteria:

* admission ICU

Exclusion Criteria:

* none

Primary outcomes:
measure: malnutrition
timeFrame: day 1 in Intensive Care
Secondary outcomes:
measure: malnutrition in elective and acute patients
timeFrame: day 1 in Intensive Care
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Intensive Care
name: Matty Koopmans, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buter H, Veenstra JA, Koopmans M, Boerma CE. Phase angle is related to outcome after ICU admission; an observational study. Clin Nutr ESPEN. 2018 Feb;23:61-66. doi: 10.1016/j.clnesp.2017.12.008. Epub 2017 Dec 20.
Clinical trial NCT05192681: Tislelizumab as Cross-line Treatment for Advanced NSCLC
Official title: Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Non-small-cell Lung Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-14
Enrollment: 35
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 study is a single-arm, prospective, open phase II clinical study, exploring the efficacy and safety for advanced non-small cell lung cancer after progression of first-line Tislelizumab combined with chemotherapy and continuing Tislelizumab in combination with docetaxel. The primary study endpoint of this study is measured by progression-free survival (PFS).

1. Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle.
2. Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle.
3. Treatment cycle: Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

1. Advanced non-small cell lung cancer diagnosed by histology or pathology, and has progressed after first-line treatment with tislelizumab combined with platinum-containing dual-drug chemotherapy
2. Patients who have progressed after first-line tislelizumab treatment for more than 3 months
3. No EGFR, ALK gene mutations (the genetic test is not required for patients with lung squamous cell carcinoma)
4. At least one measurable lesion (RECIST standard version 1.1)
5. The expected survival period is ≥3 months
6. The ECOG-PS score is 0-2 points

Exclusion Criteria:

1. The tumor histology or cytology is confirmed to be mixed adenosquamous carcinoma or combined with small cell lung cancer
2. Known or suspected active autoimmune diseases
3. A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation
4. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinical symptoms, active pneumonia or severe lung dysfunction
5. Symptomatic brain metastases
6. Those who are known or suspected to be allergic to test drugs and their excipients
7. Women who are pregnant or breastfeeding

Primary outcomes:
measure: Progression-free survival
timeFrame: five to six months
Secondary outcomes:
measure: Overall survival
timeFrame: ten to eleven months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian cancer hospital
state: Fujian
Study officials:
References:
Clinical trial NCT03471481: Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
Official title: Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epilepsy
Magnesium Deficiency
Vitamin D Deficiency
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with epilepsy and on medications

Brief summary: The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.


Eligibility criteria: Inclusion Criteria:

* Individuals receiving anti-epileptic drugs as a treatment for epilepsy

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding, receiving cancer treatments, have liver or kidney diseases, autoimmune diseases, or other diseases that may interfere with vitamin D and magnesium metabolism.

Primary outcomes:
measure: Bone mineral density
timeFrame: 1 time point - baseline
Secondary outcomes:
measure: Ionized Magnesium in serum
timeFrame: 1 time point - baseline
measure: Vitamin D - 25 hydroxy vitamin D
timeFrame: 1 time point - baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Nutrition Sciences Research Lab
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00247481: ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
Official title: A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-02
Enrollment: 77
Sex: FEMALE
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: This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer at a metastatic stage.
* Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
* World Health Organisation (WHO) performance status (PS) of 0 to 2
* Life expectancy of greater than 12 weeks
* Normal cardiac function (left ventricular ejection fraction \[LVEF\] by isotopic examination greater than or equal to 55%)

Exclusion Criteria:

* Symptomatic lepto-meningeal metastasis
* Concomitant infectious disease
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Incomplete healing from previous oncologic or other surgery
* Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
* Serum creatinine greater than 1.5 times the ULRR or clearance \< 60 ml/min
* ALT or AST greater than 2.5 times the ULRR
* ALP \> 5 times the ULRR
* ALP \> 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR

Primary outcomes:
measure: To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Secondary outcomes:
measure: o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.
measure: o To estimate the duration of response in the ZD1839-treated group and the placebo treated group
measure: o To estimate overall survival in the ZD1839-treated group and the placebo-treated group
measure: o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group
Other outcomes:
Locations:
city: Dijon
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint Cloud
country: France
facility: Research Site
city: Saint Germain en Laye
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04819581: Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
Official title: An Open-label, Randomized, Four-treatment, Four-sequence, Four-period, Crossover, Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.


Eligibility criteria: Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, ECG, and physical exam
* Body mass index ranging between 18.0-32.5 kg/m2, inclusive
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
* History of addiction, abuse, or misuse of any drug
* Use of nicotine-containing products within 30 days

Primary outcomes:
measure: Peak plasma concentration (Cmax) of lidocaine
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
measure: Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity
timeFrame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Secondary outcomes:
measure: Mean adhesion score
timeFrame: 0, 3, 6, 9, 12 hours post-dose
measure: Dermal response score
timeFrame: 12.5 and 14 hours post-dose
Other outcomes:
Locations:
city: Dilworth
country: United States
facility: AXIS Clinicals
state: Minnesota
Study officials:
affiliation: AXIS Clinicals
name: Peter Boldingh, PharmD
role: PRINCIPAL_INVESTIGATOR
References: