louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02040181: Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese
Official title: Establishment of a Creatinine Clearance Estimation Equation and Daily Creatinine Excretion Reference Table for Taiwanese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Estimated Creatinine Clearance
Keywords: renal function, creatinine clearance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 700
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients or inpatients of National Taiwan University Hospital who had 24 hour urine creatinine collections during 2010/1/1 to 2012/12/31.

Brief summary: It's important to dose according to renal function in who has impaired kidney function. There are two common methods estimating renal function: one is creatinine clearance estimated by Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by Modification of Diet in Renal Disease (MDRD) equation.

The previous study (not published) showed that CG underestimated 24 hour measured urine creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to establish a estimated creatinine clearance equation fitting in Taiwanese.

Besides, there are lots of studies discussing difference between CG and MDRD. We have found that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis which characteristics of patients the difference are largest or smallest.


Eligibility criteria: Inclusion Criteria:

* age above or equal to 20 year-old adults
* had 24 hour urine creatinine collection

Exclusion Criteria:

* lack of at least one :sex, diagnosis, age,weight, height
* serum creatinine beyond linear test range
* with extreme weight or height
* with acute kidney injury or specific diagnosis
* with extremities of daily urine creatinine excretion

Primary outcomes:
measure: Coefficient of determination of estimated creatinine clearance equation
timeFrame: 3 years
Secondary outcomes:
measure: Differences of daily urine creatinine excretion between Caucasian and Taiwanese
timeFrame: 3 years
Other outcomes:
measure: In which subgroup that difference between CG and MDRD is smallest or largest
timeFrame: 1 year
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Fe-Lin Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432881: Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
Official title: Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject is receiving care in an intensive care unit.
* Subject with an arterial catheter in place.
* Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air

Exclusion Criteria:

* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
* Subjects with known allergic reactions to adhesive tapes.
* Subjects with arterial catheter placed in a lower extremity.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.

Primary outcomes:
measure: Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
timeFrame: Approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT02595281: HE4 as a Relapse Biomarker in Ovarian Cancers
Official title: Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Carcinoma
Keywords: Ovarian Carcinoma
neoadjuvant
ROMA
Ca125
HE4
biomarker
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.


Eligibility criteria: Inclusion Criteria:

* Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
* Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
* Age ≥ 18 years .
* Performance status ECOG \> or = 2
* Adequate haemoglobin rate ≥ 10 g/dL
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria:

* Any previous treatment with platinum for ovarian carcinoma
* Patient with visceral metastases
* Contraindication for blood test
* Contraindication for surgery
* Contraindication for bevacizumab treatment

Primary outcomes:
measure: To evaluate the predictive and prognostic value of HE4 marker
timeFrame: 24 months
Secondary outcomes:
measure: Compare the evolution of HE4 and CA-125 serum concentration
timeFrame: 24 months
measure: Evaluate the progression-free survival at 18 months
timeFrame: 24 months
measure: Evaluate the quality of surgery
timeFrame: 24 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: BENGRINE-LEVEVRE Leïla
state: Centre Georges François Leclerc
city: Strasbourg
country: France
facility: DEMARCHI Martin
state: Centre Paul Strauss
city: Metz
country: France
facility: LONGO Raphaelle
state: CHU Metz Thionville
city: Strasbourg
country: France
facility: KURTZ Jean-Emmanuel
state: Hôpital Civil
city: Besançon
country: France
facility: KALBACHER Elsa
state: Hôpital Jean Minjoz
city: Vandœuvre-lès-Nancy
country: France
facility: GAVOILLE Céline
state: Institut De Cancérologie De Lorraine
city: Reims
country: France
facility: SAVOYE Aude-Marie
state: Institut Jean Godinot
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Céline Gavoille, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182881: Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery
Official title: Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery In Women Undergoing Conservative Surgery and Radiotherapy. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Myofascial-reléase
Fibromyalgia
Lymphatic drainage
Breast cancer
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective. To compare the effectiveness of myofascial therapy against manual lymphatic drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in women who survived breast cancer.

Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13 patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual lymphatic drainage.

Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range, shoulder functionality using the DASH questionnaire, quality of life assessed using the FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this was assessed before and after treatment, and one month later as follow-up.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 30 and 60 diagnosed with breast cancer undergoing conservative / partial surgery.
* Without lymphedema or mild lymphedema.
* They must have finished the coadjuvant treatment.

Exclusion Criteria:

* Women with muscle or tendon lesions in the arm.
* Kin disorders or circulatory pathology.
* Chemotherapy or radiotherapy.
* Surgical history in the area are excluded from the study.

Primary outcomes:
measure: Pain
timeFrame: 2 months
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy Breast
timeFrame: 2 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 2 months
measure: Joint mobility
timeFrame: 2 months
measure: Depressive state
timeFrame: 2 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Victoria Espí López
Study officials:
References:
citation: Serra-Ano P, Ingles M, Bou-Catala C, Iraola-Lliso A, Espi-Lopez GV. Effectiveness of myofascial release after breast cancer surgery in women undergoing conservative surgery and radiotherapy: a randomized controlled trial. Support Care Cancer. 2019 Jul;27(7):2633-2641. doi: 10.1007/s00520-018-4544-z. Epub 2018 Nov 24.
Clinical trial NCT03696381: Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
Official title: Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Impairment
Keywords: computerized cognitive rehabilitation
trns
traumatic brain injury
tbi
cognitive impairment
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 30
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 main objective of this study is to evaluate the effects of tRNS while undergoing computerized cognitive rehabilitation therapy to conclude if this combination of therapies would be effective for the cognitive rehabilitation of patients with acquired brain damage, such as traumatic brain injury. We want to study the therapeutic potential of tRNS to enhance the therapeutic outcome of cognitive training, studying its global effect over the rehabilitation of attention, memory and executive functions, compared to sham tRNS.


Eligibility criteria: Inclusion Criteria:

* age over 18 years old
* documented history of severe or moderate TBI (severe TBI: Glasgow Coma Scale 3-8; moderate TBI: Glasgow Coma Scale 9-13)
* out of post-traumatic amnesia
* less than 6 months after TBI
* cognitive impairment objectified by neuropsychological exploration.

Exclusion Criteria:

* impairment of language, affecting the production and/or comprehension of speech and the ability to read and/or write
* severe alteration of the visual field or visual perception problems that limits the use of technological devices
* sever motor impairment of both upper extremities that prevent the use of technological devices
* previous or current history of psychiatric, neurological or systemic alterations that affect the central nervous system
* history of substance abuse
* dermatological diseases in the skull
* presence of metal implants or holes in the skull
* epilepsy.

Primary outcomes:
measure: Conners Continuous Performance Test (CPT-II)
timeFrame: 1 day
measure: Digit Span Forward from the Wechsler Adult Intelligence Scale
timeFrame: 1 day
measure: Digit Span Backward from the Wechsler Adult Intelligence Scale
timeFrame: 1 day
measure: Rey Auditory Verbal Learning Test
timeFrame: 1 day
measure: Letters and Numbers from the Wechsler Adult Intelligence Scale
timeFrame: 1 day
measure: Spanish phonemic fluency test (PMR)
timeFrame: 1 day
Secondary outcomes:
measure: Trail Making Test A (TMT-A)
timeFrame: 1 day
measure: Trail Making Test B (TMT-B)
timeFrame: 1 day
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 1 day
measure: Stroop Color and Word test (Stroop Test)
timeFrame: 1 day
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Institut Guttmann
state: Barcelona
Study officials:
References:
Clinical trial NCT01469481: Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532
Official title: An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: diabetes mellitus
ADME
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of \[14C\]PF-04991532 in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg(110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
* History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
* Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).

Primary outcomes:
measure: Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
timeFrame: 0-168 hrs
measure: Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.
timeFrame: 0-168 hrs
measure: radioactivity AUC
timeFrame: 0-168 hrs
measure: plasma PF-04991532 AUC
timeFrame: 0-168 hrs
measure: radioactivity Cmax
timeFrame: 0-168 hrs
measure: plasma PF-04991532 Cmax
timeFrame: 0-168 hrs
measure: plasma PF-04991532 Tmax
timeFrame: 0-168 hrs
measure: radioactivity Tmax
timeFrame: 0-168 hrs
measure: plasma PF-04991532 t1/2
timeFrame: 0-168 hrs
measure: radioactivity t1/2
timeFrame: 0-168 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00948181: Evaluation of Plasma Catecholamine Concentration During Surgery
Official title: Evaluation of Stress Hormone Concentration During the Resection of Pheochromocytoma. Comparison of Surgeon - Anesthesiologist - Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress
Keywords: Epinephrine, Norepinephrine, normetanephrine
Catecholamine concentrations during surgery
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
Collaborators: name: Universität Duisburg-Essen
First posted: 2009-07-29
Enrollment: 8
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: The population consists of 8 patients with pheochromocytoma scheduled for tumor resection, one surgeon (with the experience of more than 50 pheochromocytoma resections) and one anesthesiologist (with the experience of more than 50 pheochromocytoma resections).

Brief summary: Stress during surgery leads to significant increase in plasma catecholamine concentrations in surgeons, anesthesiologists, and patients.

Detailed description: Hypothesis: Resection of pheochromocytomas can lead to more than normal stress in surgeons and because of abrupt hemodynamic changes in patients as well in anesthesiologists. Measurements of catecholamine concentrations at baseline, prior to surgery during and after surgery, are to be performed to test this hypothesis.

Eligibility criteria: Inclusion Criteria: Patients with pheochromocytoma (Older than 18 years) -

Exclusion Criteria: Patients younger than 18 years. Conservative treatment.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Prof. Dr. Harald Groeben
Study officials:
affiliation: Kliniken Essen-Mitte
name: Harald Groeben, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unger N, Pitt C, Schmidt IL, Walz MK, Schmid KW, Philipp T, Mann K, Petersenn S. Diagnostic value of various biochemical parameters for the diagnosis of pheochromocytoma in patients with adrenal mass. Eur J Endocrinol. 2006 Mar;154(3):409-17. doi: 10.1530/eje.1.02097.
citation: Schuttler J, Westhofen P, Kania U, Ihmsen H, Kammerecker S, Hirner A. [Quantitative assessment of catecholamine secretion as a rational principle of anesthesia management in pheochromocytoma surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1995 Oct;30(6):341-9. doi: 10.1055/s-2007-996507. German.
Clinical trial NCT06115681: Real-world Study of Dedifferentiated Liposarcoma Patients in China
Official title: Demographic, Clinical Characteristics, and Treatment Outcomes Associated With Dedifferentiated Liposarcoma Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dedifferentiated Liposarcoma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 1390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013 and confirmed dedifferentiated liposarcoma (DDLPS).

Brief summary: This study will characterize patients with dedifferentiated liposarcoma (DDLPS) in China, including an understanding of demographic, and clinical characteristics as well as treatment patterns and clinical outcomes associated with the current real-world treatment.


Eligibility criteria: Inclusion criteria:

* Patient has two or more documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013.
* Patient has a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS) during his/her lifetime.
* At least 18 years old at the date of initial diagnosis.

No exclusion criteria are applied.

Primary outcomes:
measure: Cohort 1: Overall survival
timeFrame: Up to 10 years
Secondary outcomes:
measure: Cohort 1, Cohort 2: Survival after initial diagnosis
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: First line (1L) of therapy by treatment type
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Second line (2L) of therapy by treatment type
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Third line (3L) of therapy by treatment type
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Total number of treatment lines
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Number of treatments with drugs classified as steroid therapy
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Number of treatments with drugs classified as concurrent immunosuppressant therapy
timeFrame: Up to 10 years
measure: Cohort 1, Cohort 2: Number of treatments with drugs classified as hormone replacement therapy
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
Study officials:
References: