louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00618059: Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110859: QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC
Official title: PHENOMENOLOGICAL QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC AT PIACENZA HOSPITAL, ITALY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: covid 19
first work experience
nurse
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses

Brief summary: During covid-19 pandemic an huge reorganization of all PiacenzaHospital was done to manage the increasing requests for hosptitalization.

New nurses had to face first work experience in full pandemic Emergency. Altough even before the pandemic, being a newly graduated nurses was described as a stressful and isolating experience , we can't find studies in the literatureconcerning newly graduated and newly hired nurses during the pandemic pediod.

The study purpose is to describe and analyze, trough a phenomenological research, the experience of these nurses.


Eligibility criteria: Inclusion Criteria:

* Adults
* first work experience nurses after gratuation
* not opposed to partecipate to this study

Exclusion Criteria:

* refusing to partecipate

Primary outcomes:
measure: nurses satisfaction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: Piacenza Nursing School, University of Parma,
state: PC
Study officials:
References:
Clinical trial NCT05476159: Indocyanine Green Test in Bariatric Surgery
Official title: Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Surgery
Leak, Anastomotic
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The aim of our study is to observe the preliminary results of the application of indocyanine green fluorescence (IGF) during laparoscopic Roux-en-Y Gastric Bypass (RYGB in our center and how the perfusion of the gastro-jejunal anastomosis affects the onset of fistula.

Brief summary: Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time


Eligibility criteria: Inclusion Criteria:

* BMI\>40kg/m2

Exclusion Criteria:

* Non obese patients

Primary outcomes:
measure: Positive Intraoperative Indocyanine green test
timeFrame: During surgery (within 150-180 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
affiliation: University of Foggia
name: Giovanna Pavone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377259: The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia
Official title: The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: changes
tissue
oxygenation
saturation
between
upper
lower
extremities
patients
Adverse Effect
Spinal and Epidural
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive operations under spinal anesthesia

Brief summary: Neuraxial anesthesia affords a less interventional way to desensitization of the lower body for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and the response of volume redistribution. It is believed that vasodilatation leads to better regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but they were not easily available in the operation room. Recently Near-infrared spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the tissue oxygenation change over the upper and lower limbs during the induction of neuraxial anesthesia.

Detailed description: In patients who were planned to receive an operation with intrathecal anesthesia, NIRS (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) with two adhesive patches was used to monitor rSO2. One patch was applied over the biceps brachii muscle,(the body part above the anaesthetic level), and the other patch was applied over the medial side of the gastrocnemius muscle of the non-surgical leg,(the body part below the anaesthetic level). In both extremities, rSO2 was monitored continuously and recorded every minute from before intrathecal bupivacaine injection until 15 min after injection. Isobaric bupivacaine 0.5% 10-15 mg was injected intrathecally and the level of anaesthesia was examined 10 min later by loss of cold sensation to alcohol swab by an anaesthetist not involved in the study. the changes of rSO2 of upper and lower extrimities were recorded and analysed.

Eligibility criteria: Inclusion Criteria:

* patients who receive operations under spinal anesthesia

Exclusion Criteria:

* neurological, cardiovascular diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: department of anesthesiology, national taiwan university nospital
name: ya-jung cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06765759: Prone Duration in COVID-19 ARDS
Official title: Impact of Prone Position Duration and Sex Differences on Ventilation and Oxygenation in COVID-19 ARDS Patients: a Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID - 19
Acute Respiratory Distress Syndrome (ARDS)
Keywords: COVID - 19
Acute Respiratory Distress Syndrome
Prone Position
Sex
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of Covid-19 ARDS patients hospitalized in the tertiary intensive care unit of a university hospital.

Brief summary: The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is:

Does the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* hospitalized for more than 48 hours
* patients diagnosed with COVID-19
* intubated patients
* underwent prone positioning for longer than 16 hours starting from the first session

Exclusion Criteria:

* Pregnant females
* Patients under the age of 18
* Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)

Primary outcomes:
measure: Calculation of PaO2/FiO2 ratio during short and long prone periods
timeFrame: At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.
Secondary outcomes:
measure: Measurement of PaCO2 during short and long prone periods
timeFrame: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
measure: Measurement of PEEP during short and long prone periods
timeFrame: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
Study officials:
References:
Clinical trial NCT03218059: Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Official title: Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Scar Pregnancy
Menstruation
Keywords: Cesarean Scar Pregnancy
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D\&C in the treatment of CSP.


Eligibility criteria: Inclusion Criteria:

Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria:

All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.

Primary outcomes:
measure: Duration of menstruation by questionnaire
timeFrame: six months after treatment
measure: Endocrine level by blood examination
timeFrame: six months after treatment
measure: Volume of menstruation by questionnaire
timeFrame: six months after treatment
Secondary outcomes:
measure: The length of the CSD by MRI
timeFrame: six months after treatment
measure: The depth of the CSD by MRI
timeFrame: six months after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
state: Shanghai
Study officials:
affiliation: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
name: Xipeng Wang
role: STUDY_CHAIR
References:
Clinical trial NCT02317159: Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
Official title: Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Cttq
Sponsor class: INDUSTRY
Collaborators: name: Ruijin Hospital
First posted: 2014-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in patients with chronic phase of Chronic Myeloid Leukemia.


Eligibility criteria: Inclusion Criteria:

* Age≥18；
* The new diagnosis of CML patients in six months；
* No proof of extra-medullary infiltration of leukemia；
* ECOG PS score：0-2；
* Hepatic and renal functions are normal，Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN;
* Do not receive the treatment of anti-CML；
* Subjects signed informed consent form in line with GCP requirements。

Exclusion Criteria:

* Pregnant or lactating women；
* Received TKIs any time before；
* Failure to control systemic infection or multiple organ failure；
* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
* Being diagnosed with other malignancies in the prior 12 months；
* Have a history of neurological or psychiatric disorders, including epilepsy or dementia；
* Known or suspected allergy to imatinib；
* BSA≤1.5m2；
* Using other experimental drugs or participating in other clinical trials in the prior one months。

Primary outcomes:
measure: major molecular response
timeFrame: 2 years
Secondary outcomes:
measure: complete cytogenetics response
timeFrame: 1 years
measure: over survival
timeFrame: 2 years
measure: progress free survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00842959: Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX
Official title: Check of Optical Features and Accuracy of the Zeiss ZO Lens of the Company Carl Zeiss Meditec After Selection and Calculation With OKULIX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Improvement of adjustment accuracy of intraocular lenses and imaging quality
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine.

In the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.


Eligibility criteria: Inclusion Criteria:

* Indication for cataract operation
* Written informed consent of patient after information

Exclusion Criteria:

* Immobility
* Limited capacity of understanding
* Diseases that hamper a follow-up examination
* Astigmatism \>2.0 D
* Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens
* Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis

Primary outcomes:
measure: Accuracy of prediction of target refraction
timeFrame: postop.
measure: Difference between calculated and measured contrast vision.
timeFrame: postop.
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitäts-Augenklinik Mainz
Study officials:
affiliation: Universitäts-Augenklinik Mainz
name: Jochen Wahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114659: The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire
Official title: The Study of Metabolic and Cardiac Vascular Risk in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 169
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Polycystic Ovary Syndrome(PCOS)

Brief summary: Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.


Eligibility criteria: Inclusion Criteria:

* women at reproductive age
* women with PCOS and women without PCOS.

Exclusion Criteria:

* young women who had their menarche less than 3 years
* women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.

Primary outcomes:
measure: The correlation of PCOS betwwen metabolic and cardiovascular disease.
timeFrame: Participant were followed for 1 month in study period.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Wan Fang Hospital
name: Ming-I Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01166659: Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG
* Medicated IOP ≥ 21 and ≤ 35 mmHg
* Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria:

* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Use of oral hypotensive medication treatment for glaucoma
* Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
* Clinically significant ocular pathology other than POAG

Primary outcomes:
measure: Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
timeFrame: Baseline; Month 12 postoperative
Secondary outcomes:
measure: Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication
timeFrame: Month 12 postoperative
measure: Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline
timeFrame: Baseline, Month 12 postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Transcend Medical, Inc.
name: Vice President of Medical Affairs
role: STUDY_CHAIR
References:
Clinical trial NCT01448759: Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel
Official title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumors
Keywords: Patients receiving docetaxel or paclitaxel. All tumors.
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

Detailed description: In this study, there is no experimental treatment, or experimental care.

Eligibility criteria: Inclusion Criteria:

* Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
* Patient with bitherapy are eligible only if the taxane is the first infusion.
* All type of tumor.
* Age\>18 years old.
* Signed written informed consent.

Exclusion Criteria:

* Patient under 18.
* Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
* Patient deprived of liberty.

Primary outcomes:
measure: Evaluation of plasma alcohol
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: LE TOURNEAU Christophe, MD
role: PRINCIPAL_INVESTIGATOR
References: