louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00572793: A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk
Official title: A Nested Case-Controlled Study Evaluating the Utility of Placental Protein 13 (PP13) In-vitro Diagnostic Kit as a Diagnostic Aiding Tool in Assessment of the Risk for Developing Preeclampsia Necessitating Delivery Before 37 Weeks (Early-preeclampsia) Based on First Trimester Blood Testing of Pregnant Women With Low and Unknown Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Diagnostic Technologies Ltd.
First posted: 2007-12-13
Enrollment: 431
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients seen or referred to the obstetrical clinic

Brief summary: The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.

Detailed description: After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.

Eligibility criteria: Inclusion Criteria:

* Healthy, pregnant females
* Singleton fetus at 7 0/7 to 13 6/7 weeks gestation

Exclusion Criteria:

* Multi-fetal pregnancy
* Mental retardation
* Known fetal anomaly or demise
* BMI \> 35, serious medical condition

Primary outcomes:
measure: Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia
timeFrame: 37 Weeks
Secondary outcomes:
measure: Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks
timeFrame: 34 Weeks, At Delivery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carl Weiner, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00667693: Pentax Airway Scope (AWS) Intubation
Official title: A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: intubation
obese
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-04-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.

Detailed description: 100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.

Eligibility criteria: Inclusion Criteria:

* subject is at least 18 years old
* BMI between 30 and 50
* scheduled for elective surgery requiring orotracheal intubation

Exclusion Criteria:

* a known difficult airway
* loose teeth
* subject pregnancy
* rapid sequence induction required
* subject is unable to give consent
* anesthesiologist considered use of the Pentax AWS to be contraindicated
* special endotracheal tube (ETT) is needed for the case.

Primary outcomes:
measure: Time to Intubation
timeFrame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
Secondary outcomes:
measure: Ease of Intubation
timeFrame: From the start of intubation until 24 hours after surgery
measure: Successful Intubation on the First Attempt
timeFrame: From the start of intubation until 24 hours after surgery
measure: The Number of Patients With Different Number of Intubation Attempts
timeFrame: From the start of intubation until 24 hours after surgery
measure: The Number of Patients With Bleeding
timeFrame: From the start of intubation until 24 hours after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: John Doyle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02976493: Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
Official title: Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at healthcare facilities in Japan.

Brief summary: BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.


Eligibility criteria: Inclusion Criteria:

* All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan
timeFrame: Up to 72 weeks
measure: Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
measure: Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria
timeFrame: Up to 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02191293: Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®
Official title: Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 228
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: HIV treatment centres and HIV out-patient facilities

Brief summary: Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility criteria: Inclusion Criteria:

* Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
* Women can only be included, if a test has excluded pregnancy
* Only women can be included, who use a reliable means of contraception during the observational study

Exclusion Criteria:

* Known sensitivity to Viramune or one of its excipients
* Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
* For females:

  * Pregnancy
  * Breast-feeding
  * Insufficient or unreliable contraception

Primary outcomes:
measure: Changes in viral load (HIV-RNA)
timeFrame: Baseline, up to 36 months
measure: Changes in CD4 cell count
timeFrame: Baseline, up to 36 months
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline, up to 36 months
measure: Changes in general well-being assessed on a 4-point scale
timeFrame: Baseline, up to 36 months
measure: Changes in lipid parameters
timeFrame: Baseline, up to 36 months
measure: Changes in glucose
timeFrame: Baseline, up to 36 months
measure: Changes in liver enzymes
timeFrame: Baseline, up to 36 months
measure: Number of patients with adverse events
timeFrame: up to 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03755193: Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Official title: Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:

SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months


Eligibility criteria: Inclusion Criteria:

* osteoporosis patients

Exclusion Criteria:

* not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Primary outcomes:
measure: Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
timeFrame: Change from Baseline Values of bone mineral density at 2 years in each group
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT00683293: Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
Official title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Technique no Switch to Open
Duration of Surgery
Intraoperative Complications
Postoperative Complications
Keywords: Laparoscopic Hysterectomy
Robot-assisted Laparoscopic Hysterectomy
Robot-assisted Surgery
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

Detailed description: During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

Eligibility criteria: Inclusion Criteria:

* Indication for laparoscopic hysterectomy
* Patients BMI \< 40
* Signed consent

Exclusion Criteria:

* Estimated uterus weight \>400 g
* No combination with other procedures
* No underlying malignant condition

Primary outcomes:
measure: Duration of Surgery
timeFrame: after surgey
Secondary outcomes:
measure: Complications
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: Kantonsspital Aarau
name: Dimitri Sarlos, MD
role: STUDY_CHAIR
References:
citation: Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
Clinical trial NCT02106793: Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
Official title: Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis
Postoperative Nasal Synerchia
Keywords: Chronic Rhinosinusitis
Mitomicin C
Postoperative nasal synerchia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 224
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: Primary objective

* To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
* To validate the Thai version of disease-specific quality of life tool SNOT-22

Secondary objectives

* To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
* To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
* To compare the side effects of Mitomicin C versus placebo


Eligibility criteria: Inclusion Criteria:

* All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS
* Patients must not have following diseases or conditions

  * Cystic fibrosis based on positive sweat test or DNA test
  * Gross immunodeficiency (congenital or acquired)
  * Congenital mucociliary problem (eg. Primary ciliary dyskinesia)
  * Altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease
  * Severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection
* Patients are willing to participate and provide written informed consent

Exclusion Criteria:

(None)

Primary outcomes:
measure: Postoperative Synerchia
timeFrame: 1 year
Secondary outcomes:
measure: Scoring of SNOT-22
timeFrame: 1 year
measure: Clinical Symptom Score
timeFrame: 6 months
measure: SNOT-22
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Pawin Numthavaj, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03528811: Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Official title: Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Vascular Disease in Diabetes
Keywords: Diabetes
Peripheral Vascular Disease
Microcirculation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 300
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: DIAGNOSTIC

Brief summary: The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.


Eligibility criteria: Inclusion Criteria:

* 1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.

  4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.

  5.Written informed consent signed by the patients or representatives

Exclusion Criteria:

* 1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level \> 2.5 mg/dL. Expected survival time of less than 24 months

Primary outcomes:
measure: Coincidence rate of "5 points test of Tongji university"
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tong ji University
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Xue Li, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05663411: A Study of SHR6508 in Secondary Hyperparathyroidism
Official title: An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 75
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 study is being conducted to evaluate the efficacy and safety of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving stable hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa and HB

Exclusion Criteria:

1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Subjects with a history of kidney transplant
8. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
9. Subjects with a treatment history of similar drugs
10. Allergic to a drug ingredient or component
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Subject with a history of alcohol abuse and drug abuse
14. Participated in clinical trials of other drugs
15. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: Change From Baseline in serum iPTH
timeFrame: Baseline and the efficacy period, defined as Week 16
Secondary outcomes:
measure: Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
timeFrame: Baseline and the efficacy period, defined as Week 16
measure: Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
timeFrame: Baseline and the efficacy period, defined as Week 16
measure: Change From Baseline in serum cCa and P
timeFrame: Baseline and the efficacy period, defined as Week 16
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day1 to End of Study, End of Study is about Week 20
measure: Participants with Anti-SHR6508 Antibody at baseline and postbaseline
timeFrame: Day1 to End of Study, End of Study is about Week 20
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: