louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03248791: Vasopressor Infusion in Cesarean Delivery
Official title: Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Section Complications
Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.

Detailed description: Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

Eligibility criteria: Inclusion Criteria:

* full term
* pregnant women
* scheduled for cesarean section

Exclusion Criteria:

* pre-ecpamsia
* eclampsia
* bleeding
* cardiac dysfuction

Primary outcomes:
measure: incidence of post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: incidence of severe post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: incidence of severe delivery hypotension
timeFrame: 10 minutes after delivery
measure: systolic blood pressure
timeFrame: 2 hours after subarachnoid block
measure: diastolic blood pressure
timeFrame: 2 hours after subarachnoid block
measure: heart rate
timeFrame: 2 hours after subarachnoid block
measure: APGAR score
timeFrame: 10 minutes after delivery
measure: incidence of reactive hypertension
timeFrame: 2 hours after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00179491: Study of the Therapeutic Effects of Intercessory Prayer (STEP)
Official title: Study of the Therapeutic Effects of Intercessory Prayer (STEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Bypass Grafting Surgery
Keywords: coronary artery bypass grafting surgery
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: John Templeton Foundation
name: INTEGRIS Baptist Medical Center
name: Medstar Health Research Institute
name: Baptist Memorial Health Care Corporation
name: Mayo Clinic
First posted: 2005-09-16
Enrollment: 1802
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: Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Detailed description: Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Eligibility criteria: Inclusion criteria:

* Age 18 years or older
* Able to read or understand English

Exclusion criteria:

* Scheduled for emergent CABG (next available operating room slot)
* CABG more than 14 days after enrollment
* Other planned surgery within 30 days of CABG
* Minimally invasive CABG (non full sternotomy incisions)
* CABG with planned valve replacement, stent, angioplasty or carotid endarterectomy
* Or had ongoing chest pain or unstable angina, as defined by their physicians

Primary outcomes:
measure: Whether receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
timeFrame: 30 days
Secondary outcomes:
measure: Whether being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
name: Herbert Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00899691: Study of Hair Samples From Patients With Cancer
Official title: Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at hair samples from patients with cancer.

Detailed description: OBJECTIVES:

* Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer.
* Correlate changes in protein expression with expected changes based on planned therapy in these patients.

OUTLINE: This is a pilot, multicenter study.

Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT.

PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of malignancy
* Undergoing treatment at the National Cancer Institute's Clinical Center
* Must have scalp hair

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
measure: Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NCI - Surgery Branch
name: Steven K. Libutti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01630291: The Effect of Electrical Stimulation on Tear Production
Official title: A Non-Randomized, Open-Label Study to Determine the Effect of Electrical Stimulation on Tear Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Oculeve, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 4
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: The purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe Dry Eye.

Detailed description: A non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe Dry Eye Disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.

Eligibility criteria: Inclusion Criteria:

* Schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye
* Sum of corneal and interpalpebral conjunctival staining of \> +5 in the same eye where corneal staining is \> +2 using the CLEK criteria.

Exclusion Criteria:

* Individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. Individuals who have had LASIK or other refractive surgeries are eligible. Excluded conditions include:

  * History of orbital trauma
  * History of orbital surgery
  * Orbital cancer
  * History of orbital cancer
* Within the 3 months before the Screening Visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes

Primary outcomes:
measure: Schirmer Score
timeFrame: Up to 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: La Concepcion
country: Mexico
facility: APEC
state: Distrito Federal
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Guillermo Salcedo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099891: The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stomatitis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 300
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 purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Detailed description: Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged at least 18 years

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
* Have oral mucositis or other oral conditions at study entry

Primary outcomes:
measure: Incidence of severe oral mucositis (RTOG garde 3 or 4)
timeFrame: 5 weeks(at the point of receiving 50 Gy radiation)
Secondary outcomes:
measure: Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis
timeFrame: 5 weeks(at the point of receiving 50 Gy radiation)
measure: Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis
timeFrame: 5 weeks(at the point of receiving 50 Gy radiation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National Colleage & Hospital
Study officials:
References:
Clinical trial NCT01424891: Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Official title: Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Inflammation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* 35 to 80 years old
* type 2 diabetes
* HbA1c value between 6.0 % and 9.0 %
* elevated LDL-c values \> 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion Criteria:

* refused informed consent

Primary outcomes:
measure: NF-kappa B binding activity
timeFrame: up to 5 years
Secondary outcomes:
measure: Inflammatory markers
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
Study officials:
affiliation: University Hospital of Heidelberg
name: Gottfried Rudofsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952791: Case Report in Complications After Laparoscopic Transabdominal Preperitoneal Groin Hernia Repair Using LiquiBandFIX8®
Official title: Laparoscopic Transabdominal Preperitoneal (TAPP) Groin Hernia Repair Using N-butyl-2-cyanoacrylate (LiquiBandFIX8®)for Mesh Fixation and Peritoneal Closure: Case Report About Extraperitoneal Hematoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Groin Hernia
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective case report of one patient

Brief summary: This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. The patient had anticoagulation due to a mechanical valvula and postoperatively the patient developed a huge hematoma extraperitoneally. Relaparoscopy war performed to identify the problem and check the peritoneal closure.

Detailed description: This an a case report for proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair (TAPP). The patient had anticoagulation due to a mechanical valvula and postoperatively after TAPP the patient developed a huge hematoma extraperitoneally. The investigatorsperformed relaparoscopy for diagnostic and therapeutic reasons to check stop the bleeding and control the integrety of the peritoneal closure.

Eligibility criteria: Inclusion Criteria:

* Retrospective case report of one patient undergoing laparoscopic groin hernia repair

Exclusion criteria:

- not applicable (retrospective)

Primary outcomes:
measure: Strongness of LiquiBandFIX8®
timeFrame: 2 weeks
measure: Hemtoma
timeFrame: 2 weeks
measure: Strongness of LiquiBandFIX8®
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: Kepler University Hospital Linz
name: Sandra Raab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06988891: Effects of 'Evidence-based Practice' Training Based on Flipped Learning, Web-based and Traditional Education Models on Nurses' Self-directed Learning and Metacognitive Thinking Skills
Official title: Effects of 'Evidence-based Practice' Training Based on Flipped Learning, Web-based and Traditional Education Models on Nurses' Self-directed Learning and Metacognitive Thinking Skills
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Flipped Education Model
Self Directed Learning
Metacognition
Web Based Education
Keywords: nursing education
self directed learning
metacognition
flipped learning
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled experimental study with a pre-test-post-test design consisting of two intervention groups (flipped learning and web-based training) and one control group (traditional training).
Primary purpose: OTHER

Brief summary: The research was conducted to evaluate the effects of evidence-based practice training developed based on flipped learning, web-based education and traditional education models on nurses' self-directed learning and metacognitive thinking skills. The study is a randomised controlled experimental study with a pre-test-post-test design, consisting of two intervention groups (flipped learning and web-based education) and one control group (traditional education).

Detailed description: Purpose: The purpose of the study is to evaluate the effects of evidence-based practice training developed based on flipped learning, web-based education and traditional education models on nurses' self-directed learning and metacognitive thinking skills.

Method: The study is a pre-test-post-test randomised controlled experimental research design with two intervention groups (flipped learning and web-based education models applied) and one control group (traditional education model applied). The study was conducted with 45 nurses working in a training and research hospital in Istanbul. Data were collected with self-directed learning skills and metacognitive thinking skills scales.

Eligibility criteria: Inclusion Criteria:

* Have at least a bachelor's degree in nursing

Exclusion Criteria:

* Requesting to withdraw from the study

Primary outcomes:
measure: Self Directed Learning Skills Scale
timeFrame: one month
Secondary outcomes:
measure: Metacognitive thinking skills scale
timeFrame: one month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu Training and Research Hospital
Study officials:
References:
citation: Biyik Bayram S, Gulnar E, Ozveren H, Caliskan N. The effect of flipped learning on blood pressure knowledge and self-directed learning skills of first-year nursing students: A randomized controlled trial. Nurse Educ Pract. 2023 Feb;67:103557. doi: 10.1016/j.nepr.2023.103557. Epub 2023 Jan 25.
Clinical trial NCT01987791: Observation Study of Prednisone and Cyclosporine in Treatment of Thrombocytopenia in Hepatitis B Cirrhosis
Official title: Comparison of Prednisone and Cyclosporine in the Treatment of Thrombocytopenia in Patients With Cirrhosis Associated With Hepatitis B in China: a Collaborative, Open-label, Real World Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombocytopenia
Hepatitis B
Cirrhosis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.

Brief summary: To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.


Eligibility criteria: Inclusion Criteria:

* diagnosed HBV-associated cirrhosis
* had an serum HBV DNA level of more than 500 IU per milliliter
* have compensated liver cirrhosis
* thrombocytopenia (defined as a platelet count of \<30,000 per cubic millimeter)
* accompanied with bleed tendency (including petechial, episxias, ecchymosis, hemoptysis, hematemesis and hematochezia)
* have a liver-biopsy specimen indicative of cirrhosis, ultrasonography and/or computed tomographic imaging evidence of cirrhosis, or endoscopic evidence of portal hypertension(splenomegaly, ascites, and esophageal varicose)

Exclusion Criteria:

* pregnant
* hepatocellular carcinoma
* decompensated cirrhosis
* coagulation function abnormal
* had a history of other disease (e.g. aplastic anemia, autoimmune disease, idiopathic thrombocytopenia et al) that could induced thrombocytopenia
* co-infected with the human immunodeficiency virus
* co-infected with hepatitis C virus
* co-infected with hepatitis D virus
* had a coexisting serious medical or psychiatric illness
* serum creatinine level was more than 1.5 times the upper limit of the normal range

Primary outcomes:
measure: treatment failure
timeFrame: 12 months
Secondary outcomes:
measure: proportion of patients with a complete platelet count response
timeFrame: at 4 weeks, at 6 months , and at 12 months
measure: proportion of patients with an overall platelet count response
timeFrame: at 4 weeks, at 6 months , and at 12 months
Other outcomes:
Locations:
Study officials:
References: