louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02372747: Comparison of Delta-Shaped and Billroth II After TLDG
Official title: Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Totally laparoscopic gastrectomy
laparoscopic distal gastrectomy
Intracorporeal anastomosis
Delta-Shaped Anastomosis
Billroth II Anastomosis
Gastric cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

Detailed description: Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* carcinoma located in the lower 1/3 of gastric body or antrum of stomach
* diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
* diameter of the tumor \<3cm
* no pyloric obstruction

Exclusion Criteria:

* diameter of the tumor ≥3cm
* associated with obstruction, bleeding, emergency surgery or surgical intervention
* tumor with extensive metastasis
* patient had previously undergone gastrostomy

Primary outcomes:
measure: Stage distribution
timeFrame: up to 7 days after the operation
measure: Resected margin
timeFrame: up to 7 days after the operation
measure: Operative time
timeFrame: up to 7 days after the operation
measure: Anastomosis time
timeFrame: up to 7 days after the operation
measure: The number of stapler cartridges used
timeFrame: up to 7 days after the operation
measure: Median estimated blood loss
timeFrame: up to 7 days after the operation
measure: Red blood cell transfusion
timeFrame: up to 7 days after the operation
measure: Length of the incision
timeFrame: up to 7 days after the operation
Secondary outcomes:
measure: Postoperative complication
timeFrame: up to 30 days after the operation
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02101047: Phenylephrine Dose and Mode of Administration for Spinal Anesthesia Induced Hypotension
Official title: Correlation and Effects on Cardiac Output With Intermittent Phenylephrine Administration of 50 mcg Versus 100 mcg or 100mcg/Min Prophylactic Infusion for Treatment of Hypotension in Parturients After Receiving Spinal Anesthesia for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complications; Cesarean Section
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Keywords: cesarean section
hypotension
phenylephrine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.

Detailed description: Phenylephrine will be administered in one of 3 regimens: Intermittent bolus of 50 mcg, Intermittent bolus of 100 mcg, or continuous infusion of 100 mcg/min. The infusion will contain either phenylephrine or normal saline (placebo). Subjects who are randomized to receive a bolus dose will receive placebo in the infusion. Subjects who are randomized to receive the phenylephrine infusion will have normal saline (placebo) in the bolus syringe. Baseline blood pressures will be obtained prior to surgery and then maintained using these drugs. Blood pressure and heart rate will be monitored as usual standard of care. Continuous cardiac output and hemodynamic monitoring will be obtained using CNAP (Tm) or similar (equivalent) monitoring device. Blood pressure will be maintained at 90-120% of baseline utilizing infusion and/or bolus with the 3 regimens.

Eligibility criteria: Inclusion Criteria:

* scheduled for cesarean delivery age \>/=18 years of age \>/= 37 weeks EGA ASA status I-III

Exclusion Criteria:

* allergy to medications used in the study non-English speaking

Primary outcomes:
measure: Magnitude of cardiac output changes
timeFrame: 0-90 minutes
Secondary outcomes:
measure: provider intervention
timeFrame: 0-90 minutes
measure: vasopressor requirement
timeFrame: 0-90 minutes
measure: Emetic symptoms
timeFrame: 0-90 minutes
measure: hypertension
timeFrame: 0-90 minutes
measure: hypotension
timeFrame: 0-90 minutes
measure: bradycardia
timeFrame: 0-90 minutes
measure: Anesthetic time
timeFrame: up to 120 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02259647: Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma
Official title: Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and control group will receive Sorafenib plus placebo


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years
* Child A and B cirrhosis with hepatocellular carcinoma
* Biochemical, Radiological, histological evidence of advanced hepatocellular carcinoma diagnosed as stage C and stage d with serum bilirubin \<5 mg/dl according to BCLC staging system
* HCC with portal vein thrombosis
* Unresectable cancer, as assessed carefully by individual experts
* No recent active treatment like surgery, radiofrequency ablation, trans arterial chemo embolization, radiotherapy, chemotherapy (within the past 6 months)

Exclusion Criteria:

* Patients with end-stage hepatocellular carcinoma (Stage D, BCLC)with poor performance status
* Child C cirrhosis with HCC (Hepatocellular carcinoma)
* HCC with acute decompensated state of CLD - GI bleed, increased jaundice, HE, SBP (Spontaneous Bacterial Peritonitis)
* Acute febrile illness
* Pregnancy or lactation

Primary outcomes:
measure: Overall Survival
timeFrame: 1 Year
Secondary outcomes:
measure: Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
timeFrame: 3 months
measure: Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria
timeFrame: 3 months
measure: Biochemical response - improvement in tumor biomarker level
timeFrame: 3 months
measure: Safety
timeFrame: 1 Years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT00205647: Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis
Official title: A Phase II Multicenter Efficacy, Safety and Dose-Effect Study of the Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable, Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Bronchitis
Keywords: Chronic Bronchitis
N-acetylcysteine (NAC)
Quality of Life
Mucus
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Zambon SpA
First posted: 2005-09-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randonmized, masked, placebo-controlled parallel group, clinical trial to evaluate the effects of three different doses of N-acetyl L-cysteine (NAC) and placebo on patient safety and on physical and transport properties of expectorated sputum. Patient sumptoms, quality of life and exacerbation will also be followed as well as pulmonary function testing and functional exercise capacity. We hypothesized that a prolongeed course of oral NAC favorably affects the morbidity of chronic bronchitis, particularly the incidence of acute exacerbations.


Eligibility criteria: Inclusion Criteria:

* Smokers (past or current,20 pack years) with diagnosis of chronic bronchitis
* expectorate sputum daily
* FEV1 of 40-70%
* understand and fill out questionnaire daily

Exclusion Criteria:

* other investigational within 30 days
* change in smoking habit within 6 months
* pulmonary diagnosis other that chronic bronchitis
* significant renal, cardiac, hepatic or endocrine diseases
* psychiatric disorder or evidence of alcoholism or drug abuse within year

Primary outcomes:
measure: Acute exacerbations
measure: Clinical assessments
Secondary outcomes:
measure: Functional exercise capacity
measure: Relationship between mucus physical and transport properties
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bruce K Rubin, MEng,MD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03026647: Suture Material for Closure of Hysterotomy
Official title: Evaluation of Suture Material for Closure of Hysterotomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cesarean Section; Complications, Wound, Hematoma
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female, pregnant, All ethnic backgrounds,

Brief summary: Retrospective chart review evaluating different suture types on surgical outcomes for cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures are used.

Detailed description: Cesarean sections are one of the most common surgeries performed in the United States; approximately 1 out of 3 births are completed by cesarean delivery. In 2014, 1,284,551 cesarean deliveries were performed. Unfortunately, even with this being a very common procedure some surgical topics have not been fully evaluated. One of these topics is the choice of suture for repair of the hysterotomy (uterine) incision. Several suture materials are available, yet only polygatactin-910 and catgut have been evaluated in a single study. In this study, only surgery complications were evaluated. Catgut was found to be associated with less risk of receiving a blood transfusion, otherwise no differences were found. One of the most common suture materials used at our institution is poliglecaprone 25, however no long term studies have been completed for this indication. In addition, no studies have evaluated the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25 to repair the hysterotomy. This information could be very useful in counseling for patients. As the cesarean delivery rates continue to climb, information on appropriate technique for surgery are needed.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean

Exclusion Criteria:

* unable to give consent

Primary outcomes:
measure: Preferred suture
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304447: Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia
Official title: A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leukemia, Myelocytic, Acute
Infusions, Intravenous
Keywords: Leukemia
Mylotarg
Safety
Adverse Events
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with CD33 positive, resistant or relapsed AML.
* Patients \> 18 years of age.
* ECOG performance status 0-2.

Exclusion Criteria:

* Fever (\>38), chills or hypotension (systolic BP\<105mmHg) in the 48 hours preceding therapy.
* Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment.
* Participation in any other Mylotarg® protocol.

Primary outcomes:
measure: The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.
Secondary outcomes:
measure: The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03172247: How Diabetic Patient Are Taken Care in Cardiology Service Actually?
Official title: How Diabetic Patient Are Taken Care in Cardiology Service Actually?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: cardiology diabetes
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We select every day patient admitted in cardiology department with antidiabetic treatment

Brief summary: Care of the diabetes is multidisciplinary with the involvment either private and hospital specialist


Eligibility criteria: Inclusion Criteria:

* evey patient admitted in cardiology department more than 24 hours
* 18 years old and above
* accepted to participate
* patient treated by insuline and/or with oral antidiabetic treatment
* Type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* patient admitted for angiography
* iatrogenic hyperglycaemia

Primary outcomes:
measure: Combined endpoint of diabetic hospitalized patients
timeFrame: During hospitalization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01835847: An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Official title: Tipepidine for Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Adolescent
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent depression.

The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the adolescent patients with depression.

If suggestion is obtained by this research about the effect on adolescent patients with depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment of adolescent patients with depression.


Eligibility criteria: \[Inclusion Criteria\]

1. Depressive Episode for ICD-10 criteria.
2. Patients are treated with antidepressants (SSRI ; Fluvoxamine, Paroxetine, Sertraline, Escitalopram, SNRI ; Milnacipran, Duloxetine, NaSSa; Mirtazapine), mood stabilizers (Lithium, Sodium Valproate, Carbamazepine, Lamotrigine), atypical antipsychotics (Risperidone, Olanzapine, Quetiapine, Perospirone, Aripiprazole, Blonanserin, Paliperidone) or not treated.
3. Patients are stable for 4-weeks for medication.

\[Exclusion Criteria\]

1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2. Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
3. Pregnant or breast-feeding women

Primary outcomes:
measure: Children's Depression Rating Scale, Revised (CDRS-R)
timeFrame: Changes from baseline in CDRS-R at 4-weeks
Secondary outcomes:
measure: Depression Self-Rating Scale for Children (DSRS-C) Japenese Version
timeFrame: Changes from baseline in DSRS-C at 4-weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Department of Psychiatry, Chiba University School of Medicine
state: Chuo-ku
Study officials:
References:
citation: Sasaki T, Hashimoto K, Tachibana M, Kurata T, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in adolescent patients with depression: a 4 week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 May 5;10:719-22. doi: 10.2147/NDT.S63075. eCollection 2014. No abstract available.
Clinical trial NCT04871347: The Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor
Official title: A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.


Eligibility criteria: Inclusion Criteria:

* Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;
* ECOG score 0 or 1;
* At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

* Known hypersensitivity to any ingredient of TWP-101;
* Receiving any anti-cancer drugs within 4 weeks;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Pregnancy or lactating women.

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: From the first dose of study drug up to 4 weeks
measure: Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
timeFrame: From enrollment until 90 days after the last dose
Secondary outcomes:
measure: Objective Response Rate (ORR) by RECIST Version 1.1
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Duration of Response (DOR)
timeFrame: From first dose to disease progression, an average of 2 years
measure: Disease control rate (DCR).
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Progression free survival (PFS).
timeFrame: From first dose to disease progression or end of study, an average of 2 years
measure: Maximum measured plasma concentration (Cmax) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Half-life (T1/2) of TWP-101.
timeFrame: From first dose until 90 days after the last dose
measure: Immunogenicity profile of TWP-101.
timeFrame: From first dose until 90 days after the last dose
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
References: