louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02429726: Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
Official title: Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Keywords: malignant pleural effusion, p53 gene therapy, cisplatin
Lead sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 90
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: Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.

Detailed description: Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.

Eligibility criteria: Inclusion Criteria:

1. histopathologically diagnosed original cancer with malignant pleural effusion;
2. 18 years or older;
3. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
4. signed the informed consent form

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

Primary outcomes:
measure: objective response rate
timeFrame: from starting study treatment to 3 months
Secondary outcomes:
measure: effusion-free survival
timeFrame: from starting study treatment to 2 years
measure: Karnofsky Performance Status
timeFrame: from starting study treatment to 2 years
measure: adverse events
timeFrame: from starting study treatment to 30 days after the last treatment
Other outcomes:
Locations:
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
Study officials:
References:
Clinical trial NCT02228226: Follow-up Study After Bankart Repair Using MG-1
Official title: Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Dislocation
Keywords: Arthroscopic Bankart repair
Bone hole
Ossification
Suture anchor
Shoulder dislocation
Lead sponsor: Johnson & Johnson K.K. Medical Company
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 11
Sex: ALL
Minimum age (years): 16
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 those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1

Brief summary: Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.


Eligibility criteria: Inclusion Criteria:

* Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent
* Patient who understand the contents of the study and from whom a written consent can be obtained

Exclusion Criteria:

* Patient with dementia
* Patient who cannot undergo CT examination
* Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial
* Patient who is pregnant or lactating
* Patient judged to be inappropriate for the study by the (sub)investigator

Primary outcomes:
measure: Bone Hole Condition
timeFrame: over 24 months after surgery
measure: Ossification
timeFrame: over 24 months after surgery
Secondary outcomes:
measure: Clinical Function Evaluation
timeFrame: over 24 months after surgery
Other outcomes:
Locations:
city: Funabashi
country: Japan
facility: Funabashi Orthopaedic Hospital
state: Chiba
Study officials:
affiliation: Funabashi Orthopaedic Hospital
name: Hiroyuki Sugaya, MD, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02498626: Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery
Official title: Are Venous Saturations From the Central Venous Line, Venous Side of the Heart Lung Machine Interchangeable or Not With Mixed Venous Saturation From the Pulmonary Artery in Children Undergoing Open Heart Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: mixed venous saturation
open heart surgery
children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cardiac surgery for children with congenital heart defects

Brief summary: This study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

Detailed description: Forty children aged from 1-15 years undergoing correction for different congenital heart procedures with cardiopulmonary bypass \[CPB\] were included in this study. Simultaneous samples were taken from the central venous line, pulmonary artery, and from venous side of the heart lung machine. Samples were taken after 10 minutes on full CPB and at the end of surgery before end of CPB. Bland and Altman plots were used to study the agreement between venous saturations.

Eligibility criteria: Inclusion Criteria:

* Children in the age from 1-15 years undergoing correction for congenital heart defects with cardiopulmonary bypass

Exclusion Criteria:

* Any chest renal or hepatic problems

Primary outcomes:
measure: Bland and Altman Analysis was used to plot the difference in mixed oxygen saturation
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242357: Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension
Official title: Post-Marketing Surveillance Study Micardis® Plus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 14553
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: Outpatients with hypertension

Brief summary: Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients


Eligibility criteria: Inclusion Criteria:

* Males and females for whom a medical antihypertensive therapy is indicated
* Age \>= 18 years

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Change in morning blood pressure (office and self-measured)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Change in heart rate
timeFrame: up to 6 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 weeks
measure: Assessment of efficacy by investigator on a 5-point scale
timeFrame: at week 6
measure: Assessment of tolerability by investigator on 5-point scale
timeFrame: at week 6
measure: Change in rate of morning complaints
timeFrame: up to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00669357: AbioCor Implantable Replacement Heart
Official title: AbioCor Implantable Replacement Heart
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Severe Biventricular End Stage Heart Disease
Keywords: End stage heart disease
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-30
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.


Eligibility criteria: Inclusion Criteria:

* Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.

Exclusion Criteria:

* Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03154957: Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path
Official title: Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Dislocation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with acute shoulder dislocation

Brief summary: The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients


Eligibility criteria: Inclusion Criteria:

* Adult patient consulting for acute shoulder dislocation

Exclusion Criteria:

* Patient refusing to participate in the study

Primary outcomes:
measure: Evaluation of shoulder dislocation
timeFrame: Day of consultation of the emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Urgences Medico-Chirurgicales Adultes - Htp
Study officials:
References:
Clinical trial NCT04020757: H+ Mobilization With Dialysate Bicarbonate Variation
Official title: H+ Mobilization With Dialysate Bicarbonate Variation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Dialysis Clinic, Inc.
First posted: 2019-07-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath \[HCO3-\] of 35 mEq/L and an \[acetate\] of 4 mEq/L, and second, to determine whether reducing bath \[HCO3-\] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood \[HCO3-\]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath \[HCO3-\].


Eligibility criteria: Inclusion Criteria:

1. Patients must be 18 years or older,
2. Have been on dialysis for at least 1 year,
3. Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
4. Be reasonably nourished (serum albumin \> 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
5. Self-reported urine output of \<200 cc/day
6. Functioning arteriovenous fistulas or grafts for dialysis access
7. Currently dialyzing at a dialysate \[HCO3-\] of 33-37 mEq/L.

Exclusion Criteria:

1. Pregnancy,
2. Acute illnesses of any kind,
3. Hospitalization in the prior 3 months (except for vascular access related),
4. Significant congestive heart failure, liver or lung failure.
5. Pre-dialysis blood \[HCO3-\] \<19 mEq/L) (to reduce the risk of metabolic acidosis )

Primary outcomes:
measure: Lactate levels
timeFrame: through study completion, a period of 3 weeks
measure: H+ mobilization
timeFrame: through study completion, a period of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01016457: Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Official title: Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.


Eligibility criteria: Inclusion Criteria:

* Duration of diabetes for more than 6 months
* Use of insulin pump for more than 3 months

Primary outcomes:
measure: HbA1C
timeFrame: Start of study, after 3 months, after 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: Before and after connecting to sensor
measure: Number of night hypoglycemias
timeFrame: During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting
measure: Mean glucose level
timeFrame: During the first week of connecting to sensor and during the last week of connecting
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
name: Kineret Mazor-Aronovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511757: Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Fluconazole
Crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 15
Sex: MALE
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 an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.

Detailed description: Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.

Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Cohen street, saint-laurent, montreal (quebec)
country: Canada
facility: MDS Pharma Services
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02762357: PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
Official title: Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Episiotomy
Keywords: Novosyn Quick
Episiotomy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2016-05-04
Enrollment: 46
Sex: FEMALE
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: adult patients

Brief summary: The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.


Eligibility criteria: Inclusion Criteria:

* Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
* Singleton birth between 37 and 42 weeks gestation
* Written informed consent

Exclusion Criteria:

* Age\< 18 years
* Previous perineal surgery
* Instrumental vaginal deliveries
* Multiparous (at least 1 previous perineal delivery)
* Episiotomy involving the anal sphincter or the rectum
* Medical consumption that might adversely affect healing
* Women with active infection at the time of delivery

Primary outcomes:
measure: Incidence of wound dehiscence
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Incidence of Re-suturing
timeFrame: 3 months postpartum
measure: Incidence of suture removal
timeFrame: 3 months postpartum
measure: Short-term perineal pain (VAS)
timeFrame: 24h to 48h, 10 days postpartum
measure: Long term perineal pain (VAS)
timeFrame: 3 months postpartum
measure: Pain in daily living (VAS)
timeFrame: 24h and 10 days postpartum
measure: Dyspareunia
timeFrame: 3 months post-operatively
measure: Sexual intercourse
timeFrame: 3 months post-operatively
measure: Patient satisfaction with the repair (VAS)
timeFrame: until 3 months postpartum
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Hospital General de Granollers
city: Sant Cugat del Vallés
country: Spain
facility: IDC Hospital General de Catalunya
Study officials:
References: