louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05670457: Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
Official title: Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-bleeding Peptic Ulcer
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety and efficacy of diosmin as adjuvant therapy in treatment of non-bleeding peptic ulcer patients.


Eligibility criteria: Inclusion Criteria:

-. Age 25-65 years old.

* Patients of both gender (male and female).
* Non-bleeding Peptic ulcer Patients (duodenal \&gastric) diagnosed by endoscopy.

Exclusion Criteria:

* The presence of other factors that can lead to gastric bleeding other than peptic ulcer.

  * Patients with cancerous disease
  * Breast-feeding.
  * Surgically altered stomach ( bariatric surgery),
  * Patient with liver disease.
* Bleeding \& perforated peptic ulcer.

Primary outcomes:
measure: assesment of improvement of symptoms as indicated by change in SAGIS scale.
timeFrame: 2 months
Secondary outcomes:
measure: change in Malondialdehyde (MDA) serum levels.
timeFrame: 2 months
measure: change in Prostaglandin E2 (PGE2) serum levels.
timeFrame: 2 months.
measure: change in Endothelin-1 (ET-1) serum levels.
timeFrame: 2 months
measure: change in b-cell lymphoma 2(bcl-2) serum levels.
timeFrame: 2 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbia
Study officials:
References:
Clinical trial NCT03937557: The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
Official title: The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dermatosis
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Horizontal sectioning of scalp biopsy is a better method for evaluating hair disorders than vertical sectioning because it enables the quantitative examination of hair follicles at different stages. Without having the quantitative data of normal scalp hair counts as controls, it is impossible to evaluate scalp biopsies for hair disorders. In recent years, trichoscope is more popular in analysis of hair disease. It is less invasive and simple. The aim of this study is to understand the pros and cons of trichoscpoe.


Eligibility criteria: Inclusion Criteria:

* 20-50y/o adults without any scalp disorder

Exclusion Criteria:

* adults with any scalp disorder

Primary outcomes:
measure: Average number of hairs
timeFrame: 1 year
Secondary outcomes:
measure: Average hair shaft thickness
timeFrame: 1 year
measure: Amount of Single, double and riple follicular unit
timeFrame: 1year
measure: Amount of Empty hair follicles
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01169857: Velcade for Proliferative Lupus Nephritis
Official title: Velcade for Proliferative Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lupus Nephritis
Proteinuria
Hematuria
Keywords: Proliferative lupus nephritis
WHO class III/IV/V lupus nephritis
Proteinuria
Hematuria
Velcade
SLE
Bortezomib
Proteasome inhibitor
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2010-07-26
Enrollment: 0
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 primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.

Detailed description: This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.

Eligibility criteria: Inclusion Criteria:

1. ACR criteria for lupus (minimum 4 out of 11).
2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
3. GFR must be greater or equal to 30 cc/min/1.73 m2.
4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.

Exclusion Criteria:

1. Serum creatinine of more than 3.0 mg/dL on repeated testing.
2. Greater than 50% fibrosis on renal biopsy.
3. Platelet count of less than 30× 109/L.
4. Absolute neutrophil count of less than 1.0 × 109/L.
5. Greater than or equal to Grade 1 peripheral neuropathy.
6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
7. Hypersensitivity to Velcade, boron or mannitol.
8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
9. Known history of untreated positive PPD.
10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.
11. Diagnosed or treated for another malignancy within 3 years of enrollment.
12. Greater than 1.5x upper limit of normal total bilirubin.

Primary outcomes:
measure: Proteinuria
timeFrame: 1 year
Secondary outcomes:
measure: Renal function
timeFrame: 1 year
measure: Lupus activity score
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Choli Hartono, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03295357: Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study
Official title: Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extra-Corporeal Life Support
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on ECLS

Brief summary: There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.


Eligibility criteria: Inclusion Criteria:

- Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15

Exclusion Criteria:

* Patients under 18 years old
* Patients on ECLS for a heart transplant
* Patients who died within the first 48 hours following the initiation of ECLS

Primary outcomes:
measure: Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT05571657: COVID-19 Booster Dose Reminder/Recall for Adolescents
Official title: Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Vaccines
Keywords: reminder/recall
COVID-19
intervention
adolescents
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 4304
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.


Eligibility criteria: Inclusion Criteria:

* Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
* Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose)

Exclusion Criteria:

* Primary care provider is not affiliated with Marshfield Clinic Health System
* Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications
* Received COVID-19 vaccine off label
* Missing or invalid contact information
* Deceased

Primary outcomes:
measure: COVID-19 Booster Dose
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic Health System
state: Wisconsin
Study officials:
affiliation: Marshfield Clinic Research Institute
name: Huong McLean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824157: Ketamine IV Classic Protocol : Five Years Follow up
Official title: Ketamine IV Classic Protocol : Five Years Follow up Clinical Evaluation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Drug Abuse
Medications
Relapse
Keywords: Major depressive disorder
ketamine
follow up
Antidepressants
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who participated in ketamine study 1126 and are willing to participate

Brief summary: Patients who suffer from MDD recieved ketamnie (2014-15) in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.

Detailed description: Patients who suffer from Major Depressive disorder and are outpatients in our clinic and, received in the years (2014-15) ketamine in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.

Eligibility criteria: Inclusion Criteria:

* Patient who participated in ketamine study 1126

Exclusion Criteria:

* None

Primary outcomes:
measure: Mood that will be evaluated using the MADRAS Montgomery-Asberg Depression Rating Scale".
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT06440057: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
Official title: A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Carcinoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form;
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01714557: Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Official title: Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neutropenia
Hematopoietic Stem Cell Transplantation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.

The current study will evaluate the three different regimen:

1. No prophylaxic antibiotic
2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.

Detailed description: 1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
2. Randomize the neutropenia patients into 3 groups.
3. Receive 3 regimen.
4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.

Eligibility criteria: Inclusion Criteria:

* Age 13-65 years
* Received Autologous or Allogeneic hematopoietic stem cell transplantation.
* ECOG score 0-1.
* ICF is available.

Exclusion Criteria:

* Allergic to any therapy drug.
* Documented infection before neutropenia.
* Renal dysfunction.
* Suffering from central nervous system or mental disease.

Primary outcomes:
measure: febrile rate
timeFrame: 3 weeks after beginning of prophylaxis
Secondary outcomes:
measure: Microbiologic efficacy in febrile patients
timeFrame: 3 weeks after beginning of prophylaxis
measure: Recovery rate from neutropenia
timeFrame: 3 weeks after beginning of prophylaxis
measure: AE
timeFrame: 3 weeks after beginning of prophylaxis
measure: Cost of drug and hospital-stay
timeFrame: 3 weeks after beginning of prophylaxis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Employee
name: wenrong huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947257: Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?
Official title: Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilated Patients
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.

The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Admitted to intensive care
* Mechanically ventilated and sedated
* Carrying a right catheterization
* Making a ETO indicated by the medical team or doctor in charge of the patient

Exclusion Criteria:

* Patients under 18 years
* expectant mother
* Patients without health insurance
* Refusal to close

Primary outcomes:
measure: measure of the pulmonary artery pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00518557: Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
Official title: Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
interventional radiology
Chemoembolization
Safety
Effectiveness
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2007-08-20
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: The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.


Eligibility criteria: Inclusion Criteria:

* Patients with cytologically or histologically documented HCC, who are candidates for TACE
* Child-Pugh Child A or B
* Age \>= 18
* Measurable disease by RECIST criteria;
* Performance status ECOG 0-2
* Previous local therapy completed \> 4 weeks
* Written informed consent signed
* Normal organ and marrow function defined as:

Haematopoietic:

* WBC ≥ 3,000/µlplatelet count \> 80,000/mm3
* haemoglobin \> 9g/dL
* Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \< 5 x ULN
* Renal: creatinine \< 1.5 x ULN

Exclusion Criteria:

* Metastases
* Prior or concomitant chemotherapy or radiation therapy
* VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
* Severe and/or uncontrolled medical conditions:
* Congestive heart failure, serious cardiac arrhythmia, active coronary artery
* Severe renal impairment
* Patients who anticipate receiving major surgery during the course of the
* Pregnant or breastfeeding patients
* Evidence of bleeding diathesis

Primary outcomes:
measure: Safety and tolerability, Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Interventional Radiology, Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital, Southeast University, Nanjing, China
name: Gao-Jun Teng, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: