louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04511351: Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma
Official title: Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy With or Without Chidamide in High-risk Early-stage Extranodal Nasal NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-08-13
Enrollment: 76
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: Currently, combined chemotherapy (CT) and radiation (RT) is recognized as the standard treatment for high-risk early-stage NKTCL. However, treatment failure occured in nearly 30% of patients receiving CRT and systemic failure are the most common failure form. Chidamide is a HADC inhibitor, which presents satisfactory efficacy in NKTCL especially in terms of improving durable remission time. In our previous study, IMRT followed by GDP was demonstrated effective in early-stage NKTCL. Therefore, we designed a prospective phase II clinical trial of IMRT followed by GDP with or without chidamide in patients with high-risk early-stage NKTCL.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. no prior radiotherapy or chemotherapy;
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. Ann Arbor stages I and II;
6. tumors primarily occurring in the upper aerodigestive tract;
7. at least one unfavorable prognostic factor (age \> 60 years, B symptoms, elevated LDH, ECOG score 2, regional node involvement, and PTI);
8. at least one measurable lesion;
9. adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
10. life expectancy of more than 3 months.

Exclusion Criteria:

1. Patients with advanced stage disease;
2. pregnancy or lactation;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Treatment response
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Scienses
name: Mei Dong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03679351: "FU-IFM2009" Database Post IFM/DFCI 2009 Study
Official title: "Follow Up-Intergroupe Francophone du Myélome 2009" Database Post IFM/DFCI 2009 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been already randomized in the IFM/DFCI 2009 study

Brief summary: Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators


Eligibility criteria: Inclusion Criteria:

* Patient randomized in the IFM/DFCI 2009 study.
* Patient still alive must give their non-opposition to the post IFM/DFCI 2009 study data collection until 30 November 2020
* Patient non-opposition.

Primary outcomes:
measure: progression free survival
timeFrame: 4 years
Secondary outcomes:
measure: overall long-term survival
timeFrame: 4 years
measure: secondary primary malignancies
timeFrame: 4 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hosptial toulouse
name: Michel Attal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489551: Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Official title: Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stem Cell Transplant Complications
Delirium
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-04-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study proposes to conduct an open label, feasibility study administering prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).

The study will address the following research aims: 1) To demonstrate the feasibility of enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who receive prophylactic haldol with an untreated historical control group.

Detailed description: This is an open label, safety \& feasibility, clinical drug trial. We will use historical controls from previous research with bone marrow transplant patients and delirium incidence at University of Iowa Hospitals and Clinics (UIHC) to evaluate the efficacy of prophylactic Haldol in the prevention of delirium. This study will recruit adult cancer patients undergoing hematopoietic stem cell transplant (HSCT) at UIHC.

Eligibility criteria: Inclusion Criteria:

* The participant must undergo an autologous or allogeneic bone marrow or stem cell transplant
* The participant is 18 years of age or older
* The participant provides written consent

Exclusion Criteria:

* The participant has a QTc of \>450 msec at the time of enrollment
* The participant used any antipsychotic medications within the last 30 days
* The participant has any significant allergies or past intolerance to Haloperidol
* The participant has a history of major neurological, metabolic, psychiatric, or cardiovascular disease, cerebrovascular event, or substance abuse
* The participant has a history of mental retardation or learning disability that, at the discretion of the investigator, could affect their ability to complete study assessments.

Primary outcomes:
measure: Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant
timeFrame: Daily, up to 14 days following transplant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Michelle Weckmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05071651: Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners
Official title: Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sport Injury
Blister of Foot
Lead sponsor: Institut de Formation et de Recherche en Médecine de Montagne
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ultra runners

Brief summary: PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail

SECONDARY OBJECTIVES :

To evaluate :

* The main locations of blisters.
* The severity of blisters
* The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

Detailed description: MAIN JUDGEMENT CRITERIA :

Prevention methods used before an ultra-trail via a self-questionnaire

SECONDARY JUDGING CRITERIA : Location of blisters, via a self-questionnaire Presence or not of blisters at the end of the ultra-trail or at the time of abandonment

STUDY SCHEME : Post-race questioning

Eligibility criteria: Inclusion Criteria:

* Ultra-trail participants with validated registration

Exclusion Criteria:

* Presence of blisters or other skin lesions on the feet before the race

Primary outcomes:
measure: Prevention methods used before an ultra-trail via a self-questionnaire
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Location of blisters, via a self-questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Presence or not of blisters at the end of the ultra-trail or at the time of abandonment
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chamonix-Mont-Blanc
country: France
facility: Ifremmont
Study officials:
affiliation: Institut de Formation et de Recherche en Médecine de Montagne
name: Corentin Tanné, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05264051: MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease
Official title: MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Diseases
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pts. hospitalized with acute hepatic decompensation Pts. with hepatobiliary neoplasia Pts. undergoing TIPS placement Pts. with chroinic liver disease

Brief summary: The purpose of the study is to study the muscle assessment score (MAsS, utilizing MRI, as an objective measure of frailty and muscle composition to serve as a predictor of morbidity and mortality in patients with liver disease.

Detailed description: Prospective study of patients seen at the Univ. of Chicago Medical Center hospital and ambulatory clinics. The assessment of the MAsS score will require an additional 8-10 minutes in the MRI for each patient already undergoing MRI exam.

Four groups of pts. who are already scheduled for MRI for routine clinical purposes will be evaluated.

1. Pts. hospitalized with acute hepatic decompensation for whom MRI is otherwise indicated for clinical evaluation.
2. Pts. with hepatobiliary neoplasia
3. Pts.undergoing transjugular portosystemic shunt (TIPS) placement
4. Pts. with chronic liver disease undergoing magnetic resonance elastography for routine monitoring

Eligibility criteria: Inclusion Criteria:

* Patients who are already scheduled for an MRI for routine clinical purposes will be evaluated

Exclusion Criteria:

* \<18 yrs. of age

Primary outcomes:
measure: Waitlist Mortality
timeFrame: Measured up to 10 years out from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT03225651: Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Official title: Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stem Cell Transplantation
Keywords: Stem cell
Autism
Psychological
Rehabilitation
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children

Detailed description: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
* Rett syndrome
* Fragile X syndrome

Primary outcomes:
measure: Assess the change in autism level by using tools
timeFrame: 6 months and 12 months after transplantation
measure: Evaluate the safety of therapy by record number of adverse events
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
References:
citation: Nguyen Thanh L, Nguyen HP, Ngo MD, Bui VA, Dam PTM, Bui HTP, Ngo DV, Tran KT, Dang TTT, Duong BD, Nguyen PAT, Forsyth N, Heke M. Outcomes of bone marrow mononuclear cell transplantation combined with interventional education for autism spectrum disorder. Stem Cells Transl Med. 2021 Jan;10(1):14-26. doi: 10.1002/sctm.20-0102. Epub 2020 Sep 9.
Clinical trial NCT03953651: Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
Official title: Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Oxygenation Imbalance
Myocardial Infarction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 1000
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: Male or female patients at least 18 years old admitted to the emergency department with a myocardial oxygenation imbalance

Brief summary: Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.

The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.


Eligibility criteria: Inclusion Criteria:

* age 18 years old or older ;
* At least one condition of myocardial oxygenation imbalance :

  * Oxygen saturation below 90% ;
  * Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ;
  * Persistent heart rate over 110 beats per minute, for more than 20 minutes ;
  * Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ;
  * Persistent systolic blood pressure over 180 mmHg for more than 20 minutes.

Exclusion Criteria:

* Patient admitted with type 1 myocardial infarction ;
* Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc...)
* Patient who declines to participate;
* Pregnant or breastfeeding women ;
* Patient deprived of liberty (inmate, administrative protection)

Primary outcomes:
measure: Onset of a Major Adverse Cardiovascular Event at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Laurent JACQUIN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04992351: Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery
Official title: Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Limb Wound
Lower Limb Wound
Anesthesia, Local
Keywords: WALANT
plastic surgery
upper limb
lower limb
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who undergo general plastic surgery operations in the upper or lower limb

Brief summary: Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations.

Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.

Detailed description: Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Little has been studied, regarding its indications and efficacy in general plastic surgery operations.

Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.

A prospective study will be conducted comparing the use of WALANT in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.

Eligibility criteria: Inclusion Criteria:

* upper or lower limb operation
* indication for flap or skin grafting
* operated by the principal investigator

Exclusion Criteria:

* other concomitant operations performed
* known allergy to any of the ingredients of local anesthesia mixture

Primary outcomes:
measure: total operation time
timeFrame: through operation completion
measure: operation theatre time
timeFrame: through operation completion with exit from the operation theatre
measure: Patient satisfaction
timeFrame: at 8 weeks
measure: feasibility of the WALANT method
timeFrame: through operation completion
Secondary outcomes:
measure: complications
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Plastic Surgery Department
Study officials:
References:
Clinical trial NCT02990351: Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt
Official title: Loco-regional Treatment for HCC Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
Living Donor Liver Transplantation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams Centre for Organ Transplantation (ASCOT) , Cairo Egypt

Brief summary: This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.

Detailed description: 50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

Eligibility criteria: Inclusion Criteria:

1. Adult patients 18-65 years
2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC

Exclusion Criteria:

1. Tumor progression on the waiting list
2. Vascular invasion by imaging studies
3. Extrahepatic or lymph node metastasis

Primary outcomes:
measure: Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation
timeFrame: 3 months
Secondary outcomes:
measure: the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: