louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06041893: Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
Official title: Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Haploidentical Hematopoietic Stem Cell Transplantation
Keywords: post transplant cyclophosphamide
antithymocyte globulin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 20
Sex: ALL
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 undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center

Brief summary: Aim of this study is to investigate the effect of early administration of anti-thymocyte globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem cell transplantation.

Detailed description: Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are increasingly used in patients lacking a matched donor, but the optimal strategy needs to be defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.

Exclusion Criteria:

* A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.

Primary outcomes:
measure: Emgraftment Rate
timeFrame: From the date of transplantation until 28 days after transplantation
measure: Time to Engraftment
timeFrame: From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays
measure: Acute Graft-Versus-Host Disease
timeFrame: From the date of transplantation until 365 days after transplantation
measure: Chronic Graft-Versus-Host Disease
timeFrame: From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation
Secondary outcomes:
measure: Rate of CMV infection
timeFrame: From the date of transplantation until 365 days after transplantation
measure: Rate of Hemorrhagic Cystitis
timeFrame: From the date of transplantation until 365 days after transplantation
Other outcomes:
measure: Immune reconstitution
timeFrame: From the date of transplantation until 365 days after transplantation
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Keon Hee Yoo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854293: Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
Official title: Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Palliative Care
Keywords: palliative care
cancer
quality of life
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy

Brief summary: Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).


Eligibility criteria: Inclusion criteria:

* Patient over the age of 18 years,
* Patient who has signed the informed consent form after being given a written information sheet
* Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy
* Patient referred to the palliative care team.
* French-speaking Patient

Exclusion criteria:

* Cognitive disorders
* Documented psychiatric disorders or marked psychological fragility

Primary outcomes:
measure: The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation.
timeFrame: one month
Secondary outcomes:
measure: HADS (Hospital Anxiety and Depression Scale) anxiety and depression score
timeFrame: one month
measure: QLQC-15Pal palliative quality of life score
timeFrame: one month
measure: MB coping questionnaire score
timeFrame: one month
measure: Two 5-point Likert scales on information needs and satisfaction with medical information
timeFrame: one month
measure: Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)
timeFrame: one month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Léon Berard
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Paris
country: France
facility: Institut Curie
city: Saint Cloud
country: France
facility: Hopital René Huguenin
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
Study officials:
affiliation: Institut Curie
name: Carole Bouleuc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Bredart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.
Clinical trial NCT01885793: Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Intubation Complication
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients that require endotracheal intubation.

Brief summary: This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.


Eligibility criteria: Inclusion Criteria:

* Intubation of trachea with a cuffed endotracheal tube.

Exclusion Criteria:

* None

Primary outcomes:
measure: Intracuff pressure
timeFrame: Immediately after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Senthil Gopalakrishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250393: A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
Official title: Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
monotherapy
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

Detailed description: To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility criteria: Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 1-3 for Modified Hoehn and Yahr Scale.
3. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of cancer within 5 years.
4. Diagnosis of clinically significant illness of any organ system.
5. Mini-mental status examination score of 25 or less.
6. Taking any excluded medications.
7. History of drug or alcohol abuse or dependence within the past two years.
8. History of seizures or neurological malignant syndrome.
9. Clinical depression.
10. Pregnant or lactating females.

Primary outcomes:
measure: To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
Secondary outcomes:
measure: To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.
measure: To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
measure: To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
measure: To evaluate the safety of 40mg/d doses of istradefylline.
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01341093: Education Program for Cardiac Patients
Official title: Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Coronary Artery Disease
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years or more) of both sexes
* Being submitted to the first coronary artery bypass graft surgery between April 2011 and July 2012
* Having a properly functioning residential phone line

Exclusion Criteria:

* No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)

  * Illiterate participants who did not reach the minimum score 13 on the MMSE
  * Participants with one to seven years of education who did not reach the minimum score 18 on the MMSE
  * Participants with eight or more years of education who did not reach the minimum of 26 points on the MMSE

Primary outcomes:
measure: change from baseline in perceived health status at six months
timeFrame: baseline and six months
Secondary outcomes:
measure: change from baseline in treatment adherence at six months
timeFrame: baseline and six months
measure: change from baseline in self-efficacy at six months
timeFrame: baseline and six months
measure: change from baseline in anxiety and depression at six months
timeFrame: baseline and six months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Rejane K. Furuya, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Lidia A. Rossi, PhD
role: STUDY_CHAIR
References:
citation: Furuya RK, Arantes EC, Dessotte CA, Ciol MA, Hoffman JM, Schmidt A, Dantas RA, Rossi LA. A randomized controlled trial of an educational programme to improve self-care in Brazilian patients following percutaneous coronary intervention. J Adv Nurs. 2015 Apr;71(4):895-908. doi: 10.1111/jan.12568. Epub 2014 Nov 17.
Clinical trial NCT02123693: The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Osteopathic manipulative treatment
Low back pain
Dynamic MRI
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.


Eligibility criteria: Inclusion Criteria:

* will be admitted patients of both genders
* patients with chronic low back pain at baseline
* patients aged between 18 and 35 years

Exclusion Criteria:

* patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column
* patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system
* patients with neurological disorders that can cause painful symptoms of lumbar segment

Primary outcomes:
measure: Baseline changes in degree of flection of lumbar spine
timeFrame: at entry and after 8 weeks
Secondary outcomes:
measure: Baseline changes in Visual Analogue Scale
timeFrame: at entry and after 8 weeks
measure: Baseline changes in Roland-Morris questionnaire
timeFrame: at entry and after 8 weeks
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Radiology Unit II, University Hospital San Salvatore L'Aquila
state: Abruzzo
Study officials:
References:
Clinical trial NCT02072993: A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males
Official title: A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Phase I, healthy, pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male volunteer aged 18 to 50 years
* Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
* Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator

Primary outcomes:
measure: Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood
timeFrame: Up to 62 days
Secondary outcomes:
measure: Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses
timeFrame: up to 48 hours post dose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles 6700 W 115th Street, Overland Park, KS USA
name: Eleanor Lisbon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812093: Spectroscopic Evaluation of Middle Ear Infection
Official title: Spectroscopic Evaluation of Middle Ear Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Middle Ear Infection
Keywords: Middle Ear Infection
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-03-23
Enrollment: 150
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UCI otolaryngology clinic, CHOC, and La Veta

Brief summary: Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

Detailed description: The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Eligibility criteria: Inclusion Criteria:

1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure.

Exclusion Criteria:

1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. No diagnose of middle ear infection and no plan for surgery procedure.
4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Primary outcomes:
measure: Middle Ear Exam
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County (CHOC)
state: California
city: Orange
country: United States
facility: UCI Otolaryngology Clinic
state: California
Study officials:
affiliation: University of Calfornia Irvine
name: Elliot Botvinick
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199693: Hemodynamic and Respiratory Function in Healthy Pregnant Women
Official title: Hemodynamic and Respiratory Function in Healthy Pregnant Women - A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Hemodynamic and respiratory changes and pregnancy
Healthy pregnant women
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women

Brief summary: This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a longitudinal study.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Eldrid Langesæter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692393: Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
Official title: Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 102
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: This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

Detailed description: inclusion criteria: hinchey III and IV diverticulitis

Eligibility criteria: Inclusion Criteria:

* Patient with peritonitis du to sigmoid diverticulum complication
* Surgeon - anesthetist confirming the 2 surgeries can be performed

Exclusion Criteria:

* Physical state which can not permit patient to participate
* contraindication to surgery
* non-diverticulum peritonitis

Primary outcomes:
measure: Death rate comparison between two chirurgical strategies
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU - Rouen
Study officials:
affiliation: UH Rouen
name: JJ TUECH, PhD
role: PRINCIPAL_INVESTIGATOR
References: