louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02072655: Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
Official title: Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the early 2000s , professional and patient organizations are mobilizing to highlight the psychosocial impact of cancer disease , not only during but also after the acute phase.

In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer Plan II whose objectives include : " Develop a personalized care taking into account the pain and psychological and social support " and " increase opportunities for patients to benefit from supportive care "and" promote the professional integration .

This study aims to show that beyond the immediate benefits of the social aesthetic cares in hospital (direct soothing, improving the quality of the skin injured by chemotherapy , feeling of escape ... ), these treatments can also affect quality of life for patients during and after hospitalization. They also may have an impact on the maintenance of social and / or professional satisfactory throughout the planned chemotherapy aplastic period .


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* Hospitalized in the Hematology care unit in UH Angers
* Initial Hodgkin lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma
* Without previous socio-aesthetic care.

Exclusion Criteria:

* Age \<18 years old.
* Patient protected by the law.
* Patient at end of life.
* Patient unable to respond to the questionnaire.
* Previous Socio aesthetic care.

Primary outcomes:
measure: Quality of life score
timeFrame: Change form baseline in Quality of life score at an average of 5 months (4 to 6 cycles of chemotherapy).
Secondary outcomes:
measure: Coopersmith Self-esteem inventory
timeFrame: Change form baseline in Coopersmith Self-esteem inventory score at an average of 5 months (4 to 6 cycles of chemotherapy).
measure: Body Image Scale assessment
timeFrame: Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
measure: Social life assessment
timeFrame: Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
Other outcomes:
Locations:
city: Angers
country: France
facility: Hematology Care Unit - UH Angers
Study officials:
References:
Clinical trial NCT03865355: Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients
Official title: Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Glioblastoma Multiforme
Keywords: Metabolomic profile
Biomarkers
Lead sponsor: Novosibirsk State University
Sponsor class: OTHER
Collaborators: name: FSBI "Federal Neurosurgical Center" Novosibirsk, Russia
name: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
First posted: 2019-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.

Brief summary: This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients.

Detailed description: The analysis of metabolic profile in the plasma and CSF could become the new less invasive approach in the establishing diagnosis as well as an important prognostic factor in patients with glioma. The researches will assess the blood and CSF metabolic profile in patients with different types of gliomas as well as in patient without ones. This can help to find new biomarkers for low- and high-grade gliomas correlating with patient outcomes.

Blood and CSF samples will be collected from patients with suspected newly diagnosed low-grade (I-II) or high-grade (III-IV) gliomas as well as from patients who have hospitalized for reconstructive surgery after craniofacial trauma. All samples will be collected before any surgical intervention and at various follow-up time points until progression or death. The results of the study are planned to be translated into the hospital setting as support to other diagnostics procedures and to the differential diagnosis between glioma grades.

Eligibility criteria: Inclusion Criteria:

1. All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy).
2. Patient aged 18 years or older
3. Patients have to be able to give informed consent

Exclusion Criteria:

1. Prior Radiotherapy to the central nervous system
2. Prior Chemotherapy within the last 5 years
3. Any prior central nervous system malignancy
4. Any surgery during last 6 month

Primary outcomes:
measure: Metabolic phenotype of glioma patients
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Progression free survival (PFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State University
state: Novosibirskaya Oblast'
Study officials:
References:
Clinical trial NCT03852355: the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
Official title: the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Headache
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used other medical agents and to compare the results with those of the patients who used only 3rd occipital nerve pulsed radiofrequancy on clinical and radiographic bases.
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis is a common type of autoimmune arthritis that is characterized by inflammation of the synovial membranes. Even though any joint can be affected by the disease, cervical spine is often affected, and cervical pain is reported by 40-88% of RA patients, Cervical spine involvement is a feature of long-lasting disease, where atlantoaxial impaction with odontoid process vertical subluxation through the foramen magnum being one of the greatest and dangerous complications

Detailed description: To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used other medical agents and to compare the results with those of the patients who used only 3rd occipital nerve pulsed radiofrequancy on clinical and radiographic bases.

Eligibility criteria: Inclusion Criteria:

* patients suffering from upper neck pain and/or headache due to bilateral 3rd occipital nerve involvement evidenced by magnetic resonance imaging (MRI).

Exclusion Criteria:

* disc herniation with radicular pain,
* symptomatic spinal stenosis,
* surgical interventions of the cervical spine within the last 3 months,
* uncontrolled major depression or psychiatric disorders,
* heavy opioid usage

Primary outcomes:
measure: neck disability index score
timeFrame: 6 months
Secondary outcomes:
measure: Severity of headache Visual analog scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT00422955: Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
Official title: A 16-week, Randomised, Double-blind, Placebo-controlled, Single-centre Study to Investigate Fluid Retention in Insulin-treated Subjects With Type 2 Diabetes Mellitus and Varying Degrees of Autonomic Neuropathy When Administered Rosiglitazone 4mg Twice Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathy, Diabetic
Keywords: fluid retention
Autonomic Neuropathy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fluid management study in patients with type 2 diabetes and autonomic neuropathy.


Eligibility criteria: Inclusion criteria:

* Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria \[World Health Organisation , 1988/NCD/NCS/99.2\] with stable FPG of = 7.0 and = 15.0 mmol/l who have been established on insulin therapy for at least 6 months
* BMI = 40 kg.m2
* Subject who is willing and able to provide a signed and dated written informed consent.

Exclusion Criteria:

* Subjects with an HbA1c level \> 12%
* Subjects taking oral hypoglycaemic agents other than metformin
* Subjects on insulin dosage \> 200 units/day

Primary outcomes:
measure: Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
Secondary outcomes:
measure: Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rennings AJ, Smits P, Stewart MW, Tack CJ. Autonomic neuropathy predisposes to rosiglitazone-induced vascular leakage in insulin-treated patients with type 2 diabetes: a randomised, controlled trial on thiazolidinedione-induced vascular leakage. Diabetologia. 2010 Sep;53(9):1856-66. doi: 10.1007/s00125-010-1787-8. Epub 2010 May 25.
Clinical trial NCT05716555: Deep Brain Stimulation for Treatment Resistant Depression
Official title: Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: deep brain stimulation
lateral habenula
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70, regardless of gender;
2. Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;
3. Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;
4. A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;
5. HAMD-17 scores ⩾ 20 at screening;
6. Functional General Assessment Table (GAF) rating ≤50;
7. Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.

Exclusion Criteria:

1. Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;
2. History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;
3. Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;
4. Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;
5. Any surgical contraindications to undergoing deep brain stimulation (DBS);
6. Patients who cannot give full informed consent.

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 52 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine Second Affiliated Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02246855: A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
Official title: A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).


Eligibility criteria: Inclusion Criteria:

* Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
* Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
* Postmenopausal or surgically sterile female volunteers could be enrolled.

Exclusion Criteria:

-

Primary outcomes:
measure: PK parameters for serum immunoglobulin G (IgG)
timeFrame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
Secondary outcomes:
Other outcomes:
Locations:
city: Level 7, Northwick Park Hospital
country: United Kingdom
facility: Clinical Pharmacology Research Unit (CPRU)
state: Watford Road, Harrow
Study officials:
name: David Wessels, MBChB MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06946355: Food-based Support for Hospitalized Children and Their Families
Official title: Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Keywords: Pediatric
Hospitalization
Food Intake
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-04-27
Enrollment: 9119
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of government or self-pay insurances will provide benefits. The main questions it aims to answer are:

* Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes.
* Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes.

Researchers will compare the in-hospital food support intervention and will be rolled out to sequential hospital units. In addition, the post-discharge food support intervention will be compared to standard discharge.

Some participants will:

* Receive in-hospital meal cards or standard care during hospitalization
* Receive post-discharge food support intervention or standard discharge
* Complete a 14-day post discharge follow-up survey


Eligibility criteria: Inclusion Criteria:

* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible

Exclusion Criteria:

* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.

Primary outcomes:
measure: 30-day urgent reutilization
timeFrame: 30 days post-discharge
measure: Hunger during hospitalization
timeFrame: Within 36 hours before discharge
measure: Post-discharge hunger and food insecurity
timeFrame: 14 Days post-discharge
Secondary outcomes:
measure: 30-day unplanned readmission
timeFrame: 30 Days post-discharge
measure: 30-day Emergency department utilization
timeFrame: 30 Days post-discharge
measure: Understanding of discharge instructions Confidence in care at home
timeFrame: 14 Days post-discharge
measure: Return to normal routine
timeFrame: 14 Days post-discharge
measure: Post-Discharge coping
timeFrame: 14 Days post-discharge
measure: Out of pocket expenses
timeFrame: Within 36 hours before discharge
measure: Ability to pay for medications
timeFrame: 14 Days post-discharge
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: katherine.auger@cchmc.org
name: Kathy Auger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01599455: Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury
Official title: Cardiovascular Measurements at Baseline and During Cystometry in Pediatric Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: pediatric spinal cord injury
blood pressure
heart rate
baseline
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 146
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with spinal cord injury who are admitted for spinal cord injury rehabilitation program, visiting outpatient clinics, or undergoing scheduled urodynamic study

Brief summary: Following spinal cord injury (SCI), the body loses normal control of blood pressure and heart rate, and there is a risk of sudden and dangerous increases in blood pressure, namely, autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and heart rates in individuals in order to detect AD. However, baseline values vary in developing children, and may be more variable in children with SCI. Thus, the objective of this study is to determine baseline blood pressure and heart rate measurements in children with SCI during rest and during urodynamic testing.

The investigators hypothesize that 1) blood pressures will increase with increasing age and body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will increase with increase in bladder filling; 4) blood pressures will increase will increase with increasing duration of injury.


Eligibility criteria: Inclusion Criteria:

* children and adolescents with spinal cord injury
* age 18 years or younger

Exclusion Criteria:

* known history of hypertension, cardiac, renal, or thyroid disease
* recent surgical procedure less than 2 weeks prior to admission or visit
* fever or signs of active infection or inflammation

Primary outcomes:
measure: Blood pressure readings
timeFrame: at regularly scheduled medical appointments
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shriners Hospitals for Children - Chicago
state: Illinois
Study officials:
References:
citation: Zebracki K, Hwang M, Patt PL, Vogel LC. Autonomic cardiovascular dysfunction and vitamin D deficiency in pediatric spinal cord injury. J Pediatr Rehabil Med. 2013;6(1):45-52. doi: 10.3233/PRM-130236.
citation: Hwang M, Zebracki K, Betz RR, Mulcahey MJ, Vogel LC. Normative blood pressure and heart rate in pediatric spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Spring;19(2):87-95. doi: 10.1310/sci1902-87.
Clinical trial NCT01026155: Respiratory Muscle Endurance Training in Obese Patients
Official title: Respiratory Muscle Endurance Training in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obese patients (BMI > 30 kg / m²)
Lead sponsor: Fondation Edith Seltzer
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.


Eligibility criteria: Inclusion Criteria:

* Obese patients (BMI \> 30 kg/m2), without respiratory pathology (VEMS \> 80% predicted, VEMS/CV \> 80%)
* men or women
* age between 18 and 60 years old

Exclusion Criteria:

* Respiratory, cardiovascular, musculoskeletal diseases
* Alcoholism

Primary outcomes:
measure: Dyspnea at rest and during exercise
Secondary outcomes:
measure: Exercise performance (6-min walking distance) Quality of life (SF36 questionnaire)
Other outcomes:
Locations:
city: Briançon
country: France
facility: Centre Bois de l'Ours
Study officials:
affiliation: University Hospital, Grenoble
name: Bernard Wuyam, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: