louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01998373: Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Official title: The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training Leaflet
Training Workshop
Keywords: Patient training
Rheumatoid arthritis
Quality of life
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 34
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Abstract

Background:

It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients.

Methods:

Patients were allocated to a patient training intervention group and patient without training intervention group. Both groups received routine treatments while the patient training intervention group, in addition to the routine treatments received training booklets and participated in the training workshop. All the extracted data from the written questionnaire were collected and analyzed using SPSS software.

Detailed description: Results:

The improvement in the signs of recovery for physical and mood symptoms in the patient training intervention group were seen (p \< 0.05). The score of quality of life had significantly improved in the two groups (Mean difference was 9.31±3.03 and P\<0.003). This improvement was significantly higher in the patient training intervention group (P=0.008). After adjustment for education level, the score of quality of life in patient training intervention group had a higher improvement, but the difference between the two groups was not significant (P = 0.1).

Conclusions:

This study showed the important role of training and the patients' educational level on better treatments. The appropriate training in the patient could create a change in the treatment process and has a better effect on quality of life.

Eligibility criteria: Inclusion Criteria:

* The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease).

Exclusion Criteria:

* Patients were excluded if they had another disease.

Primary outcomes:
measure: The score of quality of life had significantly improved in the two groups (using questionnaire)
timeFrame: one year
Secondary outcomes:
measure: In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)
timeFrame: one year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: the rheumatology clinic at Imam Khomeini Hospital in Tehran
Study officials:
References:
Clinical trial NCT01033773: Stop Emergency Room Visits for Hyperglycemia Project - District of Columbia (DC)
Official title: STEP-DC: Stop Emergency Room Visits for Uncontrolled Hyperglycemia Project in the District of Columbia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Uncontrolled hyperglycemia
Emergency Department
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.

Detailed description: Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Type 2 Diabetes Mellitus,
* random BG \> 200 mg/dL,
* willing and able to provide informed consent and to participate in diabetes self-management education (DSME)
* stable for discharge from the ED once hyperglycemia treatment initiated.

Exclusion Criteria:

* type 1 Diabetes Mellitus,
* diabetic ketoacidosis or hyperosmolar non-ketotic state,
* concomitant treatment with glucocorticoids (other than stable maintenance dose therapy),
* cognitive or physical impairment preventing participation in DSME
* unwillingness or inability to provide consent and/or attend follow-up visits.

Primary outcomes:
measure: Total Number of Hypoglycemia Events (Blood Glucose < 60mg/dL) Within 24 Hours of Baseline Visit
timeFrame: 24 hours
Secondary outcomes:
measure: Change in Mean Blood Glucose From Time of Presentation to Emergency Room to End of Intervention 30 Days From Baseline
timeFrame: 30 days
measure: Change in Hemoglobin A1C From Baseline to End of Intervention at 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Diabetes and Research Institutes, Georgetown University School of Medicine.
name: Michelle F Magee, MD, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02101073: ALX-0061 Phase I Bioavailability Study in Healthy Volunteers
Official title: A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aims of the study are:

* To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference.
* To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.
* To further determine the safety and tolerability of ALX-0061.
* To further evaluate the systemic (serum) immunogenicity of ALX-0061.


Eligibility criteria: Key Inclusion Criteria:

1. Healthy volunteers.
2. Gender: male or female.
3. Age 18 to 55 years.
4. Body mass index (BMI): 18.0 ≥ BMI \< 30.0 kg/m2.

Key Exclusion Criteria:

1. Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA).
2. Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration.
3. Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.

Primary outcomes:
measure: Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers
timeFrame: Day 1 to Day 32 +/- 2 days after dosing for low dose treatment arms, Day 1 to Day 46 +/-2 days after dosing for middle dose treatment arm, Day 1 to Day 53 +/- 2 days after dosing for high dose treatment arms
Secondary outcomes:
measure: Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6
timeFrame: During screening untill final visit (i.e. 60 +/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms)
measure: Safety and tolerability: safety markers
timeFrame: From signing of informed consent until final visit (i.e. 60 +/- 2 days for the low dose and middle dose treatment arms and 83 +/- 2 days for the high dose treatment arms
measure: Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum
timeFrame: From screening until final visit (i.e. 60+/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Ablynx NV
name: Steven De Bruyn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01791673: Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
Official title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Cyclocoagulation
HIFU - High Intensity Focused Ultrasound
Ciliary Body
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients


Eligibility criteria: Inclusion Criteria:

* Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
* IOP \> 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
* Patient must be aged 18 years and more
* No previous cyclophotocoagulation procedure in the eye
* No previous laser treatment in the eye during the 3 months before HIFU procedure

Exclusion Criteria:

* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
* History of ocular or retrobulbar tumor
* retinal detachment, choroidal hemorrhage or detachment
* Ocular infectious diseasee within 14 days before HIFU procedure

Primary outcomes:
measure: Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
timeFrame: up to 12 months
Secondary outcomes:
measure: Average change in IOP (mm Hg)
timeFrame: 3, 6 and 12 months
measure: Percentage change in IOP from baseline
timeFrame: 3, 6 and 12 months
measure: Average change in glaucoma hypotensive medications
timeFrame: 3, 6 and 12 months
measure: Incidence of device and procedure-related complications during follow-up
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: University Hospital
city: Grenoble
country: France
facility: Michallon University Hospital
city: Lille
country: France
facility: Huriez University Hospital
city: Lyon
country: France
facility: Croix Rousse University Hospital
city: Paris
country: France
facility: HIA - Val de Grace Hospital
Study officials:
affiliation: Croix Rousse University Hospital
name: Philippe DENIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365373: The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology
Official title: The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Orthokeratology
Keywords: Myopia
Orthokeratology
Axial length
Decentration
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 251
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Myopia children with orthokeratology lens and complete follow-up.

Brief summary: Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.

Detailed description: Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Eligibility criteria: Inclusion Criteria:

* age from 8 to 15years
* spherical equivalent(SE) was range from -1.00D to -5.00D
* conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

* ocular diseases and systemic diseases
* stop wearing for ≥7 days for any reason during the follow-up period
* keratoconjunctival complications, glare, diplopia, or any other symptoms during follow-up

Primary outcomes:
measure: The change of axial length
timeFrame: The change of baseline、6 months and 12months
Secondary outcomes:
measure: the decentration magnitudes of the treatment zone
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT05585073: Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer
Official title: Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer:a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery-Complications
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The CLASS-01 trial is a prospective multicenter randomized controlled study (ClinicalTrials.gov.number:NCT01609309) to compare the oncological efficacy of laparoscopy and laparotomy in the treatment of locally advanced distal gastric cancer. In this study, 119 patients who underwent laparoscopic surgery at our center who participated in CLASS-01 were selected. All the patients were operated with 2D laparoscopic system.The 2D/3D trial is a prospective clinical trial (ClinicalTrials.gov.number:NCT02327481) that compares the curative effect of 2D and 3D laparoscopic radical gastrectomy in our center. Seventy cases of 2D laparoscopic distal gastrectomy (LDG) were selected

Brief summary: Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.


Eligibility criteria: Inclusion Criteria:

1. all patients undergoing laparoscopic surgery
2. Laparoscopic system is 2D and has complete D2 lymph node dissection.

Exclusion Criteria:

1. patients undergoing laparotomy
2. incomplete video or clinicopathological information

Primary outcomes:
measure: surgery complicated
timeFrame: 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Gastric Surgery
state: Fujian
Study officials:
References:
Clinical trial NCT00791973: Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Official title: Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 45 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.

Primary outcomes:
measure: Change in Tryptase Level From Baseline to Post-antigen Challenge
timeFrame: After one week of treatment wtih veramyst or placebo
Secondary outcomes:
measure: Total Eye Symptom Scores After Antigen Challenge
timeFrame: After one week of treatment wtih veramyst or placebo
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02289573: Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
Official title: Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.


Eligibility criteria: Inclusion Criteria:

* AECOPD patients who need invasive mechanical ventilation
* Patients who can tolerate assist mechanical ventilation
* Patients who have signed ICF

Exclusion Criteria:

* Patients who are younger than 18 years old or older than 75 years old
* Patients whose respiratory center is severely inhibited
* Patients who can not stand NAVA gastric tube
* Patients who have coagulation disorders
* Patients whose vital signs are unstable
* Patients who are in other clinical trails

Primary outcomes:
measure: the ratio of physiologic dead space over tidal volume (VD/VT)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sun Q, Liu L, Pan C, Zhao Z, Xu J, Liu A, Qiu H. Effects of neurally adjusted ventilatory assist on air distribution and dead space in patients with acute exacerbation of chronic obstructive pulmonary disease. Crit Care. 2017 Jun 2;21(1):126. doi: 10.1186/s13054-017-1714-1.
Clinical trial NCT04604873: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers (HDJ-SPI)
Official title: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer, Advanced
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 144
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 main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).


Eligibility criteria: Inclusion Criteria:

1. Patient ≥ 18 years old with advanced solid tumor
2. Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
3. With or without anti-cancer treatment
4. With estimated life expectancy of more than 2 months and less than 12 months
5. Able to communicate in French and answer questionnaires
6. Affiliated with a social security system
7. Having signed informed consent, co-signed by the partner if designated by the patient

Exclusion Criteria:

1. Patient with primitive brain tumor or malignant hemopathy
2. Severe psychopathological disorders
3. Pregnant patient or childbearing potential without effective method of birth control
4. Unable to be followed at the cancer center until death
5. Patient deprived of liberty or under guardianship -

Primary outcomes:
measure: Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institutcurie Paris
city: Saint-cloud
country: France
facility: INSTITUT CURIE Saint-Cloud
city: Saint-herblain
country: France
facility: Institut de Cancerologie de L'Ouest
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
References:
citation: Thery L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Bredart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.