louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01054950: Quality of Life in Food Allergic Families
Official title: Quality of Life in Food Allergic Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 58
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. Food allergies place a tremendous burden not just on the patient but on his/her family as well. In an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.

Detailed description: We intend to show a difference between the intervention group, who will receive a food allergy packet, along with three follow up phone calls from our trained allergy nurse, and the control group, will be given the food allergy packet only. We expect the intervention group to score higher on the quality of life survey, showing that the support and education of our allergy nurse has a positive effect on quality of life of our patients and their families.

Eligibility criteria: Inclusion Criteria:

* IgE mediated food allergy
* Ages 0-17
* Willing to participate

Exclusion Criteria:

* Food sensitivities
* Unable to understand or read survey
* Unable to be available for follow up survey and nurse phone calls.

Primary outcomes:
measure: Difference in validated quality of life survey
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Allergy and Immunology Clinic
state: Michigan
Study officials:
affiliation: University of Michigan Allergy and Immunology Clinic
name: Alan Baptist, M.D
role: STUDY_DIRECTOR
References:
citation: Baptist AP, Dever SI, Greenhawt MJ, Polmear-Swendris N, McMorris MS, Clark NM. A self-regulation intervention can improve quality of life for families with food allergy. J Allergy Clin Immunol. 2012 Jul;130(1):263-5.e6. doi: 10.1016/j.jaci.2012.03.029. Epub 2012 Apr 26. No abstract available.
Clinical trial NCT00213850: Reference Values for Respiratory Resistance Measured by the Interrupter Technique in Adults
Official title: Reference Values for Respiratory Resistance Measured by the Interrupter Technique in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Interrupter technique
Respiratory resistance
Normal adults
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose is to obtain reference values of respiratory resistance (a technique widely used in children), in adults. The interest is that this technique needs only little co-operation and would be particularly adapted in subjects in whom co-operation is insufficient for other measurements.


Eligibility criteria: Inclusion Criteria:

* Adult non smokers, without any disease interfering with pulmonary function

Primary outcomes:
measure: References values obtained once
Secondary outcomes:
measure: Estimation of short-term reproductibility
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie Clinique et des Explorations Fonctionnelles, Hôpital Civil
Study officials:
affiliation: Service de Physiologie Clinique et des Explorations Fonctionnelles, Hôpitaux Universitaires de Strasbourg
name: Monique OSWALD-MAMMOSSER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04146350: A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis
Official title: A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Schisis
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.


Eligibility criteria: Inclusion Criteria:

1. diopter ≤-6.00D or axial length ≥ 26.00mm;
2. OCT showed macular schisis with or without macular retinal detachment;
3. agreed to participate in this project and signed informed consent form.

Exclusion Criteria:

1. OCT confirmed full-thickness macular hole with or without macular retinal detachment；
2. submacular active or inactive CNV;
3. previous vitreoretinal surgery and anti-glaucoma surgery；
4. with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
5. complicated with severe systemic disease can not tolerate surgery or follow-up;
6. do not agree to participate the project or disagree with the follow-up.

Primary outcomes:
measure: foveal thickness
timeFrame: change from baseline foveal thickness at 3, 6, 9, 12 months
measure: retinal thickness of the most significant schisis
timeFrame: change from baseline at 3, 6, 9, 12 months
Secondary outcomes:
measure: best corrected visual acuity
timeFrame: change from baseline at 3, 6, 9, 12 months
measure: mf-ERG
timeFrame: change from baseline at 3, 6, 9, 12 months
measure: Visual quality questionnaire
timeFrame: change from baseline at 3, 6, 9, 12 months
measure: axial length
timeFrame: change from baseline at 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Aier Eye Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Aier Eye Hospital
name: Weisheng Li
role: STUDY_CHAIR
References:
citation: Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6.
Clinical trial NCT03986450: ERAS Protocol in Laparoscopic Hysterectomy
Official title: The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: Enhanced recovery after surgery
Laparoscopic hysterectomy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.

Detailed description: ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.

Eligibility criteria: Inclusion Criteria:

* Must be scheduled for laparoscopic hysterectomy

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class IV
* Development of complications during surgery
* Body mass index \> 40 kg/m2

Primary outcomes:
measure: Healthcare costs
timeFrame: Up to one month
Secondary outcomes:
measure: Length of stay
timeFrame: Up to one month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Aysu Akca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06678750: A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
Official title: Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA with Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: a Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Newton-Wellesley Hospital
Sponsor class: OTHER
Collaborators: name: Exactech
First posted: 2024-11-07
Enrollment: 96
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: Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol

Detailed description: The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).

Eligibility criteria: Inclusion Criteria:

* Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant

Exclusion Criteria:

* Patients may be excluded due to some medical conditions

Primary outcomes:
measure: Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
timeFrame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
measure: Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire
timeFrame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
measure: Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire
timeFrame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
measure: Patient recovery from TKA using time from hospital stay to discharge
timeFrame: Post-op measure in hours
measure: Patient recovery from TKA by measuring number of outpatient visits
timeFrame: One year post-op
measure: Patient recovery from TKA by measuring number of PT visits
timeFrame: One year post-op
measure: Patient recovery from TKA by measuring medication consumption
timeFrame: One year post-op
measure: Patient recovery from TKA by measuring use of assisted walking devices
timeFrame: One year post-op
Secondary outcomes:
measure: Knee alignment and soft tissue balance
timeFrame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
measure: Knee alignment and soft tissue balance
timeFrame: One time (during surgery)
Other outcomes:
Locations:
city: Newton
country: United States
facility: Kaplan Joint Center, Newton Wellesley Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05214950: Oxygen Reserve Index in Airway Surgery in Children
Official title: A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia During Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (\<90%) in pediatric patients undergoing airway surgery.


Eligibility criteria: Inclusion Criteria:

* pediatric patients receiving airway surgery

Exclusion Criteria:

* baseline oxygen saturation less than 95%
* patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements

Primary outcomes:
measure: Hypoxemia
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes:
measure: Hypoxemia duration
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Incidence and duration of severe hypoxemia
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Rescue oxygenation
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: Hemodynamic instability
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: unexpected pediatric intensive care admission
timeFrame: from induction of anesthesia to end of operation, about 3 hours
measure: unanticipated postoperative mechanical support
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT03397550: The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease
Official title: The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Insufficiency, Chronic
Chronic Kidney Diseases
Keywords: taste threshold
salt restriction
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage 3-5 CKD patients

Brief summary: The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.


Eligibility criteria: Inclusion Criteria:

* stage 3-5 CKD patients
* clinical stable

Exclusion Criteria:

* renal replacement therapy
* cancer
* systemic infection
* Alzheimer's disease
* acute cardiovascular events, active hepatitis
* all other study-obstructive conditions

Primary outcomes:
measure: ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991）
timeFrame: up to 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking Universiy First Hospital
name: Jie Dong
role: STUDY_DIRECTOR
References:
citation: Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.
citation: Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.
citation: Middleton RA, Allman-Farinelli MA. Taste sensitivity is altered in patients with chronic renal failure receiving continuous ambulatory peritoneal dialysis. J Nutr. 1999 Jan;129(1):122-5. doi: 10.1093/jn/129.1.122.
citation: McMahon EJ, Campbell KL, Bauer JD. Taste perception in kidney disease and relationship to dietary sodium intake. Appetite. 2014 Dec;83:236-241. doi: 10.1016/j.appet.2014.08.036. Epub 2014 Sep 2.
Clinical trial NCT01897350: Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Segment Elevation Myocardial Infarction
Myocardial Oedema
Keywords: STEMI
Myocardial edema
Cardiovascular magnetic resonance
Lead sponsor: University of Bristol
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients will be undergo a CMR scan day 2 following STEMI

Brief summary: Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.


Eligibility criteria: Inclusion Criteria:

* STEMI
* providing written informed consent

Exclusion Criteria:

* contraindication to CMR,
* atrial fibrillation,
* claustrophobia,
* eGFR \< 30

Primary outcomes:
measure: The mass of myocardial oedema measured by CMR
timeFrame: Day 2 following STEMI
Secondary outcomes:
measure: Extra cellular volume
timeFrame: Day 2 following STEMI
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
state: Avon
Study officials:
References:
Clinical trial NCT04980950: "The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"
Official title: "The Impact of Enteral Immunonutrition on Gut Microbiota, Intestinal Permeability, and Inflammation of Intestines in Colorectal Cancer as Well as Gastric Cancer Patients - a Randomized Trials"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Colorectal Cancer
Keywords: gut microbiota
gut barrier integrity
enteral immunonutrition
gastric cancer
colorectal cancer
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.


Eligibility criteria: Inclusion Criteria:

* age \>18 y.o.
* patients with gastric or colorectal cancer
* patients treated in Department of Surgical Oncology, Medical University of Gdańsk
* patients' agreement to take part in this study

Exclusion Criteria:

* age \<18 y.o.
* other types of cancer than gastric/colorectal cancer
* the presence of inflammatory bowel disease
* pregnancy

Primary outcomes:
measure: The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.
timeFrame: at baseline and after 7 and 10 days
Secondary outcomes:
measure: The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.
timeFrame: at baseline and after 7 and 10 days
measure: The impact of immunonutrition on intestines in gastric and colorectal cancer patients.
timeFrame: at baseline and after 7 and 10 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01312350: Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Official title: Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypopharyngeal Cancer
Keywords: neoadjuvant chemotherapy
definitive chemoradiation therapy
head and neck cancer
base of tongue
Locally advanced
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 40
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: The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.


Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
* One or more evaluable or measurable lesion
* No prior chemotherapy, radiation, or surgery
* ECOG 0-2

Exclusion Criteria:

* Distant metastasis
* Other malignancy

Primary outcomes:
measure: To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
timeFrame: 18 months after the enrollment of the last patients
Secondary outcomes:
measure: To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only
timeFrame: 18 months after enrollemnt of last patients
measure: To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only
timeFrame: 18 months after the enrollment of the last patient
measure: To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only
timeFrame: 18 months after the enrollment of the last patient
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: