louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04841850: Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children
Official title: Clinic And Biologic Efficiency And Tolerance Of Oral Immunotherapy Protocol In Hazelnut Allergic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy, Nut
Pediatric ALL
Keywords: Hazelnut
Oral Immunotherapy
Children
Protocol
Efficiency
Tolerance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged under eighteen. With hazelnut allergy (convincing clinical history and positivity of hazelnut skin prick test history or specific IgE) Under IOT hazelnut protocol in Pneumology/allergology-paediatric department of the Mother and Child Hospital in Bron

Brief summary: Prevalence of food allergy in the world has been inscreasing in recent years. Among nut allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an alternatice to eviction. There are few published data concerning hazelnut OIT in Europe, where its consumption is nevertheless very high.

The main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.

The secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol.

The study is retrospective and observational, and is based on the collection of medical data from patient records.


Eligibility criteria: Inclusion Criteria:

* Aged Under eighteen years old
* Hazelnut allergy (clinically and biologically)
* Under IOT hazelnut protocol in Pneumo/allergology-paediatric departement of the Mother and Child hospital in Bron

Exclusion Criteria:

* Lack of consent to be included in the study (by their parents)
* Age \> 18 years old

Primary outcomes:
measure: the proportion of patients in maintenance phase at the one-year consultation
timeFrame: at the one-year consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Pneumology allergology-paediatric department of the Mother and Child Hospital
Study officials:
References:
citation: Sabouraud M, Bierme P, Andre-Gomez SA, Villard-Truc F, Payot F, Correard AK, Garnier L, Braun C. Real-life experience with hazelnut oral immunotherapy. Ann Allergy Asthma Immunol. 2022 Apr;128(4):432-438. doi: 10.1016/j.anai.2022.01.002. Epub 2022 Jan 8.
Clinical trial NCT00612950: Beta-Cell Function After Near-Normalisation of Blood Glucose
Official title: Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Type 2 diabetes diagnosed after 30 years of age
* BMI \> 25

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver and kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy

Primary outcomes:
measure: 2.phase insulin response measured as incremental area under the curve from 10-120 minutes
timeFrame: 2 hours
Secondary outcomes:
measure: 2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
timeFrame: 2 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Endocrinology, Hvidovre Hospital
Study officials:
affiliation: University Hospital Hvidovre
name: Patricia V Højberg, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.
Clinical trial NCT05550350: A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Official title: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cataract
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
Primary purpose: TREATMENT

Brief summary: A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

Detailed description: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 40 years of age scheduled for cataract surgery
* Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
* Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

Exclusion Criteria:

* Use of any corticosteroids within 7 days prior to Day 0
* Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

Primary outcomes:
measure: Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
timeFrame: Days 1, 3, 15, and 30
measure: Mean ocular pain scores in the study eye
timeFrame: Days 1, 3, 8, 15 and 30
measure: Proportion of subjects with absence of cells in the AC of the study eye
timeFrame: Days 1, 3, 8, 15 and 30
measure: Proportion of subjects with absence of flare in the AC of the study eye
timeFrame: Days 1, 3, 8, 15 and 30
measure: Mean AC cell score in the study eye
timeFrame: Days 1, 3, 8, 15 and 30
measure: Mean AC flare score in the study eye
timeFrame: Days 1, 3, 8, 15 and 30
measure: Rates of ocular (study eye and fellow eye) and non-ocular TEAEs
timeFrame: up to day 30
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02420808: An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study
Official title: An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: CAD
STEMI
non STEMI
Unstable angina
Greece
Lead sponsor: Hellenic Cardiovascular Research Society
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 800
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ACS

Brief summary: A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.

Detailed description: A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.

Eligibility criteria: Inclusion Criteria:

* Informed Consent
* \> 25 years
* Admission in hospital within 24 hours from beginning of symptoms of transfer from antother hospital within 24 hours from beginning of symptoms.
* Acute Coronary Syndrom

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluation of patients with Acute Coronary Syndromes.
timeFrame: 6 months
Secondary outcomes:
measure: Estimation of the percentage of patients.
timeFrame: Baseline
measure: Description of the methods of patients' evacuation.
timeFrame: Baseline
measure: Estimation of the interval until the arrival in the hospital.
timeFrame: Baseline
measure: Evaluation of the blood test analysis during hospitalization.
timeFrame: Baseline
measure: Description of the administered medication.
timeFrame: Baseline - 6 months
measure: Evaluation of the male patients with erectile dysfunction.
timeFrame: Baseline - 6 months
Other outcomes:
Locations:
city: Chalkida
country: Greece
facility: General Hospital of Chalkida
Study officials:
References:
Clinical trial NCT04403308: ONO-7913 Phase I Study (ONO-7913)
Official title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
2. ECOG Performance Status of 0-1
3. Patients with life expectancy of at least 3 months

Exclusion Criteria:

1. Patients with multiple cancers
2. Patients with history of serious allergy

Primary outcomes:
measure: Dose-limiting toxicities
timeFrame: 28 days
measure: Adverse events
timeFrame: Up to 24 months
Secondary outcomes:
measure: Concentration vs time of ONO-7913 as single dose
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Kazuhiro Nakabayashi
role: STUDY_CHAIR
References:
Clinical trial NCT03308708: Norepinephrine for Spinal-induced Hypotension
Official title: Prophylactic Norepinephrine Infusion for Spinal-induced Hypotension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Anesthesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Norepinephrine (NE) infusion is used prophylactically to counteract the vasodilator effect of spinal anesthesia. prophylactic use of NE infusion is expected to decrease bouts of hypotension, vomiting and increase patient satisfaction


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for elective surgery under spinal anesthesia

Exclusion Criteria:

* ischemic heart disease uncontrolled hypertension

Primary outcomes:
measure: incidence of hypotension
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT01573208: Custom Guides for Total Knee Arthroplasty (TKA)
Official title: Prospective Cohort of FIRST TKA With Custom Guides
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to know if the reconstruction of the lower limb mechanical axis and the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient specific instruments.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a TKA
* Informed signed consent

Primary outcomes:
measure: Changes in mechanical axis of the lower limb
timeFrame: Pre-operatively (up to 3 months);6months
measure: Changes in gait
timeFrame: Pre-operatively (up to 3 months); 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV - Site HO
state: CH
Study officials:
References:
Clinical trial NCT03466008: Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Official title: Whole-Body Cryotherapy (WBC) as an Adjunct Treatment on Pain in Fibromyalgia Persons: Short Time Effect.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: whole body cryotherapy
fibromyalgia
chronic pain
quality of life
perceived health
Lead sponsor: Haute École Robert Schuman Libramont
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: between (two groups: WBC and control), and within subjects (two repeated measures: pre and post intervention)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our aim was to determine whether Whole Body Cryotherapy (WBC) can result in improved pain status, perceived health, and quality of life in patients with fibromyalgia. It is hypothesized that this positive effect can be achieved through increased functional mobility and decreased pain intensity resulting from cold-induced modulation of the inflammation-immune axis.

Detailed description: 24 patients with fibromyalgia were randomized into 2 groups (n=11 in the WBC group, n=13 in the control group). In the WBC group, 10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days. Patients in the control group did not change anything in their everyday activities. Several self-reported variables relating to perceived health were measured repeatedly (pain intensity, functional mobility, and quality of life).

Eligibility criteria: Inclusion Criteria:

Fibromyalgia diagnosis

Exclusion Criteria:

cardiorespiratory disorder current pregnancy cold intolerance Embolic diseases

Primary outcomes:
measure: pain status at 1 month from baseline
timeFrame: change from baseline at one month follow-ups
Secondary outcomes:
measure: pain status at 2 weeks from baseline
timeFrame: change from baseline at two weeks follow-ups
measure: functional status : the Oswestry Disability Index (ODI), subjective low back pain questionnaire
timeFrame: chnage from baseline at two weeks follow-ups
measure: functional status : the Oswestry Disability Index (ODI)
timeFrame: change from baseline at one month follow-ups
measure: functional status : the Disability of the Arm, Shoulder and Hand (DASH) score
timeFrame: change from baseline at one month follow-ups
measure: functional status : Lower Extremity Functional Scale (LEFS)
timeFrame: change from baseline at one month follow-ups
measure: health related quality of life (HRQoL)
timeFrame: change from baseline to one month follow-ups
Other outcomes:
Locations:
Study officials:
affiliation: University of Reims
name: guillaume polidori, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06339723: Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients
Official title: Examination of the Effectiveness of Training Given to Caregivers About Percutaneous Endoscopic Gastrostomy Using the Pecha Kuka Method to Caregivers Who Care for Palliative Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pecha Kuka
Palliative Care
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates.


Eligibility criteria: Inclusion Criteria:

* Accepting research
* Being a relative of a palliative care patient
* Ability to communicate adequately

Exclusion Criteria:

* The patient's relative has a disability (such as vision, speech and hearing) that prevents them from communicating.
* No psychiatric problems

Primary outcomes:
measure: Evaluation Form for Feeding Practices with Percutaneous Endoscopic Gastrostomy Tube:
timeFrame: 4 week
measure: Visual Analog Scale -Anxiety:
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat university
state: Center
Study officials:
References:
Clinical trial NCT01858623: Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Normotensive Participants
Keywords: Healthy Normotensive Participants
Fixed dose combination
Pharmacokinetics
Losartan
Hydrochlorothiazide
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Who had passed all the screening parameters

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion

Primary outcomes:
measure: Heart rate
timeFrame: Participants will be followed for the duration of study, an expected average of 5 weeks.
measure: Blood pressure
timeFrame: Participants will be monitored for the duration of study, an expected average of 5 weeks.
measure: Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide
timeFrame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
measure: Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide
timeFrame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: