louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01791166: Immuno-humoral Rejection Markers in Pulmonary Transplant
Official title: Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.


Eligibility criteria: Inclusion Criteria:

* Both genders, more than 18 years of age.
* Patients with or without Cystic fibrosis
* Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
* Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
* Patients had given his agreement to be enrolled in the study

Exclusion Criteria:

* Patient less than 18 year-old
* Patient had previous organ transplant
* Pregnant and/or lactating women
* Female subject in reproductive age does not use effective contraceptive methode
* Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study

Primary outcomes:
measure: Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.
timeFrame: 12 months after pulmonary transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
state: Ile de France
Study officials:
References:
Clinical trial NCT02070666: Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)
Official title: Preventive Strategies in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ARDS
Keywords: ARDS
Prevention
Protective mechanical ventilation
low tidal volumes
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.

This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.

Detailed description: The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.

Eligibility criteria: Inclusion Criteria:

* Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
* LIPS \> 4 points.
* Absence of mild, moderate and severe ARDS criteria (Berlin definition).
* Older than 18 year-old.
* Signed informed consent

Exclusion Criteria:

* Bilateral pulmonary infiltrates in chest X-ray at admission.
* Mechanical ventilation \> 12 hours.
* Previous pneumonectomy or lobectomy.
* Severe cranial trauma (Glasgow Coma Scale\<9) or cranial hypertension.
* Severe chronic pulmonary disease (GOLD IV).
* Admission from other hospital under MV.
* Limitation of therapeutic effort.
* Pregnancy.
* Acute pulmonary embolism.
* Participation in other interventional trials.
* Previous randomized in the proposed trial.
* Absence of informed consent.

Primary outcomes:
measure: ARDS development
timeFrame: 7 days
Secondary outcomes:
measure: Mortality
timeFrame: 90 days
measure: Ventilator-free days
timeFrame: 28 days after admission
measure: Dead space
timeFrame: 7 days
measure: Length of stay
timeFrame: participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks
measure: Pneumonia
timeFrame: 7 days
measure: Atelectasis
timeFrame: 7 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell, CSUPT
state: Barcelona
Study officials:
References:
Clinical trial NCT06246266: Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique
Official title: Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique in Reducing Pain in Babies Receiving Intramuscular Vaccination
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: infant
ıntramuscular
vaccine
Helfer Skin Tap Technique
ShotBlocker
pain
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Detailed description: During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited.

Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Eligibility criteria: Inclusion Criteria:

* Born between 38 and 42 weeks of gestation,
* Between 2 and 4 months old,
* Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
* No congenital anomalies, birth asphyxia or any chronic disease

Exclusion Criteria:

* Born prematurely or postmaturely
* Not between 2 and 4 months old
* Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
* Those with congenital anomalies, birth asphyxia or any chronic disease

Primary outcomes:
measure: Neonatal Infant Pain Scale = NIPS
timeFrame: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00994266: Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
Official title: Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Diamel
Dietary supplement
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of patients to be recruited and randomized for the study is 116. Daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with insulin therapy regimen of two daily doses.
* Signed informed consent.

Exclusion Criteria:

* Type 1 diabetes.
* Type 2 diabetes with glibenclamide treatment.
* Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.
* Sepsis.
* Pregnancy.
* HbA1c values greater than 10%.

Primary outcomes:
measure: Difference of insulin daily doses at week 24 and at the beginning of the study
timeFrame: 24 weeks
measure: Difference of glucose concentrations (fasting and post-prandial) at week 24 and at the beginning of the study considering the adjusted insulin doses during treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Occurrence of hypoglycemic episodes during treatment
timeFrame: 24 weeks
measure: Difference of HbA1c concentrations at week 24 and at the beginning of the study
timeFrame: 24 weeks
measure: Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pinar del Río
country: Cuba
facility: Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital
Study officials:
affiliation: "Abel Santamaría Cuadrado" General Hospital
name: Maria Elena de la Uz Herrera, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Endocrinology
name: Arturo Hernández Yero, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04466566: A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics
Official title: Effect of Genetic Variation in the GLP-1 Receptor on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetic Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.


Eligibility criteria: Inclusion Criteria:

* 40 nondiabetic subjects will be recruited.
* 20 subjects with the AA genotype at rs3765467 and remainder will have the GG genotype.
* Individuals encompassing the age span of 25-65 years.

Exclusion Criteria:

* Individuals under 25 and over 65 years of age.

Primary outcomes:
measure: Insulin secretion quantified using the minimal model to generate an index of beta-cell responsivity (Φ)
timeFrame: This will be calculated from the 0-180 minute data of the study
Secondary outcomes:
measure: Glucagon secretion measured by immunoassay
timeFrame: This will be averaged over the 0-180 minute data of the study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04006366: Time Restricted Eating Pilot - Bariatrics
Official title: Time Restricted Eating Pilot - Bariatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Keywords: bariatrics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-controlled, single arm intervention study
Primary purpose: TREATMENT

Brief summary: Bariatric surgery patients have a variable course of weight loss, maintenance and regain. Time restricted eating is an approach that may help individuals lose weight and improve metabolic functioning. We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients. The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome.

Detailed description: We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients. The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome. We will provide behavioral weight loss education to the patients and monitor how many calories they are taking in once per week.

Eligibility criteria: Inclusion Criteria:

* Participants will be at least two years post bariatric surgery who have completed participation in an ongoing longitudinal assessment study of bariatric patients at our medical center.

Exclusion Criteria:

* Participants who were non-compliant with the previous assessment trial, as well as those who were diagnosed with an eating disorder at their final (2 year) assessment visit. We will exclude participants at the discretion of the investigators who have unstable psychiatric issues or would be too ill to participate.

Primary outcomes:
measure: Weight
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: baseline to 12 weeks
measure: Diastolic Blood Pressure
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennyslvania
name: Kelly C Allison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317366: Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies
Official title: Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies With Genetic Alterations of the PI3K/AKT Pathway
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Proteus Syndrome
PIK3CA-Related Overgrowth Spectrum (PROS)
Growth Disorders
Keywords: ARQ 092
ArQule
AKT
PIK3CA
Overgrowth
Congenital malformations
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2017-10-23
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the PI3K/AKT pathway and may be available for patients who are ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent access to ARQ 092 through an existing clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT
2. Are unable to participate in an ongoing ARQ 092 clinical trial
3. Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form.
4. Medically suitable for treatment with ARQ 092
5. Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT

Exclusion Criteria:

1. Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug
2. Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05346666: Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Official title: Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epilepsy
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
name: Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University
First posted: 2022-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, the pathogenesis of epilepsy is immuno-modulatory and neuro-inflammatory which is commonly activated in epileptogenic brain regions in humans and is clearly involved in animal models of epilepsy. Inflammatory mediators in the blood and molecular imaging of neuro-inflammation could provide diagnostic, prognostic, and predictive biomarkers for epilepsy, which will be instrumental for patient stratification in future clinical studies. Dysfunction of the blood-brain barrier (BBB) may be responsible for abnormal neuronal firing. Disruption of the BBB causes the leakage of serum protein and leucocyte invasion into the brain. These exogenous inflammatory mediators have the potential to lower seizure thresholds, which could alter channel sensitivity, neurotransmitter uptake or release, and glia-associated regulation of extracellular environments, such as potassium concentration.


Eligibility criteria: Inclusion Criteria:

* Age: 15-75 years old.
* Gender: Male and female.
* Newly diagnosed refractory status epilepticus patients who are scheduled to receive anti-epileptic drugs.
* Patients with normal renal and hematological functions.

Exclusion Criteria:

* Old age \>75 years old.
* Pregnant or lactating females.
* Severe renal impairment when GFR\<30 ml/min.
* Hepatic patients ( not recommended with active hepatic disease or hepatic impairment specially when ALT or AST \>3 times ULN).
* Neutropenia when neutrophil count \<500 cells/mm3 due to increase the risk of infection.
* Thrombocytopenia when platelet count \< 50000 cells/mm3.
* Patients take Immunosuppressant drugs.
* Cancer patient who taking chemotherapy.
* Patients with a known hypersensitivity to any of the used drugs.

Primary outcomes:
measure: change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
Study officials:
References:
Clinical trial NCT01845766: Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis or Septic Shock
Keywords: sepsis, septic shock, rehabilitation, exercise
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.


Eligibility criteria: Inclusion Criteria:

1. age ≥20;
2. confirmed or suspected infection;
3. two or more among 1)-4) 1) body temperature \>38˚C or \<36˚C 2) heart rate \>90/min 3) respiratory rate \>20/min or PaCO2\<32 mmHg 4) WBC \>12000/mm3, \<4000/mm3, or band forms \>10%;
4. within 48 hours after arriving ER

Exclusion Criteria:

1. severe functional disability before admission;
2. central nervous system infection;
3. contraindication for exercise rehabilitation according to the investigators' decision;
4. severe medical illness or mental problem or laboratory abnormality which can confound the results;
5. pregnancy

Primary outcomes:
measure: Severe functional disability
timeFrame: 6 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01498666: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Official title: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Pain
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
Collaborators: name: Sprim CRO, Italia
First posted: 2011-12-23
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).

Detailed description: Subject will be asked to consume a tablet every day for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed.

Eligibility criteria: Inclusion Criteria:

* FAP (Functional Abdominal Pain) according to Rome III criteria for
* Child/Adolescent (Rasquin, 2006);
* 1 or more abdominal pain episodes per week over the past 8 weeks;
* Informed consent by study participant and at least one parent / legal guardian;
* Age 8-14 years;
* Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
* Ability to understand and comply with the requirements of the trial;
* Stated availability throughout the study period.

Exclusion Criteria:

* Chronic illness;
* Surgery of Gastrointestinal tract;
* Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
* Weight loss of 5% or more in body weight over the preceding 3 months;
* Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
* Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
* Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
* Participation in other clinical trials in the past 3 months;
* Subjects with anemia;
* Subjects with special dietary needs

Primary outcomes:
measure: Primary endpoint
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary endpoint
timeFrame: 56 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: AO "San Paolo"
city: Milan
country: Italy
facility: AO Niguarda Ca' granda
Study officials:
affiliation: Niguarda Hospital
name: Costantino DeGiacomo, MD
role: PRINCIPAL_INVESTIGATOR
References: