louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02405052: Validation of the Panic Screening Score in Patient With Unexplained Chest Pain
Official title: A Prospective Cohort Study to Refine and Validate the Panic Screening Score for Identifying Panic Attacks Associated With Unexplained Chest Pain in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Noncardiac Chest Pain
Panic Attack
Lead sponsor: CISSS de Chaudière-Appalaches
Sponsor class: OTHER_GOV
First posted: 2015-04-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the emergency department

Brief summary: Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Panic-like anxiety may be responsible for a significant portion of the negative consequences of unexplained chest pain, such as functional limitations and chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time of discharge from the emergency department. The 4-item Panic Screening Score questionnaire was derived in order to increase the identification of panic-like anxiety in emergency department patients with unexplained chest pain.

The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2) validate the revised version of the Panic Screening Score; (3) measure the reliability of the revised version of the Panic Screening Score and (4) assess the acceptability of the instrument among emergency physicians.


Eligibility criteria: Inclusion Criteria:

Presenting unexplained chest pain as defined by:

* the absence of an identifiable cause (e.g., pneumothorax,pneumonia),
* the absence of chest trauma,
* the absence of new malignant cardiac arrhythmia, and
* a score of 2 or less on the modified version of the thrombolysis in myocardial infarction score.

Exclusion Criteria:

* presence of a terminal illness;
* presence of a severe communication problem that could interfere with the administration of the questionnaire;
* presence of a psychotic state, a major cognitive deficit or other condition that could invalidate the interview;
* being legally incompetent.

Primary outcomes:
measure: Accuracy of the Panic Screening Score
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lévis
country: Canada
facility: Centre de recherche, CSSS Alphonse-Desjardins, Centre hospitalier affilié universitaire de Lévis
state: Quebec
Study officials:
affiliation: Centre hospitalier affilié universitaire de Lévis
name: Guillaume Foldes-Busque, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foldes-Busque G, Denis I, Poitras J, Fleet RP, Archambault P, Dionne CE. A prospective cohort study to refine and validate the Panic Screening Score for identifying panic attacks associated with unexplained chest pain in the emergency department. BMJ Open. 2013 Oct 25;3(10):e003877. doi: 10.1136/bmjopen-2013-003877.
Clinical trial NCT01601652: Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Official title: Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parenteral Nutrition Associated Cholestasis
Keywords: cholestasis
PNAC
Parenteral Nutrition Associated Cholestasis
PNALD
Parenteral Nutrition Associated Liver Disease
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 12
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.


Eligibility criteria: Inclusion Criteria:

Cholestasis defined as either

* serum bilirubin \> 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
* serum bilirubin \> 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

Exclusion Criteria:

* Age \> 1y at time that omegaven is started
* Not expected to survive at least 30 days
* Fish allergy in a first degree relative
* Hemodynamic instability
* Coagulopathy
* Not likely to require PN for \> 30d
* Not expected to survive \> 30d

Primary outcomes:
measure: Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
timeFrame: approximately for 4 months
Secondary outcomes:
measure: Liver Transaminases
timeFrame: approximately for 4 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Ian J Griffin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03552952: Development of Preterm Infant Gut Microbiome
Official title: Development of Preterm Infant Gut Microbiome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Infants
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2018-06-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature and term infants

Brief summary: This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Detailed description: Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature.

One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Eligibility criteria: Inclusion Criteria:

* Premature and term infants born in Rambam healthcare campus in Haifa, Israel

Exclusion Criteria:

* Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study.

Primary outcomes:
measure: Changes in gut microbial abundance over time
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center
Study officials:
References:
Clinical trial NCT05652452: Neurodynamic Sliders Promote Flexibility in Tight Hamstring Syndrome
Official title: Neurodynamic Sliders Promote Flexibility in Tight Hamstring Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Injury
Neurodynamics
Range of Motion
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to explore the intervention effect of home-based neurodynamic slider program on hamstring flexibility. Fifty physically active male subjects will be randomly assigned to either performing a neurodynamic sliding technique (3x20 reps) or a static stretching protocol (3x30") on a daily basis for a 6-week period. Hamstring flexibility will be assessed by means of the Straight Leg Raise at baseline, immediately after the intervention and after 4 weeks follow up.


Eligibility criteria: Inclusion Criteria:

* male
* aged between 18-30yrs
* recreationally/competitively active
* limited hamstring flexibility (Tight Hamstring Syndrome) (SLR≤75°)

Exclusion Criteria:

* a history of any musculotendinous hamstring injury in the previous year
* a history of neurological or orthopedic disorder affecting the lower extremities
* a history of lumbar disc herniation; or (4) a history of a cervical whiplash injury

Primary outcomes:
measure: Hamstring flexibility
timeFrame: at Baseline
measure: Hamstring flexibility
timeFrame: 6 weeks after intervention
measure: Hamstring flexibility
timeFrame: 4 weeks after retention period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06554652: Selective Neck Dissection Versus Modified Neck Dissection in PTC
Official title: Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Thyroid Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed PTC;
* Age range: 14-80 years old;
* Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
* Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and \<1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
* Thyroid tumors without extra thyroidal extension;
* Enough thyroid volume to inject tracer.

Exclusion Criteria:

* Previous neck surgery;
* Bilateral neck lymph node dissection;
* Distant metastases;
* High risk pathological subtypes or the presence of other high-risk factors for recurrence;
* Previous treatment for thyroid cancer other than endocrine therapy;
* The patient is unable to cooperate with follow-up.

Primary outcomes:
measure: Local-regional Recurrence Free Survival，LRFS
timeFrame: 5 years
Secondary outcomes:
measure: Local-regional Recurrence Rate，LRR
timeFrame: 5 years
measure: Progression Free Survival，PFS
timeFrame: 5 years
measure: Overall Survival，OS
timeFrame: 5 years
measure: Adverse Events，AE
timeFrame: 5 years
measure: Quality of Life as assessed by UW-QOL V4.1
timeFrame: 5 years
measure: Quality of Life as assessed by QoL/Thyroid
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Univeristy Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT04923152: Effective Dose of Statin Post PCI
Official title: Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Statin Dose
Keywords: PCI
Stable Angina
statin therapy
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 582
Sex: ALL
Minimum age (years): 52
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized
Primary purpose: TREATMENT

Brief summary: In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded

Detailed description: In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups

Eligibility criteria: Inclusion Criteria:

* all patients who have undergone PCI due to chronic stable angina

Exclusion Criteria:

* Patients with acute coronary syndrome
* Primary LDL\>190 mg/DL
* Patients who developed statin-induced myopathy or rhabdomyolysis
* Persistent increase in hepatic enzyme levels or hepatic failure
* Pregnancy and breast feeding
* Statin hypersensitivity
* Patients with history of multiple atherosclerotic events
* Patients who received high intensity statin before the study enrollment.

Primary outcomes:
measure: major adverse cardiovascular events (MACE)
timeFrame: 1 year
measure: serum level of HS-CRP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Professor kojuri cardiology clinic
state: Outside Of The US
Study officials:
References:
Clinical trial NCT01527552: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Official title: A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive)
* Minimum body weight of 65 kg
* Fasting blood glucose between 3.8-6.0 mmol/L
* Glycohemoglobin (HbA1c) below 6.4 %
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
* Hepatitis B or C
* Subjects with a first-degree relative with diabetes mellitus
* Known or suspected allergy to trial product or related products
* Smoking during the past three months

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: tmax, the time to maximum insulin aspart concentration
measure: Area under the insulin aspart curve
measure: Mean residence time (MRT)
measure: The area under the glucose infusion rate curve
measure: GIRmax, maximum glucose infusion rate value
measure: tGIRmax, time to maximum glucose infusion rate value
measure: Adverse events
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01628952: Comparison of the Bilateral TAP Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study
Official title: Comparison of the Bilateral Transversus Abdominis Plane (TAP) Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: The Main of This Study is to Compare the Nerve Block of the Muscles of the Abdominal Wall Between the Bilateral TAP Block and Curare
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years and under 75 years
* Informed consent signed
* ASA I, II and III
* Patient affiliated to social security

Exclusion Criteria:

* ASA IV

  * BMI\> 35 kg / m
  * Personal or family history of malignant hyperthermia
  * History of allergy or hypersensitivity to intravenous anesthetics (remifentanil), local anesthetics or muscle relaxants
  * Contraindications to sevoflurane: a history of malignant hyperthermia, history of liver disease after sevoflurane anesthesia, halogenated agents or hypersensitivity to any of these components.
  * Contraindications to succinylcholine: hyperkalemia, plasma cholinesterase deficiency nickname, para or tetraplegia more than 24 hours, burns over 24
  * Contraindications to cisatracurium: myasthenia
  * Neuromuscular diseases
  * Contraindications to local anesthetics: hypersensitivity to local anesthetics of the amide, intravenous regional anesthesia, porphyria, ventricular atrial conduction disturbances, epilepsy uncontrolled by treatment
  * Pregnancy and lactation
  * severe coagulation disorders
  * Inability to understand and give informed consent
  * Patient under guardianship, curatorship or protected
  * Indication of use of a hypnotic ketamine (BIS change)

Primary outcomes:
measure: Muscle relaxation.
timeFrame: 20 minutes after anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens France
name: Hervé DUPONT, PU-PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05178459: Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
Official title: Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathy
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In and out patients from endocrinology and neuropathy departments

Brief summary: The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

Detailed description: Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.

Eligibility criteria: Inclusion Criteria:

* The subject is an adult, man or woman (18 years old or more)
* Subjects affiliated or eligible to a social security system
* Subjects having expressed their consent to take part in the study
* Two type of patients are included in the study :

  * Patients having diabetes (80% of the inclusion)
  * Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)

Exclusion Criteria:

* Minors under 18 years old
* Subject is pregnant or trying to get pregnant
* Subjects having a pacemaker
* Subjects having refused to give their consent
* Vulnerable subjects according to the French regulation in force:

  * Individuals deprived of liberty by a court, medical or administrative order
  * Individuals legally protected or unable to express their consent to take part in the study
  * Individuals unaffiliated to or not beneficiary of a social security system
  * Individuals who fit in multiple categories above
* Individuals linguistically or mentally unable to express their consent
* Individuals having an lower limb amputation bigger than toes
* Individuals not able to stand still for a few minutes
* Individuals under antidepressant medications

Primary outcomes:
measure: Sudomotor dysfunction diagnostic performance evaluation
timeFrame: 10 months
Secondary outcomes:
measure: Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.
timeFrame: 10 months
measure: Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires
timeFrame: 10 months
measure: Safety use of this device
timeFrame: 10 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
state: Ile-de-France
city: Créteil
country: France
facility: Henri-Mondor Hospital
state: Île De France
city: Paris
country: France
facility: Cochin Hospital
state: Île De France
city: Paris
country: France
facility: Lariboisière Hospital
state: Île-de-France
Study officials:
affiliation: Bichat-Claude Bernard Hospital
name: Louis Potier, Dr
role: PRINCIPAL_INVESTIGATOR
References: