louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06263140: Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study
Official title: A Study of Vitamin D Levels in Patients With Non-immediate Drug Hypersensitivity, Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stevens-Johnson Syndrome
Drug Reaction With Eosinophilia and Systemic Symptom
Maculopapular Exanthem
Vitamin D Deficiency
Drug-Induced Rash
Keywords: vitamin D
Stevens-Johnson Syndrome
Drug Reaction with Eosinophilia and Systemic Symptom
Maculopapular Exanthem
Drug Allergy
Drug Hypersensitivity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: Subjects who develop drug-induced non-immediate cutaneous reactions

Controls: subjects who can tolerate similar drug groups without allergic reactions

Brief summary: Serum vitamin D levels in drug-induced non-immediate reactions

Detailed description: The study of serum vitamin D levels in patients presented with drug-induced non-immediate cutaneous adverse reactions compared to those in drug-tolerant control subjects

Eligibility criteria: Inclusion Criteria:

* Diagnosed with SJS/TEN, DRESS, AGEP, MPE, or FDE as mentioned above

Exclusion Criteria:

* Reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir)
* Receiving vitamin D supplement

Primary outcomes:
measure: Serum vitamin D levels
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526640: Computed Tomography (CT) Guided Lung Biopsy With Plug
Official title: Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomized design
Primary purpose: PREVENTION

Brief summary: Protocol Title:

Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.

Detailed description: Protocol Summary:

Prospective, randomized, controlled, unblinded, post-market, single-center clinical study

Objectives:

Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).

Primary Objective:

Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy

Secondary Objectives:

Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent prior to any study related procedure
2. Male or female, aged ≥18 years or older
3. Percutaneous transthoracic needle lung biopsy indicated

Exclusion Criteria:

There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.

Primary outcomes:
measure: Evaluate the rate of chest tube
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Haseem Ashraf
state: Select A State
Study officials:
References:
citation: Zaetta JM, Licht MO, Fisher JS, Avelar RL; Bio-Seal Study Group. A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021.
citation: Ahrar JU, Gupta S, Ensor JE, Mahvash A, Sabir SH, Steele JR, McRae SE, Avritscher R, Huang SY, Odisio BC, Murthy R, Ahrar K, Wallace MJ, Tam AL. Efficacy of a Self-expanding Tract Sealant Device in the Reduction of Pneumothorax and Chest Tube Placement Rates After Percutaneous Lung Biopsy: A Matched Controlled Study Using Propensity Score Analysis. Cardiovasc Intervent Radiol. 2017 Feb;40(2):270-276. doi: 10.1007/s00270-016-1489-9. Epub 2016 Nov 8.
citation: Grage RA, Naveed MA, Keogh S, Wang D. Efficacy of a Dehydrated Hydrogel Plug to Reduce Complications Associated With Computed Tomography-guided Percutaneous Transthoracic Needle Biopsy. J Thorac Imaging. 2017 Jan;32(1):57-62. doi: 10.1097/RTI.0000000000000247.
Clinical trial NCT02380040: Plethismographic Perfusion Index in Neonates
Official title: Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus
Persistent Pulmonary Hypertension of the Newborn
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 100
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and Preterm newborns admitted to the neonatology department

Brief summary: Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.

Detailed description: Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.

Eligibility criteria: Inclusion Criteria:

* PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria:

* Other cardiac diseases

Primary outcomes:
measure: Perfusion Index
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ruben Bromiker
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Ruben Bromiker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nitzan I, Hammerman C, Fink D, Nitzan M, Koppel R, Bromiker R. The effect of patent ductus arteriosus on pre-ductal and post-ductal perfusion index in preterm neonates. Physiol Meas. 2018 Jul 20;39(7):075006. doi: 10.1088/1361-6579/aacf25.
Clinical trial NCT06793540: Effectiveness of Self-posturotherapy on the Elimination of Residual Fragments After Treatment of Lower Calyx Urinary Stones by Extracorporeal Lithotripsy or Retrograde Flexible Ureteroscopy.
Official title: Effectiveness of Self-posturotherapy on the Elimination of Residual Fragments After Treatment of Lower Calyx Urinary Stones by Extracorporeal Lithotripsy or Retrograde Flexible Ureteroscopy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stone, Kidney
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to evaluate the effectiveness of an auto posturotherapy technique on the RFS at three months of patients treated for lower calyceal urinary stones by extracorporeal lithotripsy (ECL) or retrograde flexible ureteroscopy.


Eligibility criteria: pré Inclusion Criteria:

* Patient having read and signed the consent form for participation in the study • Patient candidate for an intervention on a lower calyx stone \<15mm by LEC or URSS

Patients meeting all of the following criteria may be definitively included in the study:

* Patient treated by LEC, or patient treated by URSS and for whom the presence of lower calyceal fragments has been observed by endoscopy
* Absence of JJ stent (patients for whom a JJ stent was implanted after URSS or before LEC may be included as soon as it is removed)

Exclusion Criteria:

* Patients presenting one of the following criteria will not be included in the study:

  * Renal or ureteral malformation: ureteral stenosis, pyelo-ureteral junction syndrome, horseshoe kidney, para calyceal diverticulum, pelvic kidney.
  * LEC session interrupted due to treatment intolerance
  * Physical disability making posturotherapy impossible (particularly spinal, etc.), morbid obesity, major gastroesophageal reflux, heart or respiratory failure.
  * Balance disorder which would not allow self-posturotherapy to be carried out alone.
  * Patient under legal protection, under guardianship or under curatorship
  * Posturotherapy carried out while wearing a JJ probe
  * Posturotherapy carried out by a third party (physiotherapist or other)
  * Pregnant or breastfeeding patient
  * Patient not affiliated to the French social security system
  * Impossibility of providing the subject with informed information and/or giving written informed consent: dementia, psychosis, disorders of consciousness, non-French speaking patient
  * Treatment that may modify the clearance of fragments (beta blocker, diuretic, etc.)
  * Patient included in another therapeutic study protocol

Primary outcomes:
measure: stone free rate
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
Study officials:
References:
Clinical trial NCT04319640: Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder
Official title: the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Cognitive Behaviour Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 160
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 parallel randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.

Detailed description: sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.

Eligibility criteria: Inclusion Criteria:

1. meet the diagnostic criteria for autism DSM-5 and ADOS-2;
2. age 24months to 59months s old;
3. willing to participate in this study, and can complete the following assessments at the specific time.

Exclusion Criteria:

Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;

Primary outcomes:
measure: congnitive-neural outcomes
timeFrame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
measure: ADOS-2
timeFrame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Secondary outcomes:
measure: Sleep diaries by using Actigraphy
timeFrame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Other outcomes:
Locations:
city: Shanghai
country: China
facility: shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Fan Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519740: Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen
Official title: Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Hyperreactivity
Hypersensitivity
Allergy
Bronchial Asthma
Keywords: grass-pollen
allergy
bronchial hyperreactivity
asthma
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2007-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.


Eligibility criteria: Inclusion Criteria:

* age \>12 and \<45 years
* informed consent
* Known allergy on grass-pollen

Exclusion Criteria:

* age \<12 and \>45 years
* Clinical asthma requiring regular inhalation
* vital capacity \>80%
* FEV1 \< 75%
* Chronic disease
* pregnancy
* Inhalative or systemic steroid use
* substance abuse
* incapability of understanding the study's purpose and performance

Primary outcomes:
measure: correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.
timeFrame: aug 2006 - feb 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University, Department of Pulmonology
state: Hessen
Study officials:
affiliation: Goethe University, Department of Pulmonology
name: Stefan Zielen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
citation: Kitz R, Rose MA, Schubert R, Beermann C, Kaufmann A, Bohles HJ, Schulze J, Zielen S. Omega-3 polyunsaturated fatty acids and bronchial inflammation in grass pollen allergy after allergen challenge. Respir Med. 2010 Dec;104(12):1793-8. doi: 10.1016/j.rmed.2010.06.019. Epub 2010 Jul 15.
Clinical trial NCT03426540: Intravitreal Conbercept After Vitrectomy
Official title: Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Early Proliferative Diabetic Retinopathy
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 28
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).

Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.

Detailed description: The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.

At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.

The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications

Eligibility criteria: Inclusion Criteria:

1. We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
2. Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.

Exclusion Criteria:

1. A history of previous PPV;
2. Severe intraoperative complications
3. Postoperative silicone oil tamponade;
4. Menstruation;
5. Stroke, a thromboembolic event, or myocardial infarction in the previous
6. months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.

Primary outcomes:
measure: best corrected visual acuity
timeFrame: baseline to 24 weeks post-surgery
Secondary outcomes:
measure: postoperative complications
timeFrame: baseline to 24 weeks post-surgery
measure: central retinal thickness
timeFrame: baseline to 24 weeks post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University
name: Rong X Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465940: Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
Official title: Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthropathy
Keywords: Total hip arthroplasty
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2024-06-20
Enrollment: 23
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: Patient implanted in the selected investigational site with a HYPE® acetabular cup and HIPER liner between 2016 and 2018 were identified. The following selection criteria were used.

Brief summary: This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.


Eligibility criteria: Inclusion Criteria:

* Patient was an adult at surgery,
* Patient implanted with HYPE® acetabular cup and HIPER liner,
* Patient was followed-up at least once on retrospective part of the study,
* Patient's current social security affiliation is valid.

Exclusion Criteria:

* Patient refuses the use of his/her personal data,
* Patient is unable to follow surgeon's instruction or unavailable for follow-up,
* Patient with contraindication to x-rays,
* Patient not implanted with HYPE® acetabular cup and HIPER liner.

Primary outcomes:
measure: Functional score
timeFrame: per operative period to at least 2 year
Secondary outcomes:
measure: Patient satisfaction
timeFrame: per operative period to at least 2 year
measure: Safety adverse event
timeFrame: per operative period to at least 2 year
measure: Survival rate
timeFrame: per operative period to at least 2 year
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
Study officials:
References:
Clinical trial NCT01774240: Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Official title: Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium
Cardiac surgery
DOS scale
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delirium is a common yet under diagnosed condition in hospitalized patients, and the incidence have not previously been described in Danish cardiac surgery patients. The present study seeks to describe the incidence and duration of delirium in this group of patients, before and after the introduction of standardized screening tool and a guideline for treatment of delirium after cardiac surgery.

Detailed description: Delirium is a common yet under diagnosed condition in cardiac surgery patients, and may cause prolonged cognitive impairment and increased risk of complications. Patients are at risk of e.g. pulling catheters and lines and may fall attempting to get out of bed. The aging patient population present with many risk factors for developing delirium, but diagnostic tools have been few. Almost 50% present with hypoactive delirium, which is often not diagnosed, nor treated correctly. To optimize effect, treatment should be initiated early, maintained until clinical improvement is observed, and then tapered gradually. Recently, Delirium Observation Screening scale (DOS scale) was developed and validated in elective cardiac surgery patients in the Netherlands, with interesting results. This encouraged us to evaluate the effects of systematic delirium screening and treatment in cardiac surgery patients. To our knowledge, no prior studies have evaluated use of DOS scale in this context.

OBJECTIVES To evaluate the incidence and severity of delirium, and the effects of standardized treatment in a population of Danish cardiac surgery patients.

Eligibility criteria: Inclusion Criteria:

* adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark

Exclusion Criteria:

* patients under age 18,
* patients that died within 24 hours after admission.

Primary outcomes:
measure: number of delirium free days
timeFrame: 14 days
Secondary outcomes:
measure: complication rates
timeFrame: 14 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6
Study officials:
affiliation: Resident
name: Vibeke L Jorgensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: