louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03331601: Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
Official title: Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Carcinoma
Receptor, ErbB-2
Keywords: Brain metastasis
HER2
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 30
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: This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared.

Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent
* Age 18 years or older
* Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
* Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.

Exclusion Criteria:

* Pregnant patients
* Breast feeding patients
* Patients with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom
* Patients with any serious active infection
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
* Patients who cannot communicate reliably with the investigator
* Patients at increased risk of death from a pre-existing concurrent illness

Primary outcomes:
measure: The tumor targeting potential in brain metastasis
timeFrame: 90 min post injection
measure: The tumor targeting potential in brain metastasis
timeFrame: 90 min post injection
Secondary outcomes:
measure: Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment
timeFrame: up to 2 years after inclusion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Uz Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Tony Lahoutte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keyaerts M, Xavier C, Heemskerk J, Devoogdt N, Everaert H, Ackaert C, Vanhoeij M, Duhoux FP, Gevaert T, Simon P, Schallier D, Fontaine C, Vaneycken I, Vanhove C, De Greve J, Lamote J, Caveliers V, Lahoutte T. Phase I Study of 68Ga-HER2-Nanobody for PET/CT Assessment of HER2 Expression in Breast Carcinoma. J Nucl Med. 2016 Jan;57(1):27-33. doi: 10.2967/jnumed.115.162024. Epub 2015 Oct 8.
Clinical trial NCT06397001: Treatment of AA Amyloidosis
Official title: An Open-label Single Center, Single Patient Study of an Experimental Antisense Oligonucleotide (ASO) Treatment in AA Amyloidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AA Amyloidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of a subcutaneous injection of nL-SAA1-01in a patient with AA Amyloidosis.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven AA amyloidosis
* Measurable disease
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records

Exclusion Criteria:

* Participant has any condition that in the opinion of the site investigator, would ultimately prevent the completion of study procedures

Primary outcomes:
measure: Adverse Events and/or serious adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Change in kidney function
timeFrame: Baseline, 1 year
measure: Change in quality of life - physical well-being
timeFrame: Baseline, 1 year
measure: Change in quality of life - emotional well-being
timeFrame: Baseline, 1 year
measure: Change in quality of life - spiritual well-being
timeFrame: Baseline, 1 year
measure: Change in quality of life - intellectual well-being
timeFrame: Baseline, 1 year
measure: Change in quality of life - overall well-being
timeFrame: Baseline, 1 year
measure: Initiation of dialysis
timeFrame: 1 year
measure: Initiation of kidney transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nelson Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951401: Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital
Official title: Pattern of Dyslipidemia Among Patients With Acute Coronary Syndrome at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: about 100 adult patients will be included in this study aged above 18 years old diagnosed acute coronary syndrome

Brief summary: In this study, I am aime to analyze lipid profile in patients with ACS who presents at sohag university hospital, and its clinical and complications pattern.

Detailed description: Coronary artery disease (CAD) is the most important cause of death in men and women The great majority of ACS patients have at least one major risk factor.

Acute Coronary Syndrome (ACS) is a major reason for Coronary Care Unit ( CCU )sohag university hospital admission The risk of CAD was about 4 and 3 times higher in male and female smokers than nonsmokers respectively (Baba S et. al ; 2006) Dyslipidemia has been identified as one of most important modifiable risk factor for CAD . Treating dyslipidemia has clear benefits in the primary and secondary prevention of coronary heart disease (CHD) in both sexes . This study focused on dyslipidemia as a risk factor of acute coronary syndrome (ACS).

Eligibility criteria: Inclusion Criteria::

clinical diagnosed Acute coronary syndromes

-

Exclusion Criteria:

* chronic coronary syndrome

Primary outcomes:
measure: dyslipiemia in acute coronary syndrome
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: esraa m abdelfatah
name: esraa m abdelfatah, resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graichen C, Tanner C. Diagnosis of Acute Coronary Syndrome. Am Fam Physician. 2018 Aug 1;98(3):Online. No abstract available.
citation: Dali B. Clinical Profile, Dyslipidemia and ACS - a Correlation. JNMA J Nepal Med Assoc. 2014 Jul-Sep;52(195):907-13.
citation: Ray KK, Ditmarsch M, Kallend D, Niesor EJ, Suchankova G, Upmanyu R, Anzures-Cabrera J, Lehnert V, Pauly-Evers M, Holme I, Stasek J, van Hessen MW, Jones P; dal-ACUTE Investigators. The effect of cholesteryl ester transfer protein inhibition on lipids, lipoproteins, and markers of HDL function after an acute coronary syndrome: the dal-ACUTE randomized trial. Eur Heart J. 2014 Jul 14;35(27):1792-800. doi: 10.1093/eurheartj/ehu105. Epub 2014 Mar 17.
citation: Eisen A, Giugliano RP, Braunwald E. Updates on Acute Coronary Syndrome: A Review. JAMA Cardiol. 2016 Sep 1;1(6):718-30. doi: 10.1001/jamacardio.2016.2049.
Clinical trial NCT06914401: Oxygenation Procedure for Obese Patients During Intubation in the Operating Room
Official title: Oxygenation Procedure for Obese Patients Using High Flow Oxygen Therapy Combined With Non-invasive Ventilation During Intubation in the Operating Room: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia Induction
Keywords: Non Invasive Ventilation
High Flow Nasal Oxygen
Intubation
Obese
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 124
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: Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.


Eligibility criteria: Inclusion Criteria:

* Patient requiring general anaesthesia with orotracheal intubation in the operating room
* Obese patient (Body Mass Index , BMI ≥ 30kg/m2)
* Patient affiliated to or benefiting from a social security scheme
* Patient having signed the free and informed consent form.

Exclusion Criteria:

* Haemodynamic instability
* Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
* Emergency surgery not allowing patient consent.
* Patient with a contraindication to NIV or OHD
* Protected patients: Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; pregnant, breast-feeding or parturient women; hospitalised without consent.

Primary outcomes:
measure: Oxygen reserve
timeFrame: 2 minutes after intubation
Secondary outcomes:
measure: SpO2
timeFrame: during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation
measure: Rate of EtCO2
timeFrame: 2 minutes after intubation
measure: Patient tolerance
timeFrame: Day 2, at study end
measure: Adverse events
timeFrame: Perioperative/Periprocedural
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Ségolène MROZEK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04073901: Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars
Official title: Clinical Evaluation of Endocrowns Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars : A Pilot Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paediatric
Dentistry
Keywords: Aesthetic
Endo-crowns
primary
molars
pulpotomy
zirconium
crowns
Lead sponsor: Nahda University
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..


Eligibility criteria: Inclusion Criteria:

1. . Free of systemic diseases.
2. Age between 4 and 7 years.
3. Takes no medication on regular basis.
4. Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
5. Patient and parent compliance.

Exclusion Criteria:

* 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.

Primary outcomes:
measure: Restoration integrity
timeFrame: one year
measure: marginal adaptation
timeFrame: one year
measure: marginal discoloration
timeFrame: one year
Secondary outcomes:
measure: parent satisfaction
timeFrame: immediate after intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yassmine Mohamed Farouk El Makawi
Study officials:
References:
Clinical trial NCT04049201: Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
Official title: Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Hôpital d'enfants Béchir-Hamza
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 112
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders.

to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.

the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery

Detailed description: this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children .

after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery.

Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction.

Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.

Eligibility criteria: Inclusion Criteria:

* 3-10 years old children
* elective surgery
* ASA PS I/II

Exclusion Criteria:

* Parental refusal
* Emergency procedure
* Behavioral or psychiatric disorders
* allergy or hypersensitivity to midazolam

Primary outcomes:
measure: Preoperative anxiety
timeFrame: 20 minutes after tablet was given
measure: Preoperative anxiety
timeFrame: 25 minutes after tablet was given
measure: Preoperative anxiety
timeFrame: 30 minutes after tablet was given
Secondary outcomes:
measure: the acceptance of Facial mask
timeFrame: 30 minutes after tablet was given
measure: post operative agitation
timeFrame: 10 to 15 minutes after wakeup of anesthesia
measure: the parental satisfaction
timeFrame: 1 hour after the wake up of anesthesia
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Hopital d'Enfants Bechir Hamza
Study officials:
References:
Clinical trial NCT00652301: A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2008-04-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Detailed description: Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Eligibility criteria: Inclusion Criteria:

* Healthy males between the ages of 18-55 with LDL More than 130, but less than 180

Exclusion Criteria:

* Individuals with drug or substance abuse
* Individuals with poor mental function
* Individuals having more than 14 alcoholic drinks a week
* Individuals that have been treated with any other investigational drug in the last 30 days

Primary outcomes:
measure: reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
timeFrame: Based on 7 week treatment periods.
Secondary outcomes:
measure: To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
timeFrame: Based on 7 week treatment periods.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20.
Clinical trial NCT03317301: Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
Official title: a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pruritus
Keywords: Pruritus cutaneus
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 189
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

- Endpoint: VAS Score Change, Investigator's assessment of overall treatment


Eligibility criteria: Inclusion Criteria:

1. Both gender, 19 years ≤ age
2. Patients with pruritus due to the following diseases

   ① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema

   ② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis

   ③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)

   ④ systemic skin pruritus, focal skin pruritus
3. In visit 2, during the run-in period previous week the VAS score of day and night time were 2 or more average points per day (maximum 4 points)
4. Those who can ability to record subject diary
5. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion Criteria:

1. Patients with pruritus due other medical causes (liver disease, heart failure, etc.)
2. Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease
3. Patients with systemic infection symptoms at the time of clinical trials
4. Asthmatic patients requiring steroid treatment
5. Patients with Spastic diseases such as epilepsy

Primary outcomes:
measure: Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
timeFrame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Secondary outcomes:
measure: Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration
timeFrame: Visit 2 (0 week), Visit 3 (1 week)
measure: Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline
timeFrame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks
measure: Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline
timeFrame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
measure: Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)
timeFrame: Visit 4 (2 weeks)
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang Univ. Guri Hospital
state: Kyeonggi-do
Study officials:
References:
Clinical trial NCT00298701: Tolerability of Grazax-R in Children
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.


Eligibility criteria: Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Boys and girls, 5-12 years of age
* Positive skin prick test to grass pollen

Exclusion Criteria:

* Previous treatment with immunotherapy

Primary outcomes:
measure: Assessment of safety by recording of adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Tangstedter Landstrasse 77
Study officials:
affiliation: ALK-Abelló A/S
name: Kim Simonsen, MD
role: STUDY_DIRECTOR
References: