louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064011: Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
Official title: A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraventricular Hemorrhage
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Radiographic evidence of intraventricular hemorrhage with hydrocephalus
* Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
* Placement of an external ventricular drain with an opening pressure \>20 mm Hg

Exclusion Criteria:

* Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
* Coagulopathy (Platelet count \<100,000, International normalized ratio \>1.5. Reversal of warfarin is permitted.)
* Age \<18 or \>75
* Pregnancy (positive pregnancy test)
* Clotting disorders
* Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist
* Medical contraindications to surgery as determined by the attending neurosurgeon
* Contraindication to recombinant tissue plasminogen activator administration:

  * Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (\>5 ml) on CT obtained after EVD placement
  * Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
  * Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
* Evidence of cerebrospinal infection by Gram stain or culture
* Advanced directive indicating Do Not Resuscitate or Do Not Intubate status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04212611: Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery
Official title: Evaluation of Postoperative Analgesic Effects of Infraorbital Nerve Block by Levobupivacaine vs Ropivacaine After Cleft Palate Surgery: A Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: All India Institute of Medical Sciences, Rishikesh
Sponsor class: OTHER_GOV
First posted: 2019-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids.

Hence, regional block, using local anesthetics, becomes a good option in this surgery.

The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain.

Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries

Detailed description: When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.

Eligibility criteria: Inclusion Criteria:

* Children in the age of 2-12 years
* Children undergoing elective surgery for cleft palate.
* Children who are conscious and willing to participate in the study.
* Children who speak and understand English, Hindi, local or others.

Exclusion Criteria:

* Patient's refusal
* Allergy to the amide group of local anaesthetic agent
* Patient on anticoagulants or bleeding disorder
* Underlying other significant systemic diseases.

Primary outcomes:
measure: change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days.
timeFrame: Till the second post operative day.
Secondary outcomes:
Other outcomes:
Locations:
city: Rishikesh
country: India
facility: AIIMS Rishikesh
state: Uttarakhand
Study officials:
affiliation: AIIMS,Rishikesh
name: Vijay Adabala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979611: The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Official title: The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Insulinoma
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed description: The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.

Eligibility criteria: Inclusion Criteria:

* 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent

Exclusion Criteria:

* 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy

Primary outcomes:
measure: Standard uptake value (SUV)
timeFrame: From right after tracer injection to 1-hours post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT06422611: Comparing Dental Impression Methods for Children
Official title: Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Impression, Pediatric Dentistry, Satisfaction
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who needed routine diagnostic records were included in our study.

Brief summary: The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.

The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.

Detailed description: In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.

Eligibility criteria: Inclusion Criteria:

* not to have a history of digital or conventional impression taking
* not to have temporomandibular joint and periodontal discomfort
* not to be using psychiatric or neuropathic drugs

Exclusion Criteria:

* history of digital or conventional impression taking
* TMJ disorder
* Using any kind of drug that interferes pain perception

Primary outcomes:
measure: Assessing patient preference and treatment comfort
timeFrame: March 2023-June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT00815711: Idiopathic Pulmonary Fibrosis Registry for Future Studies
Official title: Inflammation in Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Disease, Interstitial
Idiopathic Pulmonary Fibrosis
Keywords: IPF
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 13
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: primary care clinic

Brief summary: To establish a registry of patients for future studies of Inflammation in Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis.

Detailed description: To establish a framework in which biologic samples and physiologic measures from patients with IPF can be longitudinally collected and evaluated. Having a bank of samples that are correlated with physiologic measures that follow patients through their course will allow the following proposed studies as well as future investigations to be efficiently carried out.

Eligibility criteria: Inclusion Criteria:

* any patient referred to the Interstitial Lund Disease clinic who is undergoing evaluation and or treatment for a new diagnosis of ILD. This can include patients referred for presumed pulmonary fibrosis/interstitial pneumonitis (IPF, UIP, NSIP), sarcoidosis, hypersensitivity pneumonitis, cryptogenic organising pneumonia, drug-induced, or other idiopathic ILDs.

Exclusion Criteria:

* pregnancy
* inability to follow study requirements

Primary outcomes:
measure: Framework
timeFrame: 7 + years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Clay B Marsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03318211: Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial
Official title: Continuation Versus Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preeclampsia Severe
Keywords: preeclampsia
Magnisium sulfate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two groups:

Group I ( 50 cases) No magnesium sulfate received postpartum and Group II ( 50 cases)-magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Detailed description: All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two equal groups:

Group I is the study group: No post partum magnesium sulfate doses were given. Group II is the control group where magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Eligibility criteria: Inclusion Criteria:

* women with severe preeclampsia
* Severe features of preeclampsia include any of the following findings: systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before that time),thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema or new onset cerebral or visual disturbances

Exclusion Criteria:

- severe preeclampsia with serum creatinine\[1.2 mg/dl 2. previous history of eclampsia 3. Associated maternal medical diseases: pre-existing diabetes mellitus, epilepsy, renal disease.

4. Renal insufficiency. 5. anuric or oliguric urinary out-put under 25 mL/hour. 6. contraindication to the use of magnesium sulfate such as known hypersensitivity to the drug 7. Those with evident hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome

Primary outcomes:
measure: occurrence of convulsions
timeFrame: 48 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911911: Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy
Official title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Neo-adjuvant chemotherapy
Proteomic
Histological response
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Women aged more than 18 years
* Histologically proven breast carcinoma
* Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
* No prior chemotherapy
* Written informed consent

Exclusion Criteria:

* Metastatic disease

Primary outcomes:
measure: Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
timeFrame: 6 months
Secondary outcomes:
measure: Correlation with node invasion
timeFrame: 6 months
measure: Correlation with basal, luminal phenotypes, HER2 status or hormonal status
timeFrame: 6 months
measure: Correlation with the response measured by ultrasound after chemotherapy
timeFrame: After 3 and 5 months
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Intercommunal Hospital
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hopital Saint Vincent
city: Rouen
country: France
facility: Centre Henri Becquerel
city: THONON Les BAINS
country: France
facility: Geroges PIANTA Hospital
Study officials:
affiliation: Centre Oscar Lambret
name: BONNETERRE Jacques, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191711: Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
Official title: Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Superficial Bladder Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.


Eligibility criteria: Inclusion Criteria:

* Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk
* Urinary cytology negative for severe dysplasia (G3).
* ECOG performance status 0-1
* Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy
* Absence of other present or past neoplasias except for healed skin basalioma

Exclusion Criteria:

* Tumours with infiltrative patterns at cystoscopy
* Transitional carcinoma of the upper urinary tract and prostatic urethra.
* Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.

Primary outcomes:
measure: To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .
Secondary outcomes:
measure: To assess toxicity profile in the same group of patients.
Other outcomes:
Locations:
city: Sesto Fiorentino
country: Italy
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician
state: Florence
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References:
Clinical trial NCT01404611: Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Official title: A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Keywords: with tubes
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 331
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.


Eligibility criteria: Inclusion Criteria:

* 6 months to 12 years
* ear tube in the ear which will be treated
* otorrhea for 3 weeks or less
* moderate or severe otorrhea

Exclusion Criteria:

* other ear diseases

Primary outcomes:
measure: Time to Cessation of Otorrhea
timeFrame: From baseline until the end of the study (up to 22 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Laboratorios SALVAT S.A.
state: Barcelona
Study officials:
References:
citation: Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.