louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01234194: Composite Variability Index and Propofol Remifentanil Anesthesia
Official title: Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measure of Nociception
Keywords: Composite Variability Index
Bispectral Index
Electromyography
Nociception
Pain
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.

Detailed description: On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation \[70 mA\], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml.

After measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgical procedure in general anesthesia

Exclusion Criteria:

* Pregnancy, drug abuse, cardiac arrhythmia, obesity

Primary outcomes:
measure: Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
affiliation: University of Bonn
name: Richard K Ellerkmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03435094: Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
Official title: A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Labatec Pharma SA
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.

Brief summary: Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women (at least 5 years after natural / surgical menopause).
* Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
* Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
* Ability to sign an informed patient consent

Exclusion Criteria:

* Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
* Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
* Metabolic or cancer bone disease
* Contra-indications to bisphosphonates according to product labelling
* Known or suspected allergy to study product(s) or related products
* Inability to sign an informed consent
* Previous participation in this study

Primary outcomes:
measure: s-CTX
timeFrame: Change at 6 months, 12 months, 18 months after treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Endokrinologische Praxis & Labor
state: BS
city: Genève
country: Switzerland
facility: Hôpital Universitaire de Genève, Service des maladies osseuses
state: GE
Study officials:
affiliation: Labatec Pharma SA
name: Aurélie TIREFORD, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235194: Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
Official title: Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Prediabetes
Lead sponsor: Stoffwechselzentrum Rhein - Pfalz
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.


Eligibility criteria: Inclusion Criteria:

* Early Type 2 Diabetes (i.e. on Metformin or diet only)
* Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
* HbA1c \< 7%
* BMI 28,0-39,9 kg/m²

Exclusion Criteria

* Any antidiabetic medication other than metformin
* Psychiatric Disease
* Acute Infections
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
* Any macrovascular event within previous 3 months
* Chronic kidney disease \> Stage 3
* Pregnancy or Lactation

Primary outcomes:
measure: Area under the curve for Glucose
timeFrame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Secondary outcomes:
measure: AUC for insulin
timeFrame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
measure: Markers of inflammation
timeFrame: at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
measure: markers of lipid metabolism
timeFrame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
measure: Gut peptide hormones
timeFrame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Stoffwechselzentrum Rhein Pfalz
Study officials:
References:
Clinical trial NCT00291694: Protocol for Women at Increased Risk of Developing Breast Cancer
Official title: A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast atypia
double-blind randomized clinical trial
RCT
celecoxib
COX-2 inhibitor
placebo
high risk for breast cancer
breast epithelial hyperplasia
ki-67
chemoprevention
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2006-02-14
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Detailed description: A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Eligibility criteria: Inclusion Criteria:

* women who have a high risk of breast cancer
* older than 18 years

Exclusion Criteria:

* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth

Primary outcomes:
measure: Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Mammographic Breast Density
timeFrame: Baseline and 12 months
measure: Serum Estradiol Concentration
timeFrame: Baseline to 12 months
measure: Serum Sex Hormone Binding Globulin (SHBG) Concentration
timeFrame: Baseline to 12 months
measure: Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02145494: The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
Official title: Stereotactic Prostate Augmented Radiotherapy With Cyberknife
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: SBRT (stereotactic body radiotherapy)
Focal boost
Prostate
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

Detailed description: Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.

Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))

Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)

Inclusion criteria

* Prostate cancer patients with any of the following:
* PSA\>20
* Gleason grade 4+3 or higher
* Stage T3a
* Exclusion criteria
* Nodal or metastatic disease
* PSA\>40
* Stage T3b or higher

Study interventions

This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

Eligibility criteria: Inclusion Criteria:

Prostate cancer patients with any of the following:

* PSA 20-40
* Gleason grade 4+3 or higher
* Stage T3a

Exclusion Criteria:

* Nodal or metastatic disease
* PSA\>40
* Stage T3b or higher

Primary outcomes:
measure: Acute genitourinary(GU) toxicity
timeFrame: Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)
Secondary outcomes:
measure: Acute gastrointestinal (GI) toxicity
timeFrame: Within 12 weeks of treatment completion
measure: Late GI and GU toxicity
timeFrame: From 12 weeks until study completion
measure: Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D
timeFrame: Baseline, 12 weeks, 12 months and 6 monthly to 5 years
measure: Biochemical relapse-free survival
timeFrame: Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation trust
Study officials:
References:
Clinical trial NCT00767494: Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: OAG
OH
Open-angle glaucoma or ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 YOA or older
* Either gender or any race
* OAG or OHT
* Currently on stable (at least 4 weeks) IOP lowering medication
* IOP at screening visit â‰¥ 18mmHg in at least one eye
* Mean IOP in same eye (at both eligibility 1\&2 visits
* 24 and 36 mmHg at 9AM
* 21 and 36 mmHg at 11AM and 4PM
* Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1

Exclusion Criteria:

Related to disease condition being investigated (OAG or OHT) in either eye

* Severe central visual field loss
* Angle shaffer grade \< 2
* C/D ratio \>0.8(horizontal or vertical measurement)

Related to ocular patient history or current ocular condition in either eye

* BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
* Ocular infection or inflammation or laser surgery within the last 3 months
* Intraocular surgery or trauma with the last 6 months
* Any abnormality preventing reliable applanation tonometry
* History or chronic, recurrently or current severe inflammatory disease
* History of or current clinically significant or progressive retinal disease
* History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study

Related to systemic or ocular medication in either eye

* Allergy/hypersensitivity to study medications
* Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
* Use of oral CAIs during the study
* Recent use (\<4 weeks prior to the study) of Aspirin (\>1 gram)
* Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
* Therapy with another investigational agent within 30 days prior to the Screening Visit

Primary outcomes:
measure: Mean IOP
timeFrame: 9, 11, and 16:00 time points at Week 12
Secondary outcomes:
measure: Mean diurnal IOP at Week 12
timeFrame: results pooled across 9,11, and 16:00 time points
Other outcomes:
Locations:
city: Brussels
country: Belgium
Study officials:
References:
Clinical trial NCT01157494: Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms
Official title: Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Cerebral Palsy
Keywords: cerebral palsy
hemiplegia
upper limb
assessment
classification system
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
First posted: 2010-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively studied children with hemiplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy).

Brief summary: In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.

The investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.

The aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.


Eligibility criteria: Inclusion criteria:

* clinical and instrumental (TC or RMN) diagnosis of child hemiplegia
* age \> 5 years

Exclusion criteria:

* acquired hemiplegia at the age \> 3 years
* anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings
* severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
* pharmaco-resistant epilepsy
* behavioural disorders

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: the 2 assessment has to be registered within 6 months
Secondary outcomes:
measure: Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)
timeFrame: the 2 assessment has to be registered within 6 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Hospital Azienda Santa Maria Nuova in Reggio Emilia
state: RE
Study officials:
affiliation: University of Modena and Reggio Emilia and Hospital Santa Maria Nuova
name: Adriano Ferrari, MD
role: STUDY_CHAIR
affiliation: Azienda USL Reggio Emilia
name: Giulia Borelli, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690894: Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery
Official title: Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block

Detailed description: on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done

Eligibility criteria: Inclusion Criteria:

* pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia

Exclusion Criteria:

* parent refusal
* spinal and meningeal anomalies
* mental retardation
* blood disease
* infection at site of injection
* drug allergy

Primary outcomes:
measure: number of patients need rescue analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: First analgesic request
timeFrame: 24 hours
measure: Hemodynamic changes in the study period
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: professor
name: Ibrahim Talaat, MD
role: STUDY_DIRECTOR
References:
citation: Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.