louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01284686: Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
Official title: Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
Keywords: Pathophysiology
Parkinson
neuronal oscillations
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).

Detailed description: Methods: Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG. The resonance frequency will be calculated as previously (Eusebio et al, Brain 2009). Experiments will be carried out both in the OFF medication and ON medication condition.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease idiopathique evolving for more than 5 years
* Dopa-Sensibility superior to 50 %
* Electrodes of stimulation implanted in 2 NST at Timone (Pr PERAGUT)

Exclusion Criteria:

* Bad tolerance of the condition OFF Dopa and\\or OFF stimulation

Primary outcomes:
measure: the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD
timeFrame: 24 months
Secondary outcomes:
measure: may provide a basis for different therapeutic strategies
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: APHM
name: Jean-Philippe AZULAY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03312686: Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Official title: Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Esophagitis
Keywords: endoflip
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the clinic and endoscopy who are undergoing endoscopy with endoflip

Brief summary: This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus is associated with an improved distensibility of the esophagus. Furthermore, previous studies of the esophagus using EndoFlip only measured distensibility of the distal esophagus, specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been demonstrated to affect both upper, middle and lower esophagus. The aim is to measure distensibility both proximal and distal, before and after treatment.


Eligibility criteria: Inclusion Criteria:

1. Presence of eosinophilia on esophageal biopsy, defined as a peak count of \> 15 eosinophils per high power field (HPF) on light microscopy based on biopsies from at least 2 of the 3 biopsy segments (upper, middle and distal esophagus)

Exclusion Criteria:

1. Secondary causes of esophageal eosinophilia has been excluded, such as eosinophilic GI diseases, celiac disease, Crohn's disease, esophageal infection, hypereosinophilic syndrome, drug hypersensitivity, vasculitis, pemphigus, connective tissue diseases, graft vs. host disease
2. Age \< 18 or \> 65 years
3. Contraindication for biopsy, such as presence of esophageal varices, coagulopathy
4. History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia)
5. Pregnancy
6. Prisoners

Primary outcomes:
measure: Change in Esophageal Distensibility before and after treatment
timeFrame: 2 months
Secondary outcomes:
measure: Change in eosinophilia or the number of eosinophils
timeFrame: 2 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Akiro Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04733586: Comparison Between Single Shot Ultrasonographic Guided Fascia Iliaca Block and Quadratus Lumborum Block in Hip Arthralgia. Comparative Double Blind Study
Official title: Comparison Between Single Shot Ultrasonographic Guided Fascia Iliaca Block and Quadratus Lumborum Block in Hip Arthralgia. Comparative Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 408
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: hip arthralgia is a painful condition specially geriatric patients. Trail to alleviate pain using locoregional procedures

Detailed description: hip arthralgia is a common presentation in many conditions as rheumatoid arthritis, systemic lupus . Pain is agonizing and disabling patinet to have normal life. we are considering fascial plane block versus quadratus lumborum block to dampen pain score.

Eligibility criteria: Inclusion Criteria:

* All candidates with hip arthalgia (primary or secondery)

Exclusion Criteria:

* History of warfarin or clopidogrel adminstration .
* patient on chemotherapy
* Cognitive disrder

Primary outcomes:
measure: pain score
timeFrame: one week and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01341886: Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Thyroid Stage I
Malignant Neoplasm of Thyroid Stage II
Keywords: differentiated thyroid cancer
THS suppression
metformin
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 51
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports have shown that metformin can induce TSH suppression without change in T3 and T4 concentration. The purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.


Eligibility criteria: Inclusion Criteria:

* papillary or follicular thyroid cancer
* stage 1 or 2 according to TNM system version 6
* surgery and radioiodine treatment
* levothyroxine suppression treatment

Exclusion Criteria:

* cardiopulmonary failure
* liver failure
* renal failure
* pregnancy
* drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)

Primary outcomes:
measure: TSH
timeFrame: 3 months
Secondary outcomes:
measure: freeT3,freeT4
timeFrame: 3months
Other outcomes:
Locations:
city: Mashad
country: Iran, Islamic Republic of
facility: Mashad University of Medical Sciences
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT03893786: Robotic Rehabilitation of Upper Limb in PD
Official title: Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.

Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
* Hoehn-Yahr stage 2- 3
* MMSE score ≥ 23

Exclusion Criteria:

* Severe Dyskinesia

  * On-Off Motor fluctuations
  * History of stereotaxic brain surgery for PD;
  * Changes in dopamine therapy dose in any time within 3 months prior to baseline;
  * Any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.

Primary outcomes:
measure: UPDRS rating scale- Section III
timeFrame: 2 months
measure: Nine hole peg test
timeFrame: 2 months
Secondary outcomes:
measure: Upper Limb Fugl-Mayer
timeFrame: 2 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Neurolesi
state: Sicily
Study officials:
References:
Clinical trial NCT00349986: LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
Official title: The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale of the study is to determine:

* the first dose and the titration of basal insulin
* the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
* BMI \>25 kg/m2 , \<30 kg/m2
* HbA1c value \>7.0%, \<9.0% within one month

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Known malignancy
* Drug or alcohol abuse
* Severe liver disease
* Renal failure (se Creatinine \> 150 micro mol/l)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: HgbA1c measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: László Erős, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01519986: The Effect of Fat on Vitamin D Absorption
Official title: The Effect of Fat on Vitamin D Absorption After a Single Oral Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Cholecalciferol
Supplementation
Dietary Supplements
Dietary Fats
25-hydroxyvitamin D
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-01-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.


Eligibility criteria: Inclusion Criteria:

Residents of the hospital clinics of Porto Alegre

Exclusion Criteria:

* Don't drink milk
* Obesity
* Malnutrition
* Liver disease
* Kidney disease or diabetes
* Use of dietary supplements containing calcium and vitamin D
* Medications
* Anticonvulsants
* Barbiturates, or steroids.
* Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.

Primary outcomes:
measure: Change from baseline in serum 25(OH)D at 14 day after intervention
timeFrame: Change from baseline in serum 25(OH)D at 14 days
Secondary outcomes:
measure: Change from baseline in Parathyroid hormone at 14 days after intervention
timeFrame: Change from baseline in Parathyroid hormone at 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Tania W Furlanetto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Science of Porto Alegre
name: Gustavo AM Faulhaber, PhD
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Fabiana V Raimundo, MD
role: STUDY_CHAIR
References:
citation: Raimundo FV, Faulhaber GA, Menegatti PK, Marques Lda S, Furlanetto TW. Effect of High- versus Low-Fat Meal on Serum 25-Hydroxyvitamin D Levels after a Single Oral Dose of Vitamin D: A Single-Blind, Parallel, Randomized Trial. Int J Endocrinol. 2011;2011:809069. doi: 10.1155/2011/809069. Epub 2011 Dec 7.
citation: Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71.
Clinical trial NCT02233686: A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD
Official title: A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ario Pharma Ltd
First posted: 2014-09-08
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (COPD).

The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[VAS\]), urge to cough (via VAS), global rating of change scale, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results, ECGs or vital signs

Primary outcomes:
measure: Change from baseline at the end of each treatment period in objective daytime cough frequency
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
References:
Clinical trial NCT03223363: A New Birth Weight Prediction in Chinese Population
Official title: A New Birth Weight Prediction Based on Ultrasonography in Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Birth Weight
Keywords: Birth weight Prediction
Two-dimensional Ultrasonography
Three-dimensional Ultrasonography
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
First posted: 2017-07-21
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.

Detailed description: A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.

Exclusion Criteria:

* The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.

Primary outcomes:
measure: Estimated birth weight in g
timeFrame: 7 days within delivery
Secondary outcomes:
measure: Absolute error in g
timeFrame: After birth
measure: Percentage error in %
timeFrame: After birth
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Fang Yang
role: STUDY_CHAIR
References:
citation: Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11.
Clinical trial NCT04046263: Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Official title: Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritoneal Dialysis Complication
Hyperphosphatemia
Hypoalbuminemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7
* Use of Automated Peritoneal Dialysis
* Serum phosphate \> 5.5 mg/dL or \<5.5 mg/dL on a binder other than velphoro
* Serum albumin ≤ 3.7 g/dL
* Able to provide consent
* Ability to complete self-reported questionnaire

Exclusion Criteria:

* Inadequate dialysis
* Current use of sucroferric oxyhydroxide
* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months
* Active malignancy
* Recent episode of peritonitis
* Pregnancy or planning to become pregnant
* Anticipated kidney transplantation within 6 months
* Factors judged to limit adherence to interventions
* Known adverse side effect to sucroferric oxydroxide

Primary outcomes:
measure: Serum Phosphate at Baseline
timeFrame: Baseline
measure: Serum Phosphate at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Serum Albumin
timeFrame: Baseline, 6 months
measure: Serum FGF23
timeFrame: 6 months
measure: Serum PTH
timeFrame: Baseline, 6 months
measure: Serum Prealbumin
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Jessica Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez L, You Z, Teitelbaum I, Andrews ES, Reddin R, Ramirez-Renteria L, Wilson G, Kendrick J. A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis. BMC Nephrol. 2022 Jul 9;23(1):245. doi: 10.1186/s12882-022-02878-5.