louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04117737: A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
Official title: Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Parkinson
Virtual reality
Anti-gravity treadmill
Rehabilitation
Gait disorders
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Having Parkinson's disease diagnosed by a neurological doctor.
* Having an alteration of the gait caused by the neurological disorder.
* Being able to have an independent and voluntary walk of 10 meters as minimum.
* Height more than 150 cm.

Exclusion Criteria:

* Being blind.
* Medical contraindications for walking.
* Being amputee.
* Alcohol or drugs abuse.
* Other diseases that impedes the intervention.

Primary outcomes:
measure: Changes in gait autonomy
timeFrame: Baseline and 4-weeks
Secondary outcomes:
measure: Changes in gait speed
timeFrame: Baseline and 4-weeks
measure: Changes in balance and gait ability
timeFrame: Baseline and 4-weeks
measure: Changes in quality of life
timeFrame: Baseline and 4-weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Asociación de Parkinson de Aragón
Study officials:
affiliation: Universidad San Jorge
name: Pablo Herrero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097537: Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Official title: Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bronchial asthma
* FEV1/FVC must be 70% or more
* \<10% decrease in FEV1 in response to inhalation of normal saline

Exclusion Criteria:

* Moderate or severe airflow limitation（FEV1\<60% predicted）
* Heart attack or stroke in last 3 months
* Uncontrolled hypertension, systolic BP\>200, or diastolic BP\>100
* known aortic aneurysm

Primary outcomes:
measure: The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
timeFrame: Visit 1 (Day 1)
Secondary outcomes:
measure: The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
timeFrame: Visit 1 (Day 1)
measure: The Summary Statistics of PC20
timeFrame: Visit 1 (Day 1)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT00494637: The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contrast Induced Nephropathy
Lead sponsor: Lenox Hill Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2007-07-02
Enrollment: 468
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: Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction \<30%, overt CHF, hypokalemia and alkalemia will be excluded.


Eligibility criteria: Inclusion Criteria:

* serum creatinine greater then or equal to 1.5

Exclusion Criteria:

* EF\<30
* Overt CHF
* Alkalemia
* Hypokalemia
* GFR\<20 cc/min

Primary outcomes:
measure: Incidence of contrast induced nephropathy
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lenox Hill Hospital
name: Jordan L Rosenstock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151437: Canadian Pegvisomant Compassionate Study In Acromegalic Patients
Official title: A Multi-Center, Open-Label Study For The Compassionate Use Of Pegvisomant In Acromegalic Patients Refractory To Conventional Therapy and For Patients Who Received The Product During The Clinical Development Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.


Eligibility criteria: Inclusion Criteria:

* Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies

Exclusion Criteria:

* ALT/AST\>3 times the ULN or have hepatic disease
* have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor
* unwilling to self-administer the medication.

Primary outcomes:
measure: Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary outcomes:
measure: Pegvisomant demonstrates continued safety and efficacy
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ezzat S, Gaspo R, Serri O, Ur E, Chik CL. A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly. Clin Invest Med. 2009 Dec 1;32(6):E265. doi: 10.25011/cim.v32i6.10662.
Clinical trial NCT02156037: An RCT Evaluation of a Diabetes Dashboard Team Model in Primary Care
Official title: Case Management for Underserved Hispanic Type 2 Diabetes Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Hispanic
clinical decision support
diabetes
Hba1c
psychosocial
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 399
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: To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.

Detailed description: To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c \>7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).

Eligibility criteria: Inclusion Criteria:

* age 18 years or older,
* self-identified Hispanic ethnicity,
* diagnosis of T2D,
* HbA1c \>7.5%, and
* provider approval given for patient participation

Exclusion Criteria:

* inability to consent,
* pregnant or planning to become pregnant in the next year,
* taking glucocorticoid therapy, or
* having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes distress
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Garry Welch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welch G, Zagarins SE, Santiago-Kelly P, Rodriguez Z, Bursell SE, Rosal MC, Gabbay RA. An internet-based diabetes management platform improves team care and outcomes in an urban Latino population. Diabetes Care. 2015 Apr;38(4):561-7. doi: 10.2337/dc14-1412. Epub 2015 Jan 29.
Clinical trial NCT02310737: Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision
Official title: Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: cesarean section
facial incision
postoperative pain
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 123
Sex: FEMALE
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 compare sharp and blunt fascial entry during caesarean section.

Detailed description: The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients

1. All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus

Eligibility criteria: Inclusion Criteria:

* Woman having caesarean section for the first time
* Woman, who have had no previous lower abdominal surgery
* Woman who can give informed consent

Exclusion Criteria:

Diabetes Mellitus (This does not include gestational diabetes)

* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18 years old
* Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
* BMI over 35

Primary outcomes:
measure: postoperative pain scores change on the Visual Analog Scale (VAS)
timeFrame: 1, 3 and 7 days
Secondary outcomes:
measure: postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
timeFrame: 7 days postoperatively
measure: postoperative pain scores change on the Visual Analog Scale (VAS)
timeFrame: 1and 3 months postoperatively
measure: postoperative sensory loss change on skin incision scar
timeFrame: 1and 3 months postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatma Yazıcı Yılmaz
Study officials:
affiliation: sisli etfal training research and hospital
name: fatma yazıcı yılmaz, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951737: Evaluation Of The Effect Of SGLT-2 Inhibitors On Atrial Fibrillation Recurrence In Diabetic Patients
Official title: Evaluation Of The Effect Of SGLT-2 Inhibitors On Atrial Fibrillation Recurrence In Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Atrial Fibrillation (AF)
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with DM and AF who were planned to undergo electrical cardioversion were evaluated for suitability for the study.

Brief summary: Consecutive DCCV was performed until to achieve 120 patients in SR (60 DM patients who used SGLT-2 inhibitors and 60 DM patients who did not use SGLT-2 inhibitors). Patients defined as SGLT-2 inhibitor user group and control group. The two groups were monitored for AF recurrence on the first day, then at one, three, and six months after CV.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years and \< 90 years,
* Patient diagnosed with DM
* Patient underwent electrical cardioversion due to AF and was restored to sinus rhythm

Exclusion Criteria:

* patient who are not suitable for anticoagulant use,
* have thyroid dysfunction,
* glomerular filtration rate ≤ 25 ml/min/1.73 m²,
* patients whose sinus rhythm cannot be achieved with electrical cardioversion,
* malignancy patients,
* patients with acute or chronic inflammatory disease,
* patients with peripheral artery disease,
* patients with pacemakers,
* patients with advanced valve stenosis or insufficiency,
* patients who have had coronary bypass surgery,
* patients with percutaneous or surgical bioprosthesis or metallic valve surgery.

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Hastanesi
Study officials:
References:
Clinical trial NCT06136637: Monitoring of Glycocalyx for Prediction of Complications After Cardiac Surgery
Official title: Evaluation de l'utilité du Monitorage du Glycacalyx Pour prédire Les Complications du Patient de Chirurgie Cardiaque
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Keywords: Glycocalyx
Microcirculation
Cardiopulmonary bypass
Organ failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: University of Rouen Normandie
First posted: 2023-11-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient undergoing cardiac surgery with cardiopulmonary bypass

Brief summary: This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.


Eligibility criteria: * Patient of legal age (age ≥ 18 years)
* Patient undergoing scheduled cardiac surgery with cardiopulmoary bypass (CPB) (expected duration of CPB \> 60 min)
* Person informed with collection of non-opposition at the latest, the day before the operation - Person affiliated to a social security system

Primary outcomes:
measure: Glycocalyx thickness variation
timeFrame: Two hours after the end of cardiopulmonarybypass
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT00917137: Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy
Official title: Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule
Pulmonary Mass
Keywords: Lung cancer
Lung nodule
Transbronchial needle aspiration
Transbronchial lung biopsy
Bronchoscopy
Lead sponsor: Maggiore Bellaria Hospital, Bologna
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)

Brief summary: The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

Detailed description: In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Pulmonary nodule (\< 3 cm) or mass (\> 3 cm) at computed tomography

Exclusion Criteria:

* Refusal to sign informed consent
* Uncontrolled coagulopathy
* Pregnancy

Primary outcomes:
measure: Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the predictor variables associated with a positive TBNA result
timeFrame: 1 year
measure: Compare the performance characteristics of TBNA and transbronchial lung biopsy
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital
Study officials:
References:
Clinical trial NCT02111837: Effects of Specific Lipid Fractions-enriched Infant Formulae
Official title: Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-04-11
Enrollment: 199
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.


Eligibility criteria: Inclusion Criteria:

* Healthy newborn infant
* Infant is ≤14 days old on day of enrollment
* Gestational age ≥37 weeks (full term infants)
* Birth weight ≥2500 g and ≤4500 g
* Singleton birth
* Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria:

* Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
* Infant undergoing antibiotic therapy.
* Re-hospitalization for more than 2 days in the first 14 days of life.
* Parents not expected to comply with the protocol during the period of study participation.
* Infants currently participating in another trial

Primary outcomes:
measure: Mean weight gain (g/day)
timeFrame: Enrollment to age 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Cedex 9
city: Tours
country: France
facility: Hôpital Bretonneau - UPM
state: Cedex 9
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Palermo
country: Italy
facility: Istituto di Ostetricia e Ginecologia Neonatalogia
Study officials:
affiliation: Hôpital des enfants, CHU Pellegrin, Bordeaux, France
name: Claude Billeaud, MD
role: PRINCIPAL_INVESTIGATOR
References: