louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04101266: Pain Management in Arthtroscopic Shoulder Surgery
Official title: Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Shoulder Surgery
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-24
Enrollment: 76
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: TREATMENT

Brief summary: It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery

Detailed description: In this study, the investigators planned to investigate postoperative pain, analgesic dosage, respiratory effects of the block and side effects of patients undergoing general anaesthesia after arthroscopic shoulder surgery under preoperative interscalene nerve block or suprascapular + infraclavicular nerve block.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective shoulder surgery under general anesthesia with suprascapular + infraclavicular nerve block or interscalene nerve block for any reason ASA 1-3 patients

Exclusion Criteria:

* Diabetes
* coagulopathy
* local anesthetic allergy
* chronic opioid users
* neurological deficit of the surgical limb
* obstructive or restrictive pulmoner disease
* inability to understand pain scores

Primary outcomes:
measure: postoperative pain: numeric rating scale (NRS)
timeFrame: postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour
Secondary outcomes:
measure: phrenic nerve paralysis evaluated with ultrasound
timeFrame: thirty minutes after the nerve block
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildiim Beyazit Eduation and Research Hospital
Study officials:
References:
Clinical trial NCT01453166: Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
Official title: The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2011-10-17
Enrollment: 122
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.

Detailed description: Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.

Eligibility criteria: Inclusion Criteria:

* Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
* Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
* Asymptomatic carotid artery disease;
* Body mass index\> 25 kg/m2 for adults and\> 28 kg/m2 for seniors

Exclusion Criteria:

* Neurocognitive or psychiatric condition;
* Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
* Pregnancy or breast feeding.
* Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
* Renal impairment defined as creatinine values higher than 1.5 mg/dL.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Blood Glucose
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
Study officials:
affiliation: Hospital do Coração
name: Bernardete Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber B, Galante AP, Bersch-Ferreira AC, Torreglosa CR, Carvalho VO, Victor Eda S, Espirito-Santo JA, Ross-Fernandes MB, Soares RM, Costa RP, Lara Ede S, Buehler AM, Berwanger O. Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial. Clinics (Sao Paulo). 2012 Dec;67(12):1407-14. doi: 10.6061/clinics/2012(12)10.
Clinical trial NCT01827566: Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
Official title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Celiac Gluten Sensitivity
Keywords: Celiac Disease
Gluten Sensitivity
Gluten
Double-blind challenge, placebo-controlled challenge
Gluten free flour
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.


Eligibility criteria: Inclusion Criteria:

* Adherence to gluten free diet without medical need
* Negative Celiac Disease related serology (while on gluten containing diet)
* Normal villous structure at duodenal biopsy (while on gluten containing diet)

Exclusion Criteria:

* Diagnosis of Celiac Disease
* Diagnosis of Wheat Allergy
* Diagnosis of organic gastrointestinal disease
* Severe concomitant disease

Primary outcomes:
measure: Patient's ability to correctly identify the phase with gluten
timeFrame: Time (days) 35
Secondary outcomes:
measure: Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG
timeFrame: Time (days) 0, 10, 25, 35
measure: Change in Fatigue Visual Scale
timeFrame: Time (days) 0, 10, 25, 35
measure: Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten
timeFrame: Time (days) 0,10, 25, 35
measure: Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary
timeFrame: From Time 0 (days) to 10 and from 25 to 35
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: University and Spedali Civili of Brescia, Unit of Gastroenterology
Study officials:
affiliation: University of Brescia, Unit of Gastroenterology
name: Alberto Lanzini, MD, PhD
role: STUDY_CHAIR
affiliation: University of Brescia, Unit of Gastroenterology
name: Barbara Zanini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brescia, Unit of Gastroenterology
name: Chiara Ricci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02855866: Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Official title: Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Post-operative Swallowing Disorders
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).


Eligibility criteria: Inclusion Criteria:

* Patients about to undergo total thyroidectomy by cervicotomy
* Single surgeon: Dr Osmak-Tizon Liliana
* Patients who have provided written consent to take part in the research
* Hospitalized in the endocrine surgery unit
* Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS)

Exclusion Criteria:

* Patients under 18 or adults under guardianship
* Patients about to undergo unilateral thyroid surgery (thyroid lobectomy)
* Patient who have had parathyroid surgery
* History of cervicotomy
* Intolerance to, contra-indication for or allergy to any of the treatments tested.
* Pregnant or breast-feeding women
* Patients without national health insurance cover

Primary outcomes:
measure: Swallowing Impairment Score (SIS).
timeFrame: Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03802266: Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
Official title: Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Third Military Medical University
First posted: 2019-01-14
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.

Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel


Eligibility criteria: Inclusion Criteria:

1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
2. Patients who are older than 18 year-old;
3. Patients voluntarily join the study and give written informed consent for the study.

Exclusion Criteria:

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Large blood vessels or important structures on the puncture path of peripheral lung tumors；
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Primary outcomes:
measure: Diagnostic rate
timeFrame: 18 months
Secondary outcomes:
measure: Operating time
timeFrame: 18 months
measure: Adverse events
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Hua Zhong, Phd，MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02716766: Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
Official title: Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Secondary
Keywords: Sorafenib
Drug Therapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic hepatocellular carcinoma (HCC) not suitable for surgery or various loco-regional therapies.
* Diagnosis of HCC confirmed either by cyto-histological confirmation or by non-invasive criteria according to the European Association for Study of Liver disease (EASL) criteria.
* Child-Pugh A or B7 cirrhosis.
* Eastern Co-Operative Group (ECOG) performance status ≤ 2.
* Life expectancy of ≥ 12 weeks.
* Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
* Measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (CT) or magnetic resonance imaging (MRI).
* Able and willing to meet all protocol-required treatments, investigations and visits.
* Signed written informed consent form.

Exclusion Criteria:

* Prior systemic therapy for advanced HCC.
* Central nervous system (CNS) metastasis.
* History of liver transplantation.
* Peripheral sensory neuropathy with functional impairment before the first cycle of treatment.
* History of cardiac disease.
* Uncontrolled hypertension.
* Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: Approximately 18 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Approximately 18 months
measure: Progression-free survival (PFS)
timeFrame: Approximately 18 months
measure: Overall survival (OS)
timeFrame: Approximately 33 months
measure: Frequency and severity of adverse events and laboratory abnormalities
timeFrame: Approximately 18 months
Other outcomes:
measure: Quality of life (QoL)
timeFrame: Baseline, up to approximately 18 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Thomas Yau, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03877666: Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
Official title: Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cleft Palate
Cleft Lip and Palate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with orofacial clefts undergoing surgical repair of the deformity.

Brief summary: Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.


Eligibility criteria: Inclusion Criteria:

* patients with orofacial clefts, who undergo routine cleft repair

Exclusion Criteria:

* missing datasets
* no signed consent for research.

Primary outcomes:
measure: Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured
timeFrame: One measurement before surgery, one measurement immediately after surgery
Secondary outcomes:
measure: Status of wound healing
timeFrame: at 3 month and 6 month after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: University Basel and University Hospital Basel
name: Benito K Benitez, MD DDS MHBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang MH, Lee ST, Rajendran K. Clinical implications of the velopharyngeal blood supply: a fresh cadaveric study. Plast Reconstr Surg. 1998 Sep;102(3):655-67. doi: 10.1097/00006534-199809030-00007.
citation: Mueller AA, Schumann D, Reddy RR, Schwenzer-Zimmerer K, Mueller-Gerbl M, Zeilhofer HF, Sailer HF, Reddy SG. Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair. Plast Reconstr Surg. 2012 Nov;130(5):1120-1130. doi: 10.1097/PRS.0b013e318267d4fb.
citation: Woo AS. Evidence-Based Medicine: Cleft Palate. Plast Reconstr Surg. 2017 Jan;139(1):191e-203e. doi: 10.1097/PRS.0000000000002854.
Clinical trial NCT06194266: Supporting Women Towards Risk Reduction and Management of Gynecological and Obstetric Issues
Official title: How to Support Women Already Followed Within the CSAPA Towards Risk Reduction and Management of Gynecological and Obstetric Issues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Nursing
Keywords: Nursing
Obstetric
gynecology
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adult women (≥ 18 years old) followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg

Brief summary: The health of women who use drugs is a real public health issue where the midwife has an important role to play in the multidisciplinary support of the Center for Care, Support and Prevention in Addictology (CSAPA).

The main objective is to identify the needs and expectations of the women received in terms of reducing risks and damage at the gynecological and obstetric level.


Eligibility criteria: Eligibility Criteria:

* Adult women (≥ 18 years old)
* Followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg
* Speaking and understanding French
* Agreeing to participate anonymously in this study

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Retrospective description of the needs and expectations of women in terms of gyneco-obstetric risk reduction
timeFrame: Through study completion, an average of 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Addictologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01102166: Acapella With Nebulization in Normal Subjects
Official title: Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: This study was conducted in healthy subjects
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background:

Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in bronchial hygiene.

Aims: To assess the effect of acapella® device application in the radioaerosol regional pulmonary deposition through pulmonary scintigraphy in normal subjects.

Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years participated in this study during the three phases of this research: 1st phase were done with nebulization through acapella® device, attached in the final branch according to manufacturer recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as routinely used in aerosoltherapy.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Performed spirometry
* According to the criteria of the Guidelines for Pulmonary Function-2002 published by the official organ of the Brazilian Society of Thoracic

Exclusion Criteria:

* Presence of pulmonary pathology;
* Neurological diseases and body temperature greater than 37 º C during the initial evaluation and during intervention
* Respiratory rate (RR) greater than 35ipm.

Primary outcomes:
measure: Radioaerosol regional pulmonary deposition
timeFrame: One year
Secondary outcomes:
measure: Spirometric values
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
citation: Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.
citation: Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003 Feb;48(2):124-30.
citation: Mesquita FO, Galindo-Filho VC, Neto JL, Galvao AM, Brandao SC, Fink JB, Dornelas-de-Andrade A. Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. Respir Care. 2014 Mar;59(3):328-33. doi: 10.4187/respcare.02291. Epub 2013 Aug 6.