louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01923038: Evaluation of Ventilatory Strategies During Laparoscopic Surgery
Official title: Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: atelectasis
laparoscopic surgery
anesthesia
mechanical ventilation
Prevent
shape of the airway
pressure-time curve
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.


Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiology (ASA) I, II;
* age \> 18 years;
* elective surgery

Exclusion Criteria:

* ASA III, IV;
* Age \< 18 years;
* emergency surgery

Primary outcomes:
measure: Pulmonary Stress Index
timeFrame: Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks
Secondary outcomes:
measure: Cardiac Index
timeFrame: Continuous evaluation during the time of surgery
Other outcomes:
measure: Blood gases
timeFrame: Continuous evaluation during the time of surgery
Locations:
city: Turin
country: Italy
facility: Maria Vittoria Hospital
Study officials:
affiliation: Maria Vittoria Hospital
name: Emilpaolo Manno, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03540238: The Attitudes and Behaviors of Gastroenterology Specialists on Anesthesia Procedures in Endoscopy Units
Official title: A Survey Investigating the Attitudes and Behaviors of Gastroenterology Specialists on Anesthesia Procedures in Endoscopy Units in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attitude, Staff
Behavior
Anesthesia
Keywords: sedation
endoscopy
anesthesia
gastroenterologist
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active working gastrology specialist

Brief summary: Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults.

The current survey was primarily designed to provide national data on the attidutes and behaviors of gastroentorologist on anesthesia procedures in endoscopy units in Turkey.

Detailed description: Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. Despite the use of numerous sedation and analgesic techniques for GI endoscopy procedures, the best method is still controversial. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults.The current survey was primarily designed to provide national data on current sedation and monitoring practices that was carried out during gastrointestinal endoscopy. Secondary objectives were to provide data on the endoscopic application of the turkish gastroenterologist.

The questionnaire consisting of 20 questions about the anesthesia methods applied in the procedures in the endoscopy unit will be sent to 1000 gastroenterologists registered in the Turkish Gastroenterology Association by e-mail. The questionnaire is covered the demographic data, types of endoscopic procedures and anesthesia methods applied, anesthetic agents, monitoring methods, anesthesia team, preanesthetic evaluation and consent forms, recovery unit and complications and interventions during anesthesia.

Eligibility criteria: Inclusion Criteria:

* Being a Gastroenterology specialist

Exclusion Criteria:

-

Primary outcomes:
measure: gastroenterology specialists' anesthesia choices
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Ferda Yılmaz Inal
Study officials:
References:
Clinical trial NCT02116738: Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus
Official title: Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacrococcygeal Pilonidal Disease
Keywords: flap
pilonidal sinus
vas
recurrence
Lead sponsor: Ankara Mevki Military Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Detailed description: Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Pilonidal Sinus Disease
* Must be able to suitable for the surgery

Exclusion Criteria:

* Patients with Recurrent Pilonidal Sinus disease
* Patient whom is not suitable for surgery

Primary outcomes:
measure: Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Mevki Military Hospital : General Surgery Department
Study officials:
References:
citation: Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.
Clinical trial NCT05006638: Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
Official title: Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity: A Randomized Controlled Trial In Poison Control Center Of Ain Shams University Hospitals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pesticide Poisoning
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intravenous lipid emulsion is an established, effective treatment for local anesthetic systemic toxicity. It is also efficacious in animal models of severe cardiotoxicity caused by a number of other medications. Recent case reports of successful resuscitation suggest the efficacy of lipid emulsion infusion for treating non-local anesthetic overdoses across a wide spectrum of drugs. The present study will focus on the potential role of intravenous lipid emulsion as an adjuvant therapy in pesticides toxicity.


Eligibility criteria: Inclusion Criteria:

* Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH

Exclusion Criteria:

* Patients less than 18 years and more than 65 years.
* Pregnant and lactating females.
* Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
* Allergy to soya-, egg-or peanut protein

Primary outcomes:
measure: mortality rate reduction
timeFrame: 1 year
measure: organ damage reduction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Poison Control Center of Ain-Shams University hospitals
state: Abbasya
Study officials:
References:
Clinical trial NCT04164238: Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients
Official title: Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: HNSCC
PD-1 antibody
Neoadjuvant
Major pathologic response
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).


Eligibility criteria: Inclusion Criteria:

* Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck;
* Resectable or potentially resectable lesion;
* ECOG PS 0-1;
* Age \>18 years old;
* At least one target lesion according to RECIST 1.1;
* Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;

Exclusion Criteria:

* Distant metastasis;
* Second malignancy within 5 years;
* Nasopharyngeal carcinoma;
* Active autoimmune diseases;
* HIV infected;
* Required prednisone dose \>=10mg daily;
* Heart attack within 6 months;
* Stroke within 6 months;
* Other conditions that investigators consider the patients are not suitable for PD-1antibody;

Primary outcomes:
measure: MPR
timeFrame: 6 weeks
Secondary outcomes:
measure: AE
timeFrame: 2 years
measure: RFS
timeFrame: 2 years
measure: ORR
timeFrame: 6 weeks
measure: PFS
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Medical Onocology, First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Nong Xu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03009838: Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
Official title: Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.


Eligibility criteria: Inclusion Criteria:

* History of at least one year of infertility either primary or secondary.
* Body mass index: 25-35
* Normal fallopian tubes
* Normal semen analysis of the husband
* Women who will accept to participate in the study

Exclusion Criteria:

* Body mass index above 35
* Contraindication to general anesthesia
* Previous laparoscopic drilling
* Presence of other causes of infertility
* Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
* Women who intended to start a diet program
* Women who will refuse to participate in the study.

Primary outcomes:
measure: The ovulation rate
timeFrame: 3 months
Secondary outcomes:
measure: The mid-cyclic endometrial thickness
timeFrame: one day
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Clinical trial NCT00169338: Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dystonia
Keywords: Dystonia
deep brain stimulation
globus pallidus
Post-anoxic dystonia
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 13
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.

Detailed description: Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.

Eligibility criteria: Inclusion Criteria:

* Post-anoxic generalised dystonia
* Idiopathic non-generalised dystonia
* Disease duration \> 1 year

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Mini-mental status (MMS) \< 24
* Severe psychiatric disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: Hôpital Saint-Antoine
name: Marie Vidailhet, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00472238: Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Official title: Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronisation Therapy
Sudden Cardiac Death
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 30
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: A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients


Eligibility criteria: Inclusion Criteria:

* CRT Device

Exclusion Criteria:

* refused informed consent

Primary outcomes:
measure: left ventricular function
timeFrame: 3 months
measure: aerobic threshold
timeFrame: 3 months
Secondary outcomes:
measure: quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité campus Benjamin Franklin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Dirk Müller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Fernando C Dimeo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02380638: Effects of Whole-body Vibration Training on Body Composition in Adolescents With and Without Down Syndrome
Official title: Effects of Whole-body Vibration Training on Bone Mass and Bone Metabolism in Adolescents With Down Syndrome / Efectos Del Entrenamiento Vibratorio en la Masa ósea y el Metabolismo óseo de Adolescentes Con síndrome de Down
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main aims of the present project include 1) to study the longitudinal effects of whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to evaluate whether a low frequency vibratory training program consisting of 3 sessions per week for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of 1 min with 1 min rest between bouts) can improve bone development in these populations. Finally, and additional aim of the project is 3) to determine how long these effects may last after the end of the intervention.


Eligibility criteria: Inclusion Criteria:

* Both groups: Ages 10 - 19.
* Both groups: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
* Down syndrome group only: Diagnosis of Down syndrome.

Exclusion Criteria:

* Taking medication affecting bone.
* Non-caucasian.

Primary outcomes:
measure: Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.
timeFrame: Changes from baseline in body composition at 6 months and changes from baseline in body composition at 15 months
Secondary outcomes:
measure: Changes from baseline in bone structure evaluated with peripheral quantitative computed tomography at different time points, 6 months and 15 months.
timeFrame: Changes from baseline in bone structure at 6 months and changes from baseline in bone structure at 15 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: GENUD Research Group
Study officials:
affiliation: GENUD Research Group
name: José A. Casajús, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02453438: Mood Patient Powered Research Network (MoodNetwork)
Official title: Mood Patient Powered Research Network (MoodNetwork)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Bipolar Disorder
Major Depressive Disorder
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 5716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking individuals over 18 years of age who self-identify as having a mood disorder.

Brief summary: The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Valid email address
* Self-identify as having a mood disorder

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Patient Reported Outcomes Working Group Items Questionnaire
timeFrame: average of 3 years
measure: Composite International Diagnostic Interview Mania Questionnaire
timeFrame: average of 3 years
measure: Mini International Neuropsychiatric Interview Depression
timeFrame: average of 3 years
measure: Quick Inventory of Depressive Symptoms Self Report
timeFrame: average of 3 years
measure: Altman Self Rated Mania Scale
timeFrame: average of 3 years
measure: WHO-five well-being index (WHO-5)
timeFrame: average of 3 years
measure: Depression and Bipolar Support Alliance Wellness Tracker Questionnaire
timeFrame: average of 3 years
measure: Experience of Care and Health Outcomes Questionnaire
timeFrame: average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Bipolar Clinic and Research Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew A Nierenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: