louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04781231: Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia
Official title: Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract Surgery
Anxiety
Keywords: Cataract surgery
Anxiety
MusicCare
Music
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-04
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most patients treated for cataract surgery benefit from a short outpatient course with topical local anesthesia.

Having to undergo surgery, especially on the eye, without being asleep, can be stressful. Sometimes waiting in a waiting room with other patients can increase this stress. Patient anxiety may increase blood pressure potentially leading to the prescription of nicardipine to allow surgery to be performed. The patient's anxiety also increases the surgeon's stress, which can alter the conditions for performing the intervention and increase the risk of intraoperative complications.

Besides the administration of anxiolytics, nurses have few options for patients with anxiety. However, the treatment response time is not always appropriate and the patient's cooperation during the procedure can sometimes be impaired.

The effect of music on preoperative anxiety has been evaluated in several studies and has shown a significant decrease in anxiety before surgery.

MusicCare® is a "digital treatment" based on the principles of hypnoanalgesia which has been tested in the management of patients with various pathologies (depression, Alzheimer's disease, chronic pain, etc.) and has shown relative effectiveness. the absence of intervention on the pain and anxiety of patients.

In the context of cataract surgery with topical local anesthesia, we would like to assess the contribution of offering the MusicCare® listening device on patients' anxiety about absence


Eligibility criteria: Inclusion Criteria:

* First cataract surgery (first eye)
* Patient scheduled for short outpatient cataract surgery with topical anesthesia

Exclusion Criteria:

* Pregnant or breastfeeding woman.

Primary outcomes:
measure: Self-assessed anxiety score between the 3 groups Description
timeFrame: baseline day, before entering the operating room
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Robin BARRAUD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233831: Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement
Official title: Millimeter Wave Therapy (MWT) Versus Placebo for Analgesia and Wound Healing After Elective Total Knee Arthroplasty - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Acute Pain
Keywords: Postoperative pain
analgesia
total knee arthroplasty
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)


Eligibility criteria: Inclusion Criteria:

* patients with an American Society of Anesthesiologists physical status of II or III scheduled for elective TKA
* without previous opioid medication
* patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement
* patients who have signed consent form

Exclusion Criteria:

* pregnant or nursing females
* recidivist alcoholics
* extremely obese patients (body mass index \> 35)
* inability to operate PCA-pump.
* females with the history of unstable angina pectoris (s. Risks for participants)
* patients who are unable to understand the consent form
* systemic infection
* history of psychiatric disease
* necessity to change postoperative analgesic scheme for particular patient
* severe intercurrent disease during the course of MWT

Primary outcomes:
measure: Total amount of weak opioid drug piritramide delivered via Patient-Controlled-Analgesia pump, registered daily until the 3rd postoperative day
Secondary outcomes:
measure: Total amount of ibuprofen; pain intensity measured on VAS-100 twice a day; Insall knee function score; incidence of analgesia side-effects ; inflammation and wound healing parameters; credibility of patients' and research stuff blinding
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Study officials:
affiliation: Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
name: Hardy Edinger, Resident in Anesth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Usichenko TI, Edinger H, Witstruck T, Pavlovic D, Zach M, Lange J, Gizhko V, Wendt M, Koch B, Lehmann C. Millimetre wave therapy for pain relief after total knee arthroplasty: a randomised controlled trial. Eur J Pain. 2008 Jul;12(5):617-23. doi: 10.1016/j.ejpain.2007.10.004. Epub 2007 Nov 26.
Clinical trial NCT05728931: New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
Official title: New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paraneoplastic Neurological Syndrome
Autoimmune Encephalitis
Keywords: Paraneoplastic Neurological Syndrome
Autoimmune Encephalitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient without antibodies known with neurological disorder and include in biobank of "centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".

Brief summary: Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.


Eligibility criteria: * Inclusion Criteria \* :

  * patient with neurological disorder
  * patient without antibody
* Exclusion Criteria \* :

  * patient with characterized antibody
  * patient without neurological disorder

Primary outcomes:
measure: Description of new biomarkers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT03203031: Postoperative Pain in Neonates After Abdominal Surgery Using Quadratus Lumborum Block
Official title: Postoperative Pain in Neonates After Abdominal Surgery Using Ultrasound Guided Quadratus Lumborum Block Performed at the Beginning of the Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Keywords: pain
neonate
regional anesthesia
postoperative
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 10
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with planned abdominal surgery under general anesthesia, recruited in our neonatology unit.

Brief summary: Postoperative pain scores and analgesic requirements will be evaluated in neonates after abdominal surgery, with regional quadratus lumborum block performed at the beginning of the procedure.


Eligibility criteria: Inclusion Criteria:

* abdominal surgery under general anesthesia
* spontaneously breathing before the procedure

Exclusion Criteria:

* multiple organ failure
* mechanical ventilation before the procedure

Primary outcomes:
measure: postoperative pain score
timeFrame: At the 24th hour after surgery
measure: morphine consumption
timeFrame: At the 24th hour after surgery
measure: nalbuphine consumption
timeFrame: At the 24th hour after surgery
measure: postoperative pain score
timeFrame: At the 24th hour after surgery
Secondary outcomes:
measure: morphine consumption
timeFrame: At the 48th hour after surgery
measure: nalbuphine consumption
timeFrame: At the 48th hour after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Armand Trousseau
Study officials:
affiliation: Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
name: Isabelle Constant, MD-PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00827931: Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Esophagectomy
Colectomy
Gastrectomy
Keywords: tranexamic acid
major abdominal surgery
blood loss
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 94
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: Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

Exclusion Criteria:

* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
* Patients with known coagulopathy.
* Patients with anemia (hemoglobin levels less than 8 mg/dl)
* Patients with documented DVT or PE at screening or in past three months.
* Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

Primary outcomes:
measure: Post-operative Blood Loss
timeFrame: Post-operation, Day 1, Day 2 up to drain removal
Secondary outcomes:
measure: Intra-operative Blood Loss
timeFrame: Day 1 (End of surgery)
measure: Total Blood Loss
timeFrame: Baseline through Day 2 post-surgery
measure: Total Blood Loss as Assessed by the Gross' Formula
timeFrame: Baseline through Day 2 post-surgery
measure: Percentage of Participants Receiving Transfusions
timeFrame: Up to Day 7 post-surgery
measure: Hemoglobin Levels
timeFrame: End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery
measure: Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
timeFrame: Day 7 post-surgery
Other outcomes:
Locations:
city: Baroda
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Surat
country: India
facility: Pfizer Investigational Site
state: Gujarat
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05462431: The Effect of Web-Based Deep Relaxation Exercises in Pregnant Women
Official title: The Effect of Web-Based Deep Relaxation Exercises Applied to Pregnants on Maternal Fetal Attachment and Pregnancy Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal-Fetal Relations
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnancy is a natural but complex period in a woman's life that requires a process of adaptation to physiological, psychological and social changes. The woman first goes through a process of adaptation to pregnancy and then to motherhood. Deep Relaxation exercises, which is a low-cost and non-pharmacological method, can be effective in supporting maternal-fetal attachment and improving the perception of pregnancy. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'.

Detailed description: Pregnancy is a natural but complex period in a woman's life that requires a process of adaptation to physiological, psychological and social changes. The woman first goes through a process of adaptation to pregnancy and then to motherhood. Deep Relaxation exercises, which is a low-cost and non-pharmacological method, can be effective in supporting maternal-fetal attachment and improving the perception of pregnancy. In this study, it was aimed to determine the effect of web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'. deep relaxation excercises wiil be appliedby midwives who are experts in their fields who are certified in these fields.

Eligibility criteria: Inclusion Criteria:

* Having internet access,
* 24 weeks or more of pregnancy,
* There is no risk factor in pregnancy

Exclusion Criteria:

* Mental disabilities

Primary outcomes:
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: At the end of the 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cankırı
country: Turkey
facility: Cankiri Karatekin University Faculty of Health Sciences
state: Centre
Study officials:
References:
Clinical trial NCT03245931: Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1
Official title: Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes obstetrics patients enrolled in the HOPE program who are 18 years old or older.

Brief summary: The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Detailed description: The study will compare the effectiveness of providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Eligibility criteria: Inclusion Criteria

* The study will include patients with and without Hepatitis C diagnosis.
* Patients will be recruited at their routine prenatal and post-partum visits.
* Patients who speak and understand English

Exclusion Criteria:

* Patients under the age of the 18 years

Primary outcomes:
measure: Discovering the gaps in patients' knowledge of Hepatitis C
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Michael Marcotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756431: Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Official title: Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Hvidovre University Hospital
name: Biomet U.K. Ltd.
First posted: 2008-09-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Detailed description: Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements

Eligibility criteria: Inclusion Criteria:

* Patients with trochanteric femoral fractures

Exclusion Criteria:

Primary outcomes:
measure: Harris Hip Score
timeFrame: 3months, 6 months
Secondary outcomes:
measure: DEXA
timeFrame: 3months, 6 months
measure: RSA
timeFrame: 3months,6 months
measure: Complications
timeFrame: Anytime
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre Univ. Hospital
name: Hendrik Palm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04319731: A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Official title: A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: SARS CoV-2 Infection
Keywords: Amniotic fluid
Respiratory failure
Critical illness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18
* 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
* 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment

Exclusion Criteria:

* 1. None

Primary outcomes:
measure: Ventilator Free Days
timeFrame: Measured from hospital admission day 60 after admission.
measure: Duration of supplemental oxygen use
timeFrame: Measured from hospital admission to day 60.
Secondary outcomes:
measure: All cause mortality
timeFrame: Measured at day 60 or at hospital discharge, whichever comes first.
measure: Systemic inflammation
timeFrame: Measured at day 5 post enrollment.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Craig Selzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selzman CH, Tonna JE, Pierce J, Vargas C, Skidmore C, Lewis G, Hatton ND, Phillips JD. A pilot trial of human amniotic fluid for the treatment of COVID-19. BMC Res Notes. 2021 Jan 22;14(1):32. doi: 10.1186/s13104-021-05443-9.