louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00235261: Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations
Official title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Postoperative
Keywords: Total hip replacement
Pregablin
Dexamethasone
Multimodal postoperative analgesia.
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.

Detailed description: We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for primary total hip replacement in spinal anaesthesia
* between the age of 55 and 75,
* ASA 1-3, and with
* BMI between 18 and 35.

Exclusion Criteria:

* are unable to cooperate;
* does not speak Danish;
* has allergy for drugs used in the trial;
* has drug and/or medicine abuse;
* epilepsy;
* diabetes treated with medicine;
* treatment with systemic steroids within 4 weeks prior to the operation;
* daily use of antacids;
* daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;
* known kidney disease;
* use of antidepressants

Primary outcomes:
measure: The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)
Secondary outcomes:
measure: Pain score (VAS) at rest and at mobilisation.
measure: Postoperative nausea and vomiting.
measure: Sedation.
measure: Dizziness
measure: All measurements are taken at 2,4 and 24 h postoperatively
Other outcomes:
Locations:
city: Hoersholm
country: Denmark
facility: Department of anaesthesiology; Hoersholm Sygehus
state: Frederiksborg Amt
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
name: Ole Mathiesen, MD
role: STUDY_CHAIR
affiliation: Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; Denmark
name: Lars Steen Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260361: Hypnosis and MEOPA in Regional Painful Syndrome Complex
Official title: Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Algodystrophy of Hand
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 62
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: Relation between hypnosis and MEOPA on algodystrophy.


Eligibility criteria: Inclusion Criteria:

* Regional Painful Syndrome Complex

Exclusion Criteria:

* deaf people

Primary outcomes:
measure: Pain intensity measure using visual analogical ladder (EVA)
timeFrame: 3 weeks
Secondary outcomes:
measure: QDSA ( Saint Antoine Pain Questions)
timeFrame: 3 weeks
measure: SF36 (Short Form (36) Health Survey)
timeFrame: 3 weeks
measure: HADs
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Quint Fonsegrives
country: France
facility: Croix du Sud
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Martine QUINTARD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.
Clinical trial NCT05627661: Wearable Devices to Monitor Seizures in Autoimmune Epilepsy
Official title: Managing Multiple Seizure Types With Wearable Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Epilepsy
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with or suspected of having autoimmune epilepsy.
* Normal controls - cognitively normal subjects without epilepsy

Exclusion Criteria:

• Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).

Primary outcomes:
measure: Number of high-quality physiological signals
timeFrame: 10 days
measure: Number of Reproducible changes in physiological biosignals
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Benjamin Brinkmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205361: Airway IgA: Respiratory Tract IgA Levels in Anesthetized Patients Undergoing Elective Surgical Procedures
Official title: Respiratory Tract IgA Levels in Anesthetized Patients Undergoing Elective Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Malnutrition
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing surgery with general anesthesia

Brief summary: The purpose of the study is to determine the variability of airway IgA levels in anesthetized, well-nourished and malnourished patients undergoing elective general surgical procedures and the effect of gender and race on this baseline variable. The hypothesis is that airway IgA levels are lower in malnourished than in well-nourished patients.


Eligibility criteria: Inclusion Criteria:

* Undergoing surgery via general anesthesia

Exclusion Criteria:

* Patients with a history of asthma or documented airway irritability
* Patients who have undergone previous pulmonary resection
* Patients receiving cardiac medications for arrhythmias.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Kenneth Kudsk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06087861: 5-Day Preoperative Radiation for Soft Tissue Sarcoma
Official title: Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 75
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 examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment
3. Age ≥ 18
4. KPS ≥ 70 or ECOG 0 to 2
5. Life expectancy ≥ 6 months
6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion Criteria:

1. History of prior radiation to the area to be treated.
2. Active use of other anti-cancer investigational agents.
3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
4. Pregnancy.

Primary outcomes:
measure: Post-operative Complication Rate
timeFrame: 120 days after surgery
Secondary outcomes:
measure: Local Recurrence Rate
timeFrame: 2 years and 5 years after surgical resection
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anusha Kalbasi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04358861: Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM
Official title: Healing Outcome of Nonsurgical Root Canal Treatment in Maxillary Molars With Dental Operating Microscope : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Keywords: Dental Operating Microscope
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 67
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: The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.

Detailed description: Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient and written informed consent was taken after explaining the procedure, risks and benefits. Mature maxillary first permanent molar with diagnosis of periapical periodontitis (as confirmed clinically \& by periapical radiograph) was chosen for the study. Fifty participants were randomly assigned to either the dental operating microscope group or to control group (without using dental operating microscope) for the treatment.

After administration of local anesthesia and rubber dam isolation of the involved tooth ; access cavity was prepared using carbide bur and refined using ultrasonic tip in both groups. In both the groups similar protocol for irrigation, obturation and post operative restorations was followed. Immediate post-operative radiograph was taken using preset exposure parameters and follow up clinical and radiographic examination was carried at 12th month.

Eligibility criteria: Inclusion Criteria:

* Patient willing to participate in the study
* Age \> 18 years
* Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
* Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) and a diagnosis of pulpal necrosis as confirmed by negative response to cold and electrical tests and absence of bleeding on entering the pulp chamber

Exclusion Criteria:

* Unwillingness of patient.
* Retreatment cases
* Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
* Periodontally compromised teeth
* Immunocompromised, diabetic, pregnant and hypertensive patients
* Vertical root fractures
* Teeth those are not suitable for rubber dam application

Primary outcomes:
measure: Clinical and radiographic success
timeFrame: 12 months
Secondary outcomes:
measure: Number of canals located in MB root
timeFrame: 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References:
Clinical trial NCT01940861: Cerebral Oxymetry in Traumatic Brain Injury
Official title: Cerebral Oxymetry in Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TBI

Brief summary: Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.


Eligibility criteria: Inclusion Criteria:

* Patients with acute traumatic severe brain injury requiring neuro intensive care.
* The patient admitted must be at least 18 years of age and under 60 years.
* Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.

Exclusion Criteria:

* Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.
* Patients in pharmacological studies.
* Patients with severe heart / lung / blood vessel diseases.

Primary outcomes:
measure: Dosage of vasopressor
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT05212961: COVID-19 and Rhino-orbital Mucormycosis
Official title: Clinical Profile and Outcome of Post Covid-19 Rhino-orbital Fungal Mucormycosis in Minia Governorate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucormycosis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had fungal rhino-orbital infection and positive PCR test for Covid-19. was confirmed.

Brief summary: Detect the clinical presentation and outcome of post covid-19 fungal mucormycosis in patients referred to Minia university Hospital.


Eligibility criteria: Inclusion Criteria:

1. Patients who had positive PCR test for Covid-19.
2. Fungal rhino-orbital infection was confirmed.

Exclusion Criteria:

1. Suspected patient with COVID-19 not confirmed with PCR
2. Incomplete data

Primary outcomes:
measure: Outcome of rhino-orbital mucormycosis in COVID-19 patients
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine- Minia University
Study officials:
References:
Clinical trial NCT05067361: Effectiveness of Aerobic Exercises on the Autistic Children
Official title: Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder
Physical therapy
Stereotypic behaviors
ASD
Repetitive behaviors
Aerobic exercises
Jogging
Ball exercises.
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children. A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises. Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment. Exercise was performed for 3 weeks and 4 sessions per week.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed children of autism spectrum disorder (ASD) by experts
2. Have recognized stereotypic behaviors
3. Age 6 to 20 years
4. Independent to walk
5. Both genders
6. Parent and teachers willing to give consent

Exclusion Criteria:

1. Unable to understand commands
2. Have co-morbidities like schizophrenia or ADHD
3. Having respiratory or cardiovascular problems
4. Severe ASD
5. Lower limb injury and disability

Primary outcomes:
measure: Repetitive behavior scale revised (RBS-R)
timeFrame: 3 weeks
Secondary outcomes:
measure: Jebsen Hand Function Test (JHFT)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: University of Faisalabad
state: Punjab
Study officials:
affiliation: University of Faisalabad
name: Dr Sidra Majeed;PT, MSPP
role: STUDY_DIRECTOR
References:
Clinical trial NCT03490461: Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation
Official title: Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received LT at the Severance Hospital from 2006 to 2016.

Brief summary: This study aims to investigate whether statin therapy can help prevent recurrence of hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for HCC. Multiple logistic regression analysis will be performed to evaluate the association between statin therapy and the risk of HCC recurrence after LT.


Eligibility criteria: Inclusion Criteria:

* Patients who received LT at the Severance Hospital from 2006 to 2016.

Exclusion Criteria:

* early postoperative mortality (defined as death within 2 months after LT without signs of tumor recurrence)
* patient with distant lymph node metastasis confirmed within 1 month after LT
* Patients younger than 20 years of age
* patients who had LT for cirrhosis without confirmed HCC

Primary outcomes:
measure: A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.
timeFrame: up to December, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03195361: Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Lead sponsor: Lyra Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Detailed description: The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses

Eligibility criteria: Inclusion Criteria:

1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
2. Patient age is between 50 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria:

1. Patient is pregnant or breastfeeding
2. Patient is suffering from active infection (on antibiotic therapy)
3. Patient is planning vaginal delivery
4. Patient had previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).
6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
7. Malignancy.
8. Known hypersensitivity to PEEK and/or polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Diagnosed with mental or emotional disturbance.

Primary outcomes:
measure: Improvement in POP-Q points Aa and Ba
timeFrame: 36 months
measure: Improvement in POP-Q point C:
timeFrame: 36 months
measure: No unexpected serious adverse device related events
timeFrame: 36 months
Secondary outcomes:
measure: Achieving normal urinary function:
timeFrame: 36 Months
measure: Improvement in Quality Of Life (QoL)
timeFrame: 36 Months
Other outcomes:
Locations:
city: Bnei Brak
country: Israel
facility: Mayanei HaYeshua Medical Center
city: Safed
country: Israel
facility: Ziv Medical center
city: Zrifin
country: Israel
facility: Asaf HaRofeh Medical Center
Study officials:
References: