louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03970941: Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy After Bone Resection in Patients With Septic Pseudarthrosis
Official title: Two-stage Treatment of Large Bone Defects With Cerament® G and Cerament® V Plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy After Bone Resection in Patients With Septic Pseudarthrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudarthrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having / having had a septic pseudarthrosis manage with two stage exchange (Masquelet technique)

Brief summary: Septic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation.

A possible saving situation used by CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic.

The aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and CERAMENT® and the quality of life for this patients.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* Diagnosis of septic pseudarthrosis
* septic pseudarthrosis managed by the surgical technique using the CERAMENT bone substitute combined with an autograft / allograft by the Masquelet technique OR, for the comparative cohort: septic pseudarthrosis on long bone previously managed by the masquelet method without CERAMENT®
* Medico-surgical management within the CRIOAC ("Centre de Référence des Infections Ostéo-Articulaires Complexes") of the Croix-Rousse hospital in Lyon
* Patient who was informed and did not object to participate in the study

Exclusion Criteria:

* Patient with a disability (deafness, language disorders) or whose mental or cognitive state does not allow to be informed and to express his opposition if necessary.
* Patient with a disability (deafness, language impairment) or whose mental or cognitive state does not allow to understand the questions in the quality of life questionnaire
* Patient participating in another quality of life study

Primary outcomes:
measure: Cost evaluation
timeFrame: 24 months maximum
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT01698541: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Official title: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: Renal
Transplantation
Elderly
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2012-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

Detailed description: 12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.

Eligibility criteria: Inclusion Criteria:

* Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
* Recipients 60 years of age or older.
* Signed informed consent.

Exclusion Criteria:

* Diabetes mellitus (WHO criteria).
* Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Primary outcomes:
measure: Bioequivalence
timeFrame: 10 weeks
Secondary outcomes:
measure: Population model validation
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: University of Oslo
name: Anders Åsberg, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06414941: The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy
Official title: Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality
Keywords: Esketamine
Sleep quality
Dexmedetomidine
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 105
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy.

METHODS: One hundred and five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
* Scheduled for elective modified radical mastectomy

Exclusion Criteria:

* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Preoperative bradycardia
* Preoperative atrioventricular block
* Preoperative hypertension
* BMI\>30

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: the day after surgery
Secondary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 1 day after surgery
measure: pain visual analogue scale scores
timeFrame: The first 48 hours after operation
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References:
Clinical trial NCT00000341: Evaluation of Liquid vs. Tablet Buprenorphine - 6
Official title: Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Subjective and observer rater physiological effects of bup
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818841: The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
Official title: High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carbon Monoxide Poisoning
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to test whether oxygen therapy delivered through high-flow nasal cannula devices in patients admitted to the emergency department for acute carbon monoxide poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin (COHb) concentration and delayed neurological sequelae incidence.


Eligibility criteria: Inclusion Criteria:

* Age v 18 years
* Carbon monoxide intoxication as major problem leading to emergency department admission
* Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment

Exclusion Criteria:

* Age \< 18 years
* Glasgow coma scale ≤ 13
* Refusal to give consent

Primary outcomes:
measure: COHb reduction at 90 minutes
timeFrame: 90 minutes
Secondary outcomes:
measure: Variation in the incidence of delayed neurologic sequelae
timeFrame: 6 weeks
measure: Variation in serum lactate concentration
timeFrame: 6 weeks
measure: Variation in serum troponin concentration
timeFrame: 6 weeks
measure: Variation in S100B levels concentration
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.
Study officials:
affiliation: A.O.U. Maggiore della Carità di Novara
name: Luigi M Castello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.
citation: Jeon SB, Sohn CH, Seo DW, Oh BJ, Lim KS, Kang DW, Kim WY. Acute Brain Lesions on Magnetic Resonance Imaging and Delayed Neurological Sequelae in Carbon Monoxide Poisoning. JAMA Neurol. 2018 Apr 1;75(4):436-443. doi: 10.1001/jamaneurol.2017.4618.
citation: Rose JJ, Wang L, Xu Q, McTiernan CF, Shiva S, Tejero J, Gladwin MT. Carbon Monoxide Poisoning: Pathogenesis, Management, and Future Directions of Therapy. Am J Respir Crit Care Med. 2017 Mar 1;195(5):596-606. doi: 10.1164/rccm.201606-1275CI.
citation: Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
Clinical trial NCT06070441: Adherence to Exercises for Neck Pain.
Official title: Adherence to Home Treatment of Patients With Neck Pain Through the Use of Information and Communication Technologies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Adherence and Compliance
Keywords: Treatment adherence
New technologies
Back pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms study, experimental vs control
Primary purpose: OTHER

Brief summary: This project continuing to study on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients, in this case, with cervical musculoskeletal injuries and pain. The use of digital technologies and media is an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.


Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* Diagnosis of cervical pain.
* Indication of treatment through home exercises.
* With a personal smartphone
* Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week

Exclusion Criteria:

* No to sign the informed consent.
* Not able to understand, read and write in the Spanish language

Primary outcomes:
measure: Adherence
timeFrame: 0 weeks, 12 weeks
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 0 weeks, 12 weeks
measure: Disability
timeFrame: 0 weeks, 12 weeks
measure: Satisfaction scale with the treatment received
timeFrame: 12 weeks
measure: Sistem usability scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: David Hernández Guillén
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03227341: Pulmonary Rehabilitation in Asthma Control
Official title: Does Pulmonary Rehabilitation Contribute to Asthma Control?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma control
pulmonary rehabilitation
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.

Detailed description: Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma.

Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines

Exclusion Criteria:

* If the initial diagnosis cannot be confirmed, the patient excluded from the study
* Patients were under medical treatment of -6 months and considered clinically stable.
* Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
* Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study

Primary outcomes:
measure: Asthma control test score
timeFrame: 4 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: 6 minute
measure: Dyspnea
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
measure: Pulmonary Function Test
timeFrame: 1 hour
measure: Arterial Blood Gas
timeFrame: 1 hour
measure: Anxiety and Depression
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04059341: Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
Official title: Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Extracorporeal Shockwave Therapy
Radical Prostatectomy
Keywords: Radical Prostatectomy
Prostatectomy
Nerve-sparing
Non nerve-sparing
Erectile dysfunction
Erectile function
Shockwave
LI-ESWT
ESWT
Low intensity extracorporeal shockwave therapy
extracorporeal shockwave therapy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 70
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, single-blinded, placebo-controlled trial
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).


Eligibility criteria: Inclusion Criteria:

* Radically prostatectomised men
* Non nerve-sparing or nerve-sparing RP.
* Age 20-80 years
* Have been in a relationship for more than 3 months.
* Sexually active
* Patient can give informed consent.

Exclusion Criteria:

* Men with ED of neuropathological or psychogenic origin
* Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
* Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.

Primary outcomes:
measure: IIEF-5 Score 1
timeFrame: One month after final treatment session
measure: IIEF-5 Score 3
timeFrame: Three months after final treatment session
measure: IIEF-5 Score 6
timeFrame: Six months after final treatment session
Secondary outcomes:
measure: EDITS
timeFrame: One month after final treatment session
measure: RigiScan
timeFrame: One month after final treatment session
measure: EHS 1
timeFrame: One month after final treatment session
measure: EHS 3
timeFrame: Three months after final treatment session
measure: EHS 6
timeFrame: Six months after final treatment session
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT05326841: Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Official title: Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Cholecalciferol Supplementation
Disease Activity
Quality of Life
Keywords: lupus erythematosus systemic
cholecalciferol supplementation
Mex-SLEDAI score
Lupus QoL
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks
Primary purpose: TREATMENT

Brief summary: Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL


Eligibility criteria: Inclusion Criteria:

* Women subjects aged 18-60 years old with hypovitaminosis D

Exclusion Criteria:

* declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.

Primary outcomes:
measure: level of disease activity of participants at 12 weeks
timeFrame: level of vitamin d was measured at 12 weeks after the intervention
measure: Level of quality of life of participants at 12 weeks
timeFrame: level of quality of life was measured at 12 weeks after intervention
Secondary outcomes:
measure: the level vitamin D of participants at 12 weeks
timeFrame: Level of vitamin D was measured at 12 weeks after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rscm Divisi Alergi Imunologi
state: Dki Jakarta
Study officials:
References: