louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01607580: Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)
Official title: Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 145
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.

It was found in our previous study that CD4/CD8\>=1.16、CD56bright NK\>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).

The study hypothesis:

Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD

Detailed description: patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Eligibility criteria: Inclusion Criteria:

* no severe diarrhea no serious infection

Exclusion Criteria:

* serious diarrhea active,uncontrolled infection

Primary outcomes:
measure: incidence of acute graft-versus-host disease
timeFrame: paticipants will be followed for the duration of hospital stay,an expected average of 100 days
Secondary outcomes:
measure: incidence of infection
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days
Other outcomes:
measure: engrafment
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University People's Hospital，Institute of Hematology
Study officials:
References:
citation: Chang YJ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Tang FF, Mo XD, Liu KY, Huang XJ. Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graft-versus-Host Disease and Graft-versus-Host Disease-Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial. Biol Blood Marrow Transplant. 2019 Mar;25(3):529-537. doi: 10.1016/j.bbmt.2018.11.020. Epub 2018 Nov 24.
Clinical trial NCT03333980: An Ischaemic Stroke Observational Study
Official title: A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: ReNeuron Limited
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients assessed as part of the preceding study RN-CS-0001 which forms the list of potential patients for this study.

Brief summary: A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke

Detailed description: Primary objective:

To document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study RN-CS-0001.

Other objective:

To inform the design of efficient Phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.

Eligibility criteria: Inclusion Criteria:

* Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments.
* Participation in the preceding study RN-CS-0001
* Completion of at least one of the 4 functional assessment tests (ARAT, BI, NIHSS, mRS) at any time point on the previous study RN-CS-0001
* Ability to participate in all assessments and attend all visits

Exclusion Criteria:

* Any additional incidence of stroke (Ischaemic or Haemorrhagic) since participation in the previous study RN-CS-0001 (since the last CS-0001 assessment visit date).
* Incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).

Primary outcomes:
measure: Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: New Queen Elizabeth Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital.
city: London
country: United Kingdom
facility: University College London Hospital Stroke Research Centre
city: Manchester
country: United Kingdom
facility: The University of Manchester Institute of Cardiovascular Research
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
References:
Clinical trial NCT06338280: Remotely Observed Methadone Evaluation II
Official title: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Lead sponsor: Sonara Health
Sponsor class: INDUSTRY
Collaborators: name: Chestnut Health Systems
First posted: 2024-03-29
Enrollment: 100
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: Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.


Eligibility criteria: Inclusion Criteria:

* Willing to participate in a randomized trial
* Able to complete study instruments and interviews

Exclusion criteria:

* Less than 18 years of age
* Pregnant or planning to be pregnant
* Currently involved in the criminal justice system
* Serious mental health problems
* Treated with buprenorphine

Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).

Primary outcomes:
measure: Retention
timeFrame: 24 weeks
measure: Take homes received over time
timeFrame: 24 weeks
Secondary outcomes:
measure: Opioid cravings
timeFrame: 24 weeks
measure: Urine toxicology
timeFrame: 24 weeks
measure: Opioid withdrawal severity
timeFrame: 24 weeks
measure: Health-related quality of life
timeFrame: 24 weeks
measure: Drug Abuse Treatment Costs Analysis
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: FGC Wabash
state: Illinois
Study officials:
References:
Clinical trial NCT04160780: Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
Official title: Lateral Sinus Augmentation Using L-PRF and Xenograft: Radiographic and Histomorphometry Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Diseases
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.

Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.

In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.

After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.

From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult patients.
2. Both sex, males and females.
3. Age from 24 - 49 years old.
4. All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
5. Extraction done at posterior maxilla involved with the maxillary sinus.
6. Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
7. Gingival biotype 1-2mm thickness.
8. Patient has no previous surgery in Maxillary antrum.

Exclusion Criteria:

1. Smokers.
2. Pregnant and breast-feeding females.
3. Mentally retarded Patients.
4. Presence of hematologic disease.
5. Previous radiation, chemotherapy, or immunosuppressive treatments.
6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
7. Patient with history of chronic sinus pathosis
8. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.

Primary outcomes:
measure: histomorphometric analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04539080: Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block
Official title: Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autonomic Nervous System
Nerve Block
Laparoscopy
Anesthesia and Analgesia
EEG
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: scheduled to undergo general anesthesia for laparoscopic surgery (cholecystectomy or appendectomy) at Taitung MacKay memorial hospital

Brief summary: Heart rate variability(HRV) and electroencephalography(EEG) has been used widely in anesthetic practice nowadays. One of the most dominant applications is the nociception-analgesia balance. Some evidence support that heart rate variability correlates with perioperative stimulation and postoperative pain score. There are some new evidence support EEG correlated with anesthesia depth and analgesic balance. However, the heterogeneity between the studies and interference factors has limited their usage in clinical practice. On the other hand, peripheral nerve block is broadly used as a routine technique with general anesthesia, but few studies discuss the effect on heart rate variability. Our study focuses on the different HRV and EEG patterns of incision and insufflation during laparoscopic surgery with general anesthesia. Furthermore, we measure the effect of transversus abdominis plane nerve block to heart rate variability during surgery. By this comparison, we can discuss the influences of somatic stimulation, visceral stimulation, and pneumoperitoneum to heart rate variability, and then improve the accuracy of HRV-based nociception-analgesia monitors.


Eligibility criteria: Inclusion Criteria:

* ≥20 years of age male or female
* American Society of Anesthesiologists (ASA) physical status classification I or II
* capacity to give informed consent

Exclusion Criteria:

* major cardiovascular and cerebral vascular disease, arrhythmia, respiratory disease, diabetes mellitus with evidence of neuropathy; ASA physical status classification III or greater; a documented or self-reported history of chronic pain; acute or chronic opioid analgesic use; dysautonomia; and intraoperative muscarinic anticholinergic administration during the time of monitoring.

Primary outcomes:
measure: Different heart rate variability pattern during laparoscopy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taitung
country: Taiwan
facility: Taitung MacKay memorial hospital
state: Taitung, Taiwan
Study officials:
affiliation: Taitung Mackay Memorial Hospital
name: Tzu-Chun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02699580: Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exotropia or Intermittent Exotropia
Keywords: Biodegradable collagen implant
scleral thinning
strabismus surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.


Eligibility criteria: Inclusion Criteria:

1. Patients with intermittent exotropia or constant exotropia
2. Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
3. Subjects who want to do strabismus surgery

Exclusion Criteria:

1. Subject who had previous strabismus surgery or other ocular surgery history
2. Thyroid eye disease or other connective tissue disease
3. Significant bleeding or scleral perforation during operation
4. Subjects who need to do medial rectus resection, not lateral rectus recession
5. Subjects who had a plan to do other intra or extraocular surgery within 3 months

Primary outcomes:
measure: Scleral thinning assessed with slit photography
timeFrame: Postoperative 3 months
Secondary outcomes:
measure: Ocular discharge assessed by questionnaire
timeFrame: Postoperative 1 week
measure: Tearing assessed by questionnaire
timeFrame: Postoperative 1 week
measure: Foreign body sensation assessed by questionnaire
timeFrame: Postoperative 1 week
measure: Collagen implant protrusion assessed by questionnaire
timeFrame: Postoperative 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.
Clinical trial NCT02587780: Blood Sugar Responses by Physical Activity Level and Intensity
Official title: An Observational Study of Incremental Area Under the Curve Values in Similar, Non-diabetic, Subjects- Undertaking Different Amounts and Intensities of Physical Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Small Changes
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
First posted: 2015-10-27
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals (non-diabetic or other chronic disabling conditions likely to affect blood glucose) of different habitual levels of physical activity.

Brief summary: This observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.

Detailed description: 3 groups of participants fulfilling the criteria for: sedentary (\< 30mins phys activity p/day) active (\>30 mins phys act p/day) and very active (\> 60 mins phys act p.day) will be invited to attend a laboratory session on two separate occasions separated by one week and asked to: fast overnight before having a baseline and then six further capillary (finger-prick) blood samples taken over a period of two hours following consumption of 50 grams of glucose. The blood samples will produce a standard glucose 'curve' and this will be used to calculate incremental area under the curve to identify similarities or differences between the three groups responses. Hypothetically it may be that the different levels and intensities of physical activity will affect the results with active individuals producing flatter better-controlled blood sugar responses than the inactive subjects. The Null-hypothesis would be no difference in response. it is possible, for instance, that such a low-dose of glucose in an otherwise healthy group of individuals has no discernible affect on such a curve. Physical activity will be assessed by questionnaire and interview. Anthropometric measures (height, weight and body composition) will be taken using a stadiometer and bio-electrical impedance unit (Bodystat 1500, Body Stat: Isle of man UK) at the time of the laboratory measures. No participants will have data taken of any kind before they have read a participant information sheet and signed informed consent.

Eligibility criteria: Inclusion Criteria:

* male and female.
* age:19-59
* inactive, active or very active according to criteria outlined.

Exclusion Criteria:

* Diabetics other chronic condition likely to affect blood sugar
* \<19\>59 age

Primary outcomes:
measure: Blood glucose response
timeFrame: One year
Secondary outcomes:
measure: Body mass index
timeFrame: One year
measure: Physical Activity duration
timeFrame: One year
measure: Intensity of physical activity
timeFrame: One year
measure: Body fat percentage
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05741580: Peri-urethral Bulk Agent Injection of Bulkamid®
Official title: Evolution of Symptoms After Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence
Keywords: Bulkamid®
bulk agent
peri-urethral injection
urinary incontinence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns all patients who received a first peri-uthral injection of Bulkamid® in the context of urinary incontinence between September 2020 and November 2022.

Brief summary: There are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations \[1\]. Suburethral slings are currently considered the first surgical option due to an excellent cure rate of around 90%. Nevertheless, due to a risk of prosthetic complications and numerous current controversies over the placement of synthetic tissue, other therapeutic alternatives must be offered to patients \[2\].

Peri-urethral bulk agent injections have been used since 2006 in urinary incontinence and should be integrated into the therapeutic arsenal. This is a minimally invasive technique performed under local anesthesia on an outpatient basis. The mechanism of action is explained by better coaptation of the urethra and increased resistance to urine flow during the bladder filling phase. It also increases the strength of the striated sphincter thanks to a better arrangement of muscle fibers \[3\].

According to the European Association of Urology (EAU), the use of bulk agents is recommended for the management of urinary incontinence in elderly and/or frail patients whose comorbidities contraindicate surgical management. These peri-urethral injections can also be offered to patients with incontinence due to sphincter deficiency but also to young women with stress urinary incontinence who are ready to accept a partial improvement in their incontinence \[1\]. The personal choice of the patient is currently a decisive factor for the implementation of a treatment for functional disorders and in particular for urinary incontinence.


Eligibility criteria: * Inclusion Criteria :

  * women over 18
  * patients who received a first peri-urethral injection of Bulkamid® in the context of urinary incontinence
  * intervention between September 2020 and November 2022
  * person having expressed his non-opposition
* Exclusion Criteria :

  * inability to understand the information given
  * person deprived of liberty
  * person under guardianship

Primary outcomes:
measure: Evolution of symptoms
timeFrame: at 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie, HFME, Hospices Civils de Lyon
Study officials:
References: