louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00148629: Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
Official title: Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anemia
Low Birth Weight
Neonatal Mortality
Keywords: Anemia
Birth weight
Neonatal Mortality
Tanzania
Pregnancy
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: UNICEF
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2005-09-08
Enrollment: 2500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

Detailed description: This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:

Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.

Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.

Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.

Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman

Exclusion Criteria:

* Not a permanent resident of the community

Primary outcomes:
measure: Incidence of severe anemia (Hb < 7 g/dL)
measure: Cure of severe anemia
Secondary outcomes:
measure: Infant birth weight
measure: Neonatal mortality
measure: Neonatal morbidity
measure: Blood loss during delivery
Other outcomes:
Locations:
city: Wawi
country: Tanzania
facility: Public Health Laboratory "Ivo de Carneri"
state: Zanzibar
Study officials:
affiliation: Cornell University
name: Rebecca J Stoltzfus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Johns Hopkins Bloomberg School of Public Health
name: James M Tielsch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668080: Burnout Syndrome Among Medical Residents
Official title: Burnout Syndrome Among Medical Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout Syndrome
Keywords: burnout
residents
surgical residents
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 679
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the residents attending the University of Bologna in the academic year 2017/2018

Brief summary: Whether and to what extent burnout risk is actually higher in surgical specialties than in non-surgical specialties is still unknown. Little is also known about what factors are associated with burnout between surgical residents and non-surgical residents. In this context, the present study has a three-fold aim: 1) to measure the prevalence of burnout among a sample of Italian medical residents; 2) to contrast the prevalence of burnout and psychological distress in surgical residents and non-surgical residents, and 3) to identify the work-related factors associated with burnout between surgical residents and non-surgical residents.

Detailed description: Surgical training is considered to be very stressful among residents and graduating medical students choose less often surgery for their career. To elaborate burnout prevention programs, the assessment of the prevalence of burnout during the early career stage of the surgeons and associated risk factors, becomes central.

Residents from the University of Bologna were asked to participate in an anonymous online survey. The residents completed a set of questions regarding their training schedule and three standardized questionnaires: 1) the Maslach Burnout Inventory, assessing the three dimensions of burnout: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA); 2) the Zung Self-Rating Depression scale; 3) the Psychosomatic Problems scale. High scores in either the EE or DP subscale categories predicted professional burnout.

Eligibility criteria: Inclusion Criteria:

* residents attending the University of Bologna

Exclusion Criteria:

* none

Primary outcomes:
measure: Maslach Burnout Inventory
timeFrame: 3 months
Secondary outcomes:
measure: Zung Self-Rating Depression Scale
timeFrame: 3 months
measure: Psychosomatic Problems Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: antonio d pinna, MD
role: STUDY_DIRECTOR
References:
citation: Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
citation: Serenari M, Cucchetti A, Russo PM, Fallani G, Mattarozzi K, Pinna AD, Colonnello V, Poggioli G, Cescon M. Burnout and psychological distress between surgical and non-surgical residents. Updates Surg. 2019 Jun;71(2):323-330. doi: 10.1007/s13304-019-00653-0. Epub 2019 Apr 2.
Clinical trial NCT01515280: Hull Airway Reflux Questionnaire Scores Following Cough Treatment
Official title: Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough."
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Keywords: chronic cough
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2012-01-24
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending chronic cough clinics

Brief summary: The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.


Eligibility criteria: Inclusion Criteria:

1. Male/females meeting eligibility criteria for study: - A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough.
2. Willing and able to comply with study procedures
3. Able to provide written informed consent to participate

Exclusion Criteria:

1. Any subject meeting any exclusion criteria on the study "A Multi-centre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough." Will be excluded from this study.

Primary outcomes:
measure: Hull Airway Reflux Questionnaire score
timeFrame: baseline and 2 weeks later
Secondary outcomes:
measure: HARQ SCORES
timeFrame: baseline and 14 days
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Hull and East Yorkshire Hospitals Trust
state: East Riding Of Yorkshire
Study officials:
affiliation: Hull and EastYorkshire NHS Trust
name: Alyn H Morice, MD, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morice AH, McGarvey L, Pavord ID, Higgins B, Chung KF, Birring SS. Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.
Clinical trial NCT01731080: Arterial Wall Calcium Load in Pseudoxanthoma Elasticum
Official title: Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudoxanthoma Elasticum
Type 2 Diabetes
Chronic Kidney Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pseudoxanthoma Elasticum (PXE)

Brief summary: Quantification and preferential sites of arterial wall calcification within the coronary and lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2 diabetics and Chronic Kidney disease.

Detailed description: In a previous work we have observed that patients suffering from PXE, a soft-tissue calcifying inherited autosomal disease, exhibited specific structural and functionnal features within the peripheral arteries. We now want to quantify and determine the preferential sites of the arterial wall calcification (Agatston score) between these patients compared to diabetics and patients with chronic renal insufficiency with mediacalcosis.

All variables will be collected from a cohort of PXE monitored in our PXE Health and Care centre at the university hospital of Angers. Quantification of the arterial wall calcium load will be performed using helicoidal CT-scan. These variables will be compared to the same measurements performed in type 2 diabetic and chronic kidney disease patients paired by age and gender.

Eligibility criteria: Inclusion Criteria:

* Patients with phenotypically and genotypically-proven PXE
* Type 2 diabetic patients with mediacalcosis (i.e. Ankle Brachial Index \> 1.30)
* Patients with a chronic kidney disease (CKD), before kidney transplantation
* All patients should be affiliated to a Health care system

Exclusion Criteria:

* Patient with unproved PXE
* Patient under the age of 18 yrs
* Patient unwilling to participate to the study
* Pregnant women
* Patient not affiliated to a Health care system

Primary outcomes:
measure: calcification score
timeFrame: after inclusion
Secondary outcomes:
measure: site of calcification
timeFrame: after inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
state: Pays de la Loire
Study officials:
affiliation: Department of Dermatology, University Hospital of Angers, France
name: Yannick LE CORRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06183580: Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
Official title: Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Suicide, Attempted
Suicide, Ideation
Depression
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing two different targets of treatment: either amygdala or dorsal anterior cingulate cortex neurofeedback
Primary purpose: TREATMENT

Brief summary: A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.


Eligibility criteria: Inclusion Criteria:

* Adolescents with a history of suicide attempts

Exclusion Criteria:

* Psychotic disorders.
* Primary substance use disorder.
* Primary anorexic disorder.
* Autism Spectrum Disorder.

Primary outcomes:
measure: suicide ideation
timeFrame: 1 week and 1 month following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Karina Quevedo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415280: Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
Official title: Impact of Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction During Pandemic: A Randomized Control Trails
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Stress
Keywords: psychological stress mobile phone addiction
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.

Detailed description: In the current study the data was collected from the young adults (age range 19-35 years). The high scorer from the sample selected from the participants in both control and experimental groups. furthermore, the mindfulness based stress reduction intervention was given to the experimental group. The mindfulness based stress reduction intervention comprised eight weeks period. After the provision of intervention the data for the second phase would be collected.

Eligibility criteria: Inclusion Criteria:

* The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.

Exclusion Criteria:

* Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.

Primary outcomes:
measure: COVID-19 related Stress
timeFrame: 35 minutes
measure: anxiety and depression
timeFrame: 15 minutes
Secondary outcomes:
measure: mobile phone addiction
timeFrame: 35 minutes
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Zia-Un Nisa
state: Punjab
Study officials:
affiliation: assisstant professor
name: zia-un Nisa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04259580: Calgary Registry for Advanced and Therapeutic Endoscopy
Official title: Calgary Registry for Advanced and Therapeutic Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Disease
Pancreatic Diseases
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing ERCP.

Brief summary: The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multi-centre registry. The study population consists of consecutive adult ERCP patients from September 2018 to August 2022. Informed consent is acquired for each patient. All relevant pre-procedural, procedural, peri-procedural and post-procedural data are captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes are ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. This registry also serves as a secure data collection platform for several currently recruiting prospective studies and randomized trials.


Eligibility criteria: Inclusion Criteria:

* any standard indication for ERCP, in the absence of standard contraindications;
* age 18 years or over;
* ability and willingness to give informed consent to be included in the registry and/or to involvement in one (or more) prospective sub-studies, or accompaniment by a surrogate who is willing and able to provide consent.

Exclusion Criteria:

-none other than inverses of above.

Primary outcomes:
measure: Rate of unplanned healthcare utilization
timeFrame: 30 days
Secondary outcomes:
measure: Rate of post-ERCP pancreatitis
timeFrame: 30 days
measure: Rate of post-ERCP bleeding
timeFrame: 30 days
measure: Rate of post-ERCP cholangitis or sepsis
timeFrame: 30 days
measure: Technical success rates
timeFrame: Immediate
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
citation: Mohamed R, Lethebe BC, Gonzalez-Moreno E, Kayal A, Bass S, Cole M, Turbide C, Chau M, Koury HF, Brenner DR, Hilsden RJ, Elmunzer BJ, Keswani RN, Wani S, Heitman SJ, Forbes N. Morphology of the major papilla predicts ERCP procedural outcomes and adverse events. Surg Endosc. 2021 Dec;35(12):6455-6465. doi: 10.1007/s00464-020-08136-9. Epub 2020 Nov 4.
Clinical trial NCT06063980: Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.
Official title: Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Lead sponsor: VNU University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 2
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.


Eligibility criteria: Inclusion Criteria:

* 0mm bone height at posterior maxillae region

Exclusion Criteria:

* general contraindication to implant surgery
* subjected to irradiation in the head and neck area \<1 one year before implantation
* uncontrolled diabetes
* pregnant or nursing
* substance abuse
* heavy smoker
* psychiatric therapy or unrealistic expectations
* immunosuppressed or immunocompromised
* treated or under treatment with oral or intravenous aminobisphosphonates
* untreated periodontitis
* poor oral hygiene and motivation

Primary outcomes:
measure: Bone formation recorded after two-step-sinus-augmentation.
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VNU University of Medicine and Pharmacy
Study officials:
References:
Clinical trial NCT03239080: Effect of Denosumab in Erosion Healing in RA
Official title: Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
HR-pQCT
erosion
denosumab
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 110
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: To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.

Detailed description: This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* DAS28 ≤5.1
* without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT

Exclusion Criteria:

* RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
* treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
* pregnancy or premenopausal women planning pregnancy
* previous use of denosumab, zoledronic acid or teriparatide
* Hyperparathyroidism
* contraindications to denosumab
* Bisphosphonate, biologic DMARDs and the use of oral glucocorticoid \>10 mg/day (prednisolone equivalent)

Primary outcomes:
measure: The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
timeFrame: 12 months
measure: The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
timeFrame: 24 months
Secondary outcomes:
measure: Erosion progression
timeFrame: 12 and 24 month
measure: Radiographic progression
timeFrame: 12 and 24 months
measure: Change in various patient-reported outcomes
timeFrame: 12 and 24 month
measure: Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ
timeFrame: 24 month
measure: Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT
timeFrame: 12 and 24 month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine and Therapeutics
Study officials:
affiliation: Chinese University of Hong Kong
name: Lai Shan Tam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: So H, Cheng IT, Lau SL, Chow E, Lam T, Hung VW, Li EK, Griffith JF, Lee VW, Shi L, Huang J, Kwok KY, Yim CW, Li TK, Lo V, Lee J, Lee JJ, Qin L, Tam LS. Effects of RANKL inhibition on promoting healing of bone erosion in rheumatoid arthritis using HR-pQCT: a 2-year, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2021 Aug;80(8):981-988. doi: 10.1136/annrheumdis-2021-219846. Epub 2021 Apr 2.