louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04713306: Gender Differences in Parkinsonian Patients- a Swedish Register Study
Official title: Gender Differences in Diagnostic Tools, Medication, Time to Medication and Non-motor Symptoms in Parkinsonian Patients- a Swedish Register Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: NonMotorSymptoms, medication, National Registries
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Jonkoping University
name: Karolinska Institutet
First posted: 2021-01-19
Enrollment: 1217
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Cohorts from rural areas and larger cities of Southern Sweden with diagnosed parkinsonism.

Brief summary: BACKGROUND: The complex impact of gender has been studied in different perspectives of health and disease in the literature. However, few attempts have been made to compile data from systematic disease specific registrations Swedish National Quality Registers play an important role in collecting large amounts of diagnose specific data, symptoms, and treatments. The subset Parkinson Registry has been in use for more than 20 years and are represented in all counties and hospitals where neurological care is provided in Sweden and offer optimal conditions to describe gender specific differences in the use of diagnostic tools, lead times and symptom profiles.

Detailed description: Aim: To study differences between gender in diagnostic tools, pharmacological interventions, and self-reported symptoms in Parkinson´s Disease (PD).

METHODS:

Data were extracted from the Swedish Neuro Registers, one of the Swedish National Quality Registers. A mix of urban and rural parts of the country were chosen and data were divided by gender. Self-reported first experienced PD related symptom was used to define the starting point when processing the data. Zero to three years from this point was defined as early symptoms and over three years as late symptoms.

CONCLUSION:

Differences between gender were seen in all chosen aspects, both diagnostically. Distinctions were also prominent in reported NonMotorSymptoms (NMS) profiles. These findings should be important to take into consideration for patients, professional staff, and caregivers in the daily work with gender mixed PD groups.

Eligibility criteria: Inclusion Criteria:

* Participants registered in the Swedish Neuro Registers.
* Parkinson´s Disease
* Acceptance of extraction of data

Exclusion Criteria:

* non parkinsonian patients
* Participants in the Registries who have not given allowance of extraction of data.

Primary outcomes:
measure: Differences between gender
timeFrame: 2006-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: FUTURUM
Study officials:
affiliation: Karolinska Institutet
name: Johan Lokk, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05853406: Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
Official title: Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Lead sponsor: Pole Sante Grace de Dieu
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects recruited are patients aged over 65, having balance problems.

Brief summary: The main objective of the study is to determine the Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly by a statistical method.

The first secondary objective of the study is to determine the Minimal Clinically Important Difference by the Anchor method based on a qualitative assessment by the patients of their own response. The second secondary objective is to determine the Minimal Clinically Important Difference by the Delphi method, based on the search for a consensus between physiotherapists specializing in geriatrics.

Detailed description: The French population is aging, and geriatric rehabilitation care must adapt to this growing population. The functional reach test is a common clinical test in geriatrics. It helps to determine the risk of falling. However, its metrological qualities are not all determined. The Minimal Clinically Important Difference (MCID) is in particular unknown for this test. The MCID of a test makes it possible to personalize in a way more in-depth evaluation of physiotherapy treatment. So it is necessary to characterize this essential metrological determinant of a common balance skills assessment tool.

Eligibility criteria: Inclusion Criteria:

* People over 65 years old
* People in care with balance problems

Exclusion Criteria:

* People in an emergency situation
* People unable to give their consent (including people under guardianship)
* Patients already involved in another study.

Primary outcomes:
measure: Functional Reach Test
timeFrame: 1 year
Secondary outcomes:
measure: Functional Reach Test
timeFrame: 1 year
measure: Functional Reach Test
timeFrame: 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: PSLA GDD
Study officials:
References:
citation: Rosa MV, Perracini MR, Ricci NA. Usefulness, assessment and normative data of the Functional Reach Test in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2019 Mar-Apr;81:149-170. doi: 10.1016/j.archger.2018.11.015. Epub 2018 Dec 7.
Clinical trial NCT03660306: Impact of OFA During LPV on Postoperative Oxygen Saturation
Official title: Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation on Postoperative Oxygen Saturation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decreased Lung Compliance
Oxygen Requirement
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 64
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: Major surgery requiring intubation and mechanical ventilation.

Brief summary: Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.

Detailed description: This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.

Every patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.

A lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..

If post operative satuation drops below 94% oxygen therapy is given and noted.

Eligibility criteria: Inclusion Criteria:

* major surgery where intubation with mechanical ventilation is required
* obese patients with BMI \> 35

Exclusion Criteria:

* spontaneous breathing during procedure
* allergic to any of the drugs used in both groups
* severe liver, renal, cardiac or pulmonary disease

Primary outcomes:
measure: oxygen requirement post operative to maintain saturation above 94%
timeFrame: first 24 hours post operative
Secondary outcomes:
measure: postoperative pain
timeFrame: first 24 hours post operative
measure: postoperative opioid consumption
timeFrame: first 24 hours post operative
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZ Sint-Jan AV
name: Marco Lanckneus, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01144806: Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition
Official title: Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition (SAM) Receiving Community-based Nutritional Rehabilitation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Malnutrition
Keywords: SAM
RUTF
BIA
D2O
Children with severe malnutrition
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
First posted: 2010-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project is being conducted with an aim to find out energy expenditure, body composition and recovery rates in children with severe acute malnutrition (SAM) receiving community-based nutritional rehabilitation therapy

Detailed description: Objectives

1. To assess energy expenditure and body composition by stable isotope techniques in children with Severe Acute Malnutrition
2. To evaluate the potential usefulness of body composition assessment as a predictor of outcome in children with SAM, based on stable isotope technique and multi-frequency bioelectrical impedance analysis (BIA)

Inclusion criteria

* Parents of children of age 6 months to 3 years
* Resident of study area

Exclusion criteria

* Children with congenital malformations
* Chronic debilitating illnesses
* Refusal by parents to enroll in study

Eligibility criteria: Inclusion Criteria:

* Parents of children of age 6 months to 3 years
* Resident of study area

Exclusion Criteria:

* Children with congenital malformations
* Chronic debilitating illnesses
* Refusal by parents to enroll in study

Primary outcomes:
measure: Body composition
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan Univeristy
state: Sindh
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365906: UTI Reference Standard: Delphi Method
Official title: Development of a Research Reference Standard for Urinary Tract Infection Using a Modified Delphi Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National and international experts will be invited by email to participate in the Delphi process. Since a heterogeneous expert panel is an important feature of Delphi studies, all relevant specialties will be represented in the panel, including infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care. To avoid selection bias when composing the expert panel and to create a sufficiently large panel, experts will be recruited through various platforms. Experts will be allowed to invite other experts, so called 'snowballing'.

Brief summary: This study is set up by an international core group consisting of infectious disease specialists, geriatricians, urologists, microbiologists, emergency physicians and primary care physicians to develop a consensus-based research definition of urinary tract infections. The absence of such a reference standard leads to misclassification bias and heterogeneity between studies making progress in the field of UTI difficult, for example with much needed near patient diagnostic tests.


Eligibility criteria: Inclusion criteria:

* Medical specialist working in the following fields: infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care
* Clinical and/or research experience with urinary tract infections

Exclusion criteria:

* Residency not completed yet
* Working in a different field than described above

Primary outcomes:
measure: Consensus
timeFrame: Through study completion, an average of 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
Study officials:
affiliation: Leiden University Medical Center
name: Manu Bilsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338206: Long Protocol and Growth Hormone in Poor Responders
Official title: Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: infertility
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2015-01-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.


Eligibility criteria: Inclusion Criteria:

* Poor responder females are those who posses two out of these three criteria:
* Female age ≥40 years
* Females who have at least one previous cancelled IVF cycle
* POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria:

* Females over 45 years
* Females with FSH more than 20 IU/l
* Females with previous ovarian surgery
* Females suffering from causes of infertility other than poor ovarian response
* Females refusing to be enrolled in the study

Primary outcomes:
measure: Live birth rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakhly DMR, Bassiouny YA, Bayoumi YA, Hassan MA, Gouda HM, Hassan AA. The addition of growth hormone adjuvant therapy to the long down regulation protocol in poor responders undergoing in vitro fertilization: Randomized control trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:161-165. doi: 10.1016/j.ejogrb.2018.06.035. Epub 2018 Jun 22.
Clinical trial NCT06331806: Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity
Official title: Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiomyopathy Due to Drug
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment

Detailed description: The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.

Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) \>10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.

All patients will undergo:

* at time 0

  * an echocardiogram with LVEF evaluation (biplane method)
  * a single blood sample.
* at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).

Eligibility criteria: Inclusion Criteria:

* Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.

Exclusion Criteria:

* Age \<18 years
* Contraindications to contrast medium magnetic resonance imaging

Primary outcomes:
measure: Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
timeFrame: 1 month
measure: Evaluation of blood levels of Galectin-3 (Gal-3)
timeFrame: 1 month
measure: Evaluation of Enhanced Liver Fibrosis score (ELF)
timeFrame: 1 month
measure: Evaluation of CMR imaging marker of fibrosis
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
timeFrame: 1 month
measure: Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)
timeFrame: 1 month
measure: Evaluation of levels of cytochrome C
timeFrame: 1 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Daniela Cardinale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271606: ERAS in Video-assisted Mediastinal Surgery
Official title: The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Enhanced Recovery After Surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.

Detailed description: Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.

Eligibility criteria: Inclusion Criteria:

* Patients elective mediastinal surgery;
* BMI 18-30 kg/m2.

Exclusion Criteria:

* Patient refuse;
* ASA≥3;
* Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

Primary outcomes:
measure: 15-item quality of recovery scale (QoR-15)
timeFrame: At preoperative vist
measure: 15-item quality of recovery scale (QoR-15)
timeFrame: At 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02221206: Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Official title: Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Dysgnathia
Keywords: Mini-Screw implant anchorage
retraction of maxillary incisors
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intended study is designed as a prospective randomized controlled trial (RCT), comparing and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum anchorage by retracting the maxillary incisors.

Detailed description: The objective of the clinical study proposal will be to investigate the performance of early root resorption in order to find out if the magnitude and direction of retraction is appropriate for the retraction of maxillary incisors following the mini-screw anchorage.

Therefore, the study will compare and contrast the efficacy and results of the volumetric measurement by CBCT.

Patients

Males or females whose diagnoses require implant anchorage treatment will be included in the study. Inclusion criteria for the study are as followings:

Orthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in the CBCT Good oral hygiene and normal wound healing capacity

Eligibility criteria: Inclusion Criteria:

* Orthodontic indication for skeletal anchorage
* Adequate bone quantity for a palatal implant in the CBCT
* Good oral hygiene and normal wound healing capacity

Exclusion Criteria:

* Patients with cheilognathopalatoschisis and other system syndromes associated with craniofacial anomalies
* Patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous radiation therapy or chemotherapy
* Patients with metabolic bone diseases or uncontrolled endocrine disorders
* Alcohol or drug abuse
* Pregnancy

Primary outcomes:
measure: Root resorption
timeFrame: 10 months after implant insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Orthodontics, Hospital of Stomatology, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Orthodontics, Hospital of Stomatology, Zhejiang University
name: Mengjie Wu, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References: