louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00908492: Supporting Caregivers of Persons With Dementia: A Pilot Study
Official title: Pilot Study of the Environmental Skill Building Program for Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Dementia
Keywords: Randomized control trial
Dementia caregivers
Occupational Therapy
Caregivers
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Alzheimer Society of Canada
First posted: 2009-05-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Caregivers of persons with dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention that helps caregivers adapt to their environment and build care-giving skills. The areas addressed include changes to the home set-up, adaptive equipment, instruction in strategies of problem-solving, energy conservation, safe task performance, and fall recovery techniques. A trial is needed with methodological rigor and to determine if the intervention is feasible in the Canadian health care system. Results will contribute to understanding how caregivers and people with dementia can be supported in their home environments.


Eligibility criteria: Inclusion Criteria:

* The caregiver must be the primary caregiver
* Caregiver reports that the care recipient has at least one limitation in basic activities of daily living (ADL) or two dependencies in instrumental activities of daily living (IADLs)
* The caregiver must:

  * provide at least 2 hours of care per day
  * be caregiving for at least 6 months and
  * be at least 21 years of age
* The care recipients need to have a diagnosis of dementia

Exclusion Criteria:

* Caregiver:

  * does not live with the care recipient
  * has poor health (undergoing treatments for cancer, hospitalized more than three times in past year)
  * planning to place care recipient in long term care within the next year
* Care recipients who are confined to bed most of the day or are minimally-responsive to touch or the environment are excluded

Primary outcomes:
measure: Revised Memory and Behavior Problem Checklist
timeFrame: 0, 6, 9 months
Secondary outcomes:
measure: Disability Assessment for Dementia
timeFrame: 0, 6, 9 months
measure: Number of caregiving assistance hours
timeFrame: 0, 6, 9 months
measure: Short Zarit Burden Interview
timeFrame: 0, 6, 9 months
measure: Task Management Strategy Index
timeFrame: 0, 6, 9 months
measure: Perceived Change Scale
timeFrame: 0, 6, 9 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Lori Letts
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060692: Changes of NLF in Serum of Long COVID Patients
Official title: Changes of NLF in Serum of Long COVID Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Syndrome
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Long-COVID-Syndrome

Brief summary: The study investigates the blood NFL levels in Long-COVID patients.

Detailed description: The study investigates the blood NFL levels in Long-COVID patients.

Eligibility criteria: Long-COVID Syndrom

Primary outcomes:
measure: Levels of NFL over a 1 year course of the Long-COVID Syndrom
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Laura de Boni
Study officials:
References:
Clinical trial NCT04437992: Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Official title: Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autosomal Aneuploidy
Keywords: aneuploidies, down syndrome, Edwards syndrome, Patau syndrome
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2020-06-18
Enrollment: 7000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.

Brief summary: The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the coordinating center (Unità Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore Hospital). The medical genetics centers, participating in the technical-scientific coordination group of assessment (resolution No. 1894, 4/11/2019), the family counseling centers and the region prenatal hospital clinics are involved as collaborative experimental centers.

Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.

As a result offering the new non-invasive NIPT test, it is estimated that the number of participants in the screening program will increase by up to 20,000/year.

The study will collect data on the women who will access the combined test in the first 9 months of the protocol and join the enrollment.


Eligibility criteria: Inclusion Criteria:

* Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
* Women able to understand the information, participate in pre-test counseling and provide informed consent.

Exclusion Criteria:

* Women under the age of 18 and/or unable to give informed consent
* pregnancies with more than two twins
* certain evidence of initial twinning, with subsequent disappearance of one of the twins (vanishing twin)
* known maternal chromosome mosaicisms present in the mother and involving the chromosomes subject to investigation
* presence of neoplasia in pregnant women
* previous allogeneic transplantation in pregnant women
* immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within the previous 3 months.

Primary outcomes:
measure: NIPT
timeFrame: 9 months
Secondary outcomes:
measure: Percentage of NIPT
timeFrame: 9 months
measure: diagnostic performance
timeFrame: 9 months
measure: Detection of Chromosomal Abnormalities
timeFrame: 9 months
measure: TAT (turnaround time)
timeFrame: 9 months
measure: Validate NIPT organizational infrastructure
timeFrame: 9 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Regione Emilia Romagna
Study officials:
References:
Clinical trial NCT02913092: Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
Official title: Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Stony Wold-Herbert Fund, Inc.
First posted: 2016-09-23
Enrollment: 81
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control

Detailed description: This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.

Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
* Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
* Use of daily controller inhaler medications
* Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
* Smartphone required
* English or Spanish speaking

Exclusion Criteria:

* No smartphone
* Use of oral corticosteroids in prior 4 weeks
* Pregnancy
* Psychiatric conditions

Primary outcomes:
measure: Asthma Control Test
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: Medication adherence
timeFrame: change from baseline to 6 months
measure: Health care utilization
timeFrame: change from baseline to 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Marina Reznik, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04378192: Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy
Official title: Assessment of the Use of Laryngeal Mask Airway as Abridge for Intubation of Morbidly Obese Patients Undergoing Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.

Detailed description: The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.

One problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube

Eligibility criteria: Inclusion Criteria:

* Morbid obese patient BMI\>40
* ASA I, II, III
* Elective sleeve gastrectomy

Exclusion Criteria:

* Oral cavity infection or pathological abnormalities
* Suspected or known abnormalities in supraglottic anatomy
* Patients planned for awake fiberoptic intubation

Primary outcomes:
measure: Time to intubation TTI
timeFrame: During the action of intubation after induction of anaesthesia
Secondary outcomes:
measure: View of the glottis
timeFrame: During the action of intubation after induction of anaesthesia
measure: Number of attempts required for intubation,
timeFrame: During the action of intubation after induction of anaesthesia
measure: Anaesthetist's satisfaction score
timeFrame: During the action of intubation after induction of anaesthesia
measure: Intubation difficulty score (IDS)
timeFrame: During the action of intubation after induction of anaesthesia
measure: Need for external pressure during intubation
timeFrame: During the action of intubation after induction of anaesthesia
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT06204692: Computer Guided Versus Freehand Dental Implant Surgery
Official title: Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: virtual planning;
computer guided implants;
freehand implant;
dental implant
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.

Detailed description: Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.

Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.

Eligibility criteria: Inclusion Criteria:

* totally edentulous in one or both arches,
* with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
* patients between the ages of 35 and 65 who could give informed permission,
* Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.

Exclusion Criteria:

* Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
* those who are receiving intravenous amino bisphosphonates,
* those who have untreated periodontitis,
* those with uncontrolled diabetes,
* pregnant women, or nursing mothers are among the general contraindications to implant surgery.

Primary outcomes:
measure: marginal bone loss
timeFrame: 6 months postoperative
Secondary outcomes:
measure: post-surgical pain and swelling
timeFrame: 7 days prior to implant placement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: nermine Ramadan Mahmoud
Study officials:
References:
Clinical trial NCT04123392: Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT
Official title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: TP53
Myeloid Tumors
Conditioning
Allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhujiang Hospital
First posted: 2019-10-10
Enrollment: 196
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Detailed description: Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for TP53+ myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* TP53+ Myeloid tumors undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 1 year
measure: disease-free survival (DFS)
timeFrame: 1 year
measure: transplant-related mortality (TRM)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235492: Salivary Glycated Albumin
Official title: Clinical Study of Salivary Glycated Albumin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
salivary glycated albumin
HbA1c
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: (1) to determine whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin (HbA1c).


Eligibility criteria: Inclusion Criteria:

* 123 individuals with type 1 or type 2 diabetes
* 53 non diabetic controls
* Age: 18 to 80
* Body mass index \>18.5kg / m2

Exclusion Criteria:

* Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.
* Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure
* Subjects unable to give voluntary informed consent

Primary outcomes:
measure: Salivary glycated albumin vs. blood glycated albumin
timeFrame: 30 min
measure: Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N Davis, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517892: A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
Official title: A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Oncogen-driven Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer.

This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study:

1. Patient affiliated to a social security regimen
2. Patients scheduled to receive anticancer agents or currently receiving anticancer agents
3. Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
4. Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
5. Availability of initial tumor material (ideally frozen, or non-Bouin fixed paraffin embedded material) acquired before exposure to the targeted therapy Note: Patients may have received other treatments since treatment with targeted therapies including radiation or chemotherapy, before undergoing the study biopsy.

Exclusion Criteria:

1. Coagulation abnormality prohibiting a biopsy

Primary outcomes:
measure: Type and frequency of molecular alterations in resistant tumors using whole exome sequencing
timeFrame: 30 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val De Marne
Study officials:
References:
citation: Martin-Romano P, Colmet-Daage L, Morel D, Baldini C, Verlingue L, Bahleda R, Gazzah A, Champiat S, Varga A, Michot JM, Ngo-Camus M, Nicotra C, Marabelle A, Soria JC, Rouleau E, Lacroix L, Hollebecque A, Massard C, Postel-Vinay S. Epigenetic gene alterations in metastatic solid tumours: results from the prospective precision medicine MOSCATO and MATCH-R trials. Eur J Cancer. 2022 Sep;173:133-145. doi: 10.1016/j.ejca.2022.06.014. Epub 2022 Jul 21.