louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06125899: Protocol for a Feasibility Cluster Randomised Controlled Trial of a Home-based Depression Care for Older People Delivered by Lay Providers in Nigeria
Official title: Intervention for Depression in Underserved Geriatric Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression in Old Age
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are:

1. Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial?
2. What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of;

   * Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG)
   * Adapted Problem-Solving Therapy (PST-PC)
   * Support/supervision of providers
   * Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years,
2. PHQ-9 score of ≥11 during routine consultation

Exclusion Criteria:

1. Severe co-morbidity requiring urgent attention.
2. Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
3. Active suicidal intention.
4. Evidence of bipolar/psychosis/severe substance use disorders.
5. Planning to move out of the study catchment area within 6 months.
6. Refusing/lacking capacity to consent/accent

Primary outcomes:
measure: Depression remission
timeFrame: At six months post trial entry
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04069299: Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
Official title: Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Carcinoma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Advanced Accelerator Applications
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Moffitt Cancer Center's GI Clinic

Brief summary: The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female ≥ 18 years old
* Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
* Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm).

Exclusion Criteria:

* Participants with well-differentiated neuroendocrine tumors
* Participants who have undergone 68Ga-dotatate PET scan in the past
* Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

Primary outcomes:
measure: Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
timeFrame: Up to 10 months
Secondary outcomes:
measure: Percentage of Participants with No Uptake to Very High Uptake on PET
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer & Research Institute
state: Florida
Study officials:
affiliation: H Lee Moffitt Cancer & Research Institute
name: Jonathan Strosberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03306199: TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
Official title: Turbo Power Laser Atherectomy Combined With Drug Coated Balloon Angioplasty for the Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-10
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the investigator's general patient population, and they must meet the inclusion/exclusion criteria.

Brief summary: A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).


Eligibility criteria: Inclusion Criteria:

* All patients treated for femoropopliteal de novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug coated balloon angioplasty

Exclusion Criteria:

* Any incomplete data on procedural approach and treatment

Primary outcomes:
measure: Number of Participants Free From Target Lesion Revascularization (TLR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
Study officials:
References:
Clinical trial NCT06567899: Mechanistic Underpinnings of Preeclampsia
Official title: Mechanistic Underpinnings of Preeclampsia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preeclampsia
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women above 18 years of age.

Brief summary: Preeclampsia is a dreadful disease with significant morbidity and mortality. Despite decades of research, we still need a proper diagnostic test or therapeutic option to treat this disorder. The proposed study will determine the diagnostic value of PBMC-secreted sFlt1 and determine the molecular mechanisms involved in its secretion. The molecular mechanisms can be novel therapeutic targets to treat this disorder.


Eligibility criteria: Healthy Adults:

• Healthy non-pregnant with previous normal pregnant women

Non-Health Adults:

• Patients will be admitted with the diagnosis of preeclampsia according to the internationally accepted definition of preeclampsia: Blood pressure measurement of 140/90 mm Hg or an increase of 30 mm Hg systolic or 15 mm Hg diastolic over baseline values on at least two occasions, six or more hours apart and proteinuria; 300 mg/24 hour after 20th week of gestation.

Pregnant Women:

Groups 3 - 6 will include pregnant women at different trimesters.

Criteria common to all groups:

* The study will be conducted only in females aged 18 or above.
* Patients in all the groups will be matched for age, which will be 18 or above.
* Women will be matched for body mass index; criteria for normal body mass index will be used based on the Center for Disease Control and Prevention Guidelines.
* Patients with premature rupture of the membrane, non-preeclamptic preterm labor, IUGR, placental abruption, twin? Any other complications during the pregnancy will be excluded from the study.
* Patients with any evidence of genetic or non-genetic malformations of the fetus will be excluded from the study.
* The study will be conducted on women who are non-smokers and do not consume alcohol or recreational drugs.
* The study will be conducted only on primigravida females to minimize phenotyping variability.
* The women with a known history of any chronic disorder, including but not limited to hypertension, diabetes, pulmonary, renal, cardiac, or cerebrovascular disorders, will be excluded from the studies.

Primary outcomes:
measure: sFLT1 levels
timeFrame: Outcome will be measured at 12 weeks, 24 weeks and 36 weeks of pregnancy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01963299: Clonidine - Ropivacaine in Peribulbar Anesthesia
Official title: Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 60
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: This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.

The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.

The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.


Eligibility criteria: Inclusion Criteria:

* patients who have given written informed consent
* any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia

Exclusion Criteria:

* persons without National Health Insurance
* pregnant or breast-feeding women, patients \< 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
* contra-indication for Loco-Regional Anesthesia
* hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
* disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
* uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP \< 90 mmHg)
* Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
* Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).

Primary outcomes:
measure: Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia
timeFrame: up to 1 hour
Secondary outcomes:
measure: Time to achieve akinesia
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References:
Clinical trial NCT00192842: Gemcitabine With Curcumin for Pancreatic Cancer
Official title: Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: carcinoma
pancreas
gemcitabine
curcumin
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.


Eligibility criteria: Inclusion Criteria:

* locally advanced or metastatic adenocarcinoma of the pancreas
* no prior chemotherapy
* performance status 0-2
* adequate hematology and chemistry

Exclusion Criteria:

* serious concurrent medical condition

Primary outcomes:
measure: time to tumor progression
Secondary outcomes:
measure: response rate
measure: survival
measure: clinical benefit
measure: toxicity
Other outcomes:
Locations:
Study officials:
name: Ron Epelbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914442: Eosinophilic Cystitis Mimicking Urothelial Neoplasia
Official title: Eosinophilic Cystitis Mimicking Urothelial Neoplasia: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Diseases
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Al-Azhar Hospital Urology outpatient and inpatient clinic during 4 years ftarting from January 2017

Brief summary: We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T

Detailed description: A pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. Transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.

Eligibility criteria: Inclusion Criteria:

* Clinically suspected urothelial neoplasia

Exclusion Criteria:

* Patients who did not complete the follow up period

Primary outcomes:
measure: Eosinophil cell count
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Abdulkarim Hasan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831242: Monitoring Key Activity and Physiology of Neonates in Intensive Care
Official title: Monitoring Key Activity and Physiology of Neonates in Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Seizure
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants in neonatal intensive care

Brief summary: To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Detailed description: To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Eligibility criteria: Inclusion Criteria:

* written informed parental consent

Exclusion Criteria:

-

Primary outcomes:
measure: Movement
timeFrame: First week of life
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
References:
Clinical trial NCT02772042: Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
Official title: Effectiveness of Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Neck Pain
Keywords: Manual Therapy
Physiotherapy
Manipulation
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. The International Federation of Orthopaedic Manipulative Physical Therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. However, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. The aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.


Eligibility criteria: Inclusion Criteria:

* Dizziness associated with neck stiffness and/or neck pain.
* Hypomobility of upper cervical spine.
* Sing the informed consent form.

Exclusion Criteria:

* Contraindications for Traction manipulation.
* Pending litigation or legal claim.
* Poor language and communication skills making difficult to understand the informed consent.

Primary outcomes:
measure: Change of baseline in Dizziness Intensity (100mm VAS) at 1 week and 1 month
timeFrame: Baseline- 1 week- 1 month
Secondary outcomes:
measure: Change of baseline in range of motion of cervical spine change (Tool: Cervical range of motion)
timeFrame: Baseline- 1 week- 1 month
measure: Change of baseline in upper cervical spine range of motion (Tool: Cervical range of motion)
timeFrame: Baseline- 1 week- 1 month
measure: Change of baseline in dizziness Handicap Inventory (questionnaire)
timeFrame: Baseline- 1 week- 1 month
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Unidad de Investgación en Fisioterapia. Universidad de Zaragoza
Study officials:
affiliation: Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
name: Andoni Carrasco, Pt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473342: Mila Blooms Intervention Study
Official title: Mila Blooms Intervention Study: An App for Promoting Physical Activity and Health Diet Among Adolescent Survivors of Childhood Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: Healthy survivorship
Smartphones
Treatment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-17
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is focused on the development and pilot/feasibility testing of a smartphone application to promote a healthy diet, increase physical activity, and prevent weight gain in adolescent survivors of childhood cancer.

Detailed description: While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL) have resulted in a growing cohort of survivors, these survivors are at risk for a number of long-term health problems. This study proposes to develop and conduct feasibility testing for a smartphone application that would deliver a health behavior intervention to this population.

A formative phase focused on intervention and software development will be followed by a pilot/feasibility test of the intervention. Participants in the intervention will receive a customized study-designed mobile phone app with a social networking component in which users will be able to support one another. They will also receive personal support from a health counselor to help set goals and discuss areas of concern.

Eligibility criteria: Inclusion Criteria:

* Participants must speak \& read/write fluent English;
* Adolescent must be between 12 and 19 years of age;
* Adolescent must have a previous diagnosis of childhood Acute Lymphoblastic Leukemia;
* Adolescent must be "off-therapy" (i.e., not in active or maintenance phase of cancer therapy) for at least 2 years;
* Adolescent must be cleared by his/her physician to participate (defined by obtaining a score of 80 or greater on the Karnofsky Scale as determined by their physician);
* Participants must have a working phone number;
* Adolescents must live at home with parents in order to facilitate parent involvement via support materials.

Exclusion Criteria:

* Physician reports that the patient has deficits in neurocognitive functioning that would preclude him/her from participating in a cognitive-oriented intervention;

Primary outcomes:
measure: Feasibility of the Mila Blooms Intervention at changing health behaviors.
timeFrame: ~9 weeks (from pre-intervention baseline to post-intervention follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Dept. of Community and Family Medicine
state: North Carolina
Study officials:
affiliation: Duke Health
name: Bernard F. Fuemmeler, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: