louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06506435: Radiotherapy Patient Education with Virtual Reality
Official title: RADIOACTIVE - Radiotherapy Patient Education with Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to investigate the impact of virtual reality experiences on individuals undergoing radiotherapy, aiming to assess whether this immersive technology can reduce anxiety and enhance patient overall treatment satisfaction. By comparing different virtual reality techniques and a standard informational video, the study seeks to identify optimal strategies for leveraging virtual reality to improve the patient experience during radiotherapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically proven cancer
2. ≥18 years of age
3. Able to speak and read English and/or Spanish
4. Receiving radiotherapy at the University of Miami

Exclusion Criteria:

1. Prior radiation therapy
2. Pregnant or nursing women
3. Men or women of childbearing potential who are unwilling to employ adequate contraception
4. Patients unable to consent or are prisoners
5. Participants with impaired decision-making capacity
6. Any serious illness or medical condition that would compromise patient safety during virtual reality as judged by the treating physician
7. Unwilling or unable to watch virtual reality video
8. Unwilling to fill out survey forms

Primary outcomes:
measure: Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, up to 2 weeks
Secondary outcomes:
measure: Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, up to 8 weeks
measure: Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)
timeFrame: baseline, up to 1 day (after intervention)
measure: Change in Health-Related Quality of Life measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire
timeFrame: Baseline, up to 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Benjamin J Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Crystal Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492335: Cognitive Assessment of Elderly Primary Care Patients
Official title: Cognitive Assessment of Elderly Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognitive decline
Cognitive impairment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 524
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Most primary care physicians do not screen older patients for cognitive impairment. Identification of cognitive impairment may result in earlier referral for diagnostic work-up and earlier treatment and better patient outcomes. The purpose of this study is to determine whether physicians who receive the results of a cognitive screen use this information in treatment plans and whether this results in better cognitive outcomes for the older patients.

Detailed description: Current trends in healthcare suggest that in the coming decade most older patients will obtain services solely through the general practice/family practice sector of healthcare. Effective and optimal management of older patients with multiple complex medical conditions and compromised cognitive functioning will be a challenge for the primary care physician (PCP). Early identification of older patients with cognitive deficits should allow early referral for diagnostic work-up and earlier treatment and better patient outcomes. The goal of this study is to investigate the utility of providing cognitive testing in the PCP office. PCPs will be randomized to either Treatment As Usual (TAU) or Cognitive Report (CR). The study hypotheses are (1) patients of physicians in the CR group will have improved clinical outcomes i.e. cognitively impaired patients in the CR group will have a slower rate of progression of cognitive deficits over two years than cognitively impaired patients in the TAU group; (2) PCPs in the CR group will order dementia screening tests, refer to specialists and prescribe anticholinesterase inhibitors more frequently than PCPs in the TAU group.

Eligibility criteria: Inclusion Criteria:

* Age 65 or over
* Plan to remain a patient of this physician for two years
* MMSE score greater than 18

Exclusion Criteria:

* Diagnosis of Dementia, Alzheimer's disease, Huntington's disease, Vascular disease or other dementing disorder
* MMSE score of 18 or less
* Sensory deficit e.g. limited vision or hearing precluding cognitive testing

Primary outcomes:
measure: Scores on a comprehensive battery of neuropsychological tests.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Judith Saxton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459835: Media Impact on Preschool Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Prosocial Behavior
Keywords: TV
Violence
DVDs
Behavior
Preschool children
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests the hypothesis that modifying the media diet of preschool children so that they watch more prosocial programming and less violent programming will result in decreased aggression and increased prosocial behavior.


Eligibility criteria: Inclusion Criteria:

* 2.5-4 years of age
* watches TV regularly
* English speaking

Exclusion Criteria:

* no TV
* non English

Primary outcomes:
measure: Social Competence and Behavioral Evaluation (SCBE) scores overall
timeFrame: 6 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) aggression subscale
timeFrame: 6 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
timeFrame: 6 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) scores overall
timeFrame: 12 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) scores overall
timeFrame: 18 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) aggression subscale
timeFrame: 12 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) aggression subscale
timeFrame: 18 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
timeFrame: 12 months after enrollment
measure: Social Competence and Behavioral Evaluation (SCBE) prosocial subscale
timeFrame: 18 months after enrollment
Secondary outcomes:
measure: sleep problems
timeFrame: 6 months
measure: sleep problems
timeFrame: 12 months
measure: sleep problems
timeFrame: 18 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle CHildrens Research Institute
state: Washington
Study officials:
affiliation: U of WA
name: Dimitri Christakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christakis DA, Garrison MM, Herrenkohl T, Haggerty K, Rivara FP, Zhou C, Liekweg K. Modifying media content for preschool children: a randomized controlled trial. Pediatrics. 2013 Mar;131(3):431-8. doi: 10.1542/peds.2012-1493. Epub 2013 Feb 18.
citation: Garrison MM, Christakis DA. The impact of a healthy media use intervention on sleep in preschool children. Pediatrics. 2012 Sep;130(3):492-9. doi: 10.1542/peds.2011-3153. Epub 2012 Aug 6.
Clinical trial NCT06531135: A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
Official title: A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Koo Foundation Sun Yat-Sen Cancer Center
Sponsor class: OTHER
Collaborators: name: Soochow university taipei
First posted: 2024-07-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. Participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 70 years
* Newly diagnosed breast cancer patients in stages I, II, or III (with no prior history of cancer)
* Literate, without significant cognitive impairments
* Capable of writing and expressing themselves in Chinese

Exclusion Criteria:

* Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
* Currently participating in other breast cancer-related psychotherapy studies

Primary outcomes:
measure: posttraumatic growth by the PTGI
timeFrame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
measure: Distress by the HADS
timeFrame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Secondary outcomes:
measure: Positive and Negative affect
timeFrame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
measure: Perceived Stress Management Abilities
timeFrame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
measure: Quality of Life by the SF-36
timeFrame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
Study officials:
affiliation: Soochow University ITaipei)
name: Ashley Wei TIng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04952935: Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Official title: Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Congestive Heart Failure
Hypotension
Keywords: acupuncture
midodrine
fludrocortisone
randomized controlled trial
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded sham-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old
* Chronic congestive heart failure (systolic or diastolic)
* Medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed

Exclusion Criteria:

* History of acupuncture of any kind in the last 3 months
* Acute decompensated heart failure, as indicated by clinical picture at time of enrollment
* Currently on a mechanical device (LVAD, TAH, ECMO)
* History of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition
* Lack of suitable locations for which to place acupuncture seeds

Primary outcomes:
measure: Blood Pressure
timeFrame: 9 weeks
Secondary outcomes:
measure: Blood Pressure adjusted for Medication
timeFrame: 9 weeks
measure: Standing Blood Pressure adjusted for Medication
timeFrame: 9 weeks
measure: Medication Dose Change
timeFrame: 9 weeks
measure: Got off medications
timeFrame: 9 weeks
measure: NYHA Class
timeFrame: Start, 5 weeks, and 9 weeks
measure: Quality of Life Score
timeFrame: Start, 5 weeks, and 9 weeks
measure: Composite Safety Outcome
timeFrame: Throughout study, total time 9 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps La Jolla Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Shiley Integrative Center
state: California
Study officials:
affiliation: Scripps Health
name: Christopher Suhar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Health
name: Yu-Ming Ni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Health
name: Rajeev Mohan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03129035: Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
Official title: Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention

Detailed description: All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.

Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.

Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.

Eligibility criteria: Inclusion Criteria:

* women with suspected placenta accreta
* Scarred uterus
* Approving hysterectomy

Exclusion Criteria:

* Women needed conservative surgery
* women with coagulopathy or bleeding disorders

Primary outcomes:
measure: Number of participants needed blood transfusion
timeFrame: within 24 hours from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02859935: A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial
Official title: A SYNdemic BASed Co-located Linkage to Care INtervention for Men Who Have Sex With Men With High Risk Behavior: Design of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Keywords: HIV
drug abuse
MSM
Risk behavior
Sexually transmitted diseases
Sexually transmitted infections
Lead sponsor: Public Health Service of Amsterdam
Sponsor class: OTHER_GOV
First posted: 2016-08-09
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this randomized controlled intervention study at the STI outpatient clinic of Amsterdam is to answer the following questions : Does a personalised behaviour intervention comprising of targeted in-depth screening on mental health problems and drug use and, in case identified, subsequent linkage to care increase help seeking behaviour, and decrease risk behaviour in MSM who are at high risk for STIs and HIV?


Eligibility criteria: Inclusion Criteria:

* MSM
* Sufficient understanding of Dutch or English and
* 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM

Exclusion Criteria:

* Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.

Primary outcomes:
measure: Help seeking behavior
timeFrame: one year
Secondary outcomes:
measure: Risk behavior
timeFrame: one year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: STI Clinic, Public Health Service Amsterdam
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Henry de Vries, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achterbergh RCA, van Rooijen MS, van den Brink W, Boyd A, de Vries HJC. Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial. Sex Transm Infect. 2021 Feb;97(1):11-17. doi: 10.1136/sextrans-2020-054438. Epub 2020 Jul 31.
citation: Achterbergh RCA, van der Helm JJ, van den Brink W, de Vries HJC. Design of a syndemic based intervention to facilitate care for men who have sex with men with high risk behaviour: the syn.bas.in randomized controlled trial. BMC Infect Dis. 2017 Jun 6;17(1):398. doi: 10.1186/s12879-017-2474-x.
Clinical trial NCT05678335: Tacrolimus for Thrombocytopenia in SS
Official title: Tacrolimus for Mild Thrombocytopenia in Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sjogren Syndrome With Other Organ Involvement
Keywords: Sjogren's syndrome
Thrombocytopenia
Tacrolimus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 54
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: TREATMENT

Brief summary: This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.

Detailed description: This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
* Baseline platelet counts within 30-80×109/L.

Exclusion Criteria:

* Concomitant other systemic autoimmune diseases.
* Severe complications of Sjogren's syndrome.
* Abnormal laboratory tests such as: white blood cell count \<2.5x10\^9/L, hemoglobin \<80 g/L, AST/ALT \>1.5 ULN, serum creatine \> 1.5 mg/dL.
* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
* Active acute or chronic infections.
* History of malignancy.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Complete response rate
timeFrame: week 12
Secondary outcomes:
measure: Complete response rate
timeFrame: week 4 and week 8
measure: ESSDAI improvement
timeFrame: week 12
measure: ESSPRI improvement
timeFrame: week 12
Other outcomes:
measure: Immunoglobulins
timeFrame: week 12
measure: Rheumatoid Factor
timeFrame: week 12
Locations:
Study officials:
References:
Clinical trial NCT04846335: Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk
Official title: Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Familial Fatal Insomnia
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Fondazione Telethon
First posted: 2021-04-15
Enrollment: 29
Sex: ALL
Minimum age (years): 44
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The neurodegenerative disorders is a class o pathologies including very common diseases as Alzheimer or Parkinson or very rare as fatal familial insomnia (FFI), the progression of the disease with no therapeutic remedy is the common tract of these disorders. The aim of this project is to carry out a preventive treatment in subjects with genetic risk to develop FFI to avoid the establishment of the disease. FFI is a rare genetic neurodegenerative disease characterized by disrupted sleep, autonomic hyperactivation and motor abnormalities with fatal exitus. FFI is inherited in an autosomal dominant fashion and is linked to the D178N mutation in the prion protein gene (PRNP) in association with a methionine at the polymorphic codon 129 (D178N/M129). About thirty FFI pedigrees have been described worldwide, the mfirst case being reported in 1986 in northern Italy. This patient turned out to belong to large kindred, which spans 7 generations dating back to the eighteenth century. Many people belonging to this geneaology still live in the Veneto region of Italy, and they are part of an association. The genetic screening of 85 subjects belonging to this family permitted to identify the mutation carriers. Since the disease is aggressive and the affected people usually died within thirteen months from the onset, the possibility of an efficacious therapy when the disease become evident is unrealistic. This condition indicates in a preventive approach the better condition to affect the disease. Experimental studies and clinical observation indicated the antibiotic doxycycline (DOXY) as a potential candidate for a treatment in FFI subjects. The age with maximal risk to get the disease is between 50 and 55 years old. Thus the carriers that were born between 1958 and 1969 will be recruited for a preventive treatment with DOXY for ten years, at the end of this period or before we can establish if DOXY can be useful to avoid the development of FFI.


Eligibility criteria: Inclusion Criteria:

* subjects aged 44 to 53 years;
* no conditions known to be contraindications to the use of tetracyclines;
* written informed consent.

Exclusion Criteria:

* end stage liver,
* heart and renal disease,
* active malignancy,
* female subjects who are pregnant or lactating

Primary outcomes:
measure: survival
timeFrame: after 10 years of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: