louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06208137: Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.
Official title: Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transplant-Related Disorder
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 456
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.

Detailed description: This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.

Eligibility criteria: Inclusion Criteria:

* 1) Patients must be ≥ 16 years of age;
* 2) Patients receiving haploidentical allo-HSCT;
* 3) Patients have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

* 1) Tandem transplantation or multiple transplantations;
* 2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
* 3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

Primary outcomes:
measure: Survival
timeFrame: 1.5 years after transplantation
Secondary outcomes:
measure: Non-relapse mortality rate
timeFrame: 1.5 years after transplantation
measure: Incidence of infections
timeFrame: 1.5 years after transplantation
measure: Immune cell count
timeFrame: 1.5 years after transplantation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03046537: Detection of PCOS by Sensors Array
Official title: Detection of PCOS and Ovulation Timing by NA-Nose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic State, Breath Analysis, NA-Nose
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ovulatory women will be compared to women who do not ovulate regularly (PCOS)
Primary purpose: DIAGNOSTIC

Brief summary: Detection of metabolic state of women with polycystic ovary using NA-Nose.

Detailed description: Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state. The detection will be made using sensors arrays and GCMS.

Eligibility criteria: Inclusion Criteria:women undergoing follow up for ovulation detection. -

Exclusion Criteria:Pregnancy

-

Primary outcomes:
measure: Detection of different metabolic state between groups.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00705237: Study of the Use of LUMA Lightwire
Official title: LUMA Lightwire Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sinusitis
Keywords: sinusitis
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.

Detailed description: 50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. This will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. Routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. The ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.

Eligibility criteria: Inclusion Criteria:

* patients needing endoscopic sinus surgery
* initial or previous sinus surgery subject will be included

Exclusion Criteria:

Primary outcomes:
measure: Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
timeFrame: at conclusion of subject enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic Medical Center
name: Peter J Catalano, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395837: Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging.
Official title: Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Aging
Wellness
Aerobic exercise
Prevention
Lead sponsor: St. Anthony's Health Care
Sponsor class: OTHER
First posted: 2006-11-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the impact of lifestylel changes upon measures of wellness and aging, in particular weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic exercise would improve mental performance and measures of fitness.

Detailed description: A 10-week, randomized control study conducted in a wellness center in St. Petersburg, Florida. Adults age 21-65, exercising less than 3 days/week. 56 subjects were randomized to a control or an intervention group. Subjects followed a diet with \>30 grams of fiber and \<16 grams of saturated fat daily, and were taught to reach 70-85% of their maximum heart rate 5-6 days/week, and to perform strength training 3 days/week, plus were asked to participate in 10-20 minutes of stress management activities daily. The study was designed to determine body composition, maximal aerobic capacity (VO2 max), total cholesterol/high-density lipoprotein (TC/HDL), and cognition.

Specific aspects ofcognitive performance were noted to increase with increasing levels of aerobic activity, but not with strength training, dietary fiber change, or stress managment.

Having established that the treatment group would exercise at different levels of intensity, additional subjects were recruited, and the cognitive performance of no exercise, moderate aerobic exercise, and frequent aerobic exercise could be compared with specific domains of cognitive performance: memory, psychomotor speed, reaction time, attention, and cognitive flexibility. The St Anthony's Institutional Review Board approved this research project.

Eligibility criteria: Inclusion Criteria:

* able to exercise 5-6 days per week

Exclusion Criteria:

* Free of major medical conditions, unable to exercise aerobically 5-6 days per week

Primary outcomes:
measure: Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)
Secondary outcomes:
measure: Cholesterol profile
measure: Weight change
measure: Body fat change
measure: Changes in fitness (strength, flexibility, VO2max)
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: Carillon Wellness Center
state: Florida
Study officials:
affiliation: Medical Director
name: Steven C Masley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01577537: A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Official title: A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Keywords: SPL7013
VivaGel
bacterial vaginosis
BV
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 251
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).


Eligibility criteria: Key eligibility criteria:

* Post-menarchal females, aged 12 years or more
* Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
* Nugent score of at least 4
* Otherwise healthy, as determined by medical history, physical examination
* normal Pap smear at or documented within 24 months of screening

Primary outcomes:
measure: Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
timeFrame: Day 9-12
Secondary outcomes:
measure: Number of Women With Nugent Cure at the EOT Visit
timeFrame: Day 9-12
measure: Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
timeFrame: Day 21-30
measure: Number of Women With Nugent Cure at the TOC Visit
timeFrame: Day 21-30
measure: Adverse Events Potentially Related to Treatment
timeFrame: Screening/baseline through TOC visit, Day 1-30
Other outcomes:
Locations:
Study officials:
affiliation: Starpharma Pty Ltd
name: Jeremy Paull, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06954337: MATCH-UP: MAking Telehealth-Delivery of Cancer Care at Home Effective and Safe-Upscaled: A Pragmatic Cluster Randomized Trial
Official title: MATCH-UP: MAking Telehealth-Delivery of Cancer Care at Home Effective and Safe-Upscaled: A Pragmatic Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Keywords: Telehealth
Cancer Care at Home
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 1750
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: Many people with cancer spend a lot of time and money traveling to and from the doctor's office for cancer care. MSK's goal is to make getting cancer care easier by cutting down the need to make in-person visits to MSK. MSK is trying to do this through a new option called enhanced telehealth.


Eligibility criteria: Inclusion Criteria:

* Patients with breast or prostate cancer at Memorial Sloan Kettering Cancer Center who have had at least 3 prior medical oncology visits.

Exclusion Criteria:

* Patient is enrolled on a therapeutic clinical trial.
* Patients whose primary language is not currently supported by Epic.

Primary outcomes:
measure: Proportion of the enhanced telehealth practice pattern (ET) to usual practice patterns
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Erin Bange, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04138537: Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Official title: Olfactory Function and Olfactory Bulb Volume in Acromegaly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Olfactory Disorder
Keywords: Acromegaly
Olfaction
Olfactory disorder
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A prospective, controlled, single blinded study was planned. 20 patients with Acromegaly (Acromegaly Group) and 20 healthy subjects (Control Group) were planned to include in the study. Connecticut Chemosensory Clinical Research Center (CCCRC) test was applied to evaluate olfactory functions. Olfactory bulb(OB) volumes were measured with a 1.5 T General Electric Signa Excite MRI scanner.

Detailed description: Acromegaly patients were assessed at the Endocrinology Department for their clinical symptoms, and the nasal examination and olfactory evaluation were done at the Department of Otorhinolaryngology. OB volume was evaluated by a single blinded radiologist. Control group patients that had similar demographical characteristics with the Acromegaly Group were recruited in the study.

The CCCRC test is composed of n-butanol odor threshold test and odor identification test. Olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total CCCRC test score. OB measurements were done individually on the right and left olfactory bulbs and the mean OB volume was calculated in cubic millimeters.

Eligibility criteria: Inclusion Criteria:

* Acromegaly diagnosis
* Healthy subjects that had no nasal problems

Exclusion Criteria:

* Previous nasal surgery
* Acute respiratory tract infection
* Nasal polyposis
* Nasal pathologies that causes nasal obstruction

Primary outcomes:
measure: Olfactory bulb (OB) volume
timeFrame: 18 months
measure: CCCRC test results
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Nazan Degirmenci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degirmenci N, Bektas H, Senturk E, Ilhan M, Gunaldi A, Yetis EUM, Eren SB. Changes in olfactory function and olfactory bulb after treatment for acromegaly. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2357-2362. doi: 10.1007/s00405-020-06515-5. Epub 2021 Jan 2.
Clinical trial NCT06993337: Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Recurrent Aphthous Stomatitis
Official title: Evaluation of Topical Bromelain Versus Topical Corticosteroids in Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Recurrent Aphthous Stomatitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-60 years.
* Diagnosed with RAS.
* Onset of ulcer within the last 48 hours.
* Willingness to participate and provide informed consent.

Exclusion Criteria:

* History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
* Pregnant or breastfeeding patients.
* Previous treatment for the current ulcer episode.

Primary outcomes:
measure: Pain associated with ulcers
timeFrame: Recorded at baseline, day 2, day 4 and day 7
Secondary outcomes:
measure: Reduction in ulcer size
timeFrame: Recorded at baseline, day 2, day 4 and day 7
measure: Number of oral ulcers
timeFrame: Recorded at baseline, day 2, day 4 and day 7
measure: Healing time of oral ulcer
timeFrame: Recorded at baseline, day 2, day 4 and day 7
measure: Oral ulcer activity index
timeFrame: Recorded at baseline, day 2, day 4 and day 7
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06364137: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
Official title: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Mood Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: MainSquare Co. (dba 'Teleo')
First posted: 2024-04-15
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research study will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the pilot trial will examine examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Detailed description: The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences.

Eligibility criteria: Inclusion Criteria:

* Patient ages 5-14
* Receiving psychotherapy with a licensed professional on the Teleo platform
* Likely have at least 12 sessions remaining.
* RCADS score \> 65

Exclusion Criteria:

* Not under treatment with provider using Teleo platform

Primary outcomes:
measure: PRIME-O Video Coding Score
timeFrame: Weeks 1, 2, 3, 4
Secondary outcomes:
measure: My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores
timeFrame: Post-intervention (at one month)
measure: My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores
timeFrame: Post-intervention (at one month)
measure: Attendance during Psychotherapy Sessions
timeFrame: One month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: David S Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457037: Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
Official title: Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Trophic Ulcer
Keywords: Trophic Ulcer
Mesenchymal stem cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2020-07-07
Enrollment: 18
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
Intervention model description: Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Primary purpose: TREATMENT

Brief summary: Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

Detailed description: During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).

In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.

Eligibility criteria: Inclusion Criteria:

* Trophic Ulcers

Exclusion Criteria:

* diagnosed cancer
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy

Primary outcomes:
measure: Number of patients with tropic ulcers cured
timeFrame: 1 month
measure: Number of patients with treatment-related adverse events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor Volotovski, Dr
role: STUDY_DIRECTOR
affiliation: Head of 2 Department of Surgical Diseases of BSMU
name: Stanislav Tretyak, Prof
role: STUDY_DIRECTOR
References: