louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02905851: Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
Official title: Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 4
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris

Detailed description: The investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use.

There are two arms of the study:

1. Feedback group
2. Non feedback group

All subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months).

The investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 15 years and older
* Subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet.

Exclusion Criteria:

* Subjects who have used isotretinoin in the last 6 weeks
* Those who have used oral antibiotics within the last 4 weeks
* Those who have been initiated or changed brand of oral contraceptive pill within the last one month.
* Those subjects who cannot engage with the teledermatology platform
* Prisoners
* Adults unable to consent

Primary outcomes:
measure: Reduced antibiotic use
timeFrame: Assessed at 4, 8, 12 weeks
Secondary outcomes:
Other outcomes:
measure: Change in acne grading (change in patient grading)
timeFrame: Assessed at 4, 8, 12 weeks
measure: Change in acne grading (investigator global assessment)
timeFrame: Assessed at 4, 8, 12 weeks
measure: Change in acne grading (lesion counting)
timeFrame: Assessed at 4, 8, 12 weeks
measure: Change in acne grading using the global acne grading
timeFrame: Assessed at 4, 8, 12 weeks
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology, Clinical Trials Unit
state: California
Study officials:
affiliation: UC Davis
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940251: Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
Official title: Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
Keywords: Ayurvedic formulation
type 2 diabetes mellitus
secondary failure to oral hypoglycemic agents
antidiabetic
Lead sponsor: Jyoti Clinical and Pathological Laboratory
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.


Eligibility criteria: Inclusion Criteria:

Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels \> 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.

Exclusion Criteria:

Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency

Primary outcomes:
measure: antidiabetic activity
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Shirpur
country: India
facility: Jyoti Clinical and Pathological Laboratory
state: Maharashtra
Study officials:
References:
Clinical trial NCT02547051: Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.
Official title: Dietary Factors and Disfluency. A Look Into Causes and Variations in Severity of Disfluency in Regards to Vocal Cord Tension.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vocal Cord Tension
Dysfluency Developmental
Lead sponsor: The R2 Institute
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.


Eligibility criteria: Inclusion Criteria:

* Patients reporting persistent developmental disfluency.

Exclusion Criteria:

* Patients reporting no changes in disfluency severity or frequency

Primary outcomes:
measure: Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: R2 Institute
state: Texas
Study officials:
References:
Clinical trial NCT04747951: Total Neoadjuvant Therapy in Rectal Cancer Treatment
Official title: Total Neoadjuvant Therapy in Rectal Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rectal Cancer
Keywords: rectal cancer
total neoadjuvant therapy
colorectal disease
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-02-10
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Detailed description: In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.

Eligibility criteria: Inclusion Criteria:

* Have signed an approved informed consent form for the stud;
* Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);

Exclusion Criteria:

* rectal cancer recurrence;
* Primary-multiple tumours of other localizations;
* pelvis radiotherapy in anamnesis;
* pregnancy, breastfeeding;
* distant metastasis;
* ECOG score 3-4

Primary outcomes:
measure: The rate of complete responses
timeFrame: 3-6 months
Secondary outcomes:
measure: Rate of R0-resections
timeFrame: immediately after surgery
measure: Rate of compliance with radiotherapy and chemotherapy
timeFrame: 6-8 months
measure: rate of intraoperative and postoperative complications
timeFrame: 0-30 days after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
affiliation: Head of Surgical department of oncoproctology
name: Evgeny Rybakov, Dr.Med.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.
citation: Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21.
citation: Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.
Clinical trial NCT06028854: Blood Characteristics and Abdominal Emergency Surgery
Official title: Association Between Preoperative Blood Characteristics and Mortality in Abdominal Emergency Surgeries
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Surgical Wound
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute intrabdominal pathology who requires surgery in the next 24 hours.

Brief summary: After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.

Detailed description: Surgical injuries initiate the recruitment of cellular blood components for tissue repair. Baseline inflammation levels and cellular response to tissue damage are absent from perioperative management algorithms despite their importance in regeneration. This project seeks to examine patients preoperative parameters before surgery and evaluate if there is a correlation with clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years of age at surgery.
* Patients with acute intra-abdominal pathology requiring emergency surgery.
* A complete blood count was performed in the emergency department of our center within 24 hours before surgery.

Exclusion Criteria:

* Patients who are users of anticoagulation before admission for any reason
* Patients who have had previous hospitalization or surgery in the last 6 months.

Primary outcomes:
measure: Death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Independencia
country: Chile
facility: Hospital Clínico de la Universidad de Chile
state: Santiago
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
Study officials:
affiliation: Hospital Clinico de la Universidad de Chile
name: Felipe Maldonado
role: STUDY_CHAIR
References:
Clinical trial NCT06824454: Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients
Official title: Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypophosphatemia
Kidney Transplantation
Keywords: Post-kidney transplant care
Dipyridamole
Renal phosphate loss
Serum phosphate levels
Phosphate supplementation
Transplant graft function
Kidney transplant complications
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 90
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: The primary goal is to determine if Dipyridamole can improve serum phosphate levels and reduce the need for phosphate supplementation.


Eligibility criteria: Inclusion Criteria:

* Adult kidney transplant patients.
* No known contraindications to Dipyridamole

Exclusion Criteria:

* Contraindications to Dipyridamole.
* Patients with delayed graft function (defined as the need for dialysis within seven days post-transplantation).
* Patients requiring Plavix, direct oral anticoagulants (DOACs), or Coumadin.

Primary outcomes:
measure: Change in Serum Phosphorus Levels After Dipyridamole Administration
timeFrame: Baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, and after stopping medicatio
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Stephan Busque, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396754: Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
Official title: Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Triple Negative Breast Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Case45 Ltd
First posted: 2024-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with triple negative breast cancer requiring neoadjuvant systemic therapy

Brief summary: TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.

Furthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved \>90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Confirmed diagnosis of triple negative breast cancer (non-metastatic)
* Planned for neo-adjuvant systemic therapy
* Written consent to generic Tissue for Research donation

Exclusion Criteria:

* Patients declined consent for generic Tissue for Research donation

Primary outcomes:
measure: To determine the reliability and performance of the process and AI tool
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Navita Somaiah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899154: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Official title: MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spondyloarthritis
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).


Eligibility criteria: Inclusion Criteria:

For patient with spondyloarthritis:

* Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.
* Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)
* patient not previously treated with biotherapy
* Aged ≥ 18 years
* Having given free and informed written consent
* Being affiliated to the center national security system social

For control Subject:

* Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease.
* Aged ≥ 18 years
* Having given free and informed written consent
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.
* Association with another chronic pathology

Primary outcomes:
measure: Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients
timeFrame: 18 Months
Secondary outcomes:
measure: Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.
timeFrame: 18 Months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Européen Marseille
Study officials:
References:
Clinical trial NCT05087654: 3D VR and Hands-on Horticultural Activities Effects
Official title: The Effects of a Combination of 3D Virtual Reality and Hands-on Horticultural Activities on Community-dwelling Older Adults' Mental Health: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horticultural Therapy
Virtual Reality
Keywords: 3D virtual reality
horticultural therapy
community-dwelling
older adults
mental health
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to explore the effects of a combination of 3D virtual reality (VR) and hands-on horticultural activities on the mental health of community-dwelling older adults.

Detailed description: Aging societies are of public health concern worldwide. It is critical to develop strategies that harness technology to enhance older adults' mental health. This study aimed to explore the effects of a combination of three-dimensional virtual reality (3D VR) and hands-on horticultural activities on the mental health of community-dwelling older adults. Used a quasi-experimental design. A total of 62 community-dwelling older adults were recruited. The members of the experimental group participated in an 8-week intervention program. Participants of both groups completed before-and-after intervention measurements for outcome variables that included perceived self-esteem, depression, isolation, mastery and achievement motives, which were analyzed using the generalized estimating equation (GEE). This study found beneficial effects of a combination of 3D VR and hands-on horticultural activities on community-dwelling older adults' mental health.

Eligibility criteria: Inclusion Criteria:

Intact cognition, possessing the ability to understand verbal meaning and the ability to operate a VR joystick independently.

Exclusion Criteria:

A history of hand dysfunction, severe visual and hearing impairment, being allergic to plants or pollen, and a current illness such as epilepsy or stroke.

Primary outcomes:
measure: Self-esteem
timeFrame: about three months
measure: Depression
timeFrame: about three months
measure: Perceived isolation
timeFrame: about three months
measure: Perceived mastery
timeFrame: about three months
measure: Achievement motives
timeFrame: about three months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: National Taiwan Normal University
name: Jong-Long Guo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982354: Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
Official title: A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2021-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.


Eligibility criteria: Inclusion Criteria:

* Patients must have a Karnofsky (adult) Performance Status of at least 70%.
* Patients must have adequate organ function

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Active viral, bacterial or fungal infection
* Patient seropositive for Human Immunodeficiency Virus (HIV-I /II); Human T-Cell Lymphotrophic Virus (HTLV -I /II)
* Presence of leukemia in the Central Nervous System (CNS).

Primary outcomes:
measure: Change in the complete remission rate
timeFrame: 3, 6, 12 and 24 months
measure: Change in Progression Free Survival (PFS)
timeFrame: 3, 6, 12 and 24 months
measure: Change in Overall Survival (OS)
timeFrame: 3, 6, 12 and 24 months
Secondary outcomes:
measure: Change in the rate of Minimal Residual Disease (MRD) negativity
timeFrame: 3, 6, 12 and 24 months
measure: Correlation of Minimal Residual Disease (MRD)
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health of South Florida
state: Florida
Study officials:
affiliation: Miami Cancer Institute at Baptist Health of South Florida
name: Guenther Koehne, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: