louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06820164: Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride
Official title: Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lipoma
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas.


Eligibility criteria: Inclusion Criteria:

* At least one clinically diagnosed subcutaneous lipoma

Exclusion Criteria:

* Unable to give informed consent
* Participant has a lipoma on the face
* Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas)
* Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume)
* Rapidly growing lipomas
* Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)
* Pregnant women

Primary outcomes:
measure: Post-Injection Pain (First Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Post-Injection Pain (Second Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Post-Injection Pain (Third Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Post-injection erythema (First Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Post-injection erythema (Second Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Post-injection erythema (Third Treatment)
timeFrame: 15 minutes post injection (treatment)
measure: Change in Lipoma Size
timeFrame: Baseline to Second Treatment (4-week interval between treatments)
measure: Change in Lipoma Size
timeFrame: Baseline to Third Treatment (4-week interval between treatments)
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University-Dermatology
name: Jessica Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00792064: Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
Official title: Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Organ Transplantation
Anxiety
Depression
Keywords: quality of life
adverse effects
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-11-17
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients immediately after solid organ transplantation

Brief summary: A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types of solid organ transplantation in the long-term. A sample size of 700 participants consisting of all solid organ types is envisioned. Data will be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may guide development of tailored interventions to reduce complications and to further improve outcomes.


Eligibility criteria: Inclusion Criteria:

* Follow-up at our outpatient clinics
* Written informed consent
* Sufficient German language skills to read and answer a battery of questionnaires
* Min 18 years

Exclusion Criteria:

* Illiteracy

Primary outcomes:
measure: HRQoL after transplantation
timeFrame: 5 yrs
Secondary outcomes:
measure: Social re-integration
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery
Study officials:
affiliation: Clinic for Cardiac, Thoracic, Transplantation and
name: Christiane Kugler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975164: the Real World Study of Orelabrutinib in the Treatment of CLL/SLL
Official title: A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CLL/SLL
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received orelabrutinib in real world

Brief summary: This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Detailed description: Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old
2. Patients with a definite diagnosis of CLL/SLL
3. Prior or current use of orelabrutinib for ≥3 months
4. At least one follow-up was recorded during orelabrutinib treatment

Exclusion Criteria:

1.Patients who received orelabrutinib in a prospective clinical trial

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to two years
Secondary outcomes:
measure: Time to Next Therapy (TTNT)
timeFrame: up to two years
measure: Progression Free Survival (PFS)
timeFrame: up to two years
measure: response rate of Hematologic Parameters
timeFrame: up to two years
measure: safety
timeFrame: up to two years
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Chunyan Ji, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366964: The Efficacy Of The Wavelight Mydon Laser for Hair Removal And Treatment of Leg Veins
Official title: Determine The Efficacy Of The Wavelight Mydon Laser For Hair Removal And Treatment of Leg Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Veins
Hair Removal
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-08-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to compare the efficacy of an FDA cleared laser device with other similar systems in the market for the treatment of leg veins and hair removal in patients with darker skin type.

Detailed description: The specific aim of the study is to determine the efficacy of this FDA approved laser for hair removal and treatment of leg veins in female patients having darker skin types (Fitzpatrick Skin type III-VI) and compare it with the efficacy of other similar commercial units available in the U.S.

Eligibility criteria: Inclusion Criteria:

1. Female patients of Asian and darker skin type greater than or equal to 18 years of age.
2. Ability to give informed consent.

Exclusion Criteria:

1. Pregnancy.
2. Taking medications that are photosensitizing.
3. History of skin disease in the area to be treated over the last 6 months.
4. Ongoing cutaneous lupus erythematosus, morphea, alopecia areata, or severe folliculitis.
5. History of keloidal or hypertrophic scarring.
6. Have inadequate hair growth in the test area of axilla.
7. Have unrealistic expectations of the treatment.
8. Co-existing severe emotional, medical or surgical illness leading to the inability to meet the follow-up requirements.

Primary outcomes:
measure: Safety and efficacy of the treatment will determine the outcome.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel B Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284764: Efficacy Study of a Low Volume of Water Intake and Mosapride for Endoscopy in Patients With Subtotal Gastrectomy
Official title: Efficacy of a Low Volume of Water Intake and Mosapride for Endoscopy Preparation in Gastric Cancer Patients With Subtotal Gastrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foreign Body Left During Endoscopic Examination
Keywords: Endoscopy
Gastrectomy
Stomach neoplasms
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.

Detailed description: We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. We plan to compare this method with routine midnight fasting method for endoscopy in patients with subtotal gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Outpatients who had subtotal gastrectomy for gastric cancer

Exclusion Criteria:

* Pregnancy
* Lactation
* History of anastomotic stricture
* Recurrent advanced gastric cancer
* Poor general condition( \> 2 ECOG)
* Other disseminated malignancy
* Significant renal failure or congestive heart failure (CHF)
* Liver failure

Primary outcomes:
measure: Degrees of food residue using endoscopic scoring system
timeFrame: six months
Secondary outcomes:
measure: Tolerability of a low volume of water and mosapride
timeFrame: six months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital, Inje University School of Medicine
Study officials:
affiliation: Haeundae Paik Hospital
name: Eun Hee Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haeundae Paik Hospital
name: Tae Oh Kim, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03611764: Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Official title: The Mindfulness Pilot Project: The Effects of a Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hematological Malignancy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2018-08-02
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will address whether teaching the Body Scan exercise to cancer patients with hematological malignancies and their caregivers during an inpatient hospitalization improves reported physical and psychological symptoms after a two-week period. Giving patients and caregivers the opportunity to learn mindfulness and the tools to practice on their own is expected to lead to a decrease in stress and anxiety, and help empower patients and caregivers to better cope with stress in the future.


Eligibility criteria: Inclusion Criteria:

* Voluntary \& self-selected patients and caregivers
* Located on the leukemia/lymphoma/bone marrow transplant floor at Barnes Jewish Hospital

Exclusion Criteria:

-Patients requiring a language translator or interpreter will be excluded from the study

Primary outcomes:
measure: Measure of distress in patients measured by the RSCL scores
timeFrame: Through 2 weeks
measure: Measure of distress in caregivers measured by the RSCL scores
timeFrame: Through 2 weeks
Secondary outcomes:
measure: Frequency of body scan practice
timeFrame: Through 2 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Maggie Compernolle, BSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057290: Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia
Official title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-27
Enrollment: 75
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of pediatric acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in cell samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To characterize Stat3 signaling pathway activity in primary tissue samples from pediatric patients with acute myeloid leukemia to determine the percentage of samples with increased activity and to better understand the mechanisms leading to increased activity.
* To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low and high doses of cytokines.
* To evaluate the expression levels of Stat3 protein as well as upstream and downstream regulators of Stat3 activation.
* To classify tissue samples according to a Stat3-activation pattern, and to correlate this result with event-free survival and overall survival in order to determine whether increased Stat3 phosphorylation at diagnosis predicts poor outcome.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including immunoblotting, fluorescence activated cell sorting (FACS), and protein analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Children's Cancer Center
name: Michele S. Redell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931190: Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia
Official title: Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Cervical Intraepithelial Neoplasia
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
First posted: 2009-07-02
Enrollment: 195
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 195 women referred for treatment of cervical intraepithelial neoplasia in the cathment area of Umeå university hospital. All women had abnormal smears at enrollment.

Brief summary: The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Detailed description: Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Eligibility criteria: Inclusion Criteria:

* Referral to Umeå university hospital for treatment due to abnormal Pap smear.

Exclusion Criteria:

* Lack of informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept. obstetrics and gynecology, University hospital of Northern Sweden
Study officials:
affiliation: Dept. medical microbiology, Malmö university hospital, Malmö, Sweden
name: Anna Söderlund Strand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03018990: Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Fibroses
Alcohol-Induced Disorders
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the effects of acute alcohol challenge on the gut and liver axis.

Detailed description: To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals

And all of following:

* Bodymass \> 50 kg
* Able to be fasting and abstinent on the day of intervention
* international ratio \<1.5 and platelets \>100 x 10\^9, 7 days before the intervention day
* Informed consent

Exclusion Criteria:

* Antibiotics during the last 4 weeks
* Total alcohol abstinence
* Desire of total alcohol abstinence
* Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
* Cirrhosis
* Insulin dependent diabetes mellitus
* Incapable to follow the protocol instructions
* Pregnancy
* Primary or secondary liver cancer
* Severe comorbidity
* Allergic to the contrast media iohexol

Primary outcomes:
measure: changes in concentrations of bacterial products in the liver vein
timeFrame: Within 24 hours
Secondary outcomes:
measure: changes in concentrations of bacterial products in the peripheral vein system
timeFrame: Within 24 hours
measure: changes in the gut microbiome
timeFrame: Within 24 hours
measure: changes in the liver metabolome, transcriptome and proteome
timeFrame: Within 24 hours
measure: changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
affiliation: Professor, department of gastroenterology and hepatology, Odense University Hospital
name: Aleksander Krag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Israelsen M, Kim M, Suvitaival T, Madsen BS, Hansen CD, Torp N, Trost K, Thiele M, Hansen T, Legido-Quigley C, Krag A; MicrobLiver Consortium. Comprehensive lipidomics reveals phenotypic differences in hepatic lipid turnover in ALD and NAFLD during alcohol intoxication. JHEP Rep. 2021 Jun 29;3(5):100325. doi: 10.1016/j.jhepr.2021.100325. eCollection 2021 Oct.
Clinical trial NCT04637490: Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
Official title: Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: patellar resurfacing
isokinetic testing
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

Detailed description: Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

Eligibility criteria: Inclusion Criteria:

* Patients aged 55 to 80 years
* unilateral primary osteoarthritis

Exclusion Criteria:

* bilateral osteoarthritis
* inflammatory arthritis
* post-traumatic osteoarthritis
* previous knee surgery
* neuromuscular diseases

Primary outcomes:
measure: isokinetic test
timeFrame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary outcomes:
measure: Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor
timeFrame: Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Teaching and Research Hospital
Study officials:
affiliation: Gulhane Teaching and Research Hospital
name: Deniz CANKAYA, Assoc.Professor
role: PRINCIPAL_INVESTIGATOR
References: