louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04428437: Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors
Official title: An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Humanity & Health Medical Group Limited
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Kindai University Faculty of Medicine
First posted: 2020-06-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with HCC progression after first line treatment with checkpoint inhibitors

Brief summary: The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors.

Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib.

CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1.

The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old on the day of consent
2. Capable of understanding and complying with the protocol requirements and signed informed consent
3. Documented histological or cytological diagnosis of HCC
4. HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1

Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
2. Prior TKI treatment

Primary outcomes:
measure: Response rate (RR)
timeFrame: 12 month
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity & Health Clinical Trial Centre
state: Hong Kong SAR
Study officials:
References:
Clinical trial NCT06800937: Sphingolipidomic Profile in Anorexia Nervosa
Official title: Evaluation of the Sphingolipidomic Profile in Women Suffering From Anorexia Nervosa: Relationship With Clinical-endocrine and Psychiatric Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Sphingolipids
Females
Lipidomic profile
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 female adults with Anorexia nervosa, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), hospitalized at the Division of Eating and Nutrition Disorders (END), San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy.

Half will have the AN-R subtype and the other AN-BP.

30 normal weight adult women recruited from research and hospital staff, with Body Mass Index between 18.5 and 24.9 kg/m2

Brief summary: : The objective of this research project will be to determine the sphingolipidomic profile in a group of women (\> 18 years) affected by Anorexia Nervosa (AN), phenotypically characterized (restricting \[AN-R\] vs binge-eating purging \[AN-BP\]). Specific questionnaires will be administered for the definition of the severity of the eating disorder and depressive state (suicidality), to which will be added the evaluation of gonadal function (i.e., plasma levels of estradiol/progesterone and use of oral contraceptives).

Based on the specific lipidomic profile, which the present research project hopes to characterize, it will be possible to appropriately modify the diet of rehabilitation programs and, in the future, improve the effectiveness of the treatment itself, especially in the long term.


Eligibility criteria: Patients with Anorexia Nervosa:

Inclusion Criteria:

* Female sex
* Age: 18 years or older
* Diagnosis of Anorexia Nervosa in the acute phase
* Hospitalized at the Division of Eating and Nutrition Disorders (END), San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy

Exclusion Criteria:

* Absence of signed Informed Consent

Control group:

Inclusion Criteria:

* Female sex
* Age: 18 years or older
* BMI between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Absence of signed Informed Consent

Primary outcomes:
measure: Ceramides
timeFrame: Baseline
measure: Dihydroceramides
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT05088837: Muscle Energy Technique on Sacroiliac Dysfunction
Official title: Effect of Muscle Energy Technique on Postpartum Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Disorder
Keywords: Muscle energy technique
sacroiliac dysfunction
ice and heat pack
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
Primary purpose: TREATMENT

Brief summary: Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability

Detailed description: A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study, they were selected and divided randomly into 2 equal groups (A\&B). Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each). All patients in both group were evaluated at the beginning of the study and after 12 sessions through measuring pain intensity using visual analog scale and disability using oswestry disability index (ODI)

Eligibility criteria: Inclusion Criteria:

* Their ages ranged from 20 to 40 years .
* Their BMI was ranged from 25-30 kg / m2

Exclusion Criteria:

* hip fracture,
* SIJ infection.
* scoliosis

Primary outcomes:
measure: visual analog scale Visual anlage scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Oswestry disability index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Ebrahim Elrefaye
Study officials:
References:
Clinical trial NCT01806337: CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma
Official title: Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-Cell Lymphoma
Keywords: peripheral T cell lymphoma
alemtuzumab
consolidation
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Detailed description: Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Eligibility criteria: Inclusion Criteria:

* all risk groups in international prognostic index
* diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
* these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
* Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
* written consent of the patient
* Declaration of center participation

Exclusion Criteria:

* Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
* Serious accompanying disorder or impaired organ function
* bone marrow involvement\>25%
* Known hypersensitivity to medications to be used
* Know HIV-positivity
* Active hepatitis infection, active CMV infection, prior florid tuberculosis
* floride systemic infections
* suspicion that patient compliance will be poor
* Simultaneous participation in any the study protocol
* prior chemo-or radiotherapy for malignancy
* other concomitant malignant disease
* Pregnancy or lactation period

Primary outcomes:
measure: Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
timeFrame: average of 24 weeks (treatment duration)
Secondary outcomes:
measure: rate of complete remissions
timeFrame: at week 24 after initiation
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: German High Grade Non Hodgkin´s Lymphoma Study Group
name: Lorenz Truemper
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04185337: Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes
Official title: The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This early phase I trial studies how well ultrasound-guided photoacoustic imaging works in telling the difference between healthy and cancerous inguinal (groin) lymph nodes and how well it can detect certain features of lymph nodes, including size and shape in patients with cancer. Ultrasound-guided photoacoustic is a non-invasive imaging method that can detect and display characteristics of lymph nodes based on the level of oxygen in the cells. This imaging method may provide more accurate tumor staging and prevent unnecessary surgical interventions.

Detailed description: PRIMARY OBJECTIVE:

I. To estimate the mean difference in oxygen saturation (%sO2) between healthy and malignant inguinal lymph nodes using ultrasound-guided photoacoustic imaging (PAI) in cancer patients.

SECONDARY OBJECTIVE:

I. To examine the role of ultrasound-guided PAI in detecting metastases in the inguinal lymph nodes and ultrasound features of lymph nodes such as the size, shape of the lymph nodes.

OUTLINE:

Patients undergo standard of care ultrasound of the lymph nodes, then undergo ultrasound-guided PAI over 3-5 minutes. Patients then undergo standard of care ultrasound-guided fine needle aspiration (FNA) or biopsy a suspicious lymph node.

After completion of study, patients are followed up for 3 months.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven primary malignancy
* Suspicious inguinal lymph nodes for metastasis on a conventional imaging modality
* Scheduled to undergo ultrasound-guided fine needle aspiration cytology or biopsy

Exclusion Criteria:

* Melanoma patients, since the melanocytes may have a "masking effect"
* The deeper inguinal lymph nodes (3-5 cm deep) and smaller (\< 1 cm in short axis) in dimensions will be excluded from the study

Primary outcomes:
measure: Difference between background oxygen saturation (%sO2) and nodal %sO2
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priya R Bhosale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831337: Evaluation of Probiotics in the Treatment of Portal Hypertension
Official title: The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Encephalopathy
Keywords: VSL3
Probiotics
Gut microbiota
Cytokines
Portal hypertension
Chemokines
Liver cirrhosis
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 33
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: PREVENTION

Brief summary: This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.

Detailed description: Studied probiotics: VSL3

Eligibility criteria: Inclusion Criteria:

* Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
* Confirmed portal hypertension
* 18 years and older
* compliant patients

Exclusion Criteria:

* Antibiotic treatment in last 3 months
* Lactulose treatment in last 3 months
* Patients taking NSAIDS in lat 3 months
* Steroid treatment in last 3 months
* Ongoing and active infection
* Pregnant woman
* Cancer diagnosis
* decompensated diabetes mellitus
* active or past treatment with recombinant cytokines (e.g. anty TNF, interferon etc)
* medication altering function of CNS, suffering from neurological or ophthalmological conditions
* initiating the therapy with beta blockers within the prior 12 weeks
* mental disease

Primary outcomes:
measure: Laboratory data
timeFrame: 28 days
Secondary outcomes:
measure: Clinical and laboratory data
timeFrame: 1 months
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Department of Gastroenterology, Pomeranian Medical University
Study officials:
affiliation: Pomeranian Medical University Szczecin
name: Wojciech M Marlicz, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006137: Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IGA Glomerulonephritis
Keywords: IgA glomerulonephritis
rare disease
renal and genitourinary disorders
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Stanford University
First posted: 2000-08-04
Enrollment: 43
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of a progressive renal injury in patients with IgA nephropathy.

II. Determine which of these patients are destined to progress to further injury in order to target them for therapy.

III. Elucidate the determinants of progression in those patients who exhibit evidence of either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.

Detailed description: PROTOCOL OUTLINE: Patients receive oral enalapril daily. Treatment continues for 5 years in the absence of unacceptable toxicity.

Patients undergo renal function studies every 6-12 months for 5 years. Patients undergo renal biopsy at 36-48 months after study entry.

Eligibility criteria: Histologically confirmed IgA nephropathy, diagnosed within the past 3 years

Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR

Acute nephritic or nephrotic syndrome

No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver

No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage

No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome)

Healthy volunteers will be accrued as a control group

No other concurrent medical or psychiatric illness that would preclude study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Bryan D. Myers
role: STUDY_CHAIR
References:
Clinical trial NCT00173537: Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension
Official title: Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: idiopathic pulmonary artery hypertension
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows to the heart's left side, where the left ventricle pumps it to the rest of the body through the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year. The greatest number is reported in women between ages 20 and 40. However, men and women in all age ranges as well as very young children can develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and resulting in elevated blood pressure. However, it has not yet been reported regarding the genetic variants in Taiwan. Further details have been described in this project proposal.


Eligibility criteria: Inclusion Criteria:

* diagnosed as idiopathic pulmonary artery hypertension and associated family

Exclusion Criteria:

* none

Primary outcomes:
measure: all cause follow up
timeFrame: eight years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Surgery, National Taiwan University Hospital
name: Hsao-Hsun Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532437: Computer-based Skin Aging Simulation for Skin Cancer Prevention
Official title: Computer-based Skin Aging Simulation for Skin Cancer Prevention: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Aging
Keywords: skin cancer prevention
skin aging simulation
UV-exposure
skin analysis photo system
VISIA® photo analysis system
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young healthy female volunteers aged 18-35 years, e.g. medical students of the University Basel, who do not have any skin diseases requiring medical therapy

Brief summary: This pilot study is to assess the knowledge, attitudes, and practices regarding skin cancer prevention in young adults and to determine the impact of artificial intelligence-based simulation of facial skin aging on their attitudes regarding skin cancer prevention.

Detailed description: In young adulthood an increasing UV-exposure often starts because of the belief that tanning increases attractiveness\]. Raising awareness and educating students and adults regarding practices for skin cancer prevention are critical since skin cancer is increasing rapidly worldwide. Skin cancer preventive interventions for adolescents are needed to improve their motivation for sun safety behavior. This pilot study is to assess the knowledge, attitudes, and practices regarding skin cancer prevention in young adults and to determine the impact of artificial intelligence-based simulation of facial skin aging on their attitudes regarding skin cancer prevention.

Eligibility criteria: Inclusion Criteria:

* healthy female volunteers
* written,Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved informed consent.

Exclusion Criteria:

* skin diseases requiring medical therapy

Primary outcomes:
measure: Change in visual analogue scale (VAS) score regarding importance of UV- protection
timeFrame: before and after the skin aging simulation (each scoring session will take about 15-20 minutes)
measure: Change in VAS score regarding rating of personal exposure to UV radiation
timeFrame: before and after the skin aging simulation (each scoring session will take about 15-20 minutes)
Secondary outcomes:
measure: Questionnaire asking for reduction of UV- exposure (yes/no)
timeFrame: after the skin aging simulation (each scoring session will take about 15-20 minutes)
measure: Questionnaire asking for intensification of UV protection measures (yes/ no)
timeFrame: after the skin aging simulation (each scoring session will take about 15-20 minutes)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Lara Valeska Maul, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: