louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00581919: Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Official title: Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: previously treated multiple myeloma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2007-12-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.

Detailed description: The primary objective of this study is to assess overall response rate to the treatment.

Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.

Eligibility criteria: Inclusion Criteria:

* Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein.

Exclusion Criteria:

* Patients with previous doxorubicin treatment totaling 220 mg/m2 or more
* LVEF less than 45%
* Patients with \>grade II sensory neuropathy at baseline as assessed by the PI will be excluded
* No history of seizures as ALCAR may lower the seizure threshold
* Known HIV infection
* Current pregnancy.

Primary outcomes:
measure: Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR
timeFrame: Every 21 days, up to 24 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 7 years
measure: Progression-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.
Other outcomes:
Locations:
city: Janesville
country: United States
facility: Mercy Health Systems
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Cancer Center
state: Wisconsin
city: Waukesha/Oconomowoc
country: United States
facility: Regional Cancer Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital, Aspirus Regional Cancer Center
state: Wisconsin
Study officials:
affiliation: UWCCC
name: Natalie S Callander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979819: The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
Official title: The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 20
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
Intervention model description: Validity and Reliability
Primary purpose: SCREENING

Brief summary: Multiple sclerosis negatively affects the endurance and functionality in the upper extremities. 20 female patients aged 18-70 years who were diagnosed with MS will be included in the study. Demographic, family, cigarette alcohol use, etc. information will be obtained from the patients and the study will begin. Timed 25-Step Walking Test, upper extremity endurance with UULEX, Hand-Shoulder and Arm Problems Questionnaire (DASH) and Nine-hole Board Test (DDTT) evaluation were performed on the patients. Manual muscle test for muscle strength, handheld dynamometer handheld Grip strength will be measured with a dynamometer and spasticity will be measured with the Ashworth scale. Depression status of the patients will be determined by the Beck depression scale, and the presence of dyspnea will be determined by the dyspnea scale.

The validity and reliability of the Unsupported Upper Extremity Exercise Test (UULEX) will be investigated with the obtained data. In order to give the most accurate result of the test in adults over 65 years of age, 3 repetitions will be performed with a resting period of half an hour.

Limitation of activities of daily living will be evaluated with MSQOL-54 specific to Multiple Sclerosis. Intraclass correlation coefficient (ICC) will be used to determine test-retest reliability.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple scleroisis

Exclusion Criteria:

* Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX

Primary outcomes:
measure: Upper extremity endurance testing
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT06863519: Evaluation of Endoscopic Treatment Effect Based on HVPG
Official title: Evaluation of Endoscopic Treatment Effect and Influencing Factors in Patients With Esophageal and Gastric Varices in Cirrhosis Based on HVPG
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Esophageal and Gastric Varices
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients in gastroenterology department

Brief summary: This study aims to evaluate the endoscopic treatment effect and related influencing factors of patients with esophageal and gastric varices based on HVPG. By enrolling and collecting patients with esophageal and gastric varices at different stages of liver cirrhosis, the changes in portal pressure before and during endoscopic treatment were detected. The endoscopic treatment effect of different patients was evaluated by combining the changes in HVPG and the condition of varicose veins, the effects of different endoscopic treatment methods on HVPG were analyzed, and the correlation between HVPG changes and endoscopic efficacy was explored.


Eligibility criteria: Inclusion Criteria:

1. Age range: 18-80 years old;
2. Patients with confirmed cirrhosis through clinical, imaging or pathological evidence, with causes including viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, etc.;
3. Patients with esophageal and gastric varices confirmed by endoscopic examination and varicose vein bleeding in the past;
4. Endoscopic treatment (such as band ligation, sclerotherapy or colloid injection) is an appropriate secondary prevention method;

Exclusion Criteria:

* (1) Combined with hepatocellular carcinoma or other malignant tumors; (2) Autoimmune cirrhosis, schistosomal cirrhosis, hepatic venous occlusion, etc.; (3) Combined with other diseases that affect portal hypertension, such as portal vein thrombosis; (4) Recently (within 6 months) received other treatments, such as TIPS, liver transplantation, or other treatment measures that may affect the study; (5) Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.);

Primary outcomes:
measure: HVPG
timeFrame: Regular endoscopic treatment, with HVPG testing repeated approximately every 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04303819: The Effect of Exenatide on Fasting Bile Acids
Official title: The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus in Obese
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese population

Brief summary: Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were compared before and after exenatide treatment and correlation analysis between changes of FTBAs and glycemic parameters.

Detailed description: Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were tested at baseline. Then exenatide were applied to the T2DM participants for 12 weeks. FTBAs and glycemic parameters were measured again after exenatide treatment, and correlation analysis between changes of FTBAs and glycemic parameters were conducted to investigate the role of BAs in the glycemic control effect of exenatide.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed T2DM patients

Exclusion Criteria:

* History of hepatobiliary or pancreatic diseases
* History of anti-diabetic drugs intake
* Change of anti-dyslipidemia therapy regimen
* Estimated glomerular filtration rate less than 60 mL/min/1.73 m\^2
* Pregnancy

Primary outcomes:
measure: Plasma total bile acids in fasting state
timeFrame: 12 weeks
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: 12 weeks
measure: Glycated hemoglobin A1c
timeFrame: 12 weeks
measure: C-peptide
timeFrame: 12 weeks
measure: Fasting serum insulin
timeFrame: 12 weeks
measure: Body mess index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang hospital
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Boyu Li, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li B, Hu Y, Wang G, Liu L. The effect of exenatide on fasting bile acids in newly diagnosed type 2 diabetes mellitus patients, a pilot study. BMC Pharmacol Toxicol. 2020 Jun 15;21(1):44. doi: 10.1186/s40360-020-00422-5.
Clinical trial NCT00981019: Doctors' Understanding of Survival Statistics
Official title: Study of Primary Care Physicians' Understanding and Use of Different Survival Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Screening
Keywords: survival rates
risk communication
screening counselling
screening recommendation
understanding of medical risk
Lead sponsor: Max Planck Institute for Human Development
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
First posted: 2009-09-22
Enrollment: 778
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 301 primary care physicians (internal, general, and family medicine physicians)

Brief summary: The probably most commonly used measure for expressing the pay-offs of early detection and treatment are survival rates. Yet, over time and groups this metric comes with several biases and thus, is not reliable for judging such benefits. Epidemiologists recommend using reduction of disease-specific mortality rates instead, which is unbiased. The purpose of the study is to investigate how primary care physicians understand and use different survival measures for determining the benefit of cancer screening tests.


Eligibility criteria: Inclusion Criteria:

* primary care physicians (internal, general, and family medicine physicians)

Exclusion Criteria:

* all other types of physicians

Primary outcomes:
measure: Number of Physicians (=Participants) Recommending the Screening
timeFrame: 25 minutes (mean duration of the survey)
Secondary outcomes:
measure: Number of Physicians (= Participants) Assuming a Benefit of Screening
timeFrame: 25 minutes (mean duration of the survey)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Max Planck Institute for Human Development
Study officials:
affiliation: Max Planck Institute for Human Development
name: Odette Wegwarth, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wegwarth O, Schwartz LM, Woloshin S, Gaissmaier W, Gigerenzer G. Do physicians understand cancer screening statistics? A national survey of primary care physicians in the United States. Ann Intern Med. 2012 Mar 6;156(5):340-9. doi: 10.7326/0003-4819-156-5-201203060-00005.
Clinical trial NCT06764719: Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies
Official title: Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: To Characterize and Evaluate Functional Stem Cells
Keywords: hair follicles, stem cells, pluripotent, cell differentiation
Lead sponsor: Acorn Biolabs Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy population, aged 18-80, without scalp or hair disorders, chronic illnesses that may impact scalp health or wound healing, and not on immunosuppressants, steroids, or medications that cause hair loss.

Brief summary: To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies.

Detailed description: Hair Follicles collected and transported in Acorn's proprietary transport media can serve has therapeutic starting materials for future cell-based therapeutics. This study is to characterize primary cell outgrowth, functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s) as well as evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s).

Eligibility criteria: Inclusion Criteria:

* Gender: Male or Female.
* Age: ≥18 and ≤80 years.
* Language proficiency: Able to read and understand English.
* Informed consent: Willing to provide written, informed consent to participate in all study activities.

Exclusion Criteria:

* Scalp/Hair Disorders: Subjects diagnosed with active scalp infections or inflammatory skin conditions.
* Systemic Conditions: Subjects with chronic illnesses, such as autoimmune diseases or diabetes, that may impact scalp health or wound healing.
* Medications: Subjects on immunosuppressants, steroids, or other medications associated with hair loss.

Primary outcomes:
measure: Characterize primary cellular outgrowth(s)
timeFrame: 30 days
measure: Evaluate functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s)
timeFrame: 21 days
measure: Evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Acorn Biolabs
state: Quebec
Study officials:
References:
Clinical trial NCT06283719: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
Official title: A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Neuroendocrine Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form;
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;

Exclusion Criteria:

* Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to approximately 2 years
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT00518219: To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
Official title: To Compare the Efficacy and Safety of TW vs Valsartan in the MN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Membranous Nephropathy
Keywords: TW
Valsartan
treatment
membranous nephropathy
proteinuria
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2007-08-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

Detailed description: Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.

Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of heavy proteinuria of MN.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy
* Nephrotic syndrome with proteinuria (\> 4 g/day) and serum albumin \< 30 g/dl
* Age over 18 with informed consent

Exclusion Criteria:

* Patient with abnormal liver function tests
* Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days,
* Active/serious infection,
* Patient with hepatitis B surface antigen or who is hepatitis C antibody positive

Primary outcomes:
measure: To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy
timeFrame: 12 months
Secondary outcomes:
measure: To investigate the safety and tolerability of TW vs ARB in treatment of MN
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Zhihong Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.