louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06451770: Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Official title: A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: VERVE-201
Gene Editing
Base Editing
Refractory Hypercholesterolemia
Cardiovascular Disease
ANGPTL3
Lead sponsor: Verve Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single ascending dose escalation/adaptive design
Primary purpose: TREATMENT

Brief summary: VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hypercholesterolemia.

VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C). This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.


Eligibility criteria: Inclusion Criteria:

* Refractory hypercholesterolemia
* Females of non-childbearing potential or males

Exclusion Criteria:

* Active or history of chronic liver disease
* Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe
* Clinically significant or abnormal laboratory values as defined by the protocol

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Up to Day 365
Secondary outcomes:
measure: Evaluation of maximum observed concentration (Cmax)
timeFrame: Up to Day 365
measure: Evaluation of time to maximum observed concentration (tmax)
timeFrame: Up to Day 365
measure: Evaluation of terminal elimination half-life (t1/2)
timeFrame: Up to Day 365
measure: Percent and absolute change from baseline in serum ANGPTL3 concentration
timeFrame: Up to Day 365
measure: Percent and absolute change from baseline in serum LDL-C
timeFrame: Up to Day 365
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Clinical Study Center
city: Chicoutimi
country: Canada
facility: Clinical Study Center
city: Toronto
country: Canada
facility: Clinical Study Center
city: London
country: United Kingdom
facility: Clinical Study Center
Study officials:
References:
Clinical trial NCT06609070: CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC
Official title: CHG0521 Oral Coating; TSCC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Oral Cavity
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC


Eligibility criteria: Inclusion Criteria:

* 1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.

  3. Patients who are deemed unsuitable for surgery, have surgical indications but decline the treatment, or experience relapse and metastasis after surgery with no further surgical options available.

  4. No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.

  5. Presence of at least one measurable lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

  7. Expected survival time should be equal to or greater than 3 months. 8. Liver function indicators: total bilirubin level ≤1.5 times the upper limit of normal (ULN), AST and ALT levels ≤2.5 times ULN (or ≤5 times ULN in case of liver metastasis).

  9.Renal function indicators: serum creatinine (CRE) ≤1.5×ULN and calculated creatinine clearance (using Cockcroft-Gault formula) ≥60 ml/min.

  10.The functionality of vital organs should be essentially normal.

Exclusion Criteria:

* 1. Patients with tongue squamous cell carcinoma who have undergone tumor resection without any residual tumor; 2. Patients with a known allergy to any therapeutic ingredient or a history of hypersensitivity or allergic constitution; 3. Patients who have experienced a severe infection within 4 weeks prior to the first use of the investigational drug, and whose common adverse reaction criteria were graded as \&gt;2; 4. Patients with a history of immune deficiency, organ transplantation, or allogeneic bone marrow transplantation; 5. Patients currently enrolled in another concurrent clinical study; 6. Pregnant and lactating women.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 24 weeks
Secondary outcomes:
measure: QOL
timeFrame: 24 weeks
measure: PCR
timeFrame: 24 weeks
measure: DRR
timeFrame: 24 weeks
measure: OS
timeFrame: 1 year
measure: AEs
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04971070: Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder
Official title: Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoglycemia
Lead sponsor: Chongqing Renji Hospital, University of Chinese Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2021-07-21
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Through retrospective control study, this study analyzed the high-risk factors and predisposing factors of hypoglycemia patients, laid a certain foundation for improving the diagnosis and treatment level of hypoglycemia consciousness disorder, and provided a certain scientific basis for further exploring the mechanism of hypoglycemia consciousness disorder

Brief summary: Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.


Eligibility criteria: Inclusion Criteria:

Symptoms of hypoglycemia such as palpitation, sweating and fatigue were found at the time of treatment. At the same time, the blood glucose of non-diabetic patients was less than 2.8mmol/L, and the blood glucose of diabetic patients was less than 3.9mmol/L

Exclusion Criteria:

Exclusion criteria: Although there were hypoglycemia symptoms at the time of treatment, the blood glucose of non-diabetic patients was more than 2.8mmol/L, and the blood glucose of diabetic patients was more than 3.9mmol/L.

Primary outcomes:
measure: Analysis of risk factors of hypoglycemia with disturbance of consciousness
timeFrame: 2021-2011
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Renji Hospital, University of Chinese Academy of Sciences
state: Chongqing
Study officials:
References:
Clinical trial NCT01321970: Validation/Evaluation of Multimodal Imaging Combining 3D Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease
Official title: Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has a documented coronaropathy
* The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations
* Unstable, acute coronary syndromes unstable needing emergency coronary angiography
* Patient with contraindication for conducting a stress test:
* poorly controlled hypertension
* pre-existing severe arrhythmia
* aortic stenosis
* and obstructive hypertrophic cardiomyopathy
* Patient has contraindication for atropine
* History of prostate adenoma
* Glaucoma

Primary outcomes:
measure: The difference between AUCs for multimodal imaging and scintigraphy
timeFrame: 4 days
Secondary outcomes:
measure: The difference between AUCs for multimodal imaging and stress ultrasound
timeFrame: 4 days
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Madeleine Rubini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002270: A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
Official title: A Pilot Study of the Efficacy of Recombinant Alpha Interferon (IFN-A2b) and Zidovudine (AZT) in the Treatment of Progressive Multifocal Leukoencephalopathy (PML) Complicating HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Leukoencephalopathy, Progressive Multifocal
Keywords: Leukoencephalopathy, Progressive Multifocal
Interferon Alfa-2b
Drug Evaluation
Acquired Immunodeficiency Syndrome
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To study the effectiveness of alpha interferon (IFN-A2b) and zidovudine (AZT) in treating progressive multifocal leukoencephalopathy (PML) as a complication of HIV-1 infection.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV seropositivity by both ELISA and Western blot.
* Biopsy proven progressive multifocal leukoencephalopathy (PML).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Intolerant to interferon.
* Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Patients with the following are excluded:

* Intolerant to interferon.
* Prior or concomitant central nervous system disease (CNS) such as toxoplasmosis, multiple sclerosis (MS), or neurosyphilis.

Prior Medication:

Excluded:

* Patients receiving interferon for other reasons.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
Study officials:
References:
Clinical trial NCT05314270: Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study
Official title: Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-B Non-C Liver Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023

Brief summary: To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC).

To describe the different patient's outcomes.

Detailed description: Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014)

Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019)

Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012)

The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated.

Eligibility criteria: Inclusion Criteria:

* All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023

Exclusion Criteria:

* We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis

Primary outcomes:
measure: Detection of different etiologies of liver cirrhosis that not related to HBV or HCV in our community
timeFrame: Base line
Secondary outcomes:
measure: Detection of the most common etiologies of Non B Non C liver cirrhosis in our community
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03764670: Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy
Official title: The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: tacrolimus
clinical outcomes
genetic polymorphism
clinical factors
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant recipients who underwent transplantation at National Taiwan University Hospital, and received tacrolimus based immunosupression

Brief summary: The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.

Detailed description: Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after kidney transplantation. Many genetic and clinical factors had been found to have effect on TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still controversial.

In this retrospective study, investigators will review records of kidney transplant patients with TAC based immunosuppression recruited from a previous study (IRB approval number: 201512005RINC) to understand the influence of clinical and genetic factors on their 3-years clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival and safety issues of kidney transplant patients.

Eligibility criteria: Inclusion Criteria:

1. Kidney transplantation
2. 20-65 years old
3. Receiving tacrolimus-based immunosuppressants
4. Were recruited in a previous trial

Exclusion Criteria:

1. Human immunodeficiency virus-positive status
2. Retransplantation or multiorgan transplantation
3. Non-Asian

Primary outcomes:
measure: Acute rejection
timeFrame: Within the first 1 year post-transplantation
measure: Graft survival
timeFrame: From post-transplantation to Dec 31, 2017
Secondary outcomes:
measure: Patient survival
timeFrame: From post-transplantation to Dec 31, 2017
measure: Kidney function measured by estimated glomerular filtration rate (eGFR)
timeFrame: From post-transplantation to Dec 31, 2017
measure: Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia
timeFrame: From post-transplantation to Dec 31, 2017
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Meng-Kun Tsai, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04373070: Quality-of-Life Management for COPD Patients
Official title: CAir: Quality-of-Life Management for COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Chronic Respiratory Disease
Keywords: telemonitoring
chatbot
multimodal intervention
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will perform a 2:1 randomised, two-arm, single (assessor)-blind, monocentric trial.
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" (CAir) on health-related quality-of-life in patients with COPD.

Detailed description: The disease management programme "Living well with COPD" was developed to relieve symptoms and prevent exacerbations. It covers a disease self-management approach, educational topics, lifestyle coaching and physical activity advice.

Future implications should aim to make the intervention easily accessible for a broad spectrum of patients at scalable costs. Patients need an engaging communication platform which can inform, coach and even listen in between medical visits. The inclusion of a chatbot agent may provide this tailored feedback. The investogator's aim is to investigate the effects of a telemonitoring and chatbot-based application of "Living well with COPD" on health-related quality-of-life in patients with COPD.

Eligibility criteria: Inclusion Criteria:

• Diagnosed COPD according to GOLD-guidelines

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 3 months
* Pregnant patients

Primary outcomes:
measure: Health-related quality-of-life (HrQoL)
timeFrame: 3 months
Secondary outcomes:
measure: Symptom burden
timeFrame: 3 months
measure: Spirometry
timeFrame: 3 months
measure: Spirometry
timeFrame: 3 months
measure: Accelerometry
timeFrame: 3 months
measure: Functional exercise capacity
timeFrame: 3 months
measure: Functional exercise capacity
timeFrame: 3 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Christian F Clarenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gross C, Kohlbrenner D, Clarenbach CF, Ivankay A, Brunschwiler T, Nordmann Y, V Wangenheim F. A Telemonitoring and Hybrid Virtual Coaching Solution "CAir" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Oct 22;9(10):e20412. doi: 10.2196/20412.
Clinical trial NCT02446470: Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
Official title: Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intra-articular Fractures
Keywords: calcaneus
fracture fixation, internal
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 110
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: This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.

It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.


Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients ≥ 18 years of age
* Closed intra-articular calcaneus fractures
* Undergoing surgical fixation (CPT code 28415)
* Ability to understand and agree to informed consent

Exclusion Criteria:

* Patients \< 18 years of age
* Open fractures
* Dislocations that require open reduction
* Previous calcaneus abnormality or injury
* Unable to understand or agree to informed consent

Primary outcomes:
measure: Wound complication rate
timeFrame: approximately one year
Secondary outcomes:
measure: Fracture healing
timeFrame: approximately one year
measure: Rate of sural nerve injury
timeFrame: approximately one year
measure: Rate of peroneal tendon injury
timeFrame: approximately one year
measure: Change in operative time
timeFrame: one day
measure: Rate of secondary surgery
timeFrame: approximately one year
measure: Visual Analog Scale
timeFrame: approximately one year
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
timeFrame: approximately one year
measure: Foot Function Index
timeFrame: approximately one year
measure: Short-Form 36 (SF-36) Health Survey
timeFrame: approximately one year
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga/Erlanger Health System
name: Jesse F Doty, MD
role: PRINCIPAL_INVESTIGATOR
References: