louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00072631: Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non Small Cell Lung Cancer
Failed Prior Chemotherapy
Keywords: Tarceva
erlotinib
NSCLC
Non-Small Cell Lung Cancer
EGFR
OSI-774
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2003-11-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed description: Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
* Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
* Measurable disease per RECIST criteria.
* Adequate bone marrow, hepatic and renal function.

Exclusion Criteria:

* Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
* Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
* Known hypersensitivity to minocycline.
* History of serious cardiac disease that is not controlled.
* Serious eye conditions.
* Prior treatment with inhibitors of EGFR of any kind.

Primary outcomes:
measure: Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
timeFrame: 3 years
Secondary outcomes:
measure: Feasibility of correlating objective response rate and duration of response to grade of rash
timeFrame: 3 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Institute for Drug Development Cancer Therapy and Research Center
state: Texas
Study officials:
References:
Clinical trial NCT07025031: FETAL GROWTH RESTRICTION A CASE CONTROL STUDY
Official title: MATERNAL SERUM PROGESTERONE AND PLACENTAL HMOX-1 EXPRESSION IN EARLY ONSET IDIOPATHIC FETAL GROWTH RESTRICTION: A CASE CONTROL STUDY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Idiopathic Fetal Growth Restriction
Keywords: progesterone
Heme Oxygenase-1
Idiopathic fetal growth restriction
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 58
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed to have fetal growth restriction within 24 until 32 weeks gestation the absence of hypertension, diabetes or autoimmune disease.

Brief summary: The study aims to investigate the responsible factors that leads to idiopathic fetal growth restriction.

Detailed description: The study aims to investigate the relationship between maternal serum level of progesterone, immune-expression of HMOX-1 a placental angiogenesis marker with idiopathic fetal growth restriction.

Eligibility criteria: Inclusion Criteria:

* singleton
* dated pregnancy

Exclusion Criteria:

* fetus with structural or chromosomal anomaly
* receive treatments such as aspirin, progestogen, low molecular weight heparin
* has pre-existing medical disorders such as autoimmune disease, hypertension, diabetes
* smoking
* suspected intrauterine infection

Primary outcomes:
measure: Maternal serum level of progesterone
timeFrame: At the point of recruitment from 24 until 32 weeks gestation.
measure: Placental immunoexpression of Heme Oxygenase 1
timeFrame: At delivery within 24 until 38 weeks gestation.
Secondary outcomes:
measure: Placenta histopathology examination
timeFrame: At delivery within 24 until 38 weeks gestation
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
state: Wilayah Persekutuan
Study officials:
References:
Clinical trial NCT04072731: SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer
Official title: SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: thyroid cancer
SREBP1
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all of this patients were recruited from the Affiliated Cancer Hospital of Xiangya Medical School

Brief summary: In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues, explored the biological functions of SREBP1 in thyroid cancer cells.

Detailed description: qRT-PCR and immunohistochemistry were used to detect the expression of SREBP1 in 96 pairs thyroid cancer tissues and the adjacent normal tissues. The following methods, including the MTS, colony-forming assay, flow cytometry and hoechst staining were used to detect the biological function of thyroid cancer cells based on SREBP1 interference or not.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of thyroid cancer Reciving thyroidectomy surgery No experience of radiation therapy Nice treatment compliance and follow-up regularly

Exclusion Criteria:

Prior history of malignancy ; Radiotherapy history, chemotherapy history; Serious concomitant diseases ; Chronic renal insufficiency and liver dysfunction

Primary outcomes:
measure: progression-free survival
timeFrame: average 5 years
Secondary outcomes:
measure: theraputic efficacy
timeFrame: average 18 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Affiliated Cancer Hospital of Xiangya Medical School
state: Hunan
Study officials:
affiliation: Central South University
name: Zhi Li, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537731: Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain
Official title: Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Postsurgical Pain
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.

Brief summary: Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
* Age 18-69 years
* Gender: female
* ASA status 1-3

Exclusion Criteria:

* Body Mass Index over 35
* Diabetes mellitus
* Liver disease
* Preoperative use of opioids

Primary outcomes:
measure: Presence of persistent postsurgical pain as measured at 6 months after surgery.
timeFrame: five years
Secondary outcomes:
measure: Severity, location, characteristics of persistent postsurgical pain.
timeFrame: five years
measure: Effect of postsurgical pain on activity, sleep.
timeFrame: five years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
citation: Pokkinen SM, Nieminen K, Yli-Hankala A, Kalliomaki ML. Persistent posthysterectomy pain: A prospective, observational study. Eur J Anaesthesiol. 2015 Oct;32(10):718-24. doi: 10.1097/EJA.0000000000000318.
Clinical trial NCT06215131: Feasibility of Immersive Virtual Reality Dietician Program in Metabolic-dysfunction Associated Steatotic Liver Disease
Official title: Feasibility of Immersive Virtual Reality Dietician Program in Patients with Metabolic-dysfunction Associated Steatotic Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Weight Loss
Virtual Reality
Implementation Science
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 24
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: Metabolic-dysfunction associated steatotic liver disease, often referred to as "fatty liver disease", is a leading cause of liver failure. Dietary weight loss is a cornerstone of treating fatty liver disease, but access to traditional in-person nutritional education is often limited by cost, availability, and transportation. Immersive virtual reality (iVR) has the potential to not only overcome these barriers, but also provide an interactive learning experience, such as measuring and preparing foods. Therefore, the investigators have created and validated an iVR dietician program known as the Immersive Virtual Alimentation and Nutrition (IVAN) using evidence-informed practices from the Academy of Nutrition and Dietetics.

The goal of this project is to translate the IVAN program from human and patient research to practice and community research. The investigators plan to accomplish this by performing a randomized clinical trial evaluating the effect of the IVAN program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. Concurrently, the investigators will provide a survey assessing implementation outcomes to both groups as well as the dietician at each study visit, and crossover the intervention at study completion so all participants assess the IVAN program. Additionally, the investigators will have clinic health care providers experience the IVAN program and assess implementation outcomes.


Eligibility criteria: Inclusion Criteria:

* Adults age \>18 years
* MASLD identified on imaging
* Possession of a smartphone

Exclusion Criteria:

* Inability to provide informed consent
* Institutionalized/prisoner
* Pregnant
* Other causes of hepatic steatosis or chronic liver disease
* Severe medical/psychiatric comorbidities at the study PI's discretion

Primary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: Change in percent body weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in energy intake
timeFrame: 12 weeks
measure: Change in hepatic steatosis
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State
name: Justin Tondt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130231: Predictive Value of β2-microspheres for Postoperative Delirium
Official title: The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: Delirium β2-microspheres
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 184
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥65 years undergoing orthopedic operations under spinal anesthesia were investigated.

Brief summary: This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.

Detailed description: In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.

Eligibility criteria: Inclusion Criteria:

* ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia

Exclusion Criteria:

* decline to participate

Primary outcomes:
measure: The incidence of POD
timeFrame: 4 days
Secondary outcomes:
measure: The levels of β2-microspheres in plasma and cerebrospinal fluid
timeFrame: 1 day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Jian-jun Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03221231: N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Official title: N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cannabis Use Disorder
Cannabis Dependence
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of repeated NAC administration on glutamate concentrations in the anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.


Eligibility criteria: Inclusion Criteria:

* Current DSM-IV diagnosis of cannabis dependence, \>1 week detoxified and abstinent;
* Able to provide written informed consent and to comply with study procedures.
* Dutch speaking (Dutch as primary language).

Exclusion Criteria:

* Currently dependent on any substance other than cannabis, alcohol or nicotine;
* History of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease);
* An active or any history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (\>10 minutes), or migraine headaches;
* An active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders;
* Asthma;
* Known hypersensitivity or allergy to n-acetylcysteine, or receiving chronic therapy with medication that could interact adversely with n-acetylcysteine within 30 days prior to randomization (i.e., nitroglycerin, ACE inhibitors or antihypertensive drugs, anti-coagulants);
* Exclusion criteria for MRI: having metal in the body and/or having claustrophobia

Primary outcomes:
measure: Brain glutamate concentrations
timeFrame: at study end (2 weeks after study start)
Secondary outcomes:
measure: Motor impulsivity
timeFrame: at study end (2 weeks after study start)
measure: Cognitive impulsivity
timeFrame: at study end (2 weeks after study start)
measure: Attentional Bias
timeFrame: at study end (2 weeks after study start)
measure: Neuro-inflammation
timeFrame: at study end (2 weeks after study start)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels
Study officials:
References:
Clinical trial NCT00000331: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: Heroin Dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers.

Detailed description: not available at this time

Eligibility criteria: Inclusion Criteria:

Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures)

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Observed withdrawal rating
measure: Pupil diameter
measure: Drug effect characteristics
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05653960: Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry
Official title: The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Colorectal Neoplasms - A Multicenter Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenoma
Keywords: Endoscopic mucosal resection
Endoscopic submucosal dissection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who undergo EMR or ESD for colorectal lesions.

Brief summary: This study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Detailed description: Colorectal cancer (CRC) is one of the most common causes of cancer-related death, however its morbidity and mortality can be reduced by colonoscopy screening and endoscopic removal of adenomas or early cancers.\[1\] Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms. Despite being a safe and convenient procedure, insufficient resection by EMR can result in a high risk of local recurrence, particularly in lesions ≥ 20 mm. Compared with EMR, ESD facilitates a higher rate of en bloc resection and a lower rate of local recurrence. A recent meta-analysis revealed that the local recurrence rate after colorectal ESD was 1% during a 2-year follow-up period. In addition, ESD can facilitate precise pathological diagnosis to assess the risk of lymph node metastasis of early CRC to judge whether salvage surgery is needed. Although the efficacy of colorectal ESD has been demonstrated, its usage is largely limited by its technical difficulty and risk of complications.

Both short- and long-term data on clinical outcomes and safety profiles for colorectal EMR and ESD are needed. Therefore, this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Eligibility criteria: Inclusion Criteria:

* Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Curative resection rate of EMR or ESD for colorectal neoplasms
timeFrame: 10 years
measure: Adverse event rate of EMR or ESD for colorectal neoplasms
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Prince of Wales Hospital
name: Louis Lau
role: PRINCIPAL_INVESTIGATOR
References: