louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05629039: Implementing an Intervention Named Volitional Help Sheets to Reduce Smoking Behaviour Among Young Adults in Indonesia
Official title: Volitional Help Sheet to Promote Smoking Cessation Among Young Adults in Indonesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Volitional help sheets
Young adults
Smoking cessation
Indonesia
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 2700
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.

Detailed description: The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.

Eligibility criteria: Inclusion Criteria:

* Smokers whose ages are 20-45 years old

Exclusion Criteria:

* Non-smokers whose ages are below 20 years old and above 45 years old

Primary outcomes:
measure: Smoking Cessation
timeFrame: 6 months
Secondary outcomes:
measure: Nicotine dependence
timeFrame: 6 months
measure: Intervention evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Rina Rahmatika
Study officials:
affiliation: University of Manchester
name: Christopher Armitage
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Tim Millar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392222: Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others
Official title: Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Papillary Microcarcinoma
Keywords: focus group
11-108
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be recruited from Dr. Mike Tuttle's clinic.

Brief summary: The purpose of this study is to understand more about why some patients choose to have surgery to treat their papillary microcarcinoma (PMC) and others choose to have their papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may need surgery (referred to as "active surveillance"). The investigators also hope learn more about what patients and their family members worry about or feel they will gain from surgery or active surveillance.


Eligibility criteria: Inclusion Criteria:

Thyroid cancer patient eligibility will include:

* Thyroid cancer patients who have been diagnosed with papillary microcarcinoma (or subcentimeter thyroid lesions with fine needle aspiration biopsy suspicious for papillary or follicular thyroid cancer) within the prior 6-12 months as per EMR path report and clinician assessment;
* Presented with the option of treating their papillary microcarcinomas with either surgery or active surveillance as per treating physician;
* English-fluent;
* 18 years of age or older;

Patient-designated significant other eligibility will include:

* Nomination by patient as individual who assisted patient in decision-making regarding how to treat thyroid papillary microcarcinoma;
* English-fluent;
* 18 years of age or older;

Exclusion Criteria:

Thyroid cancer patient exclusion criteria will include:

* Thyroid cancer patients with known loco-regional or distant metastases prior to initial surgical intervention as per path report.

Primary outcomes:
measure: To explore patients' and families' perceived risks and benefits of active surveillance and surgery within the context of papillary microcarcinoma.
timeFrame: 5 years
Secondary outcomes:
measure: To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Smita Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155922: The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients
Official title: The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients, Special Relevance to Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Atherosclerosis
Keywords: Diabetes mellitus
Monocyte
Gene expression
Monocyte gene expression
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The investigators hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

Detailed description: Cardiovascular events are the leading cause of death in developed countries worldwide, including Taiwan. Type 2 diabetes mellitus (T2DM), previously considered merely as one of the risk factors, has been recently unanimously accepted to be coronary artery disease-equivalent. How T2DM may lead to accelerated atherosclerosis remains obscure.

Hyperglycemia with or without hyperinsulinemia may lead to higher oxidative stress and generalized inflammation. The oxidative stress and inflammation may play a significant role in the pathogenesis in diabetic complications, including micro- and macro-vascular complications. Macrophages together with T-lymphocytes are the earliest cell-types found in fatty-streaks, the earliest atherosclerotic lesions. Macrophages are also well known cellular mediators of oxidative stress and inflammation. Therefore, it is plausible to hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with T2DM. In addition, the other cell types of the peripheral white blood cells (WBC), such as neutrophils, have been shown to be intimately related to acute coronary syndrome. Therefore, the study on the biology of peripheral WBCs may tell us something about the pathophysiology of diabetic macro-vascular complications.

Methods:

1. Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
2. T2DM: FPG \>＝126 mg/dl.

   * Group 1 (good glycemic control): hemoglobin A1c (HbA1c) \<＝ 7% in the past 6 months
   * Group 2 (poor glycemic control): HbA1c \>＝ 8% in the past 6 months
3. Blood sample will be collected at baseline and after aggressive control.

Eligibility criteria: Inclusion Criteria:

* Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
* T2DM: FPG \>＝126 mg/dl.

  * Group 1 (good glycemic control): HbA1c\<＝7% in the past 6 months
  * Group 2 (poor glycemic control): HbA1c\>＝8% in the past 6 months

Exclusion Criteria:

* Acute systemic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Shiung Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02576522: Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor
Official title: Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 87
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: Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

Detailed description: Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Karnosky performance status (KPS) ≥70
* All Solid tumor (esclusion SCLC and Germinal tumors)
* Controlled primary tumor
* Controlled other metastatic site
* Single metastatic lesion at diagnosis
* Lesions ≥ 2.1 cm in maximum diameter (4 cm3), \< 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
* Estimated survival ≥ 3 months.
* Written informed consent

Exclusion Criteria:

* Prior WBRT
* KPS ≤ 70
* Other primary cancer
* Pregnant women

Primary outcomes:
measure: Local control rate
timeFrame: 6 months
Secondary outcomes:
measure: Distant brain failure
timeFrame: 6 months
measure: Overall survival, statistical
timeFrame: 6 months
measure: Morbidity/mortality after surgery
timeFrame: 1 month
measure: Radionecrosis after treatments
timeFrame: 6 months
measure: Neuropsycological alterations after treatments, questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Pierina Navarria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242422: Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery
Official title: Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Brief summary: The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Exclusion Criteria:

* any urinary tract infection
* pregnancy
* bladder malignancy
* postoperative follow-up of less than 12 months

Primary outcomes:
measure: Change in total overactive bladder symptom score (OABSS) after surgery
timeFrame: 1-week, and 1-, 3-, 6- and 12-months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: DongGuk University
name: Min Chul Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739022: Feasibility Trial of the Early Psychological Support for the Critically Ill
Official title: Feasibility Trial of the Early Psychological Support for the Critically Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PICS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)


Eligibility criteria: critically ill adults admitted to the medical intensive care unit (ICU) and expected to stay \>48 hours

Inclusion criteria:

-mechanically ventilated patients receiving vasopressors

Exclusion criteria:

* history of dementia
* mental retardation
* suicide attempt
* psychotic disorders such as schizophrenia
* patients on comfort care non-English speaking.

Primary outcomes:
measure: Impact of Events Scale-Revised (IES-R) score
timeFrame: 1 year
Secondary outcomes:
measure: feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)
timeFrame: 1 year
measure: Hospital Anxiety and Depression Scale (HADS) score
timeFrame: 1 year
measure: Montreal Cognitive Assessment-Blind (MoCA-blind) score
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lioudmila V Karnatovskaia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan Y, Gajic O, Schulte PJ, Clark MM, Philbrick KL, Karnatovskaia LV. Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Int J Clin Exp Hypn. 2020 Oct-Dec;68(4):419-432. doi: 10.1080/00207144.2020.1795663. Epub 2020 Jul 30.
Clinical trial NCT02514122: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Official title: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post Operative Pain
Pain
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: National University, Rwanda
First posted: 2015-08-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.

Detailed description: A randomized double blind control trial. All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary outcome will be a reduction in mean Pain Scores using parametric statistical analysis to discriminate significance. Pain will be measured using an 11-point numerical rating scale. Secondary outcomes will be the presence of significant side effects. This trial is a partnership between the University of Saskatchewan and the National University of Rwanda with ethics approval from each institutions ethics board.

Eligibility criteria: Inclusion Criteria:

- All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission

Exclusion Criteria:

* Allergy to Ketamine
* History of narcotic abuse or dependence
* Those patients for which decreased cognitive function is a barrier to accurate data collection

Primary outcomes:
measure: Postoperative Pain as Measured on a 11-point Numerical Rating Scale
timeFrame: The average of twice daily pain scores, from end of surgery until 60 hours postoperative.
Secondary outcomes:
measure: Hallucination
timeFrame: From end of surgery until 60 hours postoperative.
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: University of Rwanda
Study officials:
affiliation: University of Saskatchewan
name: William Mckay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacevich C, Semakuba B, McKay WP, Thakore S, Twagirumugabe T, Nyiligira J. Subcutaneous ketamine for postoperative pain relief in Rwanda: a randomized clinical trial. Can J Anaesth. 2018 Feb;65(2):170-177. doi: 10.1007/s12630-017-1009-7. Epub 2017 Nov 13.
Clinical trial NCT06896422: Randomized Trial of Glutathione with Anti-PD-1 and Chemotherapy in Advanced NSCLC
Official title: Prospective, Randomized Controlled Clinical Trial of Glutathione Combined with PD-1 Antibody and Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Chemotherapy
PD1 Antibody
Glutathione
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. However, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. Glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. Through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. To investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (NSCLC), investigators conducted this clinical study.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma.
2. Documented disease progression following first-line chemotherapy or chemo-immunotherapy.
3. Age ≥18 years at the time of enrollment.

Exclusion Criteria:

1. Patients with small cell lung cancer or other histological subtypes of lung cancer.
2. Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis.
3. Pregnant or lactating women

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months."
measure: Overall Response Rate (ORR)
timeFrame: From the initiation of treatment until 12 weeks
Secondary outcomes:
measure: Improvement in Immune Parameters
timeFrame: From baseline until 12 weeks post-treatment completion
measure: QLQ-LC43
timeFrame: From baseline until 24 weeks post-treatment completion
measure: Overall survival
timeFrame: From randomization until death from any cause, assessed up to 60 months.
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: the First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT05870722: An In Depth Study Evaluating The Experiences of Patients In Schizophrenia Research
Official title: Pinpointing the Factors Affecting Clinical Study Experiences of Schizophrenia Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Schizophrenia patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, research participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively.

Several people will be invited to enroll in this study so that it may collect a variety of data about schizophrenia clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The data collected from this study will be analyzed and used to improve the experiences of future schizophrenia patients who are recruited for medical trials.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with schizophrenia
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant

Primary outcomes:
measure: Number of patients who decide to participate in a schizophrenia research
timeFrame: 3 months
measure: Rate of patients who remain in schizophrenia clinical trial to trial completion
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Barnett PG, Scott JY, Rosenheck RA; CSP 555 Study Group. How do clinical trial participants compare to other patients with schizophrenia? Schizophr Res. 2011 Aug;130(1-3):34-9. doi: 10.1016/j.schres.2011.03.033. Epub 2011 Apr 22.
citation: Kishimoto T, Robenzadeh A, Leucht C, Leucht S, Watanabe K, Mimura M, Borenstein M, Kane JM, Correll CU. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2014 Jan;40(1):192-213. doi: 10.1093/schbul/sbs150. Epub 2012 Dec 17.
citation: Maric NP, Jovicic MJ, Mihaljevic M, Miljevic C. Improving Current Treatments for Schizophrenia. Drug Dev Res. 2016 Nov;77(7):357-367. doi: 10.1002/ddr.21337. Epub 2016 Sep 16.