louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05589480: Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection
Official title: Multimodal Data Prediction Based on Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with PCa who underwent radical resection

Brief summary: Recurrence of Pancreatic Cancer(PCa) is a multifactorial event. Based on the clinicopathological characteristics and imaging data of patients with PCa, the investigators used image processing and machine learning algorithms to build a more comprehensive and robust model, and added some unused features to explore its clinical application value.

A retrospective analysis of patients with PCa who underwent radical resection at Zhejiang Cancer Hospital (Hangzhou, China) from January 2013 to December 2020. The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing radical PCa surgery in the investigators' hospital. The investigators used the PyRadiomics platform to extract image features.


Eligibility criteria: Inclusion Criteria:

* Have the results of enhanced CT examination of the pancreas within 1 month before surgery in our hospital;
* Radical resection of pancreatic cancer was performed in our hospital;
* There are follow-up results in our hospital, and the follow-up endpoints include disease recurrence or at least 12 months.
* Complete clinical medical records and imaging data.

Exclusion Criteria:

* non-R0 resection;
* Combined with other malignant tumors
* The patient's imaging data has technical problems or the lesion is too small (less than 1cm), which is not suitable for omics analysis.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Province Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01489280: Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System
Official title: Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Temperature During Surgery
Keywords: Temple Touch Pro
Medisim
temperature
surgery
Lead sponsor: Medisim Ltd
Sponsor class: INDUSTRY
First posted: 2011-12-09
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ages 0 and up, patients subjected to elective surgery.

Brief summary: In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.

The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.


Eligibility criteria: Inclusion Criteria:

The patients will be chosen for the trial if the following criteria are met:

* Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.
* The surgical procedure requires temperature monitoring.
* Informed consent signed by the patient or his legal guardian.

Exclusion Criteria:

The patients will be excluded from the trial if one of the following occurs:

* The medical staff decides that the patient should not participate.
* Unavailable measurement site in case of operations performed in the head area.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
Clinical trial NCT03348280: Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
Official title: Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Hypertension
Vitamin D Deficiency
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patients with hypertension

Brief summary: This trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs. sufficiency will induce hormones that increase blood pressure.

Detailed description: More than half of patients with type 2 diabetes mellitus develop hypertension, which doubles their risk for cardiovascular disease. Inflammation plays a role in the development of these diseases, and monocytes, a type of white blood cell, may be critical. This study will isolate monocytes from blood samples of patients with type 2 diabetes and high blood pressure who have either high levels of vitamin D or low levels of vitamin D, and determine what their effects are on stimulating production in kidney cells of a hormone that increases blood pressure.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (T2DM)
* Age: 25-80 years old
* Vitamin 25(OH)D3 levels \<20 or \>30 ng/ml.
* HbA1c: 5.5%-9.5%
* Blood Pressure: \<160/100 mm Hg on BP lowering medications and
* Blood Pressure: \>120/80 to 160/100 mmHg without BP lowering medications

Exclusion Criteria:

* Recent weight loss of more than 5% within 3 months prior to screening
* Current Pregnancy
* Hypercalcemia
* Previous heart attack and stroke
* Heart failure
* Atrial fibrillation
* Heavy alcohol consumption
* Extreme diets (Atkins, South Beach)
* Chronic renal failure: stage 4 or worse
* \>2 + proteinuria on urine sample
* Chronic diseases known to affect immunity

Primary outcomes:
measure: Renin production by monocytes
timeFrame: 2 weeks
Secondary outcomes:
measure: Renin production by monocyte media
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish & Washington University Diabetes Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carlos Bernal-Mizrachi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03158480: Safety and Efficacy of Immune Therapy for Condyloma
Official title: Safety and Efficacy of Immune Therapy for Condyloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Condylomata Acuminata
Keywords: DC-CIK
interferon
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.


Eligibility criteria: Inclusion Criteria:All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital -

Exclusion Criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon

-

Primary outcomes:
measure: Condylomata Acuminata recurrence rate
timeFrame: 6 months
Secondary outcomes:
measure: skin tissue HPV gene
timeFrame: 6 months
measure: side effect
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00971880: Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects
Official title: Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Sickle Cell Anemia
Keywords: Blood transfusions
Adverse events
Hepatitis C
HIV
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving blood transfusions due to chronic hematologic disorders

Brief summary: Patients suffering from Thalassemia or another hemoglobinopathies required regular blood transfusions. The complications and adverse effects of blood transfusions can be classified as immediate and late. Among the immediate effects the most common are allergic reactions and fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are mostly related to blood transmitted infections like HIV or Hepatitis C infections.

The purpose of this study is to summarize the data of those complications in a cohort of 100 patients receiving regular blood transfusion.

Detailed description: About 100 patients aged several months to 50 years are treated in the Pediatric Hematology Unit, most of those patients receive blood transfusions monthly. The adverse reactions were routinely recorded during each transfusion. All the patients were also screened annually for the incidence of blood transmitted infections principally HIV and Hepatitis C. All those records will be systematically screened and all the immediate or late adverse reactions and complications related to blood transfusions will be summarized.

A second goal of this study will be to control the staff strictness related to the ministry of health protocol dealing to blood transfusions.

Eligibility criteria: Inclusion Criteria:

* Patients receiving blood transfusions due to chronic hematologic disorders

Exclusion Criteria:

* Not applicable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
References:
Clinical trial NCT02425280: Effectiveness of Narrative Exposure Therapy Among Refugee Children and Adolescents
Official title: How to Help War-affected Children and Adolescents: the Role of Memory Functions in Therapeutic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narrative Exposure Therapy
Treatment as Usual
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to understand how war trauma affects children's and adolescents' memory functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing optimal memory functions and alleviating mental health problems. The study analyzes the mental health and cognitive and emotional healing mechanisms of therapeutic intervention among war-affected children and adolescents.


Eligibility criteria: Inclusion Criteria:

* 9-17 years old
* has spent some part of her/his life living in a country where organized violence was taking place, or at a refugee camp
* suffers from significant stress symptoms thought be trauma-related

Exclusion Criteria:

* acute psychosis
* intellectual disability

Primary outcomes:
measure: Post-traumatic Stress as measured by Revised Impact of Event Scale
timeFrame: 9 months
measure: Depression as measured by Depression Self-Rating Scale for Children
timeFrame: 9 months
measure: Psychological Distress as measured by Strengths and Difficulties Questionnaire
timeFrame: 9 months
measure: Resilience as measured by Child and Youth Resilience Measure
timeFrame: 9 months
measure: Cognitive Performance as measured by Working Memory Test Battery for Children
timeFrame: 9 months
Secondary outcomes:
measure: Quality of Traumatic Memory as measured by Trauma Memory Quality Questionnaire
timeFrame: 9 months
measure: Trauma Related Cognitions as measured by Children's Post Traumatic Cognitions Inventory
timeFrame: 9 months
measure: General functioning of autobiographical memory as measured by reported life events
timeFrame: 9 months
Other outcomes:
measure: Subjective distress during therapy measured by Subjective Units of Distress Scale
timeFrame: 9 months
measure: Peritraumatic Dissociation measured by Peritraumatic Dissociative Experiences Questionnaire
timeFrame: once, at baseline
Locations:
city: Helsinki
country: Finland
facility: Centre for Torture Survivors
city: Tampere
country: Finland
facility: Family Counselling Centre of the City of Tampere
city: Tampere
country: Finland
facility: Psychiatric Clinic for Traumatized Children at Tampere University Hospital
Study officials:
References:
citation: Kangaslampi S, Garoff F, Peltonen K. Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change. BMC Psychiatry. 2015 Jun 17;15:127. doi: 10.1186/s12888-015-0520-z.
Clinical trial NCT02733562: Results of Sleeve Gastrectomy Surgery in Relation With Eating Habits (After One Year)
Official title: The Effect of Different Eating Habits on Weight Loss in the First Year After Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Habit and Impulse Disorders
Obesity
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients underwent sleeve gastrectomy

Brief summary: Sleeve gastrectomy is one of the most common surgical procedures performed today for patients that undergo bariatric surgery. One of the primary reasons for morbid obesity is unhealthy eating habits and the belief that changes in those habits can ensure the success. Objectives: The investigators aimed to explore the effect of different eating habits prior to the bariatric surgery on the surgery success and on different aspect of quality of life. Design: The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation.

Detailed description: The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation. The investigators divided the patients into groups according to their pre-operation eating habits: binge, sweet, snack and high volume and compared different aspects of the surgery such as weight loss, BMI and distance from ideal weight. The investigators also examined the effect of the surgery on the quality of life, sexual life, physical activity, eating habits and satisfaction from the surgery by a telephonic survey that was conducted up to one year after the surgery.

Eligibility criteria: Inclusion Criteria:

* morbid obesity
* approved for bariatric surgery by the hospital's committee
* Patients that underwent primary surgery

Exclusion Criteria:

* recurrent surgery

Primary outcomes:
measure: weight loss
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nikiforova I, Barnea R, Azulai S, Susmallian S. Analysis of the Association between Eating Behaviors and Weight Loss after Laparoscopic Sleeve Gastrectomy. Obes Facts. 2019;12(6):618-631. doi: 10.1159/000502846. Epub 2019 Nov 20.
Clinical trial NCT00939562: Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Official title: An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infection
Keywords: Bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 18 to 30 kg/m2.

Exclusion Criteria:

* Evidence or history of clinically significant abnormality.
* Any condition possibly affecting drug absorption.
* A positive urine drug screen.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Doxycycline
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
measure: Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05112562: Attentional Bias Modification Training for E-cigarette Users
Official title: Attentional Bias Modification Training for E-cigarette Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: E-cigarette Use
Tobacco Use Cessation
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.


Eligibility criteria: Inclusion Criteria:

* 18 and 29 years
* Those who use ENDS exclusively, not combining with other tobacco, for 3 consecutive months
* Those who own a smartphone.

Exclusion criteria:

* Current medication or psychosocial treatment for ENDS dependence
* Serious alcohol-use problems (≥ 26 points on the Alcohol Use Disorders Identification Test)
* Ophthalmic conditions impeding eye-tracking
* Current psychiatric/psychosocial treatment for other mental health disorders in the DSM-5 (e.g., schizophrenia)
* Pregnancy.

Primary outcomes:
measure: Attentional bias to e-cigarette cues measured by cueing task
timeFrame: Pre-training
measure: Attentional bias to e-cigarette cues measured by cueing task
timeFrame: 1-month follow up
measure: Attentional bias to e-cigarette cues measured by cueing task
timeFrame: 2-months follow up
measure: Attentional bias to e-cigarette cues measured by cueing task
timeFrame: 4-months follow up
Secondary outcomes:
measure: Subjective urges for e-cigarette use
timeFrame: Pre-training
measure: Nicotine dependence
timeFrame: Pre-training
measure: Subjective urges for e-cigarette use
timeFrame: 1-momnth follow up
measure: Nicotine dependence
timeFrame: 1-month follow up
measure: Subjective urges for e-cigarette use
timeFrame: 2-momnth follow up
measure: Nicotine dependence
timeFrame: 2-month follow up
measure: Subjective urges for e-cigarette use
timeFrame: 4-momnth follow up
measure: Nicotine dependence
timeFrame: 4-month follow up
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Seok Hyun Gwon, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: