louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03832348: Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment
Official title: 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: PET scan imaging
Pembrolizumab
Response
Parametric imaging
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

Detailed description: Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed.

The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response.

Eligible patients with stage III/IV, PDL1\>50% NSCLC will receive pembrolizumab treatment as per standard of care.

Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months.

Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.

Eligibility criteria: Inclusion Criteria:

* Non operable non small cell lung cancer
* Indication of treatment by Pembrolizumab
* PD-L1 status superior to 50 %
* Age more than 18 years
* At least one measurable target
* Written inform consent

Exclusion Criteria:

* no treatment by pembrolizumab
* immunosuppressive treatment
* uncontrolled diabete
* Pregnancy or breast-feeding
* curatorship or guardianship
* not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

Primary outcomes:
measure: Determination of progression by early PET scan
timeFrame: 3 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU
Study officials:
affiliation: Centre Henri Becquerel
name: Stephanie Becker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Florian Guisier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873348: A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
Official title: A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Microbiota Transplantation
COVID-19 Infection
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 30 hospitalized patients with COVID-19 over 60 years old were enrolled in this study and were divided into the experimental group (n=15) and the control group (n=15) at a ratio of 1:1. Both groups were treated according to the 2022 Shanghai guidelines for Diagnosis and Treatment of COVID-19 infection and the hierarchical diagnosis and treatment process. The experimental group was treated with fecal microbiota transplantation (FMT) capsules for 1 week, and the control group was treated with empty capsules. Patients in both groups were followed up for 1 month after discharge. To observe the effect of combined FMT capsule treatment on the regulation of inflammatory factors in peripheral blood and the remodeling of intestinal flora, and to verify its safety.


Eligibility criteria: Inclusion Criteria:

* 1. Over 60 years old, male or female;

  2. Meet the diagnostic criteria of COVID-19;

  3. The patient signed the informed consent, agreed to receive FMT capsule treatment, agreed to cooperate with the whole process of the clinical trial, and agreed to collect clinical data and blood, saliva, urine, stool and other samples;

  4. The patient was able to swallow 3# capsules by herself.

Exclusion Criteria:

* 1. Confirmed diagnosis of non-COVID19 pneumonia;

  2. Critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules;

  3. Patients who had undergone gastrointestinal surgery;

  4. Presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.

  5. Pathological intestinal inflammatory changes, such as inflammatory bowel disease;

  6. Planned use of antacids, probiotics, antibiotics, FMT and other treatments affecting intestinal flora within the past 3 months or the following 2 months;

  7. Patients and their families did not agree to receive FMT treatment;

  8. Patients unable to cooperate with follow-up visits.

Primary outcomes:
measure: Changes of inflammatory factors in the two groups
timeFrame: 7day,1month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Li Long
Study officials:
affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
name: Long Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01030848: Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR
Official title: Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Total Knee Replacement
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital

Brief summary: The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.


Eligibility criteria: Inclusion Criteria:

* patients with knee osteoarthritis
* admitted for total knee replacement
* no rheumatoid arthritis
* no previous knee infection
* age 40-85 years

Exclusion Criteria:

-

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 10 years postoperatively
Other outcomes:
Locations:
city: Bærum
country: Norway
facility: Martina Hansens Hospital
Study officials:
affiliation: Martina Hansens Hospital
name: Tor Kjetil Nerhus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05495048: Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Official title: Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.


Eligibility criteria: Inclusion Criteria:

* volunteer to participate and the informed consent signed;
* 18-75 years;
* female who have given birth;
* pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
* preoperative staging cT1-3NanyM0
* body mass index \<30 kg/m2;
* willing to undergo laparoscopic right hemicolectomy

Exclusion Criteria:

* contraindications for laparoscopic surgery;
* emergency surgery due to acute intestinal obstruction, perforation or bleeding;
* distant metastasis;
* multiple colorectal cancer;
* has received preoperative chemoradiotherapy;
* with a history of other malignant tumors;
* unwilling to sign the informed consent or receive follow-up according to the study protocol.

Primary outcomes:
measure: disease-free survival rate
timeFrame: 3 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT06320548: The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section
Official title: The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: enhanced recovery after surgery
low-residue diet
obstetrics
perioperative management
cesarean section
postoperative ileus
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Pregnant women at ≥39 weeks of gestation scheduled for elective cesarean section at the Department of Gynecology of Policlinico Umberto I (Sapienza University of Rome) who gave written informed consent.

Exclusion Criteria:

* Urgent/emergent surgery
* Patients with gastrointestinal disorders
* Complicated pregnancy (e.g., active infection, placental adhesive disorders, hypertensive disorders), which would potentially prolong their hospitalization
* Incomplete medical records.

Primary outcomes:
measure: Number of participants who have passage of flatus within the first 24 hours after caesarean section.
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 12, 24, and 48 hours after surgery
measure: Postoperative complications
timeFrame: 24-48 hours after surgery
measure: Quality of the surgical field
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
References:
Clinical trial NCT04963348: Potential of Deep Learning in Assessing Pneumoconiosis Depicted on Digital Chest Radiography
Official title: Investigate the Potential of Deep Learning in Assessing Pneumoconiosis Depicted on Digital Chest Radiographs and to Compare Its Performance With Certified Radiologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumoconiosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 1881
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Of these subjects, 923 were diagnosed with pneumoconiosis, 958 were normal. Among these subjects, 163 were females.

Brief summary: Pneumoconiosis is relatively prevalent in low/middle-income countries, and it remains a challenging task to accurately and reliably diagnose pneumoconiosis. The investigators implemented a deep learning solution and clarified the potential of deep learning in pneumoconiosis diagnosis by comparing its performance with two certified radiologists. The deep learning demonstrated a unique potential in classifying pneumoconiosis.

Detailed description: The investigators retrospectively collected a dataset consisting of 1881 chest X-ray images in the form of digital radiography. These images were acquired in a screening setting on subjects who had a history of working in an environment that exposed them to harmful dust. Among these subjects, 923 were diagnosed with pneumoconiosis, and 958 were normal. To identify the subjects with pneumoconiosis, the investigators applied a classical deep convolutional neural network (CNN) called Inception-V3 to these image sets and validated the classification performance of the trained models using the area under the receiver operating characteristic curve (AUC).

Eligibility criteria: Inclusion Criteria:

* industrial workers with a history of exposure to dust and underwent DR screening of pneumoconiosis from 2015 to 2018

Exclusion Criteria:

* patients with poor image quality
* patients with incomplete clinical data

Primary outcomes:
measure: the diagnosis of pneumoconiosis
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Xiaohua Wang
role: STUDY_CHAIR
References:
Clinical trial NCT06993948: Hyperdynamic Left Ventricular Ejection Fraction as a Predictor of Mortality in Intensive Care Unit Patients With Septic Shock
Official title: Hyperdynamic Left Ventricular Ejection Fraction as a Predictor of Mortality in Intensive Care Unit Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperdynamic
Left Ventricular Ejection Fraction
Mortality
Intensive Care Unit
Septic Shock
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational study involved 235 patients admitted to the Intensive Care Unit (ICU) from August 2022 to July 2023.

Brief summary: The study aimed to evaluate the cause and prognosis of hyperdynamic left ventricular ejection fraction in critically ill patients with sepsis.

Detailed description: Cardiovascular dysfunction is increasingly being recognized as a significant complication in sepsis, affecting patient outcomes.

Among the key parameters used to evaluate cardiac performance is the left ventricular ejection fraction (LVEF), typically assessed via transthoracic echocardiography (TTE).

LVEF has been extensively studied; most investigations into preserved ejection fraction tend to group all values ≥50% together, thereby overlooking the potential clinical implications of LVEF ≥70%, often referred to as hyperdynamic LVEF (HDLVEF).

Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Both sexes.
* Patients who were diagnosed with septic shock.

Exclusion Criteria:

- Patients with previously documented abnormal transthoracic echocardiography (TTE) findings, such as severe valvular disease, poor echocardiographic windows, patients admitted to cardiothoracic intensive care unit (ICU), and those not meeting sepsis criteria.

Primary outcomes:
measure: Intensive care unit mortality
timeFrame: 28 days post-procedure
Secondary outcomes:
measure: Discharge against medical advice
timeFrame: 28 days post-procedure
measure: Incidence of patients who choose to leave the intensive care unit
timeFrame: 28 days post-procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05518448: The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
Official title: The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Ketosis
Keywords: Diabetes
Exogenous ketones
Postprandial glycemia
Endogenous glucose production
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2022-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Ketone vs placebo crossover
Primary purpose: BASIC_SCIENCE

Brief summary: What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

Detailed description: Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.

Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.

Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.

Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
* Non-smoking
* Blood pressure \<160/100 mm/Hg

Exclusion Criteria:

* Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
* Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
* Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
* Smoker
* Blood pressure \>160/100 mm/Hg
* Lactose intolerant

Primary outcomes:
measure: EGP
timeFrame: 6 hours
Secondary outcomes:
measure: Postprandial glycemia
timeFrame: 4 hours
measure: Insulin
timeFrame: 6 hours
measure: Plasma β-OHB
timeFrame: 6 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences, University of Exeter
state: Devon
Study officials:
References: