louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06693687: A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
Official title: A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.

Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.

Detailed description: Primary Objective • To determine the rate of therapy discontinuation due to toxicity among patients using ApricityCare.

Secondary Objectives

• To evaluate time the ease and experience of patient use of ApricityCare (i.e., patient engagement) in reporting symptoms during their systemic cancer treatments. Furthermore, the frequency of patient symptom reporting via check-in to ApricityCare will be evaluated, as will the time taken to respond and engage patients after they report toxicity or other adverse events via ApricityCare.

Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older
* Confirmed diagnosis of cancer

  * Part 1 (Run-in Phase): Only patients with prostate, kidney, and/or bladder cancer will be enrolled with either localized or metastatic disease.
  * Part 2 (Expansion Phase): Metastatic patients will be enrolled. Note, evaluable metastatic patients from Ppart 1 will be counted in Cohort A as described in section 8.4.
* Planned to receive systemic anti-cancer therapy
* Ability to understand and the willingness to sign a written informed consent document
* Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese
* Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF

Exclusion Criteria:

- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).

Primary outcomes:
measure: Safety and Adverse Events
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT06457087: Optical Biopsy for Peripheral Pulmonary Lesions
Official title: Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Pulmonary Lesions
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 150
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: Patients with peripheral pulmonary lesions scheduled for transbronchial lung biopsy.

Brief summary: The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.

Detailed description: CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years.
2. Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
3. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Patients with known allergy for fluorescein.
2. Pregnant or lactating women.
3. Patients with contraindications of bronchoscopy.
4. The investigators believe that patient has other conditions that are not suitable for the study.

Primary outcomes:
measure: Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs
timeFrame: 6 months post-procedure
measure: positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs
timeFrame: 6 months post-procedure
measure: Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs
timeFrame: 6 months post-procedure
measure: Incidence of complications
timeFrame: 1 month post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun
role: STUDY_DIRECTOR
References:
Clinical trial NCT00132587: Total Knee Arthroplasty (TKA) Cemented Versus Cementless
Official title: Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee arthroplasty
Femoral loosening
Total Knee Arthroplasty
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-22
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.

One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.

Patients will be reviewed at 2, 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
* Indication of surgical treatment by total knee arthroplasty
* Age between 50 and 90 years
* Acceptance and signature to participate

Exclusion Criteria:

* Rheumatoid or other inflammatory arthritis
* Association with other surgical procedure (osteotomy)
* Range of motion inferior to 90°
* Previous knee surgery (except arthroscopy)

Primary outcomes:
measure: IKS (International Knee Society) score at 12 months
Secondary outcomes:
measure: Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe NEYRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demey G, Servien E, Pinaroli A, Lustig S, Ait Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.
Clinical trial NCT00730587: Study of Body Composition Methodology in Young Children (InfantPod)
Official title: Development of a Body Composition Method for Infants and Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: Nutrition
Body Fat
Infant
Healthy Babies
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: University of Arkansas
First posted: 2008-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children in the greater Little Rock area.

Brief summary: The InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years.


Eligibility criteria: Inclusion Criteria:

* Healthy children between ages of 5 months and 3 years

Exclusion Criteria:

* Child that has any condition that may affect growth
* Child that has any chronic disease
* Child that has any carbohydrate metabolism disorder
* Child that takes any medications that may interfere with study parameters as determined by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Aline Andres, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06943287: Pharmacist Intervention to Improve Smoking Cessation
Official title: A Remote Pharmacist Intervention to Improve Smoking Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to assess the effectiveness of a remote pharmacist intervention to help smokers quit.

The main questions it aims to answer are:

* Will smokers being screened for lung cancer with low-radiation-level chest computed tomography (CT) be willing to participate in this study and talk to the pharmacist about smoking cessation?
* Will those in the intervention group be more likely to report smoking cessation than those in the control group.

Participants in the intervention group will be asked to complete a baseline survey; speak with a pharmacist via phone call at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks; and complete an exit survey.

Participants in the control group will be asked to complete a baseline survey and an exit survey.


Eligibility criteria: Inclusion Criteria:

* Current smoker
* Current patient in the Lung Cancer Screening Program

Exclusion Criteria:

* Unable to speak/read English
* Unable to provide their own written informed consent

Primary outcomes:
measure: Number of Interactions with Pharmacist
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Nicotine Replacement Therapies Used to Quit Smoking
timeFrame: 12 weeks
measure: Number of Non-Medication Tool Used to Quit Smoking
timeFrame: 12 weeks
measure: Number of Successful Quit Attempts
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Jacob E Simmering, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951087: Intravitreal and Intracameral DEX in NPDR
Official title: Effect of Intravitreal and Intracameral Injection of Dexamethasone Sodium Phosphate on Mild to Moderate NPDR During Cataract Phacoemulsification
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Non-Proliferative Diabetic Retinopathy
Keywords: non-proliferative diabetic retinopathy
cataract phacoemulsification
cystoid macular edema
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy

Detailed description: The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.

Eligibility criteria: Inclusion Criteria:

type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR

Exclusion Criteria:

-

Primary outcomes:
measure: measure the central point thickness (CPT) and central foveal thickness (CFT)
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Eye Institute, Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02410187: SBRT for Extra-cranial Oligorecurrent Tumor
Official title: Stereotactic Body Radiotherapy for Extra-cranial Oligorecurrent Tumor: Randomized Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Cancer
Keywords: stereotactic body radiotherapy
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 1
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: Clinical experience has shown that metastasis can often be limited in number and location, and thus amenable to local treatment. The term oligometastasis describes an intermediate state of cancer spread between localized disease and widespread metastasis. The implication of such an intermediate state is that the disease can be cured by using metastasis-directed therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical resection was often indicated, as abundant evidence suggested it could improve progression-free or overall survival. Recently, several studies have reported promising outcomes of \>80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver, non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have limitations of a retrospective nature and small sample sizes.Because allmost studies are based on single-arm studies without appropriate controls, the level of evidence to support SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for oligometastatic disease.

This study is designed as a randomized phase II study. Patients will be randomized between current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known disease.


Eligibility criteria: Inclusion Criteria:

* age \<18 years old
* ECOG score: 0-2
* number of distant metastases: 1-5
* all cancers (except lymphoma, myeloma, and germ cell tumor)
* status of primary lesion: cured
* pathologically confirmed cancer
* life expectancy: over 6 months

Exclusion Criteria:

* recurrent lesion which had been treated by radiotherapy
* complete response after systemic therapy
* patients who cannot be treated with SBRT due to any reason.
* pregnancy or breast-feeding
* malignant pleural effusion

Primary outcomes:
measure: disease progression free survival rate
timeFrame: 2 years
Secondary outcomes:
measure: overall survival rate
timeFrame: 2 years
measure: local control rate
timeFrame: 2 years
measure: Number of participants with radiation induced acute or late toxicity
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: mskim@kirams.re.kr
name: Mi-Sook Kim, M.D. Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01257087: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery
Official title: Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: Type 2 Diabetes Mellitus
Obesity
Bariatric Surgery
Glycaemic control
Microvascular complications
Intensive
Conservative
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.

Detailed description: Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

* Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery

Primary outcomes:
measure: Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6%
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively
timeFrame: 1 year after surgery
measure: Number of Participants With Microvascular Events
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Carel W le Roux, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130387: Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
Official title: Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Dehiscence
Abnormal Uterine Bleeding
Keywords: Hytsteroscopy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hysteroscopic examination for patients with AUB
Primary purpose: DIAGNOSTIC

Brief summary: Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding

Detailed description: Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding

Eligibility criteria: Inclusion Criteria:

Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :

* Normal complete blood count apart from paramaters of anemia
* Not using drugs affecting coagulation profile
* Bleeding is not related to pregnancy
* Not using intrauterine contraceptive devices or hormonal contraceptives
* By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors
* No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears

Exclusion Criteria:

* Any patient not fulfilling the inclusion criteria
* If the patient refused the technique ( office hysteroscopy )

Primary outcomes:
measure: Prevalence of cisarean section niche
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: