louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06674928: Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay
Official title: Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetics
Life Participation
Keywords: Developmental delay
Life participation
Quality of life
Whole-exome sequencing
Gene
Children Development
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimental group

Brief summary: The goal of this observational study is to learn the factors affecting the quality of life in children's development.

The main hypothesis for this study is:

If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation?

Participant will be given assessment every year for five years in total. No intervention will be given during the whole study period.


Eligibility criteria: Normal developing children

Inclusion Criteria:

* Agreeing in consent
* In the age range of 6-15 years old

Exclusion Criteria:

* Diseases of Central Nervous System
* Diseases of Neuromuscular
* Nature deficit disorder
* Genetic Disorder
* Sensory Integration disorder
* Auditory disorder

Development delay children

Inclusion Criteria:

* Agreeing in consent
* In the age range of 6-15 years old
* Diagnosed of Developmental Delay

Exclusion Criteria:

* Diseases of Central Nervous System
* Diseases of Neuromuscular
* Nature deficit disorder
* Genetic Disorder
* Sensory Integration disorder
* Auditory disorder

Primary outcomes:
measure: Score of participation (< 3y)
timeFrame: baseline
measure: Score of participation (3y > 15y)
timeFrame: Baseline
Secondary outcomes:
measure: Gene Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02202928: Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer
Official title: Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Keywords: Colorectal cancer
DC-CIK
Autologous tumor lysate
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Jingzhou Central Hospital
First posted: 2014-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Detailed description: 60 patients with stageⅠ\~ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.

Eligibility criteria: Inclusion Criteria:

* 18\~80 years old;
* Histologically confirmed with colorectal cancer at stage Ⅰ\~Ⅲ;
* Patients who can accept curative operations;
* Patients who have a life expectancy of at least 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times ;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* History of organ allograft;
* Patients who had distant metastases;
* Patients who had active infection;
* Prior use of any anti-cancer treatment in 30 days;
* Now or recently will join another experimental clinical study ;
* Other situations that the researchers considered unsuitable for this study.

Primary outcomes:
measure: Progress-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Quality of life (QOL)
timeFrame: 3 Years
measure: Phenotypic analysis of T cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Jingzhou
country: China
facility: Jingzhou Central Hospital Immunotherapy center
state: Hubei
Study officials:
affiliation: Jingzhou Central Hospital
name: Ke N Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04489628: Tele-health Enabled Clinical Trial for COVID-19
Official title: Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: SARS-CoV Infection
Keywords: Vitamin D
Telehealth
SARS-CoV-2
Immune Storm
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2020-07-28
Enrollment: 0
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: To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Laboratory confirmed SARS-CoV-2 infection \< 4 days before randomization
3. Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) \<4 days before admission
4. Asymptomatic or mild symptoms (not requiring hospital admission)
5. Access to and ability to use a mobile phone with telehealth capability

Exclusion Criteria:

1. Unable to provide informed consent or comply with study directions
2. Admitted to an acute care bed
3. Baseline serum calcium \< 8.8 mg/dL or \> 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care)
4. Women who are currently breastfeeding
5. History of kidney stone in the past year or h/o multiple (\>1) previous kidney stones
6. Does not have a smart phone that can download apps from Google Play or App Store.
7. No way to keep the phone charged consistently
8. The smartphone is shared with another individual.
9. Required laboratory data is unavailable (eg calcium levels)
10. No new oxygen requirement (see remote monitoring document)
11. Pregnant and lactating mothers.
12. Vitamin D level of 80ng/ml and above
13. No lab work for calcium or vitamin D completed in ED

Primary outcomes:
measure: Patients requiring admission to the hospital or experiencing death
timeFrame: Days 1 to 15
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Kevin Cooper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Wesley Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03993028: The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability for the ProLung Test and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
Official title: The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Fresh Medical Laboratories
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: Assess the repeatability of the ProLung Test

Detailed description: This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same device. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested.

Eligibility criteria: Inclusion Criteria:

* Age 35 to 70 years
* Able to understand and fulfill all requirements of this protocol
* Provide signed informed consent

Exclusion Criteria:

* Pacemaker or other implanted medical device
* Current life-threatening medical condition
* Current or recent use of systemic corticosteroids
* Pregnant or lactating
* Unusually strenuous exercise within previous 24 hours
* Current abuse of alcohol or drugs
* Medical or anatomical condition that precludes testing of all 62 measurement points
* Other condition or reason at the discretion of the Principal Investigator or medical monitor

Primary outcomes:
measure: Quantify EPN Scanner variability in transcutaneous volume-averaged thoracic bio-conductance when measured twice on the same subjects by the same operator on a single same day using the same EPN Scanner
timeFrame: 1 day
measure: Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week.
timeFrame: 1 week
measure: Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance
timeFrame: 1 week
measure: Number of participants with device-related adverse events from thoracic bio-conductance measurement.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06157528: Diagnosis of Pelvic Endometriosis in MRI
Official title: Diagnosis of Pelvic Endometriosis: a Preliminary Study on the Added Value of R2*MFGRE Sequence in MRI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose： Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2\*MFGRE) imaging in the diagnosis of pelvic endometriosis.

One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2\*MFGRE imaging. Clinical diagnosis was pathologically confirmed one month after MRI examination. Three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (OMAs) and deep in-filtrating endometriosis (DIE) lesions using routine MRI and its combination with R2\*MFGRE. MRI changes of lesion size before and after estrogen therapy.

Detailed description: This prospective study was approved by the Ethics Committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). All procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the Declaration of Helsinki.

Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2\*MFGRE imaging from Decemberr 2017 to December 2023. Of those, One hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. The diagnosis was confirmed by pathology within one month after the initial MR exam. Additionally, 20 out of 160 patients were excluded from the study. Of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. Finally, One hundred patients were included in the study.

All 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. Their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. Some of these patients had multiple symptoms

Eligibility criteria: Inclusion Criteria:

* patients who proven endometriosis by pathology Patients who wish to be treated

Exclusion Criteria:

* Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts

Primary outcomes:
measure: Measuring the number of lesions
timeFrame: immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03859128: Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
Official title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 402
Sex: ALL
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: This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.


Eligibility criteria: Inclusion Criteria:

1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
2. BICR confirmed no resdual tumor lesions are detected in liver;
3. Child-Puch score, Class A;
4. ECOG score is 0;

Exclusion Criteria:

1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
3. With symptoms of central nervous system metastasis;
4. With any history of active autoimmune disease or autoimmune disease;
5. Known liver diseases with clinical significance;
6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: BICR-RFS
timeFrame: Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)
Secondary outcomes:
measure: Investigator-RFS
timeFrame: up to 44 months
measure: 12-month recurrence-free survival rate (RFS12)
timeFrame: up to 44 months
measure: 24-month recurrence-free survival rate (RFS24)
timeFrame: up to 44 months
measure: Time to recurrence (TTR)
timeFrame: up to 44 months
measure: Time to local recurrence (TTLR)
timeFrame: up to 44 months
measure: Overall survival (OS)
timeFrame: up to 44 months
measure: 12- and 24-month overall survival rate (OS12 and OS24)
timeFrame: up to 44 months
measure: Incidence of AEs
timeFrame: up to 44 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05677828: SMART Protocol vs Antagonist Protocol in IVF
Official title: Effect of the Addition of Letrozole in in Vitro Fertilization (IVF) Following a Prior Failed IVF Cycle With an Antagonist or Short Protocol Without Letrozole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diminished Ovarian Reserve
Keywords: IVF
Fertility issues
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 426
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation protocols during the period from 2010 to 2020.

Brief summary: This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.

Detailed description: A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole.

In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer

Eligibility criteria: Inclusion Criteria for the SMART IVF protocol:

* Women between the ages of 20 and 42 inclusively
* Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group)
* Delay of 1 year between both IVF cycle

Exclusion Criteria:

* Women undergoing fertility preservation
* Oocyte donation IVF cycles
* Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)

Primary outcomes:
measure: Number of utilizable blastocysts obtained
timeFrame: approximately 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Robert Hemmings, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594328: Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women
Official title: Evaluating the Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women: a Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Oral Health
Pregnancy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gingivitis is a common condition, affecting more than 60% of pregnant women due to hormonal changes and inadequate plaque control. Left untreated, gingivitis can lead to more serious periodontal diseases and systemic inflammation, posing risks to overall health and reducing quality of life. Therefore, the study aims to assess the effectiveness of text messages in maintaining gingival health in pregnant women. The primary objective is to determine whether these reminders, which focus on proper brushing and flossing techniques, can reduce gingivitis and improve overall oral hygiene during pregnancy.

This research follows a two-group, parallel-arm, single-blind randomized control trial (RCT) design. The trial will be conducted at the Department of Gynecology and Obstetrics at the University of Lahore Teaching Hospital. Eligible participants are adult pregnant women showing signs of gingivitis, excluding those with bleeding disorders or moderate to severe pre-existing periodontal disease. Participants are randomly assigned to either a control group or an intervention group using computer-generated randomization.

Both groups will undergo oral health assessments at baseline, using the Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) measures to gauge plaque buildup and gingival inflammation. Follow-up assessments will be conducted at 4-6 weeks and 12-16 weeks. The intervention group will receive a weekly text message reminding them to practice proper oral hygiene, such as brushing and flossing. Both groups will also receive in-person demonstrations of oral hygiene techniques to ensure standardized knowledge on effective oral care.


Eligibility criteria: Inclusion Criteria:

* Adult pregnant female in 2nd trimester.
* Access to a personal mobile phone.
* Suffering from gingivitis (\&gt; 10% sites with bleeding on probing)

Exclusion Criteria:

* Bleeding disorders.
* Pre-existing moderate to severe periodontal disease.

Primary outcomes:
measure: Oral Health Status
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Saima Chaudhry
role: STUDY_CHAIR
References: