louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02967445: Physical Examination-Indicated Pessary
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: PreTerm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical insufficiency, previously referred to as cervical incompetence, has classically been defined as painless dilation of the cervix in the absence of contractions or bleeding in the second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical dilation is an uncommon finding in the general population occurring in less than 1% of pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm births and/or second trimester losses, as well as second trimester cervical dilatation in the index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has been variably referred to as "physical exam-indicated cerclage", "rescue cerclage", and "emergency cerclage". To date, the benefits of cerclage for this indication are not entirely clear.

A recent meta-analysis showed that physical exam-indicated cerclage is associated with a reduction in perinatal mortality and prolongation of pregnancy when compared to no such cerclage.

Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB in several populations.

Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester cervical dilation


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation

Exclusion Criteria:

* Pessary or cerclage already in situ
* active vaginal bleeding
* Placenta previa/accreta
* Multiple gestations
* Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
* Ruptured amniotic membranes at the time of diagnosis of dilated cervix
* Cervical dilation more than 5 cm
* Labor (progressing cervical dilation) or painful regular uterine contractions

Primary outcomes:
measure: Neonatal survival
timeFrame: From delivery to 28 days
Secondary outcomes:
measure: Preterm birth
timeFrame: time of delivery
measure: Latency
timeFrame: time of delivery
measure: Birth weight
timeFrame: time of delivery
measure: gestational age at delivery
timeFrame: time of delivery
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
Clinical trial NCT04111445: Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Official title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Adagene Inc
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.


Eligibility criteria: Inclusion Criteria

* Male or female, 18-75 years of age at the time of consent.
* Provide written informed consent.
* Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
* Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Adequate organ and bone marrow function
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study

Exclusion Criteria:

* Pregnant or nursing females.
* Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
* Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
* Any active autoimmune disease or documented history of autoimmune disease.
* Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
* Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
* History of clinically significant cardiac disease.
* Uncontrolled current illness.

Primary outcomes:
measure: Number of participants experiencing dose-limiting toxicities
timeFrame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
measure: Number of participants experiencing clinical and laboratory adverse events (AEs)
timeFrame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
Study officials:
References:
Clinical trial NCT05315245: Acute Gastrointestinal Injury in Pediatrics
Official title: Acute Gastrointestinal Injury in Critically Ill Children in Pediatric Intensive Care Unit of Cipto Mangunkusumo Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Gastrointestinal Injury
Gastrointestinal Failure
Critical Illness
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All critically ill patients admitted to PICU

Brief summary: Critically Ill children may develop acute gastrointestinal injury secondary to severe inflammation.

Detailed description: Data collection from enrolled subjects including profile, laboratory examinations, inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and finally outcome of the patient

Eligibility criteria: Inclusion Criteria:

* critically ill pediatric patients receiving care at the PICU
* presence of AGI (any degree)

Exclusion Criteria:

* patients who's body weight cannot be measured

Primary outcomes:
measure: PELOD-2 score
timeFrame: time of AGI diagnosis, day-1 PELOD-2 score
measure: mortality
timeFrame: days from PICU admission date up to 28 days follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Antonius H Pudjiadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04767945: Cirrhosis Registry of Hospitalized Patients
Official title: Registry of Adult Consenting Patients Admitted to the Liver Unit With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis, Liver
Frailty
Ascites
Encephalopathy
Infection
Keywords: Cirrhosis
decompensation
frailty
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included are patients with liver cirrhosis and indication for hospital admission who are or are not candidates for liver transplant and have or do not have liver cancer

Brief summary: Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit

Detailed description: On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate.

After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution \[FDR\]) Mortality data are uploaded from the national registry of dead on regular basis

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis (primarily on clinical grounds)
* decompensating event leading to hospital admission
* informed consent

Exclusion Criteria:

* declined consent

Primary outcomes:
measure: Frequency and type of decompensation of liver cirrhosis
timeFrame: "1 year"
measure: Mortality
timeFrame: "1 year"
Secondary outcomes:
measure: Mortality
timeFrame: 90-day
measure: Mortality
timeFrame: 1 year
measure: Frailty
timeFrame: On admission
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: F.D.Roosevelt Teaching Hospital
Study officials:
affiliation: F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
name: Lubomir Skladany, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00910845: Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 557
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: The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* History or evidence of pelvic or urological abnormality

Primary outcomes:
measure: Change From Baseline in Number of Daily Episodes of Urinary Incontinence
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Number of Daily Micturition Episodes
timeFrame: Baseline, Week 12
measure: Change From Baseline in Volume Voided Per Micturition
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Victoria
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.
citation: Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5.
citation: Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.
Clinical trial NCT05857345: Breastmilk as a Source of Lactocytes
Official title: Assessing Gene Expression in Lactocytes Using Human Breast Milk as a Non-Invasive Source: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastmilk Collection
Micronutrients
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lactating mothers in Germany

Brief summary: The objective of this study is to determine the suitability of lactocytes derived from human breast milk for gene expression analysis, and to explore whether there are any correlations between gene expression and the micronutrient composition of breast milk.

Detailed description: Participants will be included in the study if they are willing to express milk and if their child is between 2 weeks and 6 months old. Participants' feeding practices (exclusive breastfeeding/non-exclusive breastfeeding) and micronutrient supplementation will be recorded. On the day of donation, child's age, the health status of both the mother and child (sick/not sick), the time of sample collection, and the number of feeding sessions that have taken place since midnight will be recorded.

Eligibility criteria: Inclusion Criteria:

* Willingness to express breastmilk
* Breastfed infant aged between 2 weeks and 6 months

Exclusion Criteria:

* Not willing to express breastmilk
* Infant older or younger than specified

Primary outcomes:
measure: Gene Expression
timeFrame: 6 month after completion
measure: Micronutrient Content
timeFrame: 6 month after completion
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
References:
Clinical trial NCT03499145: Validation of the Utility of Ophthalmology Intelligent Diagnostic System
Official title: Validation of the Utility of Ophthalmology Intelligent Diagnostic System: A Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmopathy
Artificial Intelligence
Keywords: conjunctivitis
keratitis
pterygium
cataracts
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: Xidian University
First posted: 2018-04-17
Enrollment: 615
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective study of patients and residents who use the web platform for diagnosis.

Brief summary: The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. Application scenarios of the current medical algorithms are too simple to be generally applied to real-world complex clinical settings. Here, the investigators use "deep learning" and "visionome technique", an novel annotation method for artificial intelligence in medical, to create an automatic detection and classification system for four key clinical scenarios: 1) mass screening, 2) comprehensive clinical triage, 3) hyperfine diagnostic assessment, and 4) multi-path treatment planning. The investigator also establish a telemedicine system and conduct clinical trial and website-based study to validate its versatility.


Eligibility criteria: Inclusion Criteria:

* Patients and residents who underwent ophthalmic examination of the eye and recorded their ocular information in the outpatient clinic and community.

Primary outcomes:
measure: The proportion of accurate, mistaken and miss detection of the ophthalmology diagnostic system.
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Li W, Yang Y, Zhang K, Long E, He L, Zhang L, Zhu Y, Chen C, Liu Z, Wu X, Yun D, Lv J, Liu Y, Liu X, Lin H. Dense anatomical annotation of slit-lamp images improves the performance of deep learning for the diagnosis of ophthalmic disorders. Nat Biomed Eng. 2020 Aug;4(8):767-777. doi: 10.1038/s41551-020-0577-y. Epub 2020 Jun 22.
Clinical trial NCT01420445: Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
Official title: Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bronchitis
Chronic Bronchitis
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 118
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: The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.

The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.

Detailed description: The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged ≥18 year
* Provision of written informed consent
* Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points

Exclusion Criteria:

* History of any clinically significant disease
* History of drug/chemical/alcohol abuse
* Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product

Primary outcomes:
measure: Change of total symptom score from baseline to the end of treatment
timeFrame: 7 days
Secondary outcomes:
measure: safety assessment
timeFrame: 7 days
measure: time to response
timeFrame: 7 days
measure: compliance, defined by drug accountability
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary'S Hospital
Study officials:
affiliation: Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea
name: Young Kyoon Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05260645: Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Official title: Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Exercise Therapy
Health Education
Primary Prevention
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education).

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region.Therefore, the main aim of this innovative study is to to investigate the effects of a Back School based intervention on the prevention of neck pain and as secondary objectives to investigate the effects on neck flexor and extensor strength as well as scapular stability. The hypothesis is that this BS-based intervention would have positive effects on neck pain prevention, neck strength and scapular stability.


Eligibility criteria: Inclusion Criteria:

* Ages 18 - 65 years old.
* Not have had neck pain in the last 6 months.

Exclusion Criteria:

* Previous neck or shoulder surgery, cervical radiculopathy/myelopathy, history of the whiplash injury.
* Taking any medication or having any musculoskeletal, rheumatic, metabolic, cardiological, cognitive disorder or neurological disorder.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.

Primary outcomes:
measure: Changes in the incidence of neck pain.
timeFrame: From the end of the back school intervention until 12 months of follow-up
measure: Changes in the duration of neck pain.
timeFrame: From the end of the back school intervention until 12 months of follow-up
measure: Changes in the Numeric Pain Rating Scale.
timeFrame: From the end of the back school intervention until 12 months of follow-up
measure: Changes in the medical visits from baseline to eight months.
timeFrame: From the end of the back school intervention until 12 months of follow-up
Secondary outcomes:
measure: Neck flexor muscle endurance.
timeFrame: Baseline and two months.
measure: Neck extensor muscle endurance.
timeFrame: Baseline and two months.
measure: Scapular stabiliser endurance
timeFrame: Baseline and two months.
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Pablo Hernández Lucas
Study officials:
References: