louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03144700: The Natural History and Prognostic Factors of Compensated Cirrhosis.
Official title: The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compensated Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Compensated Cirrhosis

Brief summary: Study Design and Methodology

* Study Population:Compensated Cirrhosis
* Study Design: An Ambi Prospective Cohort study
* Study Period: 2 Years
* Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.
* Intervention: This is an observational study. No intervention will be given.

Monitoring and assessment: All the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years
2. Compensated cirrhosis
3. Biopsy proven cirrhosis or LSM \> 12.5 Kpa.

Exclusion Criteria:

1. Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage).
2. Pregnant Women
3. Hepatocellular Carcinoma
4. Known case of severe cardiopulmonary disease
5. Known case of severe Hepato Pulmonary Syndrome

Primary outcomes:
measure: Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
timeFrame: 2 years
Secondary outcomes:
measure: Patients with new onset/progression of esophageal varices during the period of 2 years
timeFrame: 2 years
measure: Reduction in portal pressure with >20% from baseline at 6 months
timeFrame: 6 months
measure: Reduction in portal pressure with >20% from baseline at 1 year
timeFrame: 1 year
measure: Reduction in portal pressure with >20% from baseline at 2 year.
timeFrame: 2 year
measure: Survival during the period of 2 years.
timeFrame: 2 years
measure: Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.
timeFrame: 2 years
measure: Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.
timeFrame: 2 years
measure: Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.
timeFrame: 2 years
measure: Number of patients develop Hypersplenism during follow up period of 2 years.
timeFrame: 2 years
measure: Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT04122300: Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct
Official title: Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct - a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congenita Nasolacrimal Duct Obstruction
Preterm Neonates
Ocular Discharge
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Congenital nasolacrimal duct obstruction (CNLDO) occurs in approximately 10 to 20% of all term newborns, and is the most common cause of persistent tearing and ocular discharge in children. CNLDO causes symptoms in up to 6% of children during the first year of life. The first clinical signs appear during the first month of life in 95% of cases and usually consist of tearing and debris on the eyelashes ("mattering"). Mucopurulent eye discharge occurs commonly in infants with CNLDO and, in the absence of other signs of infection, suggests bacterial overgrowth in the stagnant tear pool of the lacrimal sac.

This study investigates whether early administration of Euphrasia eye drops (Weleda AG, Arlesheim) in preterm neonates presenting with first ocular discharge with or without tearing and reddened eye fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy.


Eligibility criteria: Inclusion Criteria:

* Preterm neonates (with a gestational age of 24 to 37 weeks)
* Presenting with first signs of a congestion of the nasolacrimal duct, i.e. white, yellow, or green ocular discharge with or without tearing and reddened eye.
* Written informed consent by the parents or legal guardians

Exclusion Criteria:

* Congenital abnormalities of the eye
* Ophtalmia neonatorum
* Severe asphyxia
* Sepsis
* Intracranial bleeding (intraventricular hemorrhage ≥ grade III)

Primary outcomes:
measure: Number of patients with treatment success at 96 hours
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neonatology, Children University Hospital of Bern
Study officials:
affiliation: Institute for complementary and integrative medicine
name: Ursula Wolf
role: STUDY_CHAIR
References:
citation: Meier-Girard D, Gerstenberg G, Stoffel L, Kohler T, Klein SD, Eschenmoser M, Mitter VR, Nelle M, Wolf U. Euphrasia Eye Drops in Preterm Neonates With Ocular Discharge: A Randomized Double-Blind Placebo-Controlled Trial. Front Pediatr. 2020 Aug 11;8:449. doi: 10.3389/fped.2020.00449. eCollection 2020.
Clinical trial NCT00188500: Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy
Official title: Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
atkins diet
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures

Detailed description: In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet.

In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet.

Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.

Eligibility criteria: Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food

-

Exclusion Criteria:

* Low BMI

Primary outcomes:
measure: seizure reduction
Secondary outcomes:
measure: cognitive improvement
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: UHN
name: J Martin delCampo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254500: To Investigate the Event Related Potentials (ERPs) of Patients With Brain Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Lesions
Keywords: patients with brain lesions
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with brain lesions young normal controls old normal controls

Brief summary: Event-related potentials (ERPs）has the advantage of excellent temporal resolution on measuring real-time neural activities that reflect to higher level cognitive processes. A research project related to lesion studies in which patients with cognitive function impairment and communication disorder will be recruited as participants to examine their impairment as well as residual abilities by using ERPs. Hopefully, expected findings will provide further analysis based on the patterns of neural activities revealed by both patients and normal controls should be able to provide important evidence toward building the cross-linguistic theory. The findings also have applications on diagnostic and evaluation for patients with brain lesions for clinical application with communication disorder.


Eligibility criteria: Inclusion Criteria:

* patients with new brain lesions confirmed by imaging study

Exclusion Criteria:

* patients with recurrent brain lesions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT05172700: Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
Official title: Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Lymphocytic, Small
Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Ritcher's Transformation, Syndrome
Keywords: BTKi
BTK Inhibitor
Bruton's tyrosine kinase inhibitor
Hematologic Disease
B-cell receptor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-12-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with:

  * CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor
  * MCL that has been previously treated with a covalent BTK inhibitor
  * Richter's Transformation (RT) with previous Richter's directed-therapy
  * Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor
* Are not eligible for an ongoing pirtobrutinib clinical trial

Exclusion Criteria:

* Inadequate organ function
* Significant cardiovascular disease
* History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days
* Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection
* Active, uncontrolled autoimmune cytopenia
* Clinically significant active malabsorption syndrome
* Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01141400: The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
Official title: The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2010-06-10
Enrollment: 48865
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the MarketScan Commercial Database between January 1, 2004 and September 30, 2008 (the last month of data available)

Brief summary: The primary objective of this study is to measure the effects of patient cost-sharing on the initiation of adjunctive treatment and subsequent healthcare utilization and expenditures among a population of commercially insured adults on antidepressant therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients (aged 18-64) will be selected from the MarketScan Commercial Database between January 1, 2004, and September 30, 2008, if they have at least two medical claims with a diagnosis of depression and at least one prescription fill for an antidepressant medication.

Exclusion Criteria:

* Patients who have any claim with a diagnosis of dementia, schizophrenia, delusional disorder, psychoses, pervasive development disorder, mental retardation, cerebral degenerations, Parkinson's disease, senility, manic depression, bipolar disorder, or major depressive disorder with psychotic symptoms.

Primary outcomes:
measure: The primary outcome is any use of adjunctive treatment (combined and by class) and the time to initiation of adjunctive treatment (combined and by class).
timeFrame: 16 months
Secondary outcomes:
measure: sensitivity to cost-sharing will be examined as a function of treatment resistance
timeFrame: 16 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00153400: The California WISEWOMAN Project:Cardiovascular(CVD) Health for Hispanic Women
Official title: The California Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Project: Improving Cardiovascular Risk Factors for Underserved Hispanic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Chronic Diseases
Keywords: CVD risk
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of California, San Francisco
name: California Department of Health Services
First posted: 2005-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Provide Health coaching and Lifestyle programs
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Detailed description: This study is based on a single group. Evaluated how effectively culturally appropriate lifestyle intervention was in improving, over a relatively short-term period (\~12 months) on health behaviors and the CVD risk profile.

Eligibility criteria: Inclusion Criteria:

* National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
* Income \< 200 percent of federal poverty level
* Under or uninsured for the health care coverage
* Blood pressure \>= 120 mm Hg systolic or \>=80 mm Hg diastolic or currently taking medication to lower cholesterol

Exclusion Criteria:

* \>180 mm Hg systolic or \>110 mm Hg diastolic
* \> 400 cholesterol
* pregnant women
* had past or current CVD events

Primary outcomes:
measure: CVD risk (10 year estimated risk)
timeFrame: baseline, one-year
Secondary outcomes:
measure: Physical Activity
timeFrame: baseline, one-year
measure: Dietary Behavior
timeFrame: baseline, one-year
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Julie Will
role: STUDY_CHAIR
References:
citation: Silverstein RP, VanderVos M, Welch H, Long A, Kabore CD, Hootman JM. Self-Directed Walk With Ease Workplace Wellness Program - Montana, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 23;67(46):1295-1299. doi: 10.15585/mmwr.mm6746a3.
citation: Ahmann E, Saviet M, Conboy L, Smith K, Iachini B, DeMartin R. Health and Wellness Coaching and Sustained Gains: A Rapid Systematic Review. Am J Lifestyle Med. 2023 Jun 20;18(2):162-180. doi: 10.1177/15598276231180117. eCollection 2024 Mar-Apr.
Clinical trial NCT00988000: Initial Specialist Telephone Consultation With New Patients in Secondary Care
Official title: Telephone Consultations for New Patients Being Referred to a Specialist Respiratory Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Diseases
Keywords: outpatients
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
First posted: 2009-10-01
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Consultations with patients by hospital consultants are organised today in a manner which is barely dissimilar from that offered 30 or 40 years ago. Whilst some attempts to improve this process, such as Choose and Book, shorter waiting times and patients' receiving a copy of the correspondence sent to their general practitioner (GP) have improved the situation, there has been little radical change and little thought given to the patient experience.

The investigators wish to investigate whether patients' experience of attending respiratory outpatient clinics can be improved by a pre-clinic telephone call with a specialist thereby reducing the number of attendances at the hospital for appointments and investigations and improving overall patient satisfaction.

Detailed description: This study will investigate whether taking a new patient's history over the telephone permits better selection and arrangement of investigations prior to or synchronous with the first face to face consultation, with the potential to reduce the number of visits the patient has to make to the hospital.

Patients will be offered an initial telephone consultation by post and may opt-in or out of the study. Those having a telephone consultation would have this booked for a specific time and date and the patient would be sent an appropriate information leaflet regarding this. After the telephone consultation patients receive a summary of the consultation and details of any investigations and appointments booked by the research nurse. Patients who did not respond to the initial invitation letter within seven days or who declined to participate would be sent a routine appointment. All patients would asked to complete the MISS-21 questionnaire.

Eligibility criteria: Inclusion Criteria:

* All new adult general respiratory referrals from primary care

Exclusion Criteria:

* Follow-up patients

Primary outcomes:
measure: Patient Satisfaction of the Alternative Consultation
timeFrame: First clinic appointment (Month 0) and Follow-up appointment (6 months
Secondary outcomes:
measure: Number of Required Investigations
timeFrame: 0-6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College at Charing Cross campus
Study officials:
affiliation: Imperial College London
name: Professor MR Partridge, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398900: Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children
Official title: Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Delay
Child Development
Child Development Disorder
Global Developmental Delay
Infant Development
Motor Delay
Speech Delay
Communication Disorders
Development Delay
Keywords: Developmental delay
developmental screening
Indonesian ASQ-3 questionnaire
validity
reliability
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 245
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parents with children aged 1-12 months living in East Jakarta

Brief summary: This study aimed to provide the validity and reliability of the Indonesian ASQ-3 questionnaires as a screening tool for developmentally delayed children aged less than one year old. This study was divided into 2 phases. The first phase (April-June 2018) included the transcultural adaptation of the ASQ-3 questionnaires for 2 to 12 months age groups from English to Indonesian. The second phase (July- September 2018) included a cross-sectional study of Indonesian ASQ-3 questionnaires for parents/caregivers of children aged 1-12 months, with 35 children in each age group by cluster sampling methods, in 2 district areas in East Jakarta.


Eligibility criteria: Inclusion Criteria:

* Parents with children aged 1-12 months
* Parents who finished at least elementary school

Exclusion Criteria:

* Parents with communication difficulties
* Parents who could not speak Indonesian language

Primary outcomes:
measure: Child development
timeFrame: 1 day (Once)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district
Study officials:
References: