louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04955964: A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in Argentina
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Lanadelumab (Takhzyro®) in Patients Aged 12 Years and Older With Hereditary Angioedema (HAE) in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioedemas, Hereditary
Keywords: Lanadelumab
Post-authorization study
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will include all participants treated with lanadelumab according to approved indications in routine clinical practice settings in Argentina.

Brief summary: The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice.

This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant's medical records.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility criteria: Inclusion Criteria:

* Participants (\>=12 years) with investigator confirmed diagnosis of HAE.
* Have received at least one dose of lanadelumab according to approved indications.
* Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients.

Primary outcomes:
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to end of study (up to 24 months)
measure: Percentage of Participants With Serious and Non-serious Adverse Events (AEs)
timeFrame: Baseline up to end of study (up to 24 months)
Secondary outcomes:
measure: Monthly Mean Rate of Investigator Confirmed HAE Attacks
timeFrame: At Weeks 12 and 24
measure: Monthly Mean Rate of Investigator Confirmed Moderate or Severe HAE Attacks
timeFrame: At Weeks 12 and 24
measure: Monthly Mean Rate of Investigator Confirmed HAE Attacks Requiring Acute Treatment
timeFrame: At Weeks 12 and 24
measure: Percentage of Participants who are Attack Free
timeFrame: At Weeks 12 and 24
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Ic Projects Srl
state: Buenos Aires
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01778764: Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases
Official title: A Comparison of Overall Survival Post-CyberKnife Radiosurgery Treatment of Patients With 1-3 Versus 4 or More Brain Metastases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain and Nervous System
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with all types of primary cancers which have metastasized to the brain.

Brief summary: The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. The importance of this new knowledge will be to determine the treatment efficacy of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to support either the continuation or modification of the CK RS treatment of patients with brain metastases.

Detailed description: This is registry-based cohort study of patients with brain metastases treated at Stanford University Medical Center (SUMC) with CyberKnife radiosurgery (CK RS). It has two components: (1) a retrospective follow-up of patients treated since 2006, and (2) the accrual of a new cohort of patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter. The primary aim of this study is to estimate the effect of the number of brain tumor metastases on survival after adjusting for known risk factors for mortality.

Eligibility criteria: Inclusion Criteria:

1. the presence of a tumor metastasis or tumor metastases to the brain as manifested by the neurological examination and visibility of the metastatic lesion(s) on MRI and CT scans
2. a Karnofsky performance status (KPS) score of greater than or equal to 60.

Exclusion Criteria:

The exclusion criteria are the converse of the above, i.e. patients without a brain tumor metastasis or brain tumor metastases or a KPS of less than 60.

Primary outcomes:
measure: Overall survival
timeFrame: until death or the end of follow-up, whichever comes first.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Steven Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474564: Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
Official title: Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma
Keywords: Blood draw
pancreas
Tumorigenic Cells
11-141
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Adera Labs, LLC
First posted: 2011-11-18
Enrollment: 83
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: MSKCC clinics

Brief summary: The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.

The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
* Patient eligible for chemotherapy treatment.
* Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
* ECOG performance status 0-2.
* A minimum age of 18 years old.

Exclusion Criteria:

* Known to be HIV positive on antiretroviral therapy
* Prior organ allograft
* Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Primary outcomes:
measure: isolating and enriching circulating tumorigenic cells
timeFrame: 1 year
Secondary outcomes:
measure: successful gene expression profiling
timeFrame: 1 year
Other outcomes:
Locations:
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center at Phelps
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Yu, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00823264: Phenytoin and Multidose Activated Charcoal
Official title: Prospective Randomized Study of Multidose Activated Charcoal in Supratherapeutic Phenytoin Serum Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phenytoin Toxicity
Keywords: Anticonvulsants
Toxicology
multidose charcoal
phenytoin
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 17
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: Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from the blood. This is theorized to occur as charcoal absorbs phenytoin from across the intestines and then is secreted in the stool. Patients will be selected to receive either charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to follow their level. The different groups will then be compared to see if multidose charcoal does indeed increase the elimination of phenytoin from the body.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Phenytoin level \> 30 mg/L

Exclusion Criteria:

* Age \< 18
* Known allergy to Activated Charcoal
* Pregnant
* Inability to take PO drugs
* Non English speaking
* Inability to give consent
* Any prisoners

Primary outcomes:
measure: Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels
timeFrame: Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Carl Skinner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skinner CG, Chang AS, Matthews AS, Reedy SJ, Morgan BW. Randomized controlled study on the use of multiple-dose activated charcoal in patients with supratherapeutic phenytoin levels. Clin Toxicol (Phila). 2012 Sep;50(8):764-9. doi: 10.3109/15563650.2012.716159. Epub 2012 Aug 17.
Clinical trial NCT05082064: Observational Prospective Study.at the End of the Study the Patients Will be Classified According to PH,Serum Bicarbonate and Serum Sodium Into 6 Groups and Statistical Analysis Will be Performed Using Spss
Official title: Impact of Serum Bicarbonate and Electrolytes on Adverse Outcomes in Decompensated Cirrhotic Patients in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study protocol will be approved by ethical committee of sohag university of medicine written informed consent will be obtained from all participants

Brief summary: 1-to identify the prognostic value of serum bicarbonate and serum electrolytes at time of admission and their association with development of complications ,length of hospital stay ,prognosis and mortality in hospitalized cirrhotic patient

Detailed description: the purpose of this study will be explore the impact of data obtained for the arterial blood gas parameters and serum bicarbonate and electrolytes at the time of hospital admission on adverse clinical outcomes ,duration of length of hospital stay and mortality in patients with cirrhosis .Furthermore incorporation these parameters into model of end stage liver disease could help to improve the prognostic value of MELDscore in comparison to the prognostic value of traditional equation of original MELD and child score

Eligibility criteria: Inclusion Criteria:

patients with confirmed diagnosis of cirrhosis (age \>18 years ) who will be admitted to internal medicine department or will be admitted to intermediate care unit

* willing and agree to be included in the study

Exclusion Criteria:

* patients without evidence of cirrhosis
* cirrhotic patients whom -younger than 18 years old

  * have diabetic ketoacidosis
  * with acute coronary syndrome
  * with fulminant liver failure
  * with heart failure
  * with organ transplantation
  * when arterial blood gases not be available
  * patient refusal
  * patient with HCC

Primary outcomes:
measure: will be ICU admitted
timeFrame: from the day of admission to the day of discharge from hospital or death during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Heba Allah fadel abd elrahman
Study officials:
affiliation: Clinical trial organization
name: Heba allah Fadel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheiner B, Lindner G, Reiberger T, Schneeweiss B, Trauner M, Zauner C, Funk GC. Acid-base disorders in liver disease. J Hepatol. 2017 Nov;67(5):1062-1073. doi: 10.1016/j.jhep.2017.06.023. Epub 2017 Jul 3.
Clinical trial NCT05465564: My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
Official title: My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hearing Impairment
Hearing Loss
Lead sponsor: WSAUD A/S
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-time hearing aid users

Brief summary: The primary purpose of this study is to investigate how personality, motivation \& auditory lifestyle relate to hearing aid satisfaction \& acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.


Eligibility criteria: Inclusion Criteria:

* 18-85 years of age
* Sensorineural hearing loss within the hearing aid's fitting range
* Fluency in local language
* First-time hearing aid user
* Experienced smartphone and app user
* Must sign the informed consent

Exclusion Criteria:

* Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP)
* Inability for the TPs to travel to the clinic during the study period
* Complex hearing disorders such as Ménière's

Primary outcomes:
measure: overall hearing aid satisfaction
timeFrame: 6 months
measure: IOI-HA
timeFrame: 6 months
measure: hearing aid satisfaction (Hearing-Related Lifestyle scale)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lynge
country: Denmark
facility: Dina Lelic
state: DK
Study officials:
References:
Clinical trial NCT05187364: BioWare for AUD and PTSD
Official title: BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Alcohol Use Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.


Eligibility criteria: Inclusion Criteria:

1. Male or female; aged 18-70 years.
2. Able to provide written informed consent.
3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
4. Meet DSM-5 diagnostic criteria for current PTSD.
5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria:

1. Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
2. Current suicidal or homicidal ideation and intent.
3. Psychotropic medications which have been initiated during the past 4 weeks.
4. Acute alcohol withdrawal.
5. Pregnancy or breastfeeding for people of childbearing potential.
6. Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
7. Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.

Primary outcomes:
measure: Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
timeFrame: In-Session Visit (approximately 1 week from baseline)
measure: System Usability Scale
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Amber M Jarnecke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02593864: A Biomarker Stress Test for Detection of Early Osteoarthritis
Official title: A Novel Serum Biomarker Stress Test for Detection of Early Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2015-11-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is common among Veterans and is a leading cause of disability. The earliest stages of OA development, where the joint cartilage wears away, is usually painless. By the time Veterans experience symptoms, the OA is typically advanced and there is nothing that can be done except palliation until the joint is replaced with metal and plastic. If there was a blood test to provide early warning of cartilage wear and joint deterioration, Veterans could potentially be treated early enough to slow down or even prevent OA. So far, development of such a blood test has proved elusive. The investigators propose a new method to amplify the signs of cartilage wear in the blood by challenging the affected joint with a walking task. Similar to a cardiac stress test, this walking challenge may help to separate joints at risk from healthy joints. The investigators will also see if this 'OA stress test' can show if a simple and inexpensive load-modifying shoe can improve joint health in Veterans with early knee OA.


Eligibility criteria: Inclusion Criteria:

* age 18-80 years
* symptomatic medial compartment knee OA (KL grades 0-2)
* full weight-bearing status
* able to walk for 30 minutes or longer
* able to undergo MRI scan
* agreement and ability to use provided shoe as primary walking shoe (4 or more hours a day) during the 6 month study period

Exclusion Criteria:

* inflammatory arthritis, gout or recurrent pseudogout
* patellofemoral or lateral compartment disease that is equal to or more extensive than medial disease
* symptomatic OA of other lower extremity joints
* BMI \>35 kg/m2
* prior structural surgery of the knee except for medial meniscectomy performed \> 6 months prior
* use of shoe insert or hinged knee brace
* pes planus, and/or unusual foot size or shape

Primary outcomes:
measure: Change at 6 Months From Baseline in First Peak Knee Adduction Moment (KAM): (6 Month Value - Baseline)
timeFrame: Baseline to 6 months
measure: Change at 6 Months From Baseline in Serum COMP Biomarker Levels in Response to a Mechanical Stimulus (6 Month - Baseline)
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Constance Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06938464: Preventive Effect of Probiotics in GDM
Official title: The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Quzhou Maternal and Child Health Care Hospital
First posted: 2025-04-22
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.

  1. included between 12-16 gestational weeks
  2. A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+)

Exclusion Criteria:

1. Taking probiotics or prebiotics within the past month
2. Have a history of allergies to the drug components or similar drugs in this study
3. Having long-term smoking or drinking habits
4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
5. Diseases in other important organs such as heart, liver, and kidney
6. with clear digestive system diseases
7. Multiple pregnancy
8. with mental or cognitive impairments who are unable to complete this study

Primary outcomes:
measure: the incidence of gestational diabetes
timeFrame: 24-28th weeks gestation
Secondary outcomes:
measure: The incidence of macrosomia
timeFrame: Delivery
measure: Weight gain during pregnancy (kg)
timeFrame: Delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: