louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06568302: The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Official title: A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemophilia a
Hemophilia B
Hemophilia a with Inhibitor
Hemophilia B with Inhibitor
Keywords: Hemophilia
SerpinPC
Lead sponsor: ApcinteX Ltd
Sponsor class: INDUSTRY
Collaborators: name: Centessa Pharmaceuticals plc
First posted: 2024-08-23
Enrollment: 15
Sex: MALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia


Eligibility criteria: Inclusion Criteria:

* Male participants greater than or equal to (\>=) 12 and less than or equal to (\<=) 65 years of age at the time of informed consent
* Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.
* Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation

Exclusion Criteria:

* Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
* Participation in another interventional clinical trial, except for SerpinPC trials
* Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study
* Treatment with anticoagulant or antiplatelet drugs

Primary outcomes:
measure: Treated bleeds, expressed as annualized bleeding rate (ABR)
timeFrame: Month 0 to Month 25 or Early termination
Secondary outcomes:
measure: Treated spontaneous bleeds (expressed as ABR)
timeFrame: Month 0 to Month 25 or Early termination
measure: Treated spontaneous joint bleeds (expressed as ABR)
timeFrame: Month 0 to Month 25 or Early termination
measure: All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available)
timeFrame: Month 0 to Month 25 or Early termination
measure: Total coagulation factor and/or bypass product consumption
timeFrame: Month 0 to Month 25 or Early termination
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: ARENSIA Exploratory Medicine LLC
city: Chisinau
country: Moldova, Republic of
facility: Institute of Oncology, ARENSIA Exploratory Medicine
Study officials:
References:
Clinical trial NCT05878002: "Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Official title: "Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Disorders
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this interventional study is to learn about the clinical outcomes of acute ischemic stroke treated with mechanical thrombectomy resulting in a selective ischemia of the basal ganglia. The main question it aims to answer is:

• defining the prevalence and clinical features of possible cognitive, motor and sleep disfuncions occuring after acute ischemic stroke treated with thrombectomy

Participants will be tested for cognitive, movement and sleep disorders in the acute phase and successively in the long term follow-up.


Eligibility criteria: Inclusion Criteria:

* participant's age ≥ 18 years
* acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B)
* signature of specific written informed consent

Exclusion Criteria:

* unstable clinical conditions
* personal history of cognitive decline before the acute ischemic stroke

Primary outcomes:
measure: Post-stroke cognitive dysfunction
timeFrame: Within 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT05823402: Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
Official title: Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: BAMF Health
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.

Detailed description: All patients with PSMA-positive tumor and/or Metastases of Prostate Cancer (PSMA-TMPC) who would be undergoing a PSMA-targeted Radioligand Therapy (PRLT) based on independent eligibility criteria for the same, will receive 6 serial SPECT-CT scans for every treatment cycle as a part of our study. The purpose of this investigation is to assess the limits of agreement of commonly employed dosimetry methods used to determine or approximate absorbed doses for organs and tumors compared to a dosimetry method using a triexponential fit requiring 6 post-injection SPECT-CT scans for all treatment cycles.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, 18 years old or older
4. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
5. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial.
6. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)

Exclusion Criteria:

1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
3. All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I\&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.

Primary outcomes:
measure: Dosimetry Method
timeFrame: Immediately after the completion of SPECT/CT scanning.
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: BAMF Health
state: Michigan
Study officials:
References:
Clinical trial NCT06368479: Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
Official title: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Hepatitis B Infection
Keywords: Hepatitis B rapid test
Hepatitis B infection
Hepatitis B iStatis test
Hepatitis B point of care test
Lead sponsor: bioLytical Laboratories
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.

Detailed description: Participants are prospctively recruited and enrolled to participate in the study. The Capillary (fingerstick) whole blood, and venous whole blood samples (in serum separating tube (SST) and Ethylenediaminetetraacetic acid (EDTA) tube) are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected serum separating tube and Ethylenediaminetetraacetic acid VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected Ethylenediaminetetraacetic acid and serum separating tube VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. Ethylenediaminetetraacetic acid VWB, plasma and serum will be tested on iStatis HBsAg Test in the laboratory. An aliquot of the obtained plasma sample will be further tested for reference and confirmatory testing.

The results from iStatis HBsAg Test results will not be used for participant management decisions.

Eligibility criteria: Inclusion Criteria:

* Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:

  * at risk for Hepatitis B virus
  * having signs and symptoms indicative for Hepatitis B virus
  * Routine testing Unknown or other reasons will be captured
* Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria:

* Participant younger than 18 years old
* Participants unable to provide written informed consent

Primary outcomes:
measure: iStatis Performance
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hillcrest
country: South Africa
facility: Epicentre Health Research
state: Kwazulu Natal
Study officials:
References:
Clinical trial NCT06426979: Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy
Official title: Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Tubal
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-05-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.


Eligibility criteria: Inclusion Criteria:

* Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
* Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L.

Exclusion Criteria:

* Free of Inclusion Criteria

Primary outcomes:
measure: The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Ash Sharqia Governorate
Study officials:
References:
Clinical trial NCT00541879: Obesity and Diabetes Prevention Through Science Enrichment
Official title: Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: Childhood
Prevention
Energy balance
Glucose regulation
Healthy lifestyle
Healthy eating
Active living
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: Poudre School District, Fort Collins, CO
First posted: 2007-10-10
Enrollment: 2909
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. However, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose regulation. Can elementary school children be taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children need to learn this essential knowledge and practice these important health behavior skills. Elementary school may be an ideal place to master this subject that is a direct and logical extension of current health curricula including nutrition and physical activity blended with science and math.

Detailed description: Biomedical scientists lead a classroom series of interactive, inquiry-based science and health explorations directed at type 2 diabetes, obesity and their prevention in three elementary schools serving children at high risk for type 2 diabetes. Diabetes knowledge was measured in children and parents at the beginning, end and 9 months after the end of the intervention using validated questionnaires.

Eligibility criteria: Inclusion Criteria:

* Elementary school child in selected intervention or comparison classes/schools

Primary outcomes:
measure: Diabetes knowledge and prevention behaviors in elementary school children
timeFrame: one-three school year(s)
Secondary outcomes:
measure: Parental diabetes knowledge, self-reported physical activity
timeFrame: one -three school year(s)
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Putnam, Tavelli, Bennett and Dunn Elementary Schools
state: Colorado
Study officials:
affiliation: Colorado State University
name: L. Arthur Campfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978079: Pupillometry in Horner's Syndrome
Official title: Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horner's Syndrome
Stroke
Dissection Carotid Artery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of the etiologies for ischemic stroke in young patients.

In our current study, we will explore the diagnostic accuracy of automated binocular pupillometry in the diagnosis or HS, and its potential in identifying dissection of the carotid artery in patients of young age who suffer ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Adults 60 years of age or younger
* Acute stroke (less than 72 hours from admission)
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Ability to understand the study information and consent form

Exclusion Criteria:

* known history of HS
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Medications affecting pupillary response
* History of ocular surgery affecting the pupil

Primary outcomes:
measure: Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection
timeFrame: 1 day of initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Ophthalmology Department, University Hospital Zurich
Study officials:
affiliation: Ophthalmology Department, University Hospital Zurich
name: Konrad P Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951079: Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
Official title: The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arrhythmia
ECG Changes
Hypotension
Keywords: Digoxin
Intra-amniotic injection
feticide
second trimester abortion
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .

Detailed description: * The digoxin will be injected intra-amniotic with U.S guided, trying to avoid any placental passage or intravascular injection /
* Any patient will have prior to the procedure a full examination including E.C.G and cardiac clearance.

Eligibility criteria: Inclusion Criteria:

* healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation,
* that need to have abortion due to fetal anomalies or any other reason
* need to have feticide prior to the procedure

Exclusion Criteria:

* any patient with medical problem that may be a contra-indication to Digoxin
* cardiac problems,
* prior cardiac surgery,
* liver or kidney disease,
* hyper tension etc.

Primary outcomes:
measure: Efficiency of intra-amniotic Digoxin injection for second trimester feticide
timeFrame: a year
Secondary outcomes:
Other outcomes:
Locations:
city: Kefar-saba
country: Israel
facility: Dr. Zvi Klein
city: Kefar-saba
country: Israel
facility: Sapir medical center
Study officials:
References:
Clinical trial NCT01510379: Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Official title: Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea and Vomiting Post-foregut Surgery
Keywords: nausea
vomiting
post-operative
foregut surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use.

The hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Planned fundoplication
* Willingness to comply with randomization and follow-up protocol
* English speaking

Exclusion Criteria:

* \< 18 years of age or \> 85
* Chronic nausea requiring medical treatment
* Planned concomitant procedures
* Pacemaker or automatic internal cardiac defibrillator

Primary outcomes:
measure: Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.
timeFrame: 24 hours
Secondary outcomes:
measure: Quantify the Amounts of Phenergan Used Between the Two Groups.
timeFrame: one week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kyle Perry, MD
role: PRINCIPAL_INVESTIGATOR
References: