louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06992336: Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
Official title: A Phase II, Open-label, Randomized Trial to Compare Anlotinib and Immunotherapy and Capecitabine Versus Investigator's Choice Therapy in High Risk ctDNA Positive, Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 411
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk.

This trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.


Eligibility criteria: Inclusion Criteria:

* Stage II-III breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer
* TNBC patients. TNBC was defined as ER \<= 10%, PR \<=10%, HER 0-1, or HER2 2+ and FISH negative.

Exclusion Criteria:

-

Primary outcomes:
measure: iDFS
timeFrame: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.
Secondary outcomes:
measure: dDFS
timeFrame: from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months
measure: OS
timeFrame: from randomization to any of the following events: death of any cause，assessed up to 120 months
measure: ctDNA clearance
timeFrame: From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangodng
Study officials:
References:
Clinical trial NCT05389436: Outpatient Versus Inpatient Surgery for Ankle Fractures
Official title: Comparison Between Outpatient and Inpatient Surgically Treated Ankle Fractures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Orthopedic Procedures
Surgical Procedures
Inpatient
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single center, prospective, assessor-blinded, randomized independent clinical trial
Primary purpose: TREATMENT

Brief summary: This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Detailed description: This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Primary outcome: The primary objective of this study is to compare the 12-weeks patient reported Foot and Ankle Outcome Score (FOAS).

Secondary outcomes: Multiple other analysis are planned, but being secondary, they are hypothesis generating. They will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.

Eligibility criteria: Inclusion Criteria:

* Ankle fracture indicating surgical treatment.
* Fracture stable in lower leg cast.
* Patient 18 years or older.
* Patient is able to ambulate with walking aid, and perform ADL at home.

Exclusion Criteria:

* Impaired physical, mental or social capacity incapable of participating in study.
* Incapable of reading or understanding Danish.
* Patient does not wich to participate.
* Concurrent major fracture to lower extremity (ipsi- and/or contralateral)
* Patholocigal fracture
* ASA score 3 or higher.
* Pregnancy.
* Open fracture.
* Infectious disease requiring isolation.

Primary outcomes:
measure: Foot and Ankle Outcomes Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 2, 6 and 12 weeks
measure: EQ-5D-5L questionnaire (5-level version)
timeFrame: 2, 6 and 12 weeks
measure: Tegner activity scale
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 2 days, 2, 6 and 12 weeks
measure: Time to return to work
timeFrame: 2, 6 and 12 weeks
measure: Bone union
timeFrame: 6 and 12 weeks
measure: Pain intensity measured on a 10 cm VAS scale
timeFrame: 2 days, 2, 6 and 12 weeks
measure: Ankle range of motion
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
Study officials:
affiliation: Department of Orthopedic Surgery
name: Christian GR Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657236: Effect of Strength and Conditioning Training on Functional Performance in Children With Chronic Kidney Disease
Official title: Effect of Strength and Conditioning Training on Functional Performance in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Diseases
plyometric exercises
muscle strength
balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the benefits of physical rehabilitation among adults and children with chronic illness, they avoid to engage in different physical activities especially pediatric population. Most of the children with Chronic kidney disease receive their medical treatment and follow-up with no change of their functional performance. We still lack the evidence of plyometric exercises in pediatric population with Chronic kidney disease . Therefore, the primary aim of this study is to explore the effects of strength and conditioning training in the form of plyometric exercises on balance and muscle strength in children with Chronic kidney disease .


Eligibility criteria: Inclusion Criteria:

* Age will be ranged from 6-10 years.
* Both genders were included.
* Can follow instructions.
* Medically stable sedentary children with CKD, GFR (stage 2 (mild) eGFR of 60-89 ml/min per 1.73 m2, stage 3 (moderate) eGFR 30-59 ml/min per 1.73 m2) stage 4 (severe) eGFR of 15-29 ml/min per 1.73 m2.
* Did not yet require renal replacement therapy (non-dialysis).

Exclusion Criteria:

* Recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation.
* Severe uncontrolled diabetes,
* Neurological or cognitive disorders
* Peripheral vascular disease.

Primary outcomes:
measure: Balance
timeFrame: after 2 months
measure: muscle strength
timeFrame: after 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amira Mahmoud Abd-elmonem
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: Amira M Mahmoud
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo university, faculty of physical therapy
name: Amira M Al-tohamy
role: STUDY_CHAIR
affiliation: Cairo University
name: Rasha M Helmy
role: STUDY_DIRECTOR
References:
Clinical trial NCT03101436: Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota
Official title: Extra Virgin Olive Oil and Red Wine Polyphenols in the Modulation of Fecal Microbiota: an Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Insulin Resistance
Extra Virgin Olive Oil
Red Wine
Diet
Microbiota
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.


Eligibility criteria: Inclusion Criteria:

* Obese patients (body mass index (BMI= or \> 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) \> 5.5.
* Lean subjects (BMI\< 28kg/m2) with low insulin resistance (HOMA-IR\< 3.3).

Exclusion Criteria (all patients):

* Type 2 diabetes
* Acute or chronic infection
* Inflammatory disease or endocrine disorders.
* History of cancer.
* Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
* A history of alcohol abuse or drug dependence
* A restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
* Intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.

Primary outcomes:
measure: Microbiota Changes
timeFrame: 1 month
Secondary outcomes:
measure: Trimethylamine N-oxide (TMAO) production
timeFrame: 1 month
measure: Insulin Resistance
timeFrame: 1 Month
measure: Lipid Profile
timeFrame: 1 Month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06201936: EPIDURAL- Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia
Official title: Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroaxial Analgesia Procedures
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women before delivery for whom a neuroaxiual procedure for pain reduction during childbirth would theoretically be eligible.

Brief summary: The aim of this research project is to anonymously survey pregnant patients before the anaesthesiological consultation about their prior knowledge of planned neuroaxial procedures in the context of childbirth by conducting an online survey and to evaluate the sources of that information.

Detailed description: Within labour and delivery, neuroaxial anaesthesia (peridural or spinal anaesthesia) is commonly used in accordance with clinical practice guidelines. However, from a professional perspective, there are still questionable and incorrect statements about possible complications and side effects that cannot be justified medically. In an increasingly technological and networked society, the dissemination of medical information via various sources of information poses a potentially serious problem in terms of disinformation, and the correct classification of information is becoming more and more difficult.

Anaesthesiologists are increasingly confronted with consultations in which, in addition to the actual informed consent for the intervention, extensive clarification of existing contradictory information is required.

The aim of this research project is to survey pregnant patients prior to receiving an anaesthesiological consultation about their previous knowledge of the intended procedure by conducting an anonymous online survey.

Eligibility criteria: Inclusion Criteria:

* Pregnant women prior to delivery

Exclusion Criteria:

* Women under 18 years of age

Primary outcomes:
measure: Preliminary information on neuroaxial analgesic procedures for childbirth
timeFrame: Between the 25+0 week of pregnancy and delivery
measure: Is the prior information based on internet sources?
timeFrame: Between the 25+0 week of pregnancy and delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT03305536: Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Official title: Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aortic Valve Disease
Keywords: AVD
Lead sponsor: Hopital St. Georges, Ajaltoun
Sponsor class: OTHER
Collaborators: name: Omicron Pharmaceuticals
name: Nattopharma ASA
First posted: 2017-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment.

In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.

Detailed description: The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when using:

1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
2. 5000 IU/d Vitamin D3 as a control group

Eligibility criteria: Inclusion Criteria:

* AVCS \> 300 without aortic valve stenosis requiring operation
* Focus on patients with:

  1. Bicuspid aortic valve
  2. Dialysis or CKD
  3. Statin treatment

Exclusion Criteria:

* Use of Vitamin K antagonist
* Malabsorption Problem
* LVEF \< 40%
* A life expectancy \< 3 years

Primary outcomes:
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
timeFrame: 3 years
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
timeFrame: 3 years
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
timeFrame: 3 years
Secondary outcomes:
measure: Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
timeFrame: 3 years
measure: Reduction of the Aortic Valve calcification measured by CT Scan
timeFrame: 3 years
measure: Improvement of dyspnea (at rest and effort)
timeFrame: 3 years
measure: Improvement of the quality of life of the patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hopital Saint-George Ajaltoun
Study officials:
References:
Clinical trial NCT01878136: Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Official title: Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Cerebral Aneurysm
Hydrocephalus
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years old.
* SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
* Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
* Exclusion of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus.
* Ventriculostomy placement must occur prior to randomization.
* Informed consent obtained from the patient or patient's decision maker

Exclusion Criteria:

* Determination by treating physician(s) that no ventriculostomy is needed.
* Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
* Presence of significant anemia, defined as hemoglobin \< 8 gm/dL.
* Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
* Residual aneurysm sac filling (Raymond class III occlusion).
* Aneurysm or vessel perforation during the endovascular procedure.
* Presence of craniectomy.
* Significant neurologic disability prior to the onset of SAH.
* Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset.
* Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram.

Primary outcomes:
measure: Composite Primary Outcome
timeFrame: 1-60 days after SAH
Secondary outcomes:
measure: Rate of new intracranial hemorrhage
timeFrame: 1-14 days after SAH
measure: Rate of intracranial infection
timeFrame: 1-14 after SAH
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center, Department of Neurosurgery
name: Stephan Munich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center, Department of Neurosurgery
name: Roham Moftakhar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00520936: A Study of Pemetrexed in Children With Recurrent Cancer
Official title: A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteosarcoma
Medulloblastoma
Sarcoma, Ewing's
Neuroblastoma (Measurable Disease)
Neuroblastoma (Metaiodobenzylguanidine
Positive Evaluable)
Rhabdomyosarcoma
Ependymoma
Non-brainstem High-grade Glioma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Children's Oncology Group
First posted: 2007-08-27
Enrollment: 72
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.


Eligibility criteria: Inclusion Criteria:

* Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
* Adequate renal, liver and bone marrow function
* Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Exclusion Criteria:

* Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
* Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
* Patients with uncontrolled infection
* Patients who have received pemetrexed previously
* Patients with pleural effusions or ascites

Primary outcomes:
measure: Percentage of Participants With Overall Tumor Response (Response Rate)
timeFrame: baseline to measured progressive disease (up to 1 year)
Secondary outcomes:
measure: Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
timeFrame: every cycle (up to 2 years and 7 months)
measure: Pharmacogenomics - Measure the Response of Genes Related to Toxicity
timeFrame: baseline
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
Study officials:
affiliation: Eli Lilly and Company
name: 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05362136: Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation
Official title: Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sinus Elevation
Dental Implant
Bone Formation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.


Eligibility criteria: Inclusion Criteria:

* in need of bilateral sinus floor elevation
* residual alveolar ridge height 2-6mm
* residual alveolar ridge width \> 4mm

Exclusion Criteria:

* uncontrolled periodontal disease
* acute or chronic sinusitis

Primary outcomes:
measure: New bone formation
timeFrame: 4-6 months after sinus floor elevation
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic of Dentistry, Medical University of Vienna
Study officials:
References: