louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06753981: Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
Official title: Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Pulmonary Hypertension (PAH)
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jianghan University Affiliated Hospital
First posted: 2024-12-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with arterial pulmonary hypertension

Brief summary: This study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (PAH) who are not at low risk and are receiving initial treatment. The prognosis of arterial pulmonary hypertension is explored.


Eligibility criteria: Inclusion Criteria:

* Consent and sign the informed consent form
* Non-low-risk PAH treatment-naive patients

Exclusion Criteria:

* Positive acute vascular response test for idiopathic/hereditary/drug-related arterial pulmonary hypertension
* Pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) with arterial pulmonary
* Pregnant or lactating women
* Suffering from mental illness or cognitive impairment
* PAH patients with concurrent malignant tumors
* Patients with moderate to severe hepatic impairment, renal impairment, and severe anemia
* Currently participating in other interventional clinical studies
* Key clinical data is incomplete, or the investigator considers that the patient has other factors that make them unsuitable for this study.

Primary outcomes:
measure: Pulmonary Vascular Resistance (PVR)
timeFrame: Up to 3 months
Secondary outcomes:
measure: N terminal pro B type natriuretic peptide （NT-proBNP）
timeFrame: Up to 3 months
measure: 6-minute walking distance
timeFrame: Up to 3 months
measure: mean pulmonary arterial pressure (mPAP)
timeFrame: Up to 3 months
measure: cardiac index (CI)
timeFrame: Up to 3 months
measure: WHO Heart Function Classification
timeFrame: Up to 3 months
measure: Oxygen Saturation of Mixed Venose Blood (SvO2)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
state: Shandong
Study officials:
References:
Clinical trial NCT02843581: Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Esophageal Cancer
Keywords: Esophageal Cancer
NK immunotherapy
Safety
Efficacy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced esophageal cancer.

Detailed description: By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced esophageal cancer.

The safety will be evaluated by statistics of adverse reactions.The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Guifeng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818181: Open Label Safety Study of a Birch Pollen Allergen Extract
Official title: A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Keywords: Type I - Allergy, rhinoconjunctivitis
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 73
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: TREATMENT

Brief summary: This trial is performed to assess safety of a sublingual birch pollen extract.


Eligibility criteria: Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to birch pollen
* Positive SPT
* Positive EAST

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
* Partly controlled asthma

Primary outcomes:
measure: number of patients with at least one adverse event
timeFrame: 8 months
Secondary outcomes:
measure: Systemic reactions
timeFrame: Entire treatment period
Other outcomes:
measure: Immunologic parameters
timeFrame: during the course of the study
Locations:
city: Cologne
country: Germany
facility: Prof. Dr. Nicolas Hunzelmann
Study officials:
affiliation: University of Cologne
name: Nicolas Hunzelmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05248581: Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases
Official title: Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer Metastatic
Keywords: liver transplantation
living donor
unresectable colorectal liver metastases
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 25
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: Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by a tumor board.

Brief summary: The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Detailed description: The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Non-amenable to curative hepatic resection as defined by FLR \<30%
* Histologically confirmed adenocarcinoma of the colon or rectum
* Candidate for LDLT for colorectal liver metastasis per the University of Rochester liver transplant program

Exclusion Criteria:

* Not a candidate of the LDLT liver transplant protocol for treatment of colorectal liver metastasis.
* Unwilling to consent

Primary outcomes:
measure: percentage of patients with recurrence free survival
timeFrame: 5 years
measure: percentage overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Roberto Hernandez-Alejandro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Matthew Byrne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06825481: Uterine Doppler As StillbirthPredictor
Official title: Uterine Doppler As StillbirthPredictor
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intrauterine Fetal Death
Keywords: Uterine Doppler
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 4863
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Assuming a standard deviation of 0.5 in the Doppler values of both cases and controls and a difference in the intercepts of 30% of the two regression lines, it is estimated that 72 cases and 4791 controls are needed to obtain a power of 80% at a type I error of 5%. The controls will be represented by the Doppler values reported in the literature for pregnancies not complicated by MEF.

Brief summary: The goal of this observational study is to define the predictive value of intrauterine fetal death for different longitudinal patterns of uterine artery Doppler indices (UtA-PI, UtA-RI and notch) from the second and third trimester of pregnancy in patients admitted with a diagnosis of intrauterine foetal death in the period January 2010-April 2020.

Detailed description: No changes in the obstetrical conduct of patients with MEFs are expected, since the data will be analysed retrospectively in patients in whom the event of intrauterine foetal death has already occurred. Patients will be treated according to normal clinical protocols.

The following information will be recorded for each patient

* Age
* Body mass index (BMI)
* Ethnicity
* Parity
* Method of pregnancy onset (spontaneous vs. medically assisted procreation)
* Maternal pathologies (if any)
* Any foetal pathologies
* Ultrasound parameters in the second and third trimester of pregnancy

  * Estimation of fetal weight
  * Umbilical artery Doppler (UA-PI)
  * Uterine artery Doppler (UtA-PI, UtA-RI and notch)
* Gestational age of fetal endouterine death
* Type of delivery
* Newborn and placental weight
* Histopathological findings of newborn and annexes (placenta and umbilical cord)

Eligibility criteria: Inclusion Criteria:

* Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks
* Obtaining informed consent form

Exclusion Criteria:

* Multiple pregnancies

Primary outcomes:
measure: Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF
timeFrame: From the 13th to the 24th weeks of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Antonio Farina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05944081: Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
Official title: Multicenter, Not Randomised, Non-interventional, Postmarket Clinical Follow-Up (PMCF) Study on the Performance / Safety of Arcadius XP L® Interbody Fusion Device
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Low-back Pain
Degenerative Disc Disease
Spondylolysis Lumbar
Postdiscectomy Syndrome
Posttraumatic Instability
Keywords: stand-alone cage
lumbar spine
interbody fusion device
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that received an Arcadius XP L® interbody fusion device in accordance with the indications given in the instructions for use:

Brief summary: The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.


Eligibility criteria: Inclusion Criteria:

* all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center
* all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability
* Written informed consent for the documentation of clinical and radiological results

Exclusion Criteria:

* Patient is not willing or able to participate at the follow-up examination
* Patients living outside a radius of 100 km around the study center
* all contraindications as given by the instructions for use:

Primary outcomes:
measure: Functional outcome after minimum 1 year postoperatively
timeFrame: at follow-up approximately 1 year postoperatively
Secondary outcomes:
measure: Pain assessment
timeFrame: at follow-up approximately 1 year postoperatively
measure: Development Quality of life (EQ-5D-5L)
timeFrame: at follow-up approximately 1 year postoperatively
measure: Radiological Outcome: Bone fusion
timeFrame: at follow-up approximately 1 year postoperatively
measure: Rate of (Serious) adverse events
timeFrame: at follow-up approximately 1 year postoperatively
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Schelztor-Klinik Esslingen
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Medius Klinik Nürtingen
state: Baden-Württemberg
city: Schorndorf
country: Germany
facility: Rems-Murr-Klinik Schorndorf
state: Baden-Württemberg
Study officials:
affiliation: Schelztor-Klinik
name: Wolfram Reithmeier, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213681: CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema
Official title: CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Acute Cardiogenic Pulmonary Edema
Keywords: Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.


Eligibility criteria: Inclusion Criteria:

* age \> 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph
* breathing frequency of \> 30/min, SpO2 \>90%, use of accessory respiratory muscles

Primary outcomes:
measure: Improvement in PaCO2 at the end of ventilation
Secondary outcomes:
measure: Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
measure: Duration of the ventilation
measure: Blood gases, vital signs
measure: Time to transfer to medical ward
measure: Time to hospital discharge
measure: Easiness to use was evaluated by nurses
measure: Patients operational tolerance
measure: Complications of each ventilation mode
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Fabienne MORITZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05973981: The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment
Official title: The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking, Cigarette
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The overall aim of this research is to experimentally evaluate the extent to which partially standardizing the color of tobacco packaging influences tobacco use intentions among young adults who have varying levels of tobacco use experience.


Eligibility criteria: Inclusion Criteria:

* Ages 21-29
* Past month cigarette smoker

Exclusion Criteria:

* None.

Primary outcomes:
measure: Quit smoking motivation
timeFrame: Immediately after shopping in the RAND StoreLab
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: RAND Corporation
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02922881: Microbiota-targeted Diet for Pediatric UC
Official title: Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Wolfson Medical Center
name: IWK Health Centre
name: National Institutes of Health (NIH)
First posted: 2016-10-04
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Established diagnosis of UC
* Age: 8-19 (inclusive)
* Mild to moderate active disease, 10\<PUCAI\<45
* Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
* Participant has agreed to follow the UCD for 12 weeks

Exclusion Criteria:

* Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks
* Antibiotic or corticosteroid use in the past 2 weeks
* Use of biologics in present or in the past
* PUCAI\>45
* Acute severe UC in the previous 12 months
* Current extra intestinal manifestation of UC
* Primary Sclerosing Cholangitis (PSC) or liver disease
* Pregnancy
* Known food allergy to mandatory foods in the UCD

Primary outcomes:
measure: Clinical Remission
timeFrame: At 6 weeks following enrollment
Secondary outcomes:
measure: Dietary Compliance
timeFrame: Up to 12 weeks following enrollment
measure: Change in C-reactive protein (CRP) between baseline and week 12
timeFrame: 12 weeks
measure: Change in erythrocyte sedimentation rate (ESR) between baseline and week 12
timeFrame: 12 weeks
measure: Change in fecal calprotectin (FCP) between baseline and week 12
timeFrame: 12 weeks
measure: Microbial composition of the gastrointestinal tract
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lindsey Albenberg, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04978181: The Prevalence and Associated Factors of Early Deterioration After Successful Recanalization in Acute Ischemic Stroke
Official title: The Prevalence and Associated Factors of Early Neurological Deterioration After Successful Recanalization Treatment in Patients With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admittedto Assiut University Hospitals within time window for thrombolysis or thrombectomy within one year are included

Brief summary: stroke is a leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes.

Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. These diseases have remained the leading causes of death globally in the last 15 years.

Recent clinical trials have shown that endo-vascular thrombectomy is an effective and safe recanalization modality for acute ischemic stroke patients .

Meta-analysis results show that endovascular treatment is associated with a high ratio of successful recanalization rate and a low rate of symptomatic hemorrhage .

Approximately 2.2-37.5% of patients with acute ischemic stroke might encounter early neurological deterioration (END).

Definition of END: An increase in NIHSS ≥4 or an increase in Ia of NIHSS ≥1 within 72 h after recanalization treatment.


Eligibility criteria: Inclusion Criteria:

1. Ischemic stroke of both sex.
2. More than 08 years.
3. Accepting all study requirements.
4. within time window for thrombolysis or thrombectomy
5. fulfilling criteria for thrombolysis or thrombectomy

Exclusion Criteria:

(A)Absolute Contraindications :

1. Intracerebral hemorrhage history or presence on imaging
2. Time of onset more than 465 hours
3. Blood pressure greater than 085/000 mm Hg
4. Recent severe head trauma or neurosurgical intervention
5. Coagulopathy (INR \>067, thrombocytopenia, recent use of heparin or direct oral anticoagulants)
6. Endocarditis (infective)
7. Aortic dissection (B)Potential Contraindications :

1.Seizure at onset 2.Noncompressible arterial puncture 3.Recent surgery 4.Gastrointestinal or genitourinary bleeding 5.Multiple cortical microbleeds (\>00) 6. Large intracranial aneurysms or arteriovenous malformations 7.Recent transmural myocardial infarction 8. Small NIHSS with nondisabling stroke symptoms

Primary outcomes:
measure: Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
timeFrame: 1 year
measure: factors of deterioration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: