louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05975749: Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
Official title: A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Adjuvant treatment
Trastuzuma
Serplulimab
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.


Eligibility criteria: Inclusion Criteria:

1. Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. Her2+ diagnosed by Immunohistochemistry or FISH
5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
6. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion Criteria:

1. Patients with stage I and IV.
2. Unavailable for R0 resection and D2 lymph node dissection.
3. Multiple primary tumors
4. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
5. History of chemotherapy, radiotherapy, immunotherapy or target therapy.

Primary outcomes:
measure: Disease-free survival
timeFrame: 3-year
Secondary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Side effects
timeFrame: 12 months]
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT03340649: The Predictive Value of Hepatocyte Growth Factor and Soluble Receptor s-Met in Sepsis
Official title: The Predictive Value of Hepatocyte Growth Factor and Soluble Receptor s-Met in Evaluating Sepsis Patient's Disease Severity and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sepsis patients

Brief summary: To observe the changes of plasma hepatocyte growth factor and soluble receptor s-Met levels in patients with sepsis, and to explore its clinical significance.

Detailed description: 90 patients who diagnosed as sepsis were included in this study. Then keep blood samples from these patients in the first day, the third day, detect the hepatocyte growth factor and soluble receptor s-Met level in plasma byenzyme-linked immuno sorbent assay. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of hepatocyte growth factor and soluble receptor s-Met in plasma and the prognosis of the patients.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted to ICU diagnosed of sepsis(sepsis3.0 criteria)
2. Patients signing informed consent

Exclusion Criteria:

1. Age is less than 18 years old or more than 80 years old
2. Pregnant women
3. Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome
4. Prothrombin time is extension in patients with after liver transplantation
5. Patients with chronic renal failure
6. Patients after kidney transplantation

Primary outcomes:
measure: mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: yi yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02051049: Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)
Official title: Long-term Safety Follow-up Study of Patients Having Received Infusions of HepaStem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urea Cycle Disorders
Crigler Najjar Syndrome
Keywords: CN
UCD
Lead sponsor: Cellaion SA
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 9
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The SAF001 study will include all patients having received infusions of HepaStem in any former interventional study conducted by Promethera Biosciences.

Brief summary: The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.

Detailed description: The primary objective of the SAF001 study is the long-term safety surveillance of the patients post infusion with HepaStem. Furthermore, the evolution of both the metabolic condition and the quality of life are followed. As much as possible, the surveillance will mimic the standard follow-up of the respective diseases (standard of care). The surveillance will end when the patient is undergoing an organ transplant or takes part in another research study. This surveillance will last up to a maximum of 48 months.

Eligibility criteria: Main Inclusion Criteria:

- Subject having received HepaStem during a former interventional clinical study and who have terminated their participation in that study.

Exclusion Criteria:

- Subject has received mature liver cells, stem cells transplantation other than HepaStem, or organ liver transplant.

Primary outcomes:
measure: Characterisation of the long term safety profile of HepaStem therapy.
timeFrame: 4 years
Secondary outcomes:
measure: To characterize the disease evolution after having received HepaStem therapy and to report on general safety.
timeFrame: 4 years
Other outcomes:
Locations:
city: Mont-Saint-Guibert
country: Belgium
facility: Promethera Biosciences
Study officials:
affiliation: Cliniques universitaires Saint-Luc (Belgium)
name: Françoise Smets, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Lille - Hopital Jeanne de Flandre (France)
name: Dries Dobbelaere, MD/Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Pediátrico de Coimbra (Portugal)
name: Isabel Gonçalves, MD/Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Great Ormond Street Children Hospital
name: Stephanie Grunewald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS OSPEDALE PEDIATRICO DEL BAMBINO GESÃ (Roma)
name: Giuliano Torre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Corporation
name: Hanna Mandel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367949: Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.
Official title: Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accuracy of Surgical Guide in Computer Guided Implantology
Keywords: Surgical guide
impression inversion
stereolithographic surgical guides
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide

Impression inversion with markers technique avoids the dimension changes that may happen from pouring of the dental model cast. Also it saves time as no need for optical scan of the model cast and for scan appliance even in cases of multiple restoration. Adding markers to impression tray ensures an accurate merge even if the patient has restored dentition that may cause scatter during the CT/CBCT scan.

This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided Implantology.


Eligibility criteria: Inclusion Criteria:

1. Partially Edentulous patients seeking for dental implants
2. Patients with Bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
3. Medically free patients.

   -

   Exclusion Criteria:

1- Patients with thin ridges. 2- Patients with systemic disease that may affect bone quality. 3- Patients with poor oral hygiene and active periodontal diseases. 4- Anatomical situations requiring regenerative procedure. 5- Completely edentulous patient 6-Patient with limited mouth opening

-

Primary outcomes:
measure: Evaluation of angular deviation of virtual implants and actual implant position according to scanning protocol "optical scan of the model" Versus "impression inversion" using CBCT.
timeFrame: Immediate post operative
Secondary outcomes:
measure: Evaluation of linear deviation of virtual implants and actual implant position according to scanning protocol " optical scan of the model" Versus " impression inversion " using CBCT
timeFrame: Immediate post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry , Cairo university
Study officials:
References:
Clinical trial NCT01373749: Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
Official title: Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Pulmonary Hypertension of Newborn
Keywords: PPHN
NO inhalation
Sildenafil
Treatment
Safety
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2011-06-15
Enrollment: 40
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent Pulmonary Hypertension (PPHN), while the safety of NO long term application was under investigation. Several research suggested too much NO2 was generated in the lung after long term (\> 72h) use of NO inhalation, which cause bad effects on PS production.

Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical effect but need monitoring of blood pressure. The possible hypotension effect restrict the dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend sildenafil to The purpose of the study was to establish if NO continued with sildenafil has the same effect as single NO inhalation.


Eligibility criteria: Inclusion Criteria:Diagnosed as PPHN in the NICU,primary disease:neonate respiratory distress syndrome,meconium aspiration syndrome of newborn,severe neonatal infectious pneumonia.

* Pulmonary artery pressure \> 50mmHg
* mechanical ventilation over 48h
* primary OI(PO2/FiO2)\<300
* difference of SpO2 between up and low limbs \> 10%
* high FiO2 oxygen inhalation test: positive

Exclusion Criteria:

* congenital heart disease
* diaphragmatic hernia

Primary outcomes:
measure: persistent normal pulmonary artery pressure
timeFrame: 96 hours
Secondary outcomes:
measure: Recover without complication
timeFrame: 1 month after therapy
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics,Daping hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT01460849: Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers
Official title: Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis

Brief summary: Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.


Eligibility criteria: Inclusion Criteria:

* ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
* moderate-to-severe lung disease,
* Pseudomonas aeruginosa (PA) airway infection.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Time to tobramycin solution (TIS) initiation from first year of TIS eligibility
Secondary outcomes:
measure: Mortality
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06593249: Management of Tick-borne Encephalitis
Official title: Presentation, Management and Outcome of Tick-borne Encephalitis in Patients Referred to Infectious Diseases or Neurology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Encephalitis
Keywords: tick-borne encephalitis
outcome
neuroimaging
lumbar puncture
clinical management
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tick-borne encepalitis referred to Infectious diseases or Neurology departments of the University Medical Centre Ljubljana, Slovenia during the COVID-19 pandemic (from March 2020 to September 2022).

Brief summary: In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Associations between severity of acute illness and clinical outcome were also explored.


Eligibility criteria: Inclusion Criteria:

* microbiologically confirmed tick-borne meningoencephalitis

Exclusion Criteria:

* Exchanged between ID and neurology within the first 48 hours due to organizational constraints
* Transferred from another hospital
* Lumbar puncture not performed
* Not fulfilling study criteria

Primary outcomes:
measure: head imaging
timeFrame: at admission
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana, Ljublajana, Slovenia
Study officials:
References:
Clinical trial NCT00449449: A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Official title: A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Pertubation, tubal flushing, intrauterine insemination.
Lead sponsor: Isifer AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2007-03-20
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

Detailed description: In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.

Eligibility criteria: Inclusion Criteria:

* Female,
* 20-40 years of age,
* If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
* Normal menstruation cycle,
* Male partner 20-70 years of age,
* Male partner,
* Normal sperm sample within 5 years (\>20x106/mL, total sperm count \>30x106, normal morphology 5%),
* Duration of infertility more than one year,
* Signed informed consent

Exclusion Criteria:

* Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
* Clinical signs of PID,
* Known hypersensitivity to local anesthetics,
* Non-patent fallopian tubes,
* Pathological uterine cavity,
* Pathological PCT, myoma \> 2 cm diameter,
* Any disease or laboratory finding considered of importance by the investigator not to include the patient

Primary outcomes:
measure: clinical pregnancy
Secondary outcomes:
measure: Pregnancy rate measured by Serum-HCG day 17 after IUI
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: 1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge
Study officials:
affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden
name: Greta Edelstam, Md. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelstam G, Sjosten A, Bjuresten K, Ek I, Wanggren K, Spira J. A new rapid and effective method for treatment of unexplained infertility. Hum Reprod. 2008 Apr;23(4):852-6. doi: 10.1093/humrep/den003. Epub 2008 Feb 15.
Clinical trial NCT03820349: Cystic Fibrosis and Cognitive Function
Official title: Effects of Cystic Fibrosis and Cystic Fibrosis Related Diabetes on Brain Structure and Cognitive Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: CFRD
Cystic fibrosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Cystic Fibrosis

Brief summary: The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function

Detailed description: A growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is associated with alterations in brain structure and cognitive impairment. People with cystic fibrosis related diabetes (CRFD) are exposed to hyperglycemia as seen in other forms of diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. Both hyperglycemia and chronic inflammation have been postulated to affect brain structure and function. Cystic fibrosis trans-membrane conductance regulator (CFTR). protein is widely expressed in the neurons of the brain including in the hippocampus The hippocampus plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of metabolic stressors. The expression of CFTR in neurons has several potential implications for central nervous system function, including cognition.

The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function.

Eligibility criteria: Inclusion Criteria:

patients with Cystic fibrosis

Exclusion Criteria:

* History of stroke
* History of epilepsy
* History of neurosurgical procedures
* Past or current history of severe psychiatric illness
* Pass or current history of alcohol or substance abuse
* Presence of metallic substances in body or inability to remove before imaging procedure
* History of claustrophobia or known inability to tolerate MRI
* Current pregnancy
* Inability to consent

Primary outcomes:
measure: MRI outcome
timeFrame: baseline
Secondary outcomes:
measure: Cognitive function
timeFrame: baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT05185349: Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry
Official title: Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress
Child and Adolescent Psychiatry
Parental perceived needs
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims at exploring experiences and perceived needs among parents of children recently exposed (or who recently revealed) a potentially traumatic event.

Brief summary: This study aims at exploring qualitatively experiences and perceived needs among parents of children exposed to potentially traumatic events, including their attitudes and understanding of trauma and resilience, their perceptions of their parental role in the peri-traumatic period, and their expectations of a family intervention for post-traumatic stress. This will ultimately guide future research to develop and design and intervention that would be tailored to their needs and expectations


Eligibility criteria: Inclusion criteria:

* Being a parent of a child aged 7-17
* exposed or who recently revealed a potentially traumatic event in the past six months

Exclusion criteria: Abusive parent Child and/or parent with intellectual deficiency

Primary outcomes:
measure: Experiences and attitudes around trauma
timeFrame: 1 day
Secondary outcomes:
measure: Perceptions of parental role and ways to cope
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Diane Purper-Ouakil, M.D., Ph. D.
role: STUDY_DIRECTOR
References: