louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05837065: Prognostic Models for HCC Based on Tumor Micronecrosis
Official title: Development and Validation of Novel Models Including Tumor Micronecrosis for Predicting the Postoperative Survival of Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Tumor micronecrosis
Nomogram
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study enrolled HCC patients receiving curative hepatectomy in the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 765)

Brief summary: The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.


Eligibility criteria: Inclusion Criteria:

1. pathologically diagnosed as HCC;
2. curative hepatectomy with R0 resection;
3. conserved liver function with Child Pugh class A or B

Exclusion Criteria:

1. with macrovascular invasion or extrahepatic metastasis;
2. receiving other anti-tumor treatments such as TACE or systemic drugs;
3. with other primary cancers;
4. incomplete follow-up data;
5. without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

Primary outcomes:
measure: the Harrell concordance index (C-index)
timeFrame: Up to 5 years
Secondary outcomes:
measure: the time-dependent area under the receiver operating characteristic curve(tdAUROC)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06180265: The Diagnostic and Prognostic Value of Presepsin in Sepsis
Official title: PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment.

No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

Detailed description: Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.

Eligibility criteria: Inclusion Criteria:

* caucasian patients
* patients undergoing laparoscopic major abdominal surgery

Exclusion Criteria:

* pregnancy,
* organ transplantation,
* palliative care
* metastatic cancer
* head trauma and polytrauma
* coagulopathies
* use of anticoagulants
* neurological disease
* autoimmune disease
* thyroid disease.

Primary outcomes:
measure: incidence of mortality at 30-days
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: Puglia
Study officials:
References:
Clinical trial NCT01834365: Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly
Official title: Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 188
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.

Detailed description: Eligibility criteria are men and women over 60 years old and available to participate in the study for 3 months with blood pressure higher than 140/90.

Exclusion criteria are severe dementia, malignant hypertension, depression

Outcome measures are systolic and diastolic blood pressure after 3 months administration of structured education once a month.

Eligibility criteria: Inclusion Criteria:

* Subject with age more than 60 years
* Blood pressure higher than 140/90

Exclusion Criteria:

* Severe Dementia
* Depression
* Malignant Hypertension

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 3 Months
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: 3 Months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital Recruiting
Study officials:
affiliation: Faculty of Medicine University of Indonesia
name: Ayatullah Khomaini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05424965: Cologne Placenta Cohort (CPC)
Official title: Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Maternal
Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetrics deptartment of a University Hospital

Brief summary: Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* BMI before pregnancy \>= 18
* with \& without gestational diabetes
* c-section at gestational week 35+0 until 41+6

Exclusion Criteria:

* multiple pregnancy
* maternal serious internal disease
* infections before pregnancy (e.g. HIV, hepatitis B)
* pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)

Primary outcomes:
measure: Activity of Wnt signaling pathway in placental tissue
timeFrame: through study completion, about 4 years in total
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: Universitätsklinikum Köln
name: Sarah Appel, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238665: CLE for Differential Diagnosis of IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative colitis.

Brief summary: Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.


Eligibility criteria: Inclusion Criteria:

* equal or above 18 years of age
* ability to provide written informed consent
* well-established diagnosis of CD or UC

Exclusion Criteria:

* history of IBD reclassification in the last 3 years
* Boston Bowel Preparation Scale score's \< 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
* inability to provide written informed consent
* severe uncontrolled coagulopathy
* impaired renal function
* pregnancy or breast feeding
* active gastrointestinal bleeding
* known allergy to fluorescein
* residence in institutions

Primary outcomes:
measure: Number of participants with IBD
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
affiliation: University Hospital Erlangen
name: Helmut Neumann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tontini GE, Mudter J, Vieth M, Atreya R, Gunther C, Zopf Y, Wildner D, Kiesslich R, Vecchi M, Neurath MF, Neumann H. Confocal laser endomicroscopy for the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy. 2015 May;47(5):437-43. doi: 10.1055/s-0034-1391226. Epub 2014 Dec 18.
Clinical trial NCT05817565: Physical Therapy on Phrenic Nerve Function
Official title: Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Function Test
Phrenic Nerve Irritation
Cervical Disc Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study was conducted on 20 patients with compression of the cervical disc at the level of 3, 4, and 5. Their mean age was 43 years; mean weight was 75 kg and mean height was 170cm.They suffered from cervical disc compression for 6-8 months.

Brief summary: This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.

Detailed description: Twenty patients from the Spinal Unite represented the sample of the study. Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment. It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography. Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.

Eligibility criteria: Inclusion Criteria:

* suffered from cervical disc compression for 6-8 months.
* patients examined and referred by physician.

Exclusion Criteria:

* Any cardio pulmonary disorders which may alter pulmonary function.
* They did not receive any physical therapy program prior to their participation in the study.

Primary outcomes:
measure: pulmonary function test
timeFrame: 4 months
measure: phrenic nerve amplitude
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Ben El Sarayat
Study officials:
affiliation: Cairo University
name: Maha m El monem, Ass Prof
role: STUDY_CHAIR
References:
citation: Carvalho, M. De (2004) Electrodiagnostic assessment of respiratory dysfunction in motor neuron disease, Handbook of Clinical Neurophysiology. Elsevier B.V. doi: 10.1016/S1567-4231(04)04029-8.
Clinical trial NCT03502265: Otteroo Case Series
Official title: Exploring Otteroo Use In Early Intervention: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants With or at Risk/Concern for Developmental Delay
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 4
Sex: ALL
Minimum age (years): 8
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single subject research design case series
Primary purpose: TREATMENT

Brief summary: Rationale. The Otteroo is a floatie which supports an infant or young child with their head above and their body in water. Researchers are proposing that the Otteroo may be a good "tool" to facilitate exploring the ability to move and control one's body before locomotion develops. Intervention. Otteroo will be used as an adjunct to standard care for 4 weeks.

Detailed description: Objectives or purpose. The purpose of this project is to measure overall developmental status before, during, and after Otteroo experience. Study population or sample characteristics. Participants will be 4 pre-locomotor infants or young children for whom a healthcare provider or caregiver has identified concerns about potential developmental delay. Study methodology. A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). Study endpoints or outcomes. The end of the study is the final assessment at 12 weeks. Follow-up. None. Statistics and plans for analysis. Researchers will calculate descriptive statistics (mean, range, coefficient of variation) for all measures and describe changes over time, relating the participant's performance at each time point to norm-referenced results for their age.

Eligibility criteria: Inclusion Criteria:

* pre-locomotor (able to locomote independently less than 4 feet)
* a healthcare provider or caregiver has identified concerns about potential developmental delay

Exclusion Criteria:

* younger than 8 weeks of age
* older than 66 months of age
* body weight of more than 35 lbs
* diagnosis of Down syndrome
* clinical presentation of ligamentous laxity
* without access to an appropriate water source (bathtub or pool depending on the size of the child)
* with prior experience using Otteroo

Primary outcomes:
measure: Change in Alberta Infant Motor Scale
timeFrame: weeks 0 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Infant Neuromotor Control Laboratory
state: California
Study officials:
References:
Clinical trial NCT00004365: Study of Pituitary Size and Function in Familial Dwarfism of Sindh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Keywords: endocrine disorders
growth hormone deficiency
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Northwestern University
First posted: 1999-10-19
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.

II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.

Detailed description: PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.

All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes.

Eligibility criteria: * Familial Dwarfism of Sindh
* Severe short stature but proportionate without dysmorphic features
* Normal body size and weight at birth
* Bone age is severely delayed
* Puberty is somewhat delayed (age 15-16)
* Fertility present in at least 3 dwarfs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Gerhard Baumann
role: STUDY_CHAIR
References:
citation: Baumann G, Maheshwari H. The Dwarfs of Sindh: severe growth hormone (GH) deficiency caused by a mutation in the GH-releasing hormone receptor gene. Acta Paediatr Suppl. 1997 Nov;423:33-8. doi: 10.1111/j.1651-2227.1997.tb18366.x.
citation: Maheshwari HG, Silverman BL, Dupuis J, Baumann G. Phenotype and genetic analysis of a syndrome caused by an inactivating mutation in the growth hormone-releasing hormone receptor: Dwarfism of Sindh. J Clin Endocrinol Metab. 1998 Nov;83(11):4065-74. doi: 10.1210/jcem.83.11.5226.
Clinical trial NCT06193265: Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
Official title: Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiculopathy
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 440
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 who need discetomy for lumbar disc herniation

Brief summary: Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing impact of so-called conventional "open" discectomies.

Although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications.

This study is based on hypothesis that complete endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Detailed description: Discectomy is the most common surgical technique to solve lumbar radiculopathy caused by disc herniation and nerve roots compression .

Currently, microscopic discectomy is performed as a minimally invasive surgery, thus reducing the impact of so-called conventional "open" discectomies.

Minimally invasive spinal surgery was developed using a retractor tube, a microscope, and an endoscope to perform efficient nerves decompression while preserving spinal cord stabilizing structures.

Although more technically demanding, discectomy with full endoscopy made possible a significant reduction of surgery invasive impact, thus making possible to broaden the field of endoscopic surgery indications.

This study is based on hypothesis that full endoscopic discectomy offers several advantages over traditional microscopic discectomy, including a smaller skin incision and therefore fewer scars and less muscle damage, lower infection rate, less blood loss, less painful post-operative recovery and shorter hospital stay length.

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years
* Patient operated under endoscopy for lumbar disc herniation between February 2020 and May 2022
* Patient operated by conventional microscopic surgery for lumbar disc herniation before February 2020
* Patient having been informed of the research and not opposing its data use as part of this research

Exclusion Criteria:

* None

Primary outcomes:
measure: Hospitalization rate within 3 months after discectomy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
state: Toutes
Study officials:
References:
Clinical trial NCT03383965: CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Official title: A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma
Lead sponsor: Immune Cell, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Weifang People's Hospital
First posted: 2017-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.


Eligibility criteria: Inclusion Criteria:

Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:

* Karnofsky or Lansky score \>50;
* Expected survival\>12 weeks;
* Hgb \> 8.0;
* FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
* LVEF≥50%;
* Creatinine\<2.5mg/dl;
* Bilirubin\<2.5mg/dl;
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal;
* Patients must sign an informed consent.

Exclusion Criteria:

* Pregnant or lactating;
* Uncontrolled active infection including hepatitis B or C;
* HIV positive;
* Active clinically significant CNS dysfunction;
* Current use of systemic steroids;
* Heterogenous lymphocyte treatments within recent 6 months;

Primary outcomes:
measure: Measure the safety of ICAR30 T cells
timeFrame: 2 years
Secondary outcomes:
measure: Measure the anti-tumor effect of ICAR30 T cells
timeFrame: 3 years
measure: Measure the survival time of ICAR30 T cells in vivo
timeFrame: 5 years
Other outcomes:
Locations:
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
Study officials:
References: