louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06483399: Research on Nutritional Risk Indexes and Inflammatory Indicators in Postoperative Complications and Prognosis of Epithelial Ovarian Cancer Patients
Official title: Influence of Nutritional Risk Indexes and Inflammatory Indicators on Postoperative Complications and Prognosis of Epithelial Ovarian Cancer and Construction of Prediction Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 1108
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with epithelial ovarian cancer between January 2012 and February 2023 were recruited from seven tertiary medical centers in the China Real World Gynecological Oncology Platform (NUWA).

Brief summary: The goal of this observational study is to explore the influence and predictive significance of nutritional risk indicators and inflammatory indicators on postoperative complications and prognosis of patients with epithelial ovarian cancer (EOC). The main question it aims to answer is:

Can preoperative nutritional risk and inflammatory indexes predict postoperative complications? Do preoperative nutritional risk and inflammatory indexes better predict the prognosis of patients with epithelial ovarian cancer? Which index is the best predictor of postoperative complications or prognosis for patients?


Eligibility criteria: Inclusion Criteria:

1. histologically confirmed primary epithelial ovarian, peritoneal, and fallopian tube cancers.
2. patients received comprehensive staged surgery or debulking surgery.
3. available data of laboratory examination within 7 days before the surgery.

Exclusion Criteria:

1. borderline ovarian tumor.
2. receipt of neoadjuvant chemotherapy.
3. presence of other conditions influencing laboratory data, like hepatitis, kidney disease, autoimmune diseases, infectious diseases, blood disease, etc.
4. concurrent cancer in other organs.
5. absence of surgery or biopsy only.
6. multiple staged surgeries.

Primary outcomes:
measure: Postoperative Complications
timeFrame: Within 30 days after surgery
measure: Progression-free survival
timeFrame: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of disease progression or death or last follow-up, whichever occurred first, assessed up to 100 months.
measure: Overall survival
timeFrame: From the date the patient diagnosed with primary ovarian, fallopian tube, or peritoneal cancer to the date of death or last follow-up, whichever occurred first, assessed up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00327899: Home Inotropic Therapy in Children
Official title: Home Inotropic Therapy in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
congestive heart failure
inotropes
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 13
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Choa patients' medical charts between 2.2.04 and 12.31.05 with Coram Healthcare only. These patients would have received inotropic support at home.

Brief summary: Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and prolong life while awaiting heart transplantation. Traditionally children have been maintained on inotropic therapy in the hospital under close, monitored supervision. The United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed listing criteria allowing patients awaiting heart transplantation to be discharged to home, yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are no data on the use of home inotropic therapy in children.

Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Detailed description: Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Methods:

Data will be obtained from CHOA and Coram Home Healthcare, Inc over a two year period, January 1, 2004 through December 31, 2005. Data will be collected on approximately 35 children aged 0-18 years receiving therapy. The length of therapy, type of therapy, therapy-related complications, number of readmissions, deaths at home and catheter-related infections data will be collected.

Inclusion Criteria:

Receiving inotropic support at home Choa patients with Coram Healthcare only

Eligibility criteria: Inclusion Criteria:

* Receiving inotropic support at home
* Choa patients with Coram Healthcare only
* medical charts between 2.2.2004 and 12.31.2005

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Alexandria Berg, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207999: Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer
Official title: Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Cervical Cancer
Keywords: Human papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University of Cape Town
name: African Organization for Research and Training in Cancer (AORTIC)
First posted: 2010-09-23
Enrollment: 591
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged ≥ 21 years at the time the cervical specimen is taken, diagnosed with cervical lesion macroscopically suggestive of invasive cervical cancer, scheduled for cervical biopsy as per routine procedure.

Brief summary: The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.


Eligibility criteria: Inclusion Criteria:

* A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
* Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
* Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.
* No prior chemo- or radiotherapy for cervical cancer.

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer
timeFrame: Average time frame: 6-12 months
measure: Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma
timeFrame: Average time frame: 6-12 months
Secondary outcomes:
measure: Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer
timeFrame: Average time frame:6-12 months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: GSK Investigational Site
city: Kumasi
country: Ghana
facility: GSK Investigational Site
city: Ibadan
country: Nigeria
facility: GSK Investigational Site
city: Lagos
country: Nigeria
facility: GSK Investigational Site
city: Observatory
country: South Africa
facility: GSK Investigational Site
state: Western Province
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05122299: the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket
Official title: The Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type ii Diabetic Patients (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of CoQ10 in soft tissue healing and bone regeneration after extraction in diabetic patients seeking dental implants. Methods: This study will be a randomized controlled clinical trial, 18 patients will be divided equally into three groups. In-vitro studies will be performed to investigate the release of CoQ10 from collagen, swelling ratio, and evaluation of gelation behavior. The patients will undergo tooth extraction and filling of the socket with either collagen or CoQ10/collagen. Empty sockets will serve as a negative control. The bone regeneration of the socket will be determined by radiography, histology, histomorphometry, and polymerase chain reaction (PCR) for bone markers.


Eligibility criteria: Inclusion Criteria:

* Age 30-60 years including both males and females .
* Controlled Type II diabetic patients glycosylated hemoglobin (HbA1C) levels less than 7
* Good oral hygiene
* No history of bruxism/ para-functional habits
* Patients accept to sign the informed consent .
* Single or multiple Mandibular teeth requiring extraction.

Exclusion Criteria:

* Uncontrolled diseases that may contraindicate the surgery.
* Somkers patients.
* Osteoporosis.
* Hypersensitivity.

Primary outcomes:
measure: Soft tissue healing
timeFrame: at 1 week
measure: change in bone formation
timeFrame: at baseline, 3 months and 6 months
measure: Change in implant stability
timeFrame: at baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05067699: Vitamin D Level in Recurrent PV
Official title: Serum Vitamin D Level Detection in Patients With Recurrent Pityriasis Versicolor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Pityriasis Versicolor
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent Pityriasis Versicolor (more than 2 attacks per year) and of a disseminated nature

Brief summary: Serum Samples will be taken from patients with recurrent Pityriasis Versicolor for the evaluation of vitamin D level.


Eligibility criteria: Inclusion Criteria:

* - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
* Patients of both genders.
* Age ≥18 years old.

Exclusion Criteria:

* - Patients with other cutaneous diseases.
* Patient's having dandruff (scaly scalp) even if not symptomatizing.
* Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
* Patients with autoimmune diseases.
* Patients with immunodeficiency diseases.
* Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.

Primary outcomes:
measure: Serum 25(OH) D3 level
timeFrame: 6months-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy Teaching Hospital
Study officials:
References:
Clinical trial NCT01500499: Role of Biomarkers in Disease Progression in Samples From Patients With Acute Myeloid Leukemia
Official title: The Role of AF1q in Progression of Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-28
Enrollment: 20
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myeloid leukemia.

Brief summary: RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies the role of biomarkers in disease progression in samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To determine the subcellular localization of the MLL-AF1q fusion protein in leukemia cells.

OUTLINE: Cryopreserved specimens are analyzed for MLL-AF1q fusion protein and AF1 gene expression by mass spectrometry, western blot analysis, semi-quantitative PCR, and qPCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Cryopreserved acute myeloid leukemia specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Subcellular localization of the MLL-AF1q fusion protein in leukemia cells
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Julie D. Saba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01921699: Macrophages Effect on Chemoresistance
Official title: Impact of Macrophages on De-Novo Chemoresistance of Adenocarcinoma Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Focus of the Study is Macrophage-induced Chemoresistance in Pancreatic Carcinoma Cells During Chemotherapy.
Keywords: macrophages
adenocarcinoma
chemoresistance
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been postulated as being involved in the progression of cancer.

Based on our preliminary findings and on published data we hypothesized that macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells during chemotherapy.

The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of Pancreatic ductal adenocarcinoma (PDA).

methods:

1. The human PDA cell line Panc1 will be grown in suitable conditions.
2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy donors in medium with M-CSF for 7 days.
3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning medium (TCCM) of PDA Cells for an additional 72 hours.
4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to macrophages CM.
5. Cell proliferation will be quantified by light microscopy and by an XTT Cell Proliferation Assay Kit.


Eligibility criteria: Inclusion Criteria:

* healthy people

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: proliferation and migration of PANC1 cell line in the tested groups.
timeFrame: one day to get the blood samples, and a year after that to complete the basic research
Secondary outcomes:
measure: To determine whether direct cell-to-cell interaction or soluble factors participate in MIC.
timeFrame: a year from obtaining the blood samples
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00547599: Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects
Official title: Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 659
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.


Eligibility criteria: Inclusion Criteria:

* 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Nitrate use
* Participated in previous tadalafil study or have a current tadalafil prescription
* Heart attack within the last 90 days
* Kidney problems
* Certain heart problems

Primary outcomes:
measure: Change In Spontaneity Domain of PAIRS scale scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 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 NCT01179542: The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR
Official title: The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Preeclampsia
Keywords: iugr pet eIF4E Translation Initiation Factor
4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only the Placenta aftr delivery or abortion

Brief summary: The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental implantation and in the pathological pregnancies: preeclampsia and IUGR.

Detailed description: 4 groups

Eligibility criteria: Inclusion Criteria:

* post TOP or DELIVERY

Exclusion Criteria:

-

Primary outcomes:
measure: measure the Translation Initiation effect of experimental variables observational studies
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02822742: A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study
Official title: A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons

Primary outcomes:
measure: Intraocular pressure
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: Aihara M, Ropo A, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams N. Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study. Jpn J Ophthalmol. 2020 Jul;64(4):398-406. doi: 10.1007/s10384-020-00748-x. Epub 2020 Jun 22.