louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06748339: Gut Microbiome and Colorectal Cancer
Official title: Gut Microbiome Dyspiosis in Colorectal Cancer Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: CRC
microbiome
Lead sponsor: Heliopolis University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 12 newly diagnosed CRC patiens vs 6 healthy voulnteers

Brief summary: Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target

Detailed description: Many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in CRC development. These changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. Our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors

Eligibility criteria: Inclusion Criteria:

* Age of 40 years to 80 years
* Patients with a newly diagnosed CRC

Exclusion Criteria:

* Patients with previously known CRC
* Pregnancy or Lactation
* Abdominal surgery within/up to 6 months prior to sample collection
* Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
* History of other types of cancer
* Subjects on a special diet
* Diabetes, liver, or kidney diseases
* CRC patients who used enema or underwent colonoscopy up to one week before sample collection.

Primary outcomes:
measure: The effect of food and lifestyle on microbiome
timeFrame: "through study completion, an average of 1 year"
measure: microbiome profile and CRC pathogensis
timeFrame: "through study completion, an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: cairo university Hopitals (elKasr ELieny )
Study officials:
affiliation: Heliopolis University
name: sara M eladwy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baas FS, Brusselaers N, Nagtegaal ID, Engstrand L, Boleij A. Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis. Cell Host Microbe. 2024 Aug 14;32(8):1235-1247. doi: 10.1016/j.chom.2024.07.008.
Clinical trial NCT05323539: Comparison of Thyroid Volumes in Patients With and Without Endometrioma
Official title: Comparison of Thyroid Volumes by Ultrasonography in Patients With and Without Endometrioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrioma
Thyroid
Lead sponsor: Adana City Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of our study is to evaluate whether there is a statistical difference between thyroid gland volume in patients with pathological diagnosis of endometriosis or endometrioma and in patients who underwent surgery for other gynecological reasons, and to reveal the presence of concomitant thyroid disease in these cases.

Detailed description: Transcripts and proteins involved in thyroid metabolism are dysregulated in the eutopic and ectopic endometrium of endometriotic patients, leading to triiodothyronine (T3) action, resistance, and local thyroxine (T4) accumulation of the ectopic endometrium. Thyroid stimulating hormone (TSH) acts as a proliferative and prooxidative hormone in all endometriums of endometriosis patients and controls. Mouse studies have confirmed that endometriotic implants are larger when thyroid hormones are increased.

Since endometriosis is characterized by a chronic inflammatory process, the high prevalence of autoimmune thyroid diseases in patients with endometriosis may be the result of immune dysregulation observed in women with endometriosis (5). Thyroid involvement has already been described in the physiology of the endometrium and ovary, and thyroid diseases are often associated with gynecological and obstetric disorders such as infertility, miscarriage or preterm delivery.

Despite all the links between thyroid diseases and endometriosis, there is no study related to thyroid volume in patients with endometriosis so far. Thyroid volume was studied in patients with diabetes mellitus, pregnant women, and scleroderma. We believe that the evaluation of thyroid volume in patients with endometriosis will contribute to the investigation of the relationship between these two pathogenesis, and to the treatment and follow-up approach.

Eligibility criteria: Inclusion Criteria:

* Prediagnosis of surgically planned endometrioma

Exclusion Criteria:

* Patients with goiteri,
* Patients with past or present autoimmune thyroid dysfunction,
* Patietns on treatment with thyroid hormones or drugs containing iodine.

Primary outcomes:
measure: Measuring Thyroid Volumes by ultrasonography
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Education and Research Hospital
state: Merkez
Study officials:
affiliation: University of Heath and Sciences Adana City Training and Research Hospital
name: Gulsum Uysal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00923039: The Early Origins of Cardiovascular Disease
Official title: The Early Origins of Cardiovascular Disease : the Consequence of Growth Restriction During Foetal Life and Infancy on Cardiovascular Structure and Function in Adulthood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Keywords: The early origin of cardiovascular disease
Lead sponsor: Danone Institute International
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 Young adult students will be recruited at the Preventive Medicine Centre at Université de la Méditerranée during their annual routine medical examination

Brief summary: Small body size at birth, slow weight gain during infancy and increase in body mass index after 2 years are independent risk factors for cardiovascular disease and the metabolic syndrome. There is a large gap in our understanding of how early growth affects the cardiovascular system. Possible mechanisms include alterations in body composition, in cardiac structure, in vascular function, in renal function and epigenetic processes.

The Objective is to determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers students aged between 18-25 years old
* Having growth records

Exclusion Criteria:

* If young women subject without contraception,or pregnant

Primary outcomes:
measure: To determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: CIC-UPCET Hopital de la Timone Bat F
Study officials:
References:
Clinical trial NCT00247039: Garlic in Patients With Febrile Neutropenia
Official title: A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chemotherapy
Neutropenia
Keywords: neutropenia
fever
garlic
infection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To determine the clinical effects of garlic in preventing and treatment of patients with chemotherapy related febrile neutropenia.These patients have a very high incidence of infections which are not routinely covered by the standard empiric therapy. Adding a non- toxic and possibly effective therapy may reduce the risk for infections, synergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.

Detailed description: Patients eligible are randomized to receive placebo or garlic capsules after chemotherapy course and until leukocyte recovery.

Eligibility criteria: Inclusion Criteria:

FN patients expected to have at least 5 days or more of neutropenia will be eligible for treatment with garlic compounds AST/ALT ≤ 3 times the upper limit of institutional laboratory normal.

Total bilirubin ≤ 2 times the upper limit of institutional laboratory normal.

BUN and creatinine should be ≤ 3 times the upper limit of institutional laboratory normal.

Newly diagnosed as well as previously treated patients will be eligible.

Exclusion Criteria:

History of clinically significant liver or kidney disease.

Patients on anti-coagulation therapy with Coumadin will be excluded because of the potential garlic interference with metabolism.

Patients receiving concomitant chemotherapeutic treatment

Primary outcomes:
measure: Time to fever and beginning of empiric antibiotic treatment.
timeFrame: 0-45 days post chemotherapy
Secondary outcomes:
measure: Documented and culture positive infections.
timeFrame: as above
measure: Kind of infectious organisms and sensitivity to medicines.
timeFrame: as above
measure: Length of infection
timeFrame: as above
measure: Use of growth factors.
timeFrame: as above
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: moshe e gatt, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gatt ME, Strahilevitz J, Sharon N, Lavie D, Goldschmidt N, Kalish Y, Gural A, Paltiel OB. A Randomized Controlled Study to Determine the Efficacy of Garlic Compounds in Patients With Hematological Malignancies at Risk for Chemotherapy-Related Febrile Neutropenia. Integr Cancer Ther. 2015 Sep;14(5):428-35. doi: 10.1177/1534735415588928. Epub 2015 Jun 2.
Clinical trial NCT02732639: A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Official title: Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis D, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.


Eligibility criteria: Inclusion Criteria:

* Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
* Positive anti-delta for at least 3 months prior to screening
* Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
* A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
* Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

Exclusion Criteria:

* Antiviral therapy for CHD within the previous 6 months
* Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* Other medical condition associated with chronic liver disease
* Women with ongoing pregnancy or who are breast feeding

Primary outcomes:
measure: Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
timeFrame: At Week 72
measure: Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
timeFrame: At Week 72
Secondary outcomes:
measure: Percentage of Participants With Normal ALT at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Negative HDV RNA at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
timeFrame: At Weeks 48 and 72
measure: Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
timeFrame: At Screening and at Weeks 48 and 72
measure: Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
timeFrame: At Weeks 48 and 72
measure: Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
timeFrame: At Weeks 48 and 72
Other outcomes:
Locations:
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01966939: Influences of Types of Skull Surgery on Temporomandibular Joint Performance
Official title: Influences of Types of Skull Surgery on Temporomandibular Joint Performance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craniotomy
Craniectomy
Keywords: craniotomy
craniectomy
temporalis
TMJ
mastication
QoL
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects received craniotomy or craniectomy and age, gender and teeth condtion matched control subjects.

Brief summary: There are two purposes on this study:

- to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ) movement, function and quality of life (QoL)


Eligibility criteria: Inclusion Criteria:

* over 20 years old
* post-craniotomy or post-craniectomy
* able to follow order

Exclusion Criteria:

* severe orofacial injury
* severe teeth loss
* significant changes of occlusion

Primary outcomes:
measure: Jaw movement
timeFrame: within 1 year after surgery
measure: Jaw Functional Limitation Scale
timeFrame: within 1 year after surgery
measure: Bite force
timeFrame: within 1 year after surgery
measure: WHOQOL-BREF Taiwanese Version
timeFrame: within 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jau-Yih Tsauo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731039: Postoperative Pain in Adult Patients.
Official title: Survey of Postoperative Pain Control in Adults After Different Types of Surgeries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Surgical Procedures, Operative
Keywords: Postoperative pain
Anxiety
Depression
Adult
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 620
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients underoing surgical procedures performed on general or regional anesthesia.

Brief summary: Each surgical intervention associated with even a minor tissue injury is a source of pain which needs to be effectively controlled. Although the Polish national guidelines for post-operative pain management have been published, many patients experience moderate and severe pain in the postoperative period. The aim of this study is (1) to assess pain severity among adult patients after different types of surgeries; (2) to identify demographic and clinical factors associated with postoperative pain.


Eligibility criteria: Inclusion Criteria:

* adult
* elective surgery
* the American Society of Anesthesiologists score 1-3

Exclusion Criteria:

* diagnosed mental illness, alcohol abuse disorders, intellectual disability
* traumatic events within the last 6 months (e.g. death, breakdown of a relationship, job loss)
* problems with verbal communication

Primary outcomes:
measure: Pain intensity scores at rest
timeFrame: first 24 hours after surgery
measure: Pain intensity scores on movement
timeFrame: first 24 hours after surgery
Secondary outcomes:
measure: Anxiety scores
timeFrame: day prior to surgery
measure: Depression scores
timeFrame: day prior to surgery
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Andrzej Frycz-Modrzewski Krakow University
state: Lesser Poland
Study officials:
affiliation: Andrzej Frycz Modrzewski Krakow University
name: Lucyna Tomaszek
role: STUDY_DIRECTOR
References:
citation: Borys M, Zyzak K, Hanych A, Domagala M, Galkin P, Galaszkiewicz K, Klaput A, Wroblewski K, Miekina J, Onichimowski D, Czuczwar M. Survey of postoperative pain control in different types of hospitals: a multicenter observational study. BMC Anesthesiol. 2018 Jul 18;18(1):83. doi: 10.1186/s12871-018-0551-3.
citation: Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.
citation: Tomaszek L, Debska G. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate. J Clin Nurs. 2018 Apr;27(7-8):1641-1652. doi: 10.1111/jocn.14215. Epub 2018 Mar 2.
Clinical trial NCT01128439: Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease
Official title: A Postmarketing Observational Study Estimating The Impact Of Prevnar 13 (Trade Mark) (13vpnc) On Invasive Pneumococcal Disease Caused By Vaccine Serotypes Of Streptococcus Pneumoniae After Introduction Into Routine Pediatric Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pneumococcal Disease
Keywords: Pneumococcal conjugate vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2010-05-21
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This study will estimate the incidence of invasive pneumococcal disease in members of the Northern Kaiser Permanente healthcare system during each of the 5 following introduction of Prevnar 13.

Detailed description: No sampling as no subjects are enrolled

Eligibility criteria: Inclusion Criteria:

* Documented invasive pneumococcal disease (IPD), defined as recovery of an isolate of S pneumoniae from a normally sterile site in a member of the surveillance population.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence of IPD in the NCKP healthcare system in children 6 weeks through 5 years of age (prior to the sixth birthday) during each of the 5 years following introduction of Prevnar 13.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Baxter R, Aukes L, Pelton SI, Yee A, Klein NP, Gruber WC, Scott DA, Center KJ. Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):141-150. doi: 10.1093/jpids/piaa035.
Clinical trial NCT07000539: Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
Official title: Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Bariatric Surgery
Keywords: bariatric surgery
indocyanine green
vascular
weight loss surgery
Intraoperative Complications
Postoperative Complications
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Bariatric Medical Center
First posted: 2025-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. There is uncertainty around the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of obesity with a BMI ≥ 30 kg/m²
* Scheduled for revisional bariatric surgery

Exclusion Criteria:

* Allergy to iodides.
* Anticoagulation with products containing sodium bisulfite (due to the risk of ICG-FA inactivation).
* Use of radioactive iodine studies within the past 7 days.
* Pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of ICG-FA).
* History of liver disease or laboratory findings suggestive of moderate to severe hepatic disease: total bilirubin \>1.5 times the upper limit of normal (ULN), or any elevation of aspartate aminotransferase (AST) above ULN.
* Participants who withdraw their consent to participate in the study (elimination criterion).

Primary outcomes:
measure: Time to Fluorescence Detection
timeFrame: Intraoperative (within 5 minutes post-injection)
Secondary outcomes:
measure: Regional Tissue Perfusion by Anatomical Zone
timeFrame: Intraoperative
measure: Change in Surgical Strategy Based on ICG-FA
timeFrame: Intraoperative
measure: Adverse Events Related to ICG Use
timeFrame: Within 48 hours postoperatively
measure: Postoperative Complications
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Centro Medico Bariatrico
state: Baja California
Study officials:
References: