louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04066101: TAS1R1, TAS1R3, TLR2, TLR4, CA6 Gene Polymorphism on Dental Caries
Official title: Variants in Taste Genes on Caries Risk and Caries Activity Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Caries Risk
Low Caries Risk
Keywords: caries risk, gene polymorphisms
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Power analysis was performed with the G-Power software package. It was determined that a total of 200 patients will be needed: 100 (DMFT ≤ 5) for the low caries risk group and 100 (DMFT ≥ 14) for the high caries risk group

Brief summary: The aim of this study is to examine the effects of TAS1R1, TAS1R3, TLR2, TLR4, CA6, gene polymorphism on caries risk in adults.

Detailed description: To date, genes can be grouped into categories based on the factor influencing dental caries. The major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits.

CA6 exists in the human saliva and has a critical role of buffering, immune response and taste.Toll-like receptors are expressed in the tongue gustatory papillae where they may initiate immune responses to pathogens.Genetic variations in the TAS1R1 and TAS1R3 for umami cause perception of these tastes differently.

Eligibility criteria: Inclusion Criteria:

* adult be between 25 and 44 years old
* subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) ≥ 5, or, DMFT ≥14
* same oral health, diet and socioeconomic status

Exclusion Criteria:

* systemic or genetic disorders
* orthodontic appliances
* pregnant women

Primary outcomes:
measure: Past caries experience
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yildiz G, Ermis RB, Calapoglu NS, Celik EU, Turel GY. Gene-environment Interactions in the Etiology of Dental Caries. J Dent Res. 2016 Jan;95(1):74-9. doi: 10.1177/0022034515605281. Epub 2015 Sep 16.
citation: Yildiz Telatar G, Saydam F, Guzel AI, Telatar BC. Variants in taste genes on caries risk and caries activity status. Med Mol Morphol. 2020 Dec;53(4):244-251. doi: 10.1007/s00795-020-00263-5. Epub 2020 Aug 7.
Clinical trial NCT01472601: A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile
Official title: A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 2660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer

Brief summary: This study is a parallel translational study of a Randomized Phase III trial Investigating the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol NCCCTS-467) . Patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .


Eligibility criteria: Inclusion Criteria:

* Curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection)
* AJCC/UICC high-risk stage II, stage III colon cancer Stage II patient with high risk of relapse, if they fulfill one or more of the following criteria:(T4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion)
* Patients who are participating in the randomized phase II trial of FOLFOX 6 or 12 cycles
* Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer

Exclusion Criteria:

* Patients who do not agree with sampling of peripheral blood for genetic analysis
* Patients who are considered not to be suitable for this study at investigator's discretion

Primary outcomes:
measure: disease-free survival
timeFrame: 6years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical Center
Study officials:
References:
Clinical trial NCT03824301: Different Modes of Ventilation During Cardiopulmonary Bypass
Official title: Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Dysfunction
Keywords: cardiopulmonary bypass
pressure-controlled ventilation
volume-controlled ventilation
atelectasis
pleural effusion
lung compliance
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 66 patients divided into 3 groups with different modes of ventilation.

Detailed description: Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.

Eligibility criteria: Inclusion Criteria:

* Patients undergoingvalve surgeries
* Patients undergoing coronary artery bypass grafting surgeries

Exclusion Criteria:

* Emergency cases.
* Off-pump surgeries.
* Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
* Massive blood transfusion during surgery.
* Complicated surgeries.
* Redo surgeries.
* Patients with decompensated heart failure prior to surgery.
* Patients refusal

Primary outcomes:
measure: chest x-ray
timeFrame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
measure: lung ultrasonography
timeFrame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University cardiothoracic hospital
Study officials:
References:
Clinical trial NCT03462901: Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod
Official title: Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clavicular Fracture
Keywords: Fixation of midshaft clavicular fracture by intramedullary
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fracture clavicle in adults
Primary purpose: TREATMENT

Brief summary: Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. Open reduction and plate-screw ﬁxation was considered as the gold standard with the advantages of ﬁrm ﬁxation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. Intramedullary ﬁxation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate However, early intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually replaced due to insufficient stability. In addition, various nails such as elastic stable intramedullar

Detailed description: Fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.

Eligibility criteria: Adults pt aged (16-55 ) how is active presented with mid shaft clavicular fracture, displacement with no comorbidity and excluding pt with polytrauma aged above 55y or below 16y ,pt with fracture lateral 3rd and pt with comorbidity

Primary outcomes:
measure: Union rate
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of orthopedic and traumatology department
name: Faisal Fahmy Adam, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05471401: GI Organ Tracking Via Balloon Applicators
Official title: GI Organ Tracking Via Balloon Applicators
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Cancer
Kidney Cancer
Larynx Cancer
Liver Cancer
Lung Cancer
Digestive Organs--Cancer
Intrathoracic--Cancer
Respiratory Organs--Cancer
Pancreas Cancer
Small Intestine Cancer
Stomach Cancer
Colon Cancer
Rectal Cancer
Keywords: Gastric balloon
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach.
* Previous complete or partial surgical resection of the esophagus, stomach, or duodenum.
* Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).

Primary outcomes:
measure: Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
timeFrame: Completion of follow-up for all participants (estimated to be 1 year)
Secondary outcomes:
measure: Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation
timeFrame: Completion of follow-up (estimated to be 4 weeks)
measure: Translation movement of stomach between CBCT scans with and without balloon insufflation
timeFrame: Day of procedure (Day 1)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008201: Vitamin D Status and Supplementation in Athletes
Official title: Vitamin D Status and Supplementation in Elite Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Keywords: dose-response study
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the effect that supplementation may have during the course of a year.

The study is a double blinded parallel study design.

Detailed description: Study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines

Eligibility criteria: Inclusion Criteria:

* athletes
* 19-60y

Exclusion Criteria:

* subjects who take vitamin D supplements

Primary outcomes:
measure: Change in serum 25(OH)D
timeFrame: Every 3 months during one year
Secondary outcomes:
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Lisette de Groot, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490801: Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma
Official title: Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Nonneoplastic Condition
Keywords: childhood Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
hemophagocytic lymphohistiocytosis
Epstein-Barr virus infection
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-13
Enrollment: 50
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of Hodgkin lymphoma.

Brief summary: RATIONALE: Studying samples of blood and tissue 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 biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.

Detailed description: OBJECTIVES:

* Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
* Examine the effects of ITK mutations on expression of the ITK protein.
* Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.

OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of Hodgkin lymphoma (HL) meeting the following criteria:

  * Epstein-Barr virus-positive (EBV+) HL as assessed by positive EBV serology, elevated levels of EBV genome in the blood or tumor tissue following quantitative polymerase chain reaction (PCR) and/or evidence of EBV positivity of pathology samples (EBER+ or LMP+) and, when possible, mixed cellular histology
  * Young age (\< 10 years) at diagnosis
  * Presence of hemophagocytic lymphohistiocytosis (HLH)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Presence of germline ITK mutations
measure: Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein
measure: Correlation between ITK mutations with specific clinical or histopathological features of HL
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Kim E. Nichols, MD, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080104: Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery
Official title: Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
oxytocin
vaginal delivery
prophylactic
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2014-03-06
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial

Detailed description: Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. In this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.In some countries, intravenous access can not be provided easily . Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . For this reason, less educated , which can be applied by those offering health services .

Eligibility criteria: Inclusion Criteria:

1. Research volunteers, the undersigned, pregnant women
2. Only with vaginal delivery (episiotomy and perineal tears can)
3. \> 34 weeks or more will be
4. Cephalic presentation will be
5. At low risk of postpartum hemorrhage

Exclusion Criteria:

1. \<18 years
2. Multiple pregnancies
3. The presence of uterine myoma
4. Having postpartum hemorrhage in previous pregnancies
5. Placenta previa, polyhydramnios
6. More than four parity
7. Fetal macrosomia
8. Hb \<9mg/dl
9. preeclampsia
10. Uterine anomalies
11. Receiving anticoagulant therapy, suspected coagulopathy
12. \> 42 weeks of pregnancy
13. Oxytocin allergy -

Primary outcomes:
measure: early postpartum hemorrhage
timeFrame: postpartum 24 hours
Secondary outcomes:
measure: Blood transfusion requirement
timeFrame: postpartum 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Dr Sadi Konuk Teaching and Research Hospital
Study officials:
References:
citation: Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
Clinical trial NCT03777904: The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
Official title: The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Iron Overload
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with high ferritin levels and confirmed iron toxicity.

Brief summary: A serum ferritin level can reflect the total body iron content, thus a very low serum ferritin is commonly used as an indicator of iron deficiency and a very high serum ferritin is commonly used as a marker of iron overload. Ferritin is a shell of protein in which iron is stored. Ferritin is an acute phase reactant, and serum ferritin levels can increase during inflammatory conditions. Consequently, an elevated ferritin level might mean there is an excess of storage iron, or might simply mean that inflammation has resulted in high levels of the ferritin shell, containing little iron.

The research team is able to quantify the amount of iron in ferritin using inductively conducted plasma mass spectrometry, in the Heme and Iron Core Laboratory at the University of Utah. Thus, it can be determined whether in a child with a very high serum ferritin level, that ferritin is loaded with iron or is actually very low in iron. Neonates and young children with certain liver disorders characteristically have a very high serum ferritin level. These conditions are gestational alloimmune liver disease (GALD) and hemophagocytic lymphohistiocytosis (HLH). It is not clear what the iron content of the ferritin is in these neonates. Knowing this will be a step toward understanding whether the pathogenesis of these conditions involves iron overload. Additionally, if urine ferritin and iron levels correlate with serum ferritin and iron levels, urine may be used as a non-invasive way to monitor iron status.

In this study, serum and urine samples will be collected from children with high serum ferritin levels and confirmed iron toxicity. Both ferritin and iron content within ferritin will be measured in the serum and urine samples and compared for correlation.


Eligibility criteria: Inclusion Criteria:

* Children with ferritin levels \> 1000 ng/mL

Exclusion Criteria:

* None

Primary outcomes:
measure: Correlation of serum and urine ferritin levels
timeFrame: 1 year
measure: Correlation of iron content within serum and urine ferritin levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Robert Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References: