louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03486574: Research for Associated Genes for Gastric Cancer in Family Member With Affected First-Degree Relatives
Official title: Research for Associated Genes for Developing Gastric Cancer in Family Member With First-Degree Relatives of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Genetic Predisposition
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigator will recruit or invite the participants among persons who visit the clinic with a family history of gastric cancer.

The investigator plans to recruit gastric cancer patients and non-patients in family with 2 or more affected members.

Non-gastric cancer patients was restricted to persons over 50 years of age.

Brief summary: Familial gastric cancer accounts for 10% of all cases, but predisposing genetic variations is unknown except for CDH1 mutation.

Because Germline mutation is believed to be a key aspect of cancer predisposition, we plan to recruit persons with 2 or more affected family members in three-generation pedigree. The investigators will perform a whole-exome sequencing using DNA from blood samples of families including gastric cancer patients and non-gastric cancer patients

Detailed description: 1\> Patient selection

Enroll criteria:

1) Gastric cancer patients and their first-degree relatives and 2) family with two or more gastric cancer patients within three-generation pedigree.

A three-generation pedigree will be used for diagnostic consideration or risk assessment of rare variation.

Personal history will be acquired by questionnaire which asks smoking, alcohol intake, dietary preference, socioeconomic information and history of previous eradication of HP. For any family member with gastric cancer, age at diagnosis, histology type, methods of treatment or pathological reports will be evaluated.

2\> Whole exome sequencing, variant annotation, filtering and prioritization After whole exome sequencing, functional annotation of genetic variants will be conducted using ANNOVAR.

3\> Linkage analyses To perform variant and gene-based linkage analysis in pedigrees, data will be analyzed using pedigree-VAAST.

4\> Validation using a genechip

Eligibility criteria: Inclusion Criteria :

* Gastric cancer patients and their first-degree relatives
* Members in family with two or more gastric cancer patients within three- generation pedigree

Exclusion Criteria :

* Those who reject the enrollment

Primary outcomes:
measure: Genes with logarithm of odds (LOD)>2 in linkage analysis
timeFrame: 0 day (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00852774: Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy
Official title: Effects of Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery For Endometrial Cancer: Robotics Versus Laparotomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intraocular Pressure
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Endometrial Cancer Surgical Candidates

Brief summary: The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine preoperative facts affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to laparotomy.

Detailed description: All patients that are surgical candidates with endometrial cancer will be screened for this study. Two measurements from each eye will be taken in the following positions: awake at rest, supine before induction, after induction on anesthesia, after insufflation of abdomen with CO2 in supine position, in trendelenburg position, in deep trendelenburg position,at the end of procedure,prior to awakening in supine position and one last reading 45-60 min after awakening in supine position. The time, blood pressure, heart rate, peak airway pressure, plateau airway pressure, end tidal desflurane, end tidal CO2, total IV fluids administered, and blood loss.

Eligibility criteria: Inclusion Criteria:

* Endometrial Cancer Surgery

Exclusion Criteria:

* Not a surgical candidate

Primary outcomes:
measure: To assess the changes in intra-ocular pressure and examine perioperative factors affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to a laparotomy
timeFrame: 5years for enrollment completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: David Cohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06568874: Effect of VR Versus CT in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
Official title: Effect of Virtual Reality Versus Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises.


Eligibility criteria: Inclusion Criteria

* Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).

Age:

* Upper Extremity Impairment:
* Ability to provide informed consent to participate in the study.

Exclusion Criteria

* Severe communication difficulties that would impede the ability to follow instructions during therapy.
* Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher).
* Other Neurological Conditions

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA) for Upper Extremity
timeFrame: 12 Months
measure: Stroke Impact Scale (SIS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital,Shadman 1
state: Punjab
Study officials:
References:
Clinical trial NCT00964574: Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
Official title: Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 68
Sex: ALL
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: Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
* 6.5 \<=HbA1c \<= 11% at visit 1
* BMI \<35 kg/m²
* Provision of signed and dated informed consent prior to any study procedures
* Ability and willingness to complete study diaries and questionnaires
* Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
* A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

* Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
* Pregnant women
* Active proliferative diabetic retinopathy
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Mean change in Glycosylated haemoglobin (HbA1c)
timeFrame: Week 12
Secondary outcomes:
measure: Mean Glycosylated haemoglobin (HbA1c)
timeFrame: Week 12
measure: Mean Fasting Blood Glucose and mean Post Prandial Glycemia
timeFrame: Week 12
measure: Number of documented symptomatic hypoglycaemic episodes
timeFrame: From week 0 to week 12
measure: Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
timeFrame: week 12
measure: Mean change of Fasting Blood Glucose and Post Prandial Glycemia
timeFrame: From week 0 to week 12
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Natallia Zhyhaila
role: STUDY_DIRECTOR
References:
Clinical trial NCT00675974: Use of Pressure Garments for Burn Scars
Official title: Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Burns
Keywords: Burn
Scar
Pressure garments
Wound healing
Burn Injury
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2008-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
2. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
3. Will Pressure Garment Therapy diminish discomfort due to pruritus.


Eligibility criteria: Inclusion Criteria:

* At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
* at least 1 year of age and no more than 17 years of age
* Wound closure
* No evidence of deep venous thrombosis or other vascular compromise.
* No concomitant conflicting study protocols.

Exclusion Criteria:

* Burn injuries not bilateral to upper and/or lower extremities.
* Evidence of vascular compromise.
* Conflicting protocols.

Primary outcomes:
measure: Differences in scarring between pressure garment therapy and no pressure garment therapy
timeFrame: Time of burn to 2 years post burn
Secondary outcomes:
measure: Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.
timeFrame: Time of burn to 2 years post burn
measure: Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy
timeFrame: Time of burn to 2 years post burn
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04685174: Intraoperative NIRS of Transplanted Kidney for Prediction of Acute and Sub-acute Injury
Official title: Intraoperative Near Infrared Spectroscopy of Transplanted Kidney for Prediction of Acute and Sub-acute Kidney Injury in Transplanted Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft Failure
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate.

Exclusion Criteria:

* Patients unable to give consent,
* patients whose surgeries were aborted before transplant,
* patients who were lost to follow up during the first 7 post-transplant days,
* patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.)
* No pregnant patients will participate in this study.
* No minors will participate in this study.

Primary outcomes:
measure: Graft Failure
timeFrame: 7 days post operative
measure: Graft Failure
timeFrame: 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06966674: No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track
Official title: Assessment of No-Reflow in Patients With STEMI After Intracoronary Tirofiban After Opening of the Track
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: No-Reflow
STEMI
Intracoronary
Tirofiban
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the no-reflow in patients with STEMI after intracoronary glycoprotein IIb/IIIa inhibitors after opening of track in thrombus.

Detailed description: ST-segment-elevation myocardial infarction (STEMI) is most commonly caused by rupture or erosion of an atherosclerotic plaque, resulting in acute occlusion of the coronary artery, and the preferred reperfusion strategy is primary percutaneous coronary intervention (PCI).

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients STEMI.

In recent years, mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Both sexes.
* Patients with STEMI. ST-segment elevated myocardial infarction is defined as typical chest pain \>30 minutes with ST-segment elevation of \>1 mm in at least 2 consecutive leads on the electrocardiogram or new-onset left bundle brunch block.

Exclusion Criteria:

* Treatment with thrombolytic drugs in the previous 24 hours.
* Known malignancy.
* Thrombocytopenia.
* End-stage liver disease.
* Cardiogenic shock.
* Renal failure with glomerular filtration\<30 ml/min.
* Contraindication for the use of tirofiban.

Primary outcomes:
measure: Blood stream
timeFrame: After treatment (Up to 15 minutes)
Secondary outcomes:
measure: Incidence of major adverse cardiac events
timeFrame: After treatment (Up to 30 days)
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT00035074: A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Official title: A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2002-05-03
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment currently receive this drug by injection. MTX is also available as a pill that can be given by mouth but it is not known how well the drug enters the body in patients with Crohn's disease or ulcerative colitis. This study is being done to compare how much MTX enters the body when the drug is taken by mouth compared to when it is given by injection. If the drug is well absorbed, it may allow patients to receive the drug by mouth.


Eligibility criteria: * Adult or pediatric patients with IBD (CD or UC) currently receiving MTX as part of their clinical care.
* Patients must be receiving weekly MTX at a dose between 7.5 and 40 mg/m2.
* Weight \>= 12 kg.
* Normal serum creatinine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02879474: Study of Risk Factors and Clinical Characterization of Rapidly Growing Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 472
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: Breslow primitive melanoma \>1 mm patients

Brief summary: State of the question Over the past decade, the incidence of melanoma (MM) has steadily increased in France and in most developed countries. This increased incidence was concerned mainly MM thin while the incidence of MM thick that represent the true "killers", and mortality from MM remained stable or increased slightly over the same period. These epidemiological data and observations from everyday medical practice dermatologists suggest the existence of different growth patterns within MM. Indeed, some MM progressing slowly sometimes for decades before diagnosis but are thin at the time of resection. Conversely, others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the relative mortality in MM, as improved screening failed to influence to this day.

Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to calculate the growth rate, an Australian team recently studied the growth rate in a population of patients suffering from MM. In this population 1/3 of MM had a growth of more than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The European and Australian people are very different in particular regarding the prevention policy, these results can not be extrapolated to the French population.The main objective is to identify risk factors for FGMM in French propulation


Eligibility criteria: Inclusion Criteria:

* Patient with Breslow primitive melanoma for over 1 mm skin affected

Exclusion Criteria:

* Patient unable to answer questionnair concerning its melanoma history desease

Primary outcomes:
measure: Speed growth of melanoma size
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux De Marseille
name: Caroline GAUDY, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01429974: Detection of Meconium in Amniotic Fluid in Post Term Pregnancies
Official title: Detection of Meconium in Amniotic Fluid in Post Term Pregnancies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Meconium
Keywords: amniotic fluid
post term pregnancies
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-09-07
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post term pregnant females

Brief summary: Meconium constitutes the bowel contents of the fetus and is normally expelled only after birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which complicates delivery and is associated with increased newborn morbidity and mortality. At present there is no viable diagnostic test for Meconium prior to the onset of labor and the rupture of membranes. The system developed for the detection of Meconium, based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength. The diagnostic test being developed does not require penetration into the amniotic sac and is safe, painless and simple to perform.


Eligibility criteria: Inclusion Criteria:

* 37-42 weeks regnancy without rupture of membranes

Exclusion Criteria:

* none

Primary outcomes:
measure: Determine the capability for diagnosing Meconium stained Amniotic Fluid prior to a cervical ripening procedure in women, using the Amniometer device
timeFrame: prior to breakage of water
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Arie Orenstein, professor
role: PRINCIPAL_INVESTIGATOR
References: