louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03485196: The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
Official title: The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Microsatellite Instability
Fluorouracil
Adjuvant chemotherapy
Efficacy
Operation
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
Collaborators: name: Qinghai People's Hospital
name: LanZhou University
First posted: 2018-04-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gastric cancer

Brief summary: The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Detailed description: To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Eligibility criteria: Inclusion Criteria:

1. Histopathology or cytopathology proven gastric cancer;
2. Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
3. Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;
4. Life expectancy of at least 6 months;
5. ECOG（Eastern Cooperative Oncology Group ） score 0-1;
6. Age: 18\~80 years old;
7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

   * For example: WBC（White blood cell count ）\>4.0×109/L; NEU（Neutrophils）\>1.5×109/L; PLT（Platelet）\>100×109/L;
8. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
9. Not concomitant with other uncontrollable benign diseases before the recruitment;

9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;
2. Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
3. Pregnant or lactating women;
4. Patients who have no desire to participate in the study.

Primary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The Second Hospital Affiliated to Lanzhou University
state: Gansu
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Xining
country: China
facility: People's Hospital of Qinghai Province
state: Qinghai
Study officials:
References:
Clinical trial NCT03596996: Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Official title: Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Iron-deficiency
Iron Deficiency Anemia
Hiv
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Joint Clinical Research Center
First posted: 2018-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic \[hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)\], HIV-infected Ugandan children between the ages of 6 mos and 12 years.


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of HIV (based JCRC clinic records);
2. On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
3. Age 6 months - 12 years at the time of screening
4. Hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)by CBC at time of screening

Exclusion Criteria:

1. Acute illness or current opportunistic infection
2. Temperature \>= 38.0°C at the time of screening
3. Known sickle cell disease
4. Acute malnutrition (bilateral pitting edema or extreme wasting)
5. Any chronic illness requiring regular medical attention
6. Residence \> 50 km from JCRC hospital
7. Non-English or Luganda speaking
8. Currently taking iron supplements

Primary outcomes:
measure: Hemoglobin
timeFrame: 3 months
measure: Anemia
timeFrame: 3 months
measure: Iron status
timeFrame: 3 months
Secondary outcomes:
measure: Sick Child Visits
timeFrame: 3 months
measure: Dietary iron absorption
timeFrame: 2 weeks
measure: HIV virologic control
timeFrame: 3 month
measure: HIV related immunosuppression
timeFrame: 3 months
Other outcomes:
measure: Microbiome gut profile
timeFrame: 3 months
Locations:
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
Study officials:
affiliation: University of Minnesota
name: Sarah Cusick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125496: Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With CLBP
Official title: The Relationship Between Kinesiophobia, Physical Activity and Disability Level and Pain Management in Patients With Chronic Low Back Pain in Genders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Pain management
Kinesiophobia
Physical activity
Disability
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred twenty-six subjects were invited to participate in the study. The study was completed with the participation of 84 subjects, 42 women and 42 men.

Brief summary: The aim of this study was to examine the relationship between pain management, kinesiophobia, physical activity and disability level in patients with chronic low back pain (CLBP) in different genders. Eighty-two patients with CLBP (42 females, 42 males) between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.


Eligibility criteria: Inclusion Criteria:

* Individuals who are between 20 and 60 years old,
* Experienced low back pain lasting longer than 3 months, and had no problems with reading, writing, and comprehension were included in the study.

Exclusion Criteria:

* Individuals who underwent surgery for low back pain,
* Had any diagnosed spinal problem,
* Who were pregnant,
* And who had communication problems were not included in the study.

Primary outcomes:
measure: Pain Coping Questionnaire (PCQ)
timeFrame: From 25 December 2019 to 10 November 2021
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: From 25 December 2019 to 10 November 2021
measure: Oswestry Disability Index (ODI)
timeFrame: From 25 December 2019 to 10 November 2021
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: From 25 December 2019 to 10 November 2021
measure: International Physical Activity Questionnaire-Short Form (IPAQ -SF)
timeFrame: From 25 December 2019 to 10 November 2021
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Alanya Alaaddin Keykubat University
name: Ayşe Ünal, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04292496: Anastomotic Leak Testing in Gastrectomy
Official title: Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anastomotic Leak
Gastric Cancer
Surgery
Testing, Reality
Gastroscopy
Keywords: Anastomotic leakage
Gastric cancer
Leakage testing
Total gastrectomy
Gastroscopy
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-03
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.

Detailed description: Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.

Eligibility criteria: Inclusion Criteria:

1. resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. American Society of Anesthesiologists class of I-III.

Exclusion Criteria:

1. Patients had distant metastasis.
2. presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
3. any participation in another clinical trial within the past 6 months.
4. Previous chemotherapy or radiation therapy for any other malignancies.
5. past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 2 months
Secondary outcomes:
measure: Postoperative surgical complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References:
Clinical trial NCT05566535: Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
Official title: Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycythemia Vera
Keywords: ruxolitinib
quality of life
Lead sponsor: Multinational Center for Quality of Life Research, Russia
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with PV will be enrolled after being prescribed with Ruxo. The eligibility criteria for this study are broader than those for patients to be treated with Ruxo in randomized clinical trials, so as to be reflective of routine clinical practice

Brief summary: The purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting


Eligibility criteria: Inclusion Criteria:

* Patients who have confirmed diagnosis of PV
* Patients whose age - 18 years and older
* Patients who signed informed consent
* Patients who able to fill out questionnaires

Exclusion Criteria:

* Patients enrolled in clinical trials
* Patients with contraindications to Ruxo in accordance with instruction for use

Primary outcomes:
measure: Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
timeFrame: Baseline, 3 and 9 months of Ruxo treatment
Secondary outcomes:
measure: Change From Baseline in MPN10 Total score over time
timeFrame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
measure: Change From Baseline in severity of each symptom by MPN10 over time
timeFrame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
measure: Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time
timeFrame: 1, 3, 6, 9 and 12 months of Ruxo treatment
measure: Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment
timeFrame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
measure: The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo
timeFrame: 9 months
measure: The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo
timeFrame: 9 months
measure: The percentage of patients with positive changes of wellbeing during Ruxo treatment
timeFrame: 1, 3, 6, 9 and 12 months of Ruxo treatment
measure: The percentage of patients satisfied/dissatisfied with Ruxo treatment over time
timeFrame: 1, 3, 6, 9 and 12 months of Ruxo treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06094335: Effect of Virtual Reality on Balance in Autism
Official title: Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: autism spectrum disorder
Biodex
Postural Control
Virtual Reality
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study and control groups
Primary purpose: TREATMENT

Brief summary: Children with ASD have poorer postural balance when compared to normal individuals. So, The aim of this study is to assess the effect of Virtual Reality on postural control in Autistic children

Detailed description: Autism spectrum disorders are a collection of persistent neurodevelopmental disorders characterized by difficulties in social interactions, communication, and repetitive, stereotyped, and restricting behaviors. Movement problems can occur throughout infancy and are one of the early indications of autism. Furthermore, movement impairments are the most often observed nonverbal deficits in autistic children.

Postural stability is described as the capacity to maintain an upright posture by keeping the body's center of gravity over its base of support with little swaying or maximal steadiness, and it is considered a fundamental skill required for normal motor development.

Virtual Reality has been used in the field of balance rehabilitation and training because of its relatively low cost and enjoyment. Therefore, the purpose of this study was to study the effect of VR on balance in children with ASD.

Eligibility criteria: Inclusion Criteria:

* Mild ASD

Exclusion Criteria:

* Taking medication affect motor
* Had a head injury, genetic disorder, blindness, fracture

Primary outcomes:
measure: Static Balance
timeFrame: 12 weeks
measure: Functional Balance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Local Autism Center
Study officials:
affiliation: Batterjee Medical College
name: Mohamed A Abdel Ghafar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193035: Microparticles in Severe Aortic Stenosis
Official title: Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Microparticles
Severe aortic stenosis
Calcified aortic stenosis
transcatheter aortic valve replacement
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 15
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: Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves.

In patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.

Detailed description: Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. Inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels.

Patients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.

Eligibility criteria: Inclusion Criteria:

* Clinical indication to be treated with transcatheter aortic valve replacement.

Exclusion Criteria:

* Non native aortic valve
* Moderate aortic regurgitation
* The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.

Primary outcomes:
measure: Difference in microparticle levels
timeFrame: Day 5
Secondary outcomes:
measure: Endothelial microparticle levels
timeFrame: Day 5
measure: Macrophage microparticle levels
timeFrame: Day 5
measure: Platelet microparticle levels
timeFrame: Day 5
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute - InCor. University of Sao Paulo Medical School
Study officials:
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
name: Pedro Lemos, MD PhD
role: STUDY_CHAIR
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
name: Julio F Marchini, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marchini JF, Miyakawa AA, Tarasoutchi F, Krieger JE, Lemos P, Croce K. Endothelial, platelet, and macrophage microparticle levels do not change acutely following transcatheter aortic valve replacement. J Negat Results Biomed. 2016 Apr 11;15:7. doi: 10.1186/s12952-016-0051-2.
Clinical trial NCT06519435: Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction with Intermittent Pneumatic Compression.
Official title: Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction with Intermittent Pneumatic Compression.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Vein Thrombosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with venous ultrasound evaluation performed to rule out deep vein thrombosis

Brief summary: The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.


Eligibility criteria: Inclusion Criteria:

* Venous ultrasound study to evaluate for lower extremity DVT unilateral and/or bilateral within previous 72 hours.

Exclusion Criteria:

* Patients with inaccessible target limb (ultrasound limb) due to bandages (wound, burn, lesion, etc) or cast.
* Patients with leg trauma, fracture, above or below knee amputation, or other condition in which compressing on the calf is medically inappropriate or not possible.
* Patients unable to provide informed written consent.

Primary outcomes:
measure: Mayo Dopplex ABllity device Venous hemodynamic pressure
timeFrame: Baseline
measure: Intermittent Pneumatic Compression device Venous hemodynamic pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Damon Houghton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894735: Vitamin D in Ectopic Pregnancies
Official title: The Effect of Serum Vitamin D and Calcium Levels in Ectopic Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Vitamin D Deficiency
Keywords: Calcium
Magnesium
Inflammation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ectopic pregnancies and women with normal 1st trimester pregnancies

Brief summary: According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including preeclampsia, gestational diabetes, low birth weight, preterm delivery, and cesarean section rates. The aim of the present study was to evaluate the vitamin D levels in ectopic pregnancies, which may have clinical importance in the etiology of this disorder.


Eligibility criteria: Inclusion Criteria:

* ectopic pregnancies and
* women with normal 1st trimester pregnancies

Exclusion Criteria:

* Patients without any known operations or
* disease history

Primary outcomes:
measure: vitamin D level
timeFrame: at the time of diagnosis of ectopic pregnancy
measure: vitamin D level
timeFrame: first trimester
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: