louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01467921: Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Official title: A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* Aged 20 years or older
* Histologically confirmed squamous cell carcinoma of esophagus
* Curatively (R0) resected, lymph node positive
* ECOG performance status of 0 or 1
* Restoration of oral intake \>1500 kcal/d
* No prior chemotherapy except for neoadjuvant ones
* No prior radiotherapy within 1 month before registration
* Adequate marrow, hepatic, renal and cardiac functions
* Provision of a signed written informed consent

Exclusion Criteria:

* Severe co-morbid illness and/or active infections
* Prior treatment with oxaliplatin
* Pregnant or lactating women
* Active CNS metastases not controllable with radiotherapy or corticosteroids
* Known history of hypersensitivity to study drugs

Primary outcomes:
measure: disease-free survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00411021: Endometrial Sampling (Pipelle)in IVF Patients
Official title: Endometrial Sampling (Pipelle)in IVF Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.


Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF treatment
* Repeated Implantation failure

Exclusion Criteria:

* PID or suspected PID
* Undiagnosed Irregular Bleeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: IVF Unit, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Micha Baum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387021: Continuous Adductor Canal Block for Total Knee Arthroplasty Analgesia
Official title: Prospective Comparison Between Continuous Femoral Nerve Block and the Association of Adductor Canal Block and Sciatic Nerve Block in Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blockade
Pain Management
Keywords: analgesia
nerve block
Total knee replacement
Lead sponsor: Institut Kassab d'Orthopédie
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .


Eligibility criteria: Inclusion Criteria:

* Elective unilateral TKA,
* Planned continuous spinal anesthesia ,
* Ability to follow study protocol,
* American Society of Anesthesiologists class 1 to 3.

Exclusion Criteria:

* Contraindication for neuraxial anesthetic,
* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months),
* Hypersensitivity and/or allergies to any of the study medications,
* Intraoperative use of volatile anesthetics,
* Preexisting neuropathy on the operative limb,
* Contraindications to a femoral, adductor canal or Tibial nerve block.

Primary outcomes:
measure: Total Opioid-consumption
timeFrame: 8 hours postoperative
Secondary outcomes:
measure: NRS pain score at rest
timeFrame: 0,1,2,4,6,8,12,24 and 48 hours postoperative
measure: NRS pain score during movement
timeFrame: 0,1,2,4,6,8,12,24 and 48 hours postoperative
measure: NRS pain score after 10 meters of walk or maximum walked distance
timeFrame: 8, 24 and 48 hours postoperative
measure: Ability to walk
timeFrame: 8, 24 and 48 hours postoperative
measure: TUG Test
timeFrame: 8, 24 and 48 hours postoperative
measure: The 10-m walk test
timeFrame: 8, 24 and 48 hours postoperative
measure: patient satisfaction
timeFrame: 8, 24 and 48 hours postoperative
Other outcomes:
Locations:
Study officials:
References:
citation: Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
Clinical trial NCT06114121: Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.
Official title: Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: erector spinae plane block
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 0
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: The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section


Eligibility criteria: Inclusion criteria:

* Able to consent
* BMI\<35

Exclusion Criteria:

* Adults unable to consent
* BMI\>35
* Individuals \<18 years of age at time of admission
* Individuals taking anticoagulant medications
* Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
* Pre-existing chronic pain or pain disorder diagnosis
* Conversion from neuraxial to general anesthesia
* Prisoners

Primary outcomes:
measure: post-operative opioid analgesic medication
timeFrame: up to 24 hours
Secondary outcomes:
measure: change in post-operative pain medication by visual analog scale
timeFrame: baseline, up to 24 hours
measure: number of minutes to first use of rescue medication
timeFrame: up to 24 hours
measure: obstetric quality of recovery scale
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Reine Zbeidy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04454021: Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy
Official title: Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoro-acetabular Impingement (FAI)
Keywords: femoro-acetabular impingement
hip muscle volume
cross-sectional area
arthroscopy
MRI images
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI

Brief summary: The purpose of this study was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.

Detailed description: We performed a retrospective review of magnetic resonance imaging (MRI) data of FAI patients who underwent hip arthroscopy between January 1, 2016, and July 1, 2018. "Image J" with an embedded region-of-interest (ROI) tool was used to calculate the cross-sectional area (CSA) of muscles on MRI. Wilcoxon signed-rank test was used to determine the differences between preoperative and postperative hip muscle CSA. The correlations of change in muscle CSA with age, gender, BMI, pain level, preoperative symptom duration, and multiple validated patient-reported outcomes were also analyzed with a spearman rank correlation test.

Eligibility criteria: Inclusion Criteria:

* (1) Age 18-50 years; (2) symptoms, physical examination, imaging evidence in accordance with FAI; (3) symptoms that were not alleviated by nonsurgical treatment; (4) the operation is performed by the same senior operator.

Exclusion Criteria:

* (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6) osteonecrosis of hip; (7) sacroiliac joint disease

Primary outcomes:
measure: Change in muscle volume after hip arthroscopy
timeFrame: at least two years after hip arthroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jianquan Wang
state: Haidian District
Study officials:
References:
Clinical trial NCT06207721: Physical Therapy for Functional Constipation in Children
Official title: Physical Therapy for Functional Constipation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy in Pediatric Functional Constipation
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 400
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: TREATMENT

Brief summary: Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment


Eligibility criteria: Inclusion Criteria:

* children diagnosed as functional constipation.
* aged from 4 to 18 years old
* from both sex

Exclusion Criteria:

* children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.

Primary outcomes:
measure: Rome-III criteria
timeFrame: after 6 months of interventions
Secondary outcomes:
measure: short form 36 questionnaire
timeFrame: after 6 months of interventions
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT01837121: a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China
Official title: a Randomized Controlled Trail to Determine the Impact of a SMS Reminder Among Diabetic Retinopathy Patients in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance
Diabetic Retinopathy
SMS
Keywords: not-attended rate
re-visit
vision
knowledge
satisfaction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Orbis
name: The World Diabetes Foundation
First posted: 2013-04-22
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy in rural China.

Detailed description: SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural diabetic retinopathy patients.

Eligibility criteria: Inclusion Criteria:

- all the diabetes patients who would like to join our study in 5 CREST cooperated rural hospitals.

Exclusion Criteria:

1. Both the patient and his/her caretakers don't have cellphone,or the one who has cellphone but don't know how to use the SMS function.
2. The first re-visit appointment time is outside our study period.

Primary outcomes:
measure: Not-attended rate
timeFrame: up to 1.5 years
Secondary outcomes:
measure: Knowledge about Diabetic retinopathy on a standardized examination
timeFrame: up to 1.5 years
measure: Presenting vision
timeFrame: up to 1.5 years
measure: Loss of presenting vision
timeFrame: up to 1.5 years
measure: Satisfaction with care
timeFrame: up tp 1.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Blindness Preventment and Treatment Department, Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center
name: Nathan G Congdon, MD,MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06140121: Immersive Technology to Improve Physical Therapy Engagement
Official title: Immersive Technology to Improve Physical Therapy Engagement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Health
Keywords: Virtual Reality
Physical Activity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.


Eligibility criteria: Inclusion Criteria:

* Between age 7-25
* has an active physical therapy consultation
* Anticipated inpatient stay for more than 2 days

Exclusion Criteria:

* Legal guardian not present to obtain consent
* child with a significant neurological condition, or major developmental disability
* child with active infection of the face or hand
* a history of severe motion sickness
* a history of seizures cause by flashing light
* Major surgery within the last 48 hours

Primary outcomes:
measure: ActiGraph data points
timeFrame: During physical therapy session
Secondary outcomes:
measure: Total movement with wearable movement sensor
timeFrame: During physical therapy session
measure: Patient Fatigue
timeFrame: immediately after the physical therapy session
measure: Difference in FACIT-F questionnaire result
timeFrame: immediately after the physical therapy session
measure: Change in current mental well being as measured by the modified WHO (Five) Well-Being Index
timeFrame: immediately after the physical therapy session
measure: Difference in Fatigue - Short Form 10a questionnaire result
timeFrame: immediately after the physical therapy session
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Thomas Caruso
role: STUDY_DIRECTOR
References:
Clinical trial NCT01751321: Glucose Variability With DPP-4 Inhibition
Official title: Glucose Variability With DPP-4 Inhibition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Research Clinical Centre of the Russian Railways, JSC
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glucose Variability With DPP-4 Inhibition

Detailed description: Patients with Type 2 Diabetes, age 35-75y., will be included in this double blind randomized placebo controlled study.

The sample size of 50 patients completing the 30 day study period is based on statistical input from Merck Research Laboratories, Rahway NJ.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* receiving a stable dose of metformin ≥ 1500 mg
* HbA1c 7,5% -10/0 %

Exclusion Criteria:

* Type 1 diabetes
* HbA1c \< 7,5% and \> 10,0%

Primary outcomes:
measure: glucose variability
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Clinical Centre of the Russian Railways, JSC
name: Alexander Ametov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697821: The Number of Mesogastria Containing Metastatic Lymph Nodes Predicts Gastric Cancer Prognosis
Official title: The Number of Mesogastria Containing Metastatic Lymph Nodes Predicts Gastric Cancer Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: metastasis
Gastric Cancer
Lymph node
Mesogastrium
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric cancer who underwent total or proximal gastrectomy in Tongji Hospital were included in this study

Brief summary: To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.

Detailed description: Previous studies have established the existence of the mesogastrium, dividing it into six sections. The mesogastrium is identified during surgery and utilized in surgical practice. The aim of the present study was to further investigate its role in gastric cancer prognosis.Between January 2014 and January 2018, patients from the Tongji Hospital were included in this post-hoc analysis, including data from a randomized clinical study (DCGC01; http://www.clinicaltrials.gov, NCT01978444). Mesogastria containing metastatic lymph nodes (LNs) were referred to as metastatic mesogastria. Pathology reports were examined to assess metastases in the mesogastrium. Survival was assessed using Kaplan-Meier curves and multivariable Cox models.

Eligibility criteria: Inclusion Criteria:

1. older than 18, younger than 85
2. primary gastric adenocarcinoma confirmed by preoperative pathology
3. routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery
4. it is expected to perform radical gastrectomy through d2+cme

Exclusion Criteria:

1. pregnant or lactating women
2. severe mental disorder or language communication disorder
3. preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or R0 resection could not be achieved
4. those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons).
5. concurrent malignancies at other sites
6. emergency surgery patients

Primary outcomes:
measure: Overall survival
timeFrame: Postoperative 5-year survival
Secondary outcomes:
measure: The Number of Mesogastria Containing Metastatic Lymph Nodes
timeFrame: Postoperative 5-year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Jichao Qin, M.D./Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381821: Endometrial Volume and Sub-endometrial Vascularity as Predictors of In-vitro Fertilization Success
Official title: The Measurement of Endometrial Volume and Sub-endometrial Vascularity to Replace the Traditional Endometrial Thickness as Predictors of In-vitro Fertilization Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Techniques, Assisted
Keywords: junctional zone
Implantation
Intracytoplasmic sperm injection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 82
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with primary or secondary infertility and were scheduled for a first IVF/ICSI treatment cycle due to Pelvic Inflammatory disease, ovulatory dysfunction, tubal infertility, unexplained infertility , combined infertility with normal transvaginal ultrasound.

Brief summary: 100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.

Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.

Detailed description: 100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ). These patients are then assigned to receive fertility treatment (ICSI) They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.

Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.

Eligibility criteria: Inclusion Criteria:

* A normal transvaginal ultrasound is defined as having no visible intracavitary pathology (e.g. submucous myomas, polyps or septa) and was be performed in the follicular phase of the menstrual cycle. Intramural myomas without impression or deformation of the uterine cavity were incorporated in the definition of a normal ultrasound

Exclusion Criteria:

* Exclusion criteria included Females aged above 40 years old , patients with endometriosis, abnormal endocrine functions as Diabetes mellitus, thyroid disorders and adrenal abnormalities ,general diseases, those with ovarian cysts or have azospermic partners

Primary outcomes:
measure: pregnancy rate
timeFrame: 14 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: