louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03333967: The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province
Official title: The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: apatinib
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 1000
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 of gastric cancer in Anhui province

Brief summary: The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .


Eligibility criteria: Inclusion Criteria:

1. Male or female patients .
2. Confirmed by Pathology or histology of Gastric cancer
3. Patients should be voluntary to the trial and provide with signed informed consent
4. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories
2. Pregnant or lactating women
3. Patients with Apatinib contraindications
4. Patients of doctors considered unsuitable for the trial

Primary outcomes:
measure: Progress free survival
timeFrame: 1 year
Secondary outcomes:
measure: disease control rate
timeFrame: 1year
measure: Objective tumor response rate
timeFrame: 1year
measure: overall survival
timeFrame: 3year
measure: Disease-free survival
timeFrame: 1 year
Other outcomes:
measure: Quality of life score
timeFrame: 1year
measure: adverse events
timeFrame: 1year
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: China Anhui
role: STUDY_CHAIR
References:
citation: Peng W, Zhang F, Wang Z, Li D, He Y, Ning Z, Sheng L, Wang J, Xia X, Yu C, Wang Z, Zhao Y, Liang H, Hu B, Sun C, Wang D, Cheng Y, Pan M, Xia L, Guo X, Zhang Y, Hu Z, Li X, Lu L, Zhang J, Qian H, Xie H, Sun G. Large Scale, Multicenter, Prospective Study of Apatinib in Advanced Gastric Cancer: A Real-World Study from China. Cancer Manag Res. 2020 Aug 6;12:6977-6985. doi: 10.2147/CMAR.S249153. eCollection 2020.
citation: Du Y, Cao Q, Jiang C, Liang H, Ning Z, Ji C, Wang J, Zhou C, Jiang Z, Yu C, Li L, Zhao Y, Xu Y, Xu T, Hu W, Wang D, Cheng H, Wang G, Zhou J, Wang S, Zhang Y, Hu Z, Li X, Lu D, Zhang J, Xie H, Sun G. Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.
Clinical trial NCT05670067: Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity
Official title: Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft From the Maxillary Tuberosity Simultaneous With Immediate Implant Placement ( a Randomized Clinical Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant Placement
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two group in which the same procedure is done ( immediate implant placement) using different bone grafts
Primary purpose: TREATMENT

Brief summary: In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative

Detailed description: immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I\&II

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
* Age range (20-40) years.
* Good compliance with the plaque control instructions following initial therapy.
* Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 \& 2)
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Peri apically infected teeth
* Presence of smoking habit.
* Presence of occlusal interferences.
* Pregnant females.
* Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

Primary outcomes:
measure: buccal bone thickness
timeFrame: at baseline and 9 months
Secondary outcomes:
measure: soft tissue assessment using pink esthetic score
timeFrame: 9 months post opertive
measure: patient satisfaction
timeFrame: after 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Faculty of dentistry ain shams university
name: Hala Abu el ela, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02324101: Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
Official title: Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Protgen Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients

Detailed description: Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility criteria: Inclusion Criteria:

* breast cancer patients, healthy volunteers, benign breast diseases patients

Exclusion Criteria:

* Patients who previously received radiotherapy

Primary outcomes:
measure: Hsp90α Concentration(ng/ml) of plasma
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin cancer hospital
state: Tianjin
Study officials:
affiliation: Tianjin cance hospital
name: Zhongsheng Tong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02013401: Transmission of Mother-Infant Stress Communication
Official title: Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: mother-infant dyadic regulation
stress
psychophysiology
emotion regulation
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample of women (ages 18-40) with infants ages 4-9 months

Brief summary: The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.

Detailed description: This investigation examines a distal maternal stressor on the quality of interaction in mother-infant dyadic communication. Assessments include behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. The present research examines mother-infant interactions to test the hypothesis of whether maternal stress may be transduced to their infants via multiple pathways. The secondary aim is to explore effective emotion regulation strategies for the mother as potential buffers to stress and additionally reducing early life stress effects on the infant's regulatory development.

While the emotion regulation literature posits that reappraisal may be associated with decreased in physiological and psychological stress, this type of regulation strategy may be ineffective when interfacing with discrimination. The regulation strategy needs to be titrated to the stressor in order to be effective. These findings will have notable social, clinical, and psychological significance,

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* No presence of heart murmur or wear a pacemaker
* No medication for hypertensive or cardiovascular disease
* Not using beta blockers

Primary outcomes:
measure: Salivary Cortisol
timeFrame: One lab appointment for approximately 80 minutes.
Secondary outcomes:
measure: Salivary Amylase
timeFrame: One lab appointment for approximately 80 minutes.
Other outcomes:
measure: Mother-infant observations
timeFrame: One lab appointment for approximately 80 minutes.
Locations:
city: Boston
country: United States
facility: University of Mass. Boston
state: Massachusetts
city: Boston
country: United States
facility: University of Massachusetts, Boston, Child Development Unit
state: Massachusetts
Study officials:
affiliation: Postdoctoral Research Fellow
name: Kymberlee O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of DSRC and Horizon Center
name: Celia L Moore, PhD
role: STUDY_DIRECTOR
affiliation: Director Child Development Unit
name: Edward Tronick, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00138801: Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Official title: Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lyme Neuroborreliosis
Keywords: Neuroborreliosis
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:

  * Intrathecal production of borrelia antibodies;
  * White cell count in cerebrospinal fluid (CSF) \> 5/mm3;
  * Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;
  * Verified acrodermatitis chronica atrophicans.

Exclusion Criteria:

* Allergy to the contents in the medication, or earlier type I reaction to penicillin.
* Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
* Pregnancy or breastfeeding
* Age \< 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF
state: Vest-Agder
Study officials:
affiliation: Sorlandet Sykehus HF
name: Åse Mygland, MD, PhD
role: STUDY_CHAIR
References:
citation: Ljostad U, Skogvoll E, Eikeland R, Midgard R, Skarpaas T, Berg A, Mygland A. Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial. Lancet Neurol. 2008 Aug;7(8):690-5. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21.
Clinical trial NCT03594201: A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome
Official title: A Retrospective Study on the Effect of Male Progressive Sperm Count After Semen Pretreatment on ICSI Fertilization Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sperm Count, Low
Reproductive Sterility
Keywords: ICSI, progressive sperm count, embryo
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 12215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile couples take ART treament due to poor male semen quality.

Brief summary: The investigators plan to retrospectively analyze clinical data from 14,189 fresh ICSI cycles in Reproductive and Genetic Hospital of CITIC-Xiangya from January 2016 to December 2017.The investigators will regard total progressive sperm number of 2 x 10\^6 after pretreatment as the boundary value, and will divide total progressive sperm number of 2 x 10\^6 after pretreatment into 2 x 10\^6 or higher and \< 2 x 10\^6 groups, and will further divide \< 2 x 10\^6 group into: = 0, (0,10\^6\], (10\^6, 2 x 10\^6) three groups. Propensity score matching will be used to balance the baseline data between four groups. The matching variables are age, female BMI, AFC, AMH and ICSI.


Eligibility criteria: Inclusion Criteria:

* infertility female and sterility male for reproductive treatment

Exclusion Criteria:

* chromosomal abnormalities
* none retrieval oocyte
* none oocyte for ICSI
* Recurrent abortion
* female age≥37 years
* Assisted hatching
* abnormal oocyte zona pellucida
* In Vitro Maturation
* AZF microdeletion

Primary outcomes:
measure: high quality embryo rate for ICSI
timeFrame: two years
Secondary outcomes:
measure: fertilization rate of ICSI
timeFrame: two years
measure: normal fertilization rate of ICSI
timeFrame: two years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Liang Hu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02343601: Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
Official title: Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polyp of Large Intestine
Colorectal Neoplasms
Crohn Disease
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

Detailed description: All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Colorectal surgery

Exclusion Criteria:

* Pregnant women
* Black skin
* Chronic renal insufficiency (MDRD \<30 ml/min)

Primary outcomes:
measure: Incidence of patients presenting at least one complication after colorectal surgery
timeFrame: Up to 28 days after surgery (length of hospital stay)
Secondary outcomes:
measure: All complications happening after colorectal surgery
timeFrame: Up to 28 days after surgery (length of hospital stay)
measure: Real length of hospital stay
timeFrame: Up to 28 days after surgery (length of hospital stay)
measure: Perioperative mortality
timeFrame: 28 days after surgery
Other outcomes:
measure: Medico economic evaluation of cost of treatment
timeFrame: Up to 28 days after surgery (length of hospital stay)
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital of Caen
name: Anne-Lise Fiant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4.
Clinical trial NCT05822401: Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
Official title: Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Pain Chronic
Knee Osteoarthritis
Knee Discomfort
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: University of Southern Denmark
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2023-04-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain.

The main questions are:

Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.


Eligibility criteria: Inclusion Criteria:

* Hospital workers working at least 20 hours per week with or without chronic knee pain (\>3 months)

Exclusion Criteria:

* Life-threatening disease
* Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection)
* Systolic/diastolic blood pressure above 160/100 mmHg

Primary outcomes:
measure: Pain intensity
timeFrame: Change pre-post 8 weeks of intervention
Secondary outcomes:
measure: Functional performance
timeFrame: Change pre-post 8 weeks of intervention
measure: Work ability
timeFrame: Change pre-post 8 weeks of intervention
Other outcomes:
measure: Work-limiting pain
timeFrame: Change pre-post 8 weeks of intervention
measure: Work-related fatigue
timeFrame: Change pre-post 8 weeks of intervention
Locations:
Study officials:
References:
Clinical trial NCT03622801: Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid
Official title: Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Medium
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 133331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

Brief summary: Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.


Eligibility criteria: The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

Primary outcomes:
measure: Number of patients with anaphylactoid reactions of Iopromide after administration
timeFrame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Secondary outcomes:
measure: Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide
timeFrame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
measure: Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide
timeFrame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
Study officials:
References:
Clinical trial NCT06156501: Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences
Official title: Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Tear
Keywords: Psychology
Gender Medicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated


Eligibility criteria: Inclusion Criteria:

* ACL tear
* Over 18 years
* Patient information and consent
* No preexisting knee conditions prior ACL tear;

Exclusion Criteria:

* Under 18 years
* Preexisting knee conditions
* Accompanying knee injuries apart from ACL tear

Primary outcomes:
measure: Patient-reported Knee Function (Lysholm Knee Score, Points)
timeFrame: 0 to 12 months after surgery
measure: Objective Knee Function
timeFrame: 0 to 12 months after surgery
measure: Psychological Status (ACL-RSI, points)
timeFrame: 0 to 12 months after surgery
measure: Patient Pain (Visual Analoge Scale (points)
timeFrame: 0 to 12 months after surgery
Secondary outcomes:
measure: Graft Maturation
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: