louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05011786: Open and Laparoscopic Hernia Repair. A Comparative Study
Official title: Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all children aged between 6 months and 13 years who underwent open or laparoscopic inguinal hernia repair at the Jordan University Hospital in the period between January 2017 and July 2019

Brief summary: A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.

Detailed description: The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.

Eligibility criteria: Inclusion Criteria:

* All children within the age limit specified were included in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: OR duration
timeFrame: During surgery
measure: Length of stay LOS
timeFrame: 1 year
measure: Post operative complications
timeFrame: 1 year
measure: Hernia Recurrence
timeFrame: 1 year
measure: Total Cost of Surgery
timeFrame: 1 year
measure: Cosmesis
timeFrame: 1 Year
measure: Recovery
timeFrame: year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ibrahim Khrais
state: Please Select
Study officials:
References:
Clinical trial NCT01838486: Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
Official title: Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Keywords: Interstitial cystitis
painful bladder syndrome
bladder hydrodistention
hyperthermia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-24
Enrollment: 20
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: Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Detailed description: In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.

Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.

Eligibility criteria: Inclusion Criteria:

-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO

Exclusion Criteria:

* Active infection
* Urethral stricture

Primary outcomes:
measure: o'leary sant questionnaire
timeFrame: up to 1 year
Secondary outcomes:
measure: Bladder diary
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe Medical Center
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830986: Cognition Following Computer Assisted Total Knee Arthroplasty
Official title: Cognition Following Computer Assisted Total Knee Arthroplasty: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition
Embolism, Fat
Keywords: Mental Cognition Change
Fat Embolism
Bone Marrow Debris Emboli
Computer Assisted Total Knee Arthroplasty
Conventional Instrumented Total Knee Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 Consecutive patients requiring a total knee arthroplasty for degenerative arthritis of the knee

Brief summary: A significant number of patients experience postoperative cognitive changes following total joint arthroplasty. Among other causes, the mental status change may be the result of fat and bone marrow debris embolization. We hypothesized that the use of computer assisted total knee arthroplasty, which does not utilize intramedullary alignment rods, would produce less fat and bone marrow debris embolization and, hence, fewer mental status changes.

Detailed description: Inclusion criteria

* Primary, cemented knee arthroplasty
* Unilateral or bilateral TKA

Exclusion criteria

* Patient is unable to speak English
* Unable to read and write
* Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
* Patients with history of IV drug abuse
* Previous history of dementia
* Patients on mental status changing medications

Eligibility criteria: Inclusion Criteria:

* Primary, cemented knee arthroplasty
* Unilateral or bilateral TKA

Exclusion Criteria:

* Patient is unable to speak English
* Unable to read and write
* Patient with history of psychiatric disorders (Depression, Schizophrenia, anxiety, bipolar dis.)
* Patients with history of IV drug abuse
* Previous history of dementia
* Patients on mental status changing medications

Primary outcomes:
measure: Folstein Mini Mental State Examination (MMSE)
timeFrame: 6 Months Post-Operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rothman Institute of Orthopaedics
name: Javad Parvizi, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06105086: Risk Analysis Interview IVDR 2023
Official title: Risk Analysis Interview IVDR 2023
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Variables
Keywords: IH-IVD
in-house tests
IVDR 2017/746
Semi-structured interview
Risk analysis
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2023-10-27
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this research project is to design a risk-based model to decide when clinical performance studies should be performed on in-house developed in vitro diagnostic tests (IH-IVDs) in compliance with the European in vitro diagnostics regulation (EU IVDR 2017/746). To construct the dataset, semi-structured interviews will be conducted to assess the clinical hazards of the in-house in vitro diagnostic test assessments, their degree of significance and their importance with respect to clinical performance, as determined by the opinions of field specialists.

Detailed description: The project's intervention involves conducting semi-structured interviews with clinical laboratory managers and medical professionals. The estimated number of participants for this study is 30. Various In-house in vitro diagnostic tests (IH-IVDs) will be selected, that are classified under different categories according to the risk management in the new IVDR. Two interviews will be conducted for each test. These interviews will engage a laboratory technician and a medical expert specialized in that particular test. The purpose of these interviews is to gather data on the variables that contribute to the risks of IH-IVDs and their impact on clinical diagnosis and patient outcomes. The obtained results will be applied in creating a decision tree using a pre-validated algorithm. The semi-structured interviews feature pre-determined questions that allow participants to share their experiences and opinions within their area of expertise. Each interview is expected to last between thirty minutes to an hour. If consent is given, the interviews will be recorded but not published or shared. In accordance with the confidentiality policy, all data collected will be kept anonymous.

Eligibility criteria: Inclusion Criteria:

* Work relation with the medical field/hospital
* Achieved a master degree or higher
* Compatible to take an interview independently

Exclusion Criteria:

/

Primary outcomes:
measure: Risk attributes of the in-house in vitro diagnostic tests measured with semi-structured interviews
timeFrame: 1 hour
measure: risk impact of the in-house in vitro diagnostic tests measured with semi-structured interviews
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ brussel
Study officials:
affiliation: UZ Brussel Laboratorium Kwaliteit
name: Johan Guns, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02420886: Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation
Official title: The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In Vitro culture of human embryos
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-20
Enrollment: 443
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

Detailed description: The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between two arm of the same culture media and the same culture condition. One arm with Cytokines and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Eligibility criteria: Inclusion Criteria:

* all patients

Exclusion Criteria:

* over 40 years

Primary outcomes:
measure: ongoing pregnancy rate ( % )
timeFrame: 6 months
Secondary outcomes:
measure: clinical pregnancy rate ( % )
timeFrame: 6 months
measure: implantation rate
timeFrame: 6 months
measure: fertilization rate
timeFrame: 6 days of culture
measure: top-quality embryo rate
timeFrame: 6 days of culture
measure: rates for blastocyst formation and quality
timeFrame: 6 days of culture
measure: embryo utilization rate
timeFrame: 6 days of culture
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon IVF Center
city: Sohag
country: Egypt
facility: Ibnsina IVF center
Study officials:
References:
citation: Fawzy M, Emad M, Elsuity MA, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Sabry M, Nour M, Rasheed SM. Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial. Fertil Steril. 2019 Nov;112(5):849-857.e1. doi: 10.1016/j.fertnstert.2019.07.012. Epub 2019 Sep 21.
Clinical trial NCT01291186: Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine
Official title: The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Knee
Keywords: spinal anesthesia
intrathecal bupivacaine
median effective dose
height
Lead sponsor: Seoul Medical Center
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.

Detailed description: The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective total knee replacement arthroplasty

Exclusion Criteria:

* Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
* The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.

Primary outcomes:
measure: success of spinal anesthesia
timeFrame: every ten minutes during the surgery
Secondary outcomes:
measure: time to first request for supplemental analgesia
timeFrame: every ten minutes during and after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
affiliation: Seoul Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06379386: Long-term Prognosis and Valve Durability of TAVR
Official title: Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis and Insufficiency
Keywords: Aortic Valve Disease
TAVR
Prognosis
Valve durability
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with severe aortic stenosis or valve regurgitation undergo transcatheter aortic valve replacement (TAVR) following evaluation by a cardiac team.

Brief summary: This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.

2. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

* 1. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
* 2. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria:

* 1. Patients who cannot provide informed consent
* 2. Patients who are participating in other clinical trials

Primary outcomes:
measure: All-casuse mortality
timeFrame: 5 years
measure: Valve-related long-term clinical efficacy
timeFrame: 5 years
Secondary outcomes:
measure: Combined early safety and clinical efficacy outcomes
timeFrame: 30 days
measure: Rate of technical success
timeFrame: at exit from procedure room
measure: Rate of device success
timeFrame: discharge or 30 days
measure: Combined clinical efficacy outcomes
timeFrame: 5 years and 10 years
measure: Valve-related long-term clinical efficacy
timeFrame: 10 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D, Ph.D
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Rutao Wang, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT04113486: Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations
Official title: Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Renal Cell
Keywords: renal cancer
tumor biomarker
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are in-hospital patients treated in Xinhua Hospital

Brief summary: This study aims to observe the difference between NMAP (nicotinamide metabolism associated protein) serum levels in primary diagnosed renal cancer patients and non-renal cancer patient controls, plot the ROC curve and establish appropriate cut-off values.


Eligibility criteria: Inclusion Criteria:

1. The tumor group patients were found to have renal or hepatic mass, plan to receive surgical treatment (except for radiofrequency ablation, cryoablation, etc., which were not available for pathological examination). The control group patients were ruled out of tumor based on radiological tests and commonly used tumor biomarkers
2. Age ≥ 18 years old and able to provide written informed consent;
3. Have not received any systemic or topical treatment for kidney/liver tumors.
4. Cardiopulmonary, liver and kidney functions are able to tolerate surgery and can comply with research requirements.

Exclusion Criteria:

1. The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.
2. The subjects is known or suspected of other malignancies.
3. There has been another history of malignancy in the past 5 years.
4. Major surgery (surgery requiring general anesthesia) was performed within 4 weeks prior to screening visits.

Primary outcomes:
measure: NMAP level study
timeFrame: September 2019-September 2021
Secondary outcomes:
measure: NMAP plus other tumor biomarkers study
timeFrame: September 2019-September 2021
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04386486: BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns
Official title: The Effect of BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns in Adults in Anesthesia Polyclinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Reaction
Anxiety Preoperative
Patient Satisfaction
Keywords: preoperative anxiety
anesthesia anxiety
BATHE method
APAIS
patient satisfaction
Lead sponsor: Cumhuriyet University Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction.

Detailed description: In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction.

500 patients who were planned to undergo elective surgery and under general anesthesia as anesthesia method were included in the study. Demographic data of patients, their three biggest fears of anesthesia and APAIS scores were recorded. The patients were divided into two groups, they underwent BATHE anamnesis or standard anamnesis methods according to their groups, then their APAIS and patient satisfaction scores were recorded.

Eligibility criteria: Inclusion Criteria: A) ASA I-II patients

Exclusion Criteria:

A) ASA III-IV B) illiterate patients C) patients with known psychiatric disorders D) patients with chronic sedative E) antipsychotic drug use F) patients with a history of going to psychiatry in the last year G) patients with any cancer diagnosis were not included in the study.

Primary outcomes:
measure: t-test
timeFrame: 0-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cemil Ahmet Isbir
Study officials:
affiliation: Dr. at Cumhuriyet University Hospital
name: Cemil A Isbir, M.D.
role: STUDY_DIRECTOR
References:
citation: DeMaria S Jr, DeMaria AP, Silvay G, Flynn BC. Use of the BATHE method in the preanesthetic clinic visit. Anesth Analg. 2011 Nov;113(5):1020-6. doi: 10.1213/ANE.0b013e318229497b. Epub 2011 Aug 24.