louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03409640: Metal-on-metal Hip Replacement MRI Study
Official title: The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Athroplasty Using M2a Magnum
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 100
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 receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.

Brief summary: This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.


Eligibility criteria: Inclusion Criteria:

• Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.

Exclusion Criteria:

* If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
* If the patient is contraindicated for any of the diagnostic tests.
* If the patient fails to consent to participating in the study.

Primary outcomes:
measure: MRI Scoring change in soft tissue mass size
timeFrame: 36 months after primary device implantation
Secondary outcomes:
measure: Radiographic assessment
timeFrame: 36 months after primary device implantation
measure: Oxford Hip Score
timeFrame: 36 months after primary device implantation
measure: UCLA Activity Score
timeFrame: 36 months after primary device implantation
measure: EQ-5D
timeFrame: 36 months after primary device implantation
measure: Metal Ion Levels
timeFrame: 36 months after primary device implantation
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
Study officials:
References:
Clinical trial NCT03074240: Abdominal Wall Block Study
Official title: A Prospective and Randomized Comparison of Ultrasound-guided Transversus Abdominis Plane Versus Rectus Sheath Blocks as a Primary Anesthetic for Abdominal Wall Surgery in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Hernia
Obesity
Keywords: Truncal block
Surgical anesthesia
Postoperative pain control
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2017-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
Primary purpose: TREATMENT

Brief summary: Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.

Detailed description: The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age undergoing umbilical hernia repair
* Overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively)
* Ability to understand and provide informed consent

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, local anesthetics
* True allergy, not sensitivity, Propofol
* True allergy, not sensitivity, general anesthetic agents
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit, whether acute or chronic, as determined by the PI
* Chronic use of opioid medication

Primary outcomes:
measure: Changes between the two groups to provide surgical anesthesia
timeFrame: Changes from baseline (pre-op) to 1 hour post-operative
Secondary outcomes:
measure: Changes between the two groups assessed by post-operative pain control
timeFrame: Changes from baseline (post-operative) to 48 hours post-operative
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: Malcom Randall VA Medical Center
name: José R Soberón, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523340: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Official title: Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Recurrent
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-02-01
Enrollment: 196
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria

Brief summary: 1. Trial design: Prospective observational study
2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib

   * C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
5. Duration of Trial Recruitment: 2 years


Eligibility criteria: Inclusion Criteria:

* Informed consent
* 19\~80 year old male or female
* Histologically proven advanced or metastatic NSCLC
* Failed to 1st line chemotherapy
* Tumor tissue for genetic analysis
* Evaluable target lesion by RECIST v1.1
* ECOG performance from 0 to 3
* Expected survival more than 12 weeks

Exclusion Criteria:

* Previous treatment of EGFR-tyrosine kinase inhibitors
* Severe hypersensitivity to erlotinib
* Residual toxicities (above grade 2) after previous chemotherapy
* Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Primary outcomes:
measure: The rates of C-met expression/amplification and EGFR gene mutations
timeFrame: Average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184440: The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
Official title: The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Keywords: Cyclocarya paliurus extract
hyperglycemia
pre-diabetes and diabetes
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
Primary purpose: PREVENTION

Brief summary: This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.


Eligibility criteria: Inclusion Criteria:

* pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol;
* age:20-65 years;
* BMI :20-35kg/m2.

Exclusion Criteria:

* type 1 diabetic patients;
* type 2 diabetic patients with insulin treatment；
* pregnant or lactating women；
* adverse effect on intervention；
* acute or chronic inflammatory conditions;
* severe hepatic,kidney or other complications;
* other situations ineligible to intervention.

Primary outcomes:
measure: changes of FPG
timeFrame: at 0 week，4th week and 12th week in the intervention period
measure: changes of HbA1c
timeFrame: at 0 week，4th week and 12th week in the intervention period
measure: changes of fasting insulin
timeFrame: at 0 week，4th week and 12th week in the intervention period
measure: changes of OGTT
timeFrame: at 0 week，4th week and 12th week in the intervention period
Secondary outcomes:
measure: changes of blood lipids
timeFrame: at 0 week，4th week and 12th week in the intervention period
measure: changes of gut microbiota
timeFrame: at 0 week，4th week and 12th week in the intervention period
measure: changes of short chain fatty acids
timeFrame: at 0 week，4th week and 12th week in the intervention period
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Shiyan Taihe Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04820140: Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis
Official title: Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease patient on dialysis (stage 5D)
Muscle mass and strength
Training
Survival
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 64
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: Patients issued from dialysis units (clinic)

Brief summary: Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.


Eligibility criteria: Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 3 months
* Age \> 18 years old
* Stable clinical condition
* Absence of musculoskeletal disorders

Exclusion criteria:

* Cardiovascular contraindication
* Amputation of lower limb not allowing use of elliptical bike

Primary outcomes:
measure: Change in functional autonomy (frailty) after training
timeFrame: 4 weeks after inclusion
measure: Change in functional autonomy (frailty) after training
timeFrame: 12 weeks after inclusion
measure: Change in functional autonomy (frailty) after training
timeFrame: 16 weeks after inclusion
measure: Change in functional autonomy (frailty) after training
timeFrame: 32 weeks after inclusion
Secondary outcomes:
measure: Change in risk of falling after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in muscle strength and mass after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in endurance after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in physical activity after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in quality of dialysis after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in nutritional status after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
measure: Change in neuromuscular sensitivity after training
timeFrame: 4, 12, 16 and 32 weeks after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean-Paul CRISTOL, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06904040: A Single-center Study of CM313 in Patients With Pemphigus
Official title: A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pemphigus
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.


Eligibility criteria: Inclusion Criteria:

* Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ Positive Nikolsky's sign.
* Adult patients aged between 18 and 80 years old.
* Moderate - to - severe pemphigus vulgaris/foliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.

Exclusion Criteria:

* Pregnant or lactating women and women planning to conceive.
* Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.
* Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.

Primary outcomes:
measure: Efficacy evaluation
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Jianing Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502340: PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY
Official title: ASSESSMENT OF PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMIES
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocard Injury After Non Cardiac Surgery
Robotic Assisted Laparoscopic Radical Prostatectomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 63
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing elective robotic-assisted laparoscopic radical prostatectomy will be included in the study.

Brief summary: Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study\&#39;s secondary objective was to establish which parameters were associated with myocardial damage.


Eligibility criteria: Inclusion Criteria:

* Patients who will undergo elective robotic surgery
* Patients with I, II, and III according to ASA classification
* Those with body mass index (BMI) below 35kg/m2
* Patients whose consent was obtained before the procedure

Exclusion Criteria:

* Patients who were converted to open surgery for any reason
* patients who did not agree to participate in the research

Primary outcomes:
measure: high-sensitive Troponin I levels
timeFrame: preoperative
measure: high-sensitive Troponin I levels
timeFrame: postoperative 24th hour
measure: high-sensitive Troponin I levels
timeFrame: postoperative 48th hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04437940: Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test
Official title: Evaluation of Vaginal Fluid for Covid-19 Positivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Sars-CoV2
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are older than18 years old, who are considered to be covid-19 clinically and radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included.

Patients previously treated for covid-19 will be excluded from the study.

Brief summary: Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.

Detailed description: Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral clearance.

Eligibility criteria: Inclusion Criteria:

* Women who are positive nasofarengeal Covid-19 PCR test result
* Women who are 18 years or older
* Women who had sexual intercourse before

Exclusion Criteria:

* who had medical treatment for Covid-19

Primary outcomes:
measure: Vaginal fluid Covid-19 PCR test result
timeFrame: 1 month
Secondary outcomes:
measure: becoming negative from positive
timeFrame: 2 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
Study officials:
References:
citation: Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.
citation: Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.
Clinical trial NCT02065440: The Effect of Ebastine/Pseudoephedrine on Subacute Cough
Official title: The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Keywords: Ebastine/Pseudoephedrine
subacute cough
upper airway cough syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether ebastine/pseudoephedrine is effective on subacute cough.

Detailed description: 1. Visit 0 week

   * Patients with subacute cough,area randomized to either ebastine/pseudoephedrine or placebo for 1 week.
   * The cough severity and quality of life were measure with VAS score and cough-specific quality-of-life questionnaire(CQLQ)
2. Visit 1 week check VAS score and CQLQ
3. Visit 4 weeks check VAS score and CQLQ

Eligibility criteria: Inclusion Criteria:

* patients with subacute cough(3-8 weeks)
* age: 20-70 years

Exclusion Criteria:

* Chest X-ray abnormality(+) as a probable cause of cough
* other explainable confirmed diagnosis(+) such as acute infectious disease
* Severe cough or cough complication which needs other anti-tussive agents.
* on ACEI
* with more than three hypertensive agents
* change of hypertension medication 3 months ago
* immunocompromized host
* relative or absolute contraindication for ebastine/pseudoephedrine

  1. hypersensitivity to ebastine/pseudoephedrine
  2. glaucoma
  3. moderate to severe hypertensive disease
  4. coronary heart disease
  5. hyperthyroidism
  6. moderate to severe liver disease
  7. benign prostate hyperplasia
  8. psychological problem
  9. Parkinson's disease
  10. on linezolid or supposed to use it.

Primary outcomes:
measure: Change of VAS score
timeFrame: 1 week later after administration of ebastine/pseudoephedrine or placebo
Secondary outcomes:
measure: Change of VAS score
timeFrame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo
measure: The proportion of patients with more than 50 percent decrease in VAS score
timeFrame: 1 week
measure: Change of CQLQ score
timeFrame: 1week later after administration of ebastine/pseudoephedrine or placebo
measure: Change of CQLQ score
timeFrame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo
measure: The adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
state: Dongjak-Gu
Study officials:
affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
name: Chang-Hoon Lee, MD
role: STUDY_CHAIR
References: