louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03475602: Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy
Official title: A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Membranous Nephropathy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Idiopathic Membranous Nephropathy

Brief summary: Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.


Eligibility criteria: Inclusion Criteria:

* (1) Patients who provided informed consent
* (2) Patients who are diagnosed as membranous nephropathy by renal biopsy
* (3) 18 years of age or older, male or female

Exclusion Criteria:

* (1) identification of Secondary factors such as infectious diseases, rheumatic diseases, tumors, drugs and so on
* (2) Previous medicine history of immunosuppressive medication and corticosteroids
* (3) Patients who are not expected to complete 6 months of follow-up

Primary outcomes:
measure: Complete Remission
timeFrame: after treatment for 6 months
measure: Partial Remission
timeFrame: after treatment for 6 months
Secondary outcomes:
measure: estimated Glomerular filtration rate and serum creatinine
timeFrame: after treatment for 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Dept,Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03344302: Oxytocin Administration During Cesarean Section
Official title: Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs


Eligibility criteria: Inclusion Criteria:

* Primigravida or multigravida
* Term (37 - 42 weeks),
* Singleton pregnancies
* Booked for elective caesarean section.
* Accepting to participate in the study.

Exclusion Criteria:

* • Medical disorders involving the heart, liver, kidney or brain.

  * Diabetes mellitus and hypertension.
  * Blood disorders (e.g. coagulopathies, thrombocytopenia)
  * Patients requiring blood transfusion due to anemia.
  * Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
  * Previous 2 or more cesarean section
  * Placenta previa or placental abruption
  * Previous major obstetric haemorrhage (\>1000 ml) in previous deliveries.
  * Known fibroid or adenomyosis.
  * Women who received anticoagulant therapy.
  * Severe preeclampsis.
  * Uterine anomalies.

Primary outcomes:
measure: rate of blood loss
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT04134702: Acupuncture for Pain Control After Ambulatory Knee Arthroscopy
Official title: Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery - a Pilot Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain; Knee Arthroscopy; Acupuncture
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study: To investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (AKS) Design: Prospective pilot investigation with non-randomized arm Number of patients: N = 60 (30 patients with acupuncture additional to standard pain treatment (SPT) vs. 30 patients with SPT only Inclusion criteria: Adult patients scheduled to elective AKS in general anaesthesia with \< 80 min. duration Without previous opioid and psychotropic medication Given informed consentOutcome measures: Postoperative analgesic requirement; Pain intensity; Incidence of side effects; Physiological parameters; Mobilization score


Eligibility criteria: Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia
2. Surgery time does not exceed 80 minutes
3. Patients without previous opioid and psychotropic medication
4. Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)
5. Patients who have given written informed consent

Exclusion Criteria:

1. Current psychiatric disease
2. Local skin infection at the sites of acupuncture
3. Aged \< 19 or \> 55 years
4. Failure to follow the standardized schema of general anaesthesia
5. Surgery time more than 80 minutes
6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
7. Patients who consumed opioid medication at least 6 months before surgery
8. Patients who are unable to understand the consent form or to fill in the study questionnaire.

Primary outcomes:
measure: Analgesic requirement
timeFrame: 10 days
Secondary outcomes:
measure: Pain intensity: verbal rating scale
timeFrame: 10 days after surgery
measure: Side affects
timeFrame: 10 days after surgery
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
state: Vorpommern
Study officials:
affiliation: Dept. of Anesthesiology
name: Taras Usichenko, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01555502: Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Operable Early Stage NSCLC by the VATS Approach
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2012-03-15
Enrollment: 50
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 with operable early stage NSCLC by the VATS approach who are referred to the Thoracic surgery Center in Edmonton, Alberta, Canada.

Brief summary: To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC).

The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications.

Post operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.


Eligibility criteria: Inclusion Criteria:

* Adults (more than 18 years)
* early stage NSCLC
* speak English
* No hearing/Speaking difficulties
* Able to walk without assistance
* Surgery via the VATS approach

Exclusion Criteria:

* Less than 18 years old
* Metastatic disease to the lung
* Benign Lung disease
* Advanced NSCLC
* Small Cell Lung Cancer
* Non English speakers
* Walking/Hearing/Speaking difficulties

Primary outcomes:
measure: Health related Quality of life
timeFrame: Change in health related quality of life at 2 weeks. Change of Health Related Quality of Life at 4 weeks. Change in Health Related Quality of Life at 8 weeks. Change in Health Related Quality of Life at 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
References:
Clinical trial NCT01868802: Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Official title: Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depressive Disorder,
Treatment-Resistant Depression
Keywords: Ketamine
Depression
Depressive Disorder
Lead sponsor: American British Cowdray Medical Center
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years old
* Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
* Classification of MDD as treatment-resistant.
* No brain structural abnormalities as evidenced by an MRI scan.
* Signed acceptance of Informed Consent.

Exclusion Criteria:

* Other psychiatric diagnosis apart from MDD.
* Substance abuse or dependence (prior or during study).
* Pregnancy.
* Congestive heart disease.
* Personal history of psychosis.
* First-degree relative with history of psychosis.
* Glaucoma.
* Present neurological disease.
* High blood or pulmonary artery pressure.
* Declining the signing of the informed consent.

Primary outcomes:
measure: Changes in baseline HDRS Score
timeFrame: 20 minutes before and 40 minutes after ketamine infusion.
measure: Daily change in HDRS post-ketamine infusion.
timeFrame: 1,2,3,4,5,6 and 7. Days after ketamine infusion
Secondary outcomes:
measure: Baseline blood pressure (BP).
timeFrame: 20 minutes before ketamine infusion.
measure: Changes from baseline in blood pressure (BP)
timeFrame: every 5 minutes in a 300 minutes period
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: ABC Neurological Center
state: DF
Study officials:
affiliation: American British Cowdray Medical Center
name: Paul J Lamothe, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: American British Cowdray Medical Center
name: David N Lopez-Garza, M.D.
role: STUDY_DIRECTOR
affiliation: American British Cowdray Medical Center
name: Manuel Ruiz-Alvarez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711202: Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation
Official title: A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Charite University, Berlin, Germany
name: Miltenyi Biomedicine GmbH
First posted: 2016-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.


Eligibility criteria: Inclusion criteria:

* First deceased-donor kidney transplantation
* Age \>18 years
* Donor \<65 years
* Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity
* panel reactive antibodies (PRA) \<10%
* Written consent

Exclusion criteria:

* Retransplantation, combined transplantation
* Prior immunosuppression less than 6 months prior transplantation
* Induction therapy with antibodies
* Leukopenia \< 4000, thrombocytopenia \< 100 000, Haemoglobin \< 80 g/l
* History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α
* Tuberculosis history
* Anti-hepatitis C virus (HCV) positivity, HBsAg
* HIV positivity
* Malignancy history
* Allergy to study medication
* Fertile women without contraception
* Pregnancy, breastfeeding mothers

Primary outcomes:
measure: Number of Patients Alive
timeFrame: 1 year
measure: Number of Patients With Functional Graft
timeFrame: 1 year
Secondary outcomes:
measure: Kidney Graft Function (Measured by Serum Creatinine)
timeFrame: 1 year
measure: Number of Bioptically Verified Rejection Episodes
timeFrame: 1 year
measure: Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Ondrej Viklicky, M.D.,Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Viklicky O, Hruba P, Tomiuk S, Schmitz S, Gerstmayer B, Sawitzki B, Miqueu P, Mrazova P, Tycova I, Svobodova E, Honsova E, Janssen U, Volk HD, Reinke P. Sequential Targeting of CD52 and TNF Allows Early Minimization Therapy in Kidney Transplantation: From a Biomarker to Targeting in a Proof-Of-Concept Trial. PLoS One. 2017 Jan 13;12(1):e0169624. doi: 10.1371/journal.pone.0169624. eCollection 2017.
Clinical trial NCT00271102: Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Official title: Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: Cystocele, prolapse, anterior repair, colporrhaphy
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2005-12-30
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

Detailed description: It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

* Patients with at least 2 previous prolapse surgeries
* Patients who are pregnant or planning to have a pregnancy

Primary outcomes:
measure: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
timeFrame: 4 years
Secondary outcomes:
measure: The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.
timeFrame: 4 years
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Vatche A Minassian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.
Clinical trial NCT05751902: Translation and Validation of the Arabic Version of the OHIP Questionnaire
Official title: Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Health
Surveys and Questionnaires
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any participant fluent in Arabic language and having a removable prosthesis.

Brief summary: OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed.

254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.


Eligibility criteria: Inclusion Criteria:

* Patients having removable partial denture in the last year
* Native Arabic patients

Exclusion Criteria:

* Patients non familiar with Arabic language
* patients with mental or perception problems

Primary outcomes:
measure: Reliability and validity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
city: Cairo
country: Egypt
facility: Future University in Egypt
Study officials:
References:
Clinical trial NCT03118102: Audiological Evaluation of Anesthetists
Official title: the Effects of Noise in Operating Rooms on Anesthetists Hearing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anesthetist doctor who subject to noise in operating rooms

Brief summary: The investigators aim to investigate the effect of operating room noise on anesthetist hearing


Eligibility criteria: Inclusion Criteria:

* anesthetist doctor and non-anesthetist doctor less than 40 years

Exclusion Criteria:

* doctors above 40 years

Primary outcomes:
measure: Extended high frequency audiometry
timeFrame: 20 minutes
Secondary outcomes:
measure: Transient Evoked Otoacoustic Emission
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Khaled Salah Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References: