louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02030717: Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
Official title: Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre- and Postoperative Analgesia
Spinal Anesthesia
Renal Cell Carcinoma
Keywords: Spinal anesthesia
Epidural anesthesia
Klonidin
renal cell carcinoma
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
First posted: 2014-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.


Eligibility criteria: Inclusion Criteria:

* all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma

Exclusion Criteria:

* patients in ASA score IV-V,
* patients with advanced tumour thrombus in vena cava inferior,
* patients with high risk for bleeding
* patients with previous chronic pain symptoms
* patients having drug abuse
* patients having cognitive deficiencies or dementia disease
* patients with any contraindication of either spinal or epidural anesthesia
* patients younger than 18 years and pregnant woman
* patients having a weight less than 45 kg or weight over 120 kg

Primary outcomes:
measure: postoperative mobilisation index
timeFrame: within the first 30 days (plus or minus 5 days) after surgery
Secondary outcomes:
measure: time of hospitalization
timeFrame: within the first 15 days after surgery
Other outcomes:
measure: Need of rescue analgetics
timeFrame: within the first 15 days after surgery
Locations:
city: Umea
country: Sweden
facility: Umea University Hospital
Study officials:
affiliation: Umea University
name: Borje Ljungberg, MD, PhD
role: STUDY_CHAIR
References:
citation: Thurm M, Hultin M, Johansson G, Dahlin BI, Winso O, Ljungberg B. Spinal anaesthesia with clonidine: pain relief and earlier mobilisation after open nephrectomy - a randomised clinical trial. J Int Med Res. 2022 Sep;50(9):3000605221126883. doi: 10.1177/03000605221126883.
Clinical trial NCT00288717: Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients
Official title: A Randomized, Comparative Study of the Effects of Candesartan and Telmisartan on the Home Blood Pressure, Glucose and Lipid Metabolism in the Hypertensive Patients With the Accumulation of Visceral Fat by the Central Registration System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Saitama Medical University
Sponsor class: OTHER
Collaborators: name: Non-Profit Organaizaion "LINE"
First posted: 2006-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system

Detailed description: A randomized, comparative study of the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system

Eligibility criteria: Inclusion Criteria:

* Circumference at waist: male ≧85 cm, female ≧90 cm
* Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg
* Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg

Exclusion Criteria:

* Significant hypertensive patient with diastolic blood pressure ≧120 mmHg
* Malignant hypertensive patient
* Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
* Patient with urinary protein (qualitative) ＋～＋＋
* Patient with familial hyperlipidemia
* Other patients judged as ineligible for the study

Primary outcomes:
measure: Home blood pressure in the early morning
Secondary outcomes:
measure: Home blood pressure at bedtime
measure: M/E ratio
measure: Casual blood pressure
measure: Body fat percentage
measure: Body weight
measure: Height
measure: BMI
measure: Blood potassium
measure: Total cholesterol
measure: HDL cholesterol
measure: LDL cholesterol
measure: Triglyceride
measure: Blood glucose
measure: IRI
measure: HbAlc*
measure: HOMA-IR
measure: Urinary trace albumin
measure: Creatinine
Other outcomes:
Locations:
city: Saitama City
country: Japan
facility: Saitama Medical School Department of Renal Medicine
state: Saitama
Study officials:
affiliation: Saitama Medical School Department of Renal Medicine
name: Hidetomo Nakamoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03490617: Misoprostol Prior to IUD Insertion in Nullipara
Official title: Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Family Planning
Keywords: Intrauterine device
Misoprostol
Nulliparous women
Contraception
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 179
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.

Detailed description: Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* No chirurgical procedure in the cervix
* Wish to use IUD as a contraceptive method

Exclusion criteria are as follows:

* Presence of active cervical infection visible upon speculum exam (purulent cervicits)
* Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
* Pregnancy ending less than 6 weeks prior to enrollment in study
* History of prior IUD placement
* History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
* History of uterine surgery
* Allergy or intolerance to misoprostol or other prostaglandin
* Undiagnosed abnormal vaginal bleeding
* Malignancy of the genital tract
* Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
* Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)

Primary outcomes:
measure: Cervical dilatation
timeFrame: four hours after misoprostol use
Secondary outcomes:
measure: Difficulty in inserting IUD
timeFrame: four hours after misoprostol use
measure: Pain at insertion
timeFrame: four hours after misoprostol use
Other outcomes:
measure: Subjective sensation as reported by the woman
timeFrame: four hours after misoprostol use
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
References:
Clinical trial NCT02009917: Non- Essential Amino Acid Requirements and Metabolism in Humans
Official title: Application of Indicator Amino Acid Oxidation Technique to Determine Non-essential Amino Acids/Nitrogen Requirements in Adult Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adult Males
Keywords: Indicator Amino Acid Oxidation
Non essential Amino acids
Protein
Amino acid
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2013-12-12
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physiologically Healthy Adult males, 20-40 years of age

Brief summary: Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique.

The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.


Eligibility criteria: Inclusion Criteria:

* 20-40 years of age
* Male
* Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
* Free of any concurrent illness

Exclusion Criteria:

* Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
* Men who are classified as underweight(\<18.5kg/m2), overweight(25-30kg/m2) or obese (\>30kg/m2) using the BMI classification)
* Men who are allergic to milk, eggs and egg protein

Primary outcomes:
measure: 13 Carbon dioxide production
timeFrame: 8 hours (1study day)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child and Family Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Rajavel Elango, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper L, Ball RO, Pencharz PB, Sakai R, Elango R. Dispensable Amino Acids, except Glutamine and Proline, Are Ideal Nitrogen Sources for Protein Synthesis in the Presence of Adequate Indispensable Amino Acids in Adult Men. J Nutr. 2020 Sep 1;150(9):2398-2404. doi: 10.1093/jn/nxaa180.
Clinical trial NCT00035217: Follow-Up Study for Men Diagnosed With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program
Official title: Follow-Up Study for Men Diagnoses With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Urological Research Foundation
First posted: 2002-05-03
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: There is controversy concerning the preferred treatment for men with localized prostate cancer with regard to the relative effectiveness of different treatments in controlling the cancer and how different treatments affect the patient's quality of life. The purpose of this research is to describe the disease course of prostate cancer and to determine the effectiveness, potential complications, and quality of life after different treatments in men with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or digital rectal examination


Eligibility criteria: Men with prostate cancer diagnosed through the PSA screening study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT00784017: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Official title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Keywords: Children with previously untreated acute lymphoblastic leukemia
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 199
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL


Eligibility criteria: Inclusion Criteria:

* Previously untreated T-lineage or precursor B-lineage ALL
* Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
* Written informed consent
* Treatment according to DCOG ALL 10 protocol

Exclusion Criteria:

* Mature B-lineage ALL
* Patients with secondary ALL
* Known allergy to any ASNase preparation
* General health status according to Karnofsky / Lansky score \< 40%
* Pre-existing known coagulopathy (e.g. haemophilia)
* Pre-existing pancreatitis
* Liver insufficiency (Bilirubin \> 50 µmol/L; SGOT/SGPT \> 10 x ULN)
* Other current malignancies
* Pregnancy (planned or existent), breast feeding

Primary outcomes:
measure: To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
timeFrame: March 2012
Secondary outcomes:
measure: To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
timeFrame: March 2012
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References:
citation: van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4.
Clinical trial NCT04691934: Obstetric Anesthesia Experiences in COVID-19 Positive Patients
Official title: Our Anesthesia Experiences in COVID-19 Positive Patients Undergoing Cesarean Section: A Retrospective Single-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Obstetric Anesthesia
Keywords: COVID-19
Anesthesia
Cesarean Section
Pneumonia
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-31
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19

Brief summary: At the end of 2019, a new coronavirus named COVID-19 (SARS-CoV-2), one of the lower respiratory tract samples was detected in China. The World Health Organization (WHO) declared it a global epidemic on March 11, 2020, due to the emergence of COVID-19 cases in 113 countries other than China, where the first epidemic occurred, and the spread and severity of the virus. Pregnancy increases susceptibility to respiratory complications of viral diseases.

This study aimed to retrospectively evaluate the demographic data of COVID-19 patients undergoing cesarean section, our anesthesia practices, complications, and condition of neonates, and to summarize up-to-date information on COVID-19 in obstetric anesthesia.

Detailed description: Our study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.

All patients were operated in negative pressure operating theatres reserved for them. The whole team was equipped with Level 3 personal protective equipment (PPE) (liquid-proof apron, N-95 mask, goggles, visor, overshoes). Anesthesia was administered by 2 healthcare professionals from the anesthesia team, including an experienced anesthesiologist and an assistant anesthesia technician. A third person was kept ready outside to help in case of need.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent cesarean section
* Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria:

* Patients who tested negative and were clinically suspicious

Primary outcomes:
measure: obstetric anesthesia practices
timeFrame: until 30 minutes after arrival in the operating room
Secondary outcomes:
measure: anesthesia complications
timeFrame: up to 1 hour after anesthesia
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital
state: Yıldırım
Study officials:
affiliation: BursaYuksek Ihtisas Training and Research Hospital
name: Derya Karasu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525534: Plasma Concentration of Biological Markers in Placenta Accreta Spectrum
Official title: Plasma Concentration of Biological Markers in Placenta Spectrum
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Placenta Accreta
Placenta Diseases
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery

Brief summary: The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.

Detailed description: Maternal blood samples will be taken at various points during the intrapartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.

Eligibility criteria: Inclusion Criteria:

* Age 18 - to 45-years old, inclusive
* Suspected or confirmed PAS or phenotypically matched controls
* Delivery by cesarean section
* Gestational age greater than 28 weeks
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal demise,
* Severe fetal anomalies (infant not expected to survive)
* Emergent cesarean delivery

Primary outcomes:
measure: Determine the level of placental-derived MPs (Microparticles/mL)
timeFrame: Up to 6 hours
measure: Identify biomarkers (picogram/mL)
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Nadir e Sharawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544934: Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
Official title: A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathy
Lead sponsor: Glycadia
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects


Eligibility criteria: Inclusion Criteria:

* Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent

Exclusion Criteria:

* Sctive concomitant serious medical or surgical disease

Primary outcomes:
measure: glycated albumimin concentration
timeFrame: three weeks
Secondary outcomes:
measure: urine albumin
timeFrame: three weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Laurence Kennedy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami, Miami, Florida
name: Maria del Pilar Solano, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Suncoast Clinical Research, New Port Richey, Florida
name: Lis Cohen, D.O.
role: PRINCIPAL_INVESTIGATOR
References: