louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00399256: Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Official title: Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Failure
Keywords: contrast-induced nephropathy
Acetylcysteine
Zinc
Cystatin C
Creatinine
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.

Detailed description: In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.

Eligibility criteria: Inclusion Criteria:

1. older than 18 years of age,
2. serum creatinine \> 1.2 mg/dl or a creatinine clearance \< 50 ml/min (measured by a 12 or 24 hour urine collection).

Exclusion Criteria:

1. acute inflammatory disease,
2. medication with NSAID or metformin until 3 days before entering study,
3. abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.

Primary outcomes:
measure: Incidence of acute renal failure
Secondary outcomes:
measure: Rise in creatinine of > 0.5 mg/dl
measure: Rise in creatinine > 25%
measure: Significant rise in serum cystatin C)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital
Study officials:
affiliation: Robert-Bosch-Hospital, Stuttgart, Germany
name: Dominik M Alscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.
Clinical trial NCT06173856: Effectiveness of Phototherapy With and Without Probiotics
Official title: Effectiveness of Phototherapy With and Without Probiotics for the Treatment of Indirect Hyperbilirubinemia in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Lead sponsor: Fatima Jinnah Medical University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 76
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.

Detailed description: Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups.

Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.

Eligibility criteria: Inclusion Criteria:

* All the Neonates with indirect hyperbilirubinemia,
* Born at ;37 weeks of gestation
* Both male and female neonates were included in the study

Exclusion Criteria:

* Neonates with sepsis,
* bilirubin level in exchange transfusion range
* direct hyperbilirubinemia
* Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick

Primary outcomes:
measure: effectiveness
timeFrame: 1 to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Humaira Waseem
Study officials:
References:
Clinical trial NCT06355856: Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss
Official title: Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Alopecia
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 196
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
* Male participants age 25 or older and 60 age or younger
* Participants who have an intact scalp in the area of product analysis
* Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale \> II
* Participants with at least 20% telogen effluvium of evaluated by Tricholab

Exclusion Criteria:

* Participants who have used immunosuppressants in the 3 months prior to signing the ICF
* Participants with other causes of hair loss or scalp dermatoses
* Participants who have received hair loss treatment in the last 6 months
* Participants with uncontrolled medical conditions, kidney and liver disease
* Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss

Primary outcomes:
measure: Percentage variation of hairs in the hair loss phase
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02858856: Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
Official title: Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Catholic Kwandong University
First posted: 2016-08-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* men and women aged over 18 years
* patients who have histologically or cytologically confirmed breast tumor
* patients who applicable AC(doxorubicin + cyclophosphamide)
* ECOG score 0 to 2

Exclusion Criteria:

* patient impossible to orally intake
* patient with dementia, delirium and depression
* patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
* severe liver disability (3-fold the normal high range value for ALT, AST)
* patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
* severe systemic disease
* use of other investigational products within the past 30 days
* hypersensitivity to investigational product
* others who are judged not to be appropriate to study

Primary outcomes:
measure: Brief Fatigue Inventory change
timeFrame: 0-5 week
measure: Brief Fatigue Inventory change
timeFrame: 6-11 week
Secondary outcomes:
measure: EORTC-QLQ-C30 change
timeFrame: 0-5 week, 6-11 week
measure: EORTC-QLQ-BR23 change
timeFrame: 0-5 week, 6-11 week
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: International St. Mary's Hospital
Study officials:
References:
citation: Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
Clinical trial NCT02093156: A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
Official title: A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Ottawa Score
Keywords: bowel preparation
Ottawa Score
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective study involving two tertiary centers in China. The patients of the training cohort were enrolled from the Endoscopy Center of Xijing Hospital of Digestive Diseases in China. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital in China.

Brief summary: Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate bowel preparation is essential for optimal visualization of the colorectal mucosa. However, inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which can be broadly categorized as patient-related or procedure-related. It has been shown that split-dose regimen or some modified educational strategies can improve the quality of bowel preparation. For the patients with possible IBP before the performing of colonoscopy, it may be better to repeat bowel preparation with modified or enhanced strategies in case of failed intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a model to predict the quality of bowel preparation individually.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 years old who undergoing colonoscopy

Exclusion Criteria:

* failed colonoscopy because of technical chanllenge or poor tolerance of patients
* history of colorectal surgery
* prior finding of severe colonic stricture or obstructing tumor
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileum
* known or suspected bowel obstruction or perforation
* pregnancy
* unable to give informed consent

Primary outcomes:
measure: Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
timeFrame: up to 4 months
Secondary outcomes:
measure: Polyp detection rate
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Second People's Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT06504056: Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN)
Official title: Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN): a Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Isolated Noncompaction of the Ventricular Myocardium
Keywords: Isolated Noncompaction of the Ventricular Myocardium
Prognostic factors
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with NVM at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.

Brief summary: This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

Detailed description: This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of nvm was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
* Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria:

* Incomplete clinical data.
* Do not agree to the inclusion or refuse to authorize the informed consent.

Primary outcomes:
measure: Change in the incidence of mortality rate
timeFrame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05421156: Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy
Official title: Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hysterectomy
Keywords: Subtotal Laparoscopic Hysterectomy
Total Laparoscopic Hysterectomy
Hysterectomy
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions

Brief summary: Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.


Eligibility criteria: Inclusion Criteria:

* Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.

Exclusion Criteria:

* Women with gynecological and non-gynecological cancers.

Primary outcomes:
measure: Sexual Dysfunctions
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Urinary Dysfunctions
timeFrame: 5 years after surgery
measure: Pelvic Organ Prolapse
timeFrame: 5 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01786356: Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Cataract
Keywords: posterior capsule opacification
PCO
after cataract
intraocular lens
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

Primary outcomes:
measure: posterior capsular opacification (PCO)
timeFrame: 4 years
Secondary outcomes:
measure: best corrected visual acuity (BCVA)
timeFrame: 4 years
measure: Nd:YAG rate
timeFrame: 4 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
Study officials:
References:
Clinical trial NCT06838156: Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery
Official title: Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Consumption
Pain Postoperative
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks.


Eligibility criteria: Inclusion Criteria:

1. Elective patients scheduled for hip arthroplasty surgery
2. Patient willingness to participate in the study
3. Patients over 18 years age of, ASA I-II-III,

Exclusion Criteria:

1. Patients not wanting to participate in the study
2. Patients who do not want regional anesthesia technique
3. Allergic or coagulated patients
4. Patients with liver, kidney, lung, heart failure and septic patients
5. Neurological disorder, history of convulsions
6. ASA IV patients

Primary outcomes:
measure: Effect on pain score
timeFrame: At 1,2,4, 6, 12 and 24 hours after surgery
Secondary outcomes:
measure: Opioid Consumption
timeFrame: At 1,2,4, 6, 12 and 24 hours after surgery
Other outcomes:
Locations:
city: Başakşehi̇r
country: Turkey
facility: Başakşehir Çam Ve Sakura City Hospital
state: İ̇stanbul
Study officials:
References:
citation: Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
citation: Xia Q, Ding W, Lin C, Xia J, Xu Y, Jia M. Postoperative pain treatment with transmuscular quadratus lumborum block and fascia iliaca compartment block in patients undergoing total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2021 Jul 10;21(1):188. doi: 10.1186/s12871-021-01413-7.