louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05699447: A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.
Official title: A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.A Cohort Study in Beijing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maintenance Hemodialysis
Older Patient
Keywords: Older patients
maintenance hemodialysis
mortality
risk prediction score.
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).

Brief summary: The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk prediction score.

Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC). Logistic regression model was used to evaluate the 1-year mortality and the influence of predictive factors. Internal validation of the model was performed using the bootstrap 1000 repeat sampling method. Area under receiver operating characteristic curve (AUC) was used to evaluate the predictive ability of the model.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years.
* More than 6-month history of hemodialysis,the frequency is 3 times a week, and the dialysis time is 4 hours each.
* The dialysate Ca concentration was 1.5 mmol/L and the bicarbonate level was 32 -- 35 mmol/L.

Exclusion Criteria:

* Lack of demographic information, clinical history, or relevant laboratory values (including pre-dialysis serum calcium, phosphorus, iPTH, haemoglobin, albumin, creatinine, total cholesterol, and Kt/v for urea).

Primary outcomes:
measure: the 1-year mortality in older patients undergoing maintenance hemodialysis
timeFrame: Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05990647: Impact Evaluation of Incisional Hernia on Muscular and Postural Function
Official title: Incisional Hernia Impact on Muscular and Postural Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Keywords: incisional hernia
tension dynamometry
raster photostereography
postural balance
hernia repair
bridging technique
Rives-Stoppa
TAR
Lead sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Sponsor class: OTHER
Collaborators: name: Tashkent state dental institute
name: I.M. Sechenov First Moscow State Medical University
name: Pirogov Russian National Research Medical University
First posted: 2023-08-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Purpose of study is to assess perioperative functional parameters of the anterior abdominal wall muscles and postural control status in patients with large and giant incisional hernias in a controlled diagnostic study.

The study involved 95 patients (100% completed) with a large or giant incisional hernia of the anterior abdominal wall. The participants were divided into three groups by type of hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative functional parameters of the anterior abdominal wall muscles were assessed by tension dynamometry. The postural balance assessments were made by raster photostereography.


Eligibility criteria: Inclusion Criteria:

* big and giant incisional hernia
* hernia without recurrence
* age 18-75

Exclusion Criteria:

* acute infection diseases
* cancer
* orthopedic diseases
* terminal status
* BMI\>39,9

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
Secondary outcomes:
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov
Study officials:
affiliation: Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
name: Otabek J. Eshonkhodjaev, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02936947: Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
Official title: Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.

Detailed description: Primary objective :

Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :

1. Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
2. In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* breast cancer eligible for tomotherapy or linear accelerator with ABC system
* lung cancer eligible for curative tomotherapy and with a significant breathing movements amplitude
* lung cancer eligible for ablative stereotaxis
* WHO 0 or 1

Exclusion Criteria:

* patients requiring oxygen or not able to lie on the back (dyspnea)
* pulmonary functions altered
* cardiac insufficiency
* patient not able to breathe with the High Frequency Ventilation System
* risk of pneumothorax when experiencing High Frequency Ventilation

Primary outcomes:
measure: HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
timeFrame: 0-14 days between registration and treatment start according to standard patient care
measure: HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)
timeFrame: 0-14 days between registration and treatment start according to standard patient care
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: CHUV
name: Jean Bourhis, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690047: Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)
Official title: Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hereditary Angioedema
Keywords: prodrome
Lead sponsor: Bernstein Clinical Research Center
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 5
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries

Detailed description: After screening, subjects will be followed in the study for four consecutive prodromes. For prodromes designed to be treated with Ruconest, the drug will be administered within 12 hours of prodromal onset and prior to the onset of objective selling. Ruconset will be self-administered at home or by a healthcare professional at the recommended dose of 50 IU/kg body weight with maximum dose of 4200 IU as a slow IV injection over 5 minutes Subjects will be randomized into two arms after enrollment. Subjects in Arm A receives Ruconest after 1st and 2nd prodrome and no Ruconest after 3rd and 4th prodromes. Subjects in Arm B receive no Ruconest after 1st and 2nd prodrome and Ruconest after 3rd and 4th prodromes.

Eligibility criteria: Inclusion Criteria:

* Prior diagnosis of HAE Type 1 and 2,
* One or more HAE attacks per month,
* History of 4 prodromes that proceed to angioedema attacks

Exclusion Criteria:

* History of thrombosis or arterial/venous thromboembolic attacks
* History of atherosclerosis, morbid obesity, immobility
* History of allergy to rabbits or products from rabbits
* History of life-threatening immediate allergic reactions to C1 esterase inhibitor preparations

Primary outcomes:
measure: The primary endpoint was the difference in response rates in preventing HAE attacks between Conestat Alfa®-treated vs. untreated HAE prodrome events.
timeFrame: up to 12 months from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
Study officials:
affiliation: Bernstein Clinical Research Center
name: Jonathan Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01995747: The Effect of Anti-CεmX on IgE Production
Official title: The Effect of Humanized Anti-CεmX Antibody (h4B12) on IgE Production in the PBMC Isolated From Atopic Dermatitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: IgE
Atopic Dermatitis
antibody
allergy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of atopic dermatisis

Brief summary: Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be effective for patients with much higher serum IgE levels, such as those with atopic dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic patients.

Detailed description: This study will collect blood from patients of high serum IgE levels to investigate the function of h4b12, a humanized mAb specific for mIgE+ B cells, and compare the effects of h4B12, Omalizumab, and Rituxumab on the suppression of IgE production and the number of IgE-producing plasma cells. These blood specimens will be collected from 50 patients of atopic dermatitis or urticaria with high serum IgE levels. Fountain Biopharma will carry out the following two in vitro assays to measure the efficacy of h4B12:

* IgE ELISA to determine the concentration of IgE.
* IgE ELISPOTto determine the number of IgE-producing plasma cells.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged ≥ 18 years
* Clinical diagnosis of atopic dermatitis or chronic urticaria

Exclusion Criteria:

-

Primary outcomes:
measure: IgE
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Dept of Dermatology, NTUH
name: Chia-Yu Chu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619447: Comparison of ESP Block Versus Serratus Block
Official title: Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

Detailed description: In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Being volunteer
* Total mastectomy

Exclusion Criteria:

* ASA III and over
* Renal and hepatic failure
* Non Volunteers
* Emergency procedures

Primary outcomes:
measure: morphine consumption
timeFrame: up to postoperative 24th hours.
Secondary outcomes:
measure: numerical rating scale score
timeFrame: up to postoperative 24th hours.
Other outcomes:
Locations:
Study officials:
affiliation: Cukurova University
name: Ebru Biricik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529047: Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling
Official title: RTC of Web Versus In-Person SUD and Comorbidity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling
Alcohol Consumption
Cannabis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-02-08
Enrollment: 361
Sex: ALL
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rates of gambling and substance use behaviors are elevated among emerging adults (ages 18-24), and these behaviors are individually and jointly associated with a host of negative consequences. Evidence suggests there is significant overlap between these behaviors as well as comorbidity of associated mental disorders (i.e., pathological gambling and substance abuse/dependence). Prior research suggests that a brief in-person delivered personalized feedback intervention (PFI) may be an effective method of reducing these behaviors and their associated consequences among emerging adults. Thus, the purpose of this study is to determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample of emerging adults, as well as explore potential moderators and mediators of intervention efficacy and the longevity of intervention effects (over a period of 18-months).


Eligibility criteria: Inclusion Criteria:

* Endorse disordered gambling behavior (including 1 or more consequence)
* Meet diagnostic criteria for one or more substance use disorder

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: gambling behavior and consequences
timeFrame: across 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington Dept of Psychiatry & Behavioral Sciences
name: Mary E Larimer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03880747: Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy
Official title: Incidence of Dumping Syndrome After Laparoscopic Vagus Nerve-preserving Distal Gastrectomy for Early Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasm
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-03-19
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: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach

Brief summary: There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).

Detailed description: The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy

Exclusion Criteria:

* Sacrificed vagus nerve
* Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy
* conversion to an open procedure
* combined resection of other organs

Primary outcomes:
measure: Dumping syndrome
timeFrame: 1 year
Secondary outcomes:
measure: EORTC C-30/STO22
timeFrame: 3 months, 6 months, 1 year
measure: Postoperative complication
timeFrame: 3 months, 6 months, 1 year
measure: Incidence of gallstones
timeFrame: 1 year
Other outcomes:
measure: Operative time
timeFrame: Immediately after operation
measure: Estimated blood loss
timeFrame: Immediately after operation
measure: Time to first flatus
timeFrame: Within 1 week
measure: Hospital stay
timeFrame: Within 1 week
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01617447: A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Official title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder
Keywords: Autistic Disorder, children and adolescents
Aripiprazole
Double-blind
Randomized
children and adolescents
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder


Eligibility criteria: Inclusion Criteria:

* The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.
* Inpatient or outpatient status
* Others

Exclusion Criteria:

* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Others

Primary outcomes:
measure: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
timeFrame: baseline, 8 weeks after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: