louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01995331: Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Official title: Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aplastic Anemia
Keywords: aplastic anemia;
cyclophosphamide;
immunosuppressive therapy;
cyclosporine A
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors associated with life-threatening complications. High-dose cyclophosphamide has been found to yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of cyclophosphamide for the treatment of children with SAA.

Detailed description: Tisdale et al. (2000,2002) attempted to compare immunosuppression using ATG/CSA with high-dose cyclophosphamide (50 mg/kg/d for 4 consecutive days) plus CSA in a randomized trial of newly diagnosed adults with SAA. Both groups received CSA as part of the treatment regimen. However, the trial was terminated prematurely due to excessive morbidity among the patients treated in the cyclophosphamide arm. They documented that invasive fungal infections were severe among the cyclophosphamide group. Between January 2008 through May 2009, in our department, nine pediatric patients with a diagnosis of SAA were enrolled a study with lower dose of cyclophosphamide with 30mg/kg/day for 4 consecutive days and combination with CSA, this study shows promise for children with severe aplastic anemia.Now we want explore the dosage of cyclophosphamide.

Eligibility criteria: Inclusion Criteria:

* Acquired Childhood Severe Aplastic Anemia (SAA)

Exclusion Criteria:

* not Childhood and Acquired Severe Aplastic Anemia

Primary outcomes:
measure: The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
timeFrame: 36 months
Secondary outcomes:
measure: The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
timeFrame: 36 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Pediatrics,Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Tianjin
Study officials:
affiliation: Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
name: Xiaifan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376531: Influence Continuous Veno-venous Hemodialysis the Autoregulation
Official title: Influence of Continuous Veno-venous Hemodialysis on Cerebrovascular Autoregulation in Patients With Acute Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Keywords: acute renal failure
cerebrovascular autoregulation
transcranial Doppler
continuous veno-venous hemodialysis
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at ICU with acute renal failure and the need of continuos veno-venous hemodialysis

Brief summary: The aim of the study is to characterize the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.

Detailed description: Patients at the intensive care unit who suffered acute renal failure with the need of continuous veno-venous hemodialysis will be investigated with continuous veno-venous hemodialysis and in a time window without continuous veno-venous hemodialysis to investigate the influence of continuous veno-venous hemodialysis on the cerebrovascular autoregulation.

Eligibility criteria: Inclusion Criteria:

* acute renal failure
* need for continuous veno-venous hemodialysis
* age \>18 Years

Exclusion Criteria:

* Sepsis
* Preexisting cerebral illness
* traumatic brain injury
* Meningitis or encephalitis
* Pregnancy

Primary outcomes:
measure: Change from Baseline cerebrovascular autoregulation to cerebrovascular autoregulation during continuous veno-venous hemodialysis
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University medical centre
Study officials:
affiliation: Department of Anesthesiology, University medicine Mainz, Germany
name: Patrick Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schramm P, Closhen D, Wojciechowski J, Berres M, Klein KU, Bodenstein M, Werner C, Engelhard K. Cerebrovascular autoregulation in critically ill patients during continuous hemodialysis. Can J Anaesth. 2013 Jun;60(6):564-9. doi: 10.1007/s12630-013-9912-z. Epub 2013 Mar 28.
Clinical trial NCT03580031: Booster Dose of HCG for Unruptured Follicle in Non IVF/ICSI Cycles
Official title: Booster Dose of Human Chorionic Gonadotrophin for Unruptured Follicle in Non IVF/ICSI Cycles: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: LUF - Luteinised Unruptured Follicle Syndrome
Keywords: LUF
HCG
Booster dose
Ovulation rate
pregnancy rate
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort groups with parallel allocation
Primary purpose: TREATMENT

Brief summary: This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles.

Detailed description: In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG dose. Patients were allocated randomly into intervention group and control group. In the intervention group another booster dose (10,000 IU of hCG) was given IM while in the control group 2 ml normal saline was given IM leaving follicles for spontaneous rupture

Eligibility criteria: Inclusion Criteria:

* Ordinary stimulated cycles
* IUI stimulated cycles
* Unruptured follicle after 10000 IU IM HCG triggering

Exclusion Criteria:

* IVF/ICSI cycles

Primary outcomes:
measure: Ovulation rate
timeFrame: 48 hours
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 15 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
affiliation: Lecturer at Tanta University
name: Ayman Dawood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02278731: Exercise Protocols in Postural Balance Of Elderly Women
Official title: EFFECTS OF TWO EXERCISE PROTOCOLS IN POSTURAL BALANCE OF ELDERLY WOMEN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Physical activity
Rehabilitation
Older adults
Pilates
Proprioceptive neuromuscular facilitation
Lead sponsor: Universidade Estadual do PiauÍ
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 58
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine and compare the effects of a training program with Pilates and Facilitation Neuromuscular Proprioceptive on balance and function in elderly women.

Detailed description: Older women living in Teresina and participating in a local church project called "Pão dos Pobres" were randomly divided into three groups: Proprioceptive Neuromuscular Facilitation (PNFG), Pilates (PG) and Control(CG). Intervention: A training program (50 minutes session) was performed with the PNFG and the PG, 3 times a week, for 4 weeks. The elderly in CG suffered no intervention and continued with their daily activities. Main Outcome Measures: The stabilometric parameters, Berg Balance Scale score, functional reach test and Timed Up and Go test (TUG test) were measured before and one month after, in all participants.

Eligibility criteria: Inclusion Criteria:

* All the subjects were between 60 and 80 years old,
* sedentary and healthy

Exclusion Criteria:

-Orthopedic, cardiovascular, vestibular, psychological, neurological or any other impairment that would not allow the execution of all study tasks

Primary outcomes:
measure: Displacement of the center of pressure of the body
timeFrame: 1 month
measure: Functional mobility on the Timed Up & Go test
timeFrame: 1 month
measure: Static and dynamic balance on the Berg Balance test
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mesquita LS, de Carvalho FT, Freire LS, Neto OP, Zangaro RA. Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial. BMC Geriatr. 2015 Jun 2;15:61. doi: 10.1186/s12877-015-0059-3.
Clinical trial NCT01615731: Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Official title: Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: Mifepristone
Induced Abortion
Dilation and Evacuation
Cervical preparation
Osmotic dilators
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2012-06-11
Enrollment: 50
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: A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 19 and 24wks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria:

* Allergy to misoprostol or mifepristone

Primary outcomes:
measure: Procedure Time
timeFrame: Intraoperative Time
measure: Total Procedure Time
timeFrame: Measured at clinic visits and on OR day, over a 3 day period
Secondary outcomes:
measure: Maximum Cervical Dilation
timeFrame: Measured intra-operatively
measure: Adverse Events (EBL)
timeFrame: Intraoperatively
measure: Ease of Procedure by Blinded Surgeon
timeFrame: Measured Immediately after procedure
measure: Pain Perceived by Patient
timeFrame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
measure: Overall Patient Experience
timeFrame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
measure: Adverse Events
timeFrame: Intraoperatively and 2 weeks post operatively
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT01683331: A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Official title: A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prevention of New Onset Diabetes Among Kidney Transplant Patients
Keywords: Kidney transplant
New onset diabetes
Prevention
Insulin
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2012-09-11
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in decreasing the incidence of NODAT among de novo kidney transplant patients with manifested post-transplant hyperglycemia during the first week after transplantation.

Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress related to the surgery and use of higher doses of immunosuppressive medications, and leads to lower incidence of NODAT at 1 and 2 years.

Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.

Hypothesis 2: Early initiation of insulin therapy results in greater overall control of glycemia compared to standard care of dietary counseling, life-style modification, oral hypoglycemic agents and/or insulin as needed at 1 year.

Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.

Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (\> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
2. Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
3. Capable to understand the study protocol and to give informed consent;

Exclusion Criteria:

1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;

Primary outcomes:
measure: The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
timeFrame: 12 months
Secondary outcomes:
measure: The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
timeFrame: 24 months
Other outcomes:
measure: Incidence of Impaired Fasting Glycemia and Impaired Glucose Tolerance 6, 12 and 24 Months After Transplantation.
timeFrame: 6, 12 and 24 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Akinlolu Ojo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05708131: Outcomes of Functional Substrate Mapping of Ventricular Tachycardia
Official title: Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2023-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital

Brief summary: The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.

Detailed description: This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.

Eligibility criteria: Inclusion Criteria:

One of the following VT events (within the last 6 months) + Ejection Fraction \<40%:

A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic.

B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD.

Exclusion Criteria:

* Contraindication to VT ablation
* Renal failure (CrCl \< 15 mL/min)
* NYHA IV or CCS IV angina
* STEMI within 1 month
* CABG within 3 months
* PCI within 1 month
* Pregnant
* Life expectancy \< 1 year

Primary outcomes:
measure: Composite of cardiovascular mortality and ICD therapy
timeFrame: 12 months
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
measure: Left ventricular function on echocardiogram
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Granada
country: Spain
facility: Virgen de las Nieves University Hospital
city: Madrid
country: Spain
facility: Arrhythmia Unit, University Hospital Ramón y Cajal
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Mid and South Essex NHS FT
name: Neil Srinvasan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04950231: Investigation on Home Care Needs of ALS Patients and Their Caregivers
Official title: Investigation on the Knowledge Needs of ALS Patients and Their Caregivers at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Six rigorously trained nurses in charge will issue and collect the questionnaire, two researchers will enter the data, one researcher will perform statistical analysis of the data, and the other two researchers will control the quality of the whole process.

Brief summary: The research target

1. To investigate the home nursing knowledge needs of ALS patients;
2. Investigate the needs of ALS caregivers for home nursing knowledge;
3. To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Detailed description: The research target

1. To investigate the home nursing knowledge needs of ALS patients;
2. Investigate the needs of ALS caregivers for home nursing knowledge;
3. To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Assessment indicators

1. Scale: Self-designed questionnaire "Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Families";
2. Amyotrophic lateral sclerosis function rating scale (ALS FRS)

Eligibility criteria: Inclusion Criteria:

* confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent;

Exclusion Criteria:

* patients with severe medical diseases, such as severe cardiovascular and cerebrovascular diseases, liver and kidney failure, etc.The existing resources cannot complete the questionnaire to fill in the exclusion of patients, but the caregivers can fill in the questionnaire;

Primary outcomes:
measure: Scale
timeFrame: 1 year after recruitment
Secondary outcomes:
measure: (ALS FRS)
timeFrame: 1 year after recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Yniversity Third Hospital
Study officials:
References: