louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02787980: Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Official title: Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Newborns
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 87
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Compare serum tryptase levels of premature babies (\<37 weeks of amenorrhea) to children born at full term.

Study the evolution of serum tryptase levels in premature babies(\<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (\<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.

Detailed description: It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role.

Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.

Eligibility criteria: Inclusion Criteria "Patients" :

* all premature babies (\<37 weeks of amenorrhea)
* managed in the first 24 hours of life at the Reims university hospital
* parents accepted to participate in the research - social security card

Inclusion Criteria "Controls" :

* children born full term, just after each "patient" child included
* managed in the first 24 hours of life at the Reims university hospital
* parents accepted to participate in the research.

Exclusion Criteria "Patients" and "Controls"

* Not managed in the first 24 hours of life at the Reims University Hospital,
* Person, who has parental authority, protected by law,
* Newborns with a life and death emergency in the first 24 h of life,
* Person, who has parental authority, under age 18

Primary outcomes:
measure: serum tryptase levels
timeFrame: infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04128280: Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
Official title: Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Prostatitis
Keywords: Chronic Prostatitis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Xin Hua Hospital of Zhejiang Province
name: Huashan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Changhai Hospital
name: Peking University First Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2019-10-16
Enrollment: 180
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis

Detailed description: 1. Study purpose: To investigate the therapeutic effect of transurethral dilation of prostate with a columnar balloon on patients with chronic obstructive prostatitis
2. Study design: A randomized, controlled, multi-center clinical trial
3. Study subjects: Patients with chronic obstructive prostatitis
4. Number of subjects: 180
5. Surgery treatments:

Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon.

Control group: Patients will receive a surgery: transurethral incision of bladder neck.

Eligibility criteria: Inclusion Criteria:

1. older than 35 years old, urinary obstruction is clear;
2. the total score of chronic prostatitis symptoms index (CPSI) is greater than 14 points, and the severity of symptoms is greater than 9 points;
3. maximum urine flow rate is less than 15 ml/s;
4. cystoscopy and pathological biopsy confirmed the presence of bladder neck fibrosis, bladder trabeculae formation;
5. other conservative treatments are ineffective or ineffective, and drug treatment is not effective for more than 6 months;
6. voluntarily participated in this clinical trial, complied with the requirements of this study and signed the informed consent form.

Exclusion Criteria:

1. urinary tract infection, urinary tumor, history of intestinal inflammatory disease;
2. neurogenic bladder;
3. history of pelvic radiation therapy or chemotherapy;
4. PSA is abnormal;
5. urethral stricture, history of bladder or prostate surgery;
6. the investigator determined that it is not suitable for this clinical trial.

Primary outcomes:
measure: The score of CPSI
timeFrame: within 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01292980: Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)
Official title: Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcers
Keywords: sDTI
Pressure ulcers
Therapy surfaces
Mattresses
Deep Tissue Injury
pressure ulcer treatment
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the hospital with SDTI

Brief summary: Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

Detailed description: Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred.

Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Eligibility criteria: Inclusion Criteria:

1. Patients with sDTI on the supine aspect of their body
2. Patient does not require a pulmonary specialty bed for care
3. Patient is expected to be in the hospital for at least 3 days
4. Patient weighs between 30 and 350 Lbs.
5. Patient's height is less than 75 inches tall
6. Patient, or patient's representative, is willing and able to sign written informed consent
7. Patient is expected to survive hospitalization.

Exclusion Criteria:

1. Patient is less than 18 years of age
2. Patient has already participated in this study

Primary outcomes:
measure: Degree of breakdown
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Worth
country: United States
facility: Harris Methodist Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01980680: The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
Official title: The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40
* Normal menstrual cycles: 25-34 days
* Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
* BMI \>18 and \<35 kg/m2

Exclusion Criteria:

* Patients with \>14 follicles on day of trigger
* Previous hyperresponse with OHSS development
* Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
* Endocrine disorders

Primary outcomes:
measure: Ongoing pregnancy rate per patient
timeFrame: 10th week of gestation.
Secondary outcomes:
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic, Regional Hospital of Skive
Study officials:
References:
Clinical trial NCT01687062: Iron Absorption From Tef-injera in Women of Reproductive Age
Official title: Iron Absorption From Tef-injera in Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: NaFeEDTA
phytate
injera
iron absorption
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Anemia is one of the most common health problems all over the world with around half of preschool-aged children (\<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.


Eligibility criteria: Inclusion Criteria:

* Reproductive age females 18-40 years
* Maximum body weight 65 kg
* Normal body mass index (18.5-25 kg/m2)
* No intake of mineral/vitamin supplements 2 weeks before and during the study
* No metabolic or gastrointestinal disorders or chronic diseases
* Not pregnant or lactating
* No regular intake of medication (except oral contraceptives)
* No blood donation or significant blood loss (accident, surgery) over the past 4 months
* Not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* No former participation in a study involving administration of iron stable isotopes
* No eating disorders or food allergy
* Subject who can be expected and are willing to comply with study protocol
* Having received oral and written information about the aims and procedures of the study
* Having provided oral and written informed consent

Primary outcomes:
measure: Iron absorption
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
References:
Clinical trial NCT02511262: Detection of Mycoplasma Pneumoniae
Official title: Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycoplasma Pneumoniae
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 471
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.

Brief summary: The objective of this Clinical Trial is to define the methods to be used to document that illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.


Eligibility criteria: Inclusion Criteria:

* The subject has willingly given written informed consent.
* Specimens provided from subjects with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
* Dual throat swab collected per subject.

Exclusion Criteria:

* Subjects who are unwilling to sign the written informed consent.
* Multiple sets of specimens collected from the same subject.
* Subjects who are unwilling or unable to provide the required number of throat swabs.

Primary outcomes:
measure: Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Sacred Heart Health System
state: Florida
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Ft. Worth
country: United States
facility: Cook Children's Healthcare System (CCHCS)
state: Texas
Study officials:
References:
Clinical trial NCT01228162: Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Relaxation
Muscle Trauma
Analgetic Consumption
Total Hip Replacement
Lead sponsor: Klinikum Hildesheim GmbH
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2010-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).


Eligibility criteria: Inclusion Criteria:

1. patient agreement
2. indication for total hip replacement
3. age 55 - 80 years
4. weight 65 - 95 kg
5. first intervention
6. ASA classification I - III
7. general and spinal anaesthesia possible in this patient

Exclusion Criteria:

a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea

-

Primary outcomes:
measure: degree of muscle trauma
timeFrame: 24 hours
Secondary outcomes:
measure: consumption of analgetics
timeFrame: 3 days
Other outcomes:
Locations:
city: Hildesheim
country: Germany
facility: Klinikum Hildesheim GmbH
Study officials:
References:
Clinical trial NCT00726362: To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia
Official title: To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemias
Keywords: Statin
LDL-C
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 3270
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: based on regular practice and judged by physicians, patients with hyperlipidemia who need to start prescribed with a statin; or to switch from current therapy to a statin, or require dosage adjustment for statin

Brief summary: The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with hyperlipidemia
* Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
* Patients who are willing to participate in this study and who sign an informed consent form

Exclusion Criteria:

* Pregnancy or breast feeding
* Patient are illiterate or unable to fill the questionnaire for any reason
* Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
* Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications

Primary outcomes:
measure: Changes on LDL-C, HDL-C, TG, TC
timeFrame: 3~6 months
Secondary outcomes:
measure: ratio for treatment-to-goal
timeFrame: 3~6 months
measure: drug compliance
timeFrame: 3~6 months
measure: correlation between patient's insight and therapeutic outcome
timeFrame: 3~6 months
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Research Site
city: Hualien
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Pingtung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Yun-Lin
country: Taiwan
facility: Research Site
Study officials:
affiliation: Kaohsiung Medical University
name: Wen-Ter Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321762: Prolapse and Pregnancy Assessment
Official title: Effect of Pregnancy and Childbirth on the Pelvic Floor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Prolapse
Childbirth
Pregnancy
Lead sponsor: Croydon University Hospital
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with uncomplicated singleton pregnancy attending the ultrasound scan clinic in the second trimester were invited to participate

Brief summary: Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery. In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7 per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. Vaginal birth, advancing age and increasing body mass are the most consistent risk factors. Furthermore a racial and congenital predisposition has been reported. The cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient.

Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of POP. Caesarean section appears to protect against the development of prolapse. However, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. Ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. The primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse Quantification (POPQ)System.


Eligibility criteria: Inclusion Criteria:

* Singleton Pregnancy

Exclusion Criteria:

* Multiple pregnancies
* Previous prolapse surgery
* Medical disorders including diabetes mellitus
* Inflammatory bowel disease
* Collagen disorders

Primary outcomes:
measure: Objective assessment of Prolapse using Pelvic organ prolapse Quantification System
timeFrame: 2nd trimester, 3rd trimester, 14 weeks, 12 months and 5 years after childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Croydon University Hospital
state: Surrey
Study officials:
References: