louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00272727: Improved Quality of the Treatment and Increased Compliance in Asthmatics Through the Dialog Tool Soren - Between Patient and Caregiver
Official title: Improved Quality of the Treatment and Increased Compliance in Asthmatics Through the Dialog Tool Soren - Between Patient and Caregiver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
dialog tool
compliance
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to assess if a dialog tool can improve compliance and asthma control in patients with asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma \>/= 3 months,
* Prescribed daily use of inhaled glucocorticosteroid

Exclusion Criteria:

* Asthma exacerbation within the last month

Primary outcomes:
measure: ACQ
Secondary outcomes:
measure: Ability to follow prescription, AQLQ, lung function, No, eosinophil
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Denmark Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01713127: Remifentanil in Ventilated Preterm Infants
Official title: Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Preterm Infants
Mechanical Ventilator Care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: DongGuk University
First posted: 2012-10-24
Enrollment: 12
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants


Eligibility criteria: Inclusion Criteria:

* preterm infants (\<37weeks of gestational age)
* requiring ventilator care
* informed consent

Exclusion Criteria:

* major anomaly
* 48hrs after birth
* requiring operation during drug infusion
* cord blood pH \< 7.0
* intraventricular hemorrhage grade III or more
* investigators decision

Primary outcomes:
measure: premature infant pain profile (PIPP)
timeFrame: 24hours after remifentanil/placebo infusion
Secondary outcomes:
measure: intraventricular hemorrhage
timeFrame: up to 1 week of age
measure: pneumothorax
timeFrame: up to 1 week of age
measure: bronchopulmonary dysplasia
timeFrame: 28 days of age
measure: duration of ventilator care
timeFrame: up to 4 months of age
measure: hospital day
timeFrame: upto 4 months of age
measure: time to full feeding
timeFrame: up to 2 months of age
measure: mortality
timeFrame: up to 4 months of age
measure: development of adverse effects
timeFrame: from the start of remifentanil infusion to 1 hour after end of infusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References:
Clinical trial NCT01130727: The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus
Official title: Randomized Clinical Trial, Placebo Controlled, With Parallel Groups to Investigate Whether Green Tea or Cocoa Extracts Improves Endothelial Dysfunction in Patients With Diabetes Mellitus and Nephropathy and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Nephropathy
Arterial Hypertension
Keywords: diabetes mellitus
diabetic nephropathy
hypertension
green tea
cocoa
polyphenol
nitric oxide
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-05-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Diabetic nephropathy
* Hypertension

Exclusion Criteria:

* GFR \< 30 ml/min/1.73m2
* Serum K \> 5.5 mEq/L
* Age \< 18 y
* Pregnancy
* Breast feeding
* Cocoa or green tea intolerance
* Alcohol and drugs abuse
* Incapacity to understand the information related to the study

Primary outcomes:
measure: flow-mediated dilation (FMD)
timeFrame: up to 4 hours
Secondary outcomes:
measure: arterial blood pressure and cardiac rate
timeFrame: up to 4 hours
measure: plasma levels of flavonols
timeFrame: up to 4 hours
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University Hospital
state: Sao Paulo
Study officials:
affiliation: Universidade Estadual de Campinas, Unicamp
name: Jose b Lopes de Faria, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004327: Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Hemorrhagic Telangiectasia
Ectasia
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease
senile ectasia
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 1999-10-19
Enrollment: 8
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia.

Detailed description: PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of octreotide twice a day. The dose is adjusted based on response.

If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Hereditary hemorrhagic telangiectasia or senile ectasia Refractory to or unable to tolerate hormonal therapy, i.e.: Estrogen Progesterone Danazol Gastrointestinal (GI) hemorrhage requiring transfusion within past 3 months Recurrent GI bleeding over more than 1 year At least 4 units packed RBCs transfused within past year OR intravenous iron required more than 4 times within past year No other likely source of hemorrhage determined within past year --Prior/Concurrent Therapy-- Disease hormone-refractory --Patient Characteristics-- No octreotide sensitivity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Joshua R. Korzenik
role: STUDY_CHAIR
References:
Clinical trial NCT00067860: Diet/Growth Factor Mechanisms of Gut Adaptation
Official title: Diet/Growth Factor Mechanisms of Gut Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Short Bowel Syndrome
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-09-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Detailed description: This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Eligibility criteria: * Parenteral nutrition-dependent adults with short gut syndrome.
* Patients must not have diabetes mellitus or active malignancy within the past 5 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University
name: Thomas R Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05847660: Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient
Official title: A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Infertility
IVF
Keywords: Polycystic ovary disease
ICSI
progesterone
antagonist protocol
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 210
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility
Primary purpose: TREATMENT

Brief summary: this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.

Detailed description: A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.

Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.

Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.

Eligibility criteria: Inclusion Criteria:

- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).

2. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.

Exclusion Criteria:

- Non-PCO patients as:

* Congenital adrenal hyperplasia
* Hyperprolactinemia.
* Recurrent implantation failure.
* Hydrosalpinx.
* Uterine pathology.
* Uncontrolled medical disorder eg DM, HTN
* Male factor infertility.

Primary outcomes:
measure: The number of oocytes retrieved per patient
timeFrame: 12 months
measure: The number of MII oocytes/per patient
timeFrame: 12 months
measure: The fertilization rate/per patient.
timeFrame: 12 months
measure: Number of frozen embryos/per patient
timeFrame: 12 month
Secondary outcomes:
measure: Incidence of early OHSS yes /no
timeFrame: 12 months
measure: Pregnancy outcomes
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01254760: Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 79
Sex: ALL
Minimum age (years): 41
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.


Eligibility criteria: Inclusion Criteria:

* Age 41 to 68 (inclusive).
* Spectacle add between +0.75 and +2.75D (inclusive).
* Habitual spectacle prescription ≤ 1.00DC (cyl).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in a clinical trial.
* Prior refractive surgery.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: End of Day Comfort
timeFrame: 5 days of wear, lenses replaced daily
measure: End of Day Dryness
timeFrame: 5 days of wear, lenses replaced daily
measure: Handling at Removal
timeFrame: 5 days of wear, lenses replaced daily
measure: Overall Vision
timeFrame: 5 days of wear, lenses replaced daily
Secondary outcomes:
measure: Overall Fit
timeFrame: Day 5, lenses replaced daily
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06329960: Dorsal Scapular Nerve Injection Combined With Muscle Needle Release
Official title: Efficacy of Ultrasound-guided Dorsal Scapular Nerve Injection Combined With Rhomboideus Muscle Needle Release
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dorsal Scapular Nerve Entrapment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment.


Eligibility criteria: Inclusion Criteria:

* Patients with DSN entrapment confirmed by electrophysiological study;
* age 18-80 years;
* patients who were irresponsive to conservative treatment;
* symptoms persisted for more than 3 months.

Exclusion Criteria:

* pregnancy
* DSN entrapment caused by trauma, surgery or occupying lesions of DSN;
* concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
* C5/6 lumbar radiculopathy;
* previous history of local injection or surgery for DSN entrapment.

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: before treatment, as well as 1, 3, 6 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jiaan Zhu
Study officials:
affiliation: Peking University People's Hospital
name: Jiaan Zhu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
citation: Muir B. Dorsal scapular nerve neuropathy: a narrative review of the literature. J Can Chiropr Assoc. 2017 Aug;61(2):128-144.
Clinical trial NCT00929760: Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
Official title: Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney disease
Nephrologists
Primary Care
Death
Renal Replacement Therapy
Specialised renal care
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Schweizerische Nierenliga
First posted: 2009-06-29
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients with CKD stage 3, 4 and 5 (CCl \< 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.

Exclusion Criteria:

* Patients previously known by nephrologists.
* Estimated life expectancy \< 1 year
* Refusal or inability to sign writing consent

Primary outcomes:
measure: Primary (composite): death, and hospitalisation
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
timeFrame: 24 months after enrollment
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Nephrology Unit Geneva University Hospitals
state: Geneva City
Study officials:
References:
citation: Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.
Clinical trial NCT03475160: Sildenafil Citrate and Recurrent Abortion
Official title: Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Abortion
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Primary purpose: TREATMENT

Brief summary: Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.

The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.

Detailed description: Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.

The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (\|IUGR).

Eligibility criteria: Inclusion Criteria:

* Unexplained recurrent spontaneous abortion.

Exclusion Criteria:

* Abnormal uterine cavity.
* Luteal phase insufficiency.
* Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
* Antiphospholipid syndrome.
* Inherited or acquired thrombophilia.
* Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.

Primary outcomes:
measure: The difference between both groups in live birth
timeFrame: Through study completion, an average of 9 months.
Secondary outcomes:
measure: Uterine artery PI at cycle day 21-23 preceding pregnancy
timeFrame: At cycle day 21-23 preceding pregnancy
measure: Uterine artery RI at cycle day 21-23 preceding pregnancy
timeFrame: At cycle day 21-23 preceding pregnancy
measure: Uterine artery PI at the twelfth week of gestation
timeFrame: At the twelfth week of gestation.
measure: Uterine artery RI at the twelfth week of gestation
timeFrame: At the twelfth week of gestation.
Other outcomes:
Locations:
Study officials:
References: