louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01611051: A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Neutropenia
Febrile Neutropenia
Keywords: breast cancer
neutropenia
febrile neutropenia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Investigator diagnosis of breast cancer
* Age 18 to 70 years
* ECOG performance status ≤ 1
* Chemotherapy naïve
* Body weight ≥ 45kg
* Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

Exclusion Criteria:

* Prior bone marrow or stem cell transplantation
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Radiation therapy within 4 weeks of randomization into this study
* Pregnancy, lactation

Primary outcomes:
measure: Rate and the duration of grade 3/4 neutropenia in cycle 1
timeFrame: 21 days
Secondary outcomes:
measure: Rate and the duration of grade 3/4 neutropenia in cycle 2-4
timeFrame: Through cycle 2 to cycle 4
measure: Rate of the febrile neutropenia in cycle 1
timeFrame: Through 4 cycles
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospital Affiliated to Academy Military Medical Science
state: Beijing
Study officials:
References:
Clinical trial NCT01443351: Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Official title: Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Primary Immune Thrombocytopenia (ITP)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: ITP
romiplostim
eltrombopag
bone marrow fibrosis
long-term safety
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
First posted: 2011-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patinets will be selected from Departments of Hematology

Brief summary: Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.


Eligibility criteria: Inclusion Criteria:

* Adult patients with ITP
* platelet counts \< 25 x10\*9/L or \< 50 x10\*9/L with bleeding symptoms
* meets criteria for treatment with TPO-ra
* Females must use contraceptives when applicable for at least three months before inclusion

Exclusion Criteria:

* Pregnancy or nursing
* Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation
* Liver insufficiency (for eltrombopag only)
* TPO-ra contraindications (e.g. allergy)
* TPO-ra treatments less than 6 months prior to inclusion

Primary outcomes:
measure: Number of patients with sustained response at 6 months follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Yearly response rates
timeFrame: 5 years
measure: Frequency of relapse
timeFrame: 5 years
measure: Rate of splenectomy
timeFrame: 5 years
measure: Development of reticulin fibrosis in bone marrow biopsies
timeFrame: 5 years
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Copenhagen University Hospital Roskilde
Study officials:
affiliation: Department of Hematology, Copenhagen University Hospital Roskilde
name: Hans Hasselbalch, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Henrik Frederiksen, Dr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Roskilde
name: Sif Gudbrandsdottir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456651: Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
Official title: Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Obesity
Keywords: Sleep Apnea
Obesity
Neuropeptides
Hormones
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fundacion Caubet-Cimera Islas Baleares
name: Fondo de Investigacion Sanitaria
First posted: 2007-04-05
Enrollment: 40
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.

The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.

Detailed description: OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.

DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.

METHODS: To all subjects included in the study, the following procedures will be performed:

1. Medical History;
2. Anthropometric variables (height, weight, Body Mass Index;
3. Somnolence evaluation using the Epworth scale;
4. Conventional Polysomnography (PSG);
5. Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
6. Conventional biologic evaluation;
7. Patients will be re-evaluated after three months of treatment with CPAP.

Eligibility criteria: Inclusion Criteria:

* Apnea-Hypopnea Index \> 15
* Body Mass Index \< 27 or \> 30 Kg/m2

Exclusion Criteria:

* Presence of any chronic disease
* Drug addiction and/or alcoholism
* Refusal to sign informed consent

Primary outcomes:
measure: OBJECTIVES: To compare the plasmatic profiles of different hormones
measure: and neuropeptides, related with weight control, metabolism and intake
measure: in patients with SAHS as well as in selected control subjects according
measure: to weight.
Secondary outcomes:
measure: CPAP (Continuous Positive Airway Pressure) effect on studied variables
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Baleares
Study officials:
affiliation: Hospital Universitario Son Dureta
name: Mónica de la Peña, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681551: Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
Official title: Intra-individual Comparison Study of Intravenously Administered Magnevist (SH L 451A) on Lesion Detection Ability in MRI After an Initial Dose of 0.1 mmol/kg and After an Additional Dose of 0.1 mmol/kg in Patients With Metastatic Brain Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Neoplasms
Keywords: Detection of brain metastasis by MRI
Magnevist
Brain metastasis
Meglumine gadopentetate
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. Safety was also to be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral CT or contrast-enhanced cerebral MRI, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery.

Exclusion Criteria:

* Patients who are scheduled to receive another contrast medium for MRI (except for oral agents) or iodine contrast medium (except for oral agents), or to undergo surgical procedures during the period from the day before administration of Magnevist (SH L 451A) to examination of safety on the following day.
* Patients who underwent or are scheduled to undergo radiotherapy during the period from 14 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.
* Patients who were treated or are scheduled to be treated with anti-cancer agents (except for treatment only by the oral agents of the fixed dose continuously from 28 days or more before administration of Magnevist (SH L 451A)) during the period from 28 days before administration of Magnevist (SH L 451A) to examination of safety on the following day.

Primary outcomes:
measure: Diagnostic ability
timeFrame: MRI image in blinded read
Secondary outcomes:
measure: Visibility
timeFrame: MRI image in blinded read
measure: Diagnostic confidence
timeFrame: MRI image in blinded read
Other outcomes:
Locations:
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Osaka-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Nakakoma-gun
country: Japan
state: Yamanashi
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01669954: Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study
Official title: Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Fractures
HIV Infection
Keywords: HIV
Bone mineral density
Osteoporosis
Vitamin D
Fractures
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: St Thomas' Hospital, London
First posted: 2012-08-21
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or above, equally matched for age, and gender.

Brief summary: The purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups.

This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV.

In addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is HIV drug history.

Hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.


Eligibility criteria: Inclusion Criteria:

* 18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent

Exclusion Criteria:

* Pregnant Less than 18 years of age Unable to comply with study procedures

Primary outcomes:
measure: Bone mineral density at Hip
timeFrame: The outcome is measured within 6 months (0-6 months) after entry to the study.
Secondary outcomes:
measure: Bone mineral density at spine (L4)
timeFrame: The outcome is measured within 6 months (0-6 months) after entry to the study.
measure: Any lifetime fractures reported by subjects
timeFrame: At any stage during persons life up to and including the last visit for the volunteer to the study.
measure: Vitamin D levels
timeFrame: The outcome is measured within 6 months (0-6 months) after entry to the study.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas, Hospital
Study officials:
affiliation: King's College London
name: Barry S Peters, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822054: Childhood Body Composition and Brain Structure and Function
Official title: Childhood Body Composition and Brain Structure and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal weight or obese children (age 8-10 years)

Brief summary: The specific aim of this research project is to use MRI methods to evaluate and compare brain structure and function in normal weight and obese children age 8-10 years.


Eligibility criteria: Inclusion Criteria:

* Healthy normal weight or obese children
* Parental report of full-term gestation
* Parental report of birth weight between 5th-95th percentiles
* Parental report of breastfeeding or cow's milk formula fed during infancy
* Right hand dominance

Exclusion Criteria:

* Maternal diabetes
* Maternal alcohol, tobacco or drug use during pregnancy
* Chronic sleep disorder
* History of psychological or psychiatric diagnosis
* History of neurological impairment or injury
* Surgical implant or other foreign object in the body which may be a MRI safety concern
* Dental work which may cause artifacts in MRI
* Claustrophobia
* High likelihood of inability to tolerate loud noise from the MRI scanner

Primary outcomes:
measure: Brain structure
timeFrame: 8 - 10 years of age
Secondary outcomes:
measure: Brain Function
timeFrame: 8-10 years of age
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Xiawei Ou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404454: Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesions
Septate Uterus
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Sassari
name: Azienda Sanitaria Locale di Cagliari
name: Azienda Sanitaria Locale di Olbia
name: Azienda Sanitaria Locale di Oristano
First posted: 2015-03-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.

Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.

Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.


Eligibility criteria: Inclusion Criteria:

* uterine septum
* history of ≥1 miscarriage or infertility;
* desire to have children in the future

Exclusion Criteria:

* pregnancy;
* menopause;
* precancerous state or malignancy of the reproductive organs;
* benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
* lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
* withdrawal of patient consent;
* rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
* presence of external intercornual cleft;
* incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
* excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)

Primary outcomes:
measure: Change in Formation of intrauterine adhesions
timeFrame: baseline (operative isteroscopy and three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00221754: Pravastatin and Protease Inhibitors in HIV-Infected Patients
Official title: Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Hypercholesterolemia
Keywords: HIV,
protease inhibitors
pravastatin
Treatment Experienced
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 21
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: To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Detailed description: Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.

Design. randomized double-blind, multicentric.

Intervention. Pravastatin versus placebo for 12 weeks.

Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for \>= 3 months, plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization, total cholesterol \>= 5.5 mmol/L with LDL-cholesterol \>= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent

Outcomes. HIV RNA at 12 weeks

Eligibility criteria: Inclusion Criteria:

* confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
* Age above 18 years
* Stable antiretroviral therapy including at least one PI for \>= 3 months,
* Plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization,
* Total cholesterol \> = 5.5 mmol/L with LDL-cholesterol \> = 3.4 mmol/L on fasting status after three months of standardized dietary advice,
* signed informed consent

Exclusion Criteria:

* Current AIDS event or infectious disease
* Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
* Psychiatric conditions
* Biological elevated muscular enzymes
* Chronic alcohol consumption
* Pregnancy

Primary outcomes:
measure: HIV RNA
timeFrame: at 12 weeks
Secondary outcomes:
measure: Lipid biological markers
measure: Plasma level of protease inhibitors
measure: CD4 count at 12 weeks
measure: Safety
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint André, Service de médecine interne et maladies infectieuses
Study officials:
affiliation: University Hospital Bordeaux, France
name: Fabrice BONNET, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux France
name: Geneviève CHENE, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT02945254: Effect of Background Noise on Sleep Quality
Official title: Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Onset Insomnia
Keywords: sleep onset latency
sleep quality
insomnia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.

The number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits.

A few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency.

In an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Age between 21 and 60

Exclusion Criteria:

* Any sleep disorder
* Use of hypnotics

Primary outcomes:
measure: Sleep Onset Latency (Mins)
timeFrame: 1 night
Secondary outcomes:
measure: Subjective Sleep Quality (VAS)
timeFrame: 1 night
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Disorders Research Program Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: