louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01650987: Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function
Official title: Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corpus Uteri Carcinoma
Keywords: carcinoma
uterus
Not metastatic
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 72
Sex: FEMALE
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: Women with a corpus uteri carcinoma, without metastasis.

Brief summary: Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Detailed description: Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Eligibility criteria: * Inclusion Criteria:
* Patients whose treatment is provided to Centre Oscar Lambret
* With a corpus uteri adenocarcinoma, no metastatic, treated by:
* Surgery and observation without complementary treatment
* Or surgery and adjuvant radiotherapy
* Or Surgery and curietherapy of vaginal dome
* With a cervix carcinoma, stade IA2 to IIB proximal, treated by :
* External radiochemotherapy and curietherapy
* Or only surgery
* Or pre-surgical curietherapy and surgery
* Age \> 18 years

Primary outcomes:
measure: Toxicities including on sexual function
timeFrame: up to 3 years
Secondary outcomes:
measure: Compare the various scales of toxicity
timeFrame: up to 3 years
measure: Study the sexual behavior modifications
timeFrame: up to 3 years
measure: Specify correlation modifications of sexual behavior
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Oscar Lambret Center
name: Philippe NICKERS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01918787: rTMS for Adults With Autistic Spectrum Disorder
Official title: Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Autism
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder

Detailed description: First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder. Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.

Eligibility criteria: Inclusion Criteria:

* adults with autistic spectrum disorder

Exclusion Criteria:

* schizophrenia
* bipolar affective disorder
* major depressive disorder
* any systemic disease especially epilepsy

Primary outcomes:
measure: continuous performance test
timeFrame: continuous performance test will be arranged before and after rTMS within one hour
Secondary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
Other outcomes:
measure: Autism Spectrum Quotient
timeFrame: Autism Spectrum Quotient will be evaluated before and after rTMS within one week
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital at Linkou, Taiwan
name: Hsing-Chang Ni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004287: Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-10-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.

Detailed description: PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially.

Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis diagnosed as follows: Sweat sodium or chloride greater than 60 mEq/L by pilocarpine iontophoresis or cystic fibrosis genotype Clinical manifestations Estimated 2-year survival greater than 50%, i.e.: FEV1 at least 30% of predicted PaO2 greater than 55 mm Hg on room air PaCO2 less than 50 mm Hg on room air --Prior/Concurrent Therapy-- At least 2 months since systemic glucocorticoids At least 90 days since participation in investigational therapeutic study --Patient Characteristics-- Pulmonary: No pneumothorax within 12 months No asthma or allergic bronchopulmonary aspergillosis requiring glucocorticoids within 2 months No sputum pathogens unless sensitive to at least 2 antibiotics No hemoptysis of more than 250 mL blood over 24 hours within 1 year Other: No active adenoviral infection Ad5 (or similar type) antibody seropositive No other contraindication to protocol participation, e.g.: Drug abuse Alcoholism Psychiatric instability Inadequate motivation Documented azoospermia (men) Bilateral tubal ligation or hysterectomy (women) Screening exams within 4 weeks prior to registration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: James M. Wilson
role: STUDY_CHAIR
References:
citation: Zuckerman JB, Robinson CB, McCoy KS, Shell R, Sferra TJ, Chirmule N, Magosin SA, Propert KJ, Brown-Parr EC, Hughes JV, Tazelaar J, Baker C, Goldman MJ, Wilson JM. A phase I study of adenovirus-mediated transfer of the human cystic fibrosis transmembrane conductance regulator gene to a lung segment of individuals with cystic fibrosis. Hum Gene Ther. 1999 Dec 10;10(18):2973-85. doi: 10.1089/10430349950016384.
Clinical trial NCT02026687: Recovery and Analgesia After Surgery for Gynecological Cancer
Official title: Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gynecological Cancer
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.


Eligibility criteria: Inclusion Criteria:

* Women with gynecological cancer (suspected or verified) planned for explorative laparotomy through a middle-line incision with a curative purpose.
* WHO performance status \< 2.
* American Society of Anesthesiologists class 1-2.
* Women that understand and can express themselves in Swedish.
* Women that after verbal and written information accept participation in the study and have signed an informed consent.

Exclusion Criteria:

* Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
* Women with contra indications for intrathecal or epidural anesthesia.
* Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
* Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the woman.
* Women with psychiatric or mental disorder that according to the responsible physician makes it unsuitable to participate in the study .

Primary outcomes:
measure: Length of Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Preoperatively and until 6 weeks after surgery
Other outcomes:
measure: Change in Pain
timeFrame: Day of surgery (day 0) until 6 weeks after surgery
Locations:
city: Linköping
country: Sweden
facility: University Hospital
Study officials:
References:
citation: Kjolhede P, Bergdahl O, Borendal Wodlin N, Nilsson L. Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial. BMJ Open. 2019 Mar 4;9(3):e024484. doi: 10.1136/bmjopen-2018-024484.
Clinical trial NCT01049087: Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
Official title: Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: plasma volume
technetium-labeled albumin
radioiodine-labeled albumin
Healthy volunteers
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to compare plasma volume determination by 99mTc-labeled albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that plasma volume determined by the different methods are the same.

Detailed description: For many years, radioiodinated albumin has been "the golden standard" for measurement of plasma volume. There are a number of clinical situations in which a nuclide with a shorter half-life would be preferred. Furthermore, due to periodic lapses in the availability in the delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for plasma volume determination.

99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high labeling efficiency and short half-life.

In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume is estimated from multiple postinjection samples for accurate zero-time extrapolation in order to correct for leakage of labeled albumin from the vascular compartment.

Eligibility criteria: Inclusion Criteria:

* BMI \< 27 kg/m2
* Written informed consent

Exclusion Criteria:

* Hypertension (140/90 mmHg)
* Diabetes mellitus
* Any use of medication
* Pregnancy

Primary outcomes:
measure: Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin
timeFrame: January 2011
Secondary outcomes:
measure: Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation
timeFrame: January 2011
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine
Study officials:
affiliation: Zealand University Hospital
name: Steen Levin, MD, DMSc
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Peter K Bonfils, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Knud H Stokholm, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03902587: Application of Cervical Elastography in Obstetrics
Official title: Application of Cervical Elastography in Obstetrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Elastography
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Winthrop University Hospital
First posted: 2019-04-04
Enrollment: 1000
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: Women who present for early screening or level II ultrasound, aged 18 to 50 years

Brief summary: The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.

During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.


Eligibility criteria: Inclusion Criteria:

* Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware

Exclusion Criteria:

* \>50 years old
* prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)

Primary outcomes:
measure: Number of preterm Births
timeFrame: 24 Months
Secondary outcomes:
measure: E-cervix indices
timeFrame: 18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: NYU Winthrop Hospital
name: Martin Chavez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05682287: The Effect of Radiofrequency of 448 kHz on Pain and Function
Official title: The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lumbago
Low Back Pain, Recurrent
Keywords: chronic low back pain
448kHz capacitive resistive monopolar radiofrequency
randomised controlled trial
pain
disability
Lead sponsor: University of Applied Health Sciences
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 62
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 goal of this trial is to compare the effects 448kHz capacitive resistive monopolar radiofrequency (CRM) with Proprioceptive Neuromuscular Facilitation (PNF) versus only PNF in chronic low back pain patients.

The main questions it aims to answer are:

1. Is there any difference in interventions on reduction of pain.
2. Is there any difference in interventions on reduction of disability.

Participants will in the experimental group will be treated with a combination of:

1. 448kHz capacitive resistive monopolar radiofrequency and,
2. PNF intervention

Participants will in the control group will be treated only using

1. PNF intervention (identical to experimental group)

Researchers will compare experimental and control group to see if there are differences in reduction of pain and disability.


Eligibility criteria: Inclusion Criteria:

* older than 18 years, chronic low back pain (CLBP)

Exclusion Criteria:

* spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy

Primary outcomes:
measure: Change from baseline: Pain - Visual Analogue Scale (VAS)
timeFrame: Change from baseline pain after two weeks (14 days).
measure: Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)
timeFrame: Change from baseline disability after two weeks (14 days).
Secondary outcomes:
measure: Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)
timeFrame: Change from baseline disability after two weeks (14 days).
measure: Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Change from baseline disability after two weeks (14 days).
Other outcomes:
Locations:
city: Varaždin
country: Croatia
facility: Polyclinic Cerebellum
state: Varaždinska
Study officials:
References:
Clinical trial NCT02545387: Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells
Official title: Hepatitis C Virus in Neutrophil Granulocyte Progenitor Cells
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cells and tissue from patients with chronic hepatitis C virus infection

Brief summary: Patients with hepatitis C show impaired neutrophil function. It is not known whether this is a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis C it is possible to see whether neutrophil granulocyte progenitors are already infected with hepatitis C.

Detailed description: Neutrophil granulocytes are important components of the innate immune system and pioneers in the fight against both fungal and bacterial infections. If pathogens enter the body, they are marked as foreign by antibodies and the complement system. Afterwards receptors on the neutrophils recognize and bind on these foreign substances to make them harmless. This process is called phagocytosis. Hepatitis C virus (HCV) and neutrophils are rarely associated. The HCV belongs to the Flaviviridae. It is a single-stranded, enveloped RNA virus with a positive polarity, which cause chronic hepatitis C (CHC) in approximately 170 million people worldwide. Subsequently, such an infection leads to liver cirrhosis and carcinoma in a significant proportion of patients. The virus infects mainly hepatocytes, but extrahepatic replication has also been shown. HCV usually enters the cell through receptor-mediated endocytosis (claudin-1, cluster of differentiation (CD)81, occludin and scavenger receptor 1), before it abuses the cell's own infrastructure for the viral protein synthesis.

The aim of this study is to determine neutrophil function in chronic hepatitis C infected patients. Furthermore the investigators want to examine if neutrophils or their precursor cells are infected with HCV and if this leads to their dysfunction.

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis C
* Genotype 1-4

Exclusion Criteria:

* acute hepatitis C

Primary outcomes:
measure: viral RNA
timeFrame: day 1
Secondary outcomes:
measure: neutrophil phagocytic capacity
timeFrame: day 1
measure: hepatitis C virus proteins
timeFrame: day 1
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Vanessa Stadlbauer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03173287: Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI
Official title: Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Fibrosis
MRI
IVIM
Liver Biopsy
Keywords: Hepatic fibrosis
IVIM
1.5T MRI
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.

Detailed description: Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method.

The main objective of this study is to show that the measured perfusion-related scattering value (D \*) is related to the hepatic fibrosis stage.

Secondary objectives

* Evaluation of infusion fraction (f) and fibrosis stage.
* Evaluation of molecular diffusion (D) and fibrosis stage.
* Evaluation of ADC and fibrosis stage.
* Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
* Signature of written consent

Exclusion Criteria:

* Contra-indications to MRI
* Refusal of protocol
* Underage patients and protected adults

Primary outcomes:
measure: Measured perfusion-related scattering value
timeFrame: at day 1
Secondary outcomes:
measure: Measured perfusion-related of infusion fraction
timeFrame: at day 1
measure: Measured perfusion-related of molecular diffusion
timeFrame: at day 1
measure: Measured perfusion-related of ADC
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Benoit MAGNIN
role: PRINCIPAL_INVESTIGATOR
References: