louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03888079: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
Official title: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otosclerosis
Otosclerosis Surgery
Keywords: Otosclerosis
otosclerosis surgery
local anesthesia
general anesthesia
comfort assessment
Glasgow Benefit Inventory questionnaire
hearing results
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from otosclerosis who have surgical indication

Brief summary: Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

Detailed description: The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.

All operations will be performed by the same surgeon and the same basic surgical technique.

The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .

Eligibility criteria: Inclusion criteria:

* Patients older than 18 years suffering from otosclerosis who have surgical indication.
* Patients who want surgical treatment for their otosclerosis
* Clinic : Deafness with social prejudice and normal otoscopic exam
* Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB.
* Pré operative scan in favor of otosclerosis
* Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window

Exclusion criteria:

* History of ear surgery
* No medical objection to local anesthesia
* No medical objection to general anesthesia
* No medical objection to ear surgery
* No legal protection for adults
* No participation refusal

Primary outcomes:
measure: Visual comfort scale (EVA type ruler)
timeFrame: 10 days after surgery
Secondary outcomes:
measure: Glasgow Benefit Inventory questionnaire GBI
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Benoit Godey, PH-PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702779: Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Patients Ventilated More Than 48 h
Stable Respiratory and Hemodynamic Conditions for SBT
Consent of Patients
Arterial Line
Keywords: Weaning from mechanical ventilation
Lung ultrasound
Oxygen inhalation therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
First posted: 2012-10-08
Enrollment: 80
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: This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

Detailed description: Prospective randomized clinical multicentric study on ICU (Intensive Care University) comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound Score during weaning from mechanical ventilation

Eligibility criteria: Inclusion Criteria:

* Adult patients ventilated more than 48 h
* Stable respiratory and hemodynamic conditions for SBT
* Consent of patients
* Arterial line

Exclusion Criteria:

* COBP
* Laryngeal dyspnea
* Tracheostomy
* Arythmya
* No echogenicity
* Paraplegia \>T8

Primary outcomes:
measure: variations of lung ultrasound score
timeFrame: 24 hours after extubation
Secondary outcomes:
measure: Lung ultrasound score
timeFrame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
measure: rates of patients with postextubation distress
timeFrame: during the 48th post-extubation
measure: Electrical Impedance tomography
timeFrame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
measure: Epithelial and endothelial biomarkers
timeFrame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477879: Hsv 1 and 2 Gowey Protocol Versus Placebo
Official title: Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Herpes
Lead sponsor: Naturopaths International
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.

Detailed description: Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.

Eligibility criteria: Inclusion Criteria:

- Hsv 1\&2

Exclusion Criteria:

* No active lesions

Primary outcomes:
measure: Pain
timeFrame: 2 weeks
measure: Size
timeFrame: 2 weeks
Secondary outcomes:
measure: Appearance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Naturopaths international
state: Arizona
Study officials:
References:
Clinical trial NCT03118479: Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
Official title: Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypogonadotropic Hypogonadism
Kallmann Syndrome
Keywords: IHH
KS
Idiopathic hypogonadotropic hypogonadism
GnRH deficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).

The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
* mean testosterone level less than 300 ng/dl
* stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
* normal serum TSH
* normal serum prolactin levels

Exclusion Criteria:

* Type 2 diabetes mellitus
* history of diabetes in parents
* sleep apnea
* bleeding disorder
* seeking fertility
* 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.
* history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
* illicit drug use/alcohol use (\>4 drinks per day)

Primary outcomes:
measure: Change in glucose tolerance
timeFrame: Change between baseline and 3 months
measure: Change in insulin sensitivity
timeFrame: Change between baseline and 3 months
Secondary outcomes:
measure: Change in visceral fat
timeFrame: Change between baseline and 3 months
measure: Change in resting energy expenditure
timeFrame: Change between baseline and 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nelly Pitteloud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05141279: Accuracy Of Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy
Official title: Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients who will attend to outpatient surgical and oncology clinicS of Assiut university and diagnosed by biopsy as breast cancer

Brief summary: The aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients

Detailed description: This a prospective series ,will be performed for 50 patients diagnosed by biopsy as breast cancer who will be scheduled for surgery after completing the full coarse of neoadjuvant chemotherapy

Eligibility criteria: Inclusion Criteria:

* patient confirmed diagnosed by early breast cancer decided to received neoadjuvant treatment
* locally advanced breast cancer
* operable metastatic breast cancer

Exclusion Criteria:

* patient not candidate for NAC
* contrast allergy
* renal impairment
* pregnancy

Primary outcomes:
measure: Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients
timeFrame: Basline
Secondary outcomes:
measure: Assess best imaging modalities in pedict post neoadjuvant response
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01808079: Gene Analysis in Studying Susceptibility to Wilms Tumor
Official title: A Genome-Wide Association Study in Wilms Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Childhood Kidney Neoplasm
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-11
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tissue Bank

Brief summary: This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding genetic markers for Wilms tumor may help identify patients who are at risk of relapse.

Detailed description: PRIMARY OBJECTIVES:

I. To use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to Wilms tumor.

II. To improve our understanding of the genetic architecture and etiology of Wilms tumor.

III. To facilitate the identification of genetic markers that are associated with an increased risk of developing of Wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring.

OUTLINE:

Samples are analyzed for single nucleotide polymorphism (SNP) profiling using real-time polymerase chain reaction (PCR) and multiplex ligation-dependent probe amplification (MLPA).

Eligibility criteria: Inclusion Criteria:

* 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)

Primary outcomes:
measure: Frequencies between cases and controls at each SNP
timeFrame: Baseline
measure: Frequency of maternal and paternal allelic transmission for risk alleles
timeFrame: Baseline
measure: Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity
timeFrame: Baseline
measure: Interactions between genetic variation and treatment success or prognosis
timeFrame: Baseline
measure: Interactions between germline genetic variation and tumor phenotypes
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Paul Grundy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529579: Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Pancreatic Ductal
Keywords: adoptive Cellular Immunotherapy
patient safety
therapeutic effect
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: ImmunoGene Biotechology Co.,Ltd
First posted: 2015-08-20
Enrollment: 187
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: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Advanced Pancreatic cancer patients with histological pathology confirmation
2. Both gender, aged 18-70 year-old
3. Bone marrow functioned well
4. Renal function normal
5. Liver function normal
6. patients are voluntary, and willing to sign informed consent
7. expected lifetime was at least 3 months

Exclusion Criteria:

1. With acute inflammation
2. Accompanied with primary malignant tumor other than pancreas
3. with autoimmune disease
4. using corticosteroid or other suppress immune hormone treatment
5. had transplant operation of vital organs
6. active hepatitis
7. HIV positive
8. dysfunction in blood coagulation
9. serious diseases in circulatory and respiratory systems
10. pregnancy or breast-feeding women

Primary outcomes:
measure: 6-month SR
timeFrame: 6 months
Secondary outcomes:
measure: PFS
timeFrame: 6 months
measure: OS
timeFrame: 6 months
measure: ORR
timeFrame: 2 months
measure: QOL
timeFrame: 2 months
Other outcomes:
measure: immunological markers
timeFrame: 2 months
measure: Serum tumor biomarker
timeFrame: 2 months
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hosptial,Second Military medical University
name: Zhaoshen Ii, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562679: Coronary Artery Disease and Sleep Apnea
Official title: Long Term Effects of Sleep Apnea in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Patients with coronary artery disease
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: Norrländska Hjärtfonden
name: Jämtland County Council, Sweden
First posted: 2007-11-22
Enrollment: 408
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patiens with coronary artery disease beeing referred for evaluation of coronary intervention

Brief summary: The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995.


Eligibility criteria: Inclusion Criteria:

* Men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.

Primary outcomes:
measure: Stroke, death, acute myocardial infarction
timeFrame: 10 years from date of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Cardiology
Study officials:
affiliation: Dept Medicine, Östersund Hospital, Östersund
name: Thomas Mooe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valham F, Mooe T, Rabben T, Stenlund H, Wiklund U, Franklin KA. Increased risk of stroke in patients with coronary artery disease and sleep apnea: a 10-year follow-up. Circulation. 2008 Aug 26;118(9):955-60. doi: 10.1161/CIRCULATIONAHA.108.783290. Epub 2008 Aug 12.
Clinical trial NCT06663579: The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
Official title: The Effect of Kangaroo Care Method On The Self-Confıdence and Attachment Levels of Fathers of Preterm Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attachment Disorder
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 56
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit.


Eligibility criteria: Inclusion Criteria:

For Newborns:

* Being a newborn treated in the Istanbul Başakşehir Çam and Sakura Hospital Neonatal Intensive Care Unit
* Gestational age less than 37 weeks
* Postnatal age between 0-28 days
* The baby is considered stable by a neonatologist
* The baby can maintain body temperature during Kangaroo Care
* Safety is ensured if there is an existing umbilical or central catheter

For fathers:

* Agreeing to practice Kangaroo Care
* Having no health condition that would prevent practicing Kangaroo Care
* Being able to maintain sufficient hygiene conditions for Kangaroo Care
* Being literate
* Being able to communicate in Turkish

Exclusion Criteria:

For babies:

* Receiving respiratory support
* Having a chest tube
* Having a congenital anomaly
* Using sedative medication
* Having undergone surgery

For fathers:

* Not wanting to practice Kangaroo Care
* Using substances that cause sedation (drugs, alcohol)
* Having a disease that can be transmitted through skin contact
* Not agreeing to participate in the study
* Not living in the same house as the baby

Primary outcomes:
measure: Paternal-Infant Attachment Scale
timeFrame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
Secondary outcomes:
measure: Karitane Parenting Confidence Scale
timeFrame: This assessment scale will be administered to the father one month following the baby's discharge from the hospital.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References:
Clinical trial NCT00232479: Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer
Official title: Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-10-04
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Detailed description: Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Eligibility criteria: Inclusion Criteria:

* HER-2 overexpressing breast cancer
* Clinical stage 2-3B
* Normal ejection fraction

Exclusion Criteria:

* Metastatic disease
* Low ejection fraction

Primary outcomes:
measure: Number of Patients With Pathologic Complete Response (pCR)
timeFrame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: from the first dose of chemotherapy until surgery which was approximately 16 weeks.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Judith Hurley
role: PRINCIPAL_INVESTIGATOR
References: