louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04066270: Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
Official title: Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Sensorineural
Bilateral Vestibular Deficiency
DFNA9
Radiology
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -all patients with severe hearing loss who are eligible for cochlear implantation who do not carry the p.P51S mutation in COCH and are at least 18 years of age

Brief summary: In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.


Eligibility criteria: Inclusion Criteria:

* must be eligible for cochlear implantation
* must be 18 years of age or older

Exclusion Criteria:

* \<18 years of age
* not eligible to undergo vestibular tests, especially videonystagmography
* contra-indication for MR or CT

Primary outcomes:
measure: CT/MR of SCC
timeFrame: at time of recruitment
measure: p.P51S
timeFrame: at time of recruitment
Secondary outcomes:
measure: audiometry
timeFrame: at time of recruitment
measure: vestibular function 1
timeFrame: at time of recruitment
measure: vestibular function 2
timeFrame: at time of recruitment
measure: vestibular function 3
timeFrame: at time of recruitment
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References:
Clinical trial NCT05857670: Psyco Quality of Life and Procreation BRCA1/2
Official title: Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Genetic Predisposition
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with BRCA1/2 mutation

Brief summary: Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. BRCA1/2 mutations are inherited as an autosomal dominant manner and therefore there is a 50% probability of transmitting the mutation to the progeny. For this reason, women who have BRCA 1/2 mutation may be less likely to want children than those who test negative. The decision to have children could worry both for the probability to transfer the genetic mutation or because the parenthood could be compromised by the illness and/or by premature death. In previous studies, the psychological condition of patients with BRCA 1/2 mutations, with or without children, was only partially investigated. For this reason the main goal of the study is to deeply investigate the specific psychological condition, with particular attention to the guilt feelings on the possibility to transfer the genetic mutation to the progeny. In this wai it could be useful to development a therapeutic strategies aimed at the best adaptation of the patients to the new health condition.


Eligibility criteria: Inclusion Criteria:

* Women with BRCA1/2 mutation affected or not by breast neoplasm
* Women with BRCA1/2 mutation affected or not by breast neoplasm and with at least a son/daughter
* Women with at list middle school diploma
* Women available to do interviews

Exclusion Criteria:

* Women with other oncological pathology
* Women with cognitive deficient and/or inability to comply to the requirements of the study

Primary outcomes:
measure: Evaluation of feeling guilting
timeFrame: 24 monts
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
city: Varese
country: Italy
facility: Università dell'Insubria
Study officials:
References:
Clinical trial NCT02151370: An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer
Official title: Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with Advanced FIGO Stage (IIIb to IV) Ovarian Epithelial Cancer with measurable residual disease after surgery

Brief summary: This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.


Eligibility criteria: Inclusion Criteria:

* Female patients over 18 years of age
* Histologically confirmed Advanced Epithelial Ovarian Cancer
* Confirmed ascites prior to surgery
* Residual disease after surgery
* Patients are chemotherapy naïve or have received only one prior line of treatment for their disease
* International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2
* Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy.

Exclusion Criteria:

* Pregnancy or lactation
* Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection
* Uncontrollable hypertension
* Unexplained bleeding
* Known hypersensitivity to any components of bevacizumab
* All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.

Primary outcomes:
measure: The proportion of patients who require paracenthesis during treatment with Avastin
timeFrame: 72 weeks
measure: The amount of ascitic fluid extracted during treatment with Avastin
timeFrame: 72 weeks
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 72 weeks
measure: To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy
timeFrame: 72 weeks
measure: To determine regional epidemiologic data for the studied population
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Salvador
country: El Salvador
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00609570: Nutritional Supplements on Blood Pressure 2008
Official title: Effects of Nutritional Supplements on Blood Pressure and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Keywords: hypertension
supplement
HRV
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Three different supplements will be used in the study (fruits and vegetable powders, whey protein and calcium) for patients with hypertension. The null hypothesis was that the supplements had no effects on participants' blood pressure.

Detailed description: Hypertensive participants will be randomly assigned into three groups. The first group of participants will take the fruits and vegetable powders mixed with water. The second group takes whey protein and the third group takes calcium pills. Blood pressure and heart rate variability will be measured every two weeks for three months.

Eligibility criteria: Inclusion Criteria:

* Age 20-70
* Hypertensive male and female subjects.

Exclusion Criteria:

* Severe cardiovascular and renal conditions.
* Pregnancies and taking medications.

Primary outcomes:
measure: Blood pressure and HRV
timeFrame: every two weeks for three months
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
city: Chesterfield
country: United States
facility: Logan University
state: Missouri
Study officials:
affiliation: Logan University
name: John Zhang, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00479570: Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
Official title: Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Sexual Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 23
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.


Eligibility criteria: Inclusion Criteria:

* Women who have evidence of Female Sexual Arousal Disorder.
* Women who experience personal distress due to Female Sexual Dysfunction.
* Post menopausal women aged between 45 and 65 years.

Exclusion Criteria:

* Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
* Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
* Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.

Primary outcomes:
measure: Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.
timeFrame: From day of dosing until 7 days post-dose
Secondary outcomes:
measure: Assess effect of single doses on medium term (1 week) sexual arousal and interest.
timeFrame: Until 7 days post-dose
measure: Assess variability of response and repeatability of design between 2 similar doses.
timeFrame: Comparison of response to be assessed until 7 days post dose
measure: If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.
timeFrame: Day of dosing
measure: Assess PK , safety and toleration on day 1 of each study period.
timeFrame: Day of dosing
Other outcomes:
Locations:
city: Kobenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Danderyd
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02520570: Post-market Safety Reassessment of Ulinastatin for Injection
Official title: Post-market Safety Reassessment of Ulinastatin for Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Reaction to Drug
Lead sponsor: Techpool Bio-Pharma Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Center for ADR Monitoring of Guangdong
First posted: 2015-08-13
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ulinastatin treated

Brief summary: 1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.
3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

Detailed description: In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.

Eligibility criteria: Inclusion Criteria:

* Patients with ulinastatin treated

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: participants will be followed for the duration of using ulinastatin, an expected average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Center for Adverse Drug Reaction Monitoring of Guangdong
name: Jin Li, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747370: Dynamic MRI of the Behaviour of Female Pelvic Floor
Official title: The Suitability of Dynamic MRI for Pelvic Floor, Bladder Neck and Midurethra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stress Urinary Incontinence
Genital Prolapse
Keywords: stress urinary incontinence
Tension free vaginal tape
tension free vaginal tape obturator
genital prolapse
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2008-09-05
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study was to test the suitability of dynamic magnetic resonance imaging for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress incontinent patient and in women with genital prolapse.

Detailed description: Traditional methods for evaluation of urinary incontinence in women include urodynamics, cystourethroscopy, cystourethrography and ultrasonography.Magnetic resonance imaging (MRI) offers a new tool for evaluation of morphology and function of the urogenital compartment of the female pelvis. Moreover, MRI gives opportunity to study function of the pelvic floor organs in terms of mobility and reactions during different physiological and provocative activities.

The aim of the present study was by means of dynamic MRI to evaluate the behaviour of the mid-urethra, bladder neck, cervix and rectum in different maneuvers in three different study groups. Sixteen healthy volunteers with no complaints of urinary symptoms or urogenital prolapses, 42 stress urinary incontinence patients and 16 women with third degree genital prolapse were examined respectively.

Eligibility criteria: Inclusion Criteria:

* healthy women without any urogenital symptoms
* stress urinary incontinence ( group II )
* genital prolapse of third degree ( group III)

Exclusion Criteria:

* previous incontinence or prolapse surgery
* lower urinary tract anomaly
* current UTI or \> 3 UTI episodes within the past year
* previous radiation therapy of the pelvis
* active malignancy
* neurogenic disease which can be associated with bladder disorders
* patient unable to understand the purpose of the study
* patient immobile

Primary outcomes:
measure: The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Department of Gynecology and Radiology, Kuopio University Hospital
Study officials:
References:
Clinical trial NCT01315470: Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients
Official title: Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Infertility
Keywords: improving pregnancy rate and endometrial thickness
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.

Detailed description: The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (\<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.

Eligibility criteria: Inclusion Criteria:

1. women after 5 failures in IVF cycles with cause unknown.
2. women after 5 failures in IVF due to thin endometrium (\<6 mm) and unresponsive to estrogen supplements.

Exclusion Criteria:

1. history of hematology disease
2. allergy to GCSF
3. neutrophilia
4. severe lower back pain
5. liver dysfunction
6. hyperuricemia
7. a recent febrile disease or pneumonia
8. rheumatoid arthritis 9. sickle cell disease-

Primary outcomes:
measure: pregnancy rate
timeFrame: 18 months
Secondary outcomes:
measure: endometrial thickness during IVF treatment
timeFrame: 18 months
measure: endometrial thickness
timeFrame: 18 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem
Study officials:
name: einat zivi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398670: Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics
Official title: Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type I Diabetes
Keywords: Type I Diabetes
Wockhardt's Insulin analogue Lispro
Humalog®
Humalog Mix
Wockhardt
Biosimilar
Phase 3
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus

Detailed description: To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

Eligibility criteria: Inclusion Criteria:

1. Patients who understand the nature of the study and are willing to provide written informed consent.
2. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
3. Male or Female Patients ≥ 18 and \< 55 years of age.
4. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2
5. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
6. Ability to use the self glucose-monitoring device and to self inject insulin.

Exclusion Criteria:

1. Females who are pregnant or lactating, or not practicing adequate contraception.
2. A Patient with compromised hepatic or renal function
3. A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
4. A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
5. A Patient with history or evidence of allergy to insulin preparations.
6. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
7. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
8. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Percentage change in the immunogenic response
timeFrame: 6 months
measure: Correlation of the immunogenicity with hypoglycemia
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wockhardt
name: Dr.Rasendrakumar Jha
role: STUDY_DIRECTOR
References: