louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05683041: Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Official title: Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myoma
Keywords: Postoperative adhesions
Intrauterine adhesions
Myomectomy
Laparoscopic myomectomy
Laparotomic myomectomy
Adhesion prevention
Antiadhesion method
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Nordic Pharma SAS
First posted: 2023-01-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.
Primary purpose: PREVENTION

Brief summary: Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.

Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

Detailed description: Design:

Double-blind, randomized controlled pilot trial.

Participant:

* age between 18 and 45 years.
* intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
* absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy

Treatment:

Application of intrauterine Hyalobarrier® gel endo at time of surgery

Control:

No application of Hyalobarrier® gel endo

Follow up:

Second-look hysteroscopy after 3months

To blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 45 years.
* intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
* absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy

Exclusion Criteria:

* pregnancy.
* laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
* presence of endometritis.
* other antiadhesion methods

Primary outcomes:
measure: Adhesion formation postoperatief.
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Severity of adhesion formation
timeFrame: 3 months post surgery, at the time of the hysteroscopy.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT00158041: Subcutaneous Amifostine Safety Study
Official title: Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Cancer
Lung Cancer
Lymphoma
Keywords: Amifostine
Mucositis
Nausea
Hypotension
Rash
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
Collaborators: name: MedImmune LLC
First posted: 2005-09-12
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.


Eligibility criteria: Inclusion Criteria:

* Institutional criteria for administration of amifostine
* Radiation therapy
* ECOG PS of at least 2
* No distant mets
* Granulocyte count greater than 2000
* Platelet count greater than 100,000
* Creatinine less than 2.0

Exclusion Criteria:

* Allergy to amifostine
* Life expectancy less than 6 mos
* Investigational drug within last 4 weeks

Primary outcomes:
measure: Incidence of nausea/vomiting
measure: Incidence of hypotension
measure: Incidence of generalized skin rash
measure: Incidence of injection-site skin toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center
state: Florida
Study officials:
affiliation: Mt. Sinai Medical Center
name: Michael A Samuels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002041: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Official title: Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Esophageal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Esophagitis
Acquired Immunodeficiency Syndrome
Amphotericin B
Candidiasis, Oral
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.

Concurrent Medication:

Excluded:

* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.

Patients with the following are excluded:

* Documented Candida fungemia.
* Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
* Patient refusal to enter study.

Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.

* Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
* Informed consent must be signed and obtained.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol - Myers Squibb Co
state: New Jersey
Study officials:
References:
Clinical trial NCT02651441: D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)
Official title: Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: D-CIK
lung cancer
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
First posted: 2016-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

Detailed description: 60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Eligibility criteria: Inclusion Criteria:

* The patient who have singed the informed consent;
* Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
* Expected survival time is more than 2 month;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Patients who are suffering from serious organ dysfunction;
* Patients who are suffering from other cancer;
* Other situations that the researchers considered unsuitable for this study.

Primary outcomes:
measure: Progress-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Quality of life (QOL)
timeFrame: 3 years
measure: Phenotypic analysis of T cells
timeFrame: 1 year
measure: Severity of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Tumor Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
name: Zhi Z Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171441: Microvascular Reactivity in Prepubertal Children
Official title: Microcirculation, Adiposity, and Traditional and Emerging Cardiovascular Risk Factors in Prepubertal Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Only
Obesity
Endothelial Dysfunction
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Eliete Bouskela
First posted: 2017-05-31
Enrollment: 98
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-two obese (26 girls/26 boys), 18 overweight (13 girls/5 boys), and 28 eutrophic or lean prepubertal children (14 girls/14 boys) aged between 5 and 10 years (mean 7.44 ± 1.22 years) were consecutively selected from our pediatric endocrinology outpatients unit at the Pedro Ernesto University Hospital assessed in a cross-sectional study.

Brief summary: This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal children according to adiposity status.

Detailed description: The investigators aimed to investigate microvascular reactivity in prepubertal and to compare these data in different groups according to adiposity status. Firstly, The investigators recruited only children from 5 to 10 years at prepubertal status. After excluding those with exclusion criteria and the acceptance (from their parents) to participate in the study, a blood sample was collected and an appointment at BioVasc lab was programmed. At this day, participants were subject to nail fold videocapillaroscopy. A method used to investigate microvascular reactivity by a non-invasive mean. After this, participants children were followed to the outpatient's care unit to continue follow-up.

Eligibility criteria: Inclusion Criteria:

children aged from 5 to 10 years at prepubertal Tanner´s status

Exclusion Criteria:

* puberty
* regular use of any medication
* hypertension
* heart disease
* renal and blood diseases .the presence of any acute or chronic inflammatory/infectious diseases. .presence of diabetes mellitus.

Primary outcomes:
measure: Microvascular reactivity by nail fold videocapillaroscopy
timeFrame: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Secondary outcomes:
measure: Multivariate analysis using Canonical Discriminant analysis
timeFrame: 24 months from the beginning of the recruitment period until the ending of the manuscript.
measure: Inflammatory and biochemical biomarkers
timeFrame: 24 months from the beginning of the recruitment period until the ending of the manuscript.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00971841: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer
Official title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.


Eligibility criteria: Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).

Primary outcomes:
measure: Number of Adverse Events (AEs) Per Participant
timeFrame: Weekly Day 1 to 4 years
Secondary outcomes:
measure: Number of Participants With Complete Response to Tumor
timeFrame: Every 7 weeks Day 1 to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01563341: Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Official title: Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Deep Brain Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.


Eligibility criteria: Inclusion Criteria:

* All patients will be enrolled from the practice of the primary investigator.
* Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
* All patients will have responsivity to levodopa.
* Individuals with normal or mild cognitive impairment.

Exclusion Criteria:

* Clinically significant dementia
* Other significant neurological or psychiatric disease
* Previous brain surgery including pallidotomy or thalamotomy
* Previous placement of other implantable devices

Primary outcomes:
measure: Change in Memory Testing From Presurgical Baseline to 12 Months
timeFrame: baseline, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Ryan Uitti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00774241: PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer
Official title: An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* male and female patients, \>=18 years of age;
* stage IV, HER2 negative metastatic breast cancer;
* candidate for taxane-based therapy;
* ECOG performance status 0-2.

Exclusion Criteria:

* prior chemotherapy for metastatic breast cancer;
* concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
* suspicion of CNS metastasis;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Response rate, median progression free survival, overall survival
timeFrame: Event driven
Secondary outcomes:
measure: Adverse events
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00749541: Vitamin d Levels and Coronary Catheterization
Official title: 25 Hydroxy Vitamin d Levels in Patients Undergoing an Elective Coronary Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: vitamin d coronary catheterization
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing an elective coronary catheterization over the age of 18.

Brief summary: decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels.

decreased levels were also found to be connected to increased cardiovascular mortality.

we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d.

we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.


Eligibility criteria: Inclusion Criteria:age

* \>18 years,
* no known ihd

Exclusion Criteria:

* renal failure ,
* medications including vitamin d, calcium ,phosphate
* hyper or hypoparathyroidism,
* abnormal calcium or phosphate values,
* known pathological coronary catheterization.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Mc
Study officials:
affiliation: assaf harofeh mc
name: renana shor, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105441: Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
Official title: Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Unilateral Sensorineural Hearing Loss
Keywords: cochlear implant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adults and children over 7 years of age who have suffered single sided deafness. Word understanding on the impaired side must not exceed 50% correct in the best aided condition.

Brief summary: Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.

Detailed description: Unilateral hearing loss is known to impair binaural hearing abilities. Specifically, localization, speech understanding in noise, and binaural squelch suffer due to lack of binaural timing and level cues. This study is designed to examine how binaural hearing is improved following cochlear implantation on the impaired side. The study endpoints are collected at 6 months and 12 months post activation of the implant.

This is not a funded study. All costs are billed through insurance for reimbursement. There is an insurance approval process that we move through after a participant has been evaluated at the Mayo Clinic and found to be a candidate for cochlear implantation.

Eligibility criteria: Adults

* 18 years of age or older,
* Hearing loss in the ear to be implanted must such that speech understanding is not possible with a well fitted hearing aid. Specifically, less than 40% monosyllabic word understanding when that ear is tested in the best-aided condition and the other ear is sufficiently occluded or masked.
* Onset of hearing loss in the adult group must be post-lingual (after three years of age)

Children

* Children 7 years of age and older
* Hearing loss in the ear to be implanted configured such that word understanding is less 40% in the best aided condition
* Onset of hearing loss in the pediatric group must be post-lingual (after three years of age)

Primary outcomes:
measure: Listening Effort
timeFrame: one year post operative test time
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew L Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References: