louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02254928: Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders
Official title: Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: poor ovarian response
controlled ovarian stimulation
randomised clinical trial
corifollitropin alfa
recombinant follicle-stimulating hormone (rFSH)
human menopausal gonadotropin (HMG)
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
name: IVI Madrid
name: IVI Barcelona
First posted: 2014-10-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.


Eligibility criteria: Inclusion Criteria:

* Advanced maternal age (≥40 years)
* A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. antral follicle count \<5-7 follicles or anti-mullerian hormone level \<0.5-1.1 ng/ml)

Primary outcomes:
measure: Number of mature oocytes (metaphase II)
timeFrame: 1 year
Secondary outcomes:
measure: Total number of oocytes
timeFrame: 1 year
measure: Symptoms associated with the ovarian stimulation protocol
timeFrame: 1 year
measure: Patient perception of the stimulation treatment
timeFrame: 1 year
measure: Length of the stimulation treatment
timeFrame: 1 year
measure: Number of subcutaneous injections
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IVI Barcelona
city: Madrid
country: Spain
facility: IVI Madrid
city: Seville
country: Spain
facility: IVI Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT05887128: Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss
Official title: Accuracy of Extra-oral Bite-wing Radiography in Detecting Calculus and Crestal Bone Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periodontitis
Calculus, Dental
Bone Loss, Alveolar
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 40 individuals who are currently active patients at the University of Colorado School of Dental Medicine Graduate Periodontics Department. Intra-oral x-rays will be taken on examination, which is the standard of care. Patients who require periodontal surgery and have signed treatment plans to undergo the surgery will be asked to participate in the study. Extra-oral x-rays will be taken at that time, which is for research purpose. This is the same exposure as a panoramic x-ray, which is the standard of care to receive along with the intra-oral x-rays. Patients will be excluded if they have a recent panoramic x-ray.

Brief summary: To compare the diagnostic accuracy of extra-oral x-rays with intra-oral x-rays, in contrast to clinically observed measurements, for the detection of calculus and bone loss of either the suprabony or infrabony types in patients undergoing periodontal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients must be active patients of record at CU School of Dental Medicine
* Patients will have an active treatment plan for periodontal open flap surgery
* Patients will be classified as either ASA I or ASA II
* Patients must have periodontal probing depths \>/= 5mm and radiographic sings of marginal bone loss (supra or infra bony)

Exclusion Criteria:

* Less than 18 years of age
* ASA III or above
* Emergency patients
* Pregnant patients
* Patients who are not patients of record at the CU School of Dental Medicine
* Patients with a recent panoramic radiograph that contraindicates the need for new imaging in the form of extra-oral bitewings

Primary outcomes:
measure: Radiographic evidence of calculus
timeFrame: Baseline - Yes or No
measure: Radiographic measure of alveolar bone loss
timeFrame: Baseline - measured in mm
measure: Clinical evidence of calculus
timeFrame: Baseline - Yes or No
measure: Clinical measure of alveolar bone loss
timeFrame: Baseline - measured in mm
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado School of Dental Medicine Dental Clinic
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: William Carter, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717028: Functional Endoscopic Evaluation of Swallowing
Official title: Achados da avaliação videoendoscópica da deglutição em crianças Com Paralisia Cerebral.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Dysphagia
Keywords: Cerebral palsy
Dysphagia
Deglutition
Endoscopy
Lead sponsor: Fortaleza University
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cerebral palsy

Brief summary: The investigators objective is to describe functional endoscopic evaluation of swallowing findings in children with cerebral palsy.

Detailed description: Cerebral palsy (CP) is a predominantly motor disorder and dysphagia is a frequent complaint. Functional endoscopic evaluation of swallowing (FESS) involves anatomic and functional observation of the larynx and pharynx, evaluation of swallowing and maneuvers to improve it, also testing the laryngeal sensitivity. We evaluated nine patients with CP of both sexes, which age varied from 1 to 10 years old, attended at dysphagia multidisciplinary clinic, at NAMI (Integrated Medical Assistance Nucleons).

Eligibility criteria: Inclusion Criteria:

* medical diagnosis of cerebral palsy.

Exclusion Criteria:

* medical diagnoses not associated with cerebral palsy that affect swallowing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Dysphagia multidisciplinary clinic at Integrated Medical Assistance Nucleons
state: Ceará
Study officials:
affiliation: Fortaleza University
name: Renata Haguette, Mestre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572661: Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)
Official title: Mapping of Sentinel Lymph Node Drainage Using SPECT to Tailor Highly-Selective Elective Nodal Irradiation in Node-Negative Neck of Patients With Head and Neck Cancer (SUSPECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Radiotherapy, Sentinel Node Mapping, Spect
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
* No chemotherapy or surgery prior to inclusion
* No distant metastatic spread at the time of inclusion
* Age ≥ 18 years
* WHO performance status 0 or 1
* Signed written informed consent

Exclusion Criteria:

* Patients with previously radiation treatment in the head and neck region, for any reason
* Patients with previous neck dissection
* Patients with recurrent or second primary tumor in the head and neck region
* Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
* Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
* Pregnancy or no active contraception for pre-menopausal women
* Known hypersensitivity to iodine or nanocolloid injection
* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow up schedules

Primary outcomes:
measure: Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: the Netherlands Cancer Instiute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Abrahim Al-Mamgani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362061: 3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success
Official title: Thickness of the Junctional Zone Measured by 3D Ultrasound and Its Relation to the Success/Failure Implantation Rates in Assisted Reproduction Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: junctional zone
implantation
three D ultraosund
Assisted Reproductive Technology
Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ).

Brief summary: 100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.


Eligibility criteria: Inclusion Criteria:

* infertile women

Exclusion Criteria:

* congenital uterine anomalies medical disease contraindicating pregnancy

Primary outcomes:
measure: pregnancy rate
timeFrame: 14 days after evaluation
Secondary outcomes:
measure: healthy pregnancy
timeFrame: 6 weeks after pregnancy confirmation by pregnancy test
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed M Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800761: Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
Official title: Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Overload
Cardiomyopathy
Lead sponsor: Ospedale Microcitemico
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Locale di Cagliari
First posted: 2008-12-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myocardial iron overload is the leading cause of death in patients with beta-thalassemia major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces myocardial iron and improves cardiac function. However, the prognosis for TM patients with established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and 8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths, occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO is superior to DFO monotherapy.


Eligibility criteria: Inclusion Criteria:

Cardiomyopathy secondary to iron overload

Exclusion Criteria:

Heart failure

Primary outcomes:
measure: Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups
timeFrame: 42 months
Secondary outcomes:
measure: monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.
timeFrame: 42 months
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Adult Talassemic Center, Ospedale Microcitemico
state: Sardinia
Study officials:
affiliation: Department of Internal Medicine, University of Cagliari-Italy
name: Maria E Lai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00643461: Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Official title: Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2008-03-26
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Class V cavities

Brief summary: The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.


Eligibility criteria: Inclusion Criteria:

* Must be at least 19 years of age
* Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
* Must be willing to sign consent form
* Must be willing and able to return to UAB clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria:

* Current participation in other restorative product studies
* Severe salivary gland dysfunction
* Rampant caries (cavities)
* Chronic periodontitis (gum disease)
* Known allergies to the study materials
* Unacceptable level of oral hygiene
* Inability or unwillingness to attend study appointments

Primary outcomes:
measure: Retention of the restoration.
timeFrame: 6, 12, 24, 36 months post-placement
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham (UAB) School of Dentistry
name: John O Burgess, MS, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06085261: COPD: A Multi-center Supervised Tele-rehabilitation Study
Official title: Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
pulmonary rehabilitation
tele-rehabilitation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.


Eligibility criteria: Participants with a clinical diagnosis of and meeting the following criteria are eligible:

1. Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.
2. Motivated for participating in the project (and acceptance of randomization)
3. Sufficient mobility to attend PR

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications)
2. Severe cognitive disabilities (e.g. dementia)
3. Inability to cope with the program because of severe hearing or visual disorder.

Primary outcomes:
measure: 6-minute walk distance (6MWD)
timeFrame: 8 weeks; 20 weeks
Secondary outcomes:
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: pulmonary function
timeFrame: 8 weeks; 20 weeks
measure: Respiratory muscle strength
timeFrame: 8 weeks; 20 weeks
measure: Short Physical Performance Battery(SPPB)
timeFrame: 8 weeks; 20 weeks
measure: modified British medical research council(mMRC)
timeFrame: 8 weeks; 20 weeks
measure: COPD assessment test(CAT)
timeFrame: 8 weeks; 20 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 8 weeks; 20 weeks
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 8 weeks; 20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Shiwei Qumu, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03381261: (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Official title: Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: chronic migraine
trigeminal neuralgia
migraine surgery
nerve decompression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2017-12-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Detailed description: Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles
* Patient is capable and willing to provide informed consent
* Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox
* Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves.
* Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery.

Exclusion Criteria:

* Patient has hypersensitivity reactions or other intolerance to Botox
* Patient is pregnant or trying to become pregnant with the timeframe of the study.
* Infection at proposed injection sites.

Primary outcomes:
measure: Inflammatory Gene Expression in Chronic Migraine Patients With OnabotulinumtoxinA Injection Treatment Versus No Treatment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: William G. Austen, MD
role: PRINCIPAL_INVESTIGATOR
References: