louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03670485: To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
Official title: A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: stroke
cervical spinal cord injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to validate the 4ch NMES device.

Detailed description: * Design: Prospective study
* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
* Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"
* Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

Eligibility criteria: Inclusion Criteria:

* patient who do not belong to the criteria excluded for subjects aged 19 years or older
* Patient who is confirmed to be dysphagia by videofluoroscopy
* Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
* Those voluntarily agreeing to the clinical trial

Exclusion Criteria:

* Patient who refuse inspection, do not agree
* Simple "Commend obey", first step is impossible
* When instructions can not be executed due to dementia, psychiatric disorders, etc.
* Dysphagia occurs due to respiratory failure, neck surgery, etc.,
* Pregnant women and lactating women

Primary outcomes:
measure: The Modified Barium Swallow Impairment Profile (MBSImP™©)
timeFrame: Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Bundang
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jusuk Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03338985: Role of Senescence in the Development of Endometrial Cancer
Official title: Role of Senescence in the Development of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Hyperplasia and Endometrial Cancers
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).

A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

Detailed description: make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.

Eligibility criteria: Inclusion Criteria:

* patient with endometrial hyperplasia or endometrial cancer
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery

Primary outcomes:
measure: Genetic imbalances
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT00872885: Bunionectomy Trial With GRT6005
Official title: A Randomized, Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Moderate to Severe Pain Following Bunionectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Operative Pain
Keywords: analgesic
bunionectomy
surgery
post operative pain
single Hallux valgus repair
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).


Eligibility criteria: Inclusion Criteria:

* Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

Exclusion Criteria:

* Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
* Concomitant inflammatory disease.
* Life-long history of seizure disorder or epilepsy.
* Subjects with impaired renal function
* Subjects with impaired hepatic function
* Female subjects who are pregnant or breastfeeding.
* Resting pulse rate is \<50bpm or \>100 bpm after 5 minutes rest in supine position
* resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is \<100mmHg or \>140 mmHg Diastolic blood pressure is \<60 mmHg or \> 90 mmHg

Primary outcomes:
measure: Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
timeFrame: 8 hours
Secondary outcomes:
measure: Amount of rescue medication
timeFrame: 24 hours
measure: Adverse events
timeFrame: 24 hours
measure: Time to first rescue medication
timeFrame: 24 hours
measure: Patient Global Impression of Change
timeFrame: 24 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research Group Ltd
state: Texas
Study officials:
affiliation: Grünenthal GmbH
name: John Bothmer, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02183285: Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential
Official title: A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets


Eligibility criteria: Inclusion Criteria:

* Healthy female out-patients of child-bearing potential
* Ages ranging between 18 and 40 years
* Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study

Exclusion Criteria:

* Contraindications to the use of any of the trial ingredients
* Known hypersensitivity to any of the ingredients
* Alcohol- or drug-addiction
* Currently participation in another trial, or has participated in a trial within the previous 30 days
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
* Already taking other mult-vitamin products during the last 2 weeks

Primary outcomes:
measure: Incidence of total drug-related adverse events assessed by the investigator
timeFrame: up to 30 days
Secondary outcomes:
measure: Incidence of all adverse events
timeFrame: up to 30 days
measure: Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)
timeFrame: up to 44 days
measure: Changes from baseline in vital signs (blood pressure and heart rate)
timeFrame: up to 30 days
measure: Overall tolerability assessed by the subject and the investigator on a four-point rating scale
timeFrame: day 30
measure: Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale
timeFrame: day 30
measure: Tolerability of the trial medications by the subject
timeFrame: up to 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03674385: Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
Official title: Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Keywords: Vitamin E
Polycystic ovary
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
First posted: 2018-09-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled open label study
Primary purpose: TREATMENT

Brief summary: This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only.

Detailed description: Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

Vit E is used in treatment of pco due its anti-oxidant effect.

Eligibility criteria: Inclusion Criteria:

1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
2. Age between 18 and 39 years.
3. Period of infertility \>1 years.
4. No treatment taken during the last 2 months.
5. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

Exclusion Criteria:

1. History of pelvic surgery or infertility factor other than anovulation
2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
5. Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%).
6. Elevated serum prolactin, T.S.H and F.S.H.
7. Patients diagnosed with diabetes mellitus

Primary outcomes:
measure: ovulation rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Medical Center of Infertility
Study officials:
References:
Clinical trial NCT01105585: A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00
Official title: A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Cataracts
aspheric
IOL
ocular aberrations
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.


Eligibility criteria: Inclusion Criteria:

* Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
* Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
* \<1 diopter corneal astigmatism preoperatively;
* Able to achieve 6.5 mm dilated pupil;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Chronic disease or illness;
* Irregular optical aberration;
* Amblyopia;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
* Diabetic retinopathy;
* Macular degeneration;
* History of retinal detachment;
* Other surgeries planned at time of cataract removal;
* Severe dry eye;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Total ocular high-order aberrations
timeFrame: Month 1 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01249885: Implications of Pacifier Use in Israeli Children
Official title: Observational Study - Pacifier Use in Israeli Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crossbite
Openbite
Drooling
Keywords: pacifier sucking
children
occlusion
drooling
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 children

Brief summary: The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.

Detailed description: Pacifier study protocol

* The study will take place in children day care centers in Jerusalem and "HaSharon" area.
* First step = Receiving an approval from the Children's parents and the day care management for the research.
* Next step = Examine a total of 400 children who use a pacifier, with a dental mirror in regular lighting condition.
* The procedure is short, no need of repetition or tracing and without any side effects or discomfort.

Part 1- a short questionnaire of demographic background- will be answered by the parents:

1. Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father...)
2. Social economic status - mother's education, place of residence, number of children in the family.
3. Child's personal details -gender, age, number of siblings
4. Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier.
5. Child's Dental condition- drooling, cross bite, open bite.
6. Parents' Awareness of pacifier's effect on mouth development.
7. Parents' approval for child examination. Part 2- clinical- visual examination for identification of relevant findings

1. Child's pacifier type. 2. Dental clinical examination performed in a lightened room:

* Diagnosis of caries- data will be written in a chart.
* Diagnosis of malocclusion- open bite or cross bite 3. Diagnosis of drooling from mouth corners which indicates malocclusion. Redness or dryness around lips and chin can imply drooling.

Eligibility criteria: Inclusion Criteria:

* healthy children aged 3-4 years that use a pacifier

Exclusion Criteria:

children suffering from a chronic or developmental disease that can affect the orofacial region

* finger sucking children children suffering from low muscle tonus, abnormal drooling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah MO
name: Hadas Katz-Sagi, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah MO
name: Diana Ram, DMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04215185: Data Collection of BP Values by CS6BP
Official title: Prospective Open Study for the Development of CS6BP Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: CardiacSense Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-anaesthetized subjects in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) with arterial line placement in the radial artery.
Primary purpose: OTHER

Brief summary: The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.

Detailed description: The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well.

The study will include up to 80 subjects.

The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.

Eligibility criteria: Inclusion Criteria:

* Age of eighteen (18) year and above
* Ability and willingness to sign an informed consent form
* Monitored by radial arterial line

Exclusion Criteria:

* Subjects with hemodynamic support
* Subjects receiving more than 2-3 l of fluid per 24h
* Subjects with septic shock
* Subjects with distal edema
* Subjects with arms trauma, where the watch is not wearable
* Subjects where the radial artery could not be palpate
* Subjects with life expectancy of less than 24h.
* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
* Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)

Primary outcomes:
measure: Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events
timeFrame: measurement time (up to 24 hours)
measure: Collection of data from CardicacSense1BP measurements for algorithm development
timeFrame: measurement time (up to 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center
name: Adi Nimrod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604485: A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
Official title: A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Hyperinsulinism
Keywords: Hypoglycemia
Congenital Hyperinsulinism
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 10
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: The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of congenital hyperinsulinism
* Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
* Can safely washout of background medications used to treat hyperinsulinism.

Exclusion Criteria:

* Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
* Body Mass Index ≥ 35 kg/m2
* Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
* Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 42 days
measure: Change from baseline in glucose levels as measured using a continuous glucose monitor
timeFrame: 42 days
measure: Fasting and post prandial blood glucose levels
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
city: London
country: United Kingdom
Study officials:
affiliation: XOMA (US) LLC
name: Allan Gordon, MD, PhD
role: STUDY_DIRECTOR
References: