louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06548685: Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing
Official title: Vegetable Ivory Bone Material Study to Evaluate Whether a Biobased Natural Vegetable Ivory Formulation Can Produce Similar or Better Results Compared to Current Standard Bone Healing Treatments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Volume
Keywords: Vegetable Ivory Bone Material
Lead sponsor: Dentivia, LLC
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.

Detailed description: The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.

Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.

Eligibility criteria: Inclusion Criteria:

Have parallel sites from which teeth have been extracted

Exclusion Criteria:

They are not a candidate for bone grafting or a dental implant

Primary outcomes:
measure: Number of participants with completely healed bone graft surgical site
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St Joseph's Hospital, Syracuse
name: Pasquale Scutari, D.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449085: Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
Official title: Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cardiac Arrhythmias
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Royal Adelaide Hospital
name: Melbourne Health
First posted: 2007-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.

Detailed description: To construct geometric representation of the heart chambers using intracardiac ultrasound.The Carto™ XP Electrophysiology (EP) Navigation System v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing any EPS study and or Ablation will be eligible for this study.

Age 18 years or older Signed Patient Informed Consent Form

Exclusion Criteria:

* Patients with inadequate vascular access

Patients with any of the following criteria will be excluded:

* Women who are pregnant

  * Age \<18 years
  * Any Contraindication to the clinical procedure
  * Sepsis
* Major coagulation abnormalities
* Presence of any intracardiac thrombus
* Unstable angina
* Uncontrolled Heart failure
* Deep Vein Thrombosis
* Significant peripheral vascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Royal Adelaide Hospital
name: Prashanthan Sanders, MBBS,PhD,FRCACP
role: STUDY_DIRECTOR
affiliation: Melbourne Health
name: Jonathan Kalman, MBBS,PhD,FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02859285: A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
Official title: Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Arousal
Orgasm
Clitoral
Estradiol
Post Menopausal
Lead sponsor: ProHealth Care, Inc
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.


Eligibility criteria: Inclusion Criteria:

* Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction

Exclusion Criteria:

* Not sexually active with a partner or an arousal device
* Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
* Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
* Allergic to estradiol
* Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
* Spanish speaking

Primary outcomes:
measure: 19 point validated Female Function Index.
timeFrame: Baseline then change over time at week 4,8,12
Secondary outcomes:
measure: 36 point RAND health survey.
timeFrame: Baseline then change over time at week 4,8,12.
Other outcomes:
measure: 10 point Likert scale
timeFrame: Baseline then change over time at week 4,8,12.
Locations:
city: Waukesha
country: United States
facility: Waukesa Memorial Hospital
state: Wisconsin
Study officials:
affiliation: ProHealth Care, Inc
name: Sarit Aschkenazi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02100085: Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation
Official title: A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia 3
Keywords: Phase 1 follow up
Cervical Intraepithelial Neoplasia
Adult
Safety
Efficacy
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 9
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects who have completed the DNA vaccine administration of each dosage (1, 2 and 4 mg).

The subjects in the period less than 48 weeks after the final administration of GX-188E

Brief summary: This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

Detailed description: This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.

Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.

Eligibility criteria: Inclusion Criteria:

* Female aged between 20 and 50 (inclusive)
* The subjects who have visited within 48 weeks after final injection of GX-188E
* Those who voluntarily signed informed consent form

Exclusion Criteria:

* Prior participation in any clinical trial within 30 days prior to the visit 1
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Primary outcomes:
measure: The change of the immune response compared to that of the final visit in phase I study
timeFrame: at week 0 to 180 every 6 months
Secondary outcomes:
measure: The change of the involved lesion and HPV infection status
timeFrame: at week 0 to 180 every 6 months
measure: Safety profile
timeFrame: at week 0 to 180 every 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
state: Korea
Study officials:
affiliation: Cheil General Hospital & Women's Healthcare Center
name: Tae Jin Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427085: Changes of Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery
Official title: Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic gynecological surgery

Exclusion Criteria:

* Ophthalmic diseases
* Previous history of ophthalmic surgery.
* Neurological disorders
* History of head surgery.

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: 30 minutes after pneuroperitoneum in the Trendelenburg position
Secondary outcomes:
measure: Optic nerve sheath diameter
timeFrame: 15 minutes after pneuroperitoneum in the Trendelenburg position
measure: Optic nerve sheath diameter
timeFrame: 60 minutes after pneuroperitoneum in the Trendelenburg position
measure: Optic nerve sheath diameter
timeFrame: 10 minutes after release of pneumoperitoneum and return to the supine position
measure: Optic nerve sheath diameter
timeFrame: At 1 hour after completion of surgery
measure: Optic nerve sheath diameter
timeFrame: At 24 hours after completion of surgery
measure: Nausea and vomiting
timeFrame: At 1 hour after completion of surgery
measure: Headache
timeFrame: At 1 hour after completion of surgery
measure: Nausea and vomiting
timeFrame: At 24 hours after completion of surgery
measure: Headache
timeFrame: At 24 hours after completion of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT03780985: Post-placental Intrauterine Device Insertion During Cesarean Section
Official title: Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device Migration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.Intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum Intrauterine device because it does not require a separate postpartum visit.

Advantage of post-placental Intrauterine device insertion, Intrauterine devices are recommended as first-line contraceptives by the American Academy of Pediatricians. The Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for Contraceptive Use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of Intrauterine devices.


Eligibility criteria: Inclusion Criteria:

1. Age group : 18-40 years
2. Women who will be willing to undergo elective cesarean section
3. women desire using Copper IUD as long acting contraceptive method.

Exclusion Criteria:

1. Intrauterine infection.
2. Fundal Myoma.
3. Hemorrhagic disorder
4. Genital tract malignancy
5. Uterine atony
6. Sexually transmitted infection.

Primary outcomes:
measure: Number of displaced intrauterine device after insertion in both groups
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT06552585: Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers
Official title: Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Injury;Sports
Sports Physical Therapy
Keywords: Swimmer's shoulder
Elastic band program
Weight program
Shoulder rotators
Injury prevention
Swimming
Lead sponsor: School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Sponsor class: OTHER
Collaborators: name: University of Coimbra
name: Instituto Politécnico de Leiria
First posted: 2024-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Care provider and participants blinded, parallel, randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to verify the effectiveness of two 12-week preventive exercise programs for swimmer's shoulder with monitoring and progression over time, on the peak torque and respective conventional concentric ratio and functional ratio. One of these programs was performed with weights and the other with an elastic band. This study hypothesized that the two preventive exercise programs minimize shoulder rotators imbalanced during the swimming season. The study design is a care provider and participants blinded, parallel, randomized controlled trial


Eligibility criteria: Inclusion Criteria:

* Competitve swimmer in the current season.
* Aged between 16-35 years old.
* Have a minimum of 5 years of experience in national competitions.
* Performed a minimum of 8 hours of weekly swimming training.

Exclusion Criteria:

* Subjects who had performed at least 6 weeks of treatment such as physical therapy, injections, and medication.
* Clinical situations such as a history of significant shoulder pain in the last 6 months, a history of traumatic shoulder injuries such as fractures, subluxations, cervical or thoracic conditions, previous shoulder surgeries, shoulder range of motion deficits, or neurological injuries.

Primary outcomes:
measure: Peak torque
timeFrame: 12 weeks
Secondary outcomes:
measure: Conventional concentric external/internal shoulder rotators ratio
timeFrame: 12 weeks
measure: Functional eccentric external/concentric internal shoulder rotators ratio
timeFrame: 12 weeks
measure: Time to peak torque
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Instituto Politécnico de Coimbra - RoboCorp
Study officials:
affiliation: Instituto Politécnico de Leiria
name: Maria António Castro, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06297785: Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)
Official title: Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: Gut-directed hypnotherapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity.

Detailed description: IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Eligibility criteria: Inclusion Criteria:

* IBS diagnosis

Exclusion Criteria:

* Organic GI disease

Primary outcomes:
measure: Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS)
timeFrame: Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Mag-Tarmlab, Sahlgrenska University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Magnus Simrén
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06513637: 12 Lead ECG Database
Official title: 12-Lead ECG Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arrhythmias, Cardiac
Lead sponsor: Huxley Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will receive the same treatment; there are no groups or cohorts that receive different treatments. Study populations at each site will be enrolled from patients, site personnel, or the general population. Recruitment may, from time to time, target enrichment of a particular demographic, subject characteristic, or cardiac arrhythmia to increase the diversity and representation of the database.

Brief summary: The purpose of this investigation is to collect a database of simultaneous electrocardiogram (ECG) recordings from the SANSA device and a reference 12-lead ECG recording device.

The purpose of this database is to aid development and evaluation of algorithms to detect cardiac arrhythmias and other parameters from the electrocardiogram. Example analyses that may utilize this database are ECG vector transformations and ECG waveform timing analyses.

The study is for scientific purposes and does not intend to diagnose, cure, mitigate, treat, or prevent any disease and does not involve any medical procedures.


Eligibility criteria: Inclusion Criteria:

* are 18 years of age or older.
* are able to read, understand, and sign informed consent documentation.
* are willing to undergo simultaneous recordings with the Sansa and 12-lead ECG device.

Exclusion Criteria:

* exhibit deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would interfere with sensor placement
* have broken or injured skin that would interfere with sensor placement
* are known to experience adverse reactions to medical-grade adhesive
* are pregnant

Primary outcomes:
measure: No specified primary endpoint
timeFrame: Subjects will participate in a single visit. Subjects will be considered enrolled upon signing the informed consent. The entire duration of enrollment is expected to be less than one hour and no more than six hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00566137: Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient
Official title: Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Pulmonary Hypertension
Keywords: Scleroderma
Pulmonary Hypertension
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males, Females and Minorities

Age range of subjects 18-75 years old

Brief summary: To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma patient with Pulmonary Hypertension.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Patient must have Scleroderma

Exclusion Criteria:

* Patients who do not have Scleroderma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwell Health
name: Arunabh Talwar, MD
role: PRINCIPAL_INVESTIGATOR
References: