louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03966378: Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
Official title: Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.

Detailed description: The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.

These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.

This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

Eligibility criteria: Inclusion Criteria:

* Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.

Exclusion Criteria:

* Severe or active periodontal disease.
* Patients had received therapeutic irradiation to the head and neck region.
* Patients had participated in a clinical trial within 6 months before commencement of this trial.
* Patients unable to return for recall appointments
* Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
* Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.

Primary outcomes:
measure: Quantitative changes of white spot lesions
timeFrame: evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05448378: Evaluation of D-chiro-inositol Treatments
Official title: Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inositol
Testosterone
Insulin
Ovulation
Asprosin
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Human healthy women
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.


Eligibility criteria: Inclusion Criteria:

* Good state of health;
* Regular menstrual cycle.

Exclusion Criteria:

* pregnancy;
* delivery in the previous 6 months;
* currently breastfeeding;
* menopause;
* alcohol or drug abuse;
* insulin resistance defined as HOMA-IR index greater than or equal to 2.5;
* other medical morbidities, such as hypertension, PCOS, or diabetes;
* oligomenorrhea or amenorrhea;
* current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin);
* use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.

Primary outcomes:
measure: Testosterone
timeFrame: 30 days
Secondary outcomes:
measure: BMI
timeFrame: 30 days
measure: Glycemia
timeFrame: 30 days
measure: Insulinemia
timeFrame: 30 days
measure: HOMA-IR index
timeFrame: 30 days
measure: FSH
timeFrame: 30 days
measure: LH
timeFrame: 30 days
measure: Estradiol
timeFrame: 30 days
measure: DHEAS
timeFrame: 30 days
measure: Asprosin
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: ASL Civitavecchia
state: Lazio
city: Roma
country: Italy
facility: ALMA RES
state: Lazio
Study officials:
References:
Clinical trial NCT03617978: Passive Leg Raise During Cardiopulmonary Resuscitation
Official title: Impact of Passive Leg Raise on Hemodynamic Effect: A Randomized Crossover Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Elevation
Hemodynamic Instability
Cardiopulmonary Resuscitation
Keywords: cardiopulmonary resuscitation
hemodynamic
medical simulation
leg elevation
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2018-08-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: during cardiopulmonary resuscitation, an important element of the procedure is to achieve optimal organ perfusion. For this purpose, high quality chest compressions is one of the basic elements of the procedure. however, similarly as in the case of hypovolemic shock, elevation of the lower limbs may be helpful. The study is a randomized cross-over study and includes the effect of lower limb elevation on hemodynamic parameters in healthy participants.


Eligibility criteria: Inclusion Criteria:

* healthy participants
* voluntary informed consent

Exclusion Criteria:

* hip injury during the six months preceding the examination
* back pain
* kidney damage

Primary outcomes:
measure: Cardiac output - CO
timeFrame: during procedure
Secondary outcomes:
measure: Stroke Volume - SV
timeFrame: during procedure
measure: thoracic fluid content - TFC
timeFrame: during procedure
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Faculty of Medicine, Lazarski University
state: Masovian
Study officials:
References:
Clinical trial NCT06412978: Post-Operative Cesarean Section Cosmesis
Official title: Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Delivery
Keywords: cosmetic improvement
surgical correction
Cosmesis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: trial comparing skin closure with absorbable subcuticular staples with subcuticular suture
Primary purpose: SUPPORTIVE_CARE

Brief summary: Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Detailed description: Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.

Eligibility criteria: Inclusion Criteria:

* Age 18-44
* Any race
* Any parity
* Scheduled cesarean section
* Neuraxial analgesia

Exclusion Criteria:

* Non-English Speaking
* Incarcerated
* Maternal Connective Tissue Disorder
* Systemic maternal steroid use
* Three prior cesarean deliveries
* Body Mass Index (BMI) \>40

Primary outcomes:
measure: scar cosmetic score
timeFrame: Week 6
Secondary outcomes:
measure: Number of Wound complications
timeFrame: Week 6
measure: length of hospital stay
timeFrame: Week 6
measure: amount of in-hospital intravenous opiate analgesic use
timeFrame: Week 6
measure: amount of in-hospital oral NSAID analgesic use
timeFrame: Week 6
measure: amount of in-hospital oral opiate analgesic use
timeFrame: Week 6
measure: patient rated subjective pain score
timeFrame: Week 6
measure: patient's overall satisfaction with cosmesis scores
timeFrame: Week 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joshua F Nitsche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02939378: Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
Official title: Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: ketogenic diet
recurrent glioblastoma
chemotherapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro.

Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.

Detailed description: Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth.

In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group.

The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Eligibility criteria: Inclusion Criteria:

1. Age 18-60
2. Karnovsky Performance Score of 60 or more.
3. histologically confirmed glioblastoma multiforme, grade 4
4. Ability and willingness to signed informed consent form.
5. Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
6. normal function of liver and kidney

Exclusion Criteria:

1. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
2. History of uncontrolled hyperlipidemia or hyperglycemia.
3. History of human immunodeficiency virus, or hepatitis C
4. Pregnancy or breastfeeding
5. Inability or unwillingness of subject to give written informed consent

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Effects
timeFrame: one year
Secondary outcomes:
measure: The Chemosensitivity of Tumor
timeFrame: one year
measure: Overall Survival
timeFrame: one year
measure: Ketosis
timeFrame: one year
measure: Quality of Life
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Song Lin, M.D.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668278: I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation
Official title: I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Supraglottic airway
I-gel
Laryngeal mask
Controlled ventilation
Peak airway pressure
Seal pressure
Anaesthesia
Surgery
Lead sponsor: Northern Health and Social Care Trust
Sponsor class: OTHER_GOV
Collaborators: name: Antrim Area Hospital
First posted: 2008-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.

Hypothesis

There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.

\*as defined by peak airway pressure and sealing pressures.


Eligibility criteria: Inclusion Criteria:

* Males and females.
* Age 18-89 inclusive.
* ASA grade 1-2.
* Elective surgery

Exclusion Criteria:

* Emergency surgery.
* Surgery within the peritoneum.
* Surgery requiring prone or steep head-down positioning.
* Patients at increased risk of aspiration

Primary outcomes:
measure: Sealing pressure and peak airway pressure.
timeFrame: Under anaesthesia.
Secondary outcomes:
measure: Postoperative patient symptoms
timeFrame: 1hr and 24hrs postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom
name: William J Donaldson, MBBS FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669278: Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy
Official title: Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Otorhinolaryngologic Diseases
Keywords: sheath
flexible
endoscopy
otolaryngology
office
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.

Detailed description: Methods: Randomized, single-blinded, controlled trial

Setting: Office practice of two academic otolaryngologists at a community hospital.

Primary Outcomes: Patient pain and discomfort, Optical quality

Secondary Outcomes: Physician and nursing staff satisfaction

Cost-analysis

Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy

Eligibility criteria: Inclusion Criteria:

* Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy

Exclusion Criteria:

* Known sinonasal masses or nasal polyposis
* Unable to complete VAS surveys
* Significant septal deviation
* Unable to tolerate in-office flexible nasopharyngoscopy
* Patients who refuse consent

Primary outcomes:
measure: Patient pain and discomfort
timeFrame: 1 hour
Secondary outcomes:
measure: Physician and staff satisfaction
timeFrame: 1 week
measure: Optical quality
timeFrame: 1 hour
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Dr. Allan Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949778: Quadratus Lumborum Block for Abdominoplasty
Official title: Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Abdominoplasty
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Classification Status (ASA) I-II
* Age 18 to 64
* Weight above or equal to 60 kg
* Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
* Patient is expected able to cooperate during the treatment and follow up.
* Signed informed consent obtained and documented according to the International Conference on Harmonization (ICH) good clinical practice (GCP), and national/local regulations.

Exclusion Criteria:

* A history of anaphylactic shock
* Cardiovascular disease other than hypertension and/or hyperlipidemia
* Known allergy to ropivacaine or morphine
* A history of chronic pain
* Psychiatric comorbidity
* Scheduled opioid pain medication or neuroleptic drugs
* Coagulation disorders or treatment with platelet inhibitors
* Pregnancy or breastfeeding
* Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine
* Any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Vestre Viken HT, Baerum Hospital
Study officials:
affiliation: Vestre Viken HT, Baerum Hospital
name: Thor Wilhelm Bjelland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747378: Finding Patterns In Clinical Trial Experiences of Patients With Eczema
Official title: An In-depth Study Assessing Eczema Patients Experiences in Medical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eczema
Keywords: Eczema
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with eczema who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.

Eczema clinical trial patients help us identify these factors by sharing trial experiences during the course of the observational medical study.

This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future eczema patients who are considering participating in a clinical study.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with eczema
* Patient is 18 years old
* Patient has self-identified as planning to enroll in an observational clinical study

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Patient is pregnant
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Number of patients who decide to enroll in a clinical trial for eczema.
timeFrame: 3 months
measure: Rate of patients who remain in an eczema clinical trial to completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor MB, Garaiova I, Plummer SF, Wang D, Morgan G. Probiotics in the prevention of eczema: a randomised controlled trial. Arch Dis Child. 2014 Nov;99(11):1014-9. doi: 10.1136/archdischild-2013-305799. Epub 2014 Jun 19.
citation: Sawangjit R, Dilokthornsakul P, Lloyd-Lavery A, Lai NM, Dellavalle R, Chaiyakunapruk N. Systemic treatments for eczema: a network meta-analysis. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD013206. doi: 10.1002/14651858.CD013206.pub2.
citation: Spada F, Harrison IP, Barnes TM, Greive KA, Daniels D, Townley JP, Mostafa N, Fong AT, Tong PL, Shumack S. Recruitment of adults with moderate eczema for a randomised trial: Comparison of traditional versus modern methods. Australas J Dermatol. 2021 Nov;62(4):e510-e515. doi: 10.1111/ajd.13699. Epub 2021 Sep 3.
Clinical trial NCT01348178: Retrospective Follow-up Study After Periacetabular Osteotomy in Adults
Official title: Retrospective Follow-up Study After Periacetabular Osteotomy in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Deformity of Hip Joints
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 401
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent PAO from 1999-2007

Brief summary: This is a retrospective study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following Periacetabular Osteotomy (PAO).

Detailed description: Even though the PAO is applied worldwide and is the preferred joint preserving treatment some issues remains unclear and controversial. One is the exact indication for surgery and risk factors for early failure of the procedure. The is a retrospective cohort study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following PAO. The minimum duration of follow-up is 2 years. Failure following PAO is defined by a WOMAC pain score \> 10 or the insertion of a total hip arthroplasty.

Eligibility criteria: Inclusion Criteria:

* PAO from 1999-2007

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Research Unit, Aarhus University Hospital
name: Kjeld Soballe, Prof. D.Msc
role: STUDY_CHAIR
affiliation: Orthopedic Research Unit, Aarhus University Hospital
name: Charlotte Hartig-Andreasen, MD
role: PRINCIPAL_INVESTIGATOR
References: