louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03536260: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft
Official title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Placement in Maxillary Esthetic Zone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction.

After immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.


Eligibility criteria: Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site

Primary outcomes:
measure: Measurement of Crestal Bone Loss in grafted socket
timeFrame: 3 months after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry , Cairo university
Study officials:
References:
Clinical trial NCT03295760: Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
Official title: Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cyclic Vomiting Syndrome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 15
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome

Brief summary: The main purpose of this study is the comparison of frequency of vomiting episodes (number of episodes per year) observed during the year after the begin of Q10 coenzyme treatment to frequency observed during the year before the begin of this treatment in children with cyclic vomiting syndrome.

Secondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.


Eligibility criteria: Inclusion Criteria:

* Cyclic vomiting syndrome as defined by Rome IV criteria
* Treated with Q10 coenzyme treatment for cyclic vomiting syndrome
* Q10 coenzyme treatment started between January 2000 and July 2006

Exclusion Criteria:

- Refusal of processing of personal data reported in patient medical files

Primary outcomes:
measure: Frequency of vomiting episodes
timeFrame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
measure: Frequency of vomiting episodes
timeFrame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Secondary outcomes:
measure: Intensity of vomiting episodes
timeFrame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
measure: Intensity of vomiting episodes
timeFrame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
measure: Number of child hospitalizations
timeFrame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
measure: Number of child hospitalizations
timeFrame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
measure: Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome
timeFrame: baseline
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Children's Hospital - CHRU de Nancy
Study officials:
References:
Clinical trial NCT06797960: Ultrasound Guided Intra Articular Injection of Platelet Rich Fibrin Versus Hyaluronic Acid As Means of Pain Relief in Patients with Moderate Degree Knee Osteoarthritis
Official title: ANALGESIC EFFECT of ULTRASOUND GUIDED INTRA- ARTICULAR INJECTION of PLATELET RICH FIBRIN VERSUS INJECTION of HYALURONIC ACID in PATIENTS with MODERATE KNEE OSTEOARTHRITIS. a RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomised controlled trial


Eligibility criteria: Inclusion Criteria:

* ASA I, II.
* Moderate knee osteoarthritis

Exclusion Criteria:

* Neurological patients.
* Patients with uncontrolled co morbidities

Primary outcomes:
measure: Pain relief as measured by VAS score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03224260: To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.


Eligibility criteria: Inclusion Criteria:

* Participants must be first-generation Japanese (born in Japan and not living outside of Japan for \> 10 years; both parents must be ethnically Japanese)
* Body Mass Index 18.0 to 25.0 kg/m2, inclusive
* Women must not be of nonchildbearing potential (cannot become pregnant)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History or evidence of abnormal bleeding or coagulation disorder

Other protocol defined inclusion and exclusion criteria apply

Primary outcomes:
measure: Occurrence of Death
timeFrame: 30 days after last dose
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: 30 days after last dose
measure: Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy
timeFrame: 17 days
measure: Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding
timeFrame: 17 days
measure: Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)
timeFrame: 17 days
measure: Change from baseline in electrocardiogram findings (ECGs)
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
References:
Clinical trial NCT06595160: Association of Plant-based Diet and Gut Microbiome Signature with Response to Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma
Official title: Exploring the Relationship Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Ductal Adenocarcinoma
Stage I Pancreatic Cancer AJCC V8
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-09-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.

Brief summary: This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients.

II. Evaluate the association between pre-treatment HEI-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients.

III. Evaluate the association between pre-treatment HEI-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients.

OUTLINE: This is an observational study.

Patients complete a dietary survey and undergo fecal sample collection on study.

Eligibility criteria: Inclusion Criteria:

* \* Age ≥ 18 years with signed informed consent form

  * Patients must have a histological diagnosis of PDAC
  * Resectable or borderline resectable PDAC on imaging

Exclusion Criteria:

* \* Patients with locally advanced and metastatic stage IV PDAC

  * Patients who have already received or completed neoadjuvant chemotherapy for PDAC
  * Patients with active malignancy receiving systemic therapy

Primary outcomes:
measure: Fecal microbiome alpha diversity
timeFrame: Through study completion, an average of two years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Mihir M Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01642160: Continous Positive Airway Pressure (CPAP) Compliance Study
Official title: ICAN (Improvement in CPAP Adherence Via the Net) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.


Eligibility criteria: Inclusion Criteria:

* Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.

Exclusion Criteria:

* Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder

Primary outcomes:
measure: change in mean number of nursing interventions at one month
timeFrame: baseline to one month after initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784860: Effects of Intravenous Lidocaine During Sedation for Colonoscopy.
Official title: Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: colonoscopy
lidocaine
propofol
sedation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.

Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)

Detailed description: The potential benefits of lidocaine infusion will be tested on:

* propofol consumption (primary outcome)
* intraoperative respiratory depression
* time for patient recovery
* postoperative fatigue
* postoperative pain
* postoperative cognitive dysfunction

Eligibility criteria: Inclusion Criteria:

* colonoscopy without gastroscopy

Exclusion Criteria:

* lidocaine allergy
* epilepsy
* severe heart rhythm disorders
* renal failure with creatinine clearance lower than 30ml/minute

Primary outcomes:
measure: Consumption of propofol
timeFrame: intraoperative
Secondary outcomes:
measure: Episodes of oxygen desaturation
timeFrame: intraoperative
measure: Time for recovery
timeFrame: intraoperative
measure: Quality of working conditions assessed by the gastroenterologist
timeFrame: intraoperative
measure: Abdominal discomfort
timeFrame: intraoperative and 15 minutes later
measure: Postoperative fatigue
timeFrame: 15 min after sedation
measure: Cognitive condition
timeFrame: 15 minutes after sedation
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: University of Liege
name: Jean Joris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.
Clinical trial NCT05283460: The Effect of Mandala Activity on Life Satisfaction
Official title: The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ART
Life Satisfaction
Gynecologic Cancer
Keywords: Gynecologic Cancer
Life satisfaction
Mandala
Lead sponsor: Munzur University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized controlled prospective double-blind clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.

Detailed description: Data will be collected using the descriptive information form and the Life Satisfaction Scale.

Eligibility criteria: Inclusion Criteria:

* Receiving chemotherapy
* No communication problems
* Having at least 6 months of cancer diagnosis
* Being in Stage 2 and Stage 3 of the disease

Exclusion Criteria:

* Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.
* Being in Stage 1 and Stage 4 of the disease.

Primary outcomes:
measure: Life satisfaction scale mean
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Life satisfaction scale mean
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Munzur University
state: Merkez
Study officials:
affiliation: Munzur Ünivesitesi
name: Nursel A Dal, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04001660: Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
Official title: Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.


Eligibility criteria: Inclusion Criteria:

* Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review

Exclusion Criteria:

* Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness

Primary outcomes:
measure: visual analog scale (VAS) scores
timeFrame: postoperative 6month
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Baoqiang Song
state: Shan XI
Study officials:
References:
Clinical trial NCT02640560: One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
Official title: One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: Children
Allergy
Peanuts
Hazelnuts
Walnuts
Mollusks
Shellfish
Food
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 Italian children with or without food allergy

Brief summary: In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.

Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).

Parent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).

Parent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.


Eligibility criteria: Inclusion criteria

* Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
* Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.

Exclusion criteria

* Patients/subjects in acute phase of disease or with not controlled chronic pathologies;
* missing written informed consent by parents

Primary outcomes:
measure: Frequency of Anaphylaxis in 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: