louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02594605: Applied The Platelet Rich Fibrin in Chronic Periodontitis
Official title: Investigation of the Contributions of Platelet Rich Fibrin Combined With Conventional Periodontal Flap on Periodontal Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.

Detailed description: PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.

Eligibility criteria: Inclusion Criteria:

* Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy

Exclusion Criteria:

* The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months

Primary outcomes:
measure: Levels of IGF-1, VEGF, BMP-2, FGF-2 on Weekly
timeFrame: 4 weeks
Secondary outcomes:
measure: Alteration of Clinical Attachment Level
timeFrame: 6 month
measure: Alteration of Periodontal Pocket Depth
timeFrame: 6 month
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Alper KIZILDAĞ
Study officials:
affiliation: Adiyaman University
name: Yasin ÇiÇEK
role: STUDY_CHAIR
References:
citation: Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. No abstract available.
citation: Kizildag A, Cicek Y, Arabaci T, Kose O. The effect of leukocyte-platelet-rich fibrin on bone morphogenetic protein-2 and insulin-like growth factor-1 levels in patients with chronic periodontitis: a randomized split mouth clinical trail. Growth Factors. 2018 Dec;36(5-6):239-245. doi: 10.1080/08977194.2018.1551217. Epub 2019 Jan 9.
Clinical trial NCT01034605: The Effect of PinnoThin on Satiety and Food Intake
Official title: The Effect of PinnoThin on Satiety and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy intake during an ad libitum lunch?


Eligibility criteria: Inclusion Criteria:

* age over 18 and under 45
* women
* BMI over 23 and under 30
* breakfast eaters

Exclusion Criteria:

* men
* age under 18 and over 45
* BMI under 23 and over 30
* use of medication
* pregnant and breastfeeding

Primary outcomes:
measure: appetite profile ratings
timeFrame: 10 timepoints
Secondary outcomes:
measure: energy intake
timeFrame: 3.5 hours after PinnoThin
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: NUTRIM
name: Klaas R Westerterp, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhoef SP, Westerterp KR. No effects of Korean pine nut triacylglycerol on satiety and energy intake. Nutr Metab (Lond). 2011 Nov 10;8(1):79. doi: 10.1186/1743-7075-8-79.
Clinical trial NCT02156505: Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
Official title: Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Outlet Obstruction Due to Malignancy
Keywords: stent
gastric outlet obstruction
restenosis
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea
First posted: 2014-06-05
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.


Eligibility criteria: Inclusion Criteria:

* Malignant gastric outlet obstruction
* Symptoms compatible with gastric outlet obstruction
* An inoperable condition because of extent of disease or patient's conditions

Exclusion Criteria:

* History of enteral stent placement, undergone gastric surgery.
* Additional small bowel stenosis distal to gastric outlet obstruction.
* Refuse to be enrolled to study.

Primary outcomes:
measure: The patency rate at 8 weeks after placement.
timeFrame: 8 weeks
Secondary outcomes:
measure: Technical and clinical success rates
timeFrame: up to 8 weeks
measure: re-stenosis rate
timeFrame: 8 weeks
measure: migration rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03912805: ET-01 in Subjects With Lateral Canthal Lines, LCL-209
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines, LCL
Crow's Feet
Lead sponsor: Eirion Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 38
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: vehicle controlled, parallel group
Primary purpose: TREATMENT

Brief summary: This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed description: This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.

Eligibility criteria: Inclusion Criteria:

* females 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet on contraction
* adequate vision to assess facial wrinkles in a mirror
* willingness to refrain from products affecting skin remodeling
* female subjects must be not pregnant and non-lactating
* subjects should be in good general health

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
timeFrame: Week 1, 2, 4, 8,12,18, and 26
measure: Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit
timeFrame: Week 1, 2, 4, 8,12,18, and 26
Other outcomes:
Locations:
city: Pinellas Park
country: United States
facility: Synexis, Inc.
state: Florida
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
References:
Clinical trial NCT00415805: Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent
Official title: A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Steno-occlusive Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.


Eligibility criteria: Inclusion Criteria:

* Known or suspected renovascular disease based on one of the following criteria:

  * severe hypertension
  * hypertension refractory to standard therapy
  * abrupt onset of moderate to severe hypertension at age \< 35 years
  * normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  * unexplained by stable elevation of serum creatinine \> 2Mg/dL
  * positive findings for stenosis from another imaging modality

Primary outcomes:
measure: Sensitivity and specificity compared to DSA
timeFrame: post dose
Secondary outcomes:
measure: accuracy and predictive values; inter-reader agreement for diagnostic performance
timeFrame: post dose
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Bracco Imaging, S.p.A
Study officials:
affiliation: Bracco Diagnostics
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03143205: Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
Official title: Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus Infection
Inflammation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.


Eligibility criteria: Inclusion Criteria:

* Provide evidence or documentation of HIV positive status (e.g. a letter of diagnosis or medication bottles with matched photo ID)
* Be English speaking
* Be able to consent
* Sexual activity with a man in the 3 years prior to initial contact or identification as gay or bisexual
* Not currently be enrolled in formal substance abuse treatment
* Report at least one occasion of drinking 5 or more drinks or of using an illicit substance in the previous 3 months, but not meet criteria for a severe substance use disorder.

Exclusion Criteria:

* Presence of a severe substance use disorder
* Presence of current symptoms consistent with schizophrenia or bipolar disorder, which would indicate that an intervention targeting these symptoms would be more appropriate.

Primary outcomes:
measure: Change in Gene expression
timeFrame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Secondary outcomes:
measure: Change in Substance Use
timeFrame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT03786705: Delta Shock Index in Predicting Massive Transfusion
Official title: The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Patients Received Blood Transfusion ≥ 10 U
Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 7957
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All hospitalized trauma patients aged 20 years and above from January 1, 2009 to December 31, 2016 from the registered trauma database of the hospital.

Brief summary: Background: To determine the performance of delta shock index (ΔSI), a change in shock index (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need for massive transfusion (MT) among adult trauma patients with stable blood pressure.

Methods: This study included data from all trauma patients aged 20 years and above who were hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered trauma database of the hospital. Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n = 7,875). The odds ratios with 95% confidence intervals for associated patient conditions and the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the patient's probability of receiving MT.


Eligibility criteria: Inclusion Criteria:

* Patients who were transferred by emergency medical service (EMS) from the field of accident and had a stable blood pressure (SBP ≥ 90 mmHg) at the ER were included

Exclusion Criteria:

* Patients who were transferred from other hospitals or arrived by private vehicles.
* Patients who had incomplete data
* Patients who had an unstable blood pressure (SBP \< 90 mmHg) upon arrival at the ER were also excluded

Primary outcomes:
measure: in-hospital mortality
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05432505: Ligamentum Teres Tenodesis in Developmental Dysplasia of the Hip
Official title: The Role of Ligamentum Teres Tenodesis in the Management of Developmental Dysplasia of the Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 60
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be examined for:

1. Length of both lower limbs in relation to each other.
2. Length of both lower limbs according to patient age.
3. Presence of hump related to the outer surface of the hip
4. Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views)

An addition to the steps of the open reduction, the following were done:

1. Identification of ligamentum teres
2. ligamentum teres tenodesis

Brief summary: The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.

Detailed description: it is an operative technique to secure the femoral head after reduction in cases of developmental dysplasia of the hip

Operative technique:

The surgery will be accomplished under a general anesthesia.

An addition to the steps of the open reduction, the following were done:

1. Identification of ligamentum teres
2. ligamentum teres tenodesis

Eligibility criteria: Inclusion Criteria:

* Patient with Developmental dysplasia of the hip (DDH) with :

  * Age: from 9 months -5 years old.
  * Virgin DDH.
  * Failed closed reduction in the management of DDH.
  * Failed open reduction through medial approach in the management of DDH

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Traumatic hip dislocation .
  * Age : below 9 months or above 5 years.
  * Refusal to participate in this study.

Primary outcomes:
measure: modified HHS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.
citation: Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.
Clinical trial NCT01930305: Effects of Heating Transfusion on Brain Function
Official title: Effects of Heating Transfusion on Brain Function of Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Transfusion
Keywords: Heating transfusion
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult paitents scheduled for major surgery.

Brief summary: To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.

Detailed description: Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury in animal experiments and in clinics.In a recent study, it has been shown that perioperative warming was associated with a higher incidence of cognitive dysfunction in elderly patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect on brain function of surgical patients.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure.

Exclusion Criteria:•Patients with a history of stroke, central nervous system disease , metabolic disturbance, psychiatric illness, hearing impairment, drug abuse or unwilling to participate in assessment

-

Primary outcomes:
measure: Brain fuction during perioperative period
timeFrame: Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour
Secondary outcomes:
measure: the cognitive performance and the score of postoperative quality recovery scales ( PQRS)
timeFrame: Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay
Other outcomes:
measure: serum concentration of inflammatory cytokine
timeFrame: change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: Ningxia Medical University
state: Ningxia
Study officials:
affiliation: Ningxia Medical University
name: Xinli Ni
role: STUDY_DIRECTOR
References: