louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03997578: Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
Official title: Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: a Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Bone Loss
Periodontal; Lesion
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.

Primary outcomes:
measure: Probing pocket depth (PD)
timeFrame: 12 months
measure: Clinical attachment level (CAL)
timeFrame: 12 months
measure: Recession (REC)
timeFrame: 12 months
measure: Location of the tip of the papillae (TP)
timeFrame: 12 months
measure: Keratinized tissue width (KT)
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References:
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
Clinical trial NCT00375778: Parkinson's Disease Evaluated by PET and the Effect of Memantine
Official title: Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Positron Emission Tomography
Memantine
NMDA antagonists
Cerebral Blood Flow
Cerebral Metabolic Rate of Oxygen
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2006-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission Tomography (PET).

Background: Disturbances in brain metabolism is thought to contribute to degeneration of neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can theoretically be alleviated by memantine.

Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active. Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence and this can be detected by PET.


Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease (British Brain Bank Criteria)
* Age 50-70y

Exclusion Criteria:

* Tobacco use
* Any serious medical conditions (Heart disease, kidney disease, liver disease, endocrinological disorders etc)
* Metal implants contraindicating MR scan
* Drug use affecting the central nervous system
* Psychiatric disorders
* Head trauma or any disorders of the head, skull or brain
* Drug addiction or use of any kind of illegal substance affecting the central nervous system
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: PET center, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Karen Ostergaard, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03870178: Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.
Official title: Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking.

This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.

Exclusion Criteria:

* Musculoskeletal or neurological disorder
* Under medication

Primary outcomes:
measure: Isometric trunk extension
timeFrame: Pre and Post-test (immediately after tDCS)
measure: Trunk muscle endurance
timeFrame: Pre and Post-test (immediately after tDCS)
Secondary outcomes:
measure: Isometric trunk extension
timeFrame: 15 minutes post-stimulation
measure: Isometric trunk extension
timeFrame: 30 minutes post-stimulation
measure: Trunk muscle endurance
timeFrame: 15 minutes post-stimulation
measure: Trunk muscle endurance
timeFrame: 30 minutes post-stimulation
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: Piauí
Study officials:
affiliation: Department of Physical Therapy. Federal University of Piaui
name: Fuad Hazime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721578: A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Official title: An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Fungal Infections
Keywords: Observational study
Effectiveness
Safety
Tolerability
Systemic Fungal Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.

Brief summary: To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India.


Eligibility criteria: Inclusion Criteria:

* To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit \[ICU\] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Diagnosis of Systemic Fungal Infection (SFI)
timeFrame: Up to 9 months
measure: Management of SFI: Choice of Treatment
timeFrame: Up to 9 months
measure: Management of SFI: Reason for Selection of Antifungal Agent
timeFrame: Up to 9 months
measure: Total Daily Dose for Selected Antifungal Agent
timeFrame: Up to 9 months
measure: Number of Participants With Clinical Outcomes.
timeFrame: Up to 9 months
measure: Number of Participants With Mycological Outcomes
timeFrame: Up to 9 months
Secondary outcomes:
measure: Concomitant Medications
timeFrame: Up to 9 months
measure: Median Duration of Antifungal Therapy
timeFrame: Up to 9 months
measure: Medication Administration
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: New Delhi
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02480478: Serum Autotaxin Levels in Cholestasis of Pregnancy
Official title: Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrahepatic Cholestasis of Pregnancy
Keywords: Intrahepatic Cholestasis of Pregnancy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are admitted to obstetrics and gynecology department due to cholestasis of pregnancy

Brief summary: Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.

Detailed description: Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria:

* acute or chronic liver disease
* acute or chronic gallbladder disease

Primary outcomes:
measure: Serum autotaxin levels in cholestasis of pregnancy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Etfal Training and Research Hospital
name: Hakan Erenel, MD,OBGYN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02992678: Pentoxifylline for the Prevention of PEP
Official title: Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pancreatitis
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo (placebo group) for preventing ERCP pancreatitis.


Eligibility criteria: Inclusion Criteria:

1. Males and females, age \> 18 years.
2. Normal amylase level before undergoing ERCP.
3. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
2. Patients involved in other study within 60 days.
3. Billroth II or Roux-en-Y anatomy
4. Acute pancreatitis.
5. a history of previous ERCP
6. Pregnancy or history of allergy to pentoxifylline
7. Patient treated for arterial hypertension
8. Patient with severe coagulopathy
9. Patient with hyper sensibility of pentoxifylline
10. Nursing mothers

Primary outcomes:
measure: Acute Pancreatitis
timeFrame: 24 hours
Secondary outcomes:
measure: The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients
timeFrame: 24 hours
Other outcomes:
Locations:
city: HeFei
country: China
facility: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
state: Anhui
Study officials:
affiliation: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
name: Shao Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00598078: Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
Official title: Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Tremor
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms.
* Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days

Exclusion Criteria:

* Subjects with a clinically significant unstable medical abnormality, chronic disease or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality
* Subjects who are on sodium-restricted diets
* Subjects with a known history of sleep apnea

Primary outcomes:
measure: Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
timeFrame: Hour 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bingham Farms
country: United States
facility: Quest Research Institiute
state: Michigan
Study officials:
affiliation: Quest Research Institute
name: Aaron Ellenbogen, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03617107: Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty
Official title: Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteo Arthritis Shoulders
Proximal Humeral Fracture
Rotator Cuff Tear
Rotator Cuff Tear Arthropathy
Lead sponsor: The Orthopaedic Research & Innovation Foundation
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients of principal investigator receiving rTSA for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis.

Brief summary: The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Reverse TSA performed by principal investigator

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age

Primary outcomes:
measure: total operative time
timeFrame: preoperative to up to 8 years postoperative
measure: amount of blood loss
timeFrame: preoperative to up to 8 years postoperative
Secondary outcomes:
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: The Orthopaedic Research & Innovation Foundation
state: Kentucky
Study officials:
affiliation: The Orthopaedic Research & Innovation Foundation
name: R M Greiwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044707: Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-09-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus treated with diet and/or oral agents
* HbA1c 6.5-11.0

Primary outcomes:
measure: To determine the effect of pramlintide on the PK of an oral medication
timeFrame: 7 Days
Secondary outcomes:
measure: safety and tolerability as measured by analysis of laboratory values and adverse events
timeFrame: 7 Days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: ICSL-Clinical Studies
state: Florida
Study officials:
References:
Clinical trial NCT01900288: Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
Official title: Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Bowel Syndrome
Malabsorption
Malnutrition
Keywords: short bowel disorder
short bowel syndrome
home parenteral nutrition
HPN
total parenteral nutrition
TPN
telehealth
telemedicine
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2013-07-16
Enrollment: 121
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance.

Detailed description: HPN (Home Parenteral Nutrition) families with TPN (Total Parenteral Nutrition) users are typically geographically distant from one another (peers) as well as professional providers. Real-time mobile access to health related information, peer and professional support will be tested in this study.

Eligibility criteria: Inclusion Criteria:

* 13 years or older total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care)
* TPN users (also called HPN users) must be receiving intravenous nutrition for a non-malignant short bowel disorder
* Read, write, speak English and provide informed consent
* Be able to participate in group clinic visits

Exclusion Criteria:

* enteral nutrition dependency only
* less than 13 years of age
* 13 through 17 years of age without parental consent
* currently enrolled in an intervention study or HPN management program
* severe cognitive impairment
* disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics

Primary outcomes:
measure: Engagement in Healthy Living Activities
timeFrame: 4 Months
measure: Health Satisfaction SF-12
timeFrame: 4 Months
measure: Quality of Life
timeFrame: 4 Months
measure: Access to Health Care
timeFrame: 4 Months
measure: Engagement in Healthy Living Activities
timeFrame: 8 Months
measure: Health Satisfaction SF-12
timeFrame: 8 Months
measure: Quality of Life
timeFrame: 8 Months
measure: Access to Health Care
timeFrame: 8 months
Secondary outcomes:
measure: Preparedness to Manage Home-Care
timeFrame: 4 Months
measure: Caregiving Burden
timeFrame: 4 Months
measure: Preparedness to Manage Home-Care
timeFrame: 8 Months
measure: Caregiving Burden
timeFrame: 8 Months
measure: Virtual Nurse Caring
timeFrame: 8 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas
name: Carol Smith, RN PhD FAAN
role: PRINCIPAL_INVESTIGATOR
References: