louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06044870: Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
Official title: Clinical Evaluation of the Modified Laterally Stretched Technique in the Gingival Recession Sites of the Lower Anterior Teeth (RT2) vs Tunneling With Connective Tissue Grafting in Both Techniques: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regression analysis in a recent systematic review showed significantly greater mRC and CRC values when modifications are done to the TUN procedure to achieve more coronal advancement of the flap, coronal advancement also helps in covering the underlying graft for better recession coverage outcomes (Tavelli et al., 2018), limited data is present on the possible influence of a covered or partially uncovered graft. However, it has been suggested that minimal exposure of the CTG may aid not only in achieving CRC but also a harmonious gingival margin (John et al., 2015; Rasperini et al., 2011).


Eligibility criteria: * Single or multiple RT2 gingival recession site/sites in the lower anterior teeth.
* Age \>/= 18 years.
* Patients with healthy or treated periodontal conditions.
* Patients willing to participate in the study.
* Absence of uncontrolled medical conditions.
* Full mouth plaque score \</= 20% (O'Leary 1972).
* Full mouth bleeding score \<20% (Ainamo and Bay 1975).
* Patients with aesthetic concerns.

Exclusion Criteria:

* Pregnant or lactating females.
* deep recession sites more than 5 mm
* Tobacco smoking.
* Uncontrolled medical conditions.
* Uncooperative patients or unable to complete the study.
* Patients treated with any medication known to cause gingival hyperplasia.
* No occlusal interferences.

Primary outcomes:
measure: Recession depth reduction.
timeFrame: 1 year
Secondary outcomes:
measure: Mean root coverage
timeFrame: 1 year
measure: Recession depth
timeFrame: 1 year
measure: Recession width
timeFrame: 1 year
measure: Soft tissue thickness
timeFrame: 1 year
measure: Keratinized tissue width
timeFrame: 1 year
measure: Esthetics (RES) score
timeFrame: 1 year
measure: patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00000270: Brain Imaging: Cocaine Effects & Medication Development - 5
Official title: Brain Imaging: Cocaine Effects & Medication Development
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cocaine-Related Disorders
Keywords: cocaine
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to define temporal profile of brain activation (rCBF) using Xenon-SPECT and O 15-PET.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Absolute change in rCBF at 5 & 15 minutes (Xe)
measure: Relative change in rCBF at 5, 19, & 33 minutes (O15)
measure: Correlated with a) subjective effects, b) venous blood level of coca, c) autonomic variables
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACNP Abstract, 1995. CPDD Abstract, 1996. Society for Nuclear Medicine, 1996. Society for Neuroscience, 1997.
Clinical trial NCT04548375: Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
Official title: Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SCS
Lead sponsor: Cardio Surgical Partners
Sponsor class: NETWORK
First posted: 2020-09-14
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All SCS implants

Brief summary: The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.

Detailed description: This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.

Eligibility criteria: Inclusion Criteria:

* FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors

Exclusion Criteria:

-

Primary outcomes:
measure: Change in pain relief
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Sustained change of pain over the follow up period
timeFrame: 12 months
Locations:
city: Reno
country: United States
facility: Summit Surgery Center
state: Nevada
Study officials:
References:
Clinical trial NCT03858075: Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BLU-782 When Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Medically healthy
* Non-smoker
* Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2
* No clinically significant cardiac history
* No current electrocardiogram (ECG) abnormality
* Female must not be of childbearing potential

Exclusion Criteria:

* History of or current mental or legal incapacitation or major emotional problems
* History or current clinically significant medical/psychiatric condition/disease
* History of any illness that, in the opinion of the Investigator, might impact the results of the study or pose an additional risk to the participant
* History or current alcoholism/drug abuse
* History or current allergy to the study drug or a similar drug

Primary outcomes:
measure: Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.
timeFrame: Baseline to Day 8
measure: Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .
timeFrame: Baseline to Day 17
measure: Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.
timeFrame: Baseline to Day 20
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Undisclosed
state: Nebraska
Study officials:
References:
Clinical trial NCT06227975: A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ADME
Healthy male volunteers
Pharmacokinetics
BMS-986368
CC-97489
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
* Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\[m\])\^2

Exclusion Criteria:

* History of hypokalemia.
* Any significant acute or chronic medical illness as determined by the investigator.
* Participant has a history of syncope in the year prior to Day 1.

Other protocol-defined incusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 15
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 15
measure: Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 15
measure: Total Radioactivity (TRA)
timeFrame: Up to Day 30
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 36
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to Day 36
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to Day 36
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 30
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 30
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 30
measure: Number of participants with clinical laboratory test abnormalities
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Madison
country: United States
facility: Local Institution - 0001
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00610675: Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
Official title: Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Fifty two weeks
Open label
extension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.


Eligibility criteria: Inclusion Criteria:

* sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
* completed Protocol P05706 or P05707;
* Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria:

* clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
* clinically relevant abnormal laboratory values as judged by the investigator;
* any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
* were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: Up to 57 weeks
measure: Number of Participants Who Discontinued Treatment Due to an Adverse Event
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Total Sleep Time at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Sleep Latency at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Wake Time After Sleep Onset at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Number of Awakenings at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Quality of Sleep Scale at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00641875: The Effect of Nocturnal Haemodialysis on Arterial Stiffness
Official title: The Effect of Nocturnal Haemodialysis on Arterial Stiffness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Arterial Stiffness
Keywords: arterial stiffness
artery
aortic pulse wave velocity
pulse wave analysis
augmentation index
end stage renal disease
nocturnal hemodialysis
extended hours of hemodialysis
cardiovascular
hemodialysis
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants are adult patients who are receiving maintenance dialysis at the North West Dialysis Service. Consecutive patients enrolled in the Nocturnal Haemodialysis program are invited to participate in the study

Brief summary: Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium which reduce blood vessel compliance. Although there is growing evidence that increased arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical and biochemical parameters.


Eligibility criteria: Inclusion Criteria:

* adult dialysis patients
* able to perform home nocturnal haemodialysis

Exclusion Criteria:

* age \< 18 and \> 80 years
* any patient who is anticipating a live renal transplantation in forthcoming 12 months

Primary outcomes:
measure: To purpose of this study is to evaluate the arterial stiffness in subjects who have undergone 12 months nocturnal haemodialysis.
timeFrame: 12 months
Secondary outcomes:
measure: To examine the relationship between arterial stiffness and clinical and biochemical parameters
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nephrology, Melbourne Health
name: Michael Lian, FRACP, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931775: Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
Official title: Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Antidepressant Treatment Response
Keywords: Major depressive disorder, citalopram, pindolol, HDRS
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.

Detailed description: Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.

Eligibility criteria: Inclusion Criteria:

* Patients with a depressive episode
* HDRS score \> 18
* Written informed consent

Exclusion Criteria:

* suicidal risk \> 3
* severe organic illness
* other psychotropic drugs

Primary outcomes:
measure: Scores on Hamilton Depression Rating Scale
timeFrame: 8 time points through 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
name: Enric Álvarez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
name: Víctor Pérez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Neurochemistry department. Consejo Superior de Investigaciones Científicas
name: Francesc Artigas, PhD
role: STUDY_CHAIR
References:
citation: Portella MJ, de Diego-Adelino J, Ballesteros J, Puigdemont D, Oller S, Santos B, Alvarez E, Artigas F, Perez V. Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? A randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. J Clin Psychiatry. 2011 Jul;72(7):962-9. doi: 10.4088/JCP.09m05827blu. Epub 2010 Oct 19.
Clinical trial NCT03772275: Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Official title: Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Clinical and Economic study of some new biomarkers in chronic heart failure.

Detailed description: The study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.

Eligibility criteria: Inclusion Criteria:

* NYHA-Class II-IV

Exclusion Criteria:

* Liver or renal dysfunction. --DM

Primary outcomes:
measure: Number of participants with elevated markers (IL17)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
state: Elgharbia
Study officials:
affiliation: Prof of Clinical Pharmacy
name: Osama M Ibrahim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Department- Tanta University
name: Medhat M Eshmawy, Prof
role: STUDY_DIRECTOR
affiliation: Clinical pharmacy Department- Tanta University
name: Nermin W Ishaq, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT00260975: Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer
Official title: A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
chemotherapy
hormonal therapy
cognitive function
chemo fog
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2005-12-02
Enrollment: 112
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer

Brief summary: Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

Detailed description: Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Eligibility criteria: Inclusion Criteria:

* stage I or II breast cancer; woman; 50-65 years old; post-menopausal

Exclusion Criteria:

* history of previous cancer or chemotherapy; significant neurological or psychiatric history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OHRI
name: Barbara Collins
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart A, Collins B, Mackenzie J, Tomiak E, Verma S, Bielajew C. The cognitive effects of adjuvant chemotherapy in early stage breast cancer: a prospective study. Psychooncology. 2008 Feb;17(2):122-30. doi: 10.1002/pon.1210.
citation: Collins B, Mackenzie J, Stewart A, Bielajew C, Verma S. Cognitive effects of chemotherapy in post-menopausal breast cancer patients 1 year after treatment. Psychooncology. 2009 Feb;18(2):134-43. doi: 10.1002/pon.1379.
citation: Collins B, Mackenzie J, Stewart A, Bielajew C, Verma S. Cognitive effects of hormonal therapy in early stage breast cancer patients: a prospective study. Psychooncology. 2009 Aug;18(8):811-21. doi: 10.1002/pon.1453.