louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05849363: A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination
Official title: A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basilar Invagination
Prospective Study
Surgical Outcome
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. The purpose of our prospective study in China is to (1) further clarify the etiology of Goal B type BI, and (2) improve the surgical outcome in these patients.


Eligibility criteria: Inclusion Criteria:

* Goal B type basilar invagination (BI)

Exclusion Criteria:

* Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
* The patient was not physically fit for surgery.

Primary outcomes:
measure: JOA Score（Japanese Orthopaedic Association Scores）
timeFrame: 1 months, 3 months, and 6 months postoperatively
measure: NDI Score
timeFrame: 1 months, 3 months, and 6 months postoperatively
Secondary outcomes:
measure: Change of Basilar Invagination
timeFrame: 1 months, 3 months, and 6 months postoperatively
measure: Change of CCA
timeFrame: 1 months, 3 months, and 6 months postoperatively
measure: Change of CVJ triangle area
timeFrame: 1 months, 3 months, and 6 months postoperatively
measure: Change of CMA
timeFrame: 1 months, 3 months, and 6 months postoperatively
measure: Change of subarachnoid space
timeFrame: 1 months, 3 months, and 6 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03056963: Guided Imagery Training and Self-Referential Processing
Official title: Guided Imagery Training and Self-Referential Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Negative Thoughts
Keywords: Guided Imagery
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of a guided imagery paradigm for reducing negative ways of thinking about the self. There will be at least 60 participants enrolled at the University of Texas at Austin. Participants will be randomly selected to receive one of two types of trainings, each over the course of two weeks. Participants will undergo the training exercises at home. The training exercises will help them to think differently about themselves.

Participants will be able to determine if they are eligible, and then participate, by filling out a screening questionnaire online.

Detailed description: This study uses a randomized controlled trial to compare two types of guided imagery. One intervention is an active intervention; the other is intended to be inert. These interventions were developed based on extensive research indicating the efficacy of using imagery in depression, and a perceived lack of treatments targeting biased self-referential processing.

This protocol aims to develop a novel intervention which can be used on its own or as an adjunct to existing treatments. Common treatments for Major Depressive Disorder (MDD) are diffuse; this paradigm instead aims to specifically target negative self-schema, a part of the cognitive model of MDD. This study focuses on participants with elevated depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* willing and able to provide informed consent
* elevated depressive symptoms -- i.e., a score above a 13 on the Center for Epidemiologic Studies Depression Scale (CESD)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in response on the Self-Referent Encoding Task (SRET)
timeFrame: Participants will complete the SRET at baseline, after one week, and after two weeks. Change will be assessed primarily as SRET at two weeks MINUS SRET at baseline.
Secondary outcomes:
measure: Depressive Symptomatology
timeFrame: Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks.
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Justin Dainer-Best
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002963: A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
Official title: A Double-Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Doses Of PF-04418948 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.

Primary outcomes:
measure: Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2
timeFrame: 240 hours
measure: Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine).
timeFrame: 240 hours
Secondary outcomes:
measure: Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02813863: The Drug-drug Interaction of SP2086 and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg.
* willing to using contraception during the study and after the 6 months.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of Metformin
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of metformin
timeFrame: up to Day 9
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 9
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04507763: Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis
Official title: Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients data from local registry at the Baghdad Teaching Hospital

Brief summary: This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry


Eligibility criteria: Inclusion Criteria:

* Diagnosed AS patients.

  * 18 years old
* Did not receive previous biological treatment for any reason

Exclusion Criteria:

* Patients previously or currently treated with other biological therapies.
* Use of etanercept for less than 1 year duration.

Primary outcomes:
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
timeFrame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
timeFrame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01764763: Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 2292
Sex: ALL
Minimum age (years): 31
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2001 to December 2011, 2292 patients who underwent isolated off-pump coronary artery bypass at Yonsei Cardiovascular Hospital in Seoul

Brief summary: Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation


Eligibility criteria: Inclusion Criteria:

patients underwent who isolated off-pump coronary artery bypass

Exclusion Criteria:

1. combined carotid procedures
2. preoperative cerebral haemorrhage
3. nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest

Primary outcomes:
measure: Early Stroke After Off-pump Coronary Artery Bypass
timeFrame: number of incidence of early strok from surgery to discharge, an expected average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03391063: Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
Official title: Evaluation Of Chewing Efficiency Of Metal-Reinforced PolyAmide Denture Base In Comparison To Conventional Heat Cured Acrylic Resin Denture Base For Mandibular Complete Denture (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mouth, Edentulous
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases


Eligibility criteria: Inclusion Criteria:

1. Male or female patient with age range (45-55) completely edentulous and in good medical condition.
2. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular joint disorder.
5. The patients have good oral hygiene.
6. The edentulous ridges should be covered by firm healthy mucosa.
7. Healthy and co-operative patients.

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
2. Previous history of radiotherapy or chemotherapy.
3. Any skeletal problem dictates surgical intervention.
4. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
5. Patient with xerostomia or excessive salivation.
6. No intraoral soft and hard tissue pathosis.
7. Psychiatric problems.

Primary outcomes:
measure: chewing efficiency assessed using sieving method
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
Clinical trial NCT01139463: Study of Blood Lactate Levels in Patients Treated With Antipsychotics
Official title: Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Lactic Acidosis
Keywords: antipsychotics
lactates
side effects
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of patients from the psychiatric inpatient and outpatient sections of a primary care hospital.

Brief summary: Blood lactate levels in patients receiving typical or atypical antipsychotics have not been described in the literature.

The goal of this study is to assess the dynamics of lactate levels in the blood from typical or atypical antipsychotics not confounded by prior antipsychotic treatments, the investigators conducted a prospective study of lactate levels in patients receiving antipsychotic medication. The investigators hypothesized that 6 months of treatment with haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal side effects.

Detailed description: The aim of this study was to compare the blood lactate levels in patients receiving typical or atypical antipsychotics.

Subjects included sixty patients with psychotic disorder were assigned to treatment for 6 months with haloperidol (typical antipsychotic), N=30 or olanzapine (atypical antipsychotic), N=30. Blood lactate levels, other metabolic parameters, and scores on the extrapyramidal symptom rating scale (ESRS) were assessed.

Eligibility criteria: Inclusion Criteria:

* Men aged 20 - 50 years
* Not taking any antipsychotic medication 1 month prior to the study
* Diagnosed psychotic disorder

Exclusion Criteria:

* Female
* Tobacco use
* Diabetes mellitus
* Baseline lactate blood level over 2.0 mmol/L

Primary outcomes:
measure: Blood lactate levels
timeFrame: 1 month
measure: Blood lactate levels
timeFrame: 3 months
measure: Blood lactate levels
timeFrame: 6 months
Secondary outcomes:
measure: Extrapyramidal side effects
timeFrame: 1 month
measure: Extrapyramidal side effects
timeFrame: 3 months
measure: Extrapyramidal side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Split Clinical Hospital Center
Study officials:
affiliation: University Hospital of Split
name: Trpimir Glavina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glavina T, Mrass D, Dodig T, Glavina G, Pranic S, Uglesic B. Blood lactate levels in patients receiving first- or second- generation antipsychotics. Croat Med J. 2011 Feb;52(1):41-7. doi: 10.3325/cmj.2011.52.41.
Clinical trial NCT06534463: Registry Study of Chinese Patients with Marginal Zone Lymphoma (MOTIVE)
Official title: The Effectiveness and Safety of Different Treatment Modalities in Real-World Clinical Practice Among Chinese Patients with Marginal Zone Lymphoma: a Prospective, Observational, Multi-center Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Marginal Zone Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are about to undergo marginal zone lymphoma(MZL) treatment (i.e., those who have been recommended for and intend to receive MZL treatment at the time of signing the informed consent form)

Brief summary: This study aims to evaluate real-world treatment modalities and their corresponding effectiveness and safety in Chinese patients with marginal zone lymphoma, while also exploratively analyzing patient characteristics and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed as MZL
* Meet the treatment indications for MZL

Exclusion Criteria:

* Any reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Primary outcomes:
measure: Progression-free survival
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: End of treatment visit (approximately 6 months)
measure: Complete Response Rate
timeFrame: End of treatment visit (approximately 6 months)
measure: Time to Next Treatment
timeFrame: From the start of treatment to the initiation of next-line treatment (up to approximately 60 months)
measure: Duration of Response
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
measure: Duration of Complete Response
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
Other outcomes:
measure: Health-Related Quality of Life assessed with EORTC QLQ-C30 questionaire
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
measure: Health-Related Quality of Life assessed with EORTC QLQ-NHL-LG20 questionaire
timeFrame: Baseline up to data cut-off (up to approximately 60 months)
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04902963: What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Official title: What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Sudden Hearing Loss
Meniere Disease
Lead sponsor: Skovlund Medical Products, LLC
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 14
Sex: ALL
Minimum age (years): 26
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

Detailed description: Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants".

14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.

Eligibility criteria: Inclusion Criteria:

* meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of weeks that ventilation tube lumen is patent.
timeFrame: 0-3 months
Secondary outcomes:
measure: Number of weeks until ventilation tube is fully resorbed.
timeFrame: 0-3 months
Other outcomes:
Locations:
Study officials:
affiliation: Park Nicollet Institute, IRB Administrator
name: Tiffany Walker
role: STUDY_DIRECTOR
References: