louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03309319: A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Official title: A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Tumor
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple systemic complications. The life expectancy of patients with untreated GHomas is shortened by ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a widely used oral antidiabetic medicine. The investigator's preliminary data showed that rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with GHomas who have not been alleviated by other therapies.


Eligibility criteria: Inclusion Criteria:

* Patients with GHomas confirmed by surgery
* Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test（OGTT）\>1.0ug/L or IGF-1 exceeds age matched normal range

Exclusion Criteria:

* Patients who were allergic to rosiglitazone
* Patients with liver or kidney dysfunction, respiratory failure
* Patients with heart failure
* Patients with edema
* Patients with severe hyperlipidemia
* Patients with osteoporosis or a history of non traumatic fractures
* Patients with pregnancy and lactation
* Patients who had received radiation therapy within 3 years
* Patients who had participated in other clinical trials within 3 months
* Patients with other neoplastic diseases
* Patients with mental and neurological disorders
* Patients with other conditions which were believed not appropriate to take part in the clinical trial

Primary outcomes:
measure: Growth hormone(GH)
timeFrame: 6 months
measure: insulin like factor 1(IGF-1)
timeFrame: 6 months
measure: tumor volume
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02227719: Customized Titanium Membrane for Growing Jaw Bone Horizontally
Official title: The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bone Gain
Keywords: after augmentation
procedure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.


Eligibility criteria: Inclusion Criteria:

* Male or female, age \>18
* Overall good, stable health
* A single missing mandibular 1st molar for at least 3 months

Exclusion Criteria:

* Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)
* Pregnancy or lactating mothers
* Current heavy smokers (\>10 cigarettes/day) or previous heavy smokers who have quit less than one year
* Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)

Primary outcomes:
measure: linear bone gain
timeFrame: 4 months after surgery
Secondary outcomes:
measure: implant marginal bone level
timeFrame: 18 months after baseline surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
References:
Clinical trial NCT04715919: Long Term Outcomes of Coronavirus Disease-19 (COVID-19)
Official title: Long Term Outcomes in Patients With Coronavirus Disease-19 (COVID-19) on Pulmonary Functions, Exercise Capacity, Lung Structure and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Long term outcomes
Chest computed comography
Pulmonary functional tests
Exercise capacity
Quality of life
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: Turkish Respiratory Society
First posted: 2021-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of COVID-19 aged over 18 years old who had been admitted in University of Health Sciences, Dr. Suat Seren Chest Disease and Surgery Training and Research Hospital for COVID-19 patients in İzmir, Turkey.

Brief summary: The investigators hypothese that lung involvement due to COVID-19 may cause structural changes in the lung in the long term. In this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.

Detailed description: Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. The disease mostly infects the lower respiratory tract. Typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. There is a close relationship between tomography findings and clinical severity. It is not known whether there will be complete recovery in the lungs.

Investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least 6 months after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Patients who were ≥18 years
* COVID-19 confirmed by Real-Time PCR
* At least 6 months after discharge

Exclusion Criteria:

* Patients who were \< 18 years
* Pregnancy
* Become bedridden after discharge

Primary outcomes:
measure: Structural Change in Lung
timeFrame: up to 6 months after discharge
Secondary outcomes:
measure: Carbon monoxide diffusion capacity (DLCO)
timeFrame: up to 6 months after discharge
measure: Exercise Capacity
timeFrame: up to 6 months after discharge
measure: Short Form Health Survey Score (SF-16)
timeFrame: up to 6 months after discharge
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Study officials:
References:
Clinical trial NCT06314919: A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
Official title: A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 8606
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of primary hypercholesterolemia or mixed dyslipidemia

Brief summary: The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition


Eligibility criteria: Inclusion Criteria:

* Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
* Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe

Exclusion Criteria:

* Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
* Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
* Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.

Primary outcomes:
measure: Rate of reaching the target LDL Cholesterol level
timeFrame: 12 weeks after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
Study officials:
References:
Clinical trial NCT05876819: Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon
Official title: Comparison of Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon A Cross Sectional Study in 2023
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Quality of Life
Health Care Acceptability
Disabilities Mental
Keywords: Older People
Middle Aged
Disabled
ServQual Model
IRAN
LEBANON
Quality of Services
Health System
Instrumentation
Quality of Caring
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The Iranian \& Lebanese disabled mid/older adults who are received health care services from the local authorities out of 1 years ago.

Brief summary: The findings of this research will be a basis for improving the quality of care and welfare services for the disabled middle-aged and older people in Iran and Lebanon using the SERVQUAL model.


Eligibility criteria: Inclusion Criteria:

* Aged 50 of years and above.
* Being Disabled.
* Receiving Health Care Services out of 1 year ago.

Exclusion Criteria:

* Unwillingness to Participate in the Study
* Death and/or Migration

Primary outcomes:
measure: ServQual
timeFrame: 8 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Welfare Services Affairs
state: Dars
Study officials:
References:
Clinical trial NCT01712919: Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
Official title: IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Locoregionally advanced nasopharyngeal carcinoma
cetuximab
chemoradiation
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 61
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: The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed untreated NPC patients
* locoregionally advanced (T3-4 or N2-3 M0)
* 18-65 years
* with MRI examinations
* ECOG ≤ 2
* With written consent

Exclusion Criteria:

* Without a second cancer
* Pregnancy
* With other severe diseases (blood,liver ,kidney or heart diseases)
* Could not be staged properly
* Without written consent

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Progress free survival
timeFrame: 24 months
Other outcomes:
measure: local-relapse free survival
timeFrame: 24 months
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Xia He, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544619: Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
Official title: Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropathic Pain
Lead sponsor: Erenköy Physical Therapy and Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have neuropathic symptoms

Brief summary: In this study, investigators want to perform the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory

Detailed description: The purpose of the study is to determine the Turkish version, the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory. 120 patients with neuropathic pain will be included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results evaluated using the Intraclass Correlation Coefficient method.

Eligibility criteria: Inclusion Criteria:

* Age upper 18
* Complaints of neuropathic pain for at least 3 months

Exclusion Criteria:

* Presence of psychiatric illness
* Cancer pain, unsuccessful lumbar surgeon syndrome etc. mix type pain presence
* Presence of complex regional pain syndrome
* Cognitive impairment (mini-mental test score \<24)
* Native language is not Turkish

Primary outcomes:
measure: Reliability and adaptation
timeFrame: 7 weeks
measure: DN4
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Erenkoy Physical Treatment Nad Rehabilitation Hospital
Study officials:
affiliation: ERENKOY PHYSICAL THERAPY AND REHABILITATION HOSPITAL
name: unsal sarı
role: STUDY_CHAIR
References:
Clinical trial NCT00186719: How Smoking Causes COPD: Examination of Immune System Changes
Official title: How Smoking Causes COPD: Examination of Immune System Changes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Smoking Related Disease
Immune System Changes
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: smokers and non-smokers

Brief summary: A breathing condition known as "chronic obstructive pulmonary disease" (COPD) caused by cigarette smoking is a major health problem. The way by which smoking leads to lung disease is uncertain. Recent research done in animals provides a description of specific changes (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The study you have been asked to participate in is a pilot study to see if similar changes occur in humans who smoke. The purpose of this study is to evaluate this new method of testing blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no history of lung disease and subjects who smoke and have smoking related COPD.

Detailed description: The mechanism by which smoking leads to damage to lung tissue in susceptible hosts, is uncertain. Recently there has been description of specific changes (that is reduction) in the number and activity of certain key immune cell types - dendritic cells- as a result of cigarette smoke exposure. This work was done in animal models and we would like to develop methods that will allow us to examine if similar changes occur in humans who smoke. Reduced number and activity of dendritic cells would be expected to lead to increased incidence of infection - a common problem in patients with COPD.

Since dendritic cells come to the lung from the bloodstream, and one can detect them in the circulation, we will look at the dendritic cells that are present in the peripheral blood.

Eligibility criteria: Inclusion Criteria:

* Age \> 40 years
* Healthy Subjects - Non smokers
* FEV1/FVC \> 70% predicted
* Current Smokers - \> 10 pack year smoking history
* FEV1/FVC \> 70% predicted
* Current Smokers with COPD - \> 10 pack year smoking history
* FEV1/FVC \< 70% predicted
* Able to give informed consent

Exclusion Criteria:

* Healthy Subjects - Reside with smokers
* History of lung disease
* Current Smokers - History of lung disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Gerard Cox, MB FRCPC FRCPI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043419: Sympathetic Neural Outflow During Xenon Anesthesia in Humans
Official title: Sympathetic Neural Outflow During Xenon Anesthesia in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sympathetic Nervous System
Keywords: Xenon Anesthesia
LENOXe™ (xénon 100 % v/v) anesthesia
Muscle Sympathetic Activity
Baroreflex reagibility
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 8
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: The purpose of this study is to test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.

Detailed description: Objectives for this study :

* Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity
* Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers \> 18 years and \< 65 years of age
* ASA physical status I
* Legal competence
* for whom the consent form has been signed

Exclusion Criteria:

* Healthy volunteers \< 18 years and \> 65 years of age
* Pregnancy, lactation period or missing secure anticonvulsive therapy
* Missing legal competence
* Participation in other clinical trials
* Contraindications as mentioned on §4.3 of the SPCs of LENOXe™ (xénon 100 % v/v)
* Any medication especially of Sildenafil (Viagra®) or other potency remedy
* Existing relationship of dependency to the sponsor or the investigator

Primary outcomes:
measure: Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
timeFrame: 30 minutes
Secondary outcomes:
measure: Arterial blood pressure, Heart frequency, Arterial O2 and CO2 Saturation,Skin conductance,Concentration of plasma catecholamines, Angiotensin & Renin under Xenon Anesthesia in comparison to awake
timeFrame: In continuous during 30 minutes
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Department of Anesthesiology; University Hospital of Duesseldorf; Moorenstrasse 5
Study officials:
affiliation: Department of Anesthesiology, University Hospital Duesseldorf, Moorenstrasse 5, D-40225 Duesseldorf
name: Peter KIENBAUM, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00471419: Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Official title: Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 750
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 purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.


Eligibility criteria: Inclusion Criteria:

* documented dry eye history
* ocular symptoms
* tear use
* dry eye ocular signs

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Corneal staining; dry eye sympton
timeFrame: Immediate
Secondary outcomes:
measure: Corneal staining; dry eye sympton
timeFrame: Prolonged
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland
state: Ohio
Study officials:
affiliation: Alcon Research
name: Michael Brubaker, PhD
role: STUDY_DIRECTOR
References: