louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00179101: Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients
Official title: Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Depression
Quality of Life
Deep Brain Stimulation
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: We will evaluate the effect of deep brain stimulation on the depression and quality of life in Parkinson's disease. We aim to compare depression pre-operatively and post-operatively in Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery. We will also compare quality of life measures between patients with and without deep brain stimulation.

Detailed description: Deep brain stimulation is an approved therapy for Parkinson's patients, and this procedure is actively performed at Vanderbilt University Hospital. Questions have been raised concerning the effect of deep brain stimulation on the depression commonly seen in Parkinson's patients. Through this study, we plan to evaluate and compare the incidence and severity of depression in Parkinson's patients with deep brain stimulation to those who did not complete the surgery. Primary literature has indicated a general increase in quality of life of those patients receiving DBS, but no studies have compared these two specific patient populations.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's disease.
* Patients who have received neuropsychological testing in preparation for possible deep brain stimulation.
* Patients are within the age of 50 and 85.

Exclusion Criteria:

* Parkinson's patients not approved for deep brain stimulation on the basis of neuropsychological testing.
* Patients who received deep brain stimulation less than a year ago.
* Patients who do not consent to the study procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Courtney R Schadt, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: David Charles, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00430001: Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
Official title: A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Metastatic breast neoplasm
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Sanofi
First posted: 2007-02-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status \< 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic HER2-positive breast cancer
* WHO performance status \< 3

Exclusion Criteria:

* Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
* Severe dyspnoea
* Abnormal organ function including cardiac

Primary outcomes:
measure: Disease free survival
timeFrame: median
Secondary outcomes:
measure: response rate, overall survival, toxicity
timeFrame: Median
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
Study officials:
affiliation: Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark
name: Michael Andersson, MD D Med Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02920801: Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: saxagliptin
endothelial progenitor cell
flow-mediated dilation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Medical Association
First posted: 2016-09-30
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed type 2 diabetics (diagnosis were made according to the American Diabetes Association Guideline \[19\] ), treatment naive, age 30-75, hemoglobin A1c (HbA1c) ≥6.5%, fasting c-peptide \>1.0ng/L

Exclusion Criteria:

* pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate \<60 mL/min/1.73m2), live enzymes 3 times above the normal range, positive islet autoantibody, fasting c-peptide \<1.0ng/L, severe hypertriglyceridemia (triglyceride \>5.6mmol/L), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.

Primary outcomes:
measure: endothelial progenitor cell
timeFrame: 12weeks
measure: flow-mediated dilation
timeFrame: 12weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12weeks
measure: fasting blood glucose
timeFrame: 12weeks
measure: 2 hour postprandial blood glucose
timeFrame: 12weeks
measure: liver function test
timeFrame: 12weeks
measure: renal function test
timeFrame: 12weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fang Li
state: Shanghai
Study officials:
References:
Clinical trial NCT00409201: Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia
Official title: Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Schizophrenia
Keywords: schizophrenia
reboxetine
cognitive
behavior
Lead sponsor: Abarbanel Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2006-12-08
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: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.

Detailed description: all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg \* 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. \* 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.

Eligibility criteria: Inclusion Criteria:

* schizophrenia all types
* 18\>

Exclusion Criteria:

* uti
* \>65
* non organic state
* no depression treatment

Primary outcomes:
measure: sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test
Secondary outcomes:
measure: esrs, progesterom, sexual functioning, covy, cgi, cgi improved
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Abarbanel Medical Mental Health Center
city: Bat Yam
country: Israel
facility: Abarbanel Medical Mental Health Center
Study officials:
affiliation: abarbanel mhc
name: stanislav baranchik, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schutz G, Berk M. Reboxetine add on therapy to haloperidol in the treatment of schizophrenia: a preliminary double-blind randomized placebo-controlled study. Int Clin Psychopharmacol. 2001 Sep;16(5):275-8. doi: 10.1097/00004850-200109000-00004.
Clinical trial NCT04371367: Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )
Official title: A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
Collaborators: name: Innate Pharma
First posted: 2020-05-01
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).


Eligibility criteria: Inclusion Criteria:

* COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy
* COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation

Exclusion Criteria:

* Pregnant woman
* Uncontrolled sepsis of bacterial or fungal origin

Primary outcomes:
measure: Clinical improvement using WHO ordinal scale
timeFrame: day 28
measure: Number of ventilator-free days at Day 28 (VFD28)
timeFrame: day 28
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: day 28
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Emilie Garrido-Pradalie
role: STUDY_DIRECTOR
References:
citation: Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Clinical trial NCT02225067: Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring
Official title: Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Acid-related Diseases
Healthy
Keywords: Patients
Volunteers
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: EPS Corporation
First posted: 2014-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment
* Healthy subjects who are determined no history of Helicobacter pylori infections

Exclusion Criteria:

* Patients with hypercalcemia
* Patients with hypothyroidism
* Patients with hyperparathyroidism
* History of upper gastrointestinal surgery or resection
* Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Primary outcomes:
measure: 13CO2 concentration in expired air
timeFrame: 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration
measure: 24-hour gastric pH
timeFrame: from completion of pre-study examination to before C13-CAC adminitration
Secondary outcomes:
Other outcomes:
measure: Gastric pH holding time ratio
timeFrame: from completion of pre-study examination to before C13-CAC adminitration
Locations:
city: Osaka
country: Japan
facility: OPHAC Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kimiyoshi Sudoh
role: STUDY_DIRECTOR
References:
Clinical trial NCT00449267: Aurolab Hydrophobic Foldable Intraocular Lens Study
Official title: Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Lenses, Intraocular
Prospective Studies
Visual acuity
Clinical Trial
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.

Detailed description: Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.

Eligibility criteria: Inclusion Criteria:

* Age 40 to 65 years
* Senile Cataract
* Posterior Subcapsular Cataract (PSCC)

Exclusion Criteria:

* Obviously debilitated patients
* Cardiac and other serious illness
* Diabetic Patients
* Traumatic cataract
* Complicated cataract
* Congenital cataract
* Drug induced cataract
* Shallow anterior chamber
* Poor mydriasis
* Amblyopia
* Pseudo exfoliation (PXF)
* Dense posterior polar cataract (PPC)
* One eyed patients
* Glaucoma
* Uveitis
* Corneal Pathology
* Retinal Pathology
* Intra operative complications like PC rupture, Zonular dialysis

Primary outcomes:
measure: Visual acuity
timeFrame: 10days, 40 days, 150 days post operatively
Secondary outcomes:
measure: Refraction
timeFrame: 10days, 40 days, 150 days post operatively
measure: Intraocular pressure
timeFrame: 10days, 40 days, 150 days post operatively
measure: Corneal status
timeFrame: 10days, 40 days, 150 days post operatively
measure: Iritis
timeFrame: 10days, 40 days, 150 days post operatively
measure: IOL decentration
timeFrame: 10days, 40 days, 150 days post operatively
measure: IOL tilt
timeFrame: 10days, 40 days, 150 days post operatively
measure: IOL discoloration
timeFrame: 10days, 40 days, 150 days post operatively
measure: IOL opacity
timeFrame: 10days, 40 days, 150 days post operatively
measure: Cystoid macular oedema
timeFrame: 10days, 40 days, 150 days post operatively
measure: Hypopyon
timeFrame: 10days, 40 days, 150 days post operatively
measure: Endophthalmitis
timeFrame: 10days, 40 days, 150 days post operatively
measure: Pupillary block
timeFrame: 10days, 40 days, 150 days post operatively
measure: Retinal detachment
timeFrame: 10days, 40 days, 150 days post operatively
measure: Status of anterior and posterior capsule
timeFrame: 10days, 40 days, 150 days post operatively
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Haripriya Aravind, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056767: Changes in Digital Phenotype During PE Therapy
Official title: Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PTSD
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.

Brief summary: PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.

The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).


Eligibility criteria: Inclusion Criteria:

* PTSD diagnosis
* Proper ability to give informed consent

Exclusion Criteria:

* Active psychotic or suicidal symptoms
* Severe dissociative symptoms
* A traumatic brain injury (TBI) diagnosis
* Pregnancy

Primary outcomes:
measure: Changes in Heart Rate
timeFrame: 3 months
measure: Changes in Saturation
timeFrame: 3 months
measure: Changes in blood pressure
timeFrame: 3 months
measure: Changes in Pulse Pressure
timeFrame: 3 months
measure: Changes in Respiratory rate
timeFrame: 3 months
measure: Changes in Stroke Volume
timeFrame: 3 months
measure: Changes in Systemic Vascular Resistance
timeFrame: 3 months
measure: Changes in sweat
timeFrame: 3 months
measure: Changes in Body Temperature
timeFrame: 3 months
measure: Changes in Cardiac Output
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between changes in digital phenotype (multiple measures)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04665167: An Intervention for Eating and Body Image Concerns Among Young Adult Women
Official title: Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Symptom
Body Image Disturbance
Keywords: eating pathology
body image
exposure
self-compassion
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the current study is to assess acceptability and feasibility of online body image exposure and self-compassion interventions before conducting a larger RCT.

Detailed description: This study will determine the feasibility and effectiveness of delivering an online therapy for eating pathology and body image disturbance. It will address body image and eating pathology in a non-clinical group of young adult women, who are at risk of developing such problems . The feasibility study will determine whether there are any difficulties that would need to be addressed in recruitment, online delivery and assessment of those treatments.

Eligibility criteria: Inclusion Criteria:

* Body shape questionnaire score \> 25
* Age ≥18
* Self-identified women
* Be able to use a computer and having an Internet connection and webcam

Exclusion Criteria:

* Insufficient knowledge of English
* Learning disability, severe mental illness or alcohol/substance dependence, history of self-injuries, current eating disorder, current clinical depression
* Psychiatric illness requiring secondary care intervention
* Male
* Under 18 years old
* Body mass index below 18.5
* Currently undergoing psychological therapies
* No access to a tablet or computer with an internet connection

Primary outcomes:
measure: Number of participants recruited
timeFrame: will measure upon study termination (estimated at 2-3 months)
Secondary outcomes:
measure: The rate of completion
timeFrame: will measure upon study termination (estimated at 2-3 months)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
affiliation: University of Sheffield
name: Fidan Turk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franko DL, Striegel-Moore RH. The role of body dissatisfaction as a risk factor for depression in adolescent girls: are the differences Black and White? J Psychosom Res. 2002 Nov;53(5):975-83. doi: 10.1016/s0022-3999(02)00490-7.