louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00577356: Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Official title: Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Cell Genesys
name: Sanofi
First posted: 2007-12-20
Enrollment: 6
Sex: MALE
Minimum age (years): 18
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 find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).


Eligibility criteria: Inclusion Criteria:

* Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
* Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \<60%.

Exclusion Criteria:

* Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
* Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
* Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.

Primary outcomes:
measure: Number of Participants With Pathological Complete Response.
timeFrame: The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Jacqueline Vuky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727556: Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Keywords: skin conductance response
facial muscle activity
heart rate variability
eyetracking
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased sensitization, anxiety, and depression scores have been reported in addition to the peripheral changes in gastrointestinal tract functions. In this study, investigators will evaluate the activity of autonomic nervous system, emotional response, and visual attention to food and non-food images in 30 male and female FD patients and 30 age/gender-matched healthy volunteers. These data will provide a new finding of the influence of impaired cognitive processing of food on symptom generation in functional gastrointestinal disorder patients.


Eligibility criteria: Inclusion Criteria:

* Male and female, volunteering adults BMI: 18-25 kg/m² right-handed Age: 18-65 years Capacity to give informed consent For FD patients, Diagnosis of functional dyspepsia over the last 12 months certified by a medical record Inconspicuous gastroscopy during the last 6 months certified by a medical record

Exclusion Criteria:

* Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics

Primary outcomes:
measure: Psychological response
timeFrame: 1-2 years
measure: Psychological response
timeFrame: 1-2 years
measure: Psychological response
timeFrame: 1-2 years
measure: visual attention
timeFrame: 1-2 years
Secondary outcomes:
measure: Subjective rating
timeFrame: 1-2 years
measure: Subjective rating
timeFrame: 1-2 years
measure: Subjective rating
timeFrame: 1-2 years
measure: Subjective rating
timeFrame: 1-2 years
measure: Subjective rating
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Study officials:
affiliation: Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
name: Paul Enck, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640856: Relationship Between STOP BANG Score and Airway Management
Official title: Evaluation of Relationship Between Oxygen Reserve Index and Difficult Airway With Stop Bang Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Obstructive Sleep Apnea
Hypoxia
Keywords: Oxygen Reserve Index
STOP BANG Score
Difficult Airway
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-65 to be intubated undergoing elective surgery

Brief summary: Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III
* Between 18-65 years old
* Volunteered to participate in the study

Exclusion Criteria:

* diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS
* morbidly obese (BMI\>45 kg/m2),
* patients with a history of alcohol or drug addiction
* women in pregnancy or lactation
* allergic to the drugs used in the study

Primary outcomes:
measure: Evaluation of Oxygenation
timeFrame: up to intubation
Secondary outcomes:
measure: Evaluation of difficult Airway
timeFrame: up to intubation
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT04203615: Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
Official title: Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 39
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation.
Primary purpose: TREATMENT

Brief summary: Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. The project results will allow for the identification of potential therapeutic effects of rTMS as a tool that could contribute to the speech therapy of HD in PD patients. The results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.

Detailed description: A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation. An MRI protocol consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10 days of rTMS and then repeated after 4, 8 and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with clinically established PD (Postuma et al. 2016)

Exclusion Criteria:

* psychiatric disorders, including major depression, hallucinations
* any MRI-incompatible metal in the body
* epilepsy
* lack of cooperation
* presence of dementia

Primary outcomes:
measure: Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
timeFrame: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Secondary outcomes:
measure: Resting state
timeFrame: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Central European Institute of Technology
Study officials:
References:
Clinical trial NCT06288815: Oral Fluid vs IV Fluid After Primary TKA
Official title: Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Total Knee Arthroplasty
Oral Fluid Replacement
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.

The main question it aims to answer is:

Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?


Eligibility criteria: Inclusion Criteria:

* Age 40-85 years old
* ASA I, II
* Primary osteoarthritis

Exclusion Criteria:

* Diuretics use
* Morbid obesity
* Previous knee surgery
* Cannot undergo spinal anesthesia

Primary outcomes:
measure: Time to stand and walk
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Time up and go
timeFrame: 24 and 48 hours
measure: Incidence of oliguria
timeFrame: Postoperative day 1,2
measure: Incidence of nausea/vomiting
timeFrame: Postoperative day 1,2
measure: Urine specific gravity
timeFrame: Postoperative day 1
measure: the levels of certain electrolytes
timeFrame: Postoperative day 1,2
measure: the levels of creatinine
timeFrame: Postoperative day 1,2
measure: the levels of blood urea nitrogen (BUN).
timeFrame: Postoperative day 1,2
measure: Complications
timeFrame: Until postoperative 3months
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
References:
citation: Jennings JM, Mejia M, Williams MA, Johnson RM, Yang CC, Dennis DA. The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S3-S9. doi: 10.1016/j.arth.2020.01.029. Epub 2020 Jan 22.
Clinical trial NCT02006615: The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
Official title: The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Nervous System Diseases
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2013-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

Detailed description: Excitatory (\>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal gyrus.

Eligibility criteria: Inclusion Criteria:

1. Ischemic or hemorrhagic cerebrovascular lesion,
2. Parkinson's disease

Exclusion Criteria:

* Seizure
* With metal implantation
* Dementia or severe cognitive impairment

Primary outcomes:
measure: Change of Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change of Montreal Cognitive Assessment
timeFrame: Up to 12 weeks
measure: Change of Fugl-Meyer Assessment , Wolf Motor Function Test
timeFrame: Up to 12 weeks
Other outcomes:
measure: Change of hand grip, pinch power
timeFrame: Up to 12 weeks
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Po-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang PW, Lu CF, Chang ST, Tsai PY. Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study. Neurol Ther. 2022 Mar;11(1):103-121. doi: 10.1007/s40120-021-00300-0. Epub 2021 Nov 13.
citation: Tsai PY, Lin WS, Tsai KT, Kuo CY, Lin PH. High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans. J Psychiatry Neurosci. 2020 Jul 1;45(4):262-270. doi: 10.1503/jpn.190060.
citation: Lai CJ, Wang CP, Tsai PY, Chan RC, Lin SH, Lin FG, Hsieh CY. Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Arch Phys Med Rehabil. 2015 Jan;96(1):69-75. doi: 10.1016/j.apmr.2014.08.014. Epub 2014 Sep 11.
Clinical trial NCT03873415: Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males
Official title: Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
* Acute diarrhea, or constipation within 3 weeks prior to randomization
* Any major surgery within 4 weeks of randomization

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D
timeFrame: Determined over 5 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
timeFrame: Determined over 5 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D
timeFrame: Determined over 5 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D
timeFrame: Determined over 5 days
measure: Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D
timeFrame: Determined over 5 days
Secondary outcomes:
measure: Vital signs of body temperature
timeFrame: Up to 60 days
measure: Pulse rate
timeFrame: Up to 60 days
measure: Physical examination
timeFrame: Up to 60 days
measure: Incidence of adverse events (AE)
timeFrame: Up to 90 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 90 days
measure: Vital sign of respiratory rate
timeFrame: Up to 60 days
measure: Vital sign of supine blood pressure
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Scintipharma
state: Kentucky
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04500015: Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion
Official title: Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled study
Primary purpose: PREVENTION

Brief summary: To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion Criteria:

* pregnancy and
* contraindication or allergy to or contraindication to IUD insertion,
* chronic pelvic pain,
* pelvic inflammatory disease,
* analgesic intake 24 hours prior to IUD insertion.

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 10 minutes
measure: Provider ease of insertion
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT00447915: Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
Official title: Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Osteoporosis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 1265
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.


Eligibility criteria: Inclusion Criteria:

* Patients with fragile bone fracture
* Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
* Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
* Ambulatory

Exclusion Criteria:

* Patients with disease lowering bone volume secondarily (secondary osteoporosis)
* Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
* Patient with disorder delaying the passage of food through esophagus

Primary outcomes:
measure: Incidence of vertebral fracture
timeFrame: 36 months
Secondary outcomes:
measure: Change of bone density of lumbar spine and proximal part of femur from baseline
timeFrame: 36 months
measure: Change of bone absorption marker from baseline
timeFrame: 36 months
measure: Change of bone formation marker from baseline
timeFrame: 36 months
Other outcomes:
Locations:
city: Chubu/Kansai
country: Japan
facility: Chubu/Kansai region
city: Chugoku/Kyusyu
country: Japan
facility: Chugoku/Kyusyu region
city: Hokkaido/Tohoku
country: Japan
facility: Hokkaido/Tohoku region
city: Kanto/Koshinetsu
country: Japan
facility: Kanto/Koshinetsu region
Study officials:
affiliation: University of Occupational and Environment Health
name: Toshitaka Nakamura
role: STUDY_CHAIR
References: