louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01786031: Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
Official title: Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Castration Resistant Prostate Cancer Patients
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.


Eligibility criteria: Inclusion Criteria:

* Prostate Cancer patients
* Castration Resistant
* Prostatic tissue available
* Metastasis which may be biopsied

Exclusion Criteria:

Primary outcomes:
measure: Biomarker
timeFrame: assessed at the end of recruitment, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val de Marne
Study officials:
References:
citation: Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.
Clinical trial NCT02924831: High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome
Official title: High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).
2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).


Eligibility criteria: Inclusion Criteria:

1. The patients meeting criteria of CFS;
2. Aged from 18-65;
3. With no skin lesions for the acupuncture area;
4. Sign on the Informed Consent Form;

Exclusion Criteria:

1. Patients who can't accept and are afraid of acupuncture in the acupuncture group.
2. Patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system.
3. Persons suffering from a mental disease, Alzheimer's disease or cancer.
4. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation.
5. Pregnant women and nursing mothers.
6. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function.
7. Persons with alcohol and drug abuse history.

Primary outcomes:
measure: Chalder's Fatigue Scale Score(CFSS)
timeFrame: Two years
Secondary outcomes:
measure: Numeric Rating Scale(NRS)
timeFrame: Two years
measure: 36-item Short-Form Health Survey (SF-36)
timeFrame: Two years
measure: Deficiency of Qi Scale Score (DQSS)
timeFrame: Two years
measure: Total Power(TP)
timeFrame: Two years
measure: Low frequency(LF)
timeFrame: Two years
measure: High frequency (HF)
timeFrame: Two years
measure: LF/HF
timeFrame: Two years
measure: Ultra-low frequency(ULF)
timeFrame: Two years
measure: Very low frequency
timeFrame: Two years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei university of TCM
state: Hubei
Study officials:
References:
Clinical trial NCT00677131: Study of the Evaluation of Patient Education Efficacy in Pharmacy of National Taiwan University Hospital
Official title: Study of the Evaluation of Patient Education Efficacy: Reconstitution, Storage, and Administration of Oral Antibiotic Suspension From Powder Dosage Form at Pharmacy of National Taiwan University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: pediatrics
antibiotics
patient education
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We randomize patient family into one of the following three groups:

1. To read the package insert of the drug
2. To read the education information provided by Pharmacy of NTUH
3. Oral education provided by the pharmacist

Then we will evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

Detailed description: The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We designed twelve questions about reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form in a questionnaire. We will recruit pediatric patients who are prescribed one of the two oral antibiotics powder for suspension, Augmentin and Zithromax. We will randomize the family of these patients into one of the following three groups:

1. To read the package insert of the drug
2. To read the education information provided by Pharmacy of NTUH
3. Oral education provided by the pharmacist

Then we will ask them the twelve questions in the questionnaire and record their answer. Eventually, we will be able to compare the number of the correct answer, and to evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

Eligibility criteria: Inclusion Criteria:

* Family of pediatric patient who is prescribed one of the two oral antibiotics granule for suspension, Augmentin and Zithromax, in NTUH

Exclusion Criteria:

* Family of pediatric patient who can not read Chinese

Primary outcomes:
measure: Number of correct answer of questions that patient family make
timeFrame: At the end of education
Secondary outcomes:
measure: The type of the correct answer of question that patient family make
timeFrame: At the end of education
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Li J Shen, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02425631: CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System
Official title: CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacroiliitis
Keywords: SI joint fusion
SI joint pain
SI joint
SI joint treatment
SI joint disease
Sacroiliac joint
Simmetry
Lead sponsor: Zyga Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with the SImmetry System will be recruited for this study.

Brief summary: This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).


Eligibility criteria: Inclusion Criteria:

* Patient must have a SImmetry device implanted.
* Patient is willing to comply with study procedures and provide informed consent.

Exclusion Criteria:

* Patient is physically unable to return to the clinic for CT imaging.

Primary outcomes:
measure: SI Joint Fusion (CT evidence of SI joint fusion)
timeFrame: 12 months
Secondary outcomes:
measure: SI Joint Pain (CT evidence of SI joint fusion)
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Zyga
name: Lisa Ingham
role: STUDY_DIRECTOR
References:
Clinical trial NCT00437931: Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subclinical Hypothyroidism
Hyperthyroidism
Thyroid Dysfunction
Keywords: hypothyroidism
hyperthyroidism
thyroid dysfunction
ultrasound
doppler
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with subclinical hypothyroidism and hyperthyroidism

Brief summary: Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction

Detailed description: Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS. Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.

Eligibility criteria: Inclusion Criteria:

* patients with subclinical hypothyroidism or hyperthyroidism
* patients with thyroid nodules and normal thyroid function

Exclusion Criteria:

* patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone
* patients who had thyroid surgery or radioiodine therapy
* patients with NYHA class 3 or 4 heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center, Department of Radiology
Study officials:
affiliation: Haemek Medical Center, Endocrine Institute, Afula, Israel
name: Avraham Ishay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haemek Medical Center, Department of Radiology, Afula , Israel
name: Leonid Chervinsky
role: STUDY_CHAIR
affiliation: Haemek Medical Center, Endocrine Institute, Afula, Israel
name: Rafael Luboshitzky, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00004431: Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: neurologic and psychiatric disorders
rare disease
trigeminal neuralgia
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia.

II. Evaluate the safety and tolerance of L-baclofen in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, parallel study.

Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week. Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period.

Patients, thereafter, may enroll in a long term open label study with L-baclofen.

Patients are followed at 1, 3, 6, 9, and 12 months.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Idiopathic trigeminal neuralgia - Paroxysmal attacks of facial or frontal pain lasting a few seconds to less than 2 minutes - Pain has at least 4 of the following characteristics: Distribution along one or more divisions of the trigeminal nerve Sudden, intense, sharp, superficial, stabbing, or burning quality Pain intensity severe Precipitation from trigger areas, or by certain daily activities such as eating, talking, washing the face, or cleaning the teeth Between paroxysms entirely asymptomatic - No neurological deficit - Attacks are stereotyped in the individual patient - Exclusion of other causes of facial pain by history, physical examination and special investigations when necessary Must be uncontrolled or refractory as defined by occurrence of at least 2 paroxysms of pain per day despite conventional treatment with maximally tolerated doses of carbamazepine --Prior/Concurrent Therapy-- No concurrent medication for trigeminal neuralgia other than carbamazepine, phenytoin, and neurontin Concurrent medication for other conditions allowed Concurrent medication must be on stable dose(s) --Patient Characteristics-- Hepatic: No significant hepatic disease Renal: No significant renal disease Neurological: No evidence of progressing neurological disorder (e.g., intracranial neoplasm, multiple sclerosis) Other: No history of drug abuse Not pregnant Effective contraception required of all fertile patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael J. Soso
role: STUDY_CHAIR
References:
Clinical trial NCT01520831: Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
Official title: A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18 and 28 kg/m\^2 inclusive
* HbA1c within the normal laboratory range
* Non smoker for at least three months
* Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

* Subjects who have received any investigational drug in the 3 months prior to the start of dosing
* Any disease requiring regular use of non topical prescription medicines
* Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
* Any intercurrent illness or endocrine disorders that may affect blood glucose
* Subject with a history of drug or alcohol dependence
* Subject with a first degree relative with diabetes mellitus
* Subject with a history of clinically relevant allergic reactions to medical products
* Subjects who have donated any blood or plasma in the past 3 month preceding screening

Primary outcomes:
measure: Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
Secondary outcomes:
measure: Maximum GIR value
measure: Time to maximum GIR value
measure: Area under the GIR profile
measure: Cmax, maximum insulin aspart concentration
measure: Area under the insulin aspart concentration curve
measure: tmax, the time to maximum insulin aspart concentration
measure: t½, terminal half-life
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301
Clinical trial NCT02714231: Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion
Official title: A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Family Planning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.


Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to intrauterine device placement

Primary outcomes:
measure: Mean pain score during insertion
timeFrame: intraoperative
Secondary outcomes:
measure: Patient satisfaction score
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
affiliation: Woman health hospital Assiut
name: ahmed abbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209131: Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Official title: Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urolithiasis
Keywords: urolithiasis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 24
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 majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Detailed description: Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

Exclusion Criteria:

* Contraindications to Flomax
* Patients with renal impairment (serum creatinine above 2.0)
* Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
* Use of other oral alpha blockers

Primary outcomes:
measure: Time to Passage of Stone Fragments
timeFrame: 2 weeks and 3 months
Secondary outcomes:
measure: Medical Evaluation
timeFrame: 2 weeks and 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05537831: Ultrasound Guided Hematoma Block in Distal Forearm Fractures
Official title: Ultrasound Guided vs Landmark-based Hematoma Block in Distal Forearm Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forearm Fracture
Keywords: Ultrasound
Hematoma block
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized control trial comparing the efficacy of ultrasound (US) guided vs landmark-guided hematoma blocks on distal forearm fractures.


Eligibility criteria: Inclusion Criteria:

* Patients greater than and equal to seven years of age
* Patients with traumatic acute distal radius/ulnar fractures with displacement that require reduction and immobilization with splinting
* Patients that receive distal radius hematoma blocks, including those who require additional pain control adjuncts if pain control is not adequate

Exclusion Criteria:

* Prisoners
* Pregnant women
* Patients with altered mental status/have impaired decision-making capacity.
* Patients with allergies to amide anesthetics

Primary outcomes:
measure: Pain relief from landmark versus ultrasound guided hematoma block
timeFrame: Change in pain score from before the hematoma block to immediately after the reduction/splinting of the forearm fracture
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05756231: Cultural and Linguistic Adaptation and Normative Study of the Turkish Version of the Free and Cued Selective Reminding Test: 16-Word Version (FCSRT-T)
Official title: Cultural and Linguistic Adaptation and Normative Study of the Turkish Version of the Free and Cued Selective Reminding Test: 16-Word Version (FCSRT-T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Memory Impairment
Keywords: Alzheimer Disease
Memory Complaint
Memory
Dementia
Free and Cued Selective Reminding Test
Adaptation
Validity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: An Adaptation Study of Free and Cued Selective Reminding Test in Turkish

Detailed description: As very commonly used for objectifying Alzheimer Disease memory deficits, an adaptive selection of word choices are done for the use of free and cued selective reminding test (FCSRT) procedure in Turkish population. In this study the validity and reliability of the test to measure memory deficits in persons with memory complaints will be discussed.

Eligibility criteria: Inclusion Criteria:

* having memory complaints
* demanding clinical consultation for the memory complaint

Exclusion Criteria:

* vascular pathology
* extrapyramidal findings
* psychiatric illness
* epilepsy
* cognition affecting drug use

Primary outcomes:
measure: Validity of translation
timeFrame: once
measure: Factor Analyses
timeFrame: once
measure: Validity of the ability of the measure to objectify the memory deficit in dementia
timeFrame: once
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: İ. Hakan Gürvit, Prof. MD.
role: STUDY_DIRECTOR
References: