louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02271646: Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation
Official title: Ultrasound Guided Thoracic Paravertebral Blocks: An Effective Pain Control in Percutaneous Radiofrequency Ablation of Hepatic Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: paravertebral block
ultrasound guided
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2014-10-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital normally receive only intravenous sedative drugs which sometimes can not provide effective pain control.

TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of using ultrasound guided which make it is more reliable and has less side effects especially the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use right TPVB at T5-6, T7-8, and T9-10.

The aim of this study is to prove that TPVB can provide an effective pain control for patients undergo liver RFA both at rest and movement (cough). We are going to measure the pain score at recovery room and the effective pain control means patients has mild pain (pain score less \</= 3 and do not ask for analgesic drugs).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients undergo percutaneous radiofrequency ablation for liver tumors
* ASA classification 1-3

Exclusion Criteria:

* Psychiatric illness
* Chronic abdominal pain \> 1 week
* Regular analgesic drugs use
* Infection at back (Block area)
* Severe spinal deformity
* PT \> 16 sec, aPTT \> 32, platelet \< 50,000/cumm

Primary outcomes:
measure: pain score at recovery room both at rest and movement (cough)
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Distribution of local anesthetic drugs after performing ultrasound guided TPVB at T5-6, T7-8 and T9-10.
timeFrame: After performing TPVB at 5, 10, 20 and 30 minutes.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Mahidol University
name: Pawinee Pangthipampai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00221546: Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
Official title: Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Belgian Society against Cystic Fibrosis
First posted: 2005-09-22
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Detailed description: Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Eligibility criteria: Inclusion Criteria:

* Delta F 508 homozygote
* Stable clinical situation

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study
timeFrame: before the study start and during the 2 years of the study
Secondary outcomes:
measure: Evolution of the fatty acid profile
timeFrame: during the 2 years of the study
measure: Oxidative stress status
timeFrame: during the 2 years of the study
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Armand Christophe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470546: Metformin Experience on Minimal Hepatic Encephalopathy
Official title: Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Hepatic Encephalopathy
Keywords: Hepatic encephalopathy
Metformin
Liver cirrhosis
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary aim:

-To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.

Secondary aim:

-To evaluate if metformin is a safety drug in patients showing liver cirrhosis.

Detailed description: In this study, 30 patients will be included divided in two arms. Investigators and patients will not know the treatment used (double blind).

Arm 1: Metformin 1000mg twice a day (2000 mg/day), during 12 weeks. Arm 2: Placebo 1000mg twice a day (2000mg/day), during 12 weeks.

At the end of the study, patients will be followed-up 8 weeks more to control the appearance of adverse effects.

Eligibility criteria: Inclusion Criteria:

* Patients with \> 18 years old
* Patients with the results of all the factors evaluable at the time of inclusion
* Patients who have accepted their participation in the study through informed consent
* Patients showing liver cirrhosis by ultrasound, transient elastography or liver biopsy
* Patients showing minimal hepatic encephalopathy (PHES \< 4 or Critical Flicker Frequency \< 39 Hz)

Exclusion Criteria:

* Patients with any contraindications to the drugs used
* Patients showing type 1 diabetes mellitus
* Patients showing type 2 diabetes mellitus and previous or current use of exogenous insulin, metformin or other oral antidiabetic drug

Primary outcomes:
measure: Number of patients with Minimal hepatic encephalopathy
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patients with Minimal hepatic encephalopathy
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Study officials:
affiliation: Valme University Hospital
name: Manuel Romero-Gomez, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646446: Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
Official title: Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use, Unspecified
Sexual Assault
Lead sponsor: Lifespan
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address reducing alcohol use, sexual revictimization, and psychological distress among bisexual+ women (i.e., attraction to more than one gender: bisexual, pansexual, queer). The main questions the study seeks to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relative to control, at the 2- and 4-month follow-up period, produce reductions in the quantity and frequency of alcohol use, sexual victimization, and psychological distress (anxiety, depression). Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group.


Eligibility criteria: Inclusion Criteria:

* be between the ages of 18 and 24 years of age;
* identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary
* identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer);
* report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, incapacitation or force;
* report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;
* report past month sexual activity.

Exclusion Criteria:

* current suicide risk on the Beck Depression Inventory
* current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist

Primary outcomes:
measure: Alcohol Use
timeFrame: Change from baseline alcohol use at 4 months.
measure: Sexual Victimization
timeFrame: Reductions in comparison to control at 4 months.
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline at 4-months.
measure: Depression
timeFrame: Change from baseline at 4-months.
measure: Mindfulness
timeFrame: Change from baseline at 4-months.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT04300946: Time Prediction and Cerebellum: Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers
Official title: Effects of the Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: The aim of the study is to check the role of the cerebellum in time prediction in healthy volunteers, by means of magnetic transcranial stimulation targeted on the cerebellum, and recording of behavioural measures indexing time prediction


Eligibility criteria: Inclusion Criteria:

* Participant, male or female, between 18 and 60 years old
* Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
* Subject who has dated and signed an informed consent form
* For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study

Exclusion Criteria:

* - Participant with substance use disorders (as defined by DSM-V)
* Participants taking benzodiazepines and related substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
* Participant with neurological pathology or sequelae
* Participant with Attention Deficit Hyperactivity Disorder (ADHD)
* Participant with a borderline personality disorder
* Participant with disabling sensory impairments, including visual acuity (corrected, if applicable) \< 0.8 (due to use of visual material) (Freiburg Vision Test, Bach 1996)
* Participant deprived of liberty or subject to the safeguard of justice
* Participant under guardianship or curatorship
* Participant in a period of exclusion defined by another clinical study or participant in a study that may impact on research results
* Pregnant or breastfeeding woman
* Subject with a contraindication to performing an MRI or TMS: presence of non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular lead, certain intracerebral clips, cochlear implants, history of epilepsy, skin pathology at the point of contact with the electrodes.
* Subject with a history of major neurological or psychiatric illness with current psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine and related drugs, or hypnotic).

Primary outcomes:
measure: EEG index of time expectation
timeFrame: 40 minutes
measure: EEG index of time expectation
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References:
Clinical trial NCT02080546: Vaginal Cuff Dehiscence and Thermal Injury During TLH
Official title: Vaginal Cuff Dehiscence and Thermal Injury at the Time of Total Laparoscopic Hysterectomy: A Review of the Duke Experience and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Cuff Dehiscence
Thermal Injury
Keywords: Vaginal cuff dehiscence
Thermal Injury
Total laparoscopic hysterectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 120
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: Purpose of this randomized control study is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy.

Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Patient scheduled for total laparoscopic hysterectomy (TLH)
3. Signed informed consent

Exclusion Criteria:

1. Known pelvic infection within 30 days prior to hysterectomy

Primary outcomes:
measure: Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy
timeFrame: up to 36 months
Secondary outcomes:
measure: Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
timeFrame: 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Paula S Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teoh D, Lowery WJ, Jiang X, Ehrisman J, Halvorson P, Broadwater G, Bentley R, Secord AA, Sobolewski C, Berchuck A, Havrilesky LJ, Valea FA, Lee PS. Vaginal cuff thermal injury by mode of colpotomy at total laparoscopic hysterectomy: a randomized clinical trial. J Minim Invasive Gynecol. 2015 Feb;22(2):227-33. doi: 10.1016/j.jmig.2014.10.002. Epub 2014 Oct 8.
Clinical trial NCT00007046: Genetic Study of Patients and Families With Diaphyseal Medullary Stenosis With Malignant Fibrous Histiocytoma of the Bone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stenosis
Histiocytoma
Keywords: arthritis & connective tissue diseases
bone cancer
diaphyseal medullary stenosis
genetic diseases and dysmorphic syndromes
malignant fibrous histiocytoma of bone
musculoskeletal/mesodermal cancer
oncologic disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2000-12-07
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone.

II. Determine the clinical manifestations of this disease in these patients.

Detailed description: PROTOCOL OUTLINE: Blood samples are obtained from affected individuals and their family members after genetic counseling. Genetic linkage analysis is performed on these blood samples. Unaffected individuals undergo x-rays and technetium bone scans to detect the presence of bone disease. Affected individuals undergo bone densitometry, MRI studies, thallium scans, ophthalmologic examination, electrocardiogram, echocardiogram, and skin biopsies.

Affected family members identified after radiologic studies receive additional genetic counseling.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone

OR

Family member, including spouses, of an affected individual

--Patient Characteristics--

Renal: Not specified

* Not pregnant
* Negative pregnancy test
* No diminished mental capacity
* No prisoners

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: J.A. Martignetti
role: STUDY_CHAIR
References:
Clinical trial NCT02061046: To Study the Impact of CPAP on Gait Parameters in OSA Patients
Official title: Impact of the CPAP on Gait in OSA Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Gait
Dual task
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OSA patients without any prior treatment

Brief summary: To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.

Detailed description: To study the impact of CPAP therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the SMTEC system. Patients will be assessed before and 8 weeks after CPAP therapy.

Eligibility criteria: Inclusion Criteria:

* OSA patients newly diagnosed

Exclusion Criteria:

* acute medical illness in the past months
* neurological and psychiatric diseases
* orthopaedic, rheumatologic or any sensory conditions affecting normal walking

Primary outcomes:
measure: Gait parameters: gait velocity [m/s]
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Gilles Allali, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04823910: Personalizing Docetaxel Dosing in Advanced Prostate Cancer
Official title: Personalizing Docetaxel Dosing in Advanced Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Physiomics
Sponsor class: INDUSTRY
Collaborators: name: Portsmouth Hospitals NHS Trust
name: National Institute for Health Research, United Kingdom
First posted: 2021-04-01
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with metastatic prostate cancer due to start treatment with docetaxel

Brief summary: Patients with advanced prostate cancer are often treated with the chemotherapy drug docetaxel. The manufacturers of this drug suggest using the same dose of drug per m² body surface area for all patients. However we know that individuals end up with more or less of the drug circulating in their blood even after they have been given the same dose.

A software program (a "Dosing Tool") has been developed to provide information to doctors on how docetaxel will affect individual patients. The program may help doctors to make informed decisions about exactly how much drug to give to different people.

The purpose of the PARTNER study is to gather information from blood tests on patients being treated with docetaxel to help in the further development of the Dosing Tool. Some of these blood tests would have been taken anyway as part of patients' routine treatment. Others are extra for this study. Apart from the additional blood tests, everyone who enters the study is treated just as they would normally be if they were not taking part in the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with metastatic prostate cancer (hormone sensitive or castrate resistant) and histologically confirmed
* Metastatic at disease onset or relapsed disease
* A treatment decision has been made to start a course of docetaxel as part of their standard of care treatment in accordance with the drug's label and the treating clinician's judgement
* Patient has not received a previous cycle of docetaxel within 8 weeks of the date of enrolment
* Life expectancy \> 12 weeks
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

- Patients with autoimmune disease receiving active treatments Participant is unable to give informed consent

Primary outcomes:
measure: Measured vs predicted absolute neutrophil count over time between weeks three and six of docetaxel treatment
timeFrame: The tool will be used to predict the level of neutropenia between the second and third doses of docetaxel (so between weeks three and six of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust
Study officials:
References:
Clinical trial NCT05701410: Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.
Official title: Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Amyloidosis
Spinal Stenosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark.


Eligibility criteria: Inclusion Criteria:

* History of lumbar spinal stenosis.
* Age \> 60 years at the time of spinal stenosis surgery.
* Written informed consent.

Exclusion Criteria:

* Known amyloidosis
* Myelomatosis
* Monoclonal gammopathy of unknown origin, MGUS
* Morbus Waldenstrøm

Primary outcomes:
measure: Diagnosis of cardiac amyloidosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital
Study officials:
References: