louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03945448: Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Official title: Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cryptococcal Meningitis
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Gilead Sciences
First posted: 2019-05-10
Enrollment: 356
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda.

Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.

How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infection
* Age \> or equal to15 years
* Ability and willingness to give informed consent.
* Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater

Exclusion Criteria:

* Cannot or unlikely to attend regular clinic visits
* History of cryptococcal infection
* Symptomatic meningitis (confirmed by CSF CRAG+)
* \>14 days of fluconazole therapy
* Pregnancy (confirmed by urinary or serum pregnancy test)
* Current breastfeeding
* Known allergy to amphotericin

Primary outcomes:
measure: Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of grade 3 to 5 clinical adverse events or serious adverse events
timeFrame: within two weeks of enrollment
measure: Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale
timeFrame: within two weeks of enrollment
measure: Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy.
timeFrame: 24 weeks
measure: Number of patients that will survive in the 24-week period.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: infectious Disease Institute Kampala,Uganda
Study officials:
References:
Clinical trial NCT04670848: Contactless Detection of Sleep Apnea
Official title: Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Sleepiz AG
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.


Eligibility criteria: Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Patients suspected to suffer from sleep apnea or any other sleep related disorder

Exclusion Criteria:

* Previous enrollment into the current study,
* Enrollment of the investigator, his/her family members and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Primary outcomes:
measure: Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
timeFrame: 1 Night
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsmedizin Essen Ruhrlandklinik
state: North Rhine-Westphalia
Study officials:
affiliation: Universitätsmedizin Essen Ruhrlandklinik
name: Christoph Schöbel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010048: Compare the Therapeutic Effect Treated With Tamsulosin and Progesterone After ESWL( Extra Corporeal Shock Wave Lithotripsy) in Urinary Calculus
Official title: the Therapeutic Effect Treated With Tamsulosin After ESWL in Urinary Calculus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Calculus
Keywords: ESWL
urinary calculus
drugs treat
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the stone clearance rate treated with different drugs after ESWL in urinary calculus,These drugs are often used in urinary calculus,such as progesterone,tamsulosin,propantheline Bromide and nifedipine.In these study the investigators want to investigate different effect of these drugs use to treat urinary calculus after ESWL.

Detailed description: There is 4 groups in these investigation, group1 urinary calculus treated with ESWL only ,group2 urinary calculus treated with ESWL and tamsulosin,group3 urinary calculus treated with ESWL and progesterone,group4 urinary calculus treated with ESWL ,propantheline Bromide and nifedipine.We want to investigate which one is better or not in urinary calculus treated with ESWL .

Eligibility criteria: Inclusion Criteria:

* From 18 years old to 68 years old,
* urinary calculus could be treated by ESWL,
* the calculus size is from 4-25mm

Exclusion Criteria:

* Less than 18 years old or more than 68 years old,
* the calculus size is from Less than4 or larger than 25mm

Primary outcomes:
measure: different effect of these drugs use to treat urinary calculus after ESWL
timeFrame: 2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: ChongQing
country: China
facility: The First Affiliated Hospital, ChongQing medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: xiaohou wu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06008548: A New Conception About Individualized Treatment Allocation for HCC
Official title: A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Transarterial Chemoembolization
Resection
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Army Medical University, China
name: The First Affiliated Hospital of Shanxi Medical University
name: Sun Yat-sen University
name: Shaanxi Provincial People's Hospital
name: Xijing Hospital
name: Xi'an Jiaotong University
First posted: 2023-08-23
Enrollment: 4991
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was diagnosed based on either imaging or pathological results as previously described

Brief summary: The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.

Detailed description: Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE were included in the study. Various prognostic AI algorithms were modeled using data from a large multi-institutional cohort, where LR and TACE were considered independent factors. The C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC) were calculated to estimate the AI models.

Eligibility criteria: Inclusion Criteria

* Diagnosed with HCC
* Receiving LR or TACE therapy
* Complete clinical information
* Preserved liver function (Child-Pugh Score \[CPS\] ≤ 7)
* PS 0-1

Exclusion Criteria

* Vascular invasion or extrahepatic spread;
* Ecompensated liver cirrhosis ;
* Younger than 18 years;
* Duration of follow-up of fewer than 30 days.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tangdu hospital, Air Force medical university
name: Lei Liu, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04227548: Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation
Official title: Reference Values for the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness Polyneuromyopathy
Keywords: Critical illness myopathy
Critical illness neuropathy
direct muscle stimulation
Lead sponsor: Adana City Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 29
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Direct muscle stimulation (DMS) method is one of the electrodiagnostic methods used in the diagnosis of critical illness myopathy (CIM) and critical illness neuropathy (CIN). The ratio of amplitude of compound muscle action potential (CMAP) obtained by nerve stimulation (nCMAP) to amplitude of CMAP obtained by DMS (dmCMAP) can be used to differentiate these two diseases. Although not certain, if the ratio is \< 0.5, the diagnosis is thought to be consistent with CIN. The ratio \> 0.5 is considered to be a finding supporting CIM. The investigators aimed to find the reference values of the ratio from healthy individuals. A monopolar needle electrode was used for DMS. The dmCMAP and nCMAP were recorded with a concentric needle. The ratio was calculated by using amplitudes of dmCMAP and nCMAP obtained from deltoid and tibialis anterior muscles.

Detailed description: Age, gender, height, weight, body mass index and neurological examination findings of the participants were recorded. Healthy participants were not included if they had; polyneuropathy or a disease such as diabetes mellitus that causes polyneuropathy, complaints such as weakness or paresthesia, a neurodegenerative disease, abnormal neurological examination, myopathy or hereditary polyneuropathy in family history. In addition, healthy participants were excluded if the conventional nerve conduction study and needle electromyography (EMG) findings were abnormal. Median, ulnar, posterior tibial, peroneal, superficial peroneal, sural nerve conduction studies were performed to all participants. Needle EMG and direct muscle stimulation were applied to the deltoid and tibialis anterior muscles of the healthy participants.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Polyneuropathy
* a disease such as diabetes mellitus that causes polyneuropathy
* complaints such as weakness or paresthesia
* a neurodegenerative disease
* abnormal neurological examination

Primary outcomes:
measure: the Ratio of Compound Muscle Action Potential Amplitude Obtained by Nerve Stimulation to That Obtained by Direct Muscle Stimulation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
Study officials:
References:
Clinical trial NCT04867148: The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
Official title: The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankylosing Spondylitis
Adolescent Idiopathic Scoliosis
Gait Analysis
Keywords: Gait analysis
Spine
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Variable patterns of gait disturbance can be found in patients with spine disease including the problems of gait initiation, freezing of gait, reduced balance and postural control, reduced step lengths, increased step times, and slow walking speed.


Eligibility criteria: Inclusion Criteria:

* Pusan National University Hospital orthopedics, otorhinolaryngology, neurology outpatient or inpatient who agreed to the study.
* For adult men and women 18 years of age or older.

Exclusion Criteria:

* Patients unable to walk independently.

Primary outcomes:
measure: gait asymmetry
timeFrame: for 1minute walking
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
affiliation: Pusan National University Hospital
name: jungsub Lee, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05017948: Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
Official title: Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iatrogenic Disease
Risk Reduction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the MedWise Risk Score™ (MWRS™), a holistic approach to quantifying the risk of a patient's medication regimen. High risk patients will be identified at hospital discharge. Targeted interventions will be made to reduce their MWRS™ with a 30-day follow up. The hypothesis being tested is that a reduction in MWRS™ will lead to reduced 30-day readmission.


Eligibility criteria: Inclusion Criteria:

* Hospital admission for at least 48 hours
* Prescribed at least 5 medications at hospital discharge
* Baseline medication risk score of 20 or more

Exclusion Criteria:

* Reside greater than 25 miles from the index facility
* Discharge to hospice
* Discharge against medical advice
* Patient expiration during initial hospitalization

Primary outcomes:
measure: Number of individuals with an emergency department visit or hospital readmission
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: Difference in score between patients aged older and younger than 65 years
timeFrame: At time of intervention
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
Study officials:
References:
Clinical trial NCT02651948: Transperineal, MRI-guided, Prostate Biopsy
Official title: Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 90
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Primary purpose:

Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.

Secondary purposes:

* Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.
* Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies
* Study of correlation between radiologic images and anatomopathologic result
* Description of needle track during the procedure
* Description of real time template saturation prostate biopsy
* Comparison of transperineal prostate biopsy relevance according to EBM
* Comparison of 1.5T MRI and 3T MRI for prostate cancer detection


Eligibility criteria: Inclusion criteria:

* Men
* 40 to 80 years' old
* Affiliation to French social health system
* Signed consent
* Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies
* Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA \< 10)

Exclusion criteria:

* Gleason \> 6 prostate cancer
* Metastatic prostate cancer
* Contraindication to MRI
* Contraindication to general anesthesia
* Non-reversible hemostasis trouble
* Inability to give consent

Primary outcomes:
measure: Collection of complications and rehospitalizations by using questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'urologie
Study officials:
References:
Clinical trial NCT05247372: The Effect of Iyengar Yoga Practice on Patients with Multiple Sclerosis
Official title: The Effect of Iyengar Yoga Practice on Patients with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Iyenagar Yoga, Yoga, EDSS
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 5
Sex: FEMALE
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 aim of this work is to find out what effect the practice of Iyengar yoga has on patients with multiple sclerosis on the EDSS 5 and more, specifically in the field of mobility, self-sufficiency and anxiety.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* diagnosis of multiple sclerosis
* EDSS grade 5 or higher

Exclusion Criteria:

* age less than 18 years
* the patient is not diagnosed with multiple sclerosis EDSS grade less than 5
* refusal of the subject to participate in the study

Primary outcomes:
measure: Hypothesis 1
timeFrame: 3 months
measure: Hypothesis 2
timeFrame: 3 months
measure: Hypothesis 3
timeFrame: 3 months
measure: Hypothesis 4
timeFrame: 3 months
measure: Hypothesis 5
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol
state: Czech Republic
Study officials:
References:
Clinical trial NCT05245604: Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
Official title: A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 25 mmHg
* Patient using or to use punctual plug within 1 months.
* Patients with contact lens.

Primary outcomes:
measure: Change From Baseline in Non-anesthetic Schirmer Test at Week 32
timeFrame: Baseline and Week 32
Secondary outcomes:
measure: Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24
timeFrame: Baseline, Week 8, 16 and 24
measure: Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32
timeFrame: Baseline, Week 8, 16, 24 and 32
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyo Myung, Kim
Study officials:
affiliation: Korea University Anam Hospital
name: Hyo Myung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: