louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004644: Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Herpes Simplex
Keywords: herpes simplex virus infection
herpesvirus infection
immunologic disorders and infectious disorders
rare disease
viral infection
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2000-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus (HSV) infection.

II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess resistance to antiviral medication. IV. Amplify disease classification for the purpose of predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF) predict long-term neurologic outcome.

VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain.

Detailed description: PROTOCOL OUTLINE:

Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28, and at 6, 12, 24, 36, and 48 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods:

* Tissue culture
* Monoclonal antibody staining
* Electron microscopy

--Prior/Concurrent Therapy--

No concurrent antiviral therapy

--Patient Characteristics--

Life expectancy: No imminent demise

Birth weight at least 1200 g Gestational age over 32 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Richard J. Whitley
role: STUDY_CHAIR
References:
Clinical trial NCT02995044: Sun Protection Factor Assay (319/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT00703144: Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy
Official title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diffusive and Convective Clearance
Body Clearance
Piperacillin Tazocilline Concentrations (Cmin)
Keywords: Pharmacokinetics
piperacillin/tazobactam.
Septic patients
oliguric renal failure
continuous veno-venous hemodiafiltration.
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2008-06-23
Enrollment: 10
Sex: ALL
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 pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

Detailed description: The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study.

Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment.

Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started.

Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day.

We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older .
* Females of childbearing potential must have a negative pregnancy test at screening.
* Subjects whose life expectancy is estimated over 7 days.
* Anuric patients requiring continuous venovenous hemodiafiltration
* Septic patients,severe sepsis or septic shock
* Written informed consent should be given either by the patient or a member of his family

Exclusion Criteria:

* Subjects with a history of true allergy or adverse drug reactions
* Pathogens whose antibiotic susceptibility is not proved.
* Patients having impaired hepatic function
* Contraindication of anticoagulation by heparin
* Residual renal function
* Participation in a clinical trial
* Interruption of treatment by piper/tazo or hemodiafiltration during the study.
* Patients with psychiatric disorder or serious medical condition which in the opinion of the investigator may lead to complexity in patient management.

Primary outcomes:
measure: Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
timeFrame: 2 days
Secondary outcomes:
measure: Body clearance
timeFrame: 2 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de Néphrologie
Study officials:
affiliation: University Hospital, Toulouse
name: LAVAYSSIERE Laurence, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03052244: tDCS and VI to Treat Neuropathic Pain and Function in SCI
Official title: tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SCI - Spinal Cord Injury
Keywords: tDCS (trans cranial direct current stimulation)
Visual illusion
Neuropathic pain
Spinal cord Injury
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain

Detailed description: Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients.

Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program.

In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).

Eligibility criteria: Inclusion Criteria:

1. patients hospitalized in spinal cord rehabilitation department
2. neuropathic pain following spinal cord injury
3. able to seat on a wheel chair
4. able to understand and comply with basic instructions
5. Hebrew speakers

Exclusion Criteria:

1. epilepsy
2. pregnancy
3. non-neuropathic pain
4. medical condition that affect cognitive functioning
5. medical condition other then the spinal cord injury that affect functioning

Primary outcomes:
measure: change in SCIM 3 (scale)
timeFrame: up to 7 day before and following the treatment
Secondary outcomes:
measure: change in VAS (Visual Analog Scale)
timeFrame: up to 7 day before and following the treatment
measure: change in BPI (Brief Pain Inventory)
timeFrame: up to 24h before and following the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Loewenstein Rehabilitation Center
name: Motti Ratmansky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754944: Study of Peripheral Arterial Disease (PAD) in People With Cancer Who Will Be Having Surgery
Official title: Impact and Prevalence of PAD on Cancer Patients at High-risk for PAD Going to Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease (PAD) in Cancer Patients
Keywords: Peripheral arterial disease (PAD)
Cancer patients
22-326
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: BMS Foundation
First posted: 2023-03-06
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 years or older with either diabetes (requiring medication or insulin) or a smoking history (current smoker, smoker within the last 15 years, ≥ 20 year pack history), facing major head and neck, thoracic, abdominal, or pelvic surgery requiring at least at 2-day admission.

Brief summary: Researchers are studying whether people with risk factors for blood circulation disease have a condition called peripheral arterial disease (PAD). People with PAD have poor blood circulation because of narrowing or blocks in blood vessels caused by fat or calcium deposits (atherosclerosis). The study researchers think that PAD may lead to worse outcomes in cancer treatment, but people with cancer are not routinely tested for the disease.

The purpose of this study is to find out how common PAD is among people with cancer who have risk factors for blood circulation disease, and to compare how often PAD is diagnosed in different racial groups


Eligibility criteria: Inclusion Criteria:

* Cancer patients who are ≥ 65 years old
* Either diabetes (on medication or insulin) or smoking history (current smoker, smoking within the last 15 years, ≥ 20 pack years)
* Patients who are scheduled for major head and neck, thoracic, abdominal, or pelvic surgery requiring at least a 2-day admission
* Ambulatory
* ≥ 6 month life expectancy as determined based on clinical judgement by the treating physician. If treating clinician does not confirm life-expectancy ≥ 6 months, will calculate Lee Schoenberg Index using ePrognosis.ucsf.edu.

Exclusion Criteria:

* Hospice patient, patient with a DNR order
* Non-ambulatory, wheelchair/bed bound
* \< 6 month life expectancy based on the clinical judgement by the treating physician

Primary outcomes:
measure: prevalence of PAD in cancer patients at high-risk for PAD going to surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yolanda Bryce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03456544: Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
Official title: Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vancomycin
Staphylococcal Infections
Adverse Effect
Acute Kidney Injury
Cross-sectional Study
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who use vancomycin from all centers.

Brief summary: The objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Further, the investigators assessed the outcomes of patients who developed VA-AKI and the risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for improving the prevention and treatment of VA-AKI in China.


Eligibility criteria: Inclusion Criteria:

* Using Vancomycin
* ≥18 years old

Exclusion Criteria:

* Medical records were incomplete
* Had been diagnosed with stage 5 CKD or were regularly receiving dialysis
* SCr were not being adequately monitored to detect the development of AKI
* Had undergone nephrectomy

Primary outcomes:
measure: Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate
timeFrame: 1 year
Secondary outcomes:
measure: VAN-AKI detection rate
timeFrame: 1 year
measure: TDM detction rate
timeFrame: 1 year
measure: 0h Serum creatinine detction rate
timeFrame: 1 year
measure: 48h Serum creatinine detction rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05184244: Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire
Official title: Investigation of the Psychometric Properties of the Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Activity, Motor
Cerebral Palsy
Limitation, Mobility
Keywords: cerebral palsy
limitation
activity
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 89
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with CP aged between 2 and 18 years and their parents

Brief summary: This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Test re-test method was used for reliability.

Detailed description: Cerebral Palsy (CP) is a clinical picture with permanent disorders of the development of movement and posture whether assessing activity limitations matters. This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties.

The internal consistency of the scale was evaluated using Cronbach's alpha value and the inter-measurement reliability using the intraclass correlation coefficient (ICC). In construct validity analysis; ACTIVLIM-CP score; was correlated with PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM total scores. A known group comparison was made according to ambulation and epilepsy existence with the Principal Components Explanatory Factor Analysis.

Eligibility criteria: Inclusion Criteria:

* children with CP who were diagnosed by a child neurologist
* having physical therapy sessions at special education and rehabilitation center
* age between 2 and 18

Exclusion Criteria:

* whose parent was illiterate or doesn't speak Turkish
* whose parent wasn't complete the questionnaires

Primary outcomes:
measure: Global Activity Performance assessment
timeFrame: 15 minutes
Secondary outcomes:
measure: Gunctional capabilities and limitations
timeFrame: 5 minutes
measure: Functional independence measurement
timeFrame: 15 minutes
measure: Child's ability to walk assessment
timeFrame: 10 minutes
measure: child's manual ability assessment
timeFrame: 15 minutes
measure: Functional assessment
timeFrame: 20 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İlknur Naz Gürşan
Study officials:
References:
Clinical trial NCT03209544: Think Life, an Online Self-help Intervention for Coping With Suicidal Ideation
Official title: A Randomized Controlled Trial on the Effectiveness of an Online Self-help Intervention for Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Keywords: Suicidal ideation
Suicide
Cognitive behavioral therapy
Online intervention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2017-07-06
Enrollment: 724
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 objective of the Think Life study is to test the effect of an online, unguided self-help intervention, i.e. Think Life. The primary hypothesis is that Think Life will reduce suicidal ideation. The secondary hypothesis is that Think Life will lead to improvements in depressive symptoms, hopelessness, rumination, and anxiety. Positive changes are expected after completing Think Life and at follow-up, twelve weeks after baseline.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Have internet access and an e-mail account

Exclusion Criteria:

* No suicidal thoughts (i.e. baseline score on Beck Scale for Suicide Ideation = 0)

Primary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
Secondary outcomes:
measure: Suicidal Ideation Attributes
timeFrame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
measure: Beck Depression Inventory - second edition
timeFrame: Baseline, and 2, 4, 6 (post-test) and 12 weeks (follow-up) after baseline
measure: Beck Hopelessness Scale
timeFrame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
measure: Penn State Worry Questionnaire - Past Week
timeFrame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline, and 6 (post-test) and 12 weeks (follow-up) after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Ghent Univeristy - Flemish Centre for Expertise in Suicide Prevention
name: Kees van Heeringen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00835744: Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles
Official title: Among Non-IVF Patients Undergoing Ovulation Induction With Clomiphene Citrate (Clomid® 50 mg), Does Administration of an Increased Dose of Clomiphene Citrate (Clomid® 100 mg) Compared With Gonadotropins, Achieve Similar Rates of Folliculogenesis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: ovulation induction
clomiphene citrate
gonadotropins
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.


Eligibility criteria: Inclusion Criteria:

* \< 39 years old on day of randomisation
* FSH \< 12 (in the early follicular phase)
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Chronic oligo or anovulation (WHO 2)
* BMI between 18 and 31 (both inclusive)

Exclusion Criteria:

* ≥ 39 years old on day of randomisation

Primary outcomes:
measure: folliculogenesis
timeFrame: april 2009
Secondary outcomes:
measure: pregnancy rate
timeFrame: april 2009
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References: