louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01073501: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Official title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uremic Pruritus
Keywords: UREMIC PRURITUS
PREGABALIN
UP
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 36
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: Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).

We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.


Eligibility criteria: Inclusion Criteria:

1. History of pruritus of \>8 weeks duration.
2. Severity of pruritus of 7 or more defined by visual analogue scale.
3. No improvement by oral antihistamines or skin moisturizers.
4. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study.
5. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

1. Known allergy to Pregabalin
2. Any acute illness;
3. Liver cirrhosis
4. Active dermatological disorder other than UP
5. Decompensated heart failure;
6. Inability to give informed consent;
7. Poor compliance.

Primary outcomes:
measure: Reduction of UP by more than 50% after Pregabalin administration
timeFrame: 2012
Secondary outcomes:
measure: Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration
timeFrame: 2012
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT04696601: Rapid Screening for Olfactory Disorders in Covid-19 Infection
Official title: Rapid Screening for Olfactory Disorders in Covid-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Olfaction Disorders
COVID-19 Testing
Keywords: Olfaction Disorders
Hyposmia
Dysosmia
Anosmia
Covid-19
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.

The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.


Eligibility criteria: Inclusion Criteria:

* Subject presenting himself at the covid-19 screening centre set up by the city of Nice

Exclusion Criteria:

* Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
* Subject receiving cancer chemotherapy

Primary outcomes:
measure: Olfactory test
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Renaud DAVID, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01990001: Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool
Official title: Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Adherence and Continuation
Keywords: contraception, adherence, medication reminder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American College of Obstetricians and Gynecologists
First posted: 2013-11-21
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice.

Detailed description: The specific aims of the study are to:

1. Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit.
2. Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.

Eligibility criteria: Inclusion Criteria:

1. Female, 18-29 years old
2. Prescribed one of the following birth control:

   Oral contraceptive pills, vaginal ring, transdermal patch, or Depo Provera
3. Able to provide consent
4. Have regular access to a computer, Ipad, or a hand-held device such as a smartphone.
5. Women must be able to read and speak English(Bedsider website in not translated into Spanish)

Exclusion Criteria:

1. Male
2. Over the age of 30 years old
3. Non-English Speaking
4. Limited or no access to computer, Ipad or hand-held device(smartphone)

Primary outcomes:
measure: Proportion of patients using the online reminder tool three months after enrollment
timeFrame: 3 months
Secondary outcomes:
measure: Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
timeFrame: 3 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Women's Health- Cannon
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Ashlyn Savage, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06282601: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS
Official title: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Presbyacousie
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 27
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.

However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.

In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.

This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children.


Eligibility criteria: Inclusion Criteria:

* No objection to participation in the study
* Men and women aged ≥ 70 years
* Patients diagnosed with presbyacusis (age-related bilateral and symmetrical sensorineural hearing loss, all stages combined), with or without the use of a bilateral hearing aid.
* If they use a hearing aid: hearing must have an average free-field fitted tonal threshold of 40 dB max and free-field fitted speech discrimination without lip-reading of 90-100% at 60dB in silence.
* MMSE score ≥ 24/30

Exclusion Criteria:

* Person under legal protection (curatorship, guardianship)
* Person under court order
* Adult unable to provide consent
* Person with a neurocognitive disorder (post-stroke, dyslexia, dyspraxia) or neuro-psychiatric disorder (dementia, autism)
* Severe sensorineural hearing loss with mean free-field threshold \> 40 dB and free-field speech discrimination without lip-reading of \< 90-100% at 60dB in silence
* Asymmetrical sensorineural hearing loss due to an additional cause of hearing loss on one side.

Secondary exclusion criteria:

Person with syntax disorder (discovery of sentence comprehension or production disorders during syntax test)

Primary outcomes:
measure: linguistic performance test focusing on syntax.
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00225901: Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
Official title: Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Failure, Acute
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.

Detailed description: Fulminant and late-onset hepatic failure (LOHF) is intractable disease with high degree of fatality (70-80%). Only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or LOHF. However, approximately 75% of the patients are not able to receive liver transplantation in Japan, and effective non-surgical treatment has not been established yet. Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury.

In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF, who can not receive liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of fulminant or late-onset hepatic failure
* Must be unable to receive liver transplantation

Exclusion Criteria:

* Under 16 years old
* Cancer patients
* Pregnancy-aged women
* Impaired renal function
* Impaired cardiac function
* Severe complications including pneumonia, sepsis, DIC and so on

Primary outcomes:
measure: All adverse effects throughout the protocol
Secondary outcomes:
measure: Survival time at 4 weeks
measure: Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days
measure: Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Tsutomu Chiba, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04112901: Effects of Microprocessor-controlled Knee Joints on Community Outcomes
Official title: Activity, Mobility, Social Functioning, Mental Health and Quality of Life Outcomes in Limited Mobility Transfemoral and Knee Disarticulation Amputees Using Microprocessor-Controlled Knees or Non-Microprocessor Controlled Knees in the United Kingdom: A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: People With Trans-femoral Amputation
Keywords: Trans-femoral amputation
Limb prosthesis
Microprocessor Controlled Knee Joints
Community Outcome Measures
Lead sponsor: University of Derby
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Amputees registered with Amputee Rehabilitation Centres across the United Kingdom.

Brief summary: About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities.

Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed.

Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.


Eligibility criteria: Inclusion Criteria:

* Unilateral transfemoral amputation or knee disarticulation
* ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground,
* Users of either MPK or N-MPK for at least 6 months prior to the recruitment date.

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Short Form-36 Quality of Life (SF-36)
timeFrame: Baseline
Secondary outcomes:
measure: Special Interest Group in Amputee Medicine (SIGAM)
timeFrame: Baseline
measure: Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.
timeFrame: Baseline
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Derby
name: Reza Safari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06456801: Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
Official title: Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephropathy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic kidney disease

Brief summary: Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Detailed description: Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Eligibility criteria: Inclusion Criteria:

Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information).

Exclusion Criteria:

Exclude serum samples that meet one of the following conditions:

① Samples with insufficient sample size, ② Samples with incomplete sample information.

Primary outcomes:
measure: Calculate the correlation between the test reagents and comparison reagents
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated hospital Zhejiang University school of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Xiaoying Du
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887001: Impact of Clinical Pharmacist on the Quality and Cost of the Therapeutic Management of Patients in Two Medical Services of a Teaching Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Admitted to Infectiology or Internal Medicine Wards
Keywords: cost study
clinical pharmacist
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Incomplete information or poorly communicated to the transitional stages of the patient's drug therapy hospitalized cause medication errors. These steps are the admission, transfer within the institution and hospital discharge to home or another institution.

The adequacy of the prescription recommendations of good practice is not always optimal.

The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more and more heavily in health spending and in the prolongation of hospitalization or re hospitalization.

Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its effectiveness on these three themes; it seems appropriate to assess this practice in the environment of the French health system.


Eligibility criteria: Inclusion Criteria:

* patients admitted in in infectious and tropical diseases unit or the internal medicine unit

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of prescriptions
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00722501: Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women of non-childbearing potential between the ages of 18 and 50.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg2.
3. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Primary outcomes:
measure: To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects
timeFrame: 4 days per group
Secondary outcomes:
measure: To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects
timeFrame: 4 days per group
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Trial Manager
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: