cyrilzakka/clinical-trials huggingface dataset:
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.

This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza

Eligibility Criteria:
Inclusion Criteria:

* Critically ill adult patients \> 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
* Requiring mechanical ventilation (invasive or non-invasive)
* Receiving antiviral therapy (any medication at any dose and for any intended duration) for \< 72 hours
* Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1

Exclusion Criteria:

* Age \< 16 years
* Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
* Weight \< 40 kg
* Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)
* Rosuvastatin specific exclusions:

  1. Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)
  2. Allergy or intolerance to statins
  3. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay
  4. CK exceeds 10 times ULN or ALT exceeds 8 times the ULN
* Severe chronic liver disease (Child-Pugh Score 11-15) (see Appendix 6)
* Previous enrolment in this trial
* Pregnancy or breast feeding
* At the time of enrolment, patients must not have received \>72 hours of antiviral therapy
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.


Eligibility Criteria:
Inclusion Criteria:

* Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) \< 70 days' gestation on ultrasound
* Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score \> 4
* Age equal to or greater than 18 years
* Provide informed consent to participate
* Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone

Exclusion Criteria:

* Contraindication to medication abortion
* Allergy to mifepristone or misoprostol
* Contraindication or allergy to ibuprofen
* History of cardiac arrhythmia
* Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
* History of chronic pain disorder
* Any opioid use during previous 30 days
* Current or prior use of TENS
* BMI \> 30
Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's

Anosognosia is a recognised condition for people with Parkinson's, and is the result of physiological damage on brain structure.

Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the pre-surgery videos 12 months post-DBS, patients have forgotten and are shocked at how bad their symptoms were prior to surgery (personal communication), which may not be reflected in the change in QoL reported.

This lack of awareness, while possibly helpful in everyday life, may lead to effective treatments looking ineffective, or the benefits in QoL of effective treatment appearing reduced. This confound may not only reduce the apparent effectiveness but also the related cost-effectiveness of treatment. As cost-effectiveness is determined by both size and longevity of an effect, current methods of capturing these data may be suboptimal.

The overarching aim of this project is to identify coping mechanisms and pathological lack of self-awareness and the impact they are likely to have on patient reported quality of life (QoL) outcome measures for a chronic condition.

This will be an observational study, a case series of approx. 10 to 20 patients. These patients will be recruited over a 6 month period from the Queen Elizabeth Hospital, Birmingham and will be informed of the study during their routine pre-surgical visit.

Patients will be eligible if they are about to undergo DBS at Queen Elizabeth Hospital. If the participant has a carer, who is also willing to participate, they may also join the study. Patients will be excluded if they are unable to complete questionnaires in English.

Once recruited and following consent, a patient will complete a brief battery of questionnaires both self-reported and clinician rated prior to surgery and at their 6 month post op visit.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria

Exclusion Criteria:

* Unable to complete questionnaires in English.
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)

Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire.

Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).

Deeper knowledge of Adverse Events during routine administration.


Eligibility Criteria:
Inclusion Criteria:

* Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.

Exclusion Criteria:

* Not applicable.
The 10-years REPEATERS Cohort of French Adolescents

Losing contact with adult suicide attempters in the year after the suicide attempt (SA) increases the risk of recurrence. The situation with adolescents is unknown. Investigators aimed to determine whether being lost to contact early (LCE) by clinicians is a risk factor of longterm SA recurrence among adolescents and the associated factors.

Local clinical practice :

After an SA, adolescents receive treatment in the Children's Hospital or in the center of psychiatric consultation (few go to a private care clinic). All centers of psychiatric consultation belong to the same hospital center, which uses a unique medical record. According to the local clinical practice, patients and their parents systematically meet the child and adolescent psychiatric-department social worker at the time of the SA. The social worker informs the family that they will be called after 1 year to determine whether patients are safe or whether they need to resume care. For this call, the social worker uses the phone number listed in the medical record or finds the phone number in the national phone directory. If the social worker fails to contact the patient, the patient is considered LCE.

Patient follow-up :

Ten years after the index SA (every other year from 2004 to 2010), a self-reporting questionnaire will be sent to all adolescent suicide attempters and their parents, with a letter explaining the research. If the address of the patient is not available, the hospital records department will be contacted to collect these data for patients who will be re-hospitalized during the study period. When adolescent suicide attempters will be not contacted and when no information will be found in hospital records, the French Civil status Office will be called to determine whether patients were still alive. When no further information will be obtained, the adolescent will be considered lost to follow-up (LF) at the time of the last information from 1 to 10 years after the index SA.

Data collection :

At the time of the index SA, personal and family data will be collected from medical records for adolescents: personal characteristics (sex, age, history of SA \[yes/no\], psychiatric comorbidities of the SA \[yes/no\] according to the International Classification of Disease 10 (WHO, 1993), school difficulties \[yes/no\], and family characteristics (marital relationship of parents \[separated or not\], professional status of each parent \[working or not\], family history of SA \[yes/no\], and alcoholic dependence of parents \[yes/no\]). After the index SA, data on duration of hospitalization, psychiatric follow-up \[yes/no\], recurrence of SA in the year following the index SA (early SA recurrence \[yes/no\]), and LCE status \[yes/no\]) will be collected. Ten years after the index SA, a self-reporting questionnaire will be sent to the patient to assess SA recurrence.

Eligibility Criteria:
Inclusion Criteria:

* All adolescents who were hospitalized after an suicide attempt every other year from 1994 to 2000 in Nancy University Children's Hospital

Exclusion Criteria:

* The same patient being included twice
Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy

The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.

Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.

The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).

A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.

100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.

The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.


Eligibility Criteria:
Inclusion Criteria:

* Anti-MAG neuropathy (peripheral neuropathy and IgM monoclonal gammopathy with anti-MAG activity superior to 1000 BTU)

Exclusion Criteria:

* current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)
Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome

In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 4 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia

Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA.

The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
* Bilingual in Spanish and Catalan or bilingual in Spanish and English
* Different proficiency levels across languages are expected, any prior experience in both languages is acceptable
* Intervention study: Score of 15 or higher on the Mini-Mental State Examination
* Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination

Exclusion Criteria:

* Other central nervous system or medical diagnosis that can cause symptoms
* Other psychiatric diagnosis that can cause symptoms
* Significant, uncorrected visual or hearing impairment that would interfere with participation
* Prominent initial non-speech-language impairments (cognitive, behavioral, motoric)
* Intervention Study: Score of less than 15 on the Mini-Mental State Examination
* Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of less than 10 on the Mini-Mental State Examination
Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique

This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.

Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018
* Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital
* Ability to provide informed consent

Exclusion Criteria:

* Suspected contaminated positive blood culture
* Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
* Terminally ill patients
Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool

Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence.

This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.


Eligibility Criteria:
Inclusion Criteria:

* Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment

Exclusion Criteria:

-
Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families

Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%).

These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care.

The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old
* Be affiliated to the French military health insurance

Exclusion Criteria:

* Age \< 18 years-old
Enuresis Alarm - Is a Manual Trigger System Beneficial?

The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.

Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.

Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.

Participants must first be evaluated by a pediatric urology specialist.

Eligibility Criteria:
Inclusion Criteria:

* children ages 5-15 years
* Diagnosis of Primary Monosymptomatic Nocturnal Enuresis
* \>2 wet nights per week
* Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire
* Patients/parents compliance in recording data \> 50% of nights

Exclusion Criteria:

* Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery
* Concomitant DDAVP use, anticholinergic use, B3 agonist use
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg

Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged between 19 and 55
* Body mass index (BMI) in the range of 19 to 27 kg/m2
* Understand the requirements of the study and voluntarily consent to participate in the study
* Available for the entire study period

Exclusion Criteria:

* Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases
* Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg \> systolic blood pressure ≥ 140 mmHg, 60 mmHg \> diastolic blood pressure ≥ 90 mmHg)
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee,tea,coke)\> 4cups/day
  * smoking \> 10 cigarettes/day
  * alcohol \> 140g/week
* Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day
* Previously donate whole blood within 60 days or component blood within 30 days
* Subject has taken drugs which affects the ADME of investigational products
* Subject with known for hypersensitivity reactions to mirodenafil/ dapoxetine or other drugs
* Inadequate laboratory test result:

  * AST(SGOT) or ALT(SGPT) or total bilirubin \> 1.5 x upper limit of normal range
  * eGFR \< lower limit of normal range
* Subject considered as unsuitable based on medical judgement by investigators