cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline.

During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc.

For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 19 to 65 years old
2. DSM-5 insomnia disorder patient
3. ISI ≥11
4. Capable of using mobile device and application

Exclusion Criteria:

1. currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
2. sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
3. progressive and active medical conditions
4. received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
5. major psychiatric illness as assessed through MINI
6. suicide risk as assessed through C-SSRS
7. having occupational risk due to sleep restriction
8. shift workers
9. PHQ-9 of 20 or above
10. Individuals who have actually slept less than an average of 5 hours per night over the past month
11. Pregnant women or individuals planning pregnancy during the clinical trial period
Pharmacogenetic DNA Bank

Aims of Research Proposal:

1. To build a DNA bank in association with a comprehensive database of treatment outcomes and toxicities of cancer patients.
2. To carry out genotyping of potential candidate genes in relation to specific anti-cancer agents and to correlate genotype with treatment outcomes and toxicities.

The investigators hypothesize that genetic variations between different individuals and ethnic groups may account for inter-individual and inter-ethnic differences in treatment response and toxicities to anti-cancer therapy. The understanding of the contribution of these genetic variations may help to individualize therapy to optimize treatment outcomes and reduce toxicities. Patients will be recruited from the National University Hospital Cancer Centre. Any individual aged 18 or above who has been diagnosed with cancer is eligible. 20 ml of blood will be collected from each subject for DNA extraction and pharmacogenetics analysis. At the time of recruitment, demographic characteristics, cancer history, and past and present cancer treatment history of the study subject will be collected. The patients' progress will be followed up periodically (approximately every 6 months) through the medical records, and subsequent cancer treatments, progression of cancer, and survival outcome will be updated. Follow-up will occur until death. Important treatment information that will be collected include the drug regimen, drug doses, intent of treatment, aematologic and non-haematologic toxicities, and hospitalization episodes that may be related to treatment. Known functional single nucleotide polymorphisms (SNPs) of drug metabolizing enzymes, transporters and targets of different anti-cancer agents will be characterized. More comprehensive genotyping will be carried out in 'outliers' who experience exceptional toxicity or biological response to identify novel functional SNPs using high throughput sequencing techniques. Correlation will be made between genotype and treatment-related outcomes (tumor response, progression-free survival) and toxicities. For selected patients, lymphoblastoid transformation will be carried out to maintain an infinite supply of DNA.


Eligibility Criteria:
Inclusion Criteria:

* Any cancer patient who is aged \>=18 is eligible.

Exclusion Criteria:

* Cancer patients who are below age 18 will be excluded.
Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.

Trauma is the most frequent cause of death in persons aged under 40, with half of these deaths resulting from uncontrolled bleeding. 1 in 4 of all severely injured and shocked patients develop a clotting abnormality termed Trauma Induced Coagulopathy (TIC) within minutes of injury, which causes blood to continue being lost from the body faster than it can be stemmed. Many more injured patients will go on to develop different types of coagulopathy at different times during the course of their treatment, either as a result of their body's ongoing response to trauma or as a consequence of their clinical care. Ultimately coagulopathic patients have increased blood transfusion requirements and suffer more adverse outcomes (e.g. multi organ failure).

Current management of coagulopathic, haemorrhaging trauma patients comprises the unguided transfusion of large volumes of red blood cells and clotting product supplements. Without rapidly available and validated diagnostics, products are delivered empirically to patients blind to the type and severity of TIC they may have or indeed even if they do not have TIC. This study will compare outcomes of viscoelastic haemostatic assay (VHA)-guided resuscitation versus conventional management of critically bleeding trauma patients. The hypothesis is that goal-directed haemostatic resuscitation of coagulopathic bleeding trauma patients will yield improved outcomes and reduced blood product demand, compared to empiric massive transfusion therapy.

Eligibility Criteria:
Inclusion Criteria:

Adult trauma patients (according to local definitions) will be enrolled if they:

* Present with hemorrhagic shock at any time from the time of injury until admission to the emergency department (where shock is defined by HR\>100 b/min and/or systolic BP\<90 mmHg) AND activate the local massive transfusion protocol
* Randomized within 3 hours of injury and 1 hour of admission to the emergency department
* Agreement is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (e.g.trauma team leader)

Exclusion Criteria:

* Any inclusion criteria are not met
Project-0027. Lay User Usage Study

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.

Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions for use and record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians.

The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.

At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.

The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.

True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 or over
* Willing to conduct a personal pregnancy test and reveal their pregnancy status
* Willing to give informed consent

Exclusion Criteria:

* Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P\&G), or affiliates.
* Has an immediate relative\* currently or previously employed by SPD, Alere, Unipath or P\&G or affiliates
* Previously used the investigational HPT within the last six months
* Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
* Confirmed to be pregnant by a healthcare professional and beyond the first trimester
* Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®
Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects

To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
* Age \>= 18 and \<= 55 years
* Body Mass Index (BMI) \>= 18.5 and \<= 29.9 kg/m²

Exclusion Criteria:

* Any finding at the medical examination (including blood pressure, pulse rate and ECG (electrocardiogram)) deviation from normal and of clinical relevance
* History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease
* History of cerebral bleeding (e.g. after a car accident)
* History of commotio cerebri
* Intake of drug with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Pelvic Examination in Pregnancy

This study is designed to determine whether the pelvic examination (including bimanual and speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with the chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive HCG will be considered for this non-inferiority-designed clinical trial. All patients who present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and have had serum or urine HCG testing and a formal ultrasound by a credentialed emergency physician or radiology technician as part of standard of care will be screened for further eligibility. Those patients with intra-uterine pregnancies \< 16 weeks gestation seen on ultrasound and meet inclusion criteria will then be asked to provide informed consent to participate in the study. Randomization will occur after consent has been obtained. Half of the patients will be randomized to receive pelvic examinations and the other half will not. Further care will be determined by the treating attending physician. The primary outcome will be a composite morbidity endpoint at 30 days, including return visits to the ED, emergency surgery, need for transfusion, infection, or other missed source of bleeding/ pain. Secondary outcomes of interest include ED throughput time, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Chief complaint of vaginal bleeding or lower abdominal pain
2. Intra-uterine pregnancy seen on ultrasound
3. Date \< 16 weeks by estimated LMP or ultrasound
4. Age \>21
5. Ability to provide written informed consent
6. English speaking

Exclusion Criteria:

1. Already enrolled in study
2. Morbid Obesity (BMI \> 40)
3. Pelvic exam performed prior to ultrasound results
4. Prisoner
5. Follow up cannot be assured
6. Admitted to hospital
7. Large amount of vaginal bleeding (\>10 pads in 24 hours or equivalent)
8. Unstable vital signs (SBP\<90 or HR\>110)
9. Known cervical carcinoma in the past 1 year
10. Clinical suspicion for alternative syndrome that requires pelvic exam (such as severe pain consistent with ovarian torsion)
11. Report or suspicion of penetrating vaginal trauma
12. Suspicion of Active Labor
13. Reported Sexual Assault
14. Current pregnancy by IVF
15. IUD in place
16. Suspicion of heterotopic pregnancy on ultrasound
Stroke Wearable Operative Rehabilitation Device Impact Trial

The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module.

The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time.

The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old at stroke onset, with no superior age limit;
* Medical diagnosis of acute ischemic stroke;
* First ever stroke;
* Previously independent, defined as having a modified Rankin scale (mRS) of 0-1;
* Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion;
* Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits \>10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale;
* Inpatients, within no more than 4 weeks after stroke onset;
* Medically stable, no intravenous medication and already able to sit for more than one hour comfortably;
* Favourable opinion of the attending stroke physician;
* Patient and caregiver understand the purpose of the study and provided written informed consent.

Exclusion Criteria:

* No detectable motor deficits at baseline assessment by the neurologist;
* Severe aphasia;
* Dementia (any stage);
* Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks;
* Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position;
* Pain that limits upper limb movement either on the normal or affected side;
* Upper limb amputation or severe deformity either on the normal or affected side;
* Fixed articular limitations of upper limb either on the normal or affected side;
* Enrollment in other trial in the previous 3 months.
Effect of Oral Oxytocin on Women's Response to Emotional Stimuli

The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.

All subjects will complete a series of questionnaires firstly to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), Positive and Negative Affect Schedule (PANAS). PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning. In the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24IU) or placebo. Blood samples are collected twice before and 30 minutes after oral administration to assess the plasma OXT concentrations change. 45 minutes after oral administration subjects will be required to finish fMRI scanning including resting-state fMRI task, emotional face task (happy, fear, angry and neutral faces), affective scene task (NAPS, Nencki affective picture system, positive, neutral, and negative-valence scenes). After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury
* Head trauma
* Substance abuse
* Medication
* fMRI contraindications (e.g. metal implants)
Outpatient Parenteral Antimicrobial Therapy (OPAT)

Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne University Hospital. The investigators plan to investigate the efficacy, safety and economicity of outpatient parenteral antimicrobial therapy administered at the new OPAT unit of the Lausanne University Hospital starting in January 2014 until December 2020.

Some patients require parenteral antibiotic therapy, but are well enough to return home. Outpatient parenteral antimicrobial therapy (OPAT) was first developed in the USA in the 1970s for patients with cystic fibrosis, before being adopted by other countries. It has been recognised as a useful, cost-effective and safe alternative to inpatient treatment. It is now a standard care in several countries and different national guidelines have been established. There are various models of care for OPAT and most OPAT centres provide hospital-centred nursing programmes or services based on nurses visiting the patient's home. A few centres have also shown that self-administration of intravenous antibiotic therapy is an effective and safe option for selected patients. Furthermore, use of continuous infusion of antibiotics increases the number of feasible treatments. Continuous infusion by pumps of antibiotics with a time-dependent killing mechanism is a practical option which has been described. In Europe, even if many infectious disease specialists feel that OPAT is required, it is still underdeveloped because of lack of funding, lack of leadership and lack of coordination between hospitals and community care.

In the last decades, programs to enhance care delivery on an outpatient basis in order to contain health costs have been developed in Switzerland. However administration of outpatient intravenous antibiotic therapy for patients who require parenteral therapy, but are otherwise fit enough to go home, hasn't been used widely until recently. In December 2013, an outpatient parenteral antibiotic treatment (OPAT) unit was initiated at Lausanne University Hospital with the goal of offering an alternative treatment programme that is equally effective and as safe as inpatient treatment.

The purpose of this study will be to investigate the efficacy, safety and economicity of treatments administered at the new OPAT unit of the University Hospital of Lausanne in the context of the Swiss Health System.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the OPAT unit of Lausanne University Hospital

Exclusion Criteria:

* Unable to give informed consent
* Refusing participation
Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female aged 22 years and older
* Persistent Eustachian tube dysfunction
* Failure of medical management
* Positive diagnosis of ETD
* Absence of internal carotid artery (ICA) dehiscence
* Able to read and understand English

Exclusion Criteria:

* Females who are pregnant or lactating
* Anatomy that requires an adjunctive surgical procedure
* Concomitant nasal or sinus procedures planned on the same day as surgical procedure
* Concomitant ear procedures planned on the same day as surgical procedure
* History of major surgery of the head or neck within four (4) months prior to surgery
* History of patulous ET
* History of fluctuating sensorineural hearing loss
* Active acute otitis media
* Tympanic membrane perforation
* Tympanosclerosis
* Acute upper respiratory infection
* Temporomandibular joint disorder
* Cleft palate
* Craniofacial syndrome
* Cystic fibrosis
* Ciliary dysmotility syndrome
* Systemic mucosal or immunodeficiency disease
* Intolerance of medication for ETD
* Prior intervention of Eustachian tube