cyrilzakka/clinical-trials huggingface dataset:
Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.

PRIMARY OBJECTIVES:

I. Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period.

II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team.

III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.

OUTLINE:

Patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* English as primary language
* Planned autologous or allogeneic hematopoietic cell transplantation
* Presence of co-morbidities (hematopoietic cell transplant co-morbidity index \[HCT-CI\] score 3 or greater), high risk disease (relapse risk \> 25%), or a planned type of transplant (human leukocyte antigen \[HLA\]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse

Exclusion Criteria:

* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
* First transplant of a planned tandem procedure (the second transplant is eligible)
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy females as determined by medical evaluation
* Female participants who delivered normal-term infant (at least 37 weeks gestation) and are at least 6 weeks postpartum at the time of screening
* Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²), inclusive
* Female participants who has well-established lactation and is breastfeeding her infant. Note: Breastfeeding must be discontinued prior to the administration of tirzepatide on Day 1 and not resumed for the remaining duration of the study until a follow-up visit (or for total of 29 days after tirzepatide dosing for participants who discontinue early).

Exclusion Criteria:

* Have a history of inadequate lactation (for multiparous females who have previously breastfed)
* Have confirmed type 1 or type 2 diabetes mellitus
* Regularly use known drugs of abuse or show positive findings on drug screen
Prevalence of Resistant Hypertension With DOT

High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke, kidney failure and death. This risk is much higher in those with 'resistant' hypertension, in whom the blood pressure remains high despite more than 3 blood pressure medicines. Current estimates of the proportion of individuals with resistant hypertension may be an overestimate, since some of them are not actually adherent (i.e. not taking the medicines they are prescribed). Methods to detect non-adherence, such as asking the patient, counting pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where patients are administered medicines under observation by a health care personnel) is quite useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic, before more tests and interventions (such as CT scans, renal angiogram) are performed.

In this study, the investigators will measure the proportion of patients with resistant hypertension who are non-adherent based on direct observed therapy, and follow them up to examine the impact of this diagnosis.

This is a prospective, observational study.

Patients fitting inclusion and exclusion criteria, after informed consent, will undergo the direct observed therapy test in the hypertension unit (this is usual care in the unit, which they will undergo even if they are not part of the study).

The Direct Observation Therapy (DOT) Test includes the following components:

1. Administer and observe ingestion of usual morning antihypertensive medications.
2. Monitor BP every 30 minutes, using 5 readings of an automated oscillometric BP device ( BP-TRU), until plateau affect achieved, defined as 3 consecutive cycles of BP readings declining by less than 10 mmHg per cycle).
3. Registered Nurse (RN) repeats standing BP prior to initiation of 24 hour Ambulatory Blood Pressure Monitoring(ABPM).
4. RN initiates 24 hour ABPM

In addition, participants will undergo an additional 24-hour ABPM test 1 month after the DOT test is undertaken.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Confirmed resistant hypertension defined as daytime BP readings above 135/85 mmHg (confirmed by 24-hour ABPM results) using 3 or more BP lowering drugs
3. Adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record

Exclusion Criteria:

1. Pregnant patients
2. Inability to provide informed consent
Topical Treatment for TMJ Arthralgia

The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are:

* How does pain reduction compare?
* How does improvement in jaw function limitation compare?
* How do side effects compare? Participants will
* On day 1 be examined and report their pain level and jaw function limitation
* On days 1-21, apply their cream four times a day
* On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects.

Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects differ.

* Person 2 will label creams, patient packets (pre-stamped envelope, questionnaire, consent form), and give packets to Person 1 in the order in which they are to be dispensed.
* Person 1 will recruit all eligible patients in the order in which they are seen, enrolling all that consent. Packets and gel will be given to patient, and written and verbal instructions, including that email will be sent saying "Keep it up!" to remind them to continue applying get, as well as "Please send us your questionnaire". Consent forms will be stored in locked drawer.
* Person 1 will remind patient on days 7 and 14 to continue with the study
* Person 1 will remind patient on day 21 to mail back the completed questionnaire
* Person 1 will reach out to all patients from whom the questionnaire is not returned within 1 week of day 21, and do so at weekly intervals a minimum of 3 times.
* Person 1 will enter data in Excel as it comes, reaching out to patients if there are questions. Excel file uses random number ID, not patient name, thereby anonymizing the data
* Persons 1, 2, 3, and 4 will decide which patient's data, if any, should be removed
* Person 1 will send complete anonymized Excel data file (containing all patients) to Person 3
* Person 2 will determine, using random number generator, which group will be referred to as "Group A" during the statistical analysis, and which will be referred to as "Group B"
* Person 2 will tell Dr. Korczeniewska which data will be in Group A, and which will be in Group B
* Person 3 will perform statistical analysis
* Person 2 will reveal which group was Hydrocortisone, and which was Diclofenac

Eligibility Criteria:
Inclusion Criteria:

* Arthralgia of at least 1 TMJ for at least 3 days

Exclusion Criteria:

* Systemic pain condition
* Past adverse reaction to steroid
* Currently taking steroid
* Taken steroid in the past ___ months
* Muscle relaxants (may start after study is complete)
* New night guard during study, or within 1 month of start of study (may start after study is complete)
A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects

The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on QT/QTc interval.

The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, (therapeutic and supratherapeutic doses) to get information on effect of moxifloxacin on QT/QTc interval in healthy Korean male subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subject aged 20 to 40 at screening
* subjects who have weight over 50 kg with ideal body weight range of +- 20%
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have acute illness within 28 days of investigational drug administration
* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
* clinically significant allergic disease (except for mild allergic rhinitis)
* systolic blood pressure\>= 140 mmHg, diastolic blood pressure \>= 90 mmHg, heart rate \> 100 bpm or \< 50 bpm
* result of 12-lead electrocardiogram includes :

  * QTcF \> 450 msec
  * PR interval \> 200 msec or \<110msec
  * Evidence of second- or third-degree atrioventricular (AV) block
  * Pathologic Q waves (defined as Q-wave \> 40 msec or depth \> 0.5 millivolt
  * Evidence of ventricular pre-excitation, left bundle branch block (LBBB), right bundle branch block (RBBB)
  * Intraventricular conduction delay with QRS \> 120 msec
* risk of Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia
* Subjects considered unsuitable for inclusion by the investigator
Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns

Growing evidences indicates that the Kangaroo Mother Method is associated with health benefits for the child and her mother. Improvements have been found in physiological parameters of the preterm infants assisted by the method. Some of them are the reduction of the heart rate and respiratory, as well as the increase of the body temperature and of the arterial saturation of oxygen. More recently, it has been observed that children submitted to the method present an improvement in muscle tone, by the increase in the electromyographic activity of the biceps brachii and hamstrings. These physiological changes can result in benefits for the child, with a positive influence on their development.

It is well established that the preterm newborn has an important circulatory vulnerability, since the transition from fetal life to extrauterine life is a complex process in which the major changes are concentrated in the cardiovascular system and occur during the first Hours after birth accompanied by important consequences in physiological parameters, such as systemic vascular resistance, heart rate and blood flow in the organs. Therefore, global hemodynamic parameters have been studied in premature infants, especially after some intervention. It is worth noting, however, that these global parameters such as blood pressure, heart rate and arterial oxygen saturation do not reflect the existence of adequate tissue oxygenation, since they are macrocirculatory and non-microcirculatory parameters. In order to obtain reliable signals on tissue oxygenation, it is essential to study the microcirculation.

To further explore the effects that Kangaroo Position promotes on the physiological aspects of the newborn, especially on hemodynamic parameters, we consider it important to study aspects that may, in fact, represent an adequate tissue oxygenation. Therefore, the objective of this study is to evaluate the effect of Kangaroo Position in the electromyographic activity and on hemodynamic parameters, by means of microcirculation/macrocirculation measurements.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns with gestational ages older or equal than 27 and less than 37 completed weeks of gestation (Ballard Method)
* Preterm newborns hospitalized at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) with a corrected age less than 37 weeks at the moment of the evaluation
* Preterm newborns who were not submitted to the Kangaroo Position previously.

Exclusion Criteria:

* Apgar less than 7 in the 5''
* Previous history of intracranial hemorrhage (diagnosed by ultrasonography and recorded in the medical record)
* Previous convulsion history
* Congenital infection
* Infections of the central nervous system (meningitis or encephalitis)
* Malformations in the central nervous system
* Congenital cardiopaths
* Trauma during delivery
* Gastroesophageal reflux disease
* Phototherapy and anemia
A Feasibility Trial of Power Up

There is an increasing demand for digital tools to empower young people with mental health difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are increasingly being used to support child mental health. Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision making tools available to support young people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to participate more in decisions around their care.

The project will involve two phases:

* Development Phase -Developing Power Up according to the views and ideas expressed by young people, their parents/ carers, and clinicians in Patient and Public Involvement (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS, 10 parents/ carers and 10 clinicians to review the acceptability of the content and format of Power Up.
* Feasibility testing Phase -Conducting a feasibility trial with 120 young people with emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will receive treatment as usual and 60 will use Power Up alongside treatment as usual. Participant's ratings of empowerment, activation, and symptoms will be measured soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later.

The findings will inform the planning of a prospective cluster controlled trial. More broadly this trial will contribute an understanding of the feasibility and acceptability of developing and implementing a shared decision making app into CAMHS.


Eligibility Criteria:
Inclusion Criteria:

* Recently been referred to CAMHS (pre - first appointment)
* Presenting with emotional difficulties
* Clinician will have confirmed that the young person does not have any vulnerability which would make taking part in the study inappropriate to their context
Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO

Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years old; received V-V ECMO because of sevever respiratory failure

Exclusion Criteria:

* anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.
Physician Survey on Monitoring of Patients Treated With Quetiapine

A physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials

Assessment of physician behavior regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the EU

Eligibility Criteria:
Inclusion Criteria:

* Physicians targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.

Exclusion Criteria:

* Physicians who have participated in a survey involving SEROQUEL® / SEROQUEL® XR in the past six months are not eligible to participate in this survey.
SENSIMED Triggerfish Safety and Tolerability

The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comply with the study procedures
* Subject is 18-80 years old
* Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P\<0.05 or a glaucoma Hemifield test "outside normal limits
* Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (\>21 mmHg) but normal and reliable SAP visual fields at baseline
* Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Visual acuity of 20/200 or better in the study eye
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses
* Severe dry eye syndrome
* Keratoconus or other corneal abnormality
* Conjunctival or intraocular inflammation
* Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
* Full frame metal glasses during SENSIMED Triggerfish® recording
* Known hypersensitivity to silicone, plaster or ocular anesthesia
* Pregnancy and lactation
* Simultaneous participation in other clinical studies
Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

Eligibility Criteria:
Inclusion Criteria:

* Female with age group 20-40 years.
* Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.

Exclusion Criteria:

* Previous ovarian surgery.
* Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
* Polycystic ovary syndrome (PCO).
* Suspicion of ovarian malignancy by ultrasound.
* Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
* High basal FSH \>10mIU/mL (milli-international unit per milliliter).
Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial

This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use

The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.

Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Children aged 2-8 years

Exclusion Criteria:

* Previous surgery
* ASA \> II
* Parents' refusal