cyrilzakka/clinical-trials huggingface dataset:
The Effect of Telemonitoring on Anxiety and Quality of Life in Patients in COVID 19 Quarantine

The study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.

The COVID 19 pandemic, which continues today, has caused radical changes in social, cultural, education, and health systems around the world(Zhang and Liu 2020; Wang et all 2020; Alipour \&Abdolahzadeh 2020). In this period, health care providers tried to use telehealth services as a good alternative to solve the problems caused by quarantine, social isolation practices to reduce the rate of transmission of the disease, and the limitation of physical access to health services due to the risk of transmission.

Thus, the use of telehealth applications, which first started in the 1950s, gained momentum especially during the pandemic period (Byrne 2020; Lurie \& Carr 2018; Clipper 2020; Fagherazzi 2020). Telehealth applications, which have the opportunity to be widely used during the COVID 19 pandemic period, are generally a system that provides two-way communication between healthcare professionals and patients and includes image, speech, and digital communication technologies (Hazin \& Qaddoumi, 2010; Merz et all 2021; Bryne 2020). Tele-monitoring is a good option to support patients in the management of existing physical symptoms of quarantined patients who are isolated at home, except for patients who need outpatient or hospital treatment in the COVID 19 pandemic. In studies investigating the presence of mental problems as a result of the decrease in the social support of the patients in this group due to social isolation, the study results indicate that the patients experience negative conditions such as depression, stress, sleep problems, and anxiety (Verma 2020, Alipour et all 2020; Chakeri et all 2020).

Therefore, when quarantined patients are evaluated holistically, there is a need for studies evaluating the effect of telehealth services to increase the quality of life by coping with mental problems such as anxiety and depression. Although there are studies in the related literature showing that telemonitoring can cope with physical problems, improve quality of life, and reduce mental problems such as anxiety and depression, studies showing the effect of telemonitoring given to quarantined patients on anxiety and quality of life are quite limited (Kamei et all 2021; Jahromi et all 2016; Charekei et all 2020; Allipour et all 2020). For this reason, our study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.

Eligibility Criteria:
Inclusion Criteria:

- Volunteer patients who were diagnosed with COVID 19, over the age of 18, had no communication problems, were literate, had no diagnosed mental pathology, were able to use smartphones were included in the study

Exclusion Criteria:

* In the study, a patient whose general condition deteriorated during the COVID 19 quarantine and was hospitalized was excluded from the sample
The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome

Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both animals and humans. It has been suggested that forskolin may also suppress appetite thus reduce energy intake and results in weight loss. This study will evaluate the appetite suppressant properties of Coleus forskohlii extract. In addition the effect on central obesity and risk factors of metabolic syndrome will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Both Australian males and females, age 20-60 years, Overweight or obese (BMI \>25), waist circumference of \> 94 cm (male), waist circumference of \>80 cm (female)

Exclusion Criteria:

* Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.
Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.

PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

OBJECTIVES:

* To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
* To assess the variability in number of CTCs between patients with the same tumor type.
* To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.

OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No history of any prior cancer

PRIOR CONCURRENT THERAPY:

* No prior therapy for metastatic disease
Drug Interaction Study Between AZD3480 and Warfarin

The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool

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.

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)
Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.

The objective of this research is to compare the efficacy of stabilization exercise versus pelvic girdle pain thrust manipulation technique in females with postpartum pain.

Pelvic-girdle pain is a mechanical disorder growing rapidly as a consequence of changing delivery pattern and changing lifestyle. Medication with synthetic drugs not only has been unable to effectively curtail the spread of this disease conditions but also is most of the times linked with co-occurring side-effects. The exercise and manual therapy-based approach could lead in reducing the functional limitations and morbidity rate in females with the postpartum pain. This research could also help in spreading the awareness globally, to Prenatal and Postnatal Hospital Caregivers.

Eligibility Criteria:
Inclusion Criteria:

* • Post-partum females with the normal vaginal delivery present with pelvic girdle pain before the next conception.

  * Aged between 18 and 45
  * Posterior pelvic girdle pain located distal and/or lateral to the L5-S1
  * Pain onset during pregnancy or within 3 weeks after delivery, most recent delivery within 6 to 16 weeks
  * Positive posterior pelvic pain provocation (P4) test

Exclusion Criteria:

* Patients presenting with the history of:

  * Back pain indicating radiculopathy
  * Mechanical back pain
  * Back pain due to disc herniation
  * Rheumatological diseases
  * Neurological illness or recent surgery
  * Women who have gone through C-section
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, 18 to 70 years of age, inclusive
* Subject has an established diagnosis of epilepsy
* Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening

Exclusion Criteria:

* Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
* Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
* Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
* History or presence of status epilepticus during the 6 months prior to EMU admission
* Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
* Subject has \> 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or \> ULN total bilirubin
* Subject has chronic liver disease
* Subject has hypersensitivity to BRV or any of its excipients
* Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
* Subject with a history of psychogenic seizures
* Subject is a pregnant or lactating female
* Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
* Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
* Subject has acute narrow-angle glaucoma or myasthenia gravis
* Subject is receiving benzodiazepine treatment (defined as an average of \>=4 administrations per week) that started less than 28 days prior to EMU admission
* Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients
Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders

The goal of this randomized-controlled trial is to compare distributed treatment schedules and intensive treatment schedules in 84 school-age children with residual speech sound disorders. The main question it aims to answer is:

* How does intensive and distributed treatment affect speech sound learning in residual speech sound disorder?

Some participants will be treated with a traditional Distributed schedule of 2 sessions per weeks for 8 weeks (16 hours total), whereas others will be treated with an Intensive schedule and will complete 16 hours of treatment in 4 weeks.

Residual speech sound disorders are defined as speech sound disorders that persist past \~8-9 years and may lead to social, academic, and vocational limitations. Thus, there is a need to investigate how treatment schedules affect speech sound learning. The overall objective of this study is to optimize a suite of theoretically motivated, high-fidelity, motor-based treatments delivered at the appropriate intensity, despite practical barriers, for the most commonly impacted RSSD sounds: /ɹ, s/. Our central working hypothesis, supported by our preliminary work, is that Speech Motor Chaining is more efficacious when delivered intensively (i.e., closely spaced for a fixed number of sessions). The theoretical rationale is that increasing intensity early in treatment will mitigate erred practice between sessions, improving outcomes relative to more customary practice distributions. To test this hypothesis, children will be randomly assigned to receive a standard Distributed treatment schedule or an Intensive treatment schedule.

Eligibility Criteria:
Inclusion Criteria:

* Must speak American English as a dominant language.
* Must have began learning English by at least the age of 3 years.
* Must be between 9;0 to 17;11 years of age.
* Must have reported difficulty with /ɹ/ and/or /s/ production
* Must pass pure tone hearing screening at 25 dB at 1000, 2000, and 4000 Hz.
* Must receive a scaled score of at least 5 on the Listening Comprehension and Story Retelling subtests of the Test of Integrated Language and Literacy Skills (TILLS)
* Must receive a percentile score of 5 or below on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) Sounds in Words subtest.
* Must have 1 scorable response with 5+ consecutive correct /pataka/ with \> 3.4 syllables per second in the MRR-Tri task of the Maximum Performance Tasks OR must demonstrate no childhood apraxia of speech (CAS-only) features in BOTH articulatory and rate/prosody domains of the ProCAD.
* Must score \<40% accurate on /ɹ/ and/or /s/ probes assessing these sounds at the word level.
* Must express a desire to modify their speech.

Exclusion Criteria:

* Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, or brain injury.
* Must not have current cleft palate or voice disorder.
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers

A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002

A randomized, open-label, single-dose, replicate crossover study

Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years of age or older and 55 years of age
* BMI 18.5 \~ 27.5 kg/m2
* Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial

Exclusion Criteria:

* Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
* Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
* Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
* Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
* Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
* Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
* In the case of women, those who do not show a negative response on the pregnancy test
* Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)

Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with acute heart failure can identify patients at risk for recurrent admissions for heart failure.

Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted with acute decompensated heart failure (ADHF).

Secondary Objectives

1. Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a composite of 1 year mortality and HFH in patients admitted with ADHF.
2. Determine the ability of proportionate pulse pressure, orthostatic blood pressure changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to predict HFH and mortality

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria:

  1. Evidence of systemic congestion (manifested by any 2 of the following criteria: jugular venous distension, edema, pulmonary rales, Left ventricular S3, or radiographic evidence of pulmonary venous congestion)
  2. Elevated Brain natriuretic peptide
  3. Need for at least 1 dose of intravenous loop diuretic

Exclusion Criteria:

* Cardiogenic shock, Acute coronary syndromes (patients with mild elevation in troponin related to heart failure will not be excluded), patients who are admitted for another principal problem and develop ADHF in the hospital, pregnant females, end stage renal disease on hemodialysis, expected survival \< 6 months.
DIabetic Retinopathy Candesartan Trials.

The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 55 years with type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.
* Duration of diabetes for \> 1 year and \< 20 years with stable diabetic therapy within last 6 months.
* Patients with untreated resting mean sitting SBP \< 130 mmHg, mean sitting DBP \< 85 mmHg and with retinal photograph grading level \> 20/10 up to \< 47/47 (on ETDRS severity scale).

Exclusion Criteria:

* Patients with the following conditions are excluded from participation on the study:
* Cataract or media opacity of a degree which precludes taking gradable retinal photographs
* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
* History or presence of proliferative retinopathy
* History or presence of clinical significant macular oedema (CSME)
* History or evidence of photocoagulation of the retina
* Other retinal conditions which may mask assessment, eg, retinal vein occlusion
* Positive micral dipstick test
* Presence of secondary diabetes
* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
* Need of treatment with ACE-inhibitor
* Haemodynamically significant aortic or mitral valve stenosis
* Known renal artery stenosis or kidney transplantation
* Hypersensitivity to study drug
* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator
mCVI® Lighting Conditions Clinical Study

This single center prospective clinical study is to verify the algorithm of mCVI® in 4 different lighting conditions to accurately capture pulse rate and respiratory rate in 10 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

In this prospective clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to two commercially-available Masimo pulse oximeter devices in a single visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 21 - 70
* Informed consent obtained and signed

Exclusion Criteria:

* Self-reported medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Self-reported medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
* Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
* Participants wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
* Inability to provide informed consent
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream

To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults


Eligibility Criteria:
Inclusion Criteria:

* Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
* History of hypersensitivity to the study products or any topical or systemic corticosteroids;