cyrilzakka/clinical-trials huggingface dataset:
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT

The purpose of this study is to determine the impact a mobile health application has on adherence to a physical therapy home exercise program and its effect on functional outcomes.

Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction associated with musculoskeletal injuries. Healthcare and insurance restrictions are leading to reduced clinic visits, encouraging efficient and effective treatments and focusing a greater demand on education, proactive wellness and home exercise maintenance. Home exercise prescription has long been a fundamental aspect to a physical therapy routine or regimen. It is well established that exercise protocols can positively impact pain, fitness levels, physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, \& Shumway-Cook, 2006). It is also recognized that treatment outcomes may be negatively impacted by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden, Haywood, Portia, Gee, \& Mclean, 2014). Research historically suggests that levels of non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, \& van der Zee, 1993), and likely increase as time passes. Investigating non-adherence demonstrates a myriad of influencing factors. These factors can be characterized as motivators and barriers. With the explosion of mobile communications access and increasing number of active device users, healthcare is embarking on the concept of mobile health management. Mobile health interventions have been found to have a positive impact in the arenas of medication compliance, weight loss, chronic disease management and postoperative complication (Lee, 2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical therapy outpatient management has not been well established. It is time to investigate the impact of using a mobile health application on a prescribed physical therapy treatment regimen for the enhancement of HEP adherence and functional outcome assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Any musculoskeletal pathology: spine, UE, LE
2. Age18 or older
3. Primary language is English. Ability to read, write and understand the English language
4. Ownership of mobile smart phone
5. Functional and cognitive ability to operate/manipulate a mobile media application
6. Willingness to use their data package for support/use of mobile application

Exclusion Criteria:

Following the initial screening criteria, the study population will be scrutinized for exclusion.

Exclusion criteria:

1. History of neurological pathology with neurological impairments
2. Impaired cognition
3. Difficulty with operation and manipulation of mobile application
4. Difficulty with directions as set forth by the intake The exclusion criteria will be screened by written intake and a traditional medical history by the primary researcher. Subject enrollment will commence after eligibility is met and informed consent received.
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)

The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

The study will evaluate the effect of the combination of hydroxychloroquine and azithromycine versus placebo among 114 patients with COVID-19 and hematologic malignancy.

After randomization in 1:1 ratio, patients will receive either the study treatment or placebo :

* Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day during 4 days)
* Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules at day 1, then 1 capsule per day during 4 days)

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older patients
* Patient with hematologic malignancy who received or not hematopoietic stem cell transplantation
* Non severe Covid-19 disease
* PCR-confirmed COVID-19 disease by a nasopharyngeal swab
* Life-expectancy related to the hematologic malignancy of at least 1 month
* Men or women of child-bearing potential accepting to use effective contraception during and until 8 months after the end of the study treatment

Exclusion Criteria:

* Patients with severe form of COVID-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation
* Previous treatment with hydroxychloroquine or azithromycine for Covid-19 infection
* QTc interval greater than 480 ms
* Hypersensibility to hydroxychloroquine or azithromycine
* Retinopathy
* TGO or TGP geater than 5 x the normal upper limit
* Creatinine clearance lower than 30 ml/min
* Concomitant treatment that may lead to prolongation of the QT space
* Concomitant treatment with dihydroergotamine, ergotamine, cisapride or colchicine
* Known G6PD deficiency
Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

The primary objective of this research is to investigate the bioavailability of curcumin (CURC) and ursolic acid (UA) in a phase I clinical trial in healthy men and obtain biological material for bioavailability analysis.

Once a subject is consented and assigned to a cohort, the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood (including CBC and CMP safety labs) and urine. Medical history data will be collected and reviewed. The PI and/or study staff will provide supplement administration and supplement diary education prior to the subject starting their dose of UA, CURC, or UA and CURC combination. Pharmacokinetic (PK) and pharmacodynamic (PD) assessments will be collected at pre-dose and 6 and 24 hours after the first dose. Urine will also be collected at pre dose and 24 hours post dose. The dosing period will be for a total of 2 weeks (± 3 days). On the last day of dosing, subjects will attend a research only visit at which the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood and urine. At this time, the subject's supplement diary will be reviewed and a safety/AE assessment will be completed. In addition, research CBC and CMP safety labs will be collected. If a subject initially enrolled in Cohort 1 or 2 decides to continue in Cohort 3, the subject will undergo a wash out period of at least 4 weeks and repeat all study procedures for Cohort 3.

Eligibility Criteria:
Inclusion Criteria:

* Be able to give informed consent
* Be men age 18 or older
* Able to stop supplements

Exclusion Criteria:

* Unable to give informed consent
* Age \< 18
* Woman
* Prisoners
* Diagnosed cancer
* Unable to swallow pills
* Unable to stop supplements
Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality

On the following tests, there would be a greater increase in the functionality of COPD patients who underwent combined therapy than in those who only exercised: a set of activities of daily living (ADLs), the six-minute walk test (6MWT), an incremental symptom-limited cardiopulmonary test (CPT), and the physical functioning scale of the Short-Form 36 quality of life questionnaire (SF-36).

Impact of aerobic exercise plus noninvasive ventilation (NIV) on the functionality of patients with COPD. Thirty patients (70.5 - 8.5 years) with COPD (forced expiratory volume in the first second 48.5 - 15.4% of predicted) were randomized into either a physical training group involving aerobic treadmill exercise (PTG, n=12) or an exercise plus bilevel ventilation group (PTGNIV, n=11) with sessions three times a week for six weeks.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis
* with a forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC)\<70%
* clinical stability in the previous two months (i.e., no exacerbation of the disease).

Exclusion Criteria:

* decompensated heart failure or rheumatic, orthopedic or neuromuscular diseases that prevented the subjects from performing the tests due to exercise limitations;
* participation in a regular physical exercise program at the beginning of the study;
* noncompletion of one of the tests or the established protocol for any reason.
Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG

This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.

We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Eligibility Criteria:
Inclusion Criteria:

1. the age of 18-75year
2. Outpatients undergoing colonoscopy
3. Informed consent

Exclusion Criteria:

1. the age \>75 years or \<18 years
2. history of colectomy or bowel obstruction
3. severe constipation (defined as stool frequerncy of 3 or less/week)
4. current pregnancy or breastfeeding
5. BMI \>30, diabetes
6. known allergies to cleansing agents or ingredients of Enteral nutrition
7. inability to follow the oral bowel preparation regimen.
Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only enrolled if they fail first line therapy with metoclopramide.

The investigators are testing the following hypothesis:

In a population of patients who present to an ED with acute migraine and have been treated with parenteral metoclopramide unsuccessfully, bilateral greater occipital nerve blocks with bupivicaine will provide greater rates of short-term and sustained headache freedom than bupivacaine injected intradermally.

Eligibility Criteria:
Inclusion Criteria:

* ED patient with acute migraine or probable migraine
* Fail first line therapy with metoclopramide

Exclusion Criteria:

* Can't obtain consent
* Concern for secondary headache
* Skull defect
* Propensity for bleeding
* Overlying infection
* Pregnancy
* Allergy, intolerance study medication
Health of Pessary Versus Progesterone Supplement for Preventing Preterm Birth Children

To give strong recommendations on the efficacy and safety of vaginal progesterone versus cervical cerclage, we conduct this study to investigate the physical and mental development of children from vaginal progesterone versus cervical cerclage. Based on our research (Dang et al., 2019), the twin pregnancies with cervical lengths less than 38mm were randomly assigned to receive vaginal progesterone or cervical cerclage, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.

Preterm birth (PB) is the leading cause of neonatal morbidity and mortality. Twin pregnancies and short cervical length are two high-risk factors of PB. Generally, in singleton pregnancies with short cervical length below 25 mm, or with a history of preterm birth, preventive measures of PB are vaginal progesterone and cervical cerclage. The cervical pessary is also being investigated for effectiveness in PB prevention in different populations. However, the effective preventive methods for PB has not been identified up to now in twin pregnancies with short cervical length.

In our research, the results showed that the preterm birth rate before 34 weeks in the cervical pessary group was lower than the progesterone group (16% vs 22%, RR 0.73; 95% CI 0.46 - 1.18). The perinatal outcomes were also better in the cervical pessary group than in the progesterone group (19% vs 27%, RR 0.70; 95% CI 0.43 - 0.93). The cost of the cervical pessary method was also significantly lower than the vaginal progesterone method cost. Pessary insertion was also more convenient since it was only inserted once during pregnancy, compared to daily vaginal progesterone. Therefore, the cervical pessary may be an appropriate option for preventing preterm birth in twin pregnancies with a short cervix.

However, besides these short-term outcomes, we need to pay more attention to the longer-term issues of both mothers and infants. Some evidence up to now has demonstrated that both these two methods are safe with no impact on physical, mental, and motor development of children up to 3 years old and even in older children. However, such evidence is still rare. Also, there hasn't been any study evaluating the impact, if any, of these two PB preventive methods.

Eligibility Criteria:
Inclusion Criteria:

* Live babies born from The pessary versus vaginal progesterone in women with a twin pregnancy and a cervix \<38 mm study (NCT02623881)
* Parents agree to participate in the study.

Exclusion Criteria:

* Babies died after the perinatal period.
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.

To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 and ≤80 years.
* ECOG performance status of 0 to 1.
* Life expectancy of more than 12 weeks.
* At least one measurable lesion exists.(RECIST 1.1)
* Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
* Required laboratory values including following parameters:

ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms

* Signed informed consent.

Exclusion Criteria:

* Subjects with third space fluid that can not be controled by drainage or other methods.
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
* Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
* Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
* Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
* Receiving any other antitumor therapy.
* Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
* Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
* Known history of neurological or psychiatric disease, including epilepsy or dementia.
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria
* Eastern Cooperative Oncology Group (ECOG) status 0-2
* Adequate absolute neutrophil count (ANC), platelet count and hemoglobin
* Adequate serum calcium
* Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)

Exclusion Criteria:

* No treatment with dexamethasone for multiple myeloma
* No peripheral neuropathy of Grade 2 or higher
* No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage
* No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study
* No deep vein thrombosis (DVT) within 1 year of enrollment
* No current anticoagulation for DVT
Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer

The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.


Eligibility Criteria:
Inclusion Criteria:

* A female \> 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
* Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
* Written informed consent obtained from the subject prior to study start.
* Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.

Exclusion Criteria:

* Previous vaccination against human papillomavirus.
* History of chemotherapy or radiotherapy for cervical cancer.
* Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)

Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine.

The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it.

Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department.

Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation.

The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical).
* Patients with difficulties in understanding or using the devices studied.
* Patients with a contraindication to the use of one of the studied devices.
* Patients with a history of relevant shoulder surgery
* Presence of other associated trauma,
* Previous inclusion in the same study

Exclusion Criteria:

* Withdrawal of voluntary informed consent from the patient
* Violation of protocol
* Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)
* Posterior, inferior or erecta dislocation
* Presence of initial vascular and nerve complications
* Any indication for surgical management
Perioperative Time Course of MMP-9 and Its Inhibitor During Carotid Artery Stenting and Carotid Endarterectomy

The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS). The investigators used a matched, historical carotid endarteriectomy group as controls. Blood samples at four time points: T1: preoperative; T2: 60 minutes after stent insertion; T3: first postoperative morning; and T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.


Eligibility Criteria:
Inclusion Criteria:

elective carotid artery surgery

Exclusion Criteria:

Malignant diseases, inflammatory and systemic autoimmune disorders, psychiatric disorders and previous debilitating stroke
Responsive Parenting Program for Infants in Rural Bangladesh

Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.

There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.

Eligibility Criteria:
Inclusion Criteria:

* mother has a child 6 to 14 months of age
* mother willing to learn about child care

Exclusion Criteria:

* not severely disabled