cyrilzakka/clinical-trials huggingface dataset:
Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \& Gynecology

The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.

Eligibility Criteria:
Inclusion Criteria: ● primigravida.

* Singleton pregnancy.
* Term gestation i.e, 38-41 weeks.
* Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
* Vertex presentation with occipito anterior position.
* Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.

Exclusion Criteria: ● Abnormal presentation or occipito posterior position.

* Multiple pregnancies.
* Cephalo-pelvic disproportion.
* Cervical surgery in the past or history of cervical injury.
* Patients on antihypertensive therapy.
* Known hypersensitivity to drotaverine or meperidine.
* If any other spasmolytic agent had been used within 48 hours.
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency

This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age.
* Evidence of serum 25-OH-D levels \< 20 ng/mL or ≤ 10 ng/mL, for each cohort.
* Written informed consent.
* For females of childbearing potential only: willing to perform pregnancy tests, must agree to use highly effective methods of birth control throughout the study.

Exclusion Criteria:

* Subjects receiving any treatment with calcifediol, vitamin D analogues, vitamin complexes or vitamin D supplements.
* Subjects taking drugs that could modify vitamin D levels.
* Subjects taking calcium supplements.
* Uncorrected hypercalcaemia, known hypercalciuria or nephrolithiasis.
* Severe renal impairment.
* Subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypothyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism.
* Any present or previous malignancy.
* Known contraindications or sensitivities to the use of the IP or any of its components.
* Pregnant woman, breastfeeding woman or woman planning a pregnancy.
* Subject has received an IP within 30 days before the start of the screening or is currently enrolled in an investigational interventional study.
* Any condition that may jeopardise the clinical trial conduct according to the protocol.
* Employees of the investigator or clinical trial site, as well as family members of the employees or the principal investigator.
* Person committed to an institution by virtue of an order issued either by judicial or other authorities.
Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital

Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.

In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

The study will take place at the Cardiology institute of the Pitié-Salpêtrière hospital. All patients referred to this tertiary care center for IE management will be included.

The characteristics of the patients (demographics, clinical, laboratory, and imaging data) at the time of IE diagnosis and during the follow-up will be collected. The patients will be followed up to 10 years after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed IE according to European Society of Cardiology criteria

Exclusion Criteria:

* Opposition of the patient to participate
Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients

Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients at least 18 years of age
* Hospitalization on a general internal medicine ward

Exclusion Criteria:

* Receiving therapeutic anticoagulation at time of hospitalization
A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults with Skin-Predominant Dermatomyositis

This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
* Active cutaneous manifestations of dermatomyositis
* Adult subjects (18-75 years old)
* Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.

Exclusion Criteria:

* Dermatomyositis with end-stage organ involvement
* Dermatomyositis with irreversible muscle involvement

History of:

* Any lymphoproliferative disorder
* Active malignancy;
* History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis
* Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
* Participants at a risk of thrombosis or cardiovascular disease
* Participants with a high risk for herpes zoster reactivation
* Participants with active or recent infections
Safety and Effectiveness of Electronically Controlled Prosthetic Ankle

In this study, we aim to compare the three types of prosthetic limbs: the passive prosthetic limb that the patients have been using so far, the 'RoFT', a prosthetic limb developed by the Korea Institute of Machinery \& Materials, and the Meridium of Ottobock in terms of safety and effectiveness.

In this study, the investigators will compare the safety and effectiveness of RoFT, a robotic ankle prosthesis developed by a Korea Institute of Machinery \& Materials, Meridium of Ottobock Co., a representative commercial ankle-type robotic prosthesis, passive prosthetic limb that the patients have been using so far.

In order to compare the above three types of prostheses in terms of their effectiveness and safety, the robotic prosthesis will be evaluated after 30 minutes of familiarization after applying, and the evaluation interval using the two types of robotic prostheses will be 2 weeks to eliminate the carryover effect. For evaluation, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be used.

For safety analysis, any kinds of safety issues including skin abrasion, bone fracture, or tendon/ligament injury due to fall down injury will be recorded and categorized for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Among patients who visited each hospital's rehabilitation department after IRB approval
2. Adults over 19 years old
3. One side transtibial amputee
4. 6 months or more from the date of amputation of the lower extremities
5. Use of the same conventional passive prosthesis for at least the last 3 months
6. Factors of K level 2 or higher (have the ability to cross low-level environmental barriers such as curbs, stairs or uneven surfaces)
7. Those who understand and agree to the test description
8. Those who did not have skin lesions on the amputation at the time of study registration
9. At least 25cm of free space from the bottom connection of the socket to the floor

Exclusion Criteria:

1. When cognitive function is deteriorated and it is impossible to independently decide to participate in research or participate in evaluation
2. Contraindications to weight-bearing of the lower extremities such as severe lower extremity joint contracture, osteoporosis, and untreated fractures
3. Patients who underwent orthopedic surgery on the lower extremities within 6 months of starting the study
4. Cardiovascular disease, venous thrombosis or heart failure, respiratory disease that may affect heart function during exercise load
5. In the presence of pain in the musculoskeletal system other than amputation that affects gait
6. Stump length over 25cm
7. Subjects judged by other testers to be unsuitable for this study
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis

To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.

Exclusion Criteria:

* Acute knee injury
* Had ever accepted therapy as hormone or injection in articulation cavity
* Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
* Had planted cardiac pacemaker or any metal matter in body
* Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
* Pregnant or lactating woman
* Anyone unable to tolerate or cooperate with treatment.
Identification of Nerves Using Fluorescein Sodium

The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects
2. 18 years or older
3. Scheduled for open head and neck surgery

Exclusion Criteria:

1. Inability or unwillingness of a subject
2. Pregnancy
3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
5. History of adverse reaction to fluorescein including allergy.
6. History of renal failure or chronic kidney disease
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.


Eligibility Criteria:
Inclusion Criteria:

* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
* All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients

Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in the ICU

Exclusion Criteria:

* Patients who were readmitted to the ICU during a single hospital stay
Trajectories of Regenerating Family Resilience in Adolescents With Cancer

Family resilience is an important strength to help family to manage life challenge successfully, and to reorganize family function. However, few studies have showed the trajectory of family resilience in adolescents with cancer over time. The purposes of this study are to know the trend of family resilience in adolescents with cancer from previous 3 months to the first year of newly diagnosed, and to examine the relationships among family members' stress, family satisfaction, and family resilience in adolescents with cancer.

The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires. The study is designed as repeated measurement. Considering attrition rate may be more than 60%. Therefore, of necessity, the proposed sample size was set at 60 families.

Data will be collected by a structured questionnaire (a demographic questionnaire and 4 scales). The study consists of four times of data collection time point as follows: approximately 3 month (t1), 6 months (t2), 9 months (t3), and 12 months (t4) after the diagnosis of cancer in adolescents. Each participant may take 20-30 minutes to finish the structured questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires.

Exclusion Criteria:

* terminal stage
HypErsensitiVity PneumonITis: DiseAse Progression Characterization

EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Other secondary measures of disease progression will also be investigated such as imaging, time to death or lung transplantation, and patient-reported outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Adult outpatient subjects (18 years old or older) that fulfill the 2020 ATS/JRS/ALAT diagnostic criteria of HP of at least moderate confidence (70% confidence or more).
2. Willingness to undergo the evaluations proposed in this protocol
3. HP diagnosis within the last 24 months
4. Presence of radiological or histological fibrosis:

4.a. Radiological fibrosis consists of unequivocal fine or coarse reticulation with architectural lung distortion and/or traction bronchiectasis and/or honeycomb.

4.b. Unequivocal histopathological fibrosis evidenced on lung specimens

Exclusion Criteria:

1. Pregnancy
2. Presence of established connective tissue disease
3. Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
4. Use of supplemental oxygen at rest
5. Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
6. Unequivocal emphysematous pattern of HP on HRCT
7. Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
8. Significant pulmonary arterial hypertension:

8.a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index \< 2L/min/m2 or right heart catheterism
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI

The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).

The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).

Each program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, ages 18-35
* English fluency and literacy
* Diagnosed with a concussion in the past 10 weeks
* Owns a smartphone or computer with Internet access
* Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program
* Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks
* Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)

Exclusion Criteria:

* Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more
* Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
* Current substance abuse or dependence and current substance use disorder
* Current active self-reported suicidal ideation
* Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months
* Participation in a mind-body or CBT treatment in the past 3 months
* Currently pregnant