cyrilzakka/clinical-trials huggingface dataset:
Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM).

This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.


Eligibility Criteria:
Inclusion Criteria:

Singleton gestations

Women aged \> 18 years and \< 45 years

Recruited before 16 weeks gestation

Obese (pre-pregnancy BMI ≥ 30)

Receiving prenatal care at Tufts Medical Center

Planning to give birth at Tufts Medical Center

Can tolerate glucose tolerance test

Willing and able to wear CGM

Willing and able to sign informed consent

Exclusion Criteria:

Multiple gestation

Preexisting diabetes

Taking medications that impact body weight or metabolism (eg metformin)

Inability to tolerate glucose tolerance test

Adults unable to consent (cognitively impaired adults)

Wards of the state

Non-viable neonates

Neonates of uncertain viability
Evaluation of Transition With a Heart, a Transition Program for Adolescents With Congenital Heart Disease and Parents

The department of Congenital Heart Disease of the Ghent University Hospital (Belgium) developed a transition program dedicated to adolescents with congenital heart disease (CHD): 'Transition With a Heart´ (TWAH). TWAH was developed based on the Dutch program 'On your own feet´, starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Interventions were selected from the highest sources of scientific evidence currently available including (quasi-) experimental studies, narrative literature reviews and expert opinions.

TWAH is the intervention in the conducted study. Hence, the intervention group are adolescents with CHD and their parents who are participating in TWAH. Adolescents and their parents who are transferred according to standard care (joined transfer consultation only) are identified as the control group and will be examined in the post test phase in order to be able to make comparisons with the intervention group. At baseline (the start of TWAH) participants of the control group already made the transfer to the adult ward.

The investigators consider the following hypothetical scenario:

- TWAH will have a positive influence on disease knowledge and transition experiences of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a CHD of great or moderate complexity (6)
* From the age of 12 years or older
* Must be able to complete the questionnaires
* Dutch speaking AND/OR
* Parents having children who are meeting the inclusion criteria above

Exclusion Criteria:

-
Phase II Trial of AZD2014 in RICTOR Amplified Solid Cancer Patients Refractory to Standard Chemotherapy

Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.

Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.

Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.

If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.

Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of treatment, will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy.

   - Rare cancers are defined as sarcoma, neuroendocrine carcinoma
2. Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy)
3. Patients with RICTOR amplification through NGS.
4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

Exclusion Criteria:

1. Patients not having received recommended treatment-lines and chemotherapy regimen for the treatment of each tumor type in the advanced setting.
2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
3. HER2 positive AGC patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.

This is an open-label, comparative, and prospective study. Pregnant women, pregnancy week 26 to 36+6, between the ages 18-45, who were hospitalized in the high risk department, with history of previous preterm delivery and/or with premature contractions. Patient with premature ruptured membrane will be excluded.

In the hospital pregnant women with history of previous preterm delivery or with premature contractions, (participants) will be examined by speculum with no lubricant, The clinician will use the VS-SENSE to sample vaginal secretions and will immediately observe and record the color obtained.Should the VS-SENSE produce positive results the physician will consider giving clindamycin treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions.

Exclusion Criteria:

* Subject with ruptured membranes.
* Subject with signs and symptoms of pelvic inflammatory disease.
* Subject who has used vaginal douching within 12 hours prior to arrival at the hospital.
* Subject who has applied local antiseptic, antibiotic or vaginal treatment within the previous 3 days.
* Subjects who have had sexual intercourse within the last 12 hours.
* Subject with blood in her vaginal secretions.
* Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
* Subject is unable or unwilling to cooperate with study procedures.
Tocilizumab REMission in Early RA

The TREMERA study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (RA). Recent international treatment recommendations emphasise the need to diagnose RA early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. Remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. Tocilizumab (TCZ) is a newly introduced biologic drug that is used in established RA. The TREMERA study primarily aims to investigate the biological changes seen in blood and tissue following TCZ therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as TCZ can also switch off immunological parameters associated with a disrupted immune system of RA. The study will assess the effectiveness of TCZ given on its own or in combination with methotrexate (MTX; a standard therapy usually given with biologic treatments)in patients with early onset RA to determine the proportion that achieve remission. This study also aims to find out how quickly remission can be achieved with TCZ and the depth of remission achieved. This will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (MRI) which can detect inflammation not apparent on clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (2010 ACR/EULAR RA classification criteria)
* Symptom duration ≤12months
* No previous disease modifying antirheumatic drug (DMARD) therapy
* Active RA at baseline (defined as: DAS28 ≥ 3.2)
* Active hand and/or wrist joint evaluable by US and MRI (with no planned surgery during the study period)
* Patients without any contraindication to MRI

Exclusion Criteria:

* Patients unwilling or unable to receive MTX for the duration of the study.
* Patients with inflammatory joint disease of different origin, mixed connective tissue disease, Reiter's syndrome, psoriatic arthritis, systemic lupus erythematosis, or any arthritis with onset prior to 16 years of age.
* Suspicion of diagnosis of tuberculosis (TB): positive quantiferon +/abnormal chest x-ray, as per clinician judgement. Prior history of TB with confirmed full chemotherapy +/latent TB adequately treated may be included as per physician's discretion.
* Intramuscular, oral or intraarticular (of non-target joint) corticosteroid within 28 days of the screening visit; intra-articular steroid of the chosen target joint within 12 weeks of screening.
* Patients with serious infections within 3 month of enrolment (screening) or persistent infections.
* Patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ).
* Known positive serology for hepatitis B or C, or HIV
Efficacy of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke

This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* The bulbar palsy caused by other diseases, such as neurodegenerative diseases.
* Pseudobulbar palsy.
* Complicated with other neurological diseases.
* Tracheostomy tube inserted.
* Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
* Dysphagia caused by other possible diseases.
* Pregnant females.
Frailty in Liver Transplant Exercise (FLEX) Trial

Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.

The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.

Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥18 or ≤75 years
* Frail as defined by a LFI score of \>4.5
* Under evaluation or listed for liver transplant

Exclusion Criteria:

* Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations)
* Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe)
* Institutionalized/prisoner
* Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

The total maximum study duration, including the screening period was up to 76 weeks.

At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).

In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.

Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.

Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of PsA classified by CASPAR
* Rheumatoid factor and anti-CCP antibodies negative
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of \>= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
* Inadequate control of symptoms with NSAIDs
* Inadequate control of symptoms with a conventional DMARD.

Key Exclusion Criteria:

* Pregnant or nursing women
* Evidence of ongoing infectious or malignant process
* Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
* Subjects taking high potency opioid analgesics
* Ongoing use of prohibited psoriasis treatments/medications
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.
Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans

The study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of CT scans, including 3D CT reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose optimal approach and fixation.

The investigators retrospectively analyzed consecutive patients with ankle fractures from January 2013 and December 2019 . Participants were included with OTA/AO type 44 fractures involving posterior malleolus and CT scans. The exclusion criteria were: (1) previous ankle surgery; (2) pathological fractures; (3) previous deformity in ankle joint; (4) age ≤16 years old. Finally, A total of 128 patients were included in this study. 128 consecutive participants with posterior malleolar fractures from January 2013 and December 2019. CT data were loaded into Mimics software (V20.0, Materialize), in which 3D CT reconstruction, morphological analysis and data measurements were made. Statistical analysis was performed using the Statistical Packages for Social Sciences V23.0 (SPSS, Chicago, IL, USA). Mann-Whitney U test were used. P value of \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* OTA/AO type 44 fractures involving posterior malleolus and CT scans

Exclusion Criteria:

* Previous ankle surgery
* Pathological fractures
* Previous deformity in ankle joint
* Age ≤16 years old
Enoxamed Study in the Treatment of Acute Coronary Syndromes

Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.

Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.

Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXAMED® group : In this case the patient receives an injection of enoxaparin ( ENOXAMED® ; Unimed Laboratories) intravenously. Curative dose (100 IU/10 kg).

Control group ( LOVENOX ® ) In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 year old
* With an acute coronary syndrome confirmed

Exclusion Criteria:

* Age less than 18 years
* Persistent ST- segment elevation
* Contre indication of enoxaparin and heparin in general.
* Patient participating in another study,
* Pregnant or nursing women
* patients taking an anticoagulant in the last three months,
* Patients with coagulopathy
Design and Implementation of the Pediatric Liver Transplantation Biobank

The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with end-stage liver disease.
2. Liver transplantation in our hospital.
3. informed patient consent.
4. long-term follow-up in our hospital.

Exclusion Criteria:

No fixed contact information, difficult to follow up the patients.
The Effect of Virtual Reality Training on Mental Health Literacy and Stigma

Purpose: This study will be conducted to examine the effect of virtual reality training on nurses' mental health literacy and stigma level towards mental illnesses.

Design: The study is a randomized controlled experimental research. Method: The population of the research consists of 110 nurses working in a public hospital. Power analysis was performed with G\* Power software to determine the number of nurses constituting the research sample. The sample size was determined as 25 people in each group. Considering that there may be data loss in the study, it is planned to include 30 people in the intervention group and 30 people in the control group. Nurses who volunteer to participate in the study and fill out the pre-test will be randomly assigned to the groups using the Statistical Analysis Software program to ensure random distribution to the intervention and control groups. Personal Information Form, Mental Health Literacy Scale (MHLS) and Opening Minds Stigma Scale for Healthcare Providers (OMS-HC) will be used in study data collection.

Hypotheses:

H1: The mental health literacy level of nurses who receive training with virtual reality is higher than nurses who receive classical training.

H2: The level of stigmatization towards mental illnesses of nurses trained with virtual reality is lower than nurses who received classical training.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Becoming a nurse
* Being actively working in a public hospital in Istanbul
* Volunteering to participate in the study
* Not having worked in a psychiatric ward before

Exclusion Criteria:

Being under 18 years of age

* Not being a nurse
* Not actively working in the hospital where the study will be conducted
* Not volunteering to participate in the study
* Having worked in a psychiatric ward before
Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.

In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years of age
* Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion Criteria:

* Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
* Patients requiring more than two sessions of laser photocoagulation
* Patients who had undergone previous laser photocoagulation
* Patients who had undergone any previous vitreo-retinal surgery