cyrilzakka/clinical-trials huggingface dataset:
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia

Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. Patients should have one of the four criteria as following:
* Patients with positive screening for GDM presenting a TTG of 75 g and one of the values below:

  * fasting glucose ≥ 92;
  * 1h ≥ 180; or
  * 2h ≥ 153 will be considered gestational diabetes mellitus (GDM) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. If the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or
* Patients with pre gestational diabetes mellitus type 1 or 2; or
* Patients with positive screening for GDM and presenting normal TTG of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( Rudge et al,1990).
* Normal TTG and an abnormal glycemic profile will be considered as mild gestational hyperglycemia
* Patient provided written informed consent.

Exclusion Criteria:

* Twin pregnancy diagnosed until the date of randomization or;
* Fetal malformation diagnosed until the date of randomization.
Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients

RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time.

PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.

OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of these patients treated with these two drugs. iv. Estimate the overall survival, event-free survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these patients treated with these two drugs.

OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission. Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 × 109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for chronic-phase CML treatment.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.
2. No previous therapy with any drugs.
3. Age ≥ 16 years
4. Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
5. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

Exclusion Criteria:

1. Patients treated with any chemotherapy drugs.
2. Patients younger than 16 years.
Implementation of a GDT Algorithm for Major Surgery Patients

This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions.

Goal directed fluid management in major abdominal surgery has been shown to reduce perioperative complications. The approach aims to optimize the intravascular fluid volume by use of minimally invasive devices which calculate flow-directed variables such as stroke volume (SV) and stroke volume variation (SVV). The investigators aim to show the feasibility of routinely implementing such hemodynamic monitoring during major abdominal surgery, and to evaluate its effects in terms of perioperative fluid management and postoperative outcomes.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic surgery
* colorectal surgery

Exclusion Criteria:

* admission for revisional surgery
Evaluate Severe Hepatic Impairment on Dacomitinib PK

This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.

This is a Phase 1, open label, parallel group study to investigate the effect of severe hepatic impairment on the plasma PK, safety and tolerability after a single oral 30 mg dose of dacomitinib under fasted conditions.

Approximately 18 participants will be enrolled into the study to ensure at least 6 PK evaluable (having data for estimating primary PK parameters for dacomitinib) participants in each cohort.

Eligibility Criteria:
Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Male and/or female participants of non childbearing potential must be 18 to 75 years of age, inclusive, at the time of signing the informed consent document (ICD).
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

   Weight:
3. Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb).
4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Any condition possibly affecting drug absorption (eg, gastrectomy).
2. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
3. History of or current positive results for human immunodeficiency virus (HIV).
4. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP used in this study (whichever is longer).
5. Hypersensitivity to dacomitinib or its excipients.
6. A positive urine drug test. Participants with severe hepatic impairment (Cohort 1) will be eligible to participate if their urine drug test is positive with a drug for a prescribed condition that is not expected to interfere with the PK of dacomitinib.
7. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
8. History of sensitivity to heparin or heparin induced thrombocytopenia.
9. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
10. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
* Stable face vitiligo with F-VASI of at least 0.1%
* Stable or slowly progressive vitiligo over a 3-month period
* Fitzpatrick skin types IV-VI
* Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming

Exclusion Criteria:

* Patients with segmental vitiligo
* Fitzpatrick skin types I-III
* Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
* Previous topical treatment for vitiligo
* Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant
* History of melanoma or lentigo maligna
* Any current skin disease that may interfere with the study evaluation
* Presence of severe hepatic disease or hepatic impairment
* Renal impairment
* History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
* Female who is pregnant or lactating
* Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
* Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
* Use of any other prior and concomitant therapy which may interfere with the objective of the study
* Subjects assessed as not suitable for the study in the opinion of the Investigator
Advancing the Patient Experience in Chronic Obstructive Pulmonary Disease (APEX COPD)

APEX COPD is registry to provide a mechanism to standardize, store and utilize data to enable greater power to answer key research questions, and to improve patient outcomes in COPD primary care.

In the process of creating of a high-quality longitudinal dataset combining COPD templates and patient reported information and outcome (PRIO) to evaluate outcomes the APEX COPD registry supports changes and improvements in medical practice and deliver high quality research through the following mechanisms:

* Templates integrated into the primary care clinical systems to support standardization of care and data over time.
* Informing doctors at the point of consultation about the status of their patients through data-driven feedback.
* Pre-filled electronic data templates from existing EHR data and questionnaires to reduce administrative burden for Primary Care Clinicians (PCC).
* Engaging primary care clinicians in ongoing quality improvement initiatives directly at the point of care.
* Research publications regarding treatment effectiveness and associated risk in mild to moderate COPD, reason for therapy switch/escalation and hidden undiagnosed and untreated COPD patients in primary care.
* A strong network of primary care clinicians caring for patients with COPD in the US to drive the initiative and ensure impact on clinical practice through educational events, academic organizations and research outputs.

The APEX COPD steering committee (SC) comprise of collective clinical expertise, scientific knowledge and experience in EHR, databases and research, forming an essential element of the APEX COPD registry. The SC plays an essential role in the development and governance of the APEX COPD registry, representing the sites participating, and providing the expertise necessary to implement and drive the initiative. Within this committee a smaller management group guides the operational aspects of the registry.

The research database uses the Observational Medical Outcomes Partnership (OMOP) v5 Common Data Model (CDM) and the OMOP terminology will be updated at least bi-annually. Standardized OMOP Concept IDs will utilize SNOMED, RxNorm and may be adjusted to improve data compatibility with other OPC COPD databases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic code for COPD or COPD monitoring review code prior to or at consultation
* Aged ≥35 years at COPD diagnosis

Exclusion Criteria:

* Patients receiving hospice care
* Patients being actively treated for a cancer diagnosis (not skin)
Clinical Outcomes From NOCD Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention

This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum.


Eligibility Criteria:
Inclusion Criteria:

* obsessive-compulsive disorder

Exclusion Criteria:

* none
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)

This was the cross-sectional study to assess the period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019.

In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the Komodo Healthcare Map, and all results were based on the study period from 01/01/2018 to 12/31/2019.

Komodo Healthcare Map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.

* Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified
* Index date: 01/01/2019
* Study Period: 01/01/2018 to 12/31/2019
* Pre-index period: 01/01/2018 to 12/31/2018
* Post-index period: 01/01/2019 to 12/31/2019

Eligibility Criteria:
Inclusion Criteria:

* ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in 2019
* ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019
* ≥18 years old in 2019
* ≥2 wet AMD-related office visits in 2019

Exclusion Criteria:

- ≥1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI

All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.

A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age \> 75 og bodyweight \< 60 kg 5 mg)once daily for 30 days after the procedure.

Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.

Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.

Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)


Eligibility Criteria:
Inclusion Criteria:

* PCI with stenting and Multiplate hep-ADP \> 70 U despite clopidogrel loading

Exclusion Criteria:

* need for vit K antagonist
* women with childbearing potential
* breastfeeding women
* Planned surgery within 6 months
* Intolerance to clopidogrel, prasugrel or aspirin
* previous stroke
Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study

Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.

Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson \& Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson \& Johnson Company, Sommerville, NJ) in group II.

All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries.

Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented.

Patients were blind about what suture was used.

Eligibility Criteria:
Inclusion Criteria:

* Need 3 dental implants at the posterior of the mandible

Exclusion Criteria:

* Diabetic patients
* smoker
* poor oral hygiene
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty

Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.


Eligibility Criteria:
Inclusion Criteria:

* Knee artrosis, refered to surgery

Exclusion Criteria:

* Kognitive disability
* Inflamatory disease in muscles
* varus/ valgus and extension deficit \>15 degrees
* Neurological disorders
The Optimal Timing of Vaccination in Pregnancy

The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent.
* Willing to be vaccinated with a Tdap vaccine during pregnancy.
* Intend to be available for follow-up visits and phone call access until 6 months postpartum.
* Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.

Exclusion Criteria:

* Vaccinated with an aP containing vaccine during the last 5 years
* Significant mental illness (e.g. schizophrenia, psychosis, major depression)
* Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection...).
* Systemic treatment with immune suppressive medication, including chronic steroid use of \> 10 mg prednisone or equivalent.
* Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
* Previous severe reaction to any vaccine
* High risk for serious obstetrical complications.