cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia

The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough information on the incidence of long-term side effects.

This study, as well as other similar studies conducted around Europe, will focus on following patients treated with this therapy on a long-term basis.

Once all studies in Europe will be concluded, all data will be analyzed together.

Considering the clear therapeutic advantage associated with ATRA+ATO combination therapy and the more favorable and overall manageable safety profile compared to ATRA+chemotherapy, the benefits of the combination in the first-line indication do appear to overweigh the risks.

However, no information regarding the actual adverse event (AE) incidence and the long-term toxicity of ATRA+ATO is available at present and therefore, as a postmarketing commitment, TEVA (the Company holding the Marketing Authorisation of Trisenox® (Arsenic trioxide)) is setting up a long-term safety cohort study of Trisenox in newly diagnosed low- to intermediate-risk APL patients retrospectively analyzing data from APL disease registries all around Europe.

As a result, this observational study is part of the retrospective PASS Study (A Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First Line Low-to Intermediate-Risk Acute Promyelocytic Leukaemia Patients) that will use data from multinational APL disease registries in Europe. The present study will focus on Italian patients.

Eligibility Criteria:
Inclusion Criteria:

* APL diagnosis based on cytological criteria and confirmed by the presence of the (15;17) translocation and/or the presence of the PML/RARA rearrangement (with the determination of the breakpoint subtype).
* Newly diagnosed low- to intermediate-risk APL (white blood cells \[WBC\] count ≤10x103/µL)
* First line treatment with ATRA+ATO
* Aged 18 years or above
* Signed informed consent, if applicable

Exclusion Criteria:

* High risk APL (WBC count \> 10x103/µL)
* APL relapse
Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction

The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. The frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. In addition, the quality of life before and after implantation will be evaluated as well as the bone regeneration around implant.


Eligibility Criteria:
Inclusion Criteria:

* Obtained informed consent.
* Males or females, ≥18 years of age
* Subject with cranial defect size \> 25 cm2.
* History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
* Willing and able to comply with all study procedures and restrictions.
* The 5 subjects participating in bone regeneration analysis (PET/CT scans) has to be 50 years or older

Exclusion Criteria:

* Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
* Pregnant or nursing women.

Exclusion criteria during surgery, if applicable:

Perioperative appearance of previously not identified tumor or infection in the reconstruction area.
Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress

The study purpose is to examine the effects of breast tenderness relief intervention during the late pregnancy on the parturients' breast engorgement, lactation, breastfeeding, maternal competence, and stress.

Background:

Maternal and child health is an important global health issue. Breast milk is the best food for infants and has many benefits for both mothers and infants. However, the breastfeeding rate in Taiwan has not increased but decreased in recent years. Breast engorgement and hypogalactia often cause distress for many women, and lead to stress and abandonment of breastfeeding, which in turn affects the achievement of motherhood. Therefore, nurses should provide support interventions for parturients early.

Methods:

This study is a two-years, prospective randomized controlled trial, and will adopt a longitudinal repeated-measures design. Convenience sampling will be used to recruit 180 pregnancy and postpartum women in the obstetrics clinic and postpartum ward of a medical center. The participants will be randomly assigned into two conditions (routine care and the breast tenderness relief intervention condition). The intervention will be provided to the participants from the 36th week of pregnancy until three months after delivery. Questionnaires, and biological measurements will be used to collect data. The outcome variables include the degree of breast engorgement, lactation, breastfeeding, maternal competencies, and stress. In addition, those data will be collected at the 36th and 38th week of pregnancy, three days, six weeks, and twelve weeks after childbirth. It is expected to analyze the research results with generalized estimation equation method.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy pregnant women over 20 years old, without mental illness, and the number of pregnancy weeks has reached 36 weeks; 2. Full term production; 3. Literate or able to communicate in Chinese and Taiwanese; 4. After explaining, agree to participate in the research, sign the consent form, and accept long-term follower

Exclusion Criteria:

1. Pregnant women with a history of smoking, alcohol, and drug abuse;
2. Pregnant women have mental illness;
3. Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.;
4. Newborns with congenital abnormalities and major diseases;
5. Pregnant women who are unable or unwilling to breastfeed due to illness or other factors;
6. Refuse to accept breast compression intervention will be excluded from participating in the study
Comparison of Vasopressor Boluses for Management of Hypotension After Spinal Anesthesia

In this study the investigators will compare the efficacy and side effects of two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .

The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.

No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* scheduled for cesarean delivery

Exclusion Criteria:

* patients with severe cardiac dysfunction
* patients with low blood pressure
* patients with ante-partum bleeding
Osteoarticular Infections With Pneumococcal

Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.


Eligibility Criteria:
Inclusion Criteria:

* patients having had a bone and joint infection with S pneumoniae, with or without device.

Exclusion Criteria:

* none
Texting to Reduce Human Immunodeficiency Virus (HIV) Risk

This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.

The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.


Eligibility Criteria:
Inclusion Criteria:

* Give informed consent and document consent via a signed and dated informed consent form in REDCap
* Willing to comply with all study procedures and be available for the duration of the study
* Be able to read either in English or Spanish
* Be a dental clinic patient of record at one of our participating community health centers
* Has at least one risk factor for HIV defined as self-report of at least one of the following: Men who have sex with men; multiple sex partners, or intravenous drug use

Exclusion Criteria:

* Self-report of having HIV infection
* Participating in another HIV study or another text message study
* A woman who reports having sex exclusively with women
* Does not have a mobile phone or other device which can receive text messages from Agile Health
* Does not have unlimited texting on their mobile plan
* Has not used any type of text messaging at least once in the past month
* Single item literacy screening score of 2 or below.
Cesarean Scar Defect Formation After First Cesarean Section.

This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.

Cesarean scar defects, which may develop after cesarean deliveries, are associated with menstrual bleeding problems, infertility, and poor obstetric outcomes. No matter how excellent and standard surgical technique is applied, scar defects may develop after cesarean section. However, when cesarean operation decision is taken, the existing operational conditions can affect the formation of cesarean scar defect in the future. Although the surgical technique is the same, a planned cesarean operation and an emergency cesarean section may differ for a future cesarean scar defect that may develop in the future.

Eligibility Criteria:
Inclusion Criteria:

* 18-45-year-old patients
* Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.

Exclusion Criteria:

* Spontaneous vaginal birth
* Preterm birth
* Pregnant women with an obstetrical or gynecological complication.
Improving Fecal Occult Blood Test Completion Rates Among Veterans

This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.


Eligibility Criteria:
Inclusion Criteria:

* PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.

Exclusion Criteria:

* None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.
Uroflowmetry Results and Vitamin D Levels

The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS.

This retrospective cohort study included 186 female patients who admitted to LUTS. Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate (Qav), and voided volume (V) were recorded. Patients were divided into two groups according to age (18-50 and ≥51) and vitamin D levels (\<20 and ≥20).

Laboratory parameters, uroflowmetry results, were compared between groups.

The study was approved by the local ethics committee (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the Helsinki Declaration and Good Clinical Practices Guidelines.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of low urinary tract symptom

Exclusion Criteria:

Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease Other urinary system disorders.
Effects of Exercise on Dystonia Pathophysiology

The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training.

Dystonia is a debilitating movement disorder. It involves involuntary muscle contractions with abnormal and repetitive movements, postures, or both. The current treatments for dystonia comprise of oral medications, botulinum toxin injections, and deep brain stimulation surgery. These treatments, despite optimal management, fail to improve symptoms in more than a third of patients and the improvements are often unpredictable. We will investigate the brain adaptation effects for progressive resistance exercise-focused cervical and shoulder training (PERFECT) in patients with focal cervical dystonia with functional MRI (fMRI) and transcranial magnetic stimulation (TMS) techniques for understanding the pathophysiology of dystonia and treatment related changes. The investigators propose to enroll patients with predominantly focal cervical dystonia and compare PERFECT plus standard-of-care (SOC) therapy (n = 27) with a control group of SOC therapy (n = 27). Participants in the PERFECT + SOC group will perform physical therapist-guided exercises twice a week for 6 months and participants in the SOC group will continue receiving standard pharmacological therapies at stable doses and they will not exercise.

Eligibility Criteria:
Inclusion Criteria:

* Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society.
* Moderate disease severity.
* Are 30 to 85 years old
* Are able to tolerate exercise sessions.
* Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy.

Exclusion Criteria:

* Participating in an alternate structured exercise program, receiving regular physical or occupational therapy
* Have significant pain, spondylosis or active arthritis
* Fail the Physical Activity Readiness Questionnaire
* Have significant cognitive impairment
* Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS
* Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. As necessitated by the risks of MRI or TMS, patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), active seizure disorder are not eligible for participation in the MRI or TMS portion of the study.
* Pregnancy tests will be carried out for each female subject of child bearing potential prior to the participation in the study and prior to each follow up visit (as indicated).
Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges

Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.

Fifty seven participants will be enrolled. Participants will be randomly divided into 3 groups.

For this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. Participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. These participants will be given an 8-week exercise program. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment.

After treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. Quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients in the subacute period discharged
* Be 18 years or older
* Having received oxygen therapy or mechanical ventilation support in the hospital
* Access to online interviews and web-based exercises with a secure internet connection
* Having sufficient speaking and hearing skills for telerehabilitation
* Volunteer to participate in research

Exclusion Criteria:

* Unstable clinical condition
* Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
* Inability to walk independently, even with an assistive device
* Having serious neuromuscular problems
* Not being cooperative enough to answer and understand questionnaires and scales
Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder

The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder.

A. Aims

The overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (CR) and attention regulation (AR). CR and AR are thought to be important mechanisms underlying therapeutic change associated with Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) for generalized Social Anxiety Disorder (SAD). We seek to test whether changes in CR and AR underlie the therapeutic effects of CBT and MBSR, which have been shown in the clinical science literature to be effective treatments for SAD. We will examine CR and AR in healthy controls (HCs) and in participants with generalized SAD at baseline, as well as in participants with SAD after they have completed a randomized controlled trial (RCT) with three treatment arms: CBT, MBSR, or Waitlist (WL). This work will address 3 aims: Aim 1 will examine the efficacy of CR and AR in individuals with SAD versus HCs; Aim 2 will investigate the immediate and longer-term impact of CBT versus MBSR for SAD; and Aim 3 will examine treatment-related changes in CR and AR and test whether these changes mediate the effects of CBT versus MBSR. The broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from SAD, as well as a wide range of other anxiety and mood disorders.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
* aged 21-55
* working fluency in English
* residence in the Bay Area.
* eligible for fMRI scans (right-handed, no metal in body, etc.)

Exclusion Criteria:

* left-handed
* Medication use in the last 3 months
* Pervasive developmental disability
* acute suicide potential
* inability to travel to the treatment site
* schizophrenia or other psychotic disorder
* history of bipolar disorder
* current primary Major Depression
* current substance dependence
* Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.
Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam

The aim of the project is to study changes in symptom load after removal of all dental amalgam restorations in patients with symptoms allegedly related to amalgam.

Patients referred from dentists and physicians in the period 1993 to 1999 to the Dental Biomaterials Adverse Reaction Unit, Department of Health, UNIFOB AS, for symptoms related to amalgam restorations are randomized into treatment group (n=20) or reference group (n=20). All patients in the treatment group are followed 3, 12, 36 and 60 months after completion of amalgam removal with questionnaires on health outcomes, Minnesota Multiphasic Personality Inventory-2 (MMPI-2) and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Referred for examination of general health complaints related to amalgam
* Health complaints from at least three different organ systems
* Dental amalgam restorations present
* Data available on concentration of mercury in blood and urine at the initial examination
* Patient agreed to be contacted after the examination

Exclusion Criteria:

* Serious disease (incl. severe allergy to foodstuff and severe rheumatoid arthritis)
* Mental instability or psychiatric disease
* Cases with complicated dental rehabilitation (incl. bridge prostheses)
* Allergy to dental replacement materials
* Severe periodontitis
* High caries activity