cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
* Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Reflexology and Quality of Life

This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline.

The purpose of this study is to evaluate the effects of reflexology on the quality of life and functional capacity of patients at risk for diabetic neuropathy. This is a randomized, controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology. For the calculation of the sample size, a pilot test will be conducted with 8 diabetic patients. It will be used the statistical software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36) and for functional capacity, the Stanford Health Assessment Questionnaire. This research will follow the standards set by resolution 466/12 of the National Health Council, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil.

Exclusion Criteria:

* presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology
Heart Rate Variability After Ablation

Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation.

Catheter ablation for pulmonary vein isolation (PVI) is the most effective treatment method for atrial fibrillation (AF). For a long time, radiofrequency energy (RFA) was dominantly used for ablation, which leads to tissue heating and thus thermal damage. The methodology of pulsed-field ablation, or irreversible electroporation, has been completely newly developed. This form of energy does not lead to thermal tissue damage (as is the case with radiofrequency energy), but with the help of high-intensity nanopulses of electrical energy, the ion channels of cardiomyocytes are permanently opened, the concentration gradient of ions is canceled and thus their irreversible destruction. In addition to the electrical isolation of the pulmonary vein, standard radiofrequency isolation of the pulmonary veins leads to the ablation of collateral ganglion plexuses and thus to the influence of the autonomic nervous system. This is very positive, an imbalance between sympathetic and parasympathetic innervating the left atrium is considered a risk factor for AF induction, and its damage with standard RFA is considered part of the RFA ablation effect. Available studies suggest that PFA probably induces significantly weaker and less permanent suppression of cardiac autonomic regulation compared to RF energy used for PVI.

Measuring heart rate variability is a simple non-invasive method. A regular ECG Holter recorder can be used for the measurement. Patients will be fitted with a 24-hour Holter ECG on admission to determine the original heart rate variability. Catheter ablation will take place the next day. Patients will be treated using one of two methods of pulmonary vein isolation - RFA or PFA. One month after the catheterization procedure, a 24-hour Holter ECG will be used again to detect changes in HRV compared to preoperative values.

Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation
* indication for catheter ablation due to atrial fibrillation
* willingness to participate

Exclusion Criteria:

* atrial fibrillation throughout Holter ECG recording
* significant valve disease
* left ventricular dysfunction, EF less than 35%
Residual Neuromuscular Blockade in Pediatric Anesthesia

Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not known. The aim of this prospective observational cohort study is to evaluate the early RNB just before extubation and late RNB at the time of arrival to postanesthetic care unit (PACU).

Residual neuromuscular blockade (RNB) is frequent and it is associated with negative impact on postoperative morbidity and mortality. The incidence of the RNB in adult is well described, however in pediatric subpopulation it is currently not known. The aim of this prospective observational cohort study is to evaluate the early RNB just before extubation and late RNB at the time of arrival to postanesthetic care unit (PACU). In the trial will be enrolled all pediatric patients (28 weeks of age and older - 19 years old) whom will be administered neuromuscular blocking agent during anesthesia. The demographic data will be collected including: age, weight, type of surgery, ASA status. The anesthesia management will be described including: airway management, type and cumulative dose of neuromuscular blocking agent (NMBA) and time and dose of the last administered bolus of NMBA. The residual neuromuscular blockade will be measured according to the standards: TOF Watch accelerometry at the moment prior to extubation (two measurements) in TOF mode and at the arrival to postanesthetic care unit (PACU) (two measurements) in TOF mode.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients undergoing surgery with neuromuscular blocking agents were administered with the age limits

Exclusion Criteria:

* weight under 3000 grams
* neuromuscular disease
* haemodynamic impairment (vasopressor need)
* planned postoperative mechanical ventilation
Rabies Immune Plasma Booster Study

Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin.

The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that:

1. Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL.
2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis.

This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).


Eligibility Criteria:
Inclusion Criteria:

* Meet requirements for Source Plasma donors
* Completed initial series of rabies antibody injections with no serious adverse events for at least 90 days prior to enrollment
* Compliance with program requirements
* Signed informed consent

Exclusion Criteria:

* Failure to meet requirements to be Source Plasma donor
* Non-compliance with the program
* Experience a serious adverse reaction
Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With MCI

The aim of the study is to determine: (1) the effects of combined physical exercise and cognitive training versus exercise or cognitive training alone on cognition, physical function, daily function, quality of life and social participation outcomes, (2) determine the relative effects of simultaneous vs. sequential combination of physical exercise and cognitive training on these health-related outcomes, (3) determine the long-term effects of different types of trainings on these outcome measures.

Mild cognitive impairment (MCI) or minor neurocognitive disorder involves problems with memory, executive function and language. The age-adjusted prevalence of MCI in Taiwan is approximately 18%. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in five years. Early detection and intervention of the individuals with MCI may help delay or prevent progress from MCI to dementia, and reduce the burden of their caregivers and the medical expenses of the health-care system. Whilst numerous studies have established the potential benefits of cognitive or physical exercise training on cognition for individuals with MCI, some recent studies suggested that combining physical exercise and cognitive training may augment the intervention effects. Also, different combination methods - combining physical exercise and cognitive training either sequentially or simultaneously under a dual-task paradigm may impose differential cognitive challenges on the participants, and it is yet not clear which combination strategy has better training effects.

Eligibility Criteria:
Inclusion Criteria:

* able to follow instruction,
* age 55 to 90 years old,
* clinical dementia rating (CDR) = 0.5 or 1,
* self- or informant-reported memory or cognitive complaints,
* able to perform activities of daily living (Barthel Index ≥ 70).

Exclusion Criteria:

* Participants will be excluded if they have recent myocardial infarction, heart failure, recent heart surgery, severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study

GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).


Eligibility Criteria:
Inclusion Criteria:

* Low fertilization rate in previous IVF cycle (\<30%), or
* Poor embryo developmental problems in previous IVF cycle, or
* Diminished ovarian reserve (AMH\<1.2 or AFC\<5) and/or more than 40 y/o.

Exclusion Criteria:

* Without or just one oocyte picked up
Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study.


Eligibility Criteria:
Inclusion Criteria:

* age is 18 years or older
* Patients diagnosed with bladder cancer who will undergo radical cystectomy
* Patient has to be able to sign informed consent

Exclusion Criteria:

* Metastatic cancer
* Presence of a second primary tumor with the exception of fully deleted prostate cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control
Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis

The purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of action of fingolimod in patients with Relapsing remitting multiple Sclerosis to collect data on biomarkers after initiation of fingolimod treatment.

After treatment with fingolimod the blood of the patients will be collected at different time points to examine the changes of T cells, B cells and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed in this trial.
2. Male or female subjects aged 18-65 years.
3. Subjects with relapsing remitting forms of MS defined by 2010 revised McDonald criteria (see Appendix).
4. Patients with high disease activity despite treatment with a disease modifying therapy (≥ 1 relapse in the previous year, ≥ 9 hyperintense T2 lesions or ≥1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year) or patients with rapidly evolving severe RRMS (e.g. ≥ 2 relapses with disease progression in one year and ≥ 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).
5. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix).
6. Sufficient ability to read, write, communicate and understand

Exclusion Criteria:

1. Patients with a manifestation of MS other than relapsing remitting MS.
2. Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
3. History or presence of malignancy (other than localized basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the last 5 years
4. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c \> 7%.
5. Diagnosis of macular edema during Baseline Visit (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic baseline visit).
6. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
7. Negative for varicella-zoster virus IgG antibodies at Baseline.
8. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to baseline.
9. Patients who have received total lymphoid irradiation or bone marrow transplantation.
10. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-β, glatiramer acetate); however no washout is needed for DMDs prior to baseline.
Thalidomide in Treating Patients With Myelofibrosis

Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

PRIMARY OBJECTIVES:

I. To investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with MMM. Specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with MMM.

II. To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bFGF, TGF-b, and PDGF, and their respective receptors.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.

Patients are followed every 6 months until 5 years from study entry.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed myelofibrosis with myeloid metaplasia

  * Agnogenic myeloid metaplasia
  * Post-polycythemic myeloid metaplasia
  * Post-thrombocythemic myeloid metaplasia
* No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7), or acute myelofibrosis
* No chromosomal translocation t(9;22) or bcr/abl gene rearrangement
* Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood
* Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or hepatomegaly
* Performance status - ECOG 0-2
* Absolute neutrophil count greater than 750/mm\^3
* Platelet count less than 400,000/mm\^3
* WBC less than 50,000/mm\^3
* Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must be normal)
* AST no greater than 3 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use at least 1 highly active method AND 1 additional effective method of contraception for at least 4 weeks before study, during study, and for at least 4 weeks after study
* Fertile men must use effective contraception during study and for at least 4 weeks after study
* No uncontrolled infection
* No concurrent condition that would preclude study
* No peripheral neuropathy
* At least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa
* At least 1 month since prior hydroxyurea or other chemotherapy
* At least 1 month since prior corticosteroids or androgen derivatives
Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer

The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age
* Patients who underwent pelvic lymphadenectomy
* Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
* The patient is able to understand the study and is willing to give written informed consent to the study
* patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.

Exclusion Criteria:

* Severe systemic diseases causing peripheral edema, including renal disease
* Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
* Acute superficial or deep vein thrombosis
* Previous major surgery for lower extremities, including metallic surgical implant
* Local infection in the lower extremities
* Auto-immunological disorders or vasculitis
* Use of systemic corticosteroids
* Pregnant or currently breastfeeding
* Alcohol or drug abuse
* Uncontrolled diabetes