cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients

The purpose of this study is to test the efficacy of PAZ320 in diabetic patients.

The purpose of the present clinical study is to test the efficacy of two doses of PAZ320 in diabetic patients already on treatment with metformin, in order to assess and quantify its effect on postprandial glucose and insulin levels after a standard meal composed of rice, compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with type II diabetes since at least one year, not presenting any complications of their disease.
2. Patients under treatment with Metformin up to 3g/day, given twice or three times daily. Metformin doses should not exceed 3g/day, and should be well tolerated by the patients, its dose should have been stable for the last 3 months before inclusion in the study. Metformin should be taken in the morning of the visit only after the test meal is taken. The next doses of metformin will be taken with meals after the visit, in the habitual order the patient is used to take. The patients should not stop taking metformin during the study, but continue as usual, except that in the mornings of the visits, as the patients arrive in fasting conditions, metformin should be taken after the test meal. If a concomitant combination with an oral anti diabetic agent is given, because of elevated HbA1c levels, it should be taken together with metformin after the test meal.
3. Age - between 35 and 65, male and female.
4. Females should not be pregnant or breast feeding, women of child bearing potential should guarantee anti-contraceptive measures.
5. BMI (body mass index) - between 25 and 32.
6. Patients with glycated hemoglobin (HbA1c) lower than 9%, and higher than 6.5%, HbA1c will be determined in the first visit.
7. Patients who are able to collaborate during the entire duration of the study.

Exclusion Criteria:

1. Patients with other underlying diseases, such as cardiovascular disease, renal disease, peripheral vascular disease or any condition considered to be a complication of diabetes, should be excluded from this study.
2. Patients treated with insulin subcutaneous injections or with GLP-1 agonists, or by alpha-glucosidase inhibitors or by glinides should not be included in the study.
3. HbA1c higher than 9%, or lower than 6.5%
4. Women who are either pregnant or lactating
5. Participation in another clinical study in the month preceding recruitment into the study.
6. Patients who cannot guarantee compliance.
Assessing the Clinical Utility of tACS

The present study seeks to evaluate the clinical utility of repeated transcranial alternating current stimulation (tACS) by assessing long-term, lasting changes in oscillatory activity and subsequent changes in related behavioral processes of anxious arousal and sensory sensitivity. To date, only transient effects of tACS have been reported, lasting no longer than 30 to 70 minutes. In order to be truly impactful within a clinical setting, however, evidence for long-term effects of tACS is needed.

Recent years have witnessed increasing recognition of "oscillopathies", neuropsychiatric disorders characterized by aberrations in the neural oscillations that orchestrate various mental activities. Transcranial alternating current stimulation (tACS) provides an effective way to directly modulate these oscillations in a non-invasive and frequency-specific manner, offering groundbreaking insights into the workings of the brain and, importantly, the development of novel treatments for these oscillopathies. However, evidence is lacking for the ability of tACS to induce long-term neural plasticity and lasting behavioral changes, which is critical for establishing the clinical utility of this novel intervention.

Here, we are administering 30 minutes of alpha-frequency tACS over occipitoparietal sites for four consecutive days to evaluate both transient and long-term changes in alpha oscillatory power and long-range, directed oscillatory connectivity. As both anxious arousal and sensory sensitivity are highly related to alpha oscillations, as well as numerous neuropsychiatric disorders, changes in these behavioral outcomes were subsequently evaluated to assess clinically-relevant outcomes of the repeated tACS protocol.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* History of severe neurological disorder or traumatic brain injury
* Psychotropic medication use
* Metal plates/implants in head
* Pregnancy
* Implanted medical devices (e.x. pacemaker)
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
* BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
* Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;

Key Exclusion Criteria:

* Women of child-bearing potential;
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* CNV- conditions with a high likelihood of spontaneous resolution;
* History of intravitreal treatment with steroids;
* History of laser photocoagulation;
* History of intraocular treatment with any anti-angiogenic drugs.
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology

The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients of more than 18 years of age
* Patients presenting with anemia following chemotherapy
* Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy

  -- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
* Patients eligible for epoetin alfa biosimilar treatment

Exclusion Criteria:

* Patients are not receiving chemotherapy
* Patients already included in an epoetin zeta trial
* Patients presenting with a contraindication to epoetin zeta
* Patients presenting with hypersensitivity to the active principle or any of the excipients
* Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
* Patient with uncontrollable arterial hypertension
* Patients who cannot receive adequate prophylaxis by antithrombotic agents
Clinical Follow up After Subtotal and Total Hysterectomy

The purpose of this study was to find out subjective and objective outcomes of patients undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years after the operation. The hypothesis is that there are similar outcomes after both types of operations.

Objective: To evaluate ultra long-term follow-up after subtotal and total hysterectomy in patients operated on during 1978-1979 in Turku University Hospital, Finland.

Methods: From the original cohort of 212 patients 193 were sent a postal questionnaire in 1997 to find out possible symptoms related to hysterectomy. Again in 2011 a questionnaire based evaluation with a possibility of a clinical visit to study hospital was done for 153 patients. In the first evaluation a self-made questionnaire and in the second evaluation validated questionnaires were used. During a follow-up visit a clinical examination using also POP-Q-system was done. Additionally, hospital records of the patients were reviewed to find out subsequent operations after hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* benign indication for hysterectomy

Exclusion Criteria:

* abnormal Pap smear
Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. The physical activity or exercise program is designed for all older breast cancer survivors, and in particular for African-Americans and women of lower socio-economic status, who are the least likely to engage in physical activity.

Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer survivors who are within five years of treatment completion for stage I-III Breast Cancer (BCa).

Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks.

Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.

Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed breast cancer
* Stage I-III
* Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last. Hormonal therapy and targeted therapy are allowed
* Race: African-Americans and Non-Hispanic Whites

Exclusion Criteria:

* Stage IV breast cancer
* Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
* Inability to understand English as study instruments have not been validated in other languages
* Inability to provide informed consent
* High-risk patients (as defined by the American College of Sports Medicine risk-stratification schema using the American College of Sports Medicine (ACSM)/American Heart Association exercise pre-participation questionnaire) who do not receive clearance from cardiology
* Other medical or psychological conditions that would make participation unsafe or inhibit our ability to test our primary hypothesis, e.g. Parkinson's disease, severe dementia.
Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX)

Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.

This study will complement the clinical data on amoxicillin in breastfed new-borns considering that current knowledge in terms of authorized drugs use during breastfeeding is not sufficient to guarantee the child absence of exposure, even minimal. As a consequence, this lack of certainties leads to premature discontinuation of breastfeeding, well known to be beneficial for the breastfed new-borns. Amoxicillin, prescribed alone or with clavulanic acid at 2 to 3g per day for 7 days, including in lactating women, is mainly used to treat β-hemolytic strep throat, infections of the genitourinary tract as well as ear, nose and throat infections.

Eligibility Criteria:
Inclusion Criteria:

* Mothers over 18 years, treated by amoxicillin for at least 2 days who breastfeed their child, - Participation requires that breastfeeding is already well established (i.e., at least 2 weeks after giving birth in order to sample mature milk) and that the infant is over 4 weeks old,
* Affiliation to the social security scheme or equivalent,
* Ability to understand and willingness to sign a written Informed Consent document.

Exclusion Criteria:

* Mothers under 18 years old,
* Infants born prematurely (i.e., gestational age under 34 weeks) or requiring appropriate medical supervision or support from a team of social workers,
* Mothers who gave birth to twins,
* Inability to communicate due to language problems for the mother,
* Patient subject to a legal protection order (curatorship or tutorship).
POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors

This is a two-center, prospective continuously accruing longitudinal cohort study in patients with non-small cell lung carcinoma (NSCLC) or metastatic melanoma eligible for standard anti-PD-1 antibody treatment. The data from this prospective longitudinal cohort will be used in the POINTING (towards patient -tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging) KWF Kankerbestrijding project (WP4). The goal of this project is to develop a multifaceted predictive signature, by using new techniques on tumor characteristics before and during treatment with immune therapy. To do so, researchers will use the 'omics' approach. By combining molecular omics comprising genomics, transcriptomics, proteomics with radiomics and molecular imaging a set of factors will arise which can accurately predict the outcome of the treatment.

Participants in this cohort will undergo tumor biopsies, venous blood sampling and feces sampling before, during and at the end of standard anti-PD-1 antibody treatment. Also, data derived form routine procedures performed for standard-of-care anti-PD-1 treatment (ao laboratory assessments, CT and FDG-PET) will be collected.


Eligibility Criteria:
Inclusion criteria:

1. Histologically or cytological documented locally advanced or metastatic melanoma or NSCLC.
2. Patients must be eligible for standard treatment with anti-PD-1 antibody treatment (monotherapy or in combination with other checkpoint inhibitors).
3. Age ≥18 years.
4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
5. Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
6. Ability to comply with protocol.
7. Signed Informed Consent form.

Exclusion Criteria:

1. Malignancies other than melanoma or NSCLC within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).
2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study inclusion.

   * Patients who have received acute, low-dose, systemic immunosuppressant medications may be enrolled.
   * The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
Pre-arrival Instructions Effect on Bystander Cardiopulmonary Resuscitation (CPR).

The investigators hypothesized that pre-arrival instructions would increase the likelihood of bystanders performing Cardiopulmonary Resuscitation (CPR).

The City of Milwaukee and surrounding communities combine to form Milwaukee County covering 241 square miles and serving approximately 959,521 people. Milwaukee County includes 19 separate municipalities. Community demographics and other characteristics have remained largely stable for the past decade.

The study will take place in Milwaukee County from 2009 - 2013 in the communities providing Cardiopulmonary Resuscitation (CPR) pre-arrival instructions: West Allis and Oak Creek.

In Milwaukee County Basic Live Support (BLS) shall be started on all patients in cardiac arrest with the exception of victims with: decapitation; rigor mortis; evidence of tissue decomposition; dependent lividity; presence of a valid Do-Not-Resuscitate (DNR) or Physician Orders for Life-Sustaining Treatment (POLST); fire victim with full thickness burns to 90% or greater body surface area; hypothermic patients with signs of frozen tissue, rigid airway, ice formation in mouth, or chest noncompliant for Cardiopulmonary Resuscitation (CPR). The system standard is: Cardiopulmonary Resuscitation (CPR) will be provided whenever patient is pulseless; compressions at least 100/minute; hands on chest more than 75% of time; minimum compression depth of 2 inches in adults 75% of the time.

Therefore, the investigators will analyze data to assess how Cardiopulmonary Resuscitation (CPR) pre-arrival instructions may have affected the probability of receiving bystander Cardiopulmonary Resuscitation (CPR).

Eligibility Criteria:
Inclusion Criteria:

* Patients 21 years old or older
* Presumed cardiac origin as indicated on the Milwaukee County Emergency Medical Services (MCEMS) report
* Non-Emergency Medical Services (EMS) witnessed arrest

Exclusion Criteria:

* Patients younger than 21 years old
* Patients who are "obviously dead" (decomposition, rigor mortis, decapitation, or other)
* Trauma victims, including hanging and burns
* Patients with cardiac arrests clearly of other non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident and documented terminal illness
* Patients determined to be a do-not-resuscitate (DNR) upon arrival of Emergency Medical Services (EMS) providers
* Cardiopulmonary Resuscitation (CPR) by someone other than Emergency Medical Services (EMS) who is a trained first responder or health care provider with a predetermined duty to provide care.
Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study

This pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

Twenty women with infertility living in Saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. Fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. Outcomes will also be measured weekly for three weeks post-intervention. Feedback about how to improve the program will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments due to a diagnosis of infertility
* Lives in Saskatchewan, Canada
* Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 52 or at least mild anxious or depressive symptoms (GAD-7 score of 5 or above or PHQ-9 score of 5 or above)

Exclusion Criteria:

* Has a history of suicide attempts
* Is currently experiencing suicidal ideation
* Reports severe depressive symptoms, as indicated by a PHQ-9 score above 19
* Reports severe anxious symptoms, as indicated by a GAD-7 score above 14
Metformin Treatment in Infants After Perinatal Brain Injury

A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury


Eligibility Criteria:
Inclusion Criteria:

HIE Patients:

1. \> 35 weeks gestation at time of birth
2. ≤3 months at time of consent
3. Clinical diagnosis of HIE
4. Infant received therapeutic hypothermia for the treatment of HIE
5. Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)

Preterm Infants:

1. \<32 weeks gestation at time of birth
2. 36-44 weeks corrected (postmenstrual) gestational age at time of metformin administration
3. Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment

Exclusion Criteria:

1. Have a known genetic or chromosomal disorder.
2. Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.
3. History of hypoglycemia in the newborn period requiring glucose infusion rate \> 10 mg/kg/min or treatment with glucagon or diazoxide.
4. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
5. \>3 months of age at the time of enrollment (term HIE patients only)
6. Weight \<10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only).
7. Maternal use of metformin while actively breastfeeding.
Different Manufacturing Techniques of Facial Prostheses

All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction.

* (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin.
* Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern.
* Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated.
* The negative molds of both groups 2\&3 will be used in packing medical grade silicone (to cast the final prosthesis.
* All final prostheses will be colored and characterized to match the surrounding anatomy.
* Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
* Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
2. Patients between 20-60 years old.
3. Post traumatic patients with facial defects.
4. Patients with congenital facial defects.
5. Patients with failed facial surgical construction.
6. Compliant and cooperative patients.

Exclusion Criteria:

1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.