cyrilzakka/clinical-trials huggingface dataset:
Treatment Prior to Injection and Biopsy of the Vulva

This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.

To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area.

Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues.

The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Undergoing vulva biopsy during clinic visit
* Willing and able to comply with study protocol
* Able to understand and provide informed consent

Exclusion Criteria:

* Inability to provide informed consent
Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria

This project is a case-control study which seeks to identify modifiable risk factors for breast and colorectal cancer in Nigeria. Both cases and controls will be required to complete a risk factor questionnaire which contains information about their diet, physical activity, past medical history and life style factors. They will also be required to provide information on their body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water percentage.

Based on the existing ARGO platform where a current colorectal cancer study is going on, approximately 400 patients with a prior diagnosis or a new diagnosis will be recruited into this study. Comparatively, we will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases.


Eligibility Criteria:
Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer.

Control Group - Patients must not have a diagnosis of cancer.
Effect of Dill in Thyroiditis and Nodular Goiter Patients

The aim of the study was to investigate the functional and morphological effects of Anethum graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels, anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for 90 days.

The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose capsules were filled with 300 mg powder. Placebo was prepared in the same manner using maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and at the end of the trial with ultrasonography to identify the changes and effectiveness of dill dosage forms.

After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were examined in the group with and without Anethum graveolens L..

Again, after the study, the size of thyroid nodules was evaluated in the group who received and did not receive Anethum graveolens L. by ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* To have multi-nodular goiter,
* To be a benign result in fine needle aspiration biopsy,
* Euthyroid must be sick,
* Must be sick over the age of 18,
* To accept the research.

Exclusion Criteria:

* Thyroid function tests non-euthyroid individuals,
* To have a malignant result in thyroid biopsy,
* Not giving approval,
* To be renal failure,
* Benign pregnant,
* Taking blood thinning drugs
A Study to Evaluate the Effects of Pharmacological Chaperones in Cells From Patients With Pompe Disease

The purpose of this study is to see how molecules called pharmacological chaperones affect the cells of patients with Pompe disease. The study will last 1 or 2 visits which will include a blood collection, urine collection, and two skin biopsies. Information will also be collected from the medical records about disease history and diagnosis. Patients will not receive any study medication.

The study is designed to evaluate the response of cell lines derived from blood and skin tissue from Pompe patients to pharmacological chaperones. Samples of blood and skin tissue will be obtained to make cell lines that will be used to test pharmacological chaperones. The study will include patients with early and late-onset Pompe disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any age
* Confirmed diagnosis of Pompe disease (early or late-onset)
* Clinically stable
* Written informed consent by subject or legal representative

Exclusion Criteria:

* Other significant disease or otherwise unsuitable for the study, as determined by the investigator
Building Empowerment and Coping Outcomes for CaNcer Patients, Survivors and Their Caregivers

Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.

Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Lived experience as either a current cancer patient, cancer survivor or caregiver of someone with cancer
* Adult - 18+
* Has health insurance provided by employer or union (can be dependent of person on insurance)
* Read/speak English
* Have access to internet and personal email account

Exclusion Criteria:

* Severe mental illness that is disruptive to other group members
Leveraging the Emergency Department (LEAD) Study

This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years to 80 years
* Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
* 20 pack-year smoking history
* Has never had lung cancer screening
* Able to provide informed consent
* Able to speak and understand English

Exclusion Criteria:

* Diagnosed with lung cancer
* Has a history of having a lung cancer screening scan
* Unable to speak and understand English
Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia

This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of naïve severe or very severe aplastic anemia
* Male or female age ≥ 12 years
* Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Previously received immunosuppressive therapy \> 4 weeks
* Previously treated with TPO-RA \> 4 weeks
* Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.
* Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure.
* Tested positive for HIV or syphilis
* Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities.
* History of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years
* Combined with other serious disorders
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above.
Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.


Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed diagnosis of:

  * CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation.
  * Ph+ ALL who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the T315I mutation.
* Patients on treatment with Iclusig® or prescribed for treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).
* Written informed consent obtained from the patient, if still alive (NPP participants that were still on Iclusig® treatment on 01 March 2016, but who died before the start of this registry will be included without informed consent provided that a waiver is granted by the ethics committee for inclusion of these patients).

Exclusion Criteria:

• Concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).
Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years old
* Adapted contact lens wearer
* Sign informed consent
* Normal eyes with the exception of the need for visual correction
* Astigmatism less than or equal to -0.75 diopter
* Spherical prescription range between -10.00 and +6.00 diopters
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any known sensitivity to the test articles used in the study
* Monocular vision
* Lid or conjunctival infections or abnormalities
* Conjunctival staining greater than Grade 1
* Corneal staining greater than Grade 2
* Corneal edema or opacifications
* Aphakia
* Any previous corneal surgery
* Iritis
* Recent significant changes in visual acuity
* Ocular disease that contraindicates contact lens wear
* Tarsal abnormalities greater than Grade 2
* Any ophthalmic medication
* Any systemic medication or condition that might affect the subject's participation in the study
* Chronic upper respiratory infections or colds
* Pregnancy or planning to become pregnant
* Lactation
* Seasonal allergies
* Known infections or immunosuppressive disease
* Participation in other studies
* Other protocol-defined exclusion criteria may apply
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron.

This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be frequently measured.

The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.

Eligibility Criteria:
Inclusion criteria includes:

1. Men or women ≥ 18 years
2. Subjects having IDA caused by different etiologies
3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
4. Haemoglobin (Hb) ≤ 11 g/dL
5. Transferrin Saturation (TSAT) \< 20 %
6. S-ferritin \< 100 ng/mL
7. Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

1. Anemia predominantly caused by factors other than IDA
2. Hemochromatosis or other iron storage disorders
3. Previous serious hypersensitivity reactions to any IV iron compound
4. Erythropoiesis stimulating agent (ESA) treatment
5. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
6. Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
7. Alanine aminotransferase and/or aspartate aminotransferase \> 3 times upper limit of normal
8. Required dialysis for treatment of chronic kidney disease (CKD)
9. Alcohol or drug abuse within the past 6 months
10. Pregnant or nursing women
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module)
* Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician
* The patient will present within the normal course of care, for either a first or subsequent episode of depression

Exclusion Criteria:

* Schizophrenia or other psychotic disorders
* Bipolar disorder
* Dementia or other neurodegenerative disease significantly impacting cognitive functioning
* Mood disorder due to a general medical condition or substances
* Acute suicidality
* Patient treated for depression by a combination of different antidepressant treatments at the time of the consultation

Other exclusion criteria may apply.
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI. We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication.
* Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Patients scheduled to receive prophylactic antibiotic therapy.

Exclusion Criteria:

* Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
* Patients undergoing general anesthesia.
Need for the Assessment and Consultation Team (ACT) Following Anesthetic Care

The goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care.


Eligibility Criteria:
Inclusion Criteria:

* Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.

Exclusion Criteria:

* Any study subject that has not experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001

This is an open label, single arm study which enrolled 5 subjects with SCD who previously participated in the GBT440-001 study (NCT02285088).

This is an open label, single arm study which enrolled 5 subjects with SCD who previously participated in the GBT440-001 study (NCT02285088).

Dosing of study drug was 2 to 6 months, depending on subject's dose assignment in the last administration of study drug in GBT440-001 (NCT02285088).

The primary objective of the study was to evaluate the safety and tolerability of up to a total of 6 months dosing of subjects with SCD who participated in the GBT440-001 study (NCT02285088).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with SCD aged 18 to 60 years inclusive and \>50 kg who have participated in the GBT440-001 study.
2. Subjects, who if female and of child bearing potential, agree to continue to use highly effective methods of contraception prior to enrollment in this study and for 3 months after the last dose of study drug.
3. Subjects, who if male are willing to continue to use barrier methods of contraception, prior to enrollment in this study to 3 months after the last dose of study drug.

Exclusion Criteria:

1. Subjects requiring chronic transfusion therapy.
2. Subjects receiving a blood transfusion within 30 days of enrollment in this study.
3. Female subjects who are pregnant, trying to become pregnant or lactating.
4. Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, or additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, personal or family history of long QTc interval).
5. Subjects who have a significant infection or known inflammatory process on admission to this study.
6. Subjects who have acute gastrointestinal symptoms at the time of admission (e.g. nausea, vomiting, diarrhoea, heartburn).
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18 and 55 years of age, inclusive
2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
3. Must be HIV negative by HIV 1/0/2 testing
4. Must be Hepatitis B (HBV) surface antigen negative
5. Must be Hepatitis C (HCV) antibody negative
6. Females must have a negative serum pregnancy test
7. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
8. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug

Exclusion Criteria:

1. Pregnant or lactating subjects
2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
3. Have poor venous access and are unable to donate blood
4. Have been vaccinated within 90 days of study dosing
5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
6. Have history of significant drug sensitivity or drug allergy.
The Role of Social Determinants in Cardiovascular Health and Vascular Function

This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position and those struggling with depression are at greater risk of cardiovascular disease.

This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position are at greater risk of impairment in the large organ that is responsible for blood movement in the body and artery stiffness. Additional sims include identifying the influence of depression on vascular function and measure the interaction between depression and social determinants of health. We hypothesize that impairment will be greater in individuals with depression than in individuals without. Finally we will compare a comprehensive metabolic project against the social determinants of health and depression, hypothesizing that more severe social determinants of health and depression will increase the risk of cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older and ability to read.

Exclusion Criteria:

* (1) unable to provide informed consent (e.g., due to acute impairment or psychosis), (2) inability to read, (3) previously enrolled in the study.