cyrilzakka/clinical-trials huggingface dataset:
Assessment of Early Pregnancy MAB Completion

This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant person with early pregnancy ≤42 days
* Eligible and consented to a medication abortion
* Have access to receiving text messages and the internet
* Able to read and understand English

Exclusion Criteria:

- Privacy or safety concerns about filling out the surveys
Cosmetic Dermatology Study

This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.

This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and up
* Male or Female
* Receiving cosmetic dermatological injection
* Willing to participate

Exclusion Criteria:

* Aged younger than 18 years
* Prior history of known light sensitivity
* Other reasons as determined by investigator
Investigation Into the Microorganisms in Pregnant Women

Pregnant women with short cervical length (\<25 mm) in second-trimester ultrasonographic assessment are at high risk for preterm birth, a major cause of perinatal mortality and morbidity worldwide. Some of these short-cervix women proceed to a more advanced stage manifested as a painless prematurely dilated cervix in the second trimester. It is not fully understood why some women have short cervical length or prematurely dilated cervix (cervical insufficiency), although evidence is mounting that there is an association between short cervical length and infection by microorganisms. The investigators hypothesize that the cervical microorganisms in pregnant women with a shortened or dilated cervix are different, compared with those in women with normal cervical length and a closed cervix.

Previously, culture-dependent methods were used to detect bacterial or fungal infection, but the sensitivity was low, since not all species grew well in culture. Recently, molecular methods based on PCR amplification of the bacterial 16S ribosomal RNA (rRNA) gene or the fungal internal transcribed spacer (ITS) followed by capillary sequencing has been used to identify bacteria and fungi. However, the resolution of such capillary sequencing-based method (\<100 sequencing reads/sample) is too low to capture the major collection of microorganisms in a sample. Less abundant but possibly pathogenic microorganisms associated with short cervical length remain undetectable. To address the current gap in this field, we propose to more comprehensively survey microbial communities in the cervix of pregnant women by PCR amplification of the 16S rRNA region, ITS or other genomic regions with taxonomic classification potential. This will be followed by next-generation sequencing (\>40,000 sequencing reads/sample), which has been proven to capture the majority of microorganisms in a sample.

Eligibility Criteria:
Inclusion Criteria:

* Women with or without cervical insufficiency (cervical length \<25 mm or dilated cervix in the second trimester or the late first trimester)

Exclusion Criteria:

* multiple pregnancies and pregnancies associated with fetal chromosomal abnormality
Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris

This study aims to assess the expression of SCCA2 in the skin of patients with warts and to detect its correlation with characteristics of warts.

Type of the study: Cross sectional study. Patients: This study will include 25 patients with verruca vulgaris and 25 healthy volunteers.

Inclusion criteria:

Patients present with warts (verruca vulgaris type).

Exclusion criteria:

Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study One skin biopsy will be taken from each healthy volunteers of the control group via 2-mm disposable punches under complete sterile precautions. Two biopsies will be taken from patients with wart lesion one from verruca vulgaris via 5-mm disposable punches and another from non-affected skin via 2-mm disposable punches under complete sterile precautions.

Biopsy handling: Each specimen in both groups will be fixed in formalin and embedded in paraffin to form paraffin blocks. Serial sections will be obtained from each block and stained with hematoxylin and eosin (H\&E) for histological diagnosis.

Stained sections will be examined under a light microscope. To confirm the diagnosis of wart, the grade of inflammation and the density of dermal inflammatory infiltrate will be classified as follows Grade 0, no infiltrate; Grade 1, mild; Grade 2, moderate; or Grade 3, marked infiltrate.

Immunohistochemical staining: investigators will use monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody). Immunohistochemical staining will be performed the pattern of immunostaining for SCCA2 will be evaluated in both the epidermis and dermis of wart lesions. The immunohistochemical score (IHC) range will be as follows: 0: negative expression of SCCA2; 1+: weak expression of SCCA2; 2+: moderate expression of SCCA2; and 3+: strong expression of SCCA2.

Eligibility Criteria:
Inclusion Criteria:

* Patients present with warts (verruca vulgaris type).

Exclusion Criteria:

* Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients with Sarcoma

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).

Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have measurable disease.
* Age ≥ 12 years (Phase 2)
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3011 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma

Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
* Karnofsky Performance Score ≥ 60
* Absolute Neutrophil count ≥ 1,500
* Platelets ≥ 100,000
* BUN ≤ 25
* Creatinine ≤ 1.5
* Bilirubin ≤ 2.0
* Hemoglobin ≥ 10 gm
* SGOT \< 2 x upper limit of normal
* SGPT \< 2 x upper limit of normal

Exclusion Criteria:

* No prior radiation to the head or neck area, chemotherapy or radiosensitizer
* No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix
A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension

The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate hypertension
* Age 18-75 years, inclusive

Exclusion Criteria:

* Clinically significant illnesses or abnormalities upon evaluation
* Current treatment with 3 or more antihypertensive meds
* Presence of Type I or uncontrolled Type II diabetes
* Presence of alcohol or drug abuse
Group-based or Individual Information About Disease and Treatment Plan

The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.

Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.

There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.

The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.

Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.

Eligibility Criteria:
Inclusion criteria:

* Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
* Prostate cancer patients that are candidates for curative radiotherapy
* Signed informed consent
* Patient expected to be able to complete the planned treatment and the study procedures
* 18years or older

Exclusion Criteria:

-Patients not fulfilling inclusion criteria
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.

This is a Phase 1, open-label, dose-escalation study in NMOSD patients in which subjects will receive BAT4406F injection via intravenous infusion. A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The overall objective is to assess the safety, tolerability, and pharmacokinetics of BAT4406F injection in NMOSD patients.

Eligibility Criteria:
Inclusion Criteria:

* Compliance with the NMOSD diagnostic criteria developed by the 2015 International NMO Diagnostic Team (IPND);
* 18-65 years old , male or female;
* At least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening;
* Discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline;
* EDSS score ≤ 6;
* Men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion;
* Agree to participate in the trial and sign the informed consent in writing.

Exclusion Criteria:

* Any monoclonal antibody treatment was used within 6 months prior to dosing;
* Having been treated with anti-CD20 monoclonal antibody;
* Live vaccine received within 4 weeks before screening;
* Having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer);
* A history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs;
* Abnormal liver function, kidney function and bone marrow reserve;
* HIV-positive history or HIV-positive at screening; hepatitis B and/or hepatitis C history or hepatitis B surface antigen-positive at screening; or hepatitis C virus (HCV) antibody positive; treponema pallidum antibody positive when enrolled;
* History of infections that investigators have identified as unsuitable for testing;
* Patients with a clear history of heart disease ;
* Have a history of mental disorders;
* Pregnant or lactating women, and female subjects who have a positive pregnancy test at screening;
* None of the investigators or their relatives participating in the study could be enrolled.
Testing the Effect of a Warning About New Drugs

The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.


Eligibility Criteria:
Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes

The aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients

The first phase of the study will include a questionnaire :

* The cases and control will be asked about demographic information such as residence, age, education, and occupation.
* History of discovery of diabetes.
* Exposure to products and materials such as polycarbonate plastics, cosmetics and beverages containing bisphenol A and paraben and it will be evaluated through exposure sheet through asking about dietary exposure, Environmental exposure and medical exposure.

Then clinical evaluation including:

* Full clinical examination will be performed for cases and control.
* Anthropological data:

their weights, heights and waist circumference will be measured. The body mass index (BMI) will be calculated by weight (kg)/height (m)2 formula.

* Investigations: routine and specific investigation as blood glucose level, HbA1c and lipid profile.
* Urine specimens will be collected in clean, glass containers will labeled with the subject identification number. Turbid sample or those containing blood will be excluded.
* All specimens will be stored frozen below 20 degree centigrade.
* Urine samples will be analyzed by High Performance liquid chromatograph (HPLC) to detect bispenol A and parabens levels.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ( 18 y or elder).
2. Type 2 DM

Exclusion Criteria:

* Type 1 DM
* Less than 18 y
* History of chronic diseases such as liver failure, cardiac patients......etc
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology

The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Are 18 to 65 years old
* Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
* Engage in clinically significant dietary restriction (define as \>1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
* Have a BMI above 18.5
* Are able to give consent

Exclusion Criteria:

* Are unable to fluently speak, write and read English
* Are receiving treatment for an eating disorder
* Require immediate treatment for medical complications as a result of eating disorder symptoms
* Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
* Have diabetes
* Are pregnant or planning to become pregnant within the next year
Role of Intrauterine Insemination in Patients With Endometriosis I-II

Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. This indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients


Eligibility Criteria:
Inclusion Criteria:\< 38 years old women, antral follicle count \> 6, basal FSH \< 10mUI/ml, BMI\<30, Infertility time \<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \< 3 previous IUI cycles, no male severe factor associated

-

Exclusion Criteria:

* \> 38 years old
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy

Exclusion Criteria:

* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Tolerability of a Modified Health-Dx

Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals ages 18 - 75 inclusive
* Subject is a suitable candidate for study participation in the opinion of the Investigator
* Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB

Exclusion Criteria:

* Subjects with a history of any condition that may impact the GI tract
* Subjects who are unable to swallow a 000 sized capsule
* Subjects with an implanted medical device that has wireless data communication capability
* Subjects planning to undergo an MRI within 30 days after the study
* Subjects with a BMI \> 40 (severe obesity)
* Subjects who are pregnant or are nursing
* Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment
The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients

The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. It aims to answer the main question of whether a self-management education program can improve self-management skills, quality of life, and reduce family caregiver burden in elderly patients with enterostomies.


Eligibility Criteria:
Inclusion Criteria:

* age ≥60 years
* first enterostomy surgery
* informed consent to voluntarily participate in this study.

Exclusion Criteria:

* verbal communication disorder; cognitive dysfunction or history of mental illness;
* visual and manual mobility impairment unable to perform stoma care operations.