cyrilzakka/clinical-trials huggingface dataset:
Clearblue Pregnancy Test - Lay User Study

The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use.

This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user.

A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 45
* Willing to conduct a pregnancy test to determine or confirm their pregnancy status
* Willing to reveal their pregnancy status
* Willing to provide a blood sample
* Willing to give informed consent

Exclusion Criteria:

* Significant affiliation with SPD
* Has professional experience of using lateral flow-based devices
* Beyond the first trimester of pregnancy
* Taken a hormonal preparation containing hCG in the last month.
* Has a medical condition that means that it is not appropriate to give a blood.
GW873140 In Combination With Combivir In HIV Infected Subjects

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults

Eligibility Criteria:
Inclusion criteria:

* HIV infected subjects.
* Females must be of either non-childbearing age, or have a negative pregnancy test.
* All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
* Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
* Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
* Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
* Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
* Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
* Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
* Signed and dated written informed consent prior to study entry.

Exclusion criteria:

* Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening.
* Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
* Active Class C AIDS-defining illness.
* Laboratory abnormalities at screen.
* Significant blood loss prior to study start.
* Pregnant or breastfeeding women.
* Additional qualifying criteria to be determined by the physician.
Comparative Study of Different I-131 Doses in Graves' Disease

Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria:

* Pregnancy or lactation
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.

Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Poststernotomy chest pain and/or paresthesia

Exclusion Criteria:

* Osteoporosis, renal function impairment (creatinine value \>1.5 mg / dl.)
* Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
* Over production of scar tissue, thoracic surgery other than sternotomy -
* Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass
Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy

This is a prospective study investigating the disease course of patients with colorectal cancer that have had their cancer spread to their liver. The aim of this study is find potential biomarkers for disease recurrence and therapeutic targets for prognostic information.

Colorectal cancer (CRC), the 2nd leading cause of cancer mortality, often has a pattern of targeting the liver during initial metastases. The Comprehensive Genomic Profiling of Colorectal Cancer Patients with Isolated Liver Metastases to Understand Response and Resistance to Cancer Therapy (COMPARISON) study aims to assess the disease course of CRC by collecting primary tumor and metastatic liver specimens following pre-operative chemotherapy. If relapse occurs following surgical resection of the liver, biopsies will also be done for molecular analysis. As a result, these samples can be analyzed for chemotherapy resistance mechanisms and therapeutic targets to determine potential clinical outcomes for this particular subset of CRC patients.

Eligibility Criteria:
Eligibility Criteria:

1. Patients must have histologically confirmed CRC with isolated liver metastasis
2. Patients must be planned for a hepatic metastasectomy
3. Patients must have received at least 3 cycles of chemotherapy (FOLFOX or FOLFIRI with or without Bevacizumab) prior to the planned hepatic metastasectomy
4. Primary tumor must be considered resectable with a plan for this to either occur concurrently with the liver resection or subsequent to this.
5. If primary has already been resected before liver resection, archival tissue must be available for genomic analysis
6. Patients must be 18yrs of age or older
7. Ability to understand and willing to sign a written informed consent document

Exclusion Criteria:

1. Patients with un-resectable or borderline resectable isolated liver metastases as judged by the multidisciplinary hepatobiliary tumor board at PM or BCCA after a course of pre-operative chemotherapy will be excluded
2. Patients with evidence of possible metastatic disease at any sites outside the liver are not eligible
3. Patients with any major co-morbidity or co-morbidities that will render liver resection very high risk in investigator's opinion
4. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
5. Patients with a previous history of another primary cancer treated within 5 years of study entry are not eligible except those with basal cell or squamous cell carcinoma of the skin and intraepithelial neoplasia.
Parental Attitudes in Invitro Fertilization

The relationship between revelation of mode of conception and child behavior is not known

start of assisted reproductive techniques over the past 25 years made many otherwise infertile couples to become parents to genetically related children.

Eligibility Criteria:
Inclusion Criteria:

* Parents who were enrolled in ICSI and pregnancy occurred

Exclusion Criteria:

* ICSI with no pregnancy
Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia

Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.

Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.

Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.

Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive participants, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.

Eligibility Criteria:
Inclusion Criteria:

* all pregnancies affected by fetal esophageal, duodenal or intestinal atresia referred to our prenatal diagnosis unit
* all newborns managed for such atresia in our unit of pediatric surgery

Exclusion Criteria:

* termination of pregnancy,
* stillbirth,
* the false positive cases
Study of NGM621 in Participants With Geographic Atrophy

This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. GA lesion size in the study eye of \>=2.5 mm² as assessed by the central reading center
2. BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits

Exclusion Criteria:

1. GA in either eye because of cause other than AMD
2. History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
3. Visual impairment in the study eye due to causes other than GA
4. Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)

Other protocol-defined inclusion/exclusion criteria could apply.
Smoke of Endoscopic Gastrointestinal Surgery

The purpose of this project is to study the composition, hazard, and protection of smoke from endoscopic gastrointestinal surgery. The study is a single-center, prospective, randomized, controlled, cohort study. The investigators plan to enroll 80 patients who undergo endoscopic gastrointestinal surgery and 10 medical staff participating in surgery in the gastrointestinal endoscopy room of the First Affiliated Hospital of Xi'an Jiao Tong University. The investigators will randomize the included study subjects. The investigators will monitore smoke and try to remove the smoke with an air sterilizer in the Air sterilizer group. The control group was monitored for smoke without any intervention. The primary endpoint is concentration of PM2.5 in smoke from endoscopic gastrointestinal surgery, the risk factors, and the effect of air sterilizer on its removal. The secondary endpoint is the concentration of PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 in smoke from endoscopic gastrointestinal surgery, the risk factors, and the effect of air sterilizer on its removal. Other exploratory objectives include the hazards of smoke to staff in the gastrointestinal endoscopy room, and the viral content of smoke.

The investigators will enroll 80 patients undergo endoscopic gastrointestinal surgery and 10 medical staff participate in surgery in the gastrointestinal endoscopy room. The patients will be randomized into the control group and the Air sterilizer group. The investigators will use air quality testing equipment to monitor the concentrations of the PM2.5, PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 of the smoke near the mouth and nose of the surgeon, cooperating nurse, and anesthesiologist, and try to remove the smoke with an air sterilizer in the Air sterilizer group. The control group was monitored for concentrations of the above ingredients in smoke without any intervention. The primary endpoint is concentration of PM2.5 in smoke during endoscopic gastrointestinal surgery, the risk factors related to surgery, and the effect of air sterilizer on its removal. The secondary endpoint is the concentration of PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 in smoke during endoscopic gastrointestinal surgery, the risk factors related to surgery, and the effect of air sterilizer on their removal. Other exploratory objectives include the hazards of smoke to staff in the gastrointestinal endoscopy room, and the viral quantitative of smoke.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo endoscopic gastrointestinal surgery and medical staff who participate in the surgery in the gastrointestinal endoscopy operating room of the First Affiliated Hospital of Xi'an Jiao Tong University
* Voluntary participation in this study

Exclusion Criteria:

* Severe liver disease
* Severe Kidney disease
* Severe cardiovascular disease
* Severe cerebrovascular disease
* Severe neuropsychiatric disease
* Unable to cooperate with the research
Alcoholism: Emotion and Thinking

The purpose of this study is to determine whether long-term chronic alcoholism is associated with changes in emotional functioning and brain structure and function.

This research investigates brain structure and function in alcoholics compared to healthy nonalcoholic individuals. Alcoholics have shown impairments in cognitive processing of emotional signals. Some alcoholics are impaired in social skills, and many are unable to implement the strategies for interpersonal interactions that they recommend for themselves. For example, alcoholics have difficulty interpreting non-verbal emotional cues and recognizing facial expressions of emotion. When listening to sentences, alcoholics also have some difficulty judging emotional intonations and emotional content. In our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Male and female right-handed people 25 years of age or older.
* Participants either will have a past Diagnostic and Statistical Manual version IV (DSM-IV) diagnosis of alcohol dependence, or no such history at all.
* Participants will have signed an informed consent.

Exclusion Criteria:

* Pregnant women.
* Shrapnel or other metal in body (dental fillings OK)
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System

Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis requiring PS Knee Prosthesis

Exclusion Criteria:

* Not meeting Inclusion Criteria
* Requiring Constrained Prosthesis
* Metal Allergy
* Neurological disorders.
* Cognitive impairment
* Not giving consent.
Clinical Practice Guidelines Versus Decision-support for Latent Tuberculosis Infection (LTBI) Management

Latent Tuberculosis infection (LTBI) guidelines can be complex. LTBI-ASSIST is a web-based interactive tool to navigate US LTBI clinical practice guidelines in a patient-centered format that may guide clinical decision making around Latent TB care.

The research goal is to determine the difference in reported confidence among trainees that are not experts in LTBI care. The investigators further aim to assess if access to the LTBI-ASSIST tool improves clinical decision making in a series of simulated case scenarios containing guideline-derived, multiple choice items, as well as assess the efficiency in navigating the scenarios - measured by time to complete the survey.

The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 4 case scenarios consisting of 14 multiple choice questions. Participants providing informed consent will be randomized to receiving access to either US Centers for Disease Control (CDC)/National Tuberculosis (TB) Controllers Association (NTCA) Guidelines or the LTBI-ASSIST online tool. Those in the experimental arm will further complete a 10 question System Usability Scale to assess usability of the LTBI-ASSIST tool.

All Johns Hopkins medical trainees and residents will be eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Student at Johns Hopkins School of Medicine, or Medical trainee at Hopkins Hospital or Bayview Program

Exclusion Criteria:

* None
Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma

In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.

Given that myelosuppression was significant using the docetaxel dose of 75 mg/m\*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted. The expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed newly diagnosed Stage III/IV epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis
* Treatment must start within 8 weeks of surgery
* Subjects may be measurable per RECIST criteria or evaluable for disease response by CA125. Evaluable CA 125 levels are defined as an elevated CA125 pre operatively which either remains elevated post-operatively or normalizes after surgery
* No prior chemotherapy or radiation therapy
* Age ≥ 18
* Performance Status must be ≤ 2 (ECOG)
* Peripheral neuropathy: must be ≤ grade 1
* Hematologic (minimal values)

  * Absolute neutrophil count ≥ 1,500/mm3
  * Hemoglobin ≥ 8.0 g/dl
  * Platelet count ≥ 100,000/mm3
* Hepatic

  \*Total Bilirubin ≤ ULN
* AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.

  * If alkaline phosphatase is ≤ ULN and AST or ALT is \>5x ULN then the patient is not eligible
  * If alkaline phosphatase is \>1x but ≤2.5 x the ULN and the AST or ALT is \>1.5x the ULN then the patient is not eligible
  * If alkaline phosphatase is \>2.5x but ≤5x the ULN and the AST or ALT is \>1x the ULN then the patient is not eligible
  * If alkaline phosphatase is \>5x the ULN then the patient is not eligible
* Renal: Creatinine (serum) less than or equal to 1.5 ULN, CTC grade 1.
* Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

PT/PTT ≤ 1.5 x's ULN

Exclusion Criteria:

* Patients with a history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
* Women who are pregnant or breast-feeding.
* Patients who have signs of infection or who have not recovered from the effects of recent surgery
* Patients with a performance status of 3 or 4
* Patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma.
* Patients who have received prior myelosuppressive chemotherapy or XRT.
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed of complicated intra-abdominal infection need surgical treatment

Exclusion Criteria:

* patients diagnosed of intra-abdominal infection receive non-operative management
* patients with known allergic history of fluoroquinolone
* Severe, life threatening disease with a life expectancy of \< 48 h or APS and APACHE scores of \> 35