cyrilzakka/clinical-trials huggingface dataset:
The Evolution of Relationship Between Results of Peripheral Blood Test and Outcomes of in Vitro Fertilization

The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization.

Study Design (Brief Description)

1. Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's women hospital
2. Exclusion criteria No
3. Endpoint

1. Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate

4. Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size: total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010.

Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study when collecting extra specimen from participants No more need to collect extra specimen from participants in this study 7. Expected Endpoints of Treatment No 8. Others No

Eligibility Criteria:
Inclusion Criteria:

* Patients had underwent both infertility blood test and IVF treatment in Lee's women hospital

Exclusion Criteria:

* No
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

This study occurred in two parts: Part A and Part B.

Part A of the study was an open-label, PK evaluation of intramuscular (IM) administered suptavumab in preterm infants for whom palivizumab was not recommended to enable the selection of dosing regimens for Part B.

Part B of the study was randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of IM administration of suptavumab in preterm infants for whom palivizumab was not recommended. The total duration of Part B was up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period).

Up to 1515 subjects were planned to be included in Part B of the study. Participants were randomly assigned to 1 of 3 different groups, each with 505 infants; one group received one dose of suptavumab and one dose of placebo, the second group received two doses of suptavumab, and the third group received two doses of placebo.

There was a separate genetic testing sub study.

Eligibility Criteria:
Key Inclusion Criteria:

1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday)
2. Gestational age is ≤35 weeks, 6 days at birth
3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent

Key Exclusion Criteria:

1. Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider
2. History of CLD defined as requirement of supplemental oxygen for 28 days after birth
3. Known hemodynamically significant congenital heart disease
4. Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway
5. Known renal or hepatic dysfunction
6. Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
7. Known or suspected impairment of immunological functions or autoimmune diseases
8. History of anaphylaxis
9. Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product
10. Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies

Note: Other inclusion and exclusion criteria apply
Trial of Simvastatin for the Treatment of Severe Asthma

This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.

This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.

The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.

See above.

Eligibility Criteria:
Inclusion Criteria:

1. statin-naïve adults \>18 years old with the ATS definition of severe asthma,
2. on ICS and LABA,
3. confirmation of allergic asthma (serum IgE \>100 kU/L, positive radioallergosorbent test (RAST) panel, and/or peripheral blood absolute eosinophil count of ≥700/mm3),
4. clinically stable for 4 weeks.

Exclusion Criteria:

1. baseline FEV1 \<30% predicted,
2. current smokers or ex-smokers with \>5 pack-years of smoking history,
3. pregnant women, nursing/lactating mothers, or women of childbearing potential who are actively attempting to become pregnant,
4. nasal or sinus surgery or trauma within 3 months of study participation,
5. ischemic heart disease,
6. liver disease, and
7. the concurrent use of the following medications (amiodarone, verapamil, diltiazem, gemfibrozil, cyclosporine, antifungal azoles (itraconazole, ketoconazole, or voriconazole), and danazol.
Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Primary Objective:

To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

Secondary Objective:

To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.

The study duration by subject will include a 8-week treatment period with 3 follow-up visits.

Eligibility Criteria:
Inclusion criteria :

* Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;
* Positive and Negative Syndrome Scale (PANSS) total score ≥ 60

Exclusion criteria:

* Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement;
* Participation into another clinical trial within the last month;
* Patients previously or currently treated with amisulpride;
* Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months;
* Patients receiving electric convulsive therapy or physical therapy within the past 1 month;
* Patients with coexisting severe systemic diseases;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Relationship Between CFTR Gene Mutations and Exercise Capacity

This study will explore the effect of mutation severity on exercise capacity. Through a better understanding of the association between mutation severity and exercise capacity, clinicians will be more able to predict a given patient's level of independent functioning based on their genes, which is essential information that patients' families want to know upon diagnosis.

Cystic fibrosis (CF) is a disease that disrupts the lungs. With an average survival of 40.7 years, this condition affects around 30,000 in the US. Most commonly seen in among those of European descent, CF is present in about 1 in every 2,500 Caucasian newborns. A genetic mutation causes a thick and sticky mucus production in the lungs. Thus, CF patients are more likely to have respiratory failure and lung infections. These symptoms of CF vary among patients and primarily depend on the severity of the gene mutations.Currently, there is not a lot of literature on the relationship between CFTR genes and exercise capacity, highlighting the relevance of this study.

This study is expected to last at least 10 weeks. Participants will be given a Fitbit tracker at the beginning of the study to wear during their participation. Participants are asked to engage in their normal level of physical activity. No one from the research team will have direct access to their Fitbit information. In other words, participants will create an account on the Fitbit website and only participants will be able to see the information on there. A weekly survey about their Fitbit mileage will be given by a research member via phone. The weekly survey will also ask more opinionated questions, regarding any updates on their attitudes toward exercise. At the conclusion of this 10-week study, participants will have the option of keeping their Fitbit tracker. About 50 participants are expected to enroll in this study. At any point of the study, participants will be given the freedom to withdraw their participation.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patient who has been tested positive for a CF mutation of class 1-5.
* Part of the VCU cystic fibrosis program.
* Above 18 years old.

Exclusion Criteria:

* Has not been tested positive for a known CF mutation.
* Not a part of the VCU cystic fibrosis program.
* Cannot be under 18 years old.
Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients

The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.

Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.

Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles \>11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.

Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Eligibility Criteria:
Inclusion Criteria: Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol

* Age \< 40 years
* Anticipated high ovarian response

Exclusion Criteria:

* Endometriosis \> than grade II
* One ovary
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
* Willingness to maintain same hair style, length and hair color during study
* Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
CONNECT: Smoking Cessation and Lung Cancer Screening

This clinical trial studies the impact of CONNECT on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.

The study team will develop and test a novel smoking cessation intervention, CONNECT, which will start at the time an individual is receiving lung cancer screening (LCS). CONNECT will include an interactive Video Doctor which will provide participants with information tailored to their individual responses as well as proactive outreach using brief telephone calls and text messaging to follow up smokers with motivation enhancement to refer and engage patients in evidence based smoking cessation interventions (such as quitline utilization). After development and usability testing, we will conduct a small feasibility study followed by a pilot randomized controlled trial to estimate the impact of CONNECT on biochemically confirmed 30-day smoking abstinence among diverse current smokers seen at the San Francisco Veterans Affairs Medical Center and the University of California San Francisco Division of General Internal Medicine. Participants will be randomized to CONNECT or a control condition. Data will include self-report from participants obtained at baseline, 1 and 3 months, and the electronic health record. Outcomes will be biochemically confirmed 30-day smoking abstinence at 3 months post LCS and satisfaction as well as self-reported quit attempts, and use of evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling). The knowledge gained will provide the pilot data necessary to apply for a larger study to test our novel intervention for promoting smoking cessation among a diverse population of high-risk smokers undergoing Lung Cancer Screening.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-80
* Male or female
* English speaking
* Have an already scheduled low-dose computed tomography (LDCT) visit
* Smoke at least 1 cigarette in the last 7 days
* Have a phone that can receive text messages.

Exclusion Criteria:

* Younger than 55 or older than 80
* Does not speak English
* Does not have a scheduled low-dose computed tomography (LDCT) visit
* Does not smoke at least 1 cigarette in the last 7 days
* Does not have a phone that can receive text messages.
Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

The investigators aim to create an effective and accurate method to report, define, and classify complications and adverse events during and after Inguinal lymph node dissection (ILND) as part of the staging and treatment for penile cancer, vulvar cancer, and melanoma. In turn, this will become an objective, efficient, and reproducible tool to facilitate comparisons across surgical approaches, techniques, and surgeons.

Inguinal lymph node dissection (ILND) has shown to be a necessary surgery from the oncology standpoint being extensively used as part of the staging process in malignancies of the penis, vulva, or melanoma. Moreover, the ILND has been shown to improve survival if performed in a timely manner. Yet, ILND is linked to a high rate of complications and adverse events.

Complications and adverse events' incidence are frequently used as surrogate markers of quality in surgery. However, there is tremendous heterogeneity in the report in such specifically for this procedure. Even though different classification and grading systems on surgical complications are available. There is a lack of standardization regarding the definition and classification to report ILND complications and adverse events leading to discrepancies across the literature, often interfering with the interpretation of surgical performance and quality.

This study will provide a systematic definition and classification of ILND complications and adverse events, ultimately improving the reporting of such conditions for future studies.

To create an effective and accurate method to report, define, and classify complications and adverse events during and after ILND as part of the staging and treatment for penile cancer, vulvar cancer, and melanoma. In turn, this will become an objective, efficient, and reproducible tool to facilitate comparisons across surgical approaches, techniques, and surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Experts in open inguinal lymphadenectomy
* Experts in video endoscopic inguinal lymphadenectomy (VEIL)
* Experts in robotic video endoscopic inguinal lymphadenectomy (R-VEIL)
* Authors with at least one publication in ILND for penile cancer, vulvar cancer, or melanoma

Exclusion Criteria:

* Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded
Three-dimensional Printing in Cardiac Catheterization

Our purpose is to use 3D printing technology to make human anatomical cardiovascular model, which could apply in the medical education for medical students, in order to improve the effectiveness of the learning process to access.

Background：

The medical teaching models are expansive and rare. We try to use the 3D printing technology to print cardiovascular model. By using the 3D cardiovascular model, we try to facilitate the leaning curve of understanding the cardiac catheterization.

Study Design：

This is a single-site prospective randomized controlled trial of medical education. We expect to enrolled 50 participants. Both group will receive same teaching program. Traditional education model will be used in control group, and 3D printed model will be used in the experimental group.

Methods：

We use 3D printing technology to create cardiovascular model from the CT scanning, which are drawn by professional 3D drawing staff. The students will be divided into 2 groups: the first group receive lecture/image teaching first then trained by the 3D cardiovascular model; the second group are receiving the reverse order. The satisfaction and the learning outcomes would be evaluated by the questionnaire.

Effect：

We expect the 3D cardiovascular model will bring better learning efficiency and satisfaction. Furthermore, we will construct the individual learning project by using the 3D printing model.

Key words：

3D printing, anatomy instruction, cardiovascular system, cardiac catheterization, high-fidelity simulation.

Eligibility Criteria:
Inclusion Criteria:

* Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study.
Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV

This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV.

In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected.

The study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who satisfy all of the following criteria may be enrolled into the study:

Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).

Exclusion Criteria:

* Subjects who satisfy any of the following criteria will not be enrolled into the study:

Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
* positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
* active RA disease
* subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
* subject is naïve to RA related biologics

Exclusion Criteria:

* a diagnosis of any other inflammatory arthritis
* history of infected joint prosthesis, or other significant infection
* known Tuberculosis (TB) disease or high risk of acquiring TB infection
Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.

Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) between 26+0 and 32+0 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); (2)Birth weight less than 2000g; (3) assisted with CMV within 12 h after birth; (4)diagnosis with ARDS and/or RDS. (5)stabilization before randomization within 12 h after birth: FiO2\<=0.30, pH\>7.20, PaCO2\<=60 mmHg, Paw \<=7-8 cmH2O;

Exclusion Criteria:

* neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) congenital lung diseases or malformations or pulmonary hypoplasia.