cyrilzakka/clinical-trials huggingface dataset:
Fetal Pillow Randomized Controlled Trial

The purpose of this study is to evaluate outcomes following cesarean delivery for failure to progress with the use of the Fetal Pillow. Our hypothesis is that time to delivery of the fetus is shorter with implementation of the Fetal Pillow.

Women will be enrolled from the labor floor during their labor course when there is concern for cesarean section for failure to progress in the second stage of labor. These women may be approached if they have a prolonged labor course (before they reach full dilation), when they get to full dilation and start pushing, or following an unsuccessful operative delivery. All women who meet the inclusion criteria will be approached about participation in the study on labor and delivery. The process of informed consent will happen at that time on labor and delivery. All women will be enrolled by study staff or certain physicians at Brigham and Women's Hospital who have agreed to help consent patients for this study.

Once consent is obtained, the subjects will then be randomized 1:1 into two parallel groups, the Fetal Pillow Inflated (FPI) group and the Fetal Pillow Not Inflated (FPNI) group. A random number generator will allocate the groups in blocks of ten.

The Fetal Pillows used in the study have been donated by Safe Obstetrics Systems.

Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded to the intervention. In the FPNI group the obstetrician will continue to be able to use conventional methods for delivery of a second stage arrest including hand from below and reverse breech extraction. The Fetal Pillow will be drained by the circulating nurse in the operating room following delivery with removal at the end of the procedure by the obstetrician.

Eligibility Criteria:
Inclusion Criteria:

* women age 18-50
* term pregnancy (37- 41 6/7 weeks)
* singleton gestation in cephalic presentation
* fully dilated
* both nulliparous and multiparous women
* both spontaneous labor and labor inductions

Exclusion Criteria:

* breech presentation
* presence of contraindication to vaginal delivery
* prior cesarean section
* presence of congenital anomalies
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.
* Subjects must have no active ocular disease or allergic conjunctivitis.
* Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.
* Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen.
* Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Exclusion Criteria:

* Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma.
* Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months.
* Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components.
* Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study
* Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.
Post-line Treatment with Teniposide for C-Myc-driven Extensive-stage Small Cell Lung Cancer

The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.


Eligibility Criteria:
Inclusion Criteria:

1. extensive stage small cell lung cancer
2. Progression after receiving at least one chemotherapy drug treatment in the past;
3. ECOG score 0-1
4. c-Myc-driven
5. Expected survival period ≥3 months
6. Age: 18-75 years old;
7. The informed consent form complies with the ICH-GCP principles.

Exclusion Criteria:

1. No measurable lesions
2. Other severe and persistent diseases or organ system dysfunction;
3. Women planning pregnancy or men planning family planning;
4. Women who are pregnant or breastfeeding;
5. Those who cannot follow the research protocol provided by the investigator.
Inflammatory Cytokines in Symptom Production in Multiple Myeloma

The goal of this research study is to learn about the pain and/or other symptoms that patients may experience either while you are being monitored by your doctor before a decision is made to start you on treatment for your MM, or during and after treatment for MM, and how these symptoms may affect therapy. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled clinic visit. These questionnaires will measure pain and other symptoms, such as your mood and quality of life. You will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. Completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total.

This is an investigational study.

Up to 500 patients will take part in the cross-sectional phase of this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Must speak and understand English;
2. Must be diagnosed with MM and meet one of the following criteria: 1) have been treated for MM with steroids only, or have received no more than two cycles of induction chemotherapy for MM and are going to be treated with bortezomib or thalidomide for induction therapy; 2) have received induction therapy and have been approved (or are being approved) medically and financially to receive autologous hematopoietic stem cell transplantation (Auto-HSCT); 3) cross sectional study patients will be either with a current diagnosis of asymptomatic MM not receiving treatment; or at least 12 months from the MM diagnosis, had received induction therapy, with or without received autologous hematopoietic stem cell transplantation (Auto-HSCT) and follow-up treatments. This cohort for a cross sectional survey may include the cases been enrolled, either completed or dropped from the same study. It may also include patients who did not participate on the first phase of the protocol (longitudinal cohort).
3. Patients \>= 18 years old.

Exclusion Criteria:

1. Patients who do not understand the intent of the study, so cannot or will not give informed consent
2. Patients who are unable to use the Interactive Voice Response (IVR) system due to physical limitations (e.g., hearing impairment).
3. Induction therapy patients with a neuropathy score of 3 or greater on the NCI's Common Terminology Criteria (CTC version 3.0) either at the beginning of induction chemotherapy or after 1-2 cycles of chemotherapy as a result of previous treatment or from some other comorbid cause. This exclusion criteria does apply to the auto-HSCT patients.
Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 and less than or equal to 50 years of age
2. be able and willing to adhere to the instructions set forth in the protocol.
3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
4. Sign the STATEMENT OF INFORMED CONSENT.
5. Have normal, healthy eyes

Exclusion Criteria:

1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
2. Pre-existing ocular disease precluding contact lens fitting.
3. Insufficient lacrimal secretions
4. Aphakia, keratoconus or a highly irregular cornea
5. Previous eye surgery involving the anterior segment
6. Current pregnancy or lactation (to the best of the subject's knowledge).
7. Use of concurrent ocular medication
8. Active participation in another clinical study at any time during this study.-
Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.

If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six months.

Eligibility Criteria:
Inclusion Criteria:

* 18-years age or older
* admitted with acute decompensated heart failure for less than 48 h

Exclusion Criteria:

* pacemaker
* not signed informed consent
* other heart rhythm than sinus rhythm or atrial fibrillation
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.

This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.

Primary outcome:

1. Abscess resolution by parental report 7-10 days after incision and drainage

Secondary outcomes:

1. Admission to the hospital because of worsening infection
2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)

Eligibility Criteria:
Inclusion Criteria:

1.) Abscess \< 5 cm (\< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age \> 90 days and \< 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

Exclusion Criteria:

1. Multiple abscesses
2. Abscess located on the hands, face, or perineum
3. Abscess as a result of a bite wound
4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (\> 10 days), etc.
5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX

7.) Fever \> or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.

9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
Comparison Between Low FODMAP and SSRD in IBS

The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.

The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.

Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.

The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.

The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.

Statistics

The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.

Eligibility Criteria:
Inclusion Criteria:

* Verified IBS according to Rom IV criteria.

Exclusion Criteria:

* Serious mental disease
* Serious somatic disease
* Abuse
* Inability to understand the Swedish language
* Already on a diet
Topcon 3D OCT-1000 Optical Coherence Tomography System

The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.


Eligibility Criteria:
Retinal Disease Study

No Retinal Disease:

Inclusion Criteria:

* Male or female
* Between 18 and 80 years of age
* Either eye, but only one eye per subject will be enrolled
* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

* Any known ocular disease
* Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
* Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.

Retinal Disease

Inclusion Criteria:

* Male or female
* Between 18 and 80 years of age
* Either eye, but only one eye per subject will be enrolled
* Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
* A range of retinal thickness will be included
* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

* Presence of glaucoma
* Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.
Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients

The purpose of this prospective observational cohort study is to evaluate multimodal monitoring technologies in the perioperative care of cardiac surgical patients. Right ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic ultrasonography will be studied for their ability to detect and predict complications such as right ventricular failure, renal failure and respiratory failure.

The study has 4 main objectives:

1. To determine if right ventricular pressure tracings correlate with other indices of right ventricular failure and with positive fluid balance, renal failure and increased length of stay in the intensive care unit.
2. To determine the prevalence of portal vein pulsatility in the perioperative period and its association with right ventricular failure and positive fluid balance.
3. To determine if Near InfraRed Spectroscopy (NIRS) values correlate with mixed venous oxygen saturation (SvO2) and with poorer post-operative prognosis.
4. To determine the incidence, risk factors and prognosis of respiratory complications of cardiac surgery using transthoracic ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery performed at the Montreal Heart Institute
* 18 years old and older

Exclusion Criteria:

* Urgent surgery
* Pre-operative intra-aortic balloon pump, left ventricular assist device or ECMO
* Heart transplant
* Cirrhosis
Testing the Effect of Exercise Intervention Using a SMART Design.

Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents. Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan. The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents. In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week. Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage. Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks. Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT. The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.


Eligibility Criteria:
Inclusion Criteria:

* Community residents (a) who are 40-65 years old without diet control, (b) body fat ≧ 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included.

Exclusion Criteria:

* This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP \> 200 mmHg, or diastolic BP \>110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.