cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility Criteria:
Study Site 1:

Inclusion Criteria:

* Has physical status between ASA 1 or 2
* Able to communicate in English

Exclusion Criteria:

* Pregnant or sexually active without birth control.
* Hemoglobin less than 11g/dL
* Known alcohol or drug abuse
* Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
* Nail polish
* Head injury with loss of consciousness within the last year
* Known neurological and psychiatric conditions.
* Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
* Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
* Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
* Baseline heart rate \<50 beats per minute

Study Site 2:

Inclusion Criteria:

* Male or female
* 18-35 years of age
* Physical status of ASA I or II
* Able to read and communicate in English
* Has signed written informed consent
* If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.

Exclusion Criteria

* Age less than 18 yrs and greater than 35 years
* Hemoglobin less than 12 g/dL
* ASA physical status of III, IV, or V
* Pregnant or sexually active without birth control
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year
* Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Raynauds Syndrome.
* Hypertension: Systolic BP \>140 mmHg or Diastolic BP \> 90 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.

Eligibility Criteria:
Inclusion Criteria:

* Ability to undergo general anesthesia
* Age \> 18 yrs. of age and \< 85 yrs. of age
* Ability to give informed consent
* Candidate for elective Heller myotomy

Exclusion Criteria:

* Previous mediastinal or esophageal surgery
* Contraindications for esophagogastroduodenoscopy
* BMI \> 45
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to read, sign, and date the informed consent and HIPAA documents
* Willing and able to comply with all study procedures
* Be at least 18 years of age
* Patient-reported history of dry eye in both eyes
* Demonstrate a positive response when exposed to the Controlled Adverse Environment model
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
* Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period
* Any blood donation or significant loss of blood within 56 days of Visit 1
* Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
* Use of any topical ophthalmic preparations (including artificial tear substitutes) 72 hrs prior to Visit 1 and during the study
* Any significant chronic illness that could interfere with study parameters
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
* Known history of alcohol and/or drug abuse
* Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools

Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Specific diagnostic criteria have been proposed by the International Olympic Committee - Medical Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in athletes. Using the more specific bronchial provocation tests, our aims are

1. to compare the prevalence of asthma in swimmers and control subjects
2. to analyze the Influence of chlorine exposure on bronchial inflammatory processes in swimmers versus control subjects
3. to study the time-course of changes in airway symptoms, responsiveness, inflammation and remodeling after cessation of training


Eligibility Criteria:
Inclusion Criteria:

* 14 to 35 years old
* To swim at least 10h per week
* For control subjects, non-competitive healthy subjects

Exclusion Criteria:

* any disease that may interfere with the tests for the controls
* Triathletes are excluded
* Smokers
* Obese or with a BMI more than 29
* Former athletes (control group)
Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD \& CRT-D devices and how the ICD \& CRT-D devices are used in clinical practice through two years follow-up.

Eligibility Criteria:
Main inclusion Criteria:

•Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data)

Main exclusion Criteria:

* Presence of a contra-indication to the ICD therapy.
* Life expectancy less than 12 months.
Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.


Eligibility Criteria:
Inclusion Criteria:

* Bishop score of 5 or less
* Singleton
* Cephalic presentation
* Fewer than 4 contractions in 10 minutes
* Reactive fetal monitoring

Exclusion Criteria:

* Non-vertex presentation
* Placenta previa
* Vasa previa
* Unexplained vaginal bleeding
* Active herpes simplex virus infection
* Non-English speaking
* Previous attempt at an induction of labor in the current pregnancy
* Prolapsed umbilical cord
* More than one prior cesarean delivery or history of classical cesarean delivery
* Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent
Colorectal Cancer Screening Validation Study

The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* willing to provide informed consent
* greater than or equal to 50 years of age
* patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
* subject is willing to provide colorectal mucosal sample for gene expression testing

Exclusion Criteria:

* recent radiation or treatment for gynecologic, prostate or rectal cancer
* recent surgery for anal rectal disease
* polys, family or self history of cancer (control group only)
* GI disease
* any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results
Spontaneous Pneumothorax in Adolescents

Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing.

In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg


Eligibility Criteria:
Inclusion criteria:

* Adult patient (18-20 years old)
* Minor patient aged 14-17 years old
* Any gender
* Spontaneous pneumothorax without apparent cause, between 14 and 20 years old
* Patient operated on at the HUS between 2010 and 2021
* Patient not objecting to the reuse of their data for scientific research purposes.
* Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes.

Exclusion criteria:

* Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
* Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.
* Secondary origin of the pathology: Cystic fibrosis, postoperative pneumothorax, post-traumatic,
* Subject having been treated initially in another structure without further information.
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.

Rimegepant is a tablet that dissolves when you put it on or under your tongue.

The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours

In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.

Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.

In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.

Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* At least a 6 month history of migraine (with or without aura)
* 15 or more headache days/month
* 8 or more migraine days/month
* Migraine lasting 4-72 hours if untreated

Exclusion Criteria:

* Unrelenting headache
* Current psychiatric condition uncontrolled or untreated
* History of suicidal behavior or the subject is at risk of self-harm
* History of alcohol abuse and/or illicit drug use
* History of severe drug allergy
* Use of more than one medication for migraine prevention/prophylaxis
* Participation in another clinical trial at the same time
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).

The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.

Eligibility Criteria:
Inclusion Criteria:

* Must be on background lipid lowering treatment.
* Must be at high risk of a CV event.
* Must have an LDL C \>/=100 mg/dL (2.6 mmol/L) OR non HDL C \>/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

* Planned coronary (PCI or CABG) or other arterial revascularization.
* New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction \< 25% by cardiac imaging.
* Chronic renal insufficiency with creatinine clearance of \<30 ml/min/1.73m\^2 by MDRD formula or with end state renal disease on dialysis.
* History of hemorrhagic stroke.
* Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey

Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute.

The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with unilateral/bilateral retinoblastoma

Exclusion Criteria:

* patients with trilateral retinoblastoma
* extraoculer involvement
* patients with blood dyscrasias, bleeding and clotting disorders
Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Rationale

Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.

Purpose

Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.

To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

OBJECTIVES:

To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.

To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).

To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.

OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.

Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.

Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.

PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years

ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female

Eligibility Criteria:
Inclusion Criteria:

* women with T1N0M0 invasive breast cancer
* 18-65 years

Exclusion Criteria:

* bilateral breast cancer
* no other prior or concurrent malignancy except basal cell carcinoma
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.


Eligibility Criteria:
Inclusion Criteria:

* Females who are postmenopausal or who no longer wish to bear children
* Females \>25 years old and \<65 years old
* Diagnosis of biliary disease requiring cholecystectomy
* American Society of Anesthesiology (ASA) Class I or II
* Females who are able to understand and willing to sign an informed consent document

Exclusion Criteria:

* Pregnancy
* BMI \>= 30
* Patients who are still interested in childbearing
* Patients taking immunosuppressive medications or who are immunocompromised
* Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
* Patients with suspicion of gallbladder cancer
* Patients with history of previous open abdominal surgery
* Patients with untreated common bile duct stones
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers

Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Positive Methadone tox screen
* Received care at Good Samaritan Hospital in Cincinnati
* Delivered at Good Samaritan Hospital

Exclusion Criteria:

* Twin gestation
* Sever congenital anomalies
* Conditions requiring transfer to quaternary hospital
Intervention and Outcomes in Duarte Galactosemia

The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes of school-age children with Duarte galactosemia (DG).

Duarte galactosemia (DG) is an autosomal recessive genetic condition characterized by partial loss of galactose-1-phosphate uridylyltransferase (GALT), which results in partially impaired metabolism of the sugar, galactose, which is abundant in milk and also found at lower levels in many other foods. There is currently no consensus on long-term outcome prognosis for infants with Duarte galactosemia (DG) and some studies suggest these children might be at increased risk for developmental difficulties later in childhood. There is also no conclusive data on whether children with Duarte galactosemia (DG) might benefit from dietary restriction of galactose. The investigator will be assessing whether 6-12 year old children with Duarte galactosemia experience developmental disorders relative to controls, and if so, whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes in this patient population.

Eligibility Criteria:
Inclusion Criteria:

Healthy Children/Children with Duarte Galactosemia:

* Age between 6-12 years

Exclusion Criteria:

* Chronic illness
* Any condition unrelated to Duarte Galactosemia but known to cause developmental problems
* Children who did not have the current parent/guardian as the primary caregiver when the child was an infant
Swallowing Disorders After Prolonged Mechanical Ventilation

Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged invasive ventilation (more than seven days), using a clinical statement. All consecutive patients are screened, and clinical evaluation is performed during 48h after patient's extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data complementary are notified at day 28 (pneumonia? nutritional status?)


Eligibility Criteria:
Inclusion Criteria:

* More than 7 days of invasive mechanical ventilation

Exclusion Criteria:

* Age \< 18 years old
* Preexistent swallowing disorders, stroke, tracheostomy
* Failure of patient's agreement