cyrilzakka/clinical-trials huggingface dataset:
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN

A prospective observational cohort study was designed.

1. Comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as End-tidal carbon monoxide corrected for ambient CO(ETCOc),direct antiglobulin test(DAT), the highest total serum bilirubin level and hemoglobin. To explore the role of ETCOc in the diagnosis of neonatal ABO hemolytic disease.
2. Comparing of the clinical indicators between the neonates with IVIG treatment and the neonates without IVIG treatment in ABO hemolytic disease, such as ETCOc,total serum bilirubin level before IVIG treatment and ETCOc,total serum bilirubin level after IVIG treatment.To explore the clinical value of ETCOc in the treatment of ABO hemolytic disease.

A prospective observational cohort study was designed. The participants included in the study are the neonates with hyperbilirubinemia in ABO incompatibility.Because the serological results are not known at the time of enrollment, all the neonates should be suspected hemolysis. According to the serological results,the neonates are divided into two groups, hemolytic group and non-hemolytic group. All the relevant clinical indicators need to be recorded and each neonates needs follow-up.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 35+0 and 41+6 weeks
* birth weight ≥ 2500 grams
* respiratory rate \< 60 breaths per minute
* the neonates admitted to the neonatology department for phototherapy because of hyperbilirubinemia that conforms to the guideline of the experts consensus on the management of neonatal hyperbilirubinemia(2014,in China.)
* ABO group incompatibility between the mother and newborn
* the informed consent are obtained.

Exclusion Criteria:

* persistent dyspnea or need for respiratory support
* skin damage or structural deformity around the nasal cavity
* receive intensive care treatment in the neonatal intensive care unit(NICU)
* Severe congenital malformation, chromosomal or genetic abnormality
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC.

There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block.

We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big.

The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.

Exclusion Criteria:

* Age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years

Eligibility Criteria:
Inclusion Criteria:

1. High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
2. NYHA ≥ II.
3. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
4. Study patient is an adult of legal consent age.
5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion Criteria:

1. Acute myocardial infarction ≤ 30 days before the intended treatment.
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
4. Mixed aortic valve disease (with predominant aortic regurgitation).
Pulmonary Fibrosis Foundation Community Registry

Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with PF to be compiled into a longitudinal data set for use by researchers.

The PFF Community Registry is an observational, longitudinal cohort study. The Community Registry will enroll three different cohort groups:

1. Patients with PF, including those who are post lung transplant
2. Caregivers of patients with PF
3. Family members of patients with PF

This is an online registry open to individuals affected by PF in the US. It is not associated with a physical location or institution. Individuals may self-enroll online and contribute data to the Community Registry by answering a series of surveys at regular intervals.

Participants may also elect to be contacted about future research projects through the PFF Community Registry portal. However, this is not required to participate in the Community Registry itself.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form online
2. Male or female, aged 18 or older
3. Affected by PF as a member of at least one of the following cohorts:

   1. An individual diagnosed with PF or ILD, including those who are post lung transplant, or
   2. An individual who has cared (currently or in the past) for an individual with PF or ILD, and / or
   3. A family member (defined as parent, full or half-sibling, or child) of an individual with PF or ILD.
4. Has internet access and a valid email address.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Primary residence or place of care is outside of the US.
2. Inability or unwillingness of a participant to provide informed consent or comply with study protocol.
3. Any condition or circumstance not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
4. Patients who were diagnosed with any of the below lung diseases. Similarly caregivers and family members associated with these diseases would be excluded.

   * Sarcoid
   * Lymphangioleiomyomatosis (LAM)
   * Pulmonary alveolar proteinosis (PAP)
   * Cystic fibrosis (CF)
   * Amyloidosis
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
* Body mass index in the range of = 19 kg/m2 to \<35 kg/m2.

Exclusion Criteria:

* Pregnant
* Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
* Grade III/IV pelvic organ prolapse with or without cystocele.
* History of interstitial cystitis or bladder related pain.
* Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
* History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
* Urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
* Nocturnal enuresis only.
* Urinary retention, or other evidence of poor detrusor function.
* Current or history of Urinary Tract Infection.
* Diabetes insipidus.
* History of myocardial infarction, unstable angina, or Congestive heart failure.
* Chronic severe constipation.
* History of prior anti-incontinence surgery.
* History of radiation cystitis or a history of pelvic irradiation.
* Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
* Received any investigational product within 30 days of enrollment into the study.
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
* Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval.
* Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.

  -- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.
* Maximum time allowed between definitive therapy completion and randomization must be:

  * 10 weeks if no chemotherapy was administered
  * 26 weeks if adjuvant chemotherapy was administered
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate hematologic, hepatic, and renal function.
* Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug.

Exclusion Criteria:

* Additional oncogenic drivers in NSCLC, if known.
* Evidence of small cell lung cancer.
* Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.
* Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.
* Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds.
* Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
* Have known active hepatitis B or C.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
* Major surgery within 4 weeks prior to planned start of selpercatinib.
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
* Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.
* Pregnancy or lactation.
* Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).
Pepsin As A Biomarker For Aspiration

Evaluation of tracheal pepsin as a biomarker for aspiration

Aspiration is well recognized in children who have chronic lung disease or who are intubated. There is a known association between gastroesophageal reflux (GER) and aspiration. The distinction between aspiration of swallowed material, such as food and the aspiration of refluxed gastric contents is important. Determining whether an aspiration syndrome in an individual is due to GER may be difficult. The most widely used test to determine whether GER is the cause of aspiration involves staining bronchoalveolar lavage (BAL) fluid for lipid laden macrophages (LLM) based on the hypothesis that refluxed and aspirated fluid is phagocytosed by tracheal macrophages.

Pepsinogen is a protein unique to gastric chief cells and also requires acidic conditions for activation. Therefore the presence of pepsin in BAL fluid should only be found when gastric fluid is aspirated. In previous studies, pepsin has been detected in the tracheal fluid of children with chronic lung disease. Thus far, studies of this material have been small, not all have control groups, and LLM were not looked for in all studies.

Based on previous studies and the need to improve diagnostic methods, the following aims are proposed:

1. to determine the frequency of pepsin contamination of children without chronic respiratory disease undergoing elective surgery with intubation
2. to determine frequency of tracheal pepsin and lipid laden macrophages (LLM) in children with chronic respiratory disease or symptoms and in children with tracheostomies
3. to compare the presence or absence and concentration of pepsin to the presence of LLM
4. to relate the presence or absence and concentration of pepsin to clinical status To achieve these aims, BAL fluid will be obtained from subject patients and controls. These fluids will be transported to the research lab and stored on ice until analysis. Determination of LLM will be done in children undergoing diagnostic bronchoscopy in the clinical lab of CHW per routine. BAL analysis will consist of Western blot staining for the presence of pepsin. Demographic data will also be collected from the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria of study population

Exclusion Criteria:

* Lack of informed consent/assent
* Pulmonary disease in normal controls
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella

This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.


Eligibility Criteria:
Inclusion Criteria:

* History of breast cancer treated by conservative surgery .
* Normal inclusion radiological assessment normal (ACR1 or ACR2)
* Moderate Deformations (Type I and II of the classification of Clough).
* Delay with regard to the end of the radiotherapy superior or equal to one-year-old.
* Moderated radio-dystrophies (\< Grade 2 of the score LENT/SOMA).
* Signature of the informed consent
* Patient benefiting from social security
* Patient of more than 18 years old

Exclusion Criteria:

* Abnormal radiological assessment (ACR3, ACR4 or ACR5)
* Absence of fatty excess .
* radio surgical relapses with vast fibroses of the breast (\> Grade 2 of the score LENT/SOMA).
* Patient under 18 years old.
* administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .
* pregnant women or breast feeding women
* patient under legal guardianship
* bilateral breast cancer regardless histologic type.
Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

The purpose of this study is to evaluate the change of the optic nerve sheath diameter according to the change of the neck position in pediatric patients undergoing palatoplasty.

Palatoplaty is performed under neck extension in patients with cleft palate. The purpose of this study is to evaluate the effect of neck extension on the ultrasonographic optic nerve sheath diameter during palatoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
* Patients who agree to voluntarily participate in this study
* Patients with ASA class 1-2

Exclusion Criteria:

* History of diagnosis of neurologic or ophthalmic disease
* History of neurosurgery or ophthalmic surgery
* Patients who refused to participate in clinical studies
In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects

Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age \>= 30 and \<= 60 years
* Body Mass Index (BMI) \>= 18.5 and \<= 29.9 kg/m2
* Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication, salmeterol and/or related drugs of these classes
* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
* Systolic BP \< 115 mmHg
* Heart rate at rest of \> 80 bpm or \< 55 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval \> 220 ms, QRS interval \> 115 ms, QTcB \> 420 ms, or QT (uncorrected) \> 450 ms
* History of asthma or obstructive pulmonary disease.
* Psoriasis (own medical history or relative)
Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.

This is a single-center, Phase II randomized study of MM patients comparing 16 weeks of DLC access versus quasi-usual care (quasi-usual because both arms will receive generic wellness-related electronic handouts alongside requests for patient-reported outcome (PRO) assessments).

Primary Objective:

To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)

Secondary Objectives:

1. To evaluate DLC's impact on patient-reported general quality of life every 1-2 weeks
2. To evaluate DLC's impact on patient-reported psychosocial distress every 1-2 weeks
3. To evaluate DLC's impact on patient-reported insomnia every 1-2 weeks

Exploratory Objectives:

1. To explore DLC's impact on rates of communications between patients and their treatment teams
2. To explore DLC's impact on clinical outcomes

Participants may continue study treatment (DLC platform access) for 16 weeks from the time of initiating treatment. Participants will not be contacted by the DLC platform vendor after this point. Patients will be followed up at Day +101 after SCT, corresponding to approximately 3 months after SCT.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of one of the following (all referred to as multiple myeloma (MM) for the purposes of this protocol):

  * Multiple myeloma (ICD-10 code: C90.0)
  * Extramedullary plasmacytoma (ICD-10 code: C90.2)
* Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)

  * Patients undergoing outpatient SCT will be eligible
  * Patients who received chemomobilization will be eligible
* Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document

Exclusion Criteria:

* Age \< 18 years
* SCT as salvage therapy
* Patient-assessed lack of sufficient English proficiency
* Lack of ownership of a personal smartphone