cyrilzakka/clinical-trials huggingface dataset:
Written Communication in the Intensive Care Unit

The goal of this study is to compare the experience of intensive care unit (ICU) families and care providers before and after the implementation of an approach whereby clinicians initiate written communication with families

The main questions it aims to answer are

1. Is ICU care-provider initiated written communication feasible and acceptable to participants?
2. Does ICU care-provider initiated written communication affect the experience of families and care providers?

Participants will complete surveys and participate in interviews during a 3 month pre-implementation phase and a 3 month post-implementation phase


Eligibility Criteria:
Inclusion criteria (family members or surrogates)

• Self-identify as one of the patient's decision makers

Exclusion criteria (family members or surrogates)

* Cannot read or understand English
* Unwilling to participate in study procedures

Inclusion criteria for care providers (physicians, physician assistants, and nurses)

• Work during the day shift

Exclusion criteria for care providers (physicians, physician assistants, and nurses)

• None
Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia

This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.

The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.


Eligibility Criteria:
Inclusion Criteria:

Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.

Exclusion Criteria:

* Patients with American society of anesthesiologists physical status classification IV or higher.
* Patients who are hypersensitive to remimazolam or inhalational anesthetic.
* Patients with structural abnormalities in the upper airway or respiratory diseases.
* Patients with a history of upper respiratory tract infection within the past 2 weeks.
* Current smoker
* Pregnant
* Patients who have difficulty reading and understanding the informed consent form
Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions

The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fasting conditions.

This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fasting conditions with a washout period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. \& Max. Chart)
* Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study.
* Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
* Informed consent given in written form according to section 10.3 of the protocol.
* Female Subjects:

  1. of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
  2. postmenopausal for at least 1 year.
  3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

1. History or presence of significant:

   * Cardiovascular, pulmonary, hepatic, renal hematological; gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
   * Alcohol dependence, alcohol abuse or drug abuse within past one year.
   * Moderate to heavy smoking (\> 10 cigarettes/day) or on assumption of tobacco products.
   * History of difficulty in swallowing.
   * Clinically significant illness within 4 weeks before the start of the study
   * Asthma, urticaria or other allergic type reactions after taking any medication.
2. Subjects who, through completion of the study, would have donated in excess of:

   * 500ml of blood in 14 days, or
   * 500 - 800 m l of blood in 14 days (unless approved by the Principal Investigator)
   * 1000 ml of blood in 90 days
   * 1250 ml of blood in 120 days
   * 1500 ml of blood in 180 days
   * 2000 ml of blood in 270 days
   * 2500 ml of blood in 1 year
3. Participation in another clinical trial within the preceding 28 days of study start.
4. Subjects who have:

   * Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg
   * Diastolic blood pressure less than 60 m of Hg and more than 95 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator
   * Pulse rate below 50/min. and above 105/min.
5. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Testing a Smart Phone App to Enhance Voice Therapy Adherence

The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults \> 18 years
2. Non-smokers
3. Hearing level within normal limits
4. Absence of vocal fold pathology as confirmed by MD on laryngeal examination
5. Agree to avoid vocally abusive behaviors for the entirety of the study

Exclusion Criteria:

1. Apple phone (iOS)
2. Impaired hearing
3. Uncontrolled asthma
4. Smoking
5. H/o vocal fold surgery
6. Presence of vocal fold pathology
7. Previous history of experience with VFE performance
8. Non-English speaking participants
Feasibility of Dance in People With COPD

Despite the benefits associated with individuals with chronic obstructive pulmonary disease (COPD) engaging in pulmonary rehabilitation (PR) programs, the benefits diminish by 6 months. A new innovative approach is needed to increase motivation to exercise and to minimize diminution of effect. Dance is a fun and interactive activity, which has shown benefits in other populations, such as Parkinson's disease and stroke. The aim of this study was to investigate the feasibility of dance in individuals with COPD following PR.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD confirmed by spirometry (FEV1/FVC \< 0.7)
* Adequate communication with or without corrective hearing aids
* No intensive PR for at least 6 months before recruitment
* An ability to provide informed consent.

Exclusion Criteria:

* Presence of comorbidities that could have prevented communication or safe exercise
Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)

The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.


Eligibility Criteria:
Inclusion Criteria:

* All patients included in the previous study WYETH 3074A1-4448 then Pfizer B1811030 for which mortality status was not known at the closure of this previous study

Exclusion Criteria:

* Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.
Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.

The primary objective of this study is to evaluate extended use of bupropion with the goal of enhancing abstinence in African American daily smokers, including the full spectrum of light, moderate, and heavy smokers. A two-arm, randomized design will be used to evaluate the efficacy of extended (6 months) bupropion treatment compared to standard (7 weeks) bupropion treatment. Baseline randomization stratified by gender and cpd (≤10, \>10cpd) will assign participants (N=500) to receive extended treatment (EXT; 24 weeks of bupropion, n=250) or standard treatment (ST; 7 weeks of bupropion, n=250). All participants will receive culturally-relevant, individualized smoking cessation counseling, including support for medication adherence, and will be followed through Month 12.

Eligibility Criteria:
Inclusion Criteria:

* African American
* age \>18 years
* interested in quitting
* smoked \>1 cpd for \>1 years
* smoked on \>25 days in the past month
* willing to take 6 months of study medication and complete all visits
* have a home address and functioning telephone number

Exclusion Criteria:

* Consistent with contraindications for bupropion:
* use of psychoactive medications
* history of alcohol or substance abuse within the past year
* binge drinking (\>5 drinks on one occasion) \>2 times in the past month
* history of seizures or head trauma; history of bulimia or anorexia nervosa
* pregnant (as measured by over the counter pregnancy test kit for women of child-bearing age only) or contemplating pregnancy; breast feeding
* myocardial infarction in the past 2 months
* reported use of opiates, cocaine, or stimulants
* unstable diabetes
* bupropion is a known inhibitor of the liver enzyme CYP2D6, so those taking drugs known to be higher metabolized by this enzyme (e.g., metoprolol, tamoxifen) will be excluded.
* use of stop smoking medications (bupropion, varenicline, nicotine replacement, fluoxetine, clonidine, buspirone, or doxepin) in the past 30 days
* planning to move from the Kansas City area in the next year
* other smoker in household enrolled in the study.
Noninvasive Monitoring of Vital Signs in Neonates

the investigators are assessing a non-invasive monitor based on dynamic light scattering that measures pulse rate and respiration rate. The monitor also will be equipped with a temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements in neonates in a simple and noninvasive manner.

Monitoring vital signs in neonates is important. This currently is done with multiple standard clinical monitors. the investigators are developing a very small (coin-sized) sensor that can measure pulse rate, respiratory rate, temperature and body motion. the investigators propose to test our sensor against standard monitoring techniques in neonates in a neonatal ICU (NICU).

The monitor, called ELFI-monitor, is based on dynamic light scattering. A low-power laser beams light into the skin, and the red blood cells in the underlying skin return the light which is recorded in a light sensor. The movement of the red blood cells is affected by the rhythmic cardiac contractility. in this manner, heart rate and rhythm can be assessed. The ELFI monitor also contains an embedded temperature probe and a miniature 3-D motion sensor, allowing capture of additional parameters.

Methods:

the investigators plan to study 100 neonates admitted to the NICU of Meir Hospital Center. These infants are routinely monitored with standard equipment including ECG, oximeter, temperature, and respiratory monitors. the investigators will simultaneously monitor these children with the ELFI monitor, recording pulse rate, cardiac rhythm, respiratory rate, skin temperature and body motion. Recordings will be conducted for a one-hour period on each subject. Data recordings from the ELFI sensor will be compared to the readouts of the conventional monitors used on the patient. It is important to emphasize that the data recordings of the ELFI sensor will not affect clinical decisions in any manner, but will merely be recorded for comparison with conventional sensors.

Eligibility Criteria:
Inclusion Criteria:

* All neonates admitted the Meir Hospital center NICU
* Parents provide informed consent

Exclusion Criteria:

* Neonates with skin disease
Front-line Therapy with Carfilzomib, Lenalidomide, and Dexamethasone Induction

The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.

The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy.

It's a multicenter, open label, non randomized, phase II study. 46 patients will be enrolled.

Induction: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Stem Cell Harvest: High dose Cyclophosphamide with intensification consolidation: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Maintenance : Lenalidomide 13 cycles of 28 days

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group
* Subjects must have symptomatic myeloma with at least one CRAB criteria
* Subjects must not have been treated previously with any systemic therapy for multiple myeloma

Exclusion Criteria:

* Pregnant or lactating females
* Evidence of mucosal or internal bleeding and/or platelet refractory
* Acute active infection requiring treatment
* Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks
* Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy
* Subjects not eligible for high dose therapy
Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men

Obesity is associated with low testosterone in men and with dyslipidemia. Adropin hormone is negatively correlated with body mass index and is associated with dyslipidemia.

correlation between adropin and testosterone will be evaluated.

Obesity, a worldwide epidemic is associated with multiple adverse health outcome as diabetes mellitus, hypertension and cardiovascular diseases caused mainly by dyslipidemia linked to obesity. Low testosterone levels in obese men were found associated with dyslipidemia.

Adropin is a new metabolic hormone that was first isolated in liver and brain tissues, It was observed that mice fed on a high-fat diet (HFD) had a rapid increase in adropin expression compared to control values. In human also, adropin levels were negatively correlated with body mass index (BMI) and were associated with dyslipidemia.

Adiponectin is a protein that is mainly produced by white adipose tissue and has an important role in lipid metabolism. Serum adiponectin concentrations were decreased in obese compared to normal weight men and significantly correlated with testosterone level.

Eligibility Criteria:
Inclusion Criteria:

Age from 18 years to 50 years. Clinically free except from obesity

Exclusion Criteria:

* Diabetes mellitus Hypertension Heart failure Kidney disease Smoking
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing and able to provide informed consent
* Metastatic breast cancer, biopsy proven

  * ER+/HER2-, defined as \>5% ER+ staining
  * HER2+ (regardless of ER status), including HER2-low and high expressors
* History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
* Isolated site of disease progression on FDG PET scan
* Consented to 12-245
* ECOG performance status 0-1

Exclusion Criteria:

* Pregnancy
* Serious medical comorbidity precluding radiation, including connective tissue disorders
* Intracranial disease (including previous intracranial involvement)
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players

The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.

The secondary objectives of this study are :

A- To estimate and compare the prevalence of Internal Rotation Deficit within groups

B- To assess the association between the Internal Rotation Deficit and the appearance of a shoulder pain and/or discomfort when throwing

C- To assess the association between Internal Rotation Deficit and the appearance of a shoulder pathology demonstrated by clinical examination by at least one abnormality in one of the following three tests: the arming apprehension test, the relocation test or the O'Brien test

D- Assess changes in values of IRD 2, the ratio IRD 2/GRE 2, and the Total Range of Motion over the training season

E- Evaluate the association between the values of IRD 2 and the appearance of shoulder pain or discomfort when throwing

F- To evaluate the association between IRD 2 values and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).

G- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of shoulder pain or discomfort when throwing

H- To assess the association between values of the IRD 2/GRE 2 ratio and the appearance of a shoulder pathology (at least one anomaly in one of three tests: the arming apprehension test, the relocation test or the O'Brien test).

I- To estimate the optimal threshold value of the IRD 2/GRE 2 ratio that would define an Internal Rotation Deficit in a more relevant fashion as compred to the IRD 2 alone

Eligibility Criteria:
Inclusion Criteria:

* The subject or his/her legal guardian must have given his/her informed and signed consent
* The subject must be insured or beneficiary of a health insurance plan
* The subject is a member of the professional and pre-professional handball clubs in Nîmes, France (the USAM or HBCN clubs) -- OR-- a member of the training centers associated with the same clubs whose parents or legal representatives have given informed consent

Exclusion Criteria:

* The subject is under judicial protection, under tutorship or curatorship
* The subject or his/her legal respresentative refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject is pregnant, parturient, or breastfeeding
* The subject has been operated for shoulder instability, regardless of the surgical technique used
* The subject has a history of fracture of the proximal end of the humerus and / or elbow
* The subject has a history of rotator cuff surgery
* The subject has neurological or spinal problems, or has received physiotherapy on the shoulder complex within 30 days prior to the study assessment
Long Term Follow-up for RGX-202

RGX-202-5101 is a long-term follow up study that evaluates the long term safety and efficacy of RGX-202 in participants who have received RGX-202 (a gene therapy designed to deliver a transgene for novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain) in a separate parent study.

This is a multicenter, prospective, observational study to evaluate the long-term safety and efficacy of RGX-202. Eligible participants are those who have undergone evaluation in a previous (parent) clinical study following a single intravenous infusion of RGX-202 for the treatment of DMD. Enrollment in the current long-term follow-up (LTFU) study will occur after the participant has completed or discontinued from the parent study. Participants will be followed in this study cumulatively for up to 5 years after RGX-202 administration (inclusive of the parent study). No investigational treatment will be administered under this protocol. The total study duration for each participant may vary depending on when he enrolls in the current study following RGX-202 administration in the parent study.

Eligibility Criteria:
Inclusion Criteria:

* The parent(s) or legal guardian(s) of the participant has/(have) provided written informed consent and (where applicable) Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been explained, prior to any research-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements.
* Must have undergone evaluation in a previous clinical study following a single IV infusion of RGX-202 for the treatment of DMD and either completed or withdrawn early from that study.
* Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, and study procedures.
* Sexually active participants must be willing to use a medically accepted method of contraception from the time of the screening visit through 5 years after RGX-202 administration.

Exclusion Criteria:

* No exclusion criteria apply in this observational follow up study.