cyrilzakka/clinical-trials huggingface dataset:
GentleFit Non-Invasive Ventilation (NIV) Interface Trial

The primary objective is to compare pressure achieved by GentleFit Non-Invasive Ventilation (NIV) nasal mask and nasal prong to standard of care interface. Secondary objectives include to monitor skin integrity, clinical parameters, and adverse events. Additionally, to evaluate clinician opinion of ease of application and overall fit of GentleFit NIV interfaces and headgear.

Current NIV interfaces commercially available do not address all size and anatomical gaps present in the pediatric population. To overcome this challenge, nasal mask and nasal prong prototype interfaces have been designed to fill some of the current size gap. These interfaces, known as GentleFit NIV, need to be trialed to ensure appropriateness of design and patient tolerance for 4-8 hour application intervals, as is standard of practice for current devices on the market.

Eligibility Criteria:
Inclusion Criteria:

1. Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg.
2. Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.
2. Facial anomalies (e.g. cleft lip).
3. Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.
4. Patient's emergent condition.

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A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).


Eligibility Criteria:
Inclusion Criteria:

* Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period
HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease

Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* 18 years or older
* history of upper GI symptoms

Exclusion Criteria:

* Peptic ulcer disease
* upper gastrointestinal surgery
* malignancy
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).

Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent.

Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation:

* Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
* CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age.
* Women ≥ 24 weeks' viable gestation.
* To undergo cesarean delivery.
* Admission BMI ≥ 35.

Exclusion Criteria:

* Patient unwilling or unable to provide consent.
* No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
* Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \<200, or other.
* Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
* Current skin infection.
* Coagulopathy.
* High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
* Known allergy to CHG.
* Incarcerated individuals.
* Chorioamnionitis.
* Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence

This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.

Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (age\>18 and\<80 years)
* patients with clinically suspected recurrent ovarian cancer
* patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
* patients who did not receive any other treatment 4 weeks before PET imaging

Exclusion Criteria:

* pregnant patients
* patients with poor performance status
* patients unwilling to provide written informed consent
Study of Decision Making in Patients Participating in Phase I Clinical Trials

RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.

PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.

OBJECTIVES:

* Determine the range of personality traits of patients enrolled in a phase I clinical trial.
* Determine these patients' understanding of their medical situation and prognosis.
* Determine these patients' understanding of risks and benefits of phase I clinical trials.
* Determine these patients' reasons for participating in a phase I clinical trial.
* Determine the risk/benefit trade-offs of these patients.
* Determine the existential outlook of these patients.
* Determine the information gathering nature of these patients.

OUTLINE: This is a multicenter study.

Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.

PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Consented to enrollment in a phase I cancer clinical trial

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Understands written English

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent enrollment in other clinical trials evaluating phase I patient attitudes
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for elective colonoscopy

Exclusion Criteria:

* Patients in which polypectomy can not be performed safely
Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)

The goal of the study is to create a longitudinal study of patient reported outcomes for people living with sarcoidosis that maintains privacy. Patients report on the following: demographics, disease symptoms, diagnostic journey, provider experience, disease treatment, and burden of disease. The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.

Participants review a document, Understanding Your Participation, and check boxes on the Participant Informed Consent document that confirms they understand the risks/benefits of participation (or Assent if the patient is a minor age 7-18), they create an online account, and then are asked to complete the baseline survey questionnaire. Participants confirm they understand that their participation is completely voluntary, that their identifying information will be secured and encrypted, their private health information will be stored separately in a secure database. Their private information will never be shared with other people, unless its required by law. The registry may share de-identified information with researchers and other databases. Their personal information will be protected and not shared. They may choose to stop their participation at any time by contacting FSR. They are not required to fill out all the questions and can leave any unanswered. They will be contacted by the registry once a year to update or correct their health information. They can choose to be contacted by FSR if a study becomes available that they may wish to know more about.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. Consent
3. Sarcoidosi diagnosis -

Exclusion Criteria:

NONE
Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares

The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective in the reduction of the number of nightmares and the nightmare distress in a population of patients with psychiatric disorders.

Within the normal population 4-8% of the people suffer regularly from nightmares. Clinical observations show that nightmares are a common problem for patients who suffer from all kinds of psychiatric disorders, and not just for the patients diagnosed with PTSD. Often nightmares can lead to sleep disorders, which have a negative impact on emotional well-being and cognitive functioning during the day. As well as this a strong relationship between severity of nightmares and severity of psychopathology has been found. This gives a strong argument for treatment of nightmares as a symptom, separate from the psychiatric disorder.

A few controlled studies of the treatment of nightmares have been published, in which behavioral therapy, relaxation techniques, exposure and systematic desensitization have been studied, all of which have shown positive results. But these techniques do not seem to reduce the number of nightmares in patients who suffer from PTSD. These last few years more controlled studies of a cognitive behavioral technique called 'Imagery Rehearsal Therapy' (IRT) have been published. With IRT patients have to change the script of their nightmares into a different outcome, and rehearse this new script using cognitive imagery a few times a day.

Comparisons: treatment of nightmares with IRT compared to a waitlist control group who do not get IRT until 6 months later.

Eligibility Criteria:
Patients referred to GGZ Centraal (previously Symfora groep) by their family doctor/GP for treatment of a psychiatric disorder. Patients that suffer from anxiety disorders, eating disorders, mood disorders and/or personality disorders.

Inclusion Criteria:

* Minimum of 3 nightmares per month
* Nightmares are associated with distress in daily life
* Subject wants to get treatment for the nightmares

Exclusion Criteria:

* Imagery rehearsal therapy for nightmares in the past
* Psychotic disorders
* Acute psychiatric crisis
* Mentally challenged or neuropsychiatric syndrome
* Severe addiction problems
* Insufficient mastery of the Dutch language
Double-dorsal Versus Single-volar Digital Block

The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia.

It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times.

However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions.

According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia.

Randomized, parallel controlled, open labeled experimental study

Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years of age
* Isolated traumatic acute hand finger lacerations requiring suturing
* Admissions within 6 hours of injury
* Patients who can cooperate with the NRS score
* Patients who gave consent

Exclusion Criteria:

* Vein, nerve and tendon lacerations on the hand that require repair
* Amputation or bone fracture
* Those who have used analgesics in the last 12 hours
* Hemodynamically unstable patients
* Known allergy to prilocaine hydrochloride
Comparison of Ultrasound-guided Brachial Plexus Blocks and Selective Distal Blocks in Terms of Anesthesia

Ultrasound-guided brachial plexus blocks (infraclavicular, axillary) can be applied as the main anesthetic method in hand and wrist surgeries, as well as single or combination block applications of the median, radial and ulnar nerves at the forearm level.

Here, we aimed to retrospectively evaluate the perioperative and postoperative data of patients who underwent hand and wrist surgery under distal nerve blocks and brachial plexus blocks in our hospital.

The retrospective files of patients who used ultrasound guided regional anesthesia techniques as the main anesthetic method in hand and wrist surgeries in our hospital between 01.01.2021 and 01.09.2022 will be examined. Patients over the age of 18 who go to hand and wrist surgery will be included. Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from the study. Demographic characteristics, American Society of Anesthesiology (ASA) scores, comorbidity, block performed (distal peripheral nerve block and/or brachial nerve block) and volume applied, block performance time, first analgesia times, surgery times, surgery types, discharge times, additional The existence of the complaint will be recorded. The data obtained by grouping the patients according to the type of anesthesia applied (brachial plexus block and distal nerve blocks) will be subjected to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who go to hand and wrist surgery will be included.

Exclusion Criteria:

* Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from the study.
CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis based on the World Health Organization (WHO) 2008
2. Patients have exhausted standard therapeutic options
3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
4. Female must be not pregnant during the study

Exclusion Criteria:

1. Prior solid organ transplantation
2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Duloxetine Tibial Plateau

The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2).

This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Tibial plateau fracture that requires operative fixation
* Ambulatory patient prior to fracture

Exclusion Criteria:

* Previous tibial plateau fracture on ipsilateral knee
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of any demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance/sensation
* Acute or chronic knee infection in ipsilateral extremity
* Previous total knee arthroplasty or knee hemiarthroplasty in ipsilateral knee
* Allergy to morphine (used in the SOC PCA pump)
* Pregnant or breastfeeding as determined by standard of care pre-operative urine pregnancy test
* Polytrauma
* Open fracture
* IV drug user
* Rheumatoid arthritis
* Revision cases
* Non-ambulatory
* Anatomical deformities of the knee
* Hepatic dysfunction or cirrhosis
* Taking Selective Serotonin Reuptake Inhibitor (SSRI), serotonin-norepinephrine reuptake Inhibitor (SNRI), monoamine oxidase inhibitors (MAOIs), tri- or tetra- cyclic anti-depressant
* Renal impairment (mention in patient chart and/or creatinine clearance \<30)
* Moderate to severe depression
* Taking CYP1A2 inhibitors and CYP1A6 inhibitors
A Prognosis and Predicting Genetic Study of Lung Cancer

Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. The adenocarcinoma of lung being the most frequently identified histological type is more weakly associated with smoking, and often occurs in females and never-smokers. Although family history of lung cancer has been associated with histological subtypes, the inherited susceptibility factors that affect specific histology are unknown.

Genetic factors that determine individual predisposition to lung cancer have been identified via genome-wide association studies. These known common loci, however, explain only a small fraction of the familial risk of lung cancer. The hypothesis of this study is that there are genetic factors that confer inherited susceptibility among patients with primary non-small-cell lung cancer (NSCLC).

To delineate the genetic etiology underlying NSCLC, this study proposes to employ a family-based linkage analysis, together with rich data generated from NGS, to search for disease susceptibility locus for the patients with strong family history of primary NSCLC. By using family pedigrees, linkage analysis will be able to find co-segregation of alleles through multiple generations at a genetic susceptibility locus and a known genetic marker, and then the highly penetrate gene loci may be detected by our study. These gene loci will be a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention and screening of NSCLC in the future.

Eligibility Criteria:
Inclusion Criteria:

1. The patient's family (within third-degree relatives) has at least one diagnosed of primary non-small cell lung cancer.
2. The patient was diagnosed of primary non-small cell lung cancer at the age \< 45 years old.

Exclusion Criteria:

1. Patients without the diagnosis of primary non-small cell lung cancer.
2. Patients who are combined with other malignancy and ongoing chemotherapy / radiation therapy.
3. Patients combined with coagulopathy.
The Impact of Physical (In)Activity on Sleep Quality

The proposed research will examine the role of physical activity (PA) on altering sleep quality (SQ) while systematically examining novel mechanisms that may drive changes in SQ. Specifically, the study will examine how a 2 week reduction in PA alters sleep quality in young, healthy individuals. Additionally, during this reduction in PA, the study will examine changes in inflammation, oxidative stress, and sympathetic activity to identify potential mechanisms for alterations in sleep quality.

Sleep, which makes up approximately one third of an individual's life, plays a vital role in normal bodily functioning by regulating metabolic and endocrine function. Disturbed sleep, defined as any alteration to normal sleep patterns, is highly prevalent, affecting 35% and 41% of the general population in the United States and has been linked to poor cardiovascular health, diabetes, obesity, dyslipidemia, and hypertension. Young adults are a population at high risk for disturbed sleep-related health outcomes due to negative lifestyle behaviors such as alcohol consumption, drug use, study patterns, and excessive screen time that remain with advancing age. Due to the importance of improving or maintaining health outcomes through adequate sleep quality (SQ), the proposed research will examine the role of physical activity (PA) on altering SQ while systematically examining novel mechanisms that may drive changes in SQ. Specifically, this study will examine how alterations (increases and decreases) in PA impact SQ and how these alterations modify inflammation, oxidative stress, and sympathetic stimulation in young adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with average weekly step count greater than 7500
* Low risk of cardiovascular, pulmonary, and metabolic disease

Exclusion Criteria:

* Individuals with cardiovascular, pulmonary, and metabolic disease
* Individuals taking medications that may affect cardiovascular, pulmonary, and metabolic function
* Diet differs substantially from typical diet, significant calorie restriction, or vitamin/mineral deficiencies
* Pregnant women
* Prisoners