cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants

The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.

The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.


Eligibility Criteria:
Key Inclusion Criteria:

* Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive and a total body weight \>50 kilograms \[110 pound (lb)\].

Key Exclusion Criteria:

* Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
* Previously participated in this study or previous studies with BIIB104.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
* First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
* Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
* Age ≥ 18 years
* ECOG ≤ 2
* Normal organ and marrow function as defined below:

  * Leukocytes ≥2.5 x 109/L
  * Absolute neutrophil count ≥1.5 x 109/L
  * Platelets ≥100 x 109/L
  * Hemoglobin ≥100 g/L (10g/dL)
  * Total bilirubin ≤1.5 X institutional ULN
  * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN
  * Creatinine ≤1.5 X institutional ULN

Exclusion Criteria:

* Patients with a life expectancy ≤ 16 weeks
* Patients with ocular melanoma
* Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
* Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
* Patients with a documented history of HIV, active hepatitis B or C infection
* Female patients who are pregnant or lactating
* Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)
* Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)
* Patients in whom a proper central line cannot be established
Advanced Methods for Cancer Detection by Vaginal Screening

This pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.

Most high grade ovarian cancers originate in the fallopian tubes. Since the lining of the fallopian tube opens into the uterine cavity cancer cells from ovarian/fallopian tube cancers can travel through the uterus to the cervix and vagina. Likewise, endometrial cancer cells shed through the cervix into the vagina. It may be possible to develop a screening test for ovarian and endometrial cancers by collecting vaginal cells.

Eligibility Criteria:
Inclusion Criteria:

Ovarian Cancer and Endometrial Cancer cases:

1. Women age 19 or older.
2. Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy.
3. Give consent to access primary tumour tissue following surgery or biopsy.

Healthy participants:

1) Healthy women between the ages of 19 and 60.

Exclusion Criteria:

Ovarian Cancer and Endometrial Cancer cases:

1. Women with self-reported, known pregnancy.

   Healthy participants:
2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded.
3. Women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible.
4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study.
5. Women with self-reported, known pregnancy.
Evaluation of a New CZT System

The purpose of the study is to check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use.

Participants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations.

The CZT screening takes 10 minutes and does not require any extra intervention to the routine screening.


Eligibility Criteria:
Inclusion Criteria:

* age over 18

Exclusion Criteria:

* pregnancy
* patients unable to understand and sign an informed consent
* age under 18
Problem Solving for Caregivers of Persons With Brain Injury

Family caregivers of persons with traumatic brain injury (TBI) have long-term demands that tax their coping abilities and adversely affect their health and well-being. This project will test the effectiveness of a problem-solving training program tailored to the unique needs of family caregivers of persons with TBI. Over a 3-year period, family caregivers and their care recipients will be recruited and randomly assigned to a problem-solving intervention group (n=40 dyads) or a control group (n=40 dyads). Participants in the problem-solving intervention group will receive four face-to-face problem-solving training sessions and monthly telephone problem-solving sessions over the course of 1 year. Control group participants will receive a handbook of educational materials and a staff member will contact each control group participant monthly by telephone to review these materials and other informational needs. No problem-solving training will be provided to control participants throughout the year.

Caregivers and care recipients will be assessed at four points during their participation: at the initial assessment, at 4 months, at 8 months, and at the completion of the 1-year participation period. All evaluations will be conducted in the participants' homes. Measures of problem-solving ability, caregiver burden, and adjustment (depression, health, satisfaction with life) will be collected. Structural equation modeling and other regression/inferential analyses will be used to determine the effects of problem solving on caregiver adjustment over time after taking into account care recipient adjustment and caregiver ethnicity. This project will: (1) demonstrate how specified physical and emotional outcomes of caregivers and care recipients are related to caregiver problem-solving abilities and how these relationships vary as a function of time; (2) evaluate the effectiveness of a community-based, problem-solving intervention that will be delivered to caregivers; and (3) identify caregivers and care recipients with TBI who are at risk for adverse emotional and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

Minimum age of 19 years Brain injury diagnosis at least 6 mos in-house non-paid caregiver of person with brain injury functional literacy caregiver willing to discuss abuse issues

Exclusion Criteria:

-
Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures

"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body temperature non-invasive as it may feel uncomfortable during placement and maintenance management. Various methods have been developed to measure body temperature noninvasive, such as in the mouth, armpits, skin surfaces, and aural canals. However, developed methods can also cause discomfort to patients in that they attach sensors to their skin.

In this study, we use the esophageal temperature measurement method, the skin contact temperature measurement method, and the IR contactless temperature measurement method to simultaneously measure body temperature and to compare the accuracy of body temperature measurement according to each method."


Eligibility Criteria:
Inclusion Criteria:

1. An adult who underwent endoscopic/laparotomy Hepatectomy of living donor, Pylorus preserving pancreaticoduodenectomy, Renal allograft, Flexible ureterorenoscopic removal of calculus of upper ureter with regular surgery

Exclusion Criteria:

1. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.
Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants

This study was completed in October 2006. No further participates are being recruited.


Eligibility Criteria:
Inclusion Criteria:

* All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.
Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps.

The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator.

The proposed project will test a novel intervention that targets patients and nephrologists as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* English speaking
* Mentally competent

Exclusion Criteria:

* Prior pre-transplant workup
* Prior kidney transplant
* Active systemic infection
* Active or recent malignancy
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age ≥ 60 years
* Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture

Exclusion Criteria:

* Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time
* Previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months
* Previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for \< 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded)
* Other diseases known to affect bone, such as Paget's disease, Cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin D deficiency
* Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more \> 2 weeks within the previous 6 months)
* Current alcohol use \> 3 drinks/day
* Untreated or unstable cardiac, pulmonary, liver (SGOT \> 2X upper limit of normal) or renal disease (creatinine \> 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C \> 8.0)
* Prior radiation therapy to the skeleton
* Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips
* Claustrophobia
* Subjects whose initial MRI is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the subject will be excluded from the study
* Abnormalities of the which delay esophageal emptying such as stricture or achalasia
* Inability to stand or sit upright for at least 30 minutes
* Hypocalcemia
* Uric acid level \>7.5ml/dl
* Subjects with metallic objects in their bodies
Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.

Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

* per diabetes, ability to follow diet and study procedures

Exclusion Criteria:

* on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
Assessment of Pulmonary Functions and Peripheral Muscle Strength of COPD Patients in Different GOLD Stages

The purpose of this research was to examine the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with COPD in different groups and to evaluate their correlation with the duration and prognosis of the disease in COPD.

Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction against harmful particles and gases in the airway and lungs, and is progressive, treatable and preventable.

The severity of the disease in COPD is determined according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines (2). While determining the severity of airway obstruction with the patient's spirometric values in COPD; Combined COPD assessment is made with symptomatic evaluation, number of exacerbations and hospitalizations. Airway restriction is numerically (GOLD 1-4), symptom evaluation and exacerbation risk combined with letter grouping (Group A-D).

There is a loss of respiratory and peripheral muscle strength in COPD patients. A mixture of various local and systemic causes was responsible for respiratory muscle dysfunction in COPD. Immobility, systemic inflammation, hypoxia of the tissue, oxidative stress and increased apoptosis of the skeletal muscle have been identified as possible pathogenic factors for loss of peripheral muscle strength in COPD patients.

it was aimed to evaluate the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with different COPD groups clinically and to evaluate their correlation with the duration and prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Being in COPD stable period and over the age of 40,
* The absence of abnormal laboratory findings,
* Not having a mental problem that prevents filling the questionnaires to be used in the study, - The absence of any other respiratory disease such as asthma,
* Giving the informed consent.

Exclusion Criteria:

* COPD exacerbation (hospitalization with acute exacerbation in the last 15 days),
* Presence of cognitive impairment,
* Pregnancy status,
* Ischemic heart disease,
* Kyphoscoliosis and advanced postural disorder,
* Orthopedic problems and amputation surgery,
* Emphysema, bullous lung disease,
* Presence of bronchiectasis,
* Previous thoracic surgery history,
* Presence of lung cancer,
* Advanced heart failure.
The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training

It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.


Eligibility Criteria:
Inclusion Criteria:

* Midwifery student
* volunteers

Exclusion Criteria:

* involuntary
Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder

This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT) versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing medication treatment for the disorder.

Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. These changes are drastic, and can result in damaged relationships, poor job or school performance, and suicide. Bipolar disorder is also known as manic-depressive disorder because it is characterized by episodes of mania and depression. Some signs and symptoms of a manic episode include the following: increased energy, activity, and restlessness; excessively "high," overly good mood; and extreme irritability. Some signs and symptoms of a depressive episode include the following: sad, anxious, or empty mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. Bipolar disorder is most effectively treated using a strategy that combines medication and psychosocial treatment. This study will evaluate the effectiveness of IPSRT versus CSSRT in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing maintenance medication treatment for the disorder.

Participants in this open-label study will be randomly assigned to one of two treatment strategies: IPSRT or CSSRT. All participants will attend study visits once a week until they have been stable for 4 weeks (acute phase). At this point, they will attend study visits every other week for 12 weeks (continuation phase), and then once a month for 18 months or until another depressive or mixed episode occurs (maintenance phase). Participants who experience a recurrence will be treated with medication and the type of therapy they were assigned upon study entry (IPSRT or CSSRT). These participants will continue to be followed for a period of time equivalent to their remainder of time in the study had they not experienced a recurrence. Outcomes will be measured at Week 12 of the continuation phase and Week 18 of the maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder
* Currently in the third episode of mania or major depression
* History of one other episode of major depression within 5 years prior to study entry

Exclusion Criteria:

* Currently in the first episode of mania or schizo-affective disorder (manic type)
* Rapid cycling drug or alcohol abuse
* Unstable medical illness
* Pregnant
* Index episode caused by medically prescribed drugs
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)

The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 infection.

Primary Aim:

• To determine safety of stellate ganglion block (SGB) in ARDS

Secondary Aim:

* To determine efficacy of SGB in slowing the progression of ARDS

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 to 80
* Subjects with PCR documented diagnosis of COVID-19 ARDS requiring critical care and transfer to intensive care unit
* Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph

Exclusion Criteria:

* Subjects with pre-existing cardiac failure
* Hemodynamic Instability
* Subject on Extracorporeal membrane oxygenation (ECMO)
* Anatomical inability to do a stellate block