cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.

A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1.

Eligibility Criteria:
Key Inclusion Criteria:

* The participant is a healthy adult male or female aged 18 to 45 years, inclusive, at the time of informed consent.
* The participant weighs between 45 kg (99 lbs) and 100 kg (220 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the time of informed consent.
* The participant agrees to use highly effective method of contraception from the time of signing consent throughout 90 days after dosing.

Key Exclusion Criteria:

* The participant has received any investigational compound within 90 days before dosing.
* The participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect the participant's safety, increase risk of seizure or lower the seizure threshold, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance of any conditions the participant may have; however, consultation with the Xentria Medical Monitor may be warranted.
* The participant has a known hypersensitivity to any component of the formulation of XTMAB-16.
* The participant has a positive result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Baseline (Day -2).
* The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma

This medical study is an assessment of clinical response in women with Posttraumatic Stress Disorder (PTSD) due to domestic violence or rape trauma when treated with risperidone. Response to risperidone or placebo (inactive drug) is measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). Second, the effect of risperidone on depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety, Hamilton Rating Scale for Depression and the Clinical Global Impression.

Risperidone is an atypical antipsychotic that has been shown to be effective in both the core PTSD symptoms and psychotic symptoms associated with combat-induced PTSD in males. Case series have shown that risperidone is possibly effective in monotherapy or adjunctively in treating PTSD patients. However, risperidone has never been tested in women with severe PTSD. Thus, we propose extending and expanding this research to another antipsychotic, risperidone, in a cohort of women who suffer PTSD as a consequence of domestic violence and/or rape trauma.

Eligibility Criteria:
Inclusion Criteria:

* Women with DSM-IV clinical diagnosis of PTSD caused by domestic violence or rape, who are able to attend weekly clinic appointments;
* Age 19 -64, not pregnant and either sterile or using acceptable contraception;
* A willingness and ability to provide competent signed informed consent;
* A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English).

Exclusion Criteria:

* Any diagnosis of schizophrenia or bipolar I disorder; or active substance dependence.
* Unstable general medical condition or serious illness (e.g., death or hospitalization is anticipated within one year), poor liver or kidney function-Subjects with prior non-response to risperidone for the treatment of PTSD with an adequate trial
* Enrolment in any drug study within the last 60 days.
* Pregnancy or nursing.
* Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis

This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled, ascending dose study to investigate the safety, tolerability, and pharmacokinetics of XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females 18 to 50 years of age
* Parts 1 and 3: Healthy subjects with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
* Part 2: Otherwise healthy male and female subjects with a history of allergic rhinitis and/or allergic conjunctivitis and/or atopic dermatitis with an elevated serum IgE
* Subjects who are able and willing to give written informed consent;
* Subjects who have the ability to complete all study assessments;
* Subjects who are willing to forego other forms of experimental treatment during the study.

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases, or disorders (other than allergic rhinitis and/or conjunctivitis and/or atopic dermatitis in Part 2) that would pose a significant risk to subject safety or significantly interfere with the study evaluation, procedures, or completion
* Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and/or human immunodeficiency virus (HIV) Type I or Type II tests at Screening;
* Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
* Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
* Subjects who have used any investigational drug in any clinical trial within 8 weeks prior to admission (Day -1), or have used an experimental monoclonal antibody;
* Subjects with prior exposure to a monoclonal antibody;
* Subjects with a history of anaphylaxis;
* Subjects who have received live vaccines ≤ 3 months from Screening;
Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard

The study aim will be to determine the fit factor of surgical masks and filtering respirators in healthcare providers with and without beard. A randomized clinical trial will be carried out recruiting a sample of 52 healthcare providers with and without beard. Fit factor will be measured with both surgical masks and filtering respirators and compared between healthcare providers with and without beard.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare providers

Exclusion Criteria:

* Pulmonary diseases
* Pregnant women
* Not sign the informed consent form
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer

This study aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Cisplatin Plus Gemcitabine(CisGem), compared with Adebrelimab in Combination With CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~75 years old, both male and female;
2. Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
3. Has not received prior systemic anti-tumor therapy;
4. At least one measurable lesion based on RECIST v1.1 criteria;
5. ECOG PS score: 0-1 points;
6. Expected survival period ≥ 3 months;
7. Adequate organ function;
8. Must take one medically approved contraceptive measure;
9. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

1. history or concurrently has other solid tumor;
2. Patients with liver tumor burden greater than 50% of total liver volume;
3. History of previous hepatic encephalopathy;
4. Patients with biliary obstruction ， at risk of biliary tract infection;
5. Patients with undergone major surgical treatment within 4 weeks before randomization;
6. Patients with any active, known or suspected autoimmune disorder;
7. Patients with active pulmonary tuberculosis;
8. Patients with known history of HIV or active hepatitis;
9. Untreated central nervous system metastasis;
10. Pleural or peritoneal effusion with clinical symptoms;
11. Patients with poorly controlled cardiac clinical symptoms or disease;
12. Patients with abnormal coagulation function and bleeding tendency;
13. Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug;
14. Patients with other potential factors that may affect the study results.
Combination of Cryosurgery and NK Immunotherapy for Advanced Non-Small Cell Lung Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced NSCLC.

By enrolling patients with NSCLC adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for NSCLC.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients withgrade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Prevena Spine for Use in Spine Surgery

A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

The objective of the study is to evaluate the efficacy of the Prevena Plus 125 therapy Unit (KCI USA, Inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. Furthermore, the investigators want to illustrate which patients benefit most significantly from Prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with Prevena intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing spine surgery that requires closure by plastic surgeon
2. Over 18 years old
3. Risk Score Cutoff 80+
4. (Control) Matched to a prospective research participant

Exclusion Criteria:

1. Risk Score Cutoff \<80
2. Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into this study
3. Subjects who are pregnant at the date of surgery (SOC for surgery)
Adaptive Support Ventilation in the Weaning of COPD

Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure

Exclusion Criteria:

* Mechanical ventilation less then 24 hours (self extubation or death),
* Having a tracheotomy and
* COPD coexisted with severe cardiac or neurologic diseases.
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.

Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.

Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.

Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.

We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* admitted to surgical intensive care unit (SICU), and
* at risk of ongoing bleeding, and
* requires serial CBC measurements

Exclusion Criteria:

* \< 18 years of age, or
* a prisoner, or
* unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)
Peripheral Blood Flow Responses to Electromagnetic Energy

This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults. All participants will receive red light to their leg. They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.

670 nm energy in the form of red light dilates isolated blood vessels. This study seeks to measure vessel dilation in human subjects exposed to this energy at different irradiance intensities (25 milliwatts (mW)/cm2 and 75 mW/cm2). The intent of this protocol is to measure blood flow in the gastrocnemius muscle before and after exposure to 670 nm light energy. This protocol will be performed in healthy subjects, who do not meet exclusion criteria. The study consists of one visit. Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream. Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image. After baseline blood flow images are collected, the subject will receive red light energy to the gastrocnemius muscle with concurrent blood flow measurements with contrast ultrasound. The subject will be monitored post procedure and the study will then be completed.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy subjects over the age of 18.
* Men and women will be recruited for participation.
* All ethnicities will be included in this study.

Exclusion Criteria:

Exclusionary criteria include:

* age under 18 years and those over 60 years of age,
* those who are unable to understand the consent process,
* those who cannot read or speak English,
* a history of cancer,
* peripheral artery disease,
* diabetes mellitus,
* active pregnancy,
* hypersensitivity to perflutren contrast agents,
* pulmonary hypertension,
* chronic kidney disease,
* active tobacco or drug use,
* blood pressure over 160/90, BMI\>30,
* sickle cell disease, or
* history of intracardiac shunt.

Additional exclusion criteria include:

* a history of coronary artery disease,
* heart failure,
* the presence of an implanted defibrillator or pacemaker,
* a history of heart murmur or rhythm disorder (atrial fibrillation, atrial tachycardia, or ventricular tachycardia),
* neurological diseases such as stroke, and
* any uncontrolled medical conditions.
Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.

OBJECTIVES:

* Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.
* Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.
* Determine the duration of response and time to disease progression following this treatment regimen in these patients.

OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.

Patients are followed at least monthly for 2 years, then every 3-6 months until death.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following:

  * Bilineage cytopenia
  * Unfavorable cytogenetic abnormalities
  * Refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast)
* At least 0.5 on the International Prognostic Score System
* No chronic myelomonocytic leukemia
* No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count less than 1,500/mm3
* Platelet count less than 100,000/mm3
* Hemoglobin less than 10 g/dL

Hepatic:

* ALT less than 5 times upper limit of normal

Renal:

* Creatinine no greater than 1.4 mg/dL

Cardiovascular:

* No congestive heart failure

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Must have right atrial catheter inserted

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior blood or bone marrow transplantations

Chemotherapy:

* No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine)
* No prior topotecan
* No prior amifostine

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 24 hours since prior antihypertensive medication prior to amifostine
MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial

A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.

To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing colonoscopy

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent.
2. Is scheduled for colonoscopy within 30 days of screening
3. Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
4. Is able to communicate effectively with study personnel.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
2. Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
3. History of renal insufficiency
Influence of Anesthesia Methods on Surgical Outcomes and Renal Function

Patients who underwent retrograde intrarenal surgery (RIRS) were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and relative renal function was evaluated using nuclear medicine tests. Maneuverability and accessibility were evaluated after every surgery. We analyzed the influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal surgery in a prospective, randomized controlled study.


Eligibility Criteria:
Inclusion Criteria:

* older than 20 years with renal stones greater than 10 mm

Exclusion Criteria:

* patients who have urologic anatomical abnormalities
* patients with ASA status ≥ grade III, a contraindication for spinal anesthesia or RIRS, or unexpected intraoperative renal injury