cyrilzakka/clinical-trials huggingface dataset:
Alcohol-focused Support of Survivors in Sororities Training (ASSIST) - Pilot

The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters. ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. Individuals within each sorority will be recruited and complete a norm documentation survey. One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.


Eligibility Criteria:
Chapter-Level Inclusion Criteria:

* Greek organization of undergraduate women recognized by the Office of Fraternity \& Sorority Life with a physical house for chapter members
* At least 80 active members

Individual-Level Inclusion Criteria:

* Aged 18 years or older
* Current student
* Active member in a participating sorority chapter

Exclusion Criteria:

* \[None\]
Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19

An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients

Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings.

Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions:

Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration.

______________________________________________________ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.

______________________________________________________ Radiologic findings: pulmonary infiltrates, pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are able and agree to sign informed consent form before any study-specific procedure.
2. Males or females, age range 18-80.
3. Female subjects are eligible only if of non-child bearing potential.
4. Documented COVID19
5. O2 Saturation of ≤93%
6. Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)
7. Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.

Exclusion Criteria:

General:

1. Pregnant or breast-feeding females.
2. History of drug abuse.
3. Heavy smokers (above 2 packages a day).
4. Subjects incapable of giving consent.

Background medical conditions:

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
2. History of significant heart diseases, renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
3. Known autoimmune diseases.
4. Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
5. Immunocompromised condition from any reason, at screening.
6. Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
7. Poorly controlled diabetic subjects (HbA1c \> 9%).
8. Known active lung malignancy.

Concomitant treatment:

1. Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.

Hypersensitivity:

1. Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
2. Known history of hypersensitivity to Human Serum Albumin.
Comparing 3 Schedules of Alimta Plus Gemzar

The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small lung cancer
* No prior chemotherapy
* Able to care for self

Exclusion Criteria:

* An ongoing infection
* Pregnancy or breast feeding
* Other serious medical condition
* Cancer that has spread to the brain
* Inability to take folic acid
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers

The objectives of this study are:

* To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
* To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years
2. No significant medical history
3. Normal physical examination
4. No clinically significant abnormalities in baseline laboratory values
5. No clinically significant abnormalities on 12 lead electrocardiogram
6. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
7. Written informed consent signed

Exclusion Criteria:

1. Pregnancy or lactation
2. Know hypersensitivity to the investigational drug or any of its components
3. Current enrolment in another investigational study
4. Unwillingness to provide or continue informed consent
Clinical Performance and Acceptance of Bioflx Crowns

Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.


Eligibility Criteria:
Inclusion Criteria:

* A child with primary molars is indicated for full coverage.

Exclusion Criteria:

* Children with any systemic disease
* Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
* Children cooperation (1,2) according to Frankl scale
* Parents are unwilling to enroll their children in study
Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis

Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.

To compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime, eligible PD patients were randomly assigned to study group (IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD) and control group (IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD). Patients were followed for 3 months after the completion of the treatment period. Primary endpoint is complete cure, secondary endpoint are primary response and primary or secondary treatment failure.

Eligibility Criteria:
Inclusion Criteria:

* incident or prevalent peritoneal dialysis patients
* diagnosis of acute peritonitis according to ISPD guideline
* age \>18 years

Exclusion Criteria:

* receiving antibiotic treatment for other reasons when peritonitis occurred
* contraindication to cephalosporin, vancomycin, or fluoroquinolones
* concomitant exit-site or tunnel infection
* requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration failure at the initiation of peritonitis
* inability to tolerate oral administration due to severe gastrointestinal complication or other reasons
* history of psychological illness or condition which interfered with ability to understand or comply with the requirements of the study
* pregnant or breast-feeding
Nicotine Differences in Smokers

The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.

Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Hypothesis: The threshold for discrimination will be 0.05 mg nicotine/pulse and the doses below that (0.025, and 0.0125 mg nicotine/pulse) will be subthreshold.

Exploratory Aim: To explore the relationship between the threshold for subjective drug effects and drug discrimination.

Eligibility Criteria:
Inclusion criteria:

* Female and male smokers, aged 18 to 65 years veterans and non-veterans who have been smoking tobacco cigarettes for at least a year
* smoke ≥ 5 cigs/day ;
* urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker (23)
* not seeking treatment at the time of the study for nicotine dependence
* Good health as verified by medical history, screening examination, and screening laboratory tests
* For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion criteria:

* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
* use of e-cigarettes more than 10 days in the past 30 days
* urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops

The purpose of this study is to explore the tear lipid layer quantitatively and qualitatively before and after use of a perflurohexyloctane eye drop (NovaTears)

The tear lipid layer will be studied before and after the use of an over-the-counter eye drop (NovaTears, Novaliq GmbH, Heidelberg, Germany) using a Stroboscopic Video Color Microscope, which is non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* • Age - at least 30 years

  * Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
  * Ability to give informed consent
  * Willing to spend time for the study; approximately one hour for a screening visit and 45 minutes for a data collection visit.
  * Either gender
  * Any racial or ethnic origin
  * tear lipid thickness ≤ 75 nm

Exclusion Criteria:

* Active ocular inflammation
* Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis or Xiidra) used within 14 days of the screening visit or started prior to the measurement visit(s).
* Currently having punctal plugs inserted in lacrimal puncta
* Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence MGD, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, SSRIs, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested,
* Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects.
* Female subjects may not be pregnant or lactating. (Subject will be asked to self-report these conditions.)
* Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV). (Subjects will be asked to self-report these conditions.)
* Inability to complete the screening and examination
* Inability to provide analyzable data. For example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men

The purpose of this study is to recruit and train men to promote HIV self-testing to their network members in their camps and examine the efficacy of a peer-led HIV self-testing intervention on the uptake of HIV testing among men.

The research is the first evaluation of an unsupervised HIV self-testing strategy in Tanzania focusing on networks of heterosexual men. The reasons for focusing on heterosexual men is because heterosexual contact is the primary mode of HIV transmission in Tanzania and data from our previous trial indicate that 97% of the male camp members are heterosexual. Moreover it will be the first intervention to engage male peer leaders to promote HIV self-testing in their social networks in Tanzania. We will build on previous work our research team has conducted to identify 'camps' or local venues where young men socialize with elected leaders and members pay membership dues. Our previous intervention has proven successful to recruit and train leaders from camps to serve as community health leaders in their respective camps, with the goal of changing social norms related to HIV and gender-based violence. A novel approach to the proposed research is that we will leverage the work we have conducted within camps with social networks of men to test the acceptability and feasibility of oral fluid-based HIV self-testing and confirmatory blood-based HIV testing within existing networks of men that we know we can access through stable social venues. We will recruit male camp leaders to train them about HIV self-testing and instruct them to return to their camps and engage their male peers by informing them about HIV self-testing for prior to our research team offering participants the opportunity to self-test.

Eligibility Criteria:
Inclusion Criteria:

* Participant is at least 18 years old
* Has been member of the camp for at least 3 months
* Visits camp at least once a week
* Intends to live in Dar es Salaam for next 6 months
* Has not had suicidal thoughts in the past
* Willing to give contact information of self and relative or friend

Exclusion Criteria:

* Does not meet all inclusion criteria
* Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior
Effect of Cradle Position During Orogastric Tube Feeding on Comfort, Physiological Parameters and Vomiting

The study was planned to determine the effect of the cradle position applied during orogastric tube feeding in premature newborns on comfort, physiological parameters and vomiting frequency.

Hypotheses of the Study H1: The cradle position applied to premature newborns during orogastric tube feeding; H1a: It affects the comfort level compared to the control group. H1b: It affects physiological parameters compared to the control group. H1c: It affects the vomiting frequency compared to the control group.

It is reported that the cradle position is the most preferred position by mothers during the breastfeeding process. The cradle position is a position where the mother holds the baby in her arms, the baby's head is placed on the inside of the mother's arm-elbow area, the baby's whole body is turned towards the mother, the baby's head is in line with the mother's breast, and the mother and the baby are in intense interaction. Although it is the most preferred position for breastfeeding, no study has been found in the literature evaluating the effect of the cradle position given during OGT feeding on the comfort level, physiological parameters and vomiting frequency of premature babies. For this reason, it is thought that it can be a supportive position that can be used by both neonatal nurses and mothers who are with their babies during the OGT feeding process for newborns preparing for the breastfeeding process in NICUs. It is thought that the study results will guide health workers and researchers regarding the supportive positions that should be given during newborn feeding.

Eligibility Criteria:
Inclusion Criteria:

* Having a feeding frequency of every 3 hours,
* Having a birth weight of 1000 grams and above,
* Having an indication for intermittent feeding (bolus) with OGT,
* Being placed in a bed,
* Not having a condition that prevents giving the cradle position (having undergone surgery, having a congenital anomaly, etc.)
* Having stable physiological parameters,
* Babies whose mothers were not with them during feeding (having undergone surgery, receiving inpatient treatment, being discharged and out of town, not wanting to be held during feeding, etc.) were included in the study.

Exclusion Criteria:

* • Continuous infusion, slow bolus feeding or parenteral nutrition method used for feeding,

  * Switching to full oral feeding,
  * Having nasal obstruction,
  * Receiving oxygen therapy, mechanical ventilation/CPAP support during the study period,
  * Receiving medication affecting gastrointestinal function during the study period (drugs that increase gastrointestinal tract motility and facilitate gastric emptying and gastrointestinal passage of nutrients, and drugs that decrease gastrointestinal tract motility).
  * Any medical diagnosis determined other than prematurity (Congenital anomaly, metabolic disease, asphyxia, sepsis, hyperbilirubinemia, intracranial hemorrhage and gastrointestinal hemorrhage, anatomic gastrointestinal anomaly, gastrointestinal disease, infection, frequent vomiting, distension).
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM)：

   1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression;
   2. Relapsed after hematopoietic stem cell transplantation;
   3. Cases with recurrent positive minimal residual disease;
   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
2. Male or female aged 18-75 years;
3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
6. Estimated survival time ≥ 3 months;
7. ECOG performance status 0 to 2;
8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus

Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a primary partial liver graft from a living donor
* Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study

Exclusion Criteria:

* Patients receiving a multi-organ transplantation or having previously received an organ transplantation
* Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
* Patients allergic or intolerant to macrolide antibodies or Tacrolimus