cyrilzakka/clinical-trials huggingface dataset:
Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA

This study is designed to examine the efficacy of a brief intervention plus a cognitive-behavioral intervention compared to brief intervention alone to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in Alabama.

Participants will be randomly assigned to receive either Alcohol Brief Intervention (BI) or BI plus Common Elements Treatment Approach (T-CETA) via telephone. Participants will receive either 1 phone session of BI or 6 to 12 weekly phone sessions of BI + T-CETA. Follow ups will occur at 6 and 12 months with participants.

Participants will provide data on alcohol use, mental health comorbidities, HIV outcomes, medication adherence, and laboratory collections (CD4+ T cell count, viral load, and an alcohol biomarker: PEth) at the baseline assessment and again at the 6 and 12 month follow ups.

The study will also conduct mixed methods implementation measures with a subset of participants who are selected across various strata (i.e. gender, age, trial arm).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Living with HIV infection
* Receiving HIV care at 1 of 4 participating AQMG sites (Alabama Quality Management Group sites - i.e. Ryan White HIV/AIDS Program-funded community clinics in Alabama)
* Unhealthy alcohol use documented on the AUDIT survey delivered via PRO (i.e. 4 or greater points for women and greater than 8 points for men).

Exclusion Criteria:

* Inability to use a mobile phone due to cognitive or physical impairments
* Unable to speak sufficient English to provide informed consent and receive cognitive behavioral therapy
* Active suicidality or psychosis
* Risk for acute alcohol withdrawal or seizures
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

Exclusion Criteria:

* Estimated life expectancy of less than 3 months.
* Received the following treatments within 2 weeks prior to Visit 2:

  * Cytotoxic or cytostatic anti-cancer chemotherapy
  * Total resection or irradiation of the target lesion
  * Any investigational agent
Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants

This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.

Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label.

Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 30.0 kg/m\^2
* Must agree to adhere to the contraception requirements
* Additional criteria apply.

Exclusion Criteria:

* Received any investigational medicinal product in a clinical research study within the last 90 days
* Male participants who have pregnant or lactating partners
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption: a confirmed positive alcohol breath test at screening or admission
* Current smokers and those who have smoked or used e-cigarettes or nicotine replacement products within the last 6 months
* Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission)
* Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* Active renal and/or hepatic disease
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, chronic respiratory, neurological or psychiatric disorder, as judged by the Investigator
* Any form of cancer within the last 2 years (exceptions apply)
* History and/or symptoms of adrenal insufficiency
* Regularly consumes liquorice or other glycyrrhetic acid derivatives
* History of clinically significant gastrointestinal disease
* Currently using glucocorticoids or have a history of systemic glucocorticoid use within the last 12 months or 3 months for inhaled products
* Presence or history of clinically significant allergy requiring treatment
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Taking, or have taken, any prescribed, over-the-counter drug (other than up to 4 g per day paracetamol) or vitamins/herbal remedies within 14 days. Exceptions may apply on a case by case basis
* Additional criteria apply.
Internal Jugular Vein Flow in the Sitting Position

During neurosurgical procedures, patients need to be placed in sitting position for surgical access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common complication of sitting position craniotomy and carries high mortality and morbidity. Venous pressure decreases as the head of the patient is raised above the heart. Hence, negative venous pressure in the cerebral venous system promotes entrapment of air in accidental opening of the sinuses.

Common methods to prevent VAE in sitting position include increasing the venous pressure by either jugular venous compression and/or increasing the venous pressure by adding positive end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead to brain swelling.. In addition, improper neck position can cause the kinking of the IJV which may lead to decreased venous drainage and increased ICP. This has been shown to be the contributing factor for intraoperative brain swelling and postoperative neck and tongue swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this.

Currently, there are no studies that looked into the IJV flow in sitting position and effect of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly used physiological methods that can cause venous outflow obstruction. A custom made neck collar can be used for compression of internal jugular vein and previous investigations have used a similar device in a rat model to demonstrate the protective effects on slosh-mediated brain injury by increasing intracranial blood volume . While the collars have not yet been studied on people for their effectiveness at preventing concussions, many studies have looked at the effect of neck collars on both jugular compression and ICP..

The purpose of this study is to measure the venous blood flow of healthy volunteers by the use of an ultrasound and Doppler velocimetry in sitting position. the investigators will measure the IJV flow on both sides in sitting position at rest and at two conditions of venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30 seconds Valsalva maneuver. This study will provide information on the cerebral venous drainage. This information will be very useful in planning and positioning of patients undergoing neurosurgical procedures and to prevent complications from the improper patient position.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers who are above the age of 18 ASA 1
* Body mass index (BMI) less than and equal to 35

Exclusion Criteria:

* Lack of informed consent
* Language barrier
* Medical students and anesthesia residents going through the department as part of their rotation
Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.


Eligibility Criteria:
Inclusion Criteria:

* Meet legal criteria to obtain abortion
* Have an ongoing pregnancy of 13-22 weeks gestation
* Be willing to undergo a surgical completion if necessary
* Have no contraindications to study procedures, according to provider
* Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
Aftercare for Adolescents Treated for Alcohol Abuse and Dependence

The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)

In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3 individual aftercare (AR) conditions noted above. Manualized active interventions were composed of 5 sessions of integrated motivational enhancement and cognitive behavioral therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC completion.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between the ages of 13-18 years
* Meeting criteria for DSM-IV alcohol use disorders
* Able to comprehend and read English at the 5th grade level
* Participant and family member are willing to provide a locator information.
* Not planning to move out of state during the next 12 months

Exclusion Criteria:

* Meet any substance dependence criteria other than nicotine or cannabis
* Meet life time diagnosis of schizophrenia
* Reported a suicidal ideation with a plan, suicidal attempt, or self-injurious behavior in the last 30 days
* Having a medical condition that may prevent them from consistently attending and constructively participating in treatment and aftercare
Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis

The skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that live in symbiosis with the host. The specific etiology of psoriasis is still not-well understood; nonetheless several studies highlighted that that the skin microbiota could have a pivotal role in the maintenance and/or progression of the disease, acting as microbial predictor of psoriasis however.

The aim of the present study was to characterize the microbiota of cutaneous biopsies associated to guttate and vulgaris psoriasis, both considering lesion and healthy skin belonging to the same psoriatic subject.

Twelve individuals with guttate psoriasis and 12 individuals with vulgaris psoriasis have been enrolled at Dermatological Unit of IRCCS Galeazzi Institute, Milan.

Patients selected for the psoriasis vulgaris group had a course of disease stable for at least 1 month before collection. The second group presented guttate psoriasis, defined as "eruptive", that is characterized by a rapid appearance and worsening of the clinical presentation within the month preceding the visit.

From each participant, a punch was used to obtain a cutaneous sample from both a lesion and healthy skin area of 2 mm2 belonging to the left gluteus, for a total of 48 biological samples. Participants were selected and included in the study according to the following criteria: i) over 18 years of age; ii) use of a free-preservatives soap with moisturizing function; iii) no use of probiotics; iv) no use of antibiotics; v) no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling; vi) no use of topical corticosteroids, vitamin D derivatives or phototherapy; vi) no chronic or systemic infections; vii) no cutaneous acute infections; viii) no allergy to pollen, food and drugs ix) no pets. Informed consent was obtained from all subjects.

A metagenomics approach, performed by the use of Ion torrent Personal machine, were used to investigate the bacterial composition of the skin microbiota associated to each samples collected.

After sequencing, the data analysis were focused on the bacterial biodiversity and microbial networks existing in the skin microbiota to evaluate a hypothetical role of bacteria in the complex pathophysiological mechanisms involved in psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age;
* use of a free-preservatives soap with moisturizing function, applied once a day;pets.

Exclusion Criteria:

* no use of probiotics in the month prior the sampling;
* no use of antibiotics in the month prior the sampling;
* no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling;
* no use of topical corticosteroids, vitamin D derivatives or phototherapy in the month prior the sampling;
* no chronic or systemic infections;
* no cutaneous acute infections during sampling;
* no allergy to pollen, food and drugs
* no pets.
Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

"Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses ," will be a prospective observational cohort study looking at the epidemiology of bleeding in the pediatric ICU population at MSK.


Eligibility Criteria:
Inclusion Criteria:

* All children (≥28 days old through 18 years of age) with an oncologic diagnosis admitted to the PICU at Memorial Sloan Kettering Cancer Center
* An oncologic diagnosis will include those with a cancer diagnosis or those being treated at MSK for blood disorders, immunodeficiencies and complications of transplant.

Exclusion Criteria:

* Preterm infants (\<44 weeks gestation at age of enrollment) as in these patients most bleeding etiologies are specific to the neonatal period and the bleeding assessment tool is not calibrated for this population
* Known limitation of care at enrollment (standing Do Not Resuscitate order), as the interventions and clinical outcome would be biased
* Pre-existing bleeding disorders
Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed stage II \& IIIA non-small cell lung cancer

  * EGFR exon 19 or 21 mutations
  * Age ≥ 18 years and ECOG performance 0\~1
  * Has measurable lesion by RECIST 1.1
  * No previous chemotherapy or radiation therapy
  * Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr \< 1 x UNL or creatinine clearance \> 60 ml/min, Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL
  * Written informed consent form

Exclusion Criteria:

* Previous chemotherapy or radiation therapy
* Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
* Known allergic history of erlotinib
* Interstitial lung disease or fibrosis on chest radiogram
* Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
* Pregnant or nursing women
Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective (non emergency) surgery who will require intra-operative warming
* Patients whose surgery will be performed with them in the supine position

Exclusion Criteria:

* Abdominal aortic aneurysm repair
* All adults (over 18 years) who refuse,who are unable to fully understand the trial
* ALL laparoscopic surgeries
Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia

Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(USG- TAP) block with ropivacaine in Laparoscopic Bariatric Surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo Laparoscopic Bariatric Surgery
2. Subject's American Society of Anesthesiologists physical status is I-III.
3. BMI\>35kg/m2
4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. Subject has a diagnosis of renal or liver failure.
2. Subject has a diagnosis of mental illness
3. Subject is allergy and contraindication to Ropivacaine.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use
6. Subject is pregnant or breast-feeding.
Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.

Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage.

Eligibility Criteria:
Inclusion Criteria:

* Cerclage
* Pregnancy Outcome data available
* Neonatal Outcome data available
* Pre and Post Cerclage Cervical length measurements
* Hx of cervical procedures, if any, available

Exclusion Criteria:

* Cervical ultrasound picture(s) unacceptable
* Any missing maternal or fetal data as stated above
* Fetal anomaly
* Cervical dilation at time of cerclage
* Placental previa or abruption
* Preterm Labor
Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with relapsed/refractory Multiple Myeloma.

Previous studies have found that multiple myeloma cells express PD-L1 at a high level. Therefore, the combination of anti-PD-1 or PD-L1 antibodies with CART therapy may further improve the clinical efficacy of CART cell for multiple myeloma.

The investigators screened PD-1 mutant that have high affinity bind with the PD-L1 ligand, and the affinity of the prepared mutant PD-1 Fc fusion protein to bind to PD-L1 reached clinical anti-PD-L1 antibody levels. The investigators prepared BCMA CART cells which secretes the mutant PD-1Fc fusion protein, and the prepared CART cell culture supernatant can well block the binding of PD-L1 to PD-1. Preclinical studies have shown that BCMA CART cells secreting mutant PD-1Fc fusion protein have a superior killing effect on PD-L1 positive multiple myeloma tumor cells to BCMA CART cells which does not express PD-1 fusion protein.

The trial was conducted to explore the safety and efficacy of BCMA-PD1-CART cells in Relapsed/Refractory Multiple Myeloma.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 14 to 80 years (including 14 and 80 years old).
2. The diagnosis was Refractory/relapsed multiple myeloma.(Meeting 1 of the follow 3 items)

   A.Primary treatment patients with no effect after first and second line treatment.

   B.Patients who relapsed after complete remission and failed to respond to two kind of therapy.

   C.the predicted survival is more than three months.
3. Flow cytometry or immunohistochemistry showed BCMA positive in tumor cells.
4. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
5. No serious concomitant disease and major organ function is not serious abnormal.
6. No serious concomitant disease and major organ function is not serious abnormal.
7. the test meets the following indicators:

A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L.

B.WBC≥2.5×109/L.

C.PT/INR \< 1.7 or PT was extended by less than 4 seconds.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Transduced positive T lymphocytes \< 5% or amplified against CD3/CD28 stimulation \< 5 times.
3. Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection.
4. Patients who are using steroid drugs throughout the body currently.
5. Patients who have received any gene therapy in the past.
6. Patients who are allergy to immunotherapy and related drugs.
7. Patients with heavy heart disease or poorly controlled high blood pressure.
8. Patients who received chemotherapy or radiation 4 weeks before the study began.
9. Patients who are participating in other clinical trials.