cyrilzakka/clinical-trials huggingface dataset:
PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can generate anti-tumor activity and clinical responses in patients with metastatic lung cancer who have progressed on first line immune checkpoint blockade therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented recurrent and/or metastatic non-small cell lung cancer
* Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment
* If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required
* Measurable disease by RECIST 1.1
* ECOG Performance Status 0 or 1
* Signed written informed consent
* Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment
* Meet all the laboratory criteria per protocol

Exclusion Criteria:

* Prior treatment with PCSK9 inhibitors
* Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
* Uncontrolled diabetes mellitus, defined as HbA1c \> 10
* Major surgery less than 4 weeks prior to study enrollment
* Another malignant condition diagnosed within 3 years of study enrollment
* Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication.
* Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS)
* Additional exclusion criterion as per listed in the protocol
Diet, Obesity and Cardiovascular Risk Study

Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks, then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* BMI 28-28 kg/m2
* Male or postmenopausal female 45-65 yr

Exclusion Criteria:

* Abnormal thyroid, liver, kidney function
* Abnormal hemoglobin
* LDL-cholesterol ≤ 100 mg/dL
* Fasting triglycerides ≥ 400 mg/dL
* Diabetes or on medication for diabetes
* Chronic illness
* Elevated blood lipids
A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors); 4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function

Exclusion Criteria:

* \*Eligibility Criteria:

Inclusion Criteria:

1. Aged 18-75 (including) years old;
2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum/fluorouracil combination chemotherapy with or without immune checkpoint inhibitors);
4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;
5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2);
6. Adequate organ or bone marrow function

Exclusion Criteria:

1. Patients who have experienced toxicity during previous treatment with trastuzumab or trastuzumab biosimilars, resulting in permanent discontinuation of trastuzumab or trastuzumab biosimilars;
2. Patients with a history of allergies to any component of DP303c and deemed severe by the researchers
3. There is uncontrolled serosal fluid accumulation that requires frequent drainage or medical intervention;
4. Active leptomeningeal disease or uncontrolled CNS metastasis;
5. Has a history of serious cardiovascular and cerebrovascular diseases;
6. There was a peripheral neuropathy of grade ≥ 2 (refer to NCI CTCAE 5.0) prior to enrollment;
7. History of gastrointestinal perforation and/or fistula within 6 months of first use of medication;
8. Inability to swallow medication orally or presence of clinically significant gastrointestinal diseases;
9. Urine protein ≥++ and 24-hour urine protein quantification\>1.0 g during screening period;
10. There are eye diseases that require intervention, such as corneal diseases, retinal diseases, or active eye infections;
11. Used CYP3A4 strong inhibitors or CYP3A4 strong inducers 14 days before the first medication ;
12. Used UGT1A1 strong inhibitor before first medication and wash-off period is less than 5 half-lives.
Indirect Laryngoscopy for Nasal Intubation

Comparison of ease and convenience of nasotracheal intubation with the use of the two indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* nasotracheal intubation

Exclusion Criteria:

* anticipated difficult airway
* risk factors for gastric aspiration
* history of bleeding
* relevant allergy
L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity


Eligibility Criteria:
Inclusion Criteria:

* children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
* age 5-18 years

Exclusion Criteria:

* Another chronic hemolytic anemia.
* Patients with documented causes of pulmonary hypertension other than SCD.
* Allergy to L-arginine.
* Patients with Asthma.
* Hepatic dysfunction: serum Alanine Aminotransferase (ALT) \> 3X upper value.
* Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Intervention to Enhance Numeracy in Diabetes (IntEND)

The objective of this project is to test two interventions designed to improve diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with diabetes use numbers in a variety of ways in managing their condition (e.g., understanding blood sugar values, counting carbohydrates, taking medications at the right dose and time). As part of this project, the investigators developed and pilot tested two interventions to improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a one-time, online diabetes education class. The investigators will look to see whether participants in the education classes show improvements in their diabetes-related numeracy skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar \[A1c\]).

Sixty-five American Indians with diabetes were enrolled. Each participant was randomly assigned to 1 of 3 study arms: (1) the in-person education group, (2) the online education group, and (3) a control group. The in-person intervention group attended four class sessions addressing numeracy skills used in the management of diabetes (e.g., counting carbohydrates). The online education group completed a single online module providing training on diabetes-related numeracy skills. The control group received written diabetes educational materials. The investigators collected data at baseline, then again immediately after intervention participation (in-person or online classes), and one final time about three months after the conclusion of the intervention. The investigators will conduct analyses to determine if intervention participants experienced positive changes in diabetes numeracy (the primary outcome) as well as several secondary outcome measures following intervention. Secondary outcomes include: diabetes knowledge, self-efficacy, outcome expectancies, readiness to change, self-care behavior, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar \[A1c\]) . The investigators also will assess whether change in numeracy predicts change in these secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* American Indian/Alaska Native;
* 18 to 89 years old;
* diabetes diagnosis documented in medical records;
* active patient of the Yakama Indian Health Service.

Exclusion Criteria:

* Does not speak English;
* pregnancy;
* dialysis;
* current cancer treatment;
* blindness;
* active alcohol/substance abuse;
* planning to move out of the area in the next six months.
Hyoscine ButylBromide for Intrapartum Analgesia

The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria:

* Clinical evidence of cephalopelvic disproportion.
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy.
* Any medical disorders associated with pregnancy.
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family
Functional Recovery Changes in Subacute Stroke Patients

In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset


Eligibility Criteria:
Inclusion Criteria:

* at least 19 years of age hemiplegic stroke patients
* Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset
* Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,
* A person who understands and voluntarily participates in this study and signs a research agreement

Exclusion Criteria:

* User of artificial heartbeat
* Patients with claustrophobia
* Patients with metal implants
* Patients who are contraindicated for other common MRI
* Patients with mild motor impairment with an FMA score of 80 or higher
* Patients whose conscious state is coma and who have no response at all
* Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease
Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia.

Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events.

The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
* ASA physical status classification I, II, III
* Body Mass Index \>35kg/m2
* Fluent in English

Exclusion Criteria:

* History of allergy to protocol medications
* History of chronic opioid use
* Pregnant patients
* Drop out: Conversion to an open surgical route, patient or surgeon request.
Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Able to sign a written consent form, understand, and agree to comply with requirements of the study.
* Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
* No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy.
* At least one measurable lesion as assessed by RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) PS ≤ 1.
* Adequate organ function as indicated by laboratory tests.

Exclusion Criteria:

* Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation).
* Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug.
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
* Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast).
* Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD

The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.

The primary objective of this study is to test the hypothesis that educating hypertensive chronic kidney disease (CKD) stage 3 and 4 patients on the benefit of a whole food plant based (WFPB) diet in the context of a 15-day educational program ("Jumpstart program") will lead to improved blood pressure control and will not increase rates of hyperkalemia.

Other objectives:

A) To test the effect of the Jumpstart program on degree of uptake on a WFPB diet via a 3 day food recall.

B) To test the effect of the Jumpstart program on other important outcomes in CKD in the following domains:

1. Body composition such as weight and body mass index (BMI).
2. Quality of life.
3. Laboratory tests including- serum levels of sodium, bicarbonate, chloride, Blood urea nitrogen, creatinine, calcium, phosphorus, magnesium, albumin, parathyroid hormone, fibroblast growth factor 23, lipids, C-reactive protein and erythrocyte sedimentation rate.

C) To test the effect of the Jumpstart program on quality of life in hypertensive CKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Subjects with CKD 3 and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but \< 60 ml/min for at least three months)
* Subjects with hypertension, defined as use of antihypertension medication:
* Lack of significant proteinuria ( subjects will have a 24 hour urine protein value of \< 500 mg or a spot protein to creatinine ratio of \< 0.5 or a microalbumin to creatinine ratio \< 300) within previous 3 months.
* Fluent in English language
* Able and willing to comply with the testing schedule and the meeting schedule of the Jumpstart
* Able and willing to comply with dietary advice of whole-food plant based diet given during the educational session
* Able and willing to give informed consent
* Must have computer/internet access to participate in virtual Zoom educational sessions (intervention group only)

Exclusion Criteria:

* Kidney disease requiring immunosuppressive therapy
* Diabetes mellitus
* Pregnancy
* Life expectancy \< 12 months
* History of solid organ transplant or anticipated solid organ transplant in next 2 months
* History of hyperkalemia: (two or more potassium levels ≥ 5.0 Meq/L or those requiring intervention for high potassium levels within the last six months)
* Subjects with malabsorptive syndromes
* Subjects with history of bariatric surgery or planned bariatric surgery in the next 2 months
* Subjects on warfarin
* Subjects with documented eating disorder at the time of consent
* Allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.)
* Following a vegan diet in the six months prior to consent
* Major surgery within 60 days prior to consent
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK

This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.

Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In addition, studies have shown that influenza infection is a known independent risk factors for rejection. Considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.

Using the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza vaccination and of various infections including influenza H1N1 will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* Subject defined as acceptable in the CPRD GOLD.
* Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).

Exclusion Criteria:

• Subject from HES matched to more than one subject in the CPRD GOLD.
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.

Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 \[Day 0\]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.

The trial was terminated before any patient reached month 12.

Eligibility Criteria:
Inclusion Criteria:

* Type I or type II diabetes with HbA1c≤10%
* Visual impairment due to a diabetic macular edema
* Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

Exclusion Criteria:

* Inflammation or infection in one eye
* Women of childbearing potential without an efficient contraception, pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply
Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

Exclusion Criteria:

* Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.