cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial

The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:

Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?

Participants will:

be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients of moderate to severe plaque psoriasis Biologically naive patients

Exclusion Criteria:

* Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.
Study to Compare 2 Formulations of LY900014 in Healthy Participants

The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

- Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)

* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

* Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss within the last 3 months
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
* Smoke more than 10 cigarettes per day
* Are infected with hepatitis B or human immunodeficiency virus (HIV)
* Are taking illegal drugs
The Role of Pain-related Fear in Sexual Pain

The purpose of this study is the evaluate the extent to which an intervention aimed at reducing pain-related fear affects sexual function and pain sensitivity compared to usual care.

The overarching goal of this work is to identify the mechanisms underpinning sexual pain in women. Women with sexual pain exhibit higher vaginal pain sensitivity and lower levels of sexual desire and arousal compared to pain-free women. As a result of pain, sexual intercourse is avoided. Previous work in this area has examined a wide variety of interventions for sexual pain but has not examined how vaginal pain sensitivity and resulting sexual dysfunction may be mediated by pain-related fear. The study team proposes that a standardized exposure intervention that directly targets pain-related fear will in turn reduce vaginal pain sensitivity and translate to clinically meaningful changes in sexual function. The study team will assign women with sexual pain to receive a home-based, patient-controlled exposure intervention or standardized home-based home program. The specific aims of this proposal are: 1) To evaluate the extent to which pain-related fear mediates vaginal pain sensitivity in women with sexual pain; 2) To evaluate the extent to which graded exposure translates to changes in sexual function and partner dynamics. The completion of this work will provide us with a better understanding of the mechanisms underpinning sexual pain and specifically, how pain-related fear influences vaginal pain sensitivity and sexual function.

Eligibility Criteria:
Inclusion Criteria:

* Females with sexual pain \>= 6 months
* Appropriate to use vaginal dilators
* The ability to read English and understand the informed consent form and screening questions
* The ability and willingness to follow all requirements of the study including following all directions and completion of daily pain reports
* Signed informed consent
* Are sexually active (have had intercourse at least twice in the last 30 days)
* Pain-related fear of intercourse greater than 50 on the numerical fear rating scale

Exclusion Criteria:

* Physical, psychological and medical issues, encountered during routine care that are felt insufficient for trial participation (physician discretion), such as poor mental status or neurological deficit limiting participation physically or cognitively (Mini-mental state exam less than 20).
* Women with sexual pain who are not sexually active (have not had intercourse at least twice in the last 30 days)
* Participants who use narcotic pain medication
* Participants diagnosed with a major depressive disorder
* Participants who exhibit signs and symptoms of infection, malignancy, or other conditions identified by a member of the study team that may be contraindications to the use of dilators
* Unable to readily access computer with Internet for reporting on daily fear levels and dilator size
* Pain-related fear of intercourse less than 50 on the numerical fear rating scale
* Women who are pregnant
* Participants who report a history of sexual abuse or trauma.
Down Syndrome, Physical Activity and Sleep Apnea

To realize a sleep phenotyping in a population with Down syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome.

Sleep disorders are widely observed in the Down's syndrome population, due to a number of risk factors, and can become established in early childhood. Diagnosis of sleep disorders in Down's syndrome is difficult and often delayed, which can contribute to poor health in children with Down's syndrome. Phenotyping sleep characteristics in this Down Syndrome population will enable early identification of the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic.

Eligibility Criteria:
Inclusion Criteria:

* Total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21

Exclusion Criteria:

* People with abnormal electrocardiographic tracings,
* Existence of heart failure or cardiovascular disease, as determined by any abnormalities in cardiovascular adaptations to exercise.
* Existence of a declared or uncontrolled progressive disease.
* pregnant or breast-feeding women.
Denosumab vs Alendronate After Vertebroplasty

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Whether denosumab was non-inferior than alendronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs alendronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Must be age between 50 and 85 years old

  * X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
  * Bone mineral density T value less than -1 via dual-energy X-ray
  * A recent fracture history less than 6 weeks
  * MRI show bone marrow edema of fractured vertebrae
  * low back pain, local paravertebral tenderness

Exclusion Criteria:

* Must be able to have no intervertebral fissure

  * Must be able to have no infection
  * Must be able to have no malignancy
  * Must be able to have no neurological dysfunction
  * Must be able to have no previous use of anti-osteoporosis drugs
  * Must be able to have no inability to perform magnetic resonance imaging
  * Must be able to have no prior back open surgery
  * Must be able to have no other established contraindications for elective surgery
Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults

The aim of this study is to identify genetic loci,or gene variations contributing to the development of coronary artery disease (CAD) in Chinese young adults. Investigators will compare coronary angiogram results to genetic findings within young CAD patients.

During last 10 years, the rise in coronary artery disease (CAD) prevalence in Chinese young adults is observed and percutaneous coronary intervention (PCI) is generally considered to be low operative risk in these young patients. Genome-wide association studies have identified a considerable number of common genetic variants related to CAD. However, the extent to which these genetic variants are related to the future cardiovascular events, the prevalence, extent, severity, and prognosis of young patients with CAD is not clear.

The aim of this study is to investigate the genetic loci, or gene variations contributing to the development and prognosis of CAD in Chinese young adult. Investigators will compare the angiogram results to genetic findings first in patients with different stages of CAD. Then, investigators will collect patients from hospital discharge registry, and compare long-term outcome as well as on operative details in different gene groups.

The results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.

Eligibility Criteria:
Inclusion criteria:

1. premature CAD, includes patients who aged ≥ 18 and ≤ 45 years , and with at least one main coronary artery stenosis ≥ 50% confirmed by coronary angiography, involving left main coronary artery, left anterior descending branch, left circumflex branch or right coronary artery, and manifested as occult CAD, stable CAD, unstable angina pectoris, non-ST segment elevated myocardial infarction and ST segment elevated myocardial infarction;
2. mature CAD, refers to patients who aged ≥ 65 years and meat the same CAD diagnostic criteria as above;
3. age matched individuals who had coronary arteries without obvious stenosis.

Exclusion criteria:

1. severely sick with limited life-expectancy \< 1 year;
2. patients with malignancies;
3. pregnant or planning for pregnancy.
Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis

The stool color scale was set in 2018 in the health books of French children. The study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.

The first part of the study consist in send a questionnaire to health professionnal to see their use of the stool color scale in the health book of newborn.

The second part of the study is to see the age of children with cholestasis at the date of the first consult with a specialist.

Eligibility Criteria:
Inclusion Criteria:

* cholestasis

Exclusion Criteria:

-
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.

This is a phase 1/1b open label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) in adult subjects with selected advanced solid tumors. TPST-1120 will be administered as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors. This trial is composed of dose escalation and dose expansion cohorts.

Eligibility Criteria:
Inclusion Criteria

* Eastern Cooperative Oncology Group performance status of 0-1 at enrollment
* Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
* Have at least one measurable lesion according to RECIST v1.1
* Subjects with the following histologies are eligible and who are refractory to, have failed, are intolerant to, are ineligible for standard therapy, or for which no standard therapy exists are eligible: Part 1 (Dose Escalation- Monotherapy): RCC, NSCLC, CRC, metastatic castration resistant prostate cancer (mCRPC), cholangiocarcinoma, TNBC, pancreatic cancer, HCC, gastroesophageal cancer, squamous cell carcinoma of head and neck (SCCHN), urothelial bladder cancer (UBC), and sarcoma (liposarcomas and leiomyosarcomas); Part 2 (Dose Escalation-Combination with nivolumab): RCC, HCC, and cholangiocarcinoma; Part 3 (Dose Expansion-Monotherapy): RCC, HCC and cholangiocarcinoma; Part 4 (Dose Expansion-Combination with nivolumab): HCC.

Exclusion Criteria

* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
* Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
* For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy:

  1. Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
  2. Any unresolved irAE \> Grade 1 with prior immunotherapy treatment.
* Symptomatic, untreated or actively progressing central nervous system metastases
* Have received fibrates within 28 days before first dose of investigational agent
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)

Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.

Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy

In concurrence with chemotherapy, radiotherapy will be delivered as follows:

* First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions
* Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.

In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic

Chemotherapy schedules allowed:

1. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
2. Concurrent part: (day 1 = first day of radiotherapy)

   * cisplatin - vinorelbine
   * cisplatin - docetaxel
   * cisplatin - etoposide
   * cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles

When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven NSCLC
* IUCC stage I-III, or solitary metastases (\<6), which are amendable for radical local treatment.
* Performance status 0-2
* IMRT technique

Exclusion Criteria:

* Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
* Stage IV, except for solitary (\<6) metastases
* Performance status 3 or more
* No IMRT technique
Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting

The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.

Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline.

Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date.

Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye.

Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards.

Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nAMD
* Patients with ≥18 years of age at index
* Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
* Signed informed consent

Exclusion Criteria:

* Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
* Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
* Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
* Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
* Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
* Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
* Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
* Patients participating in parallel in an interventional clinical trial Note: if a patient experiences an adverse event (AE), they may still be recruited in another study following this AE if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
* Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

* Determine the growth inhibitory effects of opioid growth factor (\[Met\^5\]-enkephalin) in patients with advanced unresectable pancreatic cancer.

Secondary

* Determine the pharmacokinetics of this drug in these patients.
* Determine the quality of life of patients treated with this drug.
* Determine the pain control, depression, and nutritional status of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive opioid growth factor (\[Met\^5\]-enkephalin) IV over 45 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 weeks during study treatment, and at the completion of study treatment.

Patients are followed weekly for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
Inclusion criteria

* Diagnosis of pancreatic cancer
* Advanced, unresectable disease
* Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or fluorouracil) for pancreatic cancer
* Measurable disease by radiography
* Age Over 18
* Performance status Karnofsky 50-100%
* Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* WBC ≥ 3,500/mm\^3
* Hemoglobin ≥ 8.5 g/dL
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 4.0 mg/dL (stents allowed)
* PT or INR ≤ 2 seconds over control OR ≤ 1.8 (unless on warfarin) renal \& metabolic
* BUN ≤ 30 mg/dL (hydrated)
* Creatinine ≤ 2.0 mg/dL
* Sodium ≥ 130 mmol/L
* Potassium ≥ 3.2 mmol/L
* Glucose 60-300 mg/dL
* Pulse 60-110 beats/minute
* Systolic blood pressure 90-170 mm Hg

Exclusion Criteria

* No primary CNS tumors or known brain metastases Cardiovascular
* - congestive heart failure
* symptoms of coronary artery disease
* cardiac arrhythmia
* poorly controlled hypertension
* myocardial infarction within the past year
* abnormal EKG
* asthma
* hronic obstructive pulmonary disease
* pregnant or nursing
* Fertile patients must use effective contraception
* serious infection requiring antibiotics within the past 2 weeks
* poorly controlled diabetes
* seizure disorders
* fever \> 37.8° C
* other malignancy within the past 5 years
* concurrent chemotherapy
* concurrent oral steroids
* concurrent radiotherapy
* Surgery within 4 weeks