cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries

Study to investigate and determine the difference between the extent and severity of intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients with no adhesion barrier inserted.

Hypothesis: Due to the preclinical safety data and clinical case reports in various indications it is anticipated that the surgical sites where the resorbable anti-adhesion barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control group with no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal cancer, ulcerative colitis or other pathologies requiring a second surgery for ileostomy closure.
* Age between 18 and 78 years.
* Patient or his/her legal representative has read and signed the approved Informed Consent form before randomization.

Exclusion Criteria:

* Previous abdominal operation through a midline approach
* Use of hernia mesh
* Use of any antiadhesive irrigants or irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs.
* Pregnancy
Age-Related Changes in Myosin Heavy Chain Composition in Human Orbicularis Oculi Muscle

Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. We believe that understanding the age-related histomorphometric changes in orbicularis oculi muscle is important for improving the current rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this topic has never been performed before, simply because it is difficult and dangerous to perform needle biopsy on orbicularis oculi muscle.

Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral orbicularis oculi muscle can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and determines the maximum contraction speed of the muscle fiber. Therefore, The composition of MHC isoforms represents the composition of different types of muscle fiber.

These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After electrophoresis and staining, bands of different types of MHC can be visualized. The gel is scanned and processed with an image analysis system. The density of each band can be determined, and the ratio of the different types of MHC can be calculated.

By dividing the subjects who had their orbicularis oculi muscle sampled during upper blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC subtypes composition ratios can be compared among the different groups. Therefore, the age-related changes of the composition of different muscle types can be concluded.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving blepharoplasty

Exclusion Criteria:

-
Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted.

This is an investigational study. The FDA has approved each of these drugs for the treatment of low-grade lymphoma. The combined use of these drugs for Waldenstrom's macroglobulinemia is investigational, although each drug has been effective by itself for this disease. About 50 patients will take part in this study. This study will take place only at UTMDACC (outpatient basis).

Before the study starts, patients will have a complete exam. Blood and urine tests will be done. A bone marrow test, a chest x-ray and a CT scan of the abdomen will be done if not studied recently.

Blood tests will be repeated after 14, 21, and 42 days. Provided the disease has responded, another bone marrow sample will be taken to confirm remission. X-rays may be repeated for the same reason.

The patient or a family member will be taught to inject 2CdA under the skin three times a day for 7 days. The patient will also take cyclophosphamide by mouth twice each day. Rituxan will be given by vein once weekly for 4 weeks after a test infusion on the day prior to the first injection. A second course of the 3 drugs will be given about 6 weeks after the start of the first course. All patients with improving disease will then be followed without further treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with symptomatic macroglobulinemic lymphoma are eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven small lymphocytic lymphoma or chronic lymphocytic leukemia and monoclonal IgM. Also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia.
2. Patients must have adequate liver function (bilirubin \<2.5 mg%) and renal function (creatinine \<2.0 mg%).

Exclusion Criteria:

None.
Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected)

Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study

Hypothesis:

AZVUDINE has a therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2.

Goals:

Main goal:

To evaluate the efficacy and safety of AZVUDINE (FNC) in patients infected with SARS-COV-2, in a mild stage;

Specific objective:

To assess the clinical outcome of mild-stage SARS-CoV-2 infected participants treated with AZVUDINE (FNC) versus placebo

Statistical planning:

Statistical description: all statistical tests are performed by bilateral testing. A significance level of 5% will be adopted.

Baseline analysis: including subject distribution, data demographics, and baseline analysis.

Eligibility Criteria:
Inclusion Criteria:

Individuals who present the following characteristics will be included in this study:

1. Age ≥18 years, regardless of gender;
2. Fluorescence RT-PCR test result of respiratory or blood samples must be positive for COVID-19, or viral gene sequencing of respiratory tract samples must be highly homologous to COVID-19; Individuals with COVID-19 must meet the diagnostic criteria in the "latest version of clinical guidelines for COVID-19" issued by the World Health Organization (WHO) on June 4, 2020;
3. Symptomatic patients who meet the case definition for COVID-19, according to WHO, without evidence of bacterial pneumonia or hypoxia (Sat O2 \< 95%) P. \[score 1-3\];
4. Voluntary participation and signing of the informed consent form.

Exclusion Criteria:

Individuals who present one or more of the following characteristics will not be eligible to participate in this study:

1. Know or suspect that you are allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
2. Individual presenting shortness of breath and Sat O2 \< 95%; or any other symptom requiring treatment through hospital admission;
3. Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);
4. Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);
5. Patients with a history of renal insufficiency (glomerular filtration rate \< 60mL/min/1,73m2);
6. Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;
7. Individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically;
8. Total neutrophil count \<750 cells/L;
Treatment Of Supracondylar Fractures Closed Reduction And Circular Ring External Fixation Versus Open Reduction and Internal Fixation

Patients treated with circular external fixation will have better outcomes (as measured by range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and internal fixation (ORIF).

The purpose of this study is to compare patients who undergo ORIF versus circular external fixation for supracondylar humerus fractures in children ages 12-18. We are asking parental permission to collect information about their child's injury, x-rays, obtain ROM measures, collect input from questionnaires, and review other medical information relating to the injury.

The study is NOT about randomizing subjects to treatment, rather we are asking permission to keep track of the decisions that are made about our population's treatment and how it impacts their recovery.

The eligibility criteria is subject's between 12 and 18 years, if supracondylar/periarticular humerus fracture needed operative fixation, and the fracture is unable to be treated with percutaneous skeletal fixation. Patients will be excluded if they have had a previous elbow injury, Osteogenesis imperfecta or another fragile bone disease, elbow stiffness from another cause, or any pre-existing arm weakness.

The outcome measures all enrolled subjects will complete are the QuickDASH and the Pediatric and Adolescent Outcomes Instruments (PODCI). The QuickDASH is a shortened version of the DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure which is intended to measure symptoms and functions in people with musculoskeletal disorders of the upper limb. The QuickDASH is valid and reliable and is used for clinical and research purposes. The PODCI is designed to assess patients overall health, pain and ability to participate in normal daily activities in patients under 19 years of age. We will only distribute both questionnaires to the subjects and we are not collecting parent perception.

Eligibility Criteria:
Inclusion Criteria:

* 12 and 18 years old
* Supracondylar/periarticular humerus fracture needed operative fixation
* Fracture is unable to be treated with percutaneous skeletal fixation.

Exclusion Criteria:

* Any previous elbow injury
* Osteogenesis imperfecta or another fragile bone disease
* Elbow stiffness from another cause
* Any pre-existing arm weakness.
Effect of Long-term Psoriasis on Patients' Life - CORONATE

Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants.

Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months.

There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI\<10 with involvement of sensitive areas) since at least 10 years.
* Adult partner in relationship with the participant since at least 3 years(Part 2 only).

Exclusion Criteria:

- Participants with psychiatric conditions.
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy


Eligibility Criteria:
Inclusion Criteria:

* Homozygous S sickle cell disease
* Diagnosed by newborn screening
* determined to have persistent microalbuminuria
* satisfied criteria for microalbuminuria screening
* parental consent

Exclusion Criteria:

* Asymptomatic bacteriuria on screening urine cultures
* On Hydroxyurea therapy
* Pre-existing complications of SCD which would meet local criteria for HU therapy
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

To assess the long-term safety and efficacy of erenumab.

This was a multicenter, 52-week, open-label study designed to assess the long-term safety and efficacy of erenumab in adults with chronic migraine. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study. Enrollment occurred within 14 days after the parent study's week 12 visit.

The initial dose used in the study was erenumab 70 mg every month (QM). The protocol was subsequently amended to increase the dose to erenumab 140 mg QM (Protocol Amendment 2). Participants who had already completed the week 28 visit (ie, midpoint of the study) at the time of Protocol Amendment 2 continued to receive open-label erenumab 70 mg QM for the remainder of the study. Participants who enrolled but had not completed the week 28 visit at the time of Protocol Amendment 2 increased the open-label erenumab dose from 70 mg QM to 140 mg QM at the next visit. All participants who enrolled after Protocol Amendment 2 received open-label erenumab 140 mg QM throughout the study.

Participants may elect to participate in a separate clinical home use (CHU) substudy to assess subjects' ability to self-administer 140 mg of erenumab for in-home use using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pens). Enrollment in the 12-week substudy occurred at either week 12 or week 40 of study 20130255. Participants were randomized to self-administer erenumab using either the PFS or AI/pen on CHU days 29 and 57 at home.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures
2. Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is appropriate for continued treatment.

Exclusion Criteria:

1. Development of any unstable or clinically significant medical condition, laboratory or electrocardiogram (ECG) abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.
3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study
Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.


Eligibility Criteria:
Inclusion Criteria:

* female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old≤age≤35 years old,take a long protocol or super-long protocol,18≤BMI≤25, menstrual regularity(periodic change \< 7 days)

Exclusion Criteria:

* Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥2.0 cm, and/or Uterine fibroids located within the endometrium≤1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea
Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.

The inclusion criteria included:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function.
2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
4. Patients should be expected to live no shorter than 1.5 months

The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
4. Patients should be expected to live no shorter than 1.5 months

Exclusion Criteria:

1. Patients receiving other anti-cancer drugs;
2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
3. Patient with inadequate Blood system,liver function and renal function.
4. Brain metastasis is of symptoms
5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
6. Chronic enteritis or intestinal obstruction
7. Bone marrow failure
8. Mental disease difficult to control
9. Participated other clinic trial within 3 months
10. Pregnant or lactation patients
11. The researcher evaluate the patient is not suitable for this trial.
Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL

Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrated clinical benefit (SD, PR, or CR) on clinical trial protocol IGM-2323-001
* There is no adequate alternative treatment available for the patient.
* Provided consent to continue treatment on expanded access program.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to the first dose.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive.

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to mAb (or recombinant antibody related fusion proteins).
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of investigational product, or indicating patient would unlikely have potential benefit.
* Pregnant, breastfeeding, or intending to become pregnant during the program or within 2 months after the final dose of imvotamab.
* In the treating physician's judgement, the patient is unlikely to complete all procedures, including follow-up visits, or comply with the requirements for participation.
* Vaccination with live virus vaccines during treatment and for 3 months following the last cycle of Imvotamab.
Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea

This is an interventional and prospective study. The study is designed to evaluate the additional benefits of a combination of IPL treatment and local application of Bromonide 0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).

Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. In addition half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.

Eligibility Criteria:
Inclusion Criteria:

* patient (male or female) must be over 18 yaers old of age and fulfil one of the following:

  1. Suffer from ETR
  2. Suffer from PPR
  3. Suffer from a combination of ETR and PPR.

Exclusion Criteria:

* 1.Under 18 years old of age. 2.Pregnant women. 3.Systemic treatment of rosacea at the previous six months before enrollment. 4.Topical treatment of rosacea at the previous one month before enrollment. 5.Phymatous or occular rosacae.