cyrilzakka/clinical-trials huggingface dataset:
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation

This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA \[direct-acting antiviral agent\] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.


Eligibility Criteria:
Inclusion Criteria:

* 3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
* Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
* Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

* Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
* Participants with Child Pugh B and C cirrhosis
* Participants with a history of prior direct-acting antiviral agent (DAA) therapy
* Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label
Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation

Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.

Soluble protein sST2 has recently become a prognostic biomarker in the context of acute myocardial infarction and chronic heart failure, and recent studies also show that sST2 is involved in acute rejection of the cardiac graft in recipients. Experimental studies confirm that the ST2 / IL-33 pathway is involved in the process leading to cardiac transplant rejection in animals. In particular, administration of IL-33 would have a positive effect on pre-clinical cardiac graft survival. No study have looked at the level of ST2 / IL-33 of the donor, with the purpose that it might reflect the condition of the transplanted heart and its initial level of Immune tolerance and maybe predict the risk of subsequent dysfunction.

In this non-interventional study, several blood samples will be taken on donors before organ procurement and on recipients prior to grafting, on day 7 and at the time of each myocardial biopsy (approximately 16 myocardial biopsies the first year). Serum level of sST2 and IL-33 will then be determined according to the ELISA method on each blood sample.

Fifty consecutive couple donors/ recipients will be included in the study. This number of subjects is calculated to detect a doubling of the donor sST2 level between the two recipient groups with 30-day mortality and without mortality (potency: 90%, alpha risk: 0.05, bilateral).

Eligibility Criteria:
Inclusion Criteria:

* Consenting recipients
* Consenting donors to organ/tissue donation for the purpose of scientific research

Exclusion Criteria:

* Non consenting recipients
* Non consenting donors to organ/tissue donation for the purpose of scientific research
* Multi-organ transplantation
Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* all adult recipient

Exclusion Criteria:

* massive blood transfusion
* grade III esophageal varices
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 or 1
* Advanced, histologically documented epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 12 months of treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
* History of receiving five or fewer prior chemotherapy-containing regimens for EOC, PPC, or FTC (including primary therapy)

Exclusion Criteria:

* Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks prior to Day 1
* Prior treatment with oregovomab (OvaRex(R)) or abagovomab
* History or clinical evidence of central nervous system or brain metastases
* Grade ≥ 2 peripheral neuropathy
* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
* History of clinically symptomatic liver disease, including viral or other hepatitis, history of or current alcoholism, or cirrhosis
* Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)
Open and Laparoscopic Hernia Repair. A Comparative Study

A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.

The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.

Eligibility Criteria:
Inclusion Criteria:

* All children within the age limit specified were included in the study

Exclusion Criteria:

* none
Just-In-Time Intervention to Reduce Alcohol-Facilitated Intimate Partner Violence Perpetration

Acute alcohol intoxication is a robust predictor of intimate partner violence (IPV) perpetration for young adult men and women; therefore, interventions delivered proximally to drinking episodes - a period of high risk - are needed to reduce alcohol-facilitated IPV. This project seeks to improve public health by delivering a just-in-time text messaging intervention proximally to drinking episodes and evaluating the impact of the intervention on alcohol-facilitated IPV in a sample of at-risk young adult men and women. Additionally, through an innovative design this project is poised to answer these important questions: whether receiving a message, when, for whom, what type, and under what conditions this just-in-time messaging intervention leads to reductions in alcohol use and IPV perpetration.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old
* Consumed alcohol an average of 2 times per week in last 3 months
* At least two instances of heavy episodic drinking in last month
* Currently in a romantic relationship
* History of IPV perpetration within last 3 months
* Willing to provide cell phone number and carrier and receive text messages for 30 days

Exclusion Criteria:

* None
Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as

1. compression and pulling forces through a customizable rigid brace
2. lumbar flexion by using a supporting air-belt.
3. three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
4. adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users

Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 10-13,
2. scoliosis with a Cobb angle larger between 10 -25 degrees;
3. No prior treatment
4. Pre-menarche or post- menarche by no more than 1 year
5. Ability to read and understand English or Chinese
6. Physical and mental ability to adhere to intelligent nighttime braces protocol

Exclusion Criteria:

1. History of previous surgical or orthotic treatment for AIS
2. Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
3. Contraindications for pulmonary and/ or exercise tests
4. Psychiatric disorders
5. Recent trauma
Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia

The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.

A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time.

Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective cesarean delivery

Exclusion Criteria:

* Patients unable to communicate in English
* Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
* Patients with contraindications to spinal anesthesia
* Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen
* Patients who have taken any pain medication in the past 24 hours
* Patients with a BMI \> 40
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 55 (inclusive)
* Clinical history of allergy to at least 1 of the foods contained in ADP101
* Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101

Exclusion Criteria:

* Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
* History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
* History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
* Severe asthma
* Mild or moderate asthma, if uncontrolled or difficult to control
* History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema
* History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
* History of cardiovascular disease, including hypertension requiring \> 2 antihypertensive medications
* History of interstitial lung disease
* History of celiac disease
* Active autoimmune disease that has required systemic treatment within 3 months
* Known malignancy that is progressing or has required active treatment within the past 3 years
* Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
* Prior/concurrent therapies as follows:

  * beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
  * regular steroid medication use
  * therapeutic antibody treatment currently or within the previous 6 months
  * any food immunotherapy currently or within the previous 12 weeks
  * In the build up phase of non-food immunotherapy
* Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
* Develops dose-limiting symptoms to placebo during the Screening DBPCFC
* Any other condition that might preclude safe participation in the study
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

The use of MDS to access the presence of melanoma in the skin.

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
* The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
* Male and female ≥ 21 years old.
* Subject is capable of giving written informed consent.
* Primary excision.

Exclusion Criteria:

* The lesion is less than 1 cm from the eyes.
* The lesion is on the palms of hands or soles of the feet.
* Mucosal lesion.
* Pregnant females.
* Low study procedure compliance.
* Patients who are mentally or physically unable to comply with all aspects of the study.
* Undergoing chemotherapy.
* Minor or legally incompetent and not able to sign the consent form.
* Patient previously tested by MDS and was diagnosed with melanoma during the study.
* Sensitivity to fluorescein
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19

Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions.

Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function.

Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

Objective is to evaluate prevalence of long-term respiratory complications after severe SARS-CoV2 pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient with with severe SARS-CoV2 pneumonia
* Patient consenting to participate to the study
* Patient enrolled in the national healthcare insurance program

Exclusion Criteria:

* Patient under 18 years
Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD20 positive mantle cell lymphoma;
* Patients with MCL-related symptomatic and need immediate therapy; Include any of the following: (1) Blastoid variant (2) Pleomorphic variant (3) Ki-67 ≥30% (4) Bulky mass \> 7 cm or ≥2 tumors, each ≥5 cm in diameter (5) Mutations in TP53, c-MYC or NOTCH genes (6) Size of spleen ≥20 cm (7) Lymphoma B symptoms (8) Mantle Cell International Prognostic Score (MIPI) \> 3 (9) Lymphoma threatening organ function (10) Elevated lactate dehydrogenase (11) Peripheral blood white blood cell \> 50×10\^9/L (12) Pancytopenia due to bone marrow involvement (13) Pain due to lymphoma;
* Patients received no prior anti-lymphoma treatment;
* At least one evaluable lesion according to 2014 Lugano criteria;
* Ann Arbor stage II-IV;
* Eastern Cooperative Oncology Group (ECOG) of 0-2;
* Life expectancy \> 3 months;
* Able to participate in all required study procedures;
* Proper functioning of the major organs: 1) The absolute value of neutrophils (\>1.5×10\^9/L); 2) platelet count (\> 75×10\^9/L); 3) Hemoglobin (\> 80 g/L); 4) Serum creatinine \<1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin \< 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \< 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) \< 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time);

Exclusion Criteria:

* Involvement of central nervous system (CNS)
* Patients with Hemophagocytic syndrome;
* Patients with active bleeding, bleeding tendency or require anticoagulation treatment;
* Patients require treatment with strong CYP3A inhibitors;
* Uncontrolled active infection, with the exception of tumor-related B symptom fever;
* History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
* Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
* Diagnosed with or receiving treatment for malignancy other than lymphoma;
* Pregnant or breastfeeding women;
* Other researchers consider it unsuitable for patients to participate in this study.
Black Tea Compresses for Facial Eczema and Perioral Dermatitis

Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the face and present a special therapeutic challenge. Topical corticosteroids that are commonly applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they may result in rapid atrophy of facial skin and in the long term rather aggravate facial dermatoses. Black tea compresses have been successfully used by German-speaking dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action is unknown but is presumably based on astringent properties of tannins in the black tea and on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally available and practically free of side-effects. Despite these perceived advantages the effects and tolerance of black tea compresses have not been formally studied to date. Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis over a period of 6 days each within the current trial. The disease activity will be assessed before, during and after completion of treatment using several clinical scores. In addition, side-effects, if any, will be documented.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of facial eczema or perioral dermatitis
* minimum age of 18 years
* patient is capable of granting informed consent
* patient is expected to comply with the trial treatment protocol
* for outpatients: close place of residence

Exclusion Criteria:

* initiation or increase of systemic immunosuppressive or antibiotic treatment necessary
* psychiatric disease or other factors making poor patient compliance probable
* participation in another clinical trial within the past 6 months