cyrilzakka/clinical-trials huggingface dataset:
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years
* Chronic HBV infection (serum HBsAg detectable for \> 6 months)
* Serum HBeAg positive with HBV DNA \>10\^6copies/mL (or \>20,000 IU/mL),orSerum HBeAg negative with HBV DNA \>10\^5copies/mL (or \>2,000 IU/mL)
* Serum ALT must be \> 2 x ULN but below 10 x ULN

Exclusion Criteria:

* Steroid treatment or immunosuppression 3 months prior to entry.
* Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
* Active lung disease or history of interstitial lung disease.
* Hb\< LLN or, and ANC \< 750/mm3 or , and platelet count \< 75,000 mm3 ,or WBC\<3000/mm3 .
* Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
* Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
* Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
* History of thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply
Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Several drugs and chemotherapies seem to have an impact on the hepatological system. This study investigates reports of hepatological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the hepatological system and are responsible of a wide range of hepatological diseases and side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare hepatological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 04/02/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease

An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.

There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.

The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).

Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.

Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.

The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 8 years- female and male patients
* Heart-rate exercise tolerance test planned in the usual patient's follow-up
* Congenital heart disease: single ventricle with Fontan circulation or bicavo-bipulmonary bypass or systemic right ventricle or pulmonary failure

Exclusion Criteria:

* Chronic or acute intercurrent respiratory disease
* In exclusion period in relation with another trial or for
* Participation to another study
* Patient doesn't benefit from an insurance disease regimen
* Pregnant woman or breast-feeding, law-protected person, vulnerable person
Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis

The aim of this study is to investigate the effects of 6-week physiotherapy and rehabilitation programs involving different 'Proprioceptive Neuromuscular Facilitation' (PNF) techniques in patients with knee osteoarthritis on pain, proprioception, postural control, muscle strength, range of motion and knee functions

The results obtained from this study will contribute to the selection of PNF technique which is most suitable for physiotherapies working on knee osteoarthritis in clinics as well as demonstrating the efficacy of PNF which has been studied in the literature very few times.

As a result of this study, the evidence value of the PNF technique will be determined in the physiotherapy and rehabilitation program of patients with knee osteoarthritis, and the efficacy of this technique, which is theoretically adopted, will be demonstrated scientifically. It will also determine the most ideal of the two PNF techniques to be applied in patients with knee osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 45-65
* The diagnosis of stage 1-2 osteoarthritis by the orthopedist
* Volunteerig for research
* No hearing, vision and speech impediment

Exclusion Criteria:

* Patients with intra-articular contracture,
* No Meniscus and no ligament problems
* Presence of any neurological or cardiopulmonary disease that may affect the results of the study
Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy

To compare the effects of Kinesio taping and compression garmets on the upper extremity lymphedema,functional disability and quality of life after mastectomy.

The study's primary goal was to find the effects of Kinesio taping and compression garments on the upper extremity lymphedema following mastectomy. This aim was realized through the current study results, the findings of the current study showed that Kinesio taping and compression garments were equally effective on the upper extremity lymphedema following mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* • Age (45 years-75 years)

  * Patients with edema after 1-year mastectomy
  * Unilateral lymphedema
  * Arm circumference change (Arm circumference unilateral than 2 cm or less than 8 cm in comparison with the other side was included)
  * Functional disability or limited movements (shoulder, arm, and hand)

Exclusion Criteria:

* • Active disease leading to swelling

  * Patients on medications, especially diuretics
  * Allergy
  * Infection
  * Pregnancy
  * Heart and kidney diseases
  * Bilateral lymphedema
  * Skin diseases
  * Cellulitis.
Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer

To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

This study include a multi-center, randomized, parallel controlled clinical trial. The randomized clinical trial will enroll approximately 320 patients. Participants will be randomly divided into experimental (n=160) and control groups (n=160). Patients in the experimental group was treated with first-line scheme + compound kushen injection. Patients in the control group will receive first-line scheme. The primary endpoint is PFS. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Eligibility Criteria:
Inclusion Criteria:

① Patients with advanced CRC confirmed by pathology or cytology and receiving first-line therapy;② Aged ≥ 18 years old, male or female;③ ECOG score 0-2 points;④ Expected survival ≥ 3 months;⑤ According to RECIST1.1 criteria, at least one detectable lesion;⑥ Voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up.

Exclusion Criteria:

* Combined with other malignant primary tumors;

  * Immunohistochemistry/polymerase chain reaction/second-generation sequencing results suggest MSI-H/dMMR patients;

    * Patients with recurrence and metastasis within 6 months after radical tumor surgery;

      * Patients who have previously or are undergoing cancer immunotherapy ; Patients undergoing radiation therapy;

        * Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ Psychiatric patients; ⑦ Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ Patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ Patients who are known to be allergic to or intolerant of study drugs.
Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent

Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group and Everolimus platinum chrome stent treated group.

Drug eluting stents (DES) leave a permanent metal implant that interferes with vasomotion, endothelial function and vascular remodeling. the rigid structure and the pharmacological properties of DES could overcome acute complications related to balloon dilation and late complications related to in-stent restenosis. However, they do not restore normal arterial function after the procedure.

Drug eluting balloons (DEB) offer an alternative to the implantation of a durable material. They release a transient antiproliferative drug. They promise potential advantages over DES as:

* an ad integrum restitution of the endothelium and its vasomotor properties.
* a reduction of late thrombosis risk.
* the possibility of grafting on the treated segment.
* avoid the problems of side-branch trapped in the treatment of bifurcations.
* improve the profitability of non-invasive imaging (coroscanner, magnetic resonance imaging) during patient follow-up.

DEB is validated for the treatment of in-stent restenosis, especially focal and on small caliber arteries. The use of DEB in de novo lesions has been the subject of several studies. This therapeutic option should be evaluated in the Tunisian context The aim of this clinical trial is to compare the results of angioplasty by DEB (SEQUENT PLEASE) versus last generation DES: coronary stent system in platinum chromium alloy with everolimus elution (Promus Premier and Promus Elite) The Primary endpoint: late lumen loss at 12 months. The Secondary endpoint: the major cardiovascular event rate (MACE).

Eligibility Criteria:
Inclusion Criteria:

* Patients with silent ischemia, stable angina, unstable angina, or non-Q wave myocardial infarction.
* a de Novo lesion on a never treated native artery.
* A reference artery diameter between 2 mm and 4 mm.

Non-inclusion criteria

* Patients with STEMI in the acute phase or presenting a cardiogenic shock.
* Patients with an allergy or a contraindication to double anti-platelet aggregation.
* Pre-menopausal patients not using regularly an oral contraceptives or breast-feeding .
* Patients with severe comorbidity or with an estimated survival of less than 12 months.
* Dissected lesions or spontaneous dissections other than grade A or B requiring DES angioplasty.
* In-stent restenosis.
* Thrombotic lesions.

Exclusion Criteria:

* None
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
* Participants must have HbA1c of ≥7.0 and ≤10.0%.
* Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
* Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).

Exclusion Criteria:

* Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening.
* Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening.
* Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
Interstitial Lung Disease in Early Rheumatoid Arthritis

The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.

Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 90 years
2. Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
3. Able to read, speak, and understand English
4. Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time

Exclusion Criteria:

1. Subjects who do not meet all inclusion criteria
2. Pregnant women
Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy induced nausea and vomiting.

Chemotherapy induced nausea and vomiting (CINV) is a difficult to treat and potentially debilitating complication of chemotherapy. Nausea and vomiting are one of the most prevalent and problematic side effects associated with chemotherapy treatment, effecting numerous patients.

Autonomic nervous system (ANS) and the vagus nerve are important modulators of nausea and vomiting and are responsible for conveying visceral sensory information to the central nervous system responsible for nausea and vomiting. The aim of the study is to determine if stimulating a branch of the vagus nerve in the outer ear would reduce the frequency and severity of nausea and vomiting for patients undergoing chemotherapy treatment.

Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy which would be applied for maximum of 5 days at the onset of inpatient admission for moderate to severe emetogenic chemotherapy cycle. They will then cross over to the other group (active vs sham) during the admission of the following identical chemotherapy cycle. Nausea, vomiting, the need for additional antiemetic support and potential side effects will be monitored during the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are scheduled to be admitted for chemotherapy administration and who will have at least one additional cycle of the same chemotherapy
* Chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy

Exclusion Criteria:

* Significant developmental delays that would prohibit participation
* Infection or severe dermatological condition of ear
* Uncontrolled or severe infection
* No implanted electrical device is permitted
* Pregnancy
* Severe cardiopulmonary disease
* Diagnosis of hemophilia or other bleeding disorders
* Diagnosis psoriasis vulgaris
Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy

Surgical treatment is the most effective way to achieve effective and sustainable weight loss in patients with obesity and to improve the comorbidities caused by it.

Although minimally invasive bariatric surgical procedures are applied today, postoperative pain is one of the most basic problems. Opioid-derived drugs used for pain control cause respiratory depression and constipation. Enhanced Recovery After Surgery (ERAS) protocols recommend reducing opioid use after bariatric surgery to help patients have a healthier postoperative period.

Different methods such as transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are used to reduce the postoperative opioid dose and for effective pain control. While these methods are effective in controlling somatic pain, they have no effect on visceral pain.

It has been shown that patients' pain and opioid consumption decrease especially after celiac plexus block. Vagal and sympathetic afferent stimuli from the gastrointestinal tract, on the other hand, stimulate the vomiting center and cause nausea and vomiting. Paragastric neural block is a new method performed by injecting local anesthetic into the posterosuperior paragastric area in the area covering the left gastric artery by revealing the esophagogastric junction, proximal stomach, middle of the stomach, distal antrum, hepatoduodenal ligament and stomach posterior along the border of the lesser omentum. In this way, it is aimed to prevent both visceral pain and the symptoms of nausea and vomiting.

In our study, the investigators aimed to evaluate the efficacy and safety of paragastric nerve block applied during laparoscopic sleeve gastrectomy by comparing it with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of over 35 and an obesity-related comorbidity,
* Body mass index of over 40,
* Patients who underwent laparoscopic sleeve gastrectomy,
* ASA risk score of 2-3,
* Agreed to be included in the study.

Exclusion Criteria:

* Chronic pain disorder or using gabapentin,
* Opioid addicts,
* Using anticoagulant drugs,
* History of previous upper gastrointestinal system surgery,
* Surgical complications during or after surgery,
* Hepatic or renal failure,
* Moderate or severe cardiovascular or respiratory disease,
* Allergy to the local anesthetic agent to be applied for the block,
* Limited cooperation,
* More than one surgical intervention in the same session,
* Allergy to the drugs to be used in the postoperative treatment protocol.
Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis

The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.

67 patients with sepsis were enrolled in this study. On admission, PCT was measured together with serum creatinine, urea, and other inflammatory markers. Quick Sepsis-related Organ Failure Assessment was calculated at the emergency department. Patients were classified into those with Acute kidney injury (AKI) and non-AKI groups.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients with sepsis

Exclusion Criteria:

* Patient known to have End-stage kidney disease
* Patients on Renal replacement therapy
* patients without procalcitonin level within 24 hours from admission.
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
* Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
* No clinical or radiological evidence of nodal or distant metastasis(es).
* In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
* Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
* No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
* No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
* No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is \> 80%.
* Patient signed informed consent.
Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.

Background: The purpose of this study is to investigate the clinical effects of moxibustion for treating diabetes peripheral neuropathy.

Hypothesis: Subjects who have participated in the moxibustion treatment will have greater improvement in people with diabetes with signs and symptoms of peripheral neuropathy than the control group after 8 weeks.

Design and subjects: A pilot randomized controlled trial. Subjects with diabetes peripheral neuropathy will be recruited from the community. 30 subjects will be randomized to moxibustion groups and control groups in a 1:1 ratio.

Interventions: Subjects in the moxibustion group will receive three times per week for 12 weeks; control groups will be allocated to the waitlist will receive no moxibustion treatments throughout the 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria.
* Proven peripheral neuropathy.
* Written consent with documentation that all participants received relevant information about this study is given to the patient.
* The participants must be willing and able to meet the planned visit and meet the planned schedule, including participation in the experimental investigations.

Exclusion Criteria:

* Health professionals' assessment makes the patient have medical or surgical diseases unsuitable to participate in the study.
* Pregnancy or breastfeeding for female patients.
* Competitive conditions that can cause peripheral neuropathy.
* Participants involved in the planning or execution of the study.