cyrilzakka/clinical-trials huggingface dataset:
Text Messaging for Supporting Quit Attempts

This study is a preliminary research aimed to compare the feasibility and effectiveness of motivational interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus on smoking cessation as the main outcome. Smokers patients have received brief interventions and nicotine replacement therapy during the hospitalization. After discharge smokers were allocated into a intervention or control arm. In the first and third months, after randomization, the patients were contact to smoke abstinence assessment.

Background: Research suggests that smokers who receive treatment inside the hospital and post-discharge follow up for at least a month are more likely to quit smoking than those who didn't receive any intervention. The current challenge is to know the best way to support post-discharge quit attempts in the Brazilian context. Objective: The aim of this study was to compare the feasibility and effectiveness of motivational interview (MI) plus Personalized text messages (TM) and usual care for support smoking cessation among post-discharge patients. Methods: All patients admitted to the University Hospital of Juiz de Fora (HU/UFJF), between 06/2015 to 01/2016, were asked about the cigarettes consumption in the last 30 days. Smokers patients received brief interventions and nicotine replacement therapy during the hospitalization. After hospitalization discharge smokers were allocated into a intervention or control arm. The intervention group received a singular MI session by phone and mobile phone TM twice a day during eight or fifteen days. The control group received only usual care available inside the hospital. Results: At the first and third months, after randomization, the patients were contacted for smoke abstinence assessment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Smoked cigarettes in the last 30 days (even a puff)
* Have own mobile phone
* Have received at least one text message in the last year
* Have no problem with the mobile phone signal

Exclusion Criteria:

* Don't have a mobile phone
* Unstable cognitive or physical condition
* Physical or breath contact restrictions
* Intensive care units
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T)
* Age 18 years - 55 years
* Treatment according to German Multicenter Trials for adult Acute Lymphoblastic Leukaemia (GMALL) 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL
* Written informed consent
* Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
* Negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

* Patients with Philadelphia chromosome (BCR-ABL) positive ALL
* Severe comorbidity or leukaemia-associated complications
* Known hypersensitivity to asparaginase
* History of severe pancreatitis
* History of thrombosis or pulmonary embolism
* Pre-existing clinically relevant coagulopathy
* Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
* Bilirubin \> 1.5 x Upper Limit Norm (ULN)
* Other current malignancies
* Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
* Body mass index \> 30 kg/m²
* Known pregnancy, breast feeding
Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients

The aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma.

Hepatic dysplastic nodules (DNs) include high grade dysplastic nodules (HGDNs) and low grade dysplastic nodule (LGDNs), their incidences are high in patients with liver cirrhosis. Once diagnosed, all latest versions of the major guidelines recommend enhanced follow-up, and no treatment would be provided until the diagnosis of hepatocellular carcinoma (HCC) is established during the follow-up.

While on the other hand, mounting evidence shows that DNs have relatively high transition rate to progress to HCC. In 154 patients with chronic hepatitis and cirrhosis, Kobayashi et al. reported the annual transition rate of 20% for patients with HGDN and 10% for patients with LGDN. The 5-year cumulative transition rate from HGDN and LGDN was 80.8% and 30.2%, respectively. Even regenerative nodules (RNs) without dysplasia evolved into HCC in 12.4%.More recently, Sato et al. studied 68 large regenerative nodules (LRNs) and 20 DNs from 1,500 consecutive nodular lesions; the 50-month transition rate was 13.6% in LRNs and 40% in DNs. Earlier studies support these findings.

Adenomatous polyps are accepted precursors to colorectal cancer (CRC) and removed to prevent cancer. Compared to the above transition rates, A recent cohort study estimated that the average annual transition rate from advanced adenoma to CRC in men was 3.1%,so the 5-year-transition rate was around 15%. Since the transition rate of hepatic DNs is much higher than the colorectal adenomatous polyps, is "enhanced follow-up" really the best choice of the treatment?

So in this proposed clinical trial, we hypothesize that for hepatic DNs discovered in patients with chronic hepatitis B, early minimally-invasive ablation treatment will decrease the incidence of HCC.

Recruited patients will be divided in to two groups randomly, in the "Observation group", patients will be followed-up and receive no therapy; while in the "Ablation group", the DNs will be ablated by minimally-invasive ablation therapies, including RFA, PEI, MWA, etc. All patients will be followed-up according to the AASLD guideline. Then the incidence of HCC of the two arms will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HBV
* Diagnosis of hepatic dysplastic nodule(s) be confirmed by biopsy.

Exclusion Criteria:

* concurrent HCV infection
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
Topical Application of AS101 for the Treatment of Psoriasis

This protocol relates to a phase II randomized double blind, placebo controlled study of the AS101 topical application for the treatment of mild to moderate Psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Patient have a diagnosed mild to moderate stable plaque type psoriasis (less than 10% of body skin surface).
2. Patient must be 18-70 years of age.
3. General health must be adequate to allow for compliance with the requirements of this protocol.
4. Patient or his/her legal guardian must sign an informed consent form prior to study participation.
5. Patient must be able and willing to comply with all protocol requirements.

Exclusion Criteria:

1. Patients who are mentally disabled or are otherwise unable to provide fully informed consent.
2. Pregnant or breast-feeding females.
3. Patients with evidence of an infection in the targeted zones.
4. Patients with known sensitivity to any of the drug components.
5. Patients treated by systemic anti psoriatic medications within one month prior to the initial treatment with the AS101, or topical anti psoriatic preparations within two weeks prior to the initial treatment with the AS101.
6. Patient with psoriatic arthritis.
7. Patients taking immunosuppressive drugs.
8. Immunocompromised patients
MonoPlus® in Orthopedic Surgery

Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery

This post-market clinical follow-up (PMCF) study on the use of MonoPlus®, a polydioxanone absorbable suture material, will expand the information available on the performance and safety of MonoPlus® used for orthopedic surgeries conducted in daily practice conditions.

The study is designed as a prospective, non-interventional, single-center, PMCF cohort study. The product under investigation will be used in routine clinical practice and according to the Instructions for Use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Need for orthopedic surgery
* Use of MonoPlus® for the orthopedic surgery in the routine clinical practice
* Written informed consent form.

Exclusion Criteria:

* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
* Prosthetic surgery secondary to infection
* Radiation to the surgical area
* Participation or planned participation in any clinical trial before study follow-up is completed
* Previous tendon/ligament repair intervention
* Pregnancy
* Patients with hypersensitivity or allergy to the suture material
* Patients taking medical consumption that might affect wound healing.
Study to Examine Pain Relief With Supplemental Intrathecal Morphine in TKA Patients

This is a prospective, randomized, double-blinded, placebo-controlled study designed to examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and (2) a retrospective assay for endocannabinoids on previously collected specimens.

This is a prospective, case-controlled randomized, double-blinded, placebo-controlled study expected to enroll up to 100 patients scheduled to undergo unilateral total knee arthroplasty (TKA) under regional anesthesia (defined as intrathecal spinal + femoral nerve blockade + femoral nerve catheter for post-operative analgesia) at Stony Brook Hospital. The patients were randomized to receive either IT morphine 0.2 mg (Group 1) or placebo (Group 2) in combination with their standard-of-care spinal anesthesia. Post-operatively, the patients were given an intravenous patient-controlled analgesic opioid for breakthrough pain.

Only the pharmacist preparing the drug/placebo has knowledge of how each subject was randomized. Study staff completed multiple questionnaires regarding subjects' pain scores and patient disability from pain to assess changes between different study periods (ie. pre-operative, post-operative and follow up). Biological samples were also taken from each subject to measure and analyze differences and changes in endocannabinoid levels.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral TKA under regional anesthesia
* ASA Class 1, 2 or 3
* Able to give informed consent
* Able to understand English

Exclusion Criteria:

* Medical condition(s) that prevents use of regional anesthesia (e.g. infection at site of injection, coagulopathy, severe hypovolemia, severe aortic or mitral stenosis, increased intracranial pressure, severe spinal deformity, spinal cord hardware or stimulator implanted)
* Allergy to morphine
* Morbid obesity (BMI \> 45)
* Respiratory compromise (difficult airway, severe emphysema or COPD)
* Obstructive sleep apnea (only if diagnosed in a sleep disorders clinic and CPAP was prescribed)
* Chronic pain with opioid usage over 100 mg morphine-equivalents po/day
* History of abuse of opioids or other drugs of abuse
* Scheduled for bilateral TKA
* Revision of knee arthroplasty
* Any medical condition that would affect the patient's ability to metabolize or excrete the study drugs (e.g. chronic kidney failure with patient on dialysis) or other medical condition that in the investigator's opinion would render the patient unsuitable for this research study
Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea

The objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea.

A Randomized Control Trial study will be directed at Riphah International University Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist the patients. Patients will be enrolled according to the pre-characterized criteria. Sample size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The patients of one group will recieve exercise therapy and patients of other group will recieve high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be assessed following a month of treatment . Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences version 20.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed instance of primary dysmenorrhea
2. Age somewhere in the range of 18 and 30 years,
3. A history of lower stomach torment for in excess of 6 periods.
4. Moderate or serious torment, with a numeric rating scale (NRS) score ≥5 out of 10.
5. No elective treatment including TENS inside multi month before enlistment in the investigation; and
6. Provision of educated agree preceding enlistment in the examination.

Exclusion Criteria:

1. Pregnant or Breastfeeding,
2. History of medical procedure of the lower midsection,
3. Heart sickness,
4. Cancer,
5. Severe mental problems.
6. Those who couldn't utilize TENS, for instance, in view of a lasting pacemaker or skin infection.
Hemodynamic Response After Six Months of Sildenafil

The purpose of this study is to determine the clinical, functional and hemodynamic response after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension is a chronic devastating disease. There are few approval oral treatments. Sildenafil, a phosphodiesterase 5 inhibitors, has been recently approved for patients on functional class II and III showing hemodynamic benefits after 12 weeks of treatment. Long term hemodynamic evaluation after sildenafil treatment has not been evaluating in pulmonary arterial patients on functional class II to IV.

The protocol has been designed to evaluate patients on functional class II to IV from baseline conditions and after 6 months of sildenafil treatment (50 mg po TID). Clinical (functional class), functional (walked distance-6 minute walking test) and Hemodynamic evaluation is planned to be performed at baseline and after 6 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years old with Pulmonary arterial hypertension according with WHO hemodynamic definition,
* Who signed informed consent,
* Able to swallow tablets and follow instructions.

Exclusion Criteria:

* Patients with pulmonary hypertension with other categories than pulmonary arterial hypertension (associated to COPD, lund diseases, sleep apnea, thromboembolic disease, hight altitude), patients asymptomatic, patients who were responders to adenosine during hemodynamic test, patients treated with specific treatments for pulmonary arterial hypertension before started the study such as sildenafil, prostanoids, endothelin receptors blockers.
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers

The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with normal renal function.

The results will determine whether or not a dose adjustment should be recommended when treating patients with asciminib who have impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male or sterile / post-menopausal female
* BMI between 18 and 36 kg/m2, body weight greater than or equal to 50 kg and no more than 120 kg
* Adequate venous access for blood sampling
* For healthy volunteers: subject must be matched to at least one renal impaired subject by age (+/- 10 years), body weight (+/- 20%) and gender
* For renal impaired subjects: documented stable renal disease without evidence of progressive decline in renal function (stable renal disease is defined as no significant change, such as, stable aGFR \< 90, for 12 weeks prior to study entry)

Exclusion Criteria:

* women of child-bearing potential / pregnant / nursing
* contraindication or hypersensitivity to any drug or metabolites from similar class as asciminib or to any excipients of the study drug
* cardiac or cardiac repolarization abnormality
* history of psychiatric illness within the past 2 years
* history of acute or chronic pancreatitis
* subject on dialysis
* smokers (use of tobacco products in the previous 3 months) and not willing to abstain from using tobacco during the study
* any surgical or medical condition altering the absorption, distribution, metabolism or excretion of drug
* history of immunodeficiency diseases, including a positive Human Immunodeficiency Virus (HIV) test result at screening
* chronic infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) at screening
* donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
* use of the following drugs within 28 days prior to dosing: drugs that prolong the QT interval; CYP3A4 inhibitors and inducers; BCRP, UGT and PgP inhibitors and inducers

Other protocol-defined inclusion/exclusion criteria may apply
Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block

In this prospective randomized controlled observer-blinded study we aimed to compare the efficacy of a single operator technique so called Jedi Grip and conventional technique requiring double operator in ultrasound guided axillary brachial plexus block.

Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively enrolled. Patients were randomly assigned to Group C (conventional technique) or group J (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and musculocutaneous nerves. Parameters such as performance time and the number of needle passes were recorded during procedure. Subsequently, a blinded observer evaluated and recorded parameters related to the success of blockage. The main outcome variable was performance time and success rate (surgical anesthesia).

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective hand, wrist and forearm surgery

Exclusion Criteria:

* hepatic or renal failure, serious cardiac or pulmoner disease, local or systemic infection, sepsis, coagulation disorder, neurological, muscular or psychiatric disease, body mass index (BMI) below 18.5 or above 35, drug and substance abuse, pregnancy, refusal of regional anesthesia, history of allergy to local anesthetics, mental-motor retardation (inability to consent or assess the visual analog scale(VAS) pain score), preoperative long-term NSAIDs or opioid use and prior surgery in the axillary regions.