cyrilzakka/clinical-trials huggingface dataset:
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster

The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.

Primary Endpoint:

- Lesion assessment - Rash severity, in terms of rash counts

Secondary Endpoints:

* Pain assessment
* Clinical global impression
* Safety information of valacyclovir

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 20 to 80 years of age.
* Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash.
* Patients with zoster-related rash (rash severity is greater than or equal to mild).
* Patients are able to be enrolled into the study 72 hours from appearance of rash (for example, lesions or vesicles).
* Patients provided written informed consent.
* Patients who are able to complete all study visits per protocol.
* Men and premenopausal women must agree to practice a barrier method of birth control or the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted). Subject should be withdrew from the study if contraceptions are faild.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Patients with multidermatomal or disseminated HZ (greater than 20 lesions beyond the dermatomes adjacent to the primarily involved dermatome).
* Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
* Patients with history of impaired renal function, (e.g., calculated creatinine clearance less than 50 mL/min/1.73 m2)
* Patients are taking narcotic analgesic routinely for a chronic pain condition
* Patients are taking tricyclic antidepressants
* Patients who received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ
* Patients with immunosuppressive or immunodeficient condition resulting from:

disease (e.g., HIV) corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent \< 800 mcg/day), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation )

* Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study
* Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements
* Patients with history of allergy to valacyclovir hydrochloride and acetaminophen
* Patients are unlikely to adhere to protocol follow-up
Bed Rest After Preterm Premature Rupture of the Membranes

Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and neonatal outcomes in pregnancies complicated by premature rupture of the membranes.

Aims - To access the impact of bed rest in latency time to delivery, chorioamnionitis incidence and other maternal and neonatal outcomes in pregnancies complicated by PPROM, thus enabling proper sample size calculation for future powered RCT.

Study population and Sample size - Eligible patients included those with single pregnancies with PPROM at 24+0-33+6 weeks of gestation who were admitted to and delivering at our tertiary center. PPROM was diagnosed on the basis of patient's history and sterile speculum examination with visualization of amniotic fluid pooling in the vagina and/or leaking from the cervical canal. Exclusion criteria included indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress), fetal malformations, multiple gestation, and maternal immunosuppressive disease. Considering future sample size calculation based upon assumed differences between groups regarding latency and infection, we aimed a sample of 30 participants.

Randomization - A pilot unblinded randomized controlled trial (RCT) in a 1:1 allocation ratio between two groups (complete bed rest versus activity restriction after PPROM). Simple random allocation sequence was generated by the investigators and implemented by sequentially numbered sealed envelopes. Participants were enrolled by physicians after hospital admission and written informed consent was obtained before randomization. The trial was conducted in a single tertiary center of the Portuguese national health system after approval by its ethical committee.

Statistical analysis - An intention-to-treat analysis was performed with a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* single pregnancies AND
* PPROM at 24+0-33+6 weeks of gestation AND
* admitted to our tertiary center.

Exclusion Criteria:

* indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress)
* fetal malformations
* multiple gestation
* maternal immunosuppressive disease
Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment

Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.

One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.

A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.

On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.

In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.

At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 90 years old
* Patients exhibiting deficient KT and indicated for FGG procedure (28)
* Good systemic health with absence of active periodontal disease
* Plaque and bleeding index \<20%

Exclusion Criteria:

* Uncontrolled systemic disease
* Heavy smokers (\> 10 cigarettes per day)
* Restorations that cannot be removed for proper treatment
* Pregnant or lactant women
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects.

The second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in clinical studies;
2. Male or female, aged ≥ 18 years;
3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and/or metastatic HCC;
4. Child-Pugh liver function score ≤7；
5. No prior systemic therapy for locally advanced or metastatic and/or unresectable HCC；
6. At least 1 measurable lesion ；
7. Adequate organ function；
8. ECOG score of 0 to 1；
9. Life expectancy ≥ 12 weeks;

Exclusion Criteria:

1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；
2. History of serious allergic diseases；
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. History of severe cardiovascular diseases within 6 months;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy

Exclusion Criteria:

* Pregnant or lactating females
* Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.
Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine

The goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. The main questions it aims to answer are:

* compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population.
* construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients.

Participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. When necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Signing the consent of informedness;
2. Patients with breast mass who need surgery after examination;
3. Cardiac ultrasound indicates that the blood score of the heart is within the normal range;
4. ECOG≤0-2 points;
5. Oversure function is acceptable.

Exclusion Criteria:

1. Merge other malignant tumors such as gynecologic oncology;
2. After evaluation, the internal organs are not suitable.
CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery

The purpose of the study will be to compare the efficacy of single-injection interscalene block versus continuous interscalene block on the quality of recovery in patients undergoing outpatient arthroscopic rotator cuff repair surgery.

The participants will:

* Be randomized to receive either a single-injection interscalene block or continuous infusion via an elastomeric pump.
* Be monitored via telephone by the research team to complete the QoR-15 survey, assess pain levels, the need for tramadol use, and any complications.
* Have follow-up by the Acute Pain Unit during the first 3 days.

After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent.

Following surgery and placement of the interscalene block with a catheter, in the recovery unit, participants will be assigned to one of two groups according to a random number table, in a 1:1 ratio using block randomization (block sizes of 4, 6, and 8) through sealed envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years, \< 75 years) scheduled for elective outpatient arthroscopic rotator cuff repair surgery.
* Patients capable of managing a continuous outpatient regional analgesia system based on an interscalene block (eligibility criteria: able to understand verbal and written instructions, have home support, and live geographically close to the healthcare center).
* Willing and able to provide informed, written consent to participate in the study.

Exclusion Criteria:

* History of chronic opioid use (\>3 months).
* Severe comorbidities (e.g., renal or hepatic failure, ASA classification of 3 or higher).
* Allergy to local anesthetics, dexamethasone, or the analgesic drugs used in the study.
* Patients with contraindications for peripheral nerve block.
A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* A positive urine drug screen
* Pregnant or nursing females
Proteomics of Severe Traumatic Brain Injury: A Feasibility Study

The purpose of this study is to:

1. Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury
2. Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury
3. Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has GCS less than 9
* Patient requires intracranial pressure monitoring
* Patient life expectancy greater than 72 hours

Exclusion Criteria:

* Patient's TBI is greater than 24 hours old
* Patient is less than 18 years of age
* Patient does not require intracranial pressure monitoring
* Patient has life expectancy less than 72 hours
* Patient has GCS greater or equal to 9
* Patient is currently enrolled in another study
Sensory Perception After Thoracotomy

The study will investigate characteristics of chronic pain after thoracotomy


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease
Recovery and Rehabilitation After Lung Cancer Surgery

The specific aims of this translational, interdisciplinary, multi-center, international research study with 300 Lung cancer patients are to:

Aim 1 Explore how the patients experience the transfer between different locations and between different levels of care at the same location and how they experienced coming home.

Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time.

Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health related quality of life and social support.

Approximately 2500 patients are diagnosed with lung cancer annually i Norway, and approximately 400 of these undergo surgery. Many patients report that life after lung cancer surgery is difficult. After surgery, the patients are frequently transferred to a local hospital or to another level of care at the hospital where they were operated. The transfer is critical for patients' safety because communication failure is one of the most common causes of medical error.

Studies that have analyzed the quality of life of lung cancer patients after surgery reach different conclusions about the patients' Quality of life (QOL), some studies state that lung cancer patients are back to normal quality of life after 9 months, while others indicate that the patients still have reduced QOL two years after surgery. It is difficult to assess the reason for the differences in results as most of the studies used the same QOL questionnaire. Studies that have evaluated the social support that lung cancer patients receive indicate that lung cancer patients receive less support than other cancer patients.

Lung cancer patients have a wide range of physical problems (fatigue, dyspnea, coughing and pain) and psychological (depression) problems following surgery.

Based on findings from this literature review a need exist for improved postoperative follow-up of patients after surgery for lung cancer The proposed study will evaluate the social support, the levels of lung cancer stigma, symptoms and changes in this over time as well as evaluate patient experience with transfer in the immediate postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,

Exclusion Criteria:

* and who suffer no cognitive impairment.
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and histologically confirmed PDAC by biopsy
* Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter
* ECOG performance status 0-2
* Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis
* Lesions between 1 - 4cm in size

Exclusion Criteria:

* Patients that show evidence of distant metastasis
* Endoscopically non-accessible mass
* Pregnant patients
* Inability to provide informed consent
* Lesions \<1cm, or \>4cm in greatest diameter
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI

Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

Currently, there are two cardiovascular disease QoL scales which have been used in studies of patients with aortic stenosis - the Minnesota Living with Heart Failure (MLHF) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ).

The KCCQ has now become the only cited health related (HR) QoL validated scale for use among a growing TAVI (Transcatheter Aortic Valve Implantation) patient population; however questions on the KCCQ do not reflect the concerns and lifestyle of patients proceeding for aortic valve intervention. Many of the questions do not reflect this patient population's perspective of well-being in contrast to perceptions by the general cardiac population on which it was validated. It is important to capture the disruptions caused by a chronic disease and its treatment on lifestyles, activities, and interests; that is interference with psychologically meaningful activity. It has been noted that this interference varies by disease process and treatment by general scales such as the Illness Intrusiveness Scale .

Due to issues of limited validity of the KCCQ for TAVI / SAVR (Surgical Aortic Valve Replacement) patients related to symptom items not being revised from their original use for congestive heart failure, a new original HR-QoL questionnaire was proposed: The "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) is a health specific measurement tool designed to measure changes in quality of life in aortic stenosis patients. The aim of this study is to validate this questionnaire in this specific patient population.

Eligibility Criteria:
Inclusion Criteria:

* severe aortic stenosis
* age \> 18 years
* in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve

Exclusion Criteria:

* patients not providing informed consent
* patients with major cognitive impairment
* emergency patients
Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years old
* The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management \[5\]
* The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC)

Exclusion Criteria:

- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.