cyrilzakka/clinical-trials huggingface dataset:
Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors

In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin. This study is to evaluate the role of computed tomography/MRI with contrast in assessing the deep surgical margin.

The patients of buccal mucosa squamous cell carcinomas after histopathological confirmation are selected for the study. As a routine computed tomography imaging/MRI with contrast will be done preoperatively.

The involvement of the skin is assessed by the palpation (skin pinch test). In imaging, the distance between the base of the tumour and the skin of the cheek is measured. If the distance between the base of the tumour and the skin is more than 5mm, then the skin is spared and the tumour is excised with 5 mm margin, if the distance is less than 5mm, then the skin is excised along with the tumour. The specimen will be sent for histopathological examination, and the depth of invasion of the tumour is measured and the clearance of the deep surgical margin is assessed.

The difference between clinical examination and imaging and histopathological confirmation of the specimen in determining the number of cases where skin preservation is done is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients of buccal mucosa squamous cell carcinomas of stage 1,2 and 3 are included in the study
* Patient of all age groups are included in the study
* Both males and females are included in the study

Exclusion Criteria:

* Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.
How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting

This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting.

Participants will use Feelee for 4 weeks, which means specifying an emoji each day and collecting the passive data on the background. The collected active and passive data will be discussed through the clinicians during the participants' weekly treatment sessions.

Participants will be subjected to a ABA baseline design: including a 2-weeks baseline phase (A), 4-weeks intervention phase (B) and 2-weeks follow-up phase.

During the baseline phase (A), participants will fill in a daily questionnaire that measures different aspects of their emotion regulation skills. The use of the Feelee app is not allowed yet. After 2-weeks, the intervention phase starts, meaning participants will use the Feelee app every day during a 4-weeks period. The use of the Feelee app includes specifying an emoji and collecting the passive data on the background. Furthermore, the collected active and passive data will be discussed through the clinicians during the participants weekly treatment sessions. Participants will also be continuing to complete the daily questionnaire. After 4-weeks, the follow-up phase starts. Participants need to remove the Feelee app and will follow their treatment as usual. However, participants still need to complete the daily questionnaire. After 2-weeks the follow-up phase and main study part has ended.

Throughout the ABA baseline, pre-measurement (T0), post-measurement (T1) follow-up measurement (Tf1) will be conducted before and after the intervention and during follow-up. Last, a 3-months follow-up will be conducted to identify possible long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* At the time of the study in treatment at a forensic outreach youth care organization.
* Expected to be in treatment for at least another 3 months.
* Using a smartphone with Android or IOS operating system.
* Have basic understanding about the use of a smartphone

Exclusion Criteria:

* Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide
* Insufficient understanding of spoken and written Dutch language.
* Adolescents without a smartphone.
The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality

Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. Hill et al developed a grading system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. One study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted to evaluate the relationship between dietary habit and GEFV abnormality. The investigators used a questionnaire regarding the dietary habit to the population undergoing EGD in a self-paid health examination.


Eligibility Criteria:
Inclusion Criteria:

* The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital.

Exclusion Criteria:

* None
Prednisone for Decompensated Congestive Heart Failure

We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.

Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with primary diagnosis of CHF
* Patients with normal cortical function
* LVEF \<40%
* Significant fluid overload, defined as ≥ 2 of the following

  * Enlarged liver or ascites
  * Peripheral or sacral edema ( ≥ 2+)
  * Jugular venous distention ≥ 10 cm
  * Pulmonary rales, pleural effusion on chest x-ray or orthopnea

Exclusion Criteria:

* Severe stenotic valvular disease
* Serum creatinine \> 4 mg/dl
* Patient refusal
* Any signs of infection or any condition that would contraindicate an glucocorticoids use
* Poor controlled hypertension
* Poor controlled diabetes mellitus
* Active myocarditis
* Malignancy or other terminal illness
SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

S-ICD (subcutaneous implantable cardioverter-defibrillator) has become the last years widespread in various pathological conditions and implantation rates are increasing each year worldwide. Previous to implantation it is mandatory to realize a screening in order to assess specific electrocardiographic vectors used to analyze cardiac rhythm. In routine practice, approximatively 10% of patients are recused for S-ICD device implantation due to failed screening 1-3. Causes are mainly abnormalities of R wave (low or high amplitude) and low R/T wave ratio. Determinants for screening failure have not yet been clearly studied. Moreover, it is a common finding in S-ICD implantation to find variations between pre-implant electrograms and electrograms recorded by the device. Variations of R wave amplitude and R/T ration are also observed with small variations of electrode positioning prior to implantation. It has been also shown that despite initial screening failure, S-ICD could be securely performed in some cases 4,5. Patients included in the study will undergo usual screening protocol. In case of failure a 2nd screening will be realize with slight electrode positioning variations compatible with S-ICD and lead placement. In case of success modality of implantation will be decided by physician.

In case of S-ICD implantation screening data will be compared to post implantation device electrograms. A 2 month follow-up will be performed with comparison of a new screening procedure with electrodes at the level of sub-cutaneous electrodes.

Eligibility Criteria:
Inclusion Criteria:

* The population will be composed of all patients referred for ICD method, aged over 18 years

Exclusion Criteria:

* Age \< 18 years old
* Patients who cannot freely give their consent, or patients who refuse to participate
SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease

The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years and older.
* Indication: Morbus Parkinson.
* Treatment with piribedil for the first time.
* Monotherapy with piribedil.
* Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs.

Exclusion Criteria:
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat \[ITT\] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus \[CMV\], human herpesvirus 6 \[HHV-6\], Epstein-Barr virus \[EBV\], JC virus \[JCV\], and/or adenovirus \[AdV\]) in order to evaluate efficacy in this broader population (ITT Population).

Eligibility Criteria:
Key Inclusion Criteria

Participants must meet all of the following criteria in order to be eligible to participate in the study:

* Male or female ≥1 year of age.
* Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
* Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count \>10,000/mm³ at the time of randomization.
* Diagnosed with HC based on the following criteria (all 3 criteria must be met):

  1. Clinical signs and/or symptoms of cystitis.
  2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
  3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
* At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.

Key Exclusion Criteria

Participants who meet any of the following criteria will be excluded from participation in the study:

* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent).
* Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
* Evidence of active Grade \>2 acute graft versus host disease (GVHD).
* Uncontrolled or progressive bacterial or fungal infections.
* Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
* Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
* Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
* Pregnant or lactating or planning to become pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effect of an Individualized Education Intervention on Pain Following Inguinal Hernia Repair Surgery

Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain but patients can be reluctant to take analgesics due to potential adverse effects such as nausea, vomiting or constipation. Patients may also be concerned about addiction to analgesics or they may believe that experiencing moderate to severe pain after surgery is to be expected.

The purpose of this study is to investigate the impact of an individualized education program regarding pain and management of adverse effects on pain after inguinal hernia repair surgery.

There is clear evidence that patients who have undergone ambulatory inguinal hernia (IHR) repair have significant pain following surgery. Inguinal hernia repair has been identified as one of the most painful ambulatory surgery procedures, with 98% of patients reporting pain 24 hours following IHR surgery, and 54% of patients experiencing moderate to severe pain in the first 72 hours. Despite experiencing continued pain, patients do not always take the prescribed analgesics. Analgesics are helpful in managing post-operative pain but may have adverse effects, including nausea, vomiting or constipation, which are often not managed. Almost half of all patients who undergo ambulatory surgery experience these adverse effects with 45% experiencing constipation and 46% experiencing nausea and/or vomiting in the first 48 hours after surgery.

As well, patients may have concerns about addiction, or asking for help to manage their pain and may believe that moderate to severe pain is to be expected, contributes to healing and therefore is to be tolerated following surgery. Patients are expected to manage this pain and adverse effects of analgesics at home. Minimal research has been found regarding interventions to manage pain following ambulatory surgery, and none found specifically for patients undergoing inguinal hernia repair.

The purpose of this trial is to investigate the impact of an individualized pre-operative pain education intervention that includes a booklet with telephone support pre-operatively and after discharge home versus usual care for patients having IHR surgery. The primary outcome will be worst pain on movement in the past 24 hours and the secondary outcomes will be pain related interference, pain quality, analgesic use and adverse effects, and patient satisfaction and concerns with pain management.

Eligibility Criteria:
Inclusion Criteria:

* male
* able to speak, read and understand English,
* have telephone access.
* are scheduled for a unilateral inguinal hernia repair.

Exclusion Criteria:

* patients scheduled for a repeat IHR on the same surgical side
* patients who have emergency surgery.
* patients undergoing bilateral inguinal hernia repair.
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)

This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.

Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.

No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, HIV seronegative adults at high risk of acquiring HIV infection
* Cannot have previously received an investigational vaccine

Exclusion Criteria:

* In a monogamous relationship with an HIV-1 seronegative partner for \> 1 year
* History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
* Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
* Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
* Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
* Known history of immunodeficiency
* History of malignancy (with some exceptions)
* Contraindication to intramuscular (IM) injection such as anticoagulant therapy or thrombocytopenia
* Female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through Week 30 of the study
* Male subject who is planning to impregnate or provide sperm donation through Week 30 of the study
* Previously received an investigational HIV vaccine
* Has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study
* Has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives
Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD)

This study will explore the relationship between changes in plasma cortisol and symptom reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating in an 8-week program of mindfulness-based stretching and breathing exercise. The investigators hypothesize that at the completion of participation in the 8-week program, exercise-induced symptom reduction will be associated with changes in cortisol levels.

This study will employ an intent-to-treat design to evaluate the relationship between exercise-induced posttraumatic stress disorder (PTSD) symptom reduction and exercise-induced changes in cortisol level. The participants consist of nurses and the intervention will be conducted at the Clinical and Translational Science Center of the University of New Mexico. The study was approved by the Human Research Protections Office of the university. Nurses who are screened positively for PTSD will be randomly assigned to either control or exercise group. At baseline and in weeks 4, 8, 12 and 16, immediately after the phlebotomy for serum cortisol, the investigators will ask the participants to rate the severity of their PTSD symptoms using the PTSD Checklist (PCL).

Eligibility Criteria:
Inclusion Criteria:

* employed as a nurse
* PCL-C score of at least 28 with at least a score of 3 on one or more items for inclusion in the PTSD symptomatic groups (EX and CON)
* PCL-C score of 27 or lower for inclusion in the non-PTSD symptomatic group (BASE).

Exclusion Criteria:

* the inability to complete the exercise program
* a positive answer to any of the seven screening questions on the Physical Activity Readiness Questionnaire (PAR-Q)
* current use of prednisone or other forms of cortisone medication excluding cortisone in inhaled form
Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)

The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.


Eligibility Criteria:
Inclusion Criteria:

* Be a current resident of France
* Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
* Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
* Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
* Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
* Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity
* If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening

Exclusion Criteria:

* Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
* Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
* Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) \> 6
* Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
* Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study