cyrilzakka/clinical-trials huggingface dataset:
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine


Eligibility Criteria:
Inclusion Criteria:

* Evidence of lamivudine (LVD) resistance
* Subjects must have a history of previous LVD treatment at screening, and must have evidence of at least 1 LVD resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (M204V/I/S)
* Nucleoside- and nucleotide-naive, except for LVD, and had chronic hepatitis B (HBV) infection
* Compensated liver function and must have met ALL of the following criteria:International normalization ratio (INR) ≤ 1.5; Serum albumin ≥ 3 g/dL (≥ 30 g/L); Serum total bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)
* HBV DNA \> 1.72 x 10\*4\* IU/mL (approximately 10\*5\* copies/mL)
* Documentation of hepatitis B e antigen (HBeAg) positive and hepatitis B e antibody (HBeAb) negative status at screening
* alanine aminotransferase (ALT) ≤ 10 \* upper limit of normal (ULN) at screening
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
* WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Post menopausal is defined as:
* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product

Exclusion Criteria:

* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus, hepatitis C virus , or hepatitis D virus
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners were WOCBP
* Laboratory values out of protocol-specified range
Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease

The presence of a specific mutation in the gene known as B-RAF has been found in patients who have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be ascertained in peripheral blood samples of patients who have this disease and in a group of patients who have a similar chronic lymphoproliferative conditions such as splenic marginal lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis of Hairy Cell Leukemia and determine whether patients are in remission.


Eligibility Criteria:
Inclusion Criteria:

Patients over the age of 18 years -

Exclusion Criteria:

Patients less than 18 years in age or mentally defectives.

-
Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes

The aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment.

This is a quasi-experimental, longitudinal study. Identified youth and families will receive the intervention within the four study site clinic locations. Comparison group families will receive usual care. Each primary care study site will have designated Family Support Specialist, Clinical Care Manager and Child Psychiatry resources. The intervention includes an integrated care consultation which combines diagnostic evaluation, family assessment, and multi-disciplinary, team-based treatment recommendations, with follow-up community linkages and support, as indicated.

Eligibility Criteria:
Inclusion Criteria:

* Must be between ages 0 to 17.5 years
* Referred by primary care physician at one of these Cambridge Health Alliance clinics: Windsor Street Care Center, Broadway Care Center, Everett Care Center, Malden Family Medicine Center
* Referred youth must have a caregiver (a parent of guardian) who agrees to participate in the assessment and treatment process

Exclusion Criteria:

* 17.6 years or older
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects

An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* History of addiction, abuse, and misuse of any drug
* Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application
A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (\>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.

The study is a randomized controlled trial comparing three different treatments during four weeks:

1. Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)

   * Eat at regular hours; 3 main meals and 3 snacks
   * Eat in peace, chew the food properly
   * Peel all fruits and vegetables
   * Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum
   * Choose soluble rather than insoluble fibres
   * Avoid foods high in FODMAPs
2. Diet low in carbohydrates

   * 10 E% carbohydrates, 23 E% protein, 67 E% fat
   * Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables
   * No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits
   * No specific consideration about FODMAP content
3. Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment.

Pain/discomfort:

* Pain: Amitriptyline 25 mg. Increase to 50 mg if needed
* Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed
* Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed
* Pain with constipation: Linaclotide 290 microgram 1x1

Constipation:

* Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed
* Osmotic laxative (Macrogol (Movicol) 1x1
* Linaclotide 290 microgram 1x1 Diarrhea
* Loperamide 1x2 . Adjust dose if needed
* Cholestyramine 1x1. Increase ever 3-5 d as needed
* Ondansetron 4mg 1x1. Increase to 1x2-3 if needed
* Eluxadoline 100mg 1x2

Primary endpoint: IBS-SSS reduction \>50 points

Eligibility Criteria:
Inclusion Criteria:

* IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident

Exclusion Criteria:

* Heart, liver, neurologic or psychiatric disease or illness
* Serious gastrointestinal diseases
* Celiac disease
* Diabetes
* Other conditions or surgery that affects the gastrointestinal function
* Hyperlipidemia
* Food allergy or intolerance other than lactose
* Adherence to a specific diet
* Being pregnant or breastfeeding
* Previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient
Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.

Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.

In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).

However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects \[Foucher, 2007\]. Finally, the therapeutic results of rTMS are very modest whatever the study \[Daskalakis, 2008\]. Additional studies are therefore needed to optimize stimulation parameters.


Eligibility Criteria:
Inclusion Criteria:

Patients with resistant depressive disorders (Hamilton-17-item scale \> 22, failure ≥ 2 antidepressants) with at least one of the following criteria :

* venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included),
* therapeutic failure in PHRC national rTMS 2007,
* refusal to participate in the PHRC national rTMS 2007.

Exclusion Criteria:

* Bipolar disorders: type I or II,
* Depression with psychotic characteristics,
* Schizophrenia,
* Risky or harmful use of alcohol and/or an illicit psychoactive substance,
* Dependence on alcohol and/or an illicit psychoactive substance,
* Sick and hospitalized under duress or under legal protection (guardianship, curatorship),
* Contraindication to the practice of rTMS; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...),
* Contraindication to brain MRI,
* Pregnancy or breastfeeding in progress
* Resistance to Escitalopram
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
* Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

* Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
* Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
* Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer

This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.

Magnetic resonance-guided focused ultrasound (MRg-FU) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. In MRg-FU, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. MR is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. The focused ultrasound beam produces therapeutic hyperthermia (40-42°C) in the target field causing protein denaturation and cell damage.

Currently, there is no prospective clinical data reported on the use of MRg-FU in the setting of recurrent rectal cancer. Recurrent rectal cancer is a vexing clinical problem. Current retreatment protocols have limited efficacy. The addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. With recent advances in technology, the investigators hypothesize that MRg-FU is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Weight \<140kg
* Biopsy-proven recurrent rectal adenocarcinoma
* Assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases
* Assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy
* Prior pelvic radiotherapy
* Target lesion visible by MR
* Target lesion accessible for MRg-FU procedure
* Target lesion maximum dimension ≤ 6cm
* Able to communicate sensation during MRg-FU treatment

Exclusion Criteria:

* Abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
* Chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment
* Previous radiotherapy ≤ 6 weeks prior to enrolment
* Recurrent tumour involves small bowel
* Unable to characterize pain
* Pregnant / Nursing woman
* Orthopaedic implant along proposed MRg-FU beam path or at site of target lesion.
* Serious cardiovascular, neurological, renal or hematological chronic disease
* Active infection
* Unable to tolerate required stationary position during treatment
* Allergy to MR contrast agent or sedation
Docetaxel in Head and Neck Cancer

Primary Objective:

* Phase II: To determine the best treatment scheme (TPF vs. PF).
* Phase III: To compare the time to progression and the treatment failure at the 3 arms.

Secondary objectives:

* To evaluate the safety at the 3 arms.
* To compare the progression , overall survival and locoregional control at the 3 arms.


Eligibility Criteria:
Inclusion Criteria:

* Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.
* Inoperable tumor after revision by a multidisciplinary oncology team.
* Proved epidermoid carcinoma.
* ECOG = 0-1
* Good hematologic function (i.e, hemoglobin \> 10 g/dl, ...)
* Good hepatologic function
* Good renal function

Exclusion Criteria:

* Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.
* Nasopharynx, nasal cavity and paranasal sinusitis will be excluded
* Previous chemotherapeutic or radiotherapeutic treatment for this disease.
* Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma
* Symptomatic peripheral neuropathy
* Other clinical severe diseases
* Concomitant treatment with corticoids within 6 months prior to inclusion.
* Concomitant treatment with any other neoplastic therapy
* Previous treatment for current disease.
* Loss of weight greater than 10% within the last 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Post Excision/Mohs Scar Laser Resurfacing

The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.

The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser.

There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.

Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form.
* Must be male or female and aged \>18 years at the time of consent.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Patients undergoing skin excisions of the face/trunk/extremities.

Exclusion Criteria:

* Inability to provide voluntary informed consent
* Use of laser or light based treatments to affected areas in past year
* Fitzpatrick Skin types 3-5
* Surgical lesions located on the central chest
* History of keloid formation
* History of Accutane in the last six months
Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.

Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.

Eligibility Criteria:
3.1 Inclusion Criteria

To be eligible for this trial, patients must meet all of the following criteria:

* Have confirmed acute, symptomatic, first lower extremity proximal DVT and/or PE that is NOT associated with a transient risk factor.
* Have completed an initial treatment course of oral anticoagulant therapy for 3-12 months and have a recommendation from their provider to continue anticoagulation indefinitely.
* Have the capacity to understand and sign an informed consent form.
* Be 18 years of age and older.
* Under the direct care of a healthcare provider for treatment of VTE for the length of time in the study.

3.2 Exclusion Criteria

If a patient meets any of the following criteria, he or she may not be enrolled in the study:

* Creatinine clearance (CrCl) \< 30 mL/min as determined by Cockcroft-Gault formula documented within 3 months from date of consent
* Significant liver disease (Child-Pugh B or C)
* Concomitant use of medications that are strong P-glycoprotein or CYP3A4 inducers/inhibitors
* Another indication for chronic therapeutic-dose anticoagulation, such as atrial fibrillation (i.e., rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily, would not be appropriate therapy)
* A clinical indication for a specific anticoagulant regimen (e.g., warfarin with a target INR of 2-3 is recommended for patients with 'triple-positive' antiphospholipid syndrome).
* Life expectancy \< 3 months
* Currently pregnant or breast feeding
* Unable / unwilling to pay for one (or more) of the treatment options
* Active Cancer defined as:

Diagnosed with cancer within the past 6 months; or Recurrent, regionally advanced or metastatic disease; Currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or A hematologic malignancy not in complete remission

• Unwilling / unlikely to agree to follow up
Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR
* At least 7 years of formal education
* MOCA score \>24

Exclusion Criteria:

* Diagnoses of SIADH, Diabetes Insipidus
* Substance dependence in the past 12 months, excluding nicotine dependence
* Current comorbid axis 1 psychiatric disorder
* Hypersensitivity or previous allergy to Vasopressin
* Serious medical or neurological illness which may interfere with assessment and administration of vasopressin
* Hypertension
* Impaired renal functions based on serum creatinine above 1.5
* Electrolyte imbalance
* Receiving ECT or has received ECT in the past 8 weeks
* Clinical history of mental retardation
* Pregnancy • Lactation
* Risk of harm to self or others
* Any significant nasal pathology which may hinder the intranasal absorption of the drug
* Hearing or visual impairment that significantly affects the comprehension and execution of the study