cyrilzakka/clinical-trials huggingface dataset:
Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study

The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?


Eligibility Criteria:
Inclusion Criteria:

Diagnosed as prostate cancer pathologically by prostate biopsy Evaluated as localized prostate cancer by imaging studies Prostate volume\>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging Gleason score≤ 4+3=7 Preoperative PSA\<20ng/mL Estimated survival\> 10 years； Informed consent is obtained from the patient

Exclusion Criteria:

The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.

Any contraindication of surgery or anaesthesia
Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis

This study is designed to find out the effectiveness of combination of ethanol extract of neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis.

Arsenic, a non-essential trace element, is a major water pollutant in Bangladesh. Arsenical keratosis, which occurs in the palm and sole, is a common symptom of arsenicosis. The objective of this study is to find the effectiveness of combination of topical administration of the ethanol extract of leaf of neem (Azadirachta indica), propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis. On the basis of inclusion and exclusion criteria, 30 patients of moderate palmar arsenical keratosis will be recruited from an arsenic affected area. They will be divided into two groups: study group and placebo comparator group. Each group consisting of 15 members. Study group will be given combination of ethanol extract of leaf of neem, propylene glycol (40%) and salicylic acid (10%) to apply on palm overnight once daily for 12 weeks. On the other hand placebo comparator group will be given salicylic (10%) acid to apply on palm overnight once daily for 12 weeks. Water and nail samples will be collected before starting recruitment to confirm arsenicosis. After conclusive recruitment of the subjects the objective, nature, purpose and potential risks and benefits of all procedures of the study will be explained in details to the patients and informed written consent will be taken from them. Detail history, clinical examination and photograph (palm) will also be collected. Clinical improvement will be assessed by measuring palmar nodular size on both hands, before starting treatment and after 12 weeks completion of treatment and perception of patients about their improvement. The study will explore the effectiveness of topical use of combination of ethanol extract of neem, propylene glycol and salicylic acid for the treatment of palmar arsenical keratosis.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years
* Palmar arsenical keratosis
* Drinking arsenic contaminated water (\>50 µg/L) for more than six months
* Patient voluntarily agree to participate

Exclusion Criteria:

* Pregnancy and lactating mother
* Skin lesion :Psoriasis and eczema
* Bowen's disease
* Any kind of systemic disease, inflammatory disease and infectious condition that affect skin (Diabetes mellitus, Rheumatoid arthritis, Systemic lupus erythematosus , Hepatitis and Tuberculosis)
* Hypersensitivity to any drug
* Patient who received treatment within last three months
Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive)
* Measurable disease (breast and/or lymph nodes)
* No prior surgery other than biopsy and no prior chemotherapy or radiation therapy
* Age ≥18 years and age ≤70 years
* Karnofsky Performance score ≥70%
* Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
* In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study)
* Her2/neu receptor analysis performed on the primary tumour in the biopsy material
* Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

* Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy \> grade 2 whatever the cause
* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
* Evidence of distant metastases (M1)
* Patients with a history of breast cancer
* Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception
Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip

The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic value of using LigaSure in gastric surgeries will be appraised.

In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited.

Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients who will undergo a Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation)
* Patients with a BMI between 40-60

Exclusion Criteria:

* Patients under 18 years of age
* Patients participating in other competing research protocol(s)
* Patients for whom electrosurgery is contraindicated
* Patients unable to tolerate general anesthesia
* Patients who are pregnant
* Patients unwilling or unable to provide informed consent
* Patients who have undergone significant upper GI surgery leading to adhesion formation, as determined by the Principal Investigator.
Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea

The prevalence of sleep disorders has achieved epidemic proportions in Western countries. Despite this, assessment and treatment of sleep disorders remains infrequent, unattainable, and often costly. Dayzz is aware of the need for easily accessible, user-friendly, and affordable treatment strategies for known sleep conditions. This research proposes a randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app which assesses and manages insomnia and CPAP adherence in persons with sleep apnea. The app's sleep training protocols recommend life-style and behavioral changes and tracks these changes with the aim of improving sleep and well-being. In this study, the dayzz app digital treatment protocol will be compared to the standard treatment for these sleep conditions by a sleep professional.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21-65 years of age referred to the Carmel Hospital sleep clinic and diagnosed by the clinic physician with either Sleep Apnea (referred for CPAP treatment) or Insomnia.

Exclusion Criteria:

* Patient age \<21 years.
* Patient who is not a member of Clalit Healthcare services.
* Persons with insufficient control of the English language required for adequate use of app.
* Persons with insufficient experience/knowledge and/or use of digital apps/smartphones.
* Persons with serious medical or psychiatric conditions.
* Women who are pregnant or breastfeeding.
* Nighttime shift-workers.
* Persons who are unable to provide consent due to mental incapacity.
* Persons referred for evaluation of sleep by Ministry of Transportation (for licensing purposes).
* Persons with comorbid insomnia and sleep apnea
Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization

Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.

At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.

The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.

The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* First IVF cycle;
* With normal ovarian reserve(FSH \< 10 mIU/mL; antral follicle count\>5);
* With normal uterine.
* PCOS women according to Rotterdam criteria

Exclusion Criteria:

* Pre-implantation genetic diagnosis cycles;
* Oocyte donation or sperm donation cycles.
Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.

Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
* Total score of greater than or equal to 60 on the LSAS
* Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities

Exclusion Criteria:

* Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
* Eating disorder within the 6 months prior to study entry
* History of organic brain syndrome, mental retardation, or other cognitive dysfunction
* Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
* Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
* Suicidal thoughts
* Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
* Significant personality dysfunction
* Serious medical illness or instability for which hospitalization may be likely within the next year
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA\<38weeks


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who admitted for induction of labor
* Bishop score \<= 6

Exclusion Criteria:

* Contraindication to induction of labor
* Active labor
* Vaginal bleeding, unknown origin
* Hypersensitive to Prostaglandin E
* History of asthma, glaucoma
* Infection (birth canal)
* Placental abruption
* Multiparity(\>5)
* Pelvic inflammatory disease
* Heart, lung, kidney disease
* Multiple pregnancy
* Major anomaly
* Fetal distress before induction of labor
The Relationship Between the Differential Expression of FosB Protein in Laryngeal Cancer Tissues and Clinical Prognosis

To determine whether there is statisstical difference in FosB (FBJ murine osteosarcoma viral oncogene homolog B) protein expression between laryngeal cancer tissue and adjacent tissue through immunohistochemistry methods.

If there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. ultimately analyze whether it is related to the expression of FOsB in laryngeal cancer tissue and adjacent tissues

First,the investigators will collect 100 to 200 cases of laryngeal cancer patients who have been finally diagnosed and treated in our institution in the past five years. Laryngeal cancer pathological tissues and adjacent tissues will be selected to make pathological sections. Use immunohistochemistry to confirm the differences in FosB protein between laryngeal cancer tissues and adjacent tissues, and clarify whether there are differences.

secondly,if there are differences, further the investigators will collect relevant patients information,such as clinical stages, pathological types, clinical prognosis and so on. Review the clinical data of corresponding patients, including age, gender, smoking and alcohol history, clinical stages, pathological types and clinical prognosis, etc., and compare whether there are statistical differences.

Finally, clinical prognostic data of relevant patients were collected through outpatient follow-up, online and telephone follow-up, to determine whether there is a correlation between Fosb expression in laryngeal cancer tissue and clinical prognosis.

Eligibility Criteria:
Inclusion Criteria:

* laryngeal squamous cell carcinoma was diagnosed ,and biopsy was confirmed by two pathologists;
* Primary tumor of Laryngeal ,and there was no distant metastasis;
* Standard treatment such as surgery and Preliminarily-diagnosed parients;
* full clinical and pathological data information and good follow-up;
* there was no previous fatal diseases such as complicated tumors.

Exclusion Criteria:

* Secondary cancer or cancer with distant metastasis;
* Patients who have not seen a doctor for the first time or have received surgery or radiotherapy or chemotherapy in other hospitals;
* Clinical and pathological data were missing and loss to follow-up;
* Patients who abandoned treatment or standard treatment procedures has not been completed;
* The past medical history of other lethal diseases such as complicated tumors.
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates

The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological intervention on the mitigation of nociception-specific responses to a skin breaking procedure in term and preterm neonates. Such responses will be measured using behavioral measures as well as with electroencephalography-based methods.

Eligible neonates who are 36-56 weeks post-menstrual age and who are scheduled to undergo a clinically required heel lance will be studied after obtaining appropriate verbal and written consent from the respective parents. Subjects will be monitored during a baseline resting state, during vibratory stimuli alone, and during a heel lance that is randomized to be preceded or not preceded by the vibratory stimulus. The sessions will include time-locked video recordings and electroencephalography using a specialized net of 128 electrodes (Electrical Geodesics Inc., EGI; Eugene, OR). Behavioral and cortical responses will be then be analyzed in a blinded fashion to determine the efficacy of the vibratory intervention, as well as to validate what behavioral responses are most correlated with nociception-specific cortical activity.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal Intensive Care Unit patient
* Between 36 to 56 weeks post-menstrual age
* Medically stable
* Due to have a clinically required bedside heel stick as part of their routine care

Exclusion Criteria:

* Congenital anomalies or abnormalities affecting the brain
* Patient is over 4 months corrected age
* Infants who receive analgesics or sedatives within 72 hours prior to assessment
* Administration of maternal analgesics or sedatives to which the infant may be exposed
Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation

Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.


Eligibility Criteria:
Inclusion Criteria:

* End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
* Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
* Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study

Exclusion Criteria:

* Receiving or having previously received an organ transplant other than a kidney
* Cold ischemia time of the donor kidney \> 24 hours
* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
* Significant liver disease
* Receiving a graft from a hepatitis C or B positive donor
* Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
* Subject has malignant tumor
* Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
* Subject with a high immunological risk
Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.