cyrilzakka/clinical-trials huggingface dataset:
Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy

The main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different groups: group A - rectal cleansing and disinfection of the needle tip vs group B - controls.

Prostate cancer is the most common neoplasm of solid organs in Brazil. Definitive diagnosis of the tumor is established through prostate biopsy, indicated in patients with elevated levels of PSA or suspicious rectal examination. The ultrasound or MRI-guided prostate biopsy is mostly performed through the transrectal route worldwide. Although it is a relatively safe procedure, transrectal prostate biopsy (TRUSB) can present several complications, such bleeding, acute urinary retention or infection. Infectious complications are an important concern for the urologist and have different presentation, ranging from isolated fever to severe sepsis. Antibiotic prophylaxis is an effective widely used practice, however, due to increasing rates of bacterial resistance, there is a growing trend in the incidence of infectious complications after TRUSB. Therefore, alternative strategies to decrease infections rates following biopsies are welcome. Our aim was to compare the infectious complications of intrarectal povidone-iodine cleansing associated to formalin disinfection of biopsy needle tip at prostate biopsy.

A prospective controlled study will be conducted enrolling 1152 consecutive prostate biopsies in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1: 1 ratio for two different groups: group A - rectal cleansing and disinfection of the needle tip vs. Group B - controls at transrectal ultrasound guided prostate biopsy. Patients will obtain a urine culture 48 hours after biopsy and complete a telephone interview 7 days after undergoing the procedure. The primary endpoint will be the rate of infectious complications, defined as 1 or more of the following events: fever ≥37.8 ºC; urinary tract infection (UTI) or sepsis (standardized definition). We will also evaluate the predictive factors of infectious complications

Eligibility Criteria:
Inclusion Criteria:

* Signature of the consent term;
* Agreement with the study follow-up protocol;
* Indication of biopsy due to increased PSA (\> 2.5), abnormal rectal touch or patients under active surveillance protocol

Exclusion Criteria:

* Existence of cognitive deficit that impedes the reading and comprehension of the EHIC;
* Allergy to ciprofloxacin or iodine
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.


Eligibility Criteria:
Inclusion Criteria:

1. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).

Exclusion Criteria:

1. Have been treated with:

   * immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
   * immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment).
2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
3. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
4. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
5. Current severe depression.
6. Pregnant or nursing (lactating) women.
7. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
8. A new diagnosis of diabetes
9. Positive testing for tuberculosis (QuantiFeron or chest X-ray).
10. Subjects with clinically significant cardiac abnormalities
11. Unable or unwilling to undergo multiple venipunctures
12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy

This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cerebral palsy(CP) with one or more affected sides.
2. Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log \< 2.5).
3. No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
4. No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
5. No injections of botulinum toxin type A or operations on the upper limb within 6 months.
Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

Currently there are few options for skin antisepsis, commercially antiseptic triclosan is mainly used. To have more options, this study is necessary, where investigators will determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and choose the one with the best characteristics for skin antisepsis.

2% chlorhexidine has been used as an antiseptic for invasive procedures, such as the skin preparation for surgery or insertion of intravascular catheters, thereby decreasing the incidence of infections. The preparation of the skin with antiseptics, helps mechanically clean the surface of the skin to be subjected to surgical intervention, removing fat, sweat, dead cells and kill bacteria that are in the skin. It has been shown that 2% chlorhexidine in solution with 70% isopropyl alcohol has greater activity than chlorhexidine in aqueous solution. The constant use of triclosan causes resistance of some microorganisms on some antibiotics.It has been shown that 0.5% of triclosan in 60% alcohol isopropyl chlorhexidine is more effective than alcohol. The aim of the study is to know if 2% chlorhexidine has more residual effect than triclosan 1%, both antiseptic diluted in 70% isopropyl alcohol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers
* Volunteers who have completed the stabilization phase of skin flora.
* Volunteers who does not taken a shower or bath 24 hours before the test.

Exclusion Criteria:

* Volunteers with a score below 100 Colony Forming Unit per square centimeter (CFU/cm2) of forearm skin surface in the control after the stabilization of the skin flora.
* History of skin allergies or atopy, as well as reactions to alcohol, soaps, iodine, chlorine or latex.
Vaginal Diazepam for the Treatment of Female Pelvic Pain

To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.

Women who are asked to participate will already be receiving a standard conservative therapy consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and Kegel exercises. Participants will randomly be assigned by a computer-derived random number sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam) or the placebo group Investigators and patients will be blinded to group assignment. The placebo or diazepam tablet will be distributed to the participant in the examining room on the day of allocation. The participant will be instructed to insert the diazepam or placebo tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal tablet 1-2 times daily as needed in addition to the standard conservative therapy. The placebo group will receive the standard conservative therapy, and an intravaginal tablet (visually indistinguishable from diazepam) commercially produced by the university pharmacy. After 4 weeks, patients from either group will have the option of enrolling into a standard routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain Questionnaire and Global Response Assessment will be completed by the participant at the initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of choosing one or more methods for returning questionnaires: electronic mail, self-addressed home envelope, or telephone call.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old
* Primary complaint of acute or chronic pelvic pain with or without dyspareunia
* Physical exam findings consistent with levator muscle spasm
* Capable of inserting tablet in vagina without use of applicator.

Exclusion Criteria:

* Chronic narcotic use
* Non-English speaking
* Currently serving a prison sentence
* Stage III or greater vaginal prolapse
* Allergies or contraindications to benzodiazepines
* Pregnant or breastfeeding
* Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal valium therapy
* Unwilling or incapable of inserting tablet in vagina without applicator.
Fertility Changes Due to Cancer: an Investigation of Meaning, Psychological Distress, and Psychologi

Establish the relationship between meaning and psychological distress in young women with breast cancer who experienced reproductive concerns due to cancer diagnosis and treatment and their partners.

This research will focus on identifying avenues for improving the quality of life of young women with breast cancer who endorse reproductive concerns due to cancer diagnosis and treatment, as there is an increased likelihood of distress and decreased likelihood of receiving information and appropriate psychological care. Existential distress appears to play a role in coping with infertility due to cancer (8) and thus the relationship between this distress and the other types of reproductive concerns warrants further exploration. The proposed project will use a mixed methods design to characterize the relationship between sense of meaning and purpose and psychological distress and assess psychosocial support needs of these young women. It will also assess the experience of the identified partners of these young women.

Eligibility Criteria:
Participant Inclusion Criteria:

* Provision to complete the consent form.
* Stated willingness to comply with all study procedures and be available for the duration of the study.
* Able to confirm they have a valid and private email account and access to the internet.
* Patients age 18 to 45 with a diagnosis of breast cancer. Patients will endorse that they experience reproductive concerns due to cancer as assessed by a single screening item.
* Fluent and literate in English.

Partner participant inclusion criteria:

* Provision to complete the consent form.
* Stated willingness to comply with all study procedures and be available for the duration of the study.
* Able to confirm they have a valid and private email account and access to the internet.
* Be the identified supportive partner of a study participant.
* Fluent and literate in English.

Exclusion Criteria:

* An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study.
Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.

Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
3. Disease must be clinically limited to the stomach or GEJ.
4. Pre-treatment Port-a-Cath insertion obligatory
5. No prior chemotherapy.
6. No prior radiotherapy.
7. Patients must be surgical candidates as determined by the treating surgeon.
8. Adequate organ function defined as:
9. Patients must have an ECOG Performance Status \< 1.
10. Patients must be able to sign the informed consent document.

Exclusion Criteria:

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. New York Heart Association Class III or IV heart disease.
6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
7. Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
9. Clinically significant hearing loss.
10. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
11. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
12. Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
Single-shot TAP Block vs Continuous TAP Block

The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.

Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.

This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

Eligibility Criteria:
Inclusion criteria:

* Healthy subject undergoing laparoscopic live donor nephrectomy
* (ASA) American Society of Anesthesiologists class 1 or 2
* Age 18 or older, male or female
* Desires TAP block for postoperative pain control

Exclusion criteria:

* Any contraindication for TAP block - single or continuous
* History of substance abuse
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known allergy or other contraindications to the study medications (Ropivacaine, Normal Saline, Hydromorphone, Oxycodone and Acetaminophen)
A Study to Assess S-309309 in Healthy and Obese Participants

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.

Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG at the Screening Visit and upon admission to the clinical research unit (CRU).
* Body weight ≥50 kilograms (kg), and body mass index (BMI) within the range ≥18.5 to \<30.0 kilogram/meter square (kg/m\^2) for all groups except Group G-2. For Group G-2, BMI ≥ 30 to \< 40 kg/m2 at the Screening Visit.

Exclusion Criteria:

* History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years.
* Unable to swallow capsules.
* Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab.

SECONDARY OBJECTIVES:

I. To determine late toxicity and immune pharmacodynamic changes after SBRT followed by ipilimumab.

OUTLINE:

Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab intravenously (IV) every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of melanoma
* Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria
* Presence of an index lesion between 1 and 5 cm
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Signed informed consent document
* Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
* Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

Exclusion Criteria:

* Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
* Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
* Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active
* Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study
* Prior radiation therapy (RT) that precludes the delivery of SBRT