cyrilzakka/clinical-trials huggingface dataset:
Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women

Urodynamic Study (UDS) represents a series of agreed-upon clinical tests and is used to evaluate the functional status of the lower urinary tract, providing a pathophysiological basis for urinary symptoms. Urodynamic Study involves catheterization of the lower urinary tract. The prevalence of urinary tract infection after UDS ranges from 1,5% to 30 %.

Studies of prophylactic antibiotics for UDSs have offered data of contradictory and limited predictive values. Some investigators concluded that prophylactic antibiotics were valuable and others have not.

The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS in women, using different antibiotic regimens.

This study is randomized, double blind study was carried out in the Department of Gynecology at Sao Paulo Federal University from January 2009 to December 2012.

The patients were randomized in four groups: Group A received 500mg of levofloxacin, group B received placebo, group C received 80mg trimethoprim and 400mg sulfamethoxazole (SMZ-TMP) and group D received 100mg of nitrofurantoin. The tablets were administered 30 minutes before de UDS.

All patients were instructed to collect midstream urine sample to the microbiology laboratory 14 days after the UDS. Significant bacteriuria was considered when \>1.000.000 organisms/mL of a single species was isolated.

All data were entered into Statistical Package for Social Sciences (SPSS) 16.0 for statistical analysis and graphic representation. Likelihood -ratio test and Fisher's exact test were used to compare the prevalence of significant bacteriuria after UDS in the different groups and Student's t-test and ANOVA test were used to compare continuous variables. To compare the groups regarding the BMI variable and parity, the model analysis of variance (ANOVA) was used, or if necessary, the nonparametric Kruskal-Wallis test and to compare the groups in relation to menopause variable, we used the Chi-square test. A significance level of 0.05 was established for statistical analysis.

Eligibility Criteria:
* Inclusion Criteria: Women with 20 to 85 years old, clinical diagnosis of urinary incontinence with indication for urodynamic study, absence of genital prolapse or prolapse peak effort that does not exceed the hymen, absence of urinary tract infection
* Exclusion Criteria: Patients with diabetes mellitus, history of recurrence urinary tract infection, with genital prolapse that exceed de hymen, pregnant, kidney stone, allergy to antibiotics, use of urethral catheters delay
Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma

Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients.

Thus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.

Multiple myeloma (MM) is the second most common hematologic malignancy in adults. Overall survival (OS) in MM has improved significantly in the last 15 years with the emergence of novel therapies such as thalidomide, bortezomib and lenalidomide. The median life expectancy of patients with MM treated in the current era is more than 6 years, while SEER data from a slightly earlier time period (2008-12) estimated the 5 year survival at 48.5%. However, prognosis is not uniform and varies considerably based on a presenting features and response to therapy.

The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). There is controversy regarding the timing of autoHCT after initial novel therapy induction with randomized trials showing similar OS whether done early or delayed to time of relapse as salvage therapy. However, more recent trials comparing early versus delayed transplant support the benefit of early upfront autoHCT.

Allogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients. Current data from the Center for International Blood and Marrow Research (CIBMTR) show transplant-related mortality rates of 23 (20-26)% at 5 years with myeloablative conditioning.

Thus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiary
* Stage II or III multiple myeloma and/or primary plasma cell leukemia
* Eligible to receive an allogeneic HCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood
* Will receive allogeneic HCT at a US transplant center
* Agree to submit comprehensive clinical data on their pre- and post-transplant clinical status and outcomes to the CIBMTR
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain

Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.

It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.

Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.

Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;

Eligibility Criteria:
Inclusion Criteria:

* Written consent
* LBP with radiation to one leg, that lasts more than 6 weeks
* Abnormal response to SLR test
* With or without neurological signs

Exclusion Criteria:

* History of spinal surgery
* Patient with FUO
* History of malignancies
* Patient with saddle anesthesia
Learning and Decision-making

A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Numerous studies suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement learning, guided exploration/exploitation, and behavioural energisation, although no studies to date have investigated the distinct role of DA and NE on cost-benefit decision-making and learning in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign an informed consent
* Age between 18 and 35
* Body-Mass Index (BMI) between 17.5-30
* Availability for participation through the duration of the study

Exclusion Criteria:

* Diagnosis of a psychiatric or neurological disorder, including substance abuse or dependence (yes/no self-report - lifetime)
* Use of any psychopharmacological treatment 3 weeks before the test day (yes/no self-report)
* Use of any blood pressure medication (yes/no self-report - lifetime)
* Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have plans to get pregnant in the near future (yes/no self-report) (females only)
* Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory disease (medical questionnaire), abnormal blood pressure (diastolic\< 60mmHg; systolic\< 90mmHg) (medical screening)
* Chronic renal failure (medical questionnaire)
* Hypothyroidism (medical questionnaire)
* Diabetes (medical questionnaire)
* Hypersensitivity to phenothiazines (medical questionnaire)
* Diagnosis of a cardiac disease (medical questionnaire)
* Alcohol consumption in the 24 hours before the test session starts (yes/no self-report)
* Food intake less than 3 hours before the test day (yes/no self-report)
CBTpro: Scaling up CBT for Psychosis Using Simulated Patients and Spoken Language Technologies

The primary objective of this grant is to develop and evaluate an Artificial Intelligence-based clinical training tool--CBTpro--to support high-quality skills training in CBT for psychosis (CBTp). CBTpro will provide a rapid means of scaling and sustaining high-quality CBTp in routine care settings across the US.

This fast-track Small Business Technology Transfer (STTR) grant is a partnership between the University of Washington and private company LYSSN that includes the development and iterative testing of CBTpro, a Computerized Clinician Support Tool designed to teach behavioral health providers and students Cognitive Behavioral Therapy for psychosis (CBTp). CBTpro uses natural language processing to provide automated speech-to-text and machine learning to score trainee's responses to simulated patients with psychosis.

Once technical reliability of the tool is achieved through iterative modifications based on usability and field trials, a randomized control trial will be conducted to assess CBTpro training vs. training as usual with N=100 providers / N=300 clients on clinician skills and client outcomes.

Eligibility Criteria:
Provider Inclusion Criteria:

* Frontline clinical staff who provide direct clinical services to adult outpatients at designated study sites
* Providers must carry a caseload that includes adults with primary psychotic disorders and / or major mood disorders with psychotic features

Provider Exclusion Criteria:

* Providers who participated in previous activities for this grant
* Providers who have been previously trained in CBTp

Client Inclusion Criteria:

* Over 18
* English-speaking and can read English at a 4th grade level or higher
* Chart diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar or depressive disorder with psychotic features, brief psychotic disorder, other specified psychotic disorder, unspecified schizophrenia spectrum and other psychotic disorder.
* Working with a provider who is enrolled in the study
* Can provide consent

Client Exclusion Criteria:

* Psychosis secondary to substance intoxication, withdrawal or medical condition
* Unwilling to commit to weekly or biweekly clinic-based appointments
* Unwilling to consent to have clinic sessions recorded
* Plan to move or discontinue services at a participating clinic over the 6-month study period
Opioid Counseling Following Orthopaedic Surgery

Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery

Exclusion Criteria:

* male of female less than 18 years old
* patients schedule to undergo inpatient procedures
* patients undergoing surgeries distal to the wrist
* patients undergoing surgeries under local anesthesia only
A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Chronic hepatitis C.
* Compensated liver disease (Child-Pugh Class A).
* Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
* Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
* Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
* For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
* Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Male partners of women who are pregnant.
* Patients with hemoglobinopathies.
* Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
* Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
* Liver disease other than chronic hepatitis C, including hepatic carcinoma.
Pilot Trial of Pregnenolone in Autism

This is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.


Eligibility Criteria:
Inclusion Criteria:

* outpatients between 14 and 25 years of age with a Tanner stage of IV or V;
* male and female subjects who were physically healthy;
* diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5, expert clinical opinion and confirmed with Autism Diagnostic Interview - Revised (ADI-R) and either Autism Diagnostic Observation Schedule (ADOS) or Childhood Autism Rating Scale (CARS-2);
* Aberrant Behavior Checklist -Irritability (ABC-I)≥ 18 and Clinical Global Impression (CGI)-Severity subscale ≥ 4;
* stable concomitant medications for at least 2 weeks;
* no planned changes in psychosocial interventions during the trial.

Exclusion Criteria:

* Diagnostic and Statistical Manual (DSM-5) diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder;
* prior adequate trial of pregnenolone;
* active medical problems: unstable seizures (\>2 in past month), significant physical illness;
* pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics;
* participants taking steroid medications.
Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are

* Is CSHD inferior to CS in immediate pain relief as the solution is diluted?
* Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated?

Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL.

Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL.

Clinical scores and range of motion will be compared between the groups up to six months post-injection.

A single-centre, double-blinded, prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder (AC).

Patients were randomly allocated to either corticosteroid injection with hydrodilatation (group CSHD) or corticosteroid injection only (group CS).

For the CS group, a solution of 1 mL triamcinolone (40mg) and 4 mL 1% lidocaine, 5 mL in total, was injected intraarticularly through the posterior approach using ultrasound guidance.

The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution. The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head.

Patients underwent the following assessments just before the injection, and at post-injection three weeks, seven weeks, three months, and six months.

Range of motion in forward elevation, external rotation, and internal rotation Clinical scores include the pain visual analogue scale (pVAS), the American Shoulder and Elbow Surgeons score, and the Constant-Murley score.

Subjective patient satisfaction was recorded on a scale from 0 to 100, with 100 being the most satisfied.

The recorded data were compared within each group before and after the injection, and also between the groups.

Eligibility Criteria:
Inclusion Criteria:

Two or more of the following criteria within the shoulder's range of motion:

* Abduction and forward elevation below 100˚
* External rotation at the side below 30˚
* Internal rotation at 90˚ of abduction below 30˚

Exclusion Criteria:

* History of shoulder surgery, trauma, nerve injury
* Concomitant rotator cuff/biceps lesions in ultrasound or MRI
* Glenohumeral arthritis in simple X-ray
* Calcific tendinosis in simple X-ray
* Underlying conditions: cancer, mental illness, hormonal imbalance
* Diabetes with HbA1c levels exceeding 7.0%
Compare Effects of Dressing With Honey and EUSOL

Honey is super saturated solution containing sugar derived from nectar gathered by honeybee. Honey is viscus supersaturated solution mainly composed of sugar and water along with minor constituents such as minerals, vitamins, amino acids, organic acids, flavonoids, and other phenolic compound and aromatic substances. Honey contents according to percentages are fructose 38.6%, glucose 31%, water 17%, lactose 7.2%, larger sugars 4.7% and rest of micronutrients and elemental compounds are 1.5%. Honey enhances wound healing by removing slough and necrotic tissue from wound. It promotes wound healing by increasing angiogenesis, granulation and epithelization. Honey possess antimicrobial activity against bacteria like methicillin resistant staphylococcus aureus, vancomycin resistant Escherichia Coli, pseudomonas aeruginosa, and many other species. It also has activity against some yeast species such as aspergillus and penicillium.

Honey used for dressing will be 'Langnese Honey". Langnese honey is raw honey / unprocessed packed as collected, quality and quantity will be same for patients.

This prospective randomized trial will be conducted in all patients undergoing dressing after debridement of necrotizing fasciitis wounds. Study will be conducted for 6 months after approval IRB. Patient will be inducted through emergency department. After debridement, patient will be enrolled in study via simple random sampling for dressing with either EUSOL or Honey. Honey quantity for wound will be 4ml per square inch. In patient whose both limbs involved by necrotizing fasciitis, after debridement, dressing will be done with honey in one limb and EUSOL in other limb. Patient will be enrolled in study whose debridement already done.

EUSOL is solution commonly used for dressing of wounds. Honey is also used for dressing of wounds. Honey is a viscous, supersaturated sugar derived from nectar gathered by a honeybee. Honey enhances wound healing by providing moist environment, antibacterial activity, deodorizes, decrease inflammation, edema and exudation. Honey increase rate of wound healing by promoting angiogenesis, granulation and epithelization. Dressing will be done by residents of our ward under supervision of faculty. At first time of debridement pus or tissue will be sent for culture and sensitivity meanwhile broad-spectrum antibiotic will be started. Once dressing will started, wide wound span will be measured and assessed daily for granulation tissue and removal of slough. Questionnaire will be filled by PI for allergic reaction to solution, appearance of granulation tissue and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<70 years.
* Necrotizing fasciitis wounds
* Wide span of wound \<20cm

Exclusion Criteria:

* Diabetic Foot wounds
* Traumatic wounds
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection

Effect of Covid-19 disease in clotting factors levels in hospitalized patients

Effect of Covid-19 disease in clotting factors levels in hospitalized patients positive for sars-cov2 infection.

Association between clotting factors levels and disease severity,morbidity and mortality in these patients.

Effect of anticoagulant therapy in the clotting factors' levels in these patients

Eligibility Criteria:
Inclusion Criteria:

* AGE\> 18
* SINGED INFORMED CONSENT FORM
* POSITIVE PCR TEST FOR SARS-COV2 INFECTION
* FINDINGS IN CXR OR CT OF THE LUNGS CONSISTENT WITH INFECTION OF LOWER RESPIRATORY TRACT

Exclusion Criteria:

* AGE\<18
* DENIAL TO PROVIDE INFORMED CONSENT FORM
* HISTORY OF MALIGNANCY
* PRIOR USE OF ANTICOAGULANT THERAPY
* PRIOR USE OF STEROIDS LONGER THAN 14 DAYS
* LACTATION-PREGNANCY