cyrilzakka/clinical-trials huggingface dataset:
The Utility of Urinalysis Prior to In-Office Procedures

The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.

OVERVIEW:

Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. If the patient's urinalysis is positive, they are then required to have a urine culture done, which takes 1-3 days to show results, and they may also be prescribed antibiotics. This practice may cause diagnostic delays, unnecessary cancellations of procedures, and the overuse of antibiotics.

The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies, intravesical BCG treatments, and prostate biopsies. The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis. The investigators propose a change in protocol could allow for improved clinical efficiency, antibiotic stewardship, and be economically advantageous.

OUTLINE:

Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand. Participants will have follow up questionnaires seven days and thirty days after their procedure. A total of 664 participants will be enrolled between the two study sites.

Eligibility Criteria:
Inclusion Criteria:

• Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy

Exclusion Criteria:

* Patients under 18
* Patients with symptomatic UTI infections at the time of recruitment
* Patients on antibiotics at the time of recruitment, not including prophylaxis
* Patients with a history of UTI within 1 year
* Patients with indwelling catheters
* Patients with clean intermittent catheterization
* Patients undergoing stent removals or with ureteral stents
Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke

Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.

Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.

Eligibility Criteria:
Inclusion Criteria:

* lower extremity Brunnstrom stage 2,
* lower extremity modified ashworth \< 3,
* has the ability to follow 3-step command in English,
* has only unilateral involvement.

Exclusion Criteria:

* lower extremity Brunnstrom stage 1,
* lower extremity modified ashworth 3 or higher,
* history of prior stroke,
* Passive Range of Motion limitation of hip and or knee flexion \< 90,
* has visual deficits which prevent participation.
Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Despite the availability of effective anti-tuberculosis agents that exist to treat this illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use. There is no consensus on method of the reintroduction of anti-TB medications. The risk of reintroducing of a anti-TB medications could be hazardous. There are several differences between the guidelines from the ATS, BTS and the Task Force of the European Respiratory Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the methods of reintroducing of anti-TB medications.

The investigators plan to do a prospective study to evaluate the outcome and safety of reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment among TB patients in the investigators hospital.

Tuberculosis (TB) remains a leading health problem in both developing and developed countries. Despite the availability of effective chemotherapeutic agents that exist to treat this illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use. In the case of confirmed moderate or severe drug-induced hepatotoxicity, treatment should be interrupted and reintroduced after the hepatotoxicity has resolved.

There is no consensus on method of the reintroduction of anti-TB medications. The risk of reintroducing of a anti-TB medications could be hazardous. There are several differences between the guidelines from the ATS, BTS and the Task Force of the European Respiratory Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the methods of reintroducing of anti-TB medications.

We plan to do a prospective study to evaluate the outcome and safety of reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment among TB patients in our hospital.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis during anti-tuberculosis treatment
* Hold RMP, INH and PZA after hepatitis
* Age \>= 18 years old
* HIV(-)
* T-bilirubin \< 2.5 mg/dL
* No allergy to RMP, INH and PZA

Exclusion Criteria:

* Liver cirrhosis, child B or C
* Pregnancy and breast feeding
* Life expectation \< 1 year
Free Mucogingival Graft for Isolated Root Coverage

The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients with deep GR associated with lower incisor MCD.
* Full mouth plaque and bleeding scores were \<20%.

Exclusion Criteria:

Patient characteristics:

* Smoking ≥10 cigarettes a day.
* Medications or systemic contraindications for oral surgery.
* Pregnancy.

Defects:

* Thin scalloped biotype (AND/OR)
* Underlying bone dehiscence (AND /OR)
* Generalized GR affecting most sextants.
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.


Eligibility Criteria:
Inclusion Criteria:

1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
2. Between the ages of 18 and 65 at last birthday

Exclusion Criteria:

1. Persons unable to safely undergo an MRI;
2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
3. Persons with severe peripheral nerve injury gap length \> 10 cm;
4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
7. History of active substance abuse;
8. Persons allergic to gentamicin;
9. Persons who test positive for HIV or Hepatitis B or C virus.
10. Persons unable to provide consent independently due to cognitive impairment
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically or cytologically confirmed adenocarcinoma of the prostate
* Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Prior treatment with an androgen receptor (AR) degrader
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP
* Clinically significant venous thromboembolism within 3 months prior to the first dose of IP
* Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness

Other protocol-defined inclusion/exclusion criteria apply
Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers

All participants in this study are healthy volunteers.

Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking.

Each participant will get all three treatments (A, B and C). Only the order in which they receive them will be different.

There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have an equal chance of being assigned to any of these groups.

For each treatment period, participants will:

* fast overnight
* receive the assigned treatment with or without food
* have a small tube of blood drawn prior to treatment
* after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours
* have a break from treatment for 6 days between each treatment period

All participants must reside in the clinic for a total of 20 days.

The primary objectives of this study are:

* To assess the effect of low-fat food on the pharmacokinetics (PK) of pexidartinib following a single oral dose of 400 mg administered in healthy subjects
* To assess the PK of pexidartinib following a single oral dose of 200 mg administered with low-fat food in healthy subjects

The secondary objective of this study is:

* To characterize the safety and tolerability of pexidartinib in healthy subjects following administration of a single oral dose of pexidartinib with low fat food and without food

Eligibility Criteria:
Inclusion Criteria:

* Is healthy at screening visit
* Is not pregnant or lactating
* Is surgically or naturally unable to reproduce, or agrees to remain sexually abstinent or to use double barrier methods of contraception from check-in until 90 days after the final dose of pexidartinib
* Has a Body Mass Index (BMI) of 18-30 kg/m\^2, inclusive
* Has negative test results for protocol-defined drugs and diseases at screening and/or check-in
* Is willing to avoid food or beverages before check-in until the end of the study:

  1. containing caffeine/xanthine or alcohol from 48 hours before check-in
  2. containing grapefruit or Seville oranges 6 days before check-in

Exclusion Criteria:

* Per protocol or in the opinion of the investigator at screening and/or check-in, has something that would preclude participation:

  1. has a clinically significant disorder, disease or lab value
  2. consumes a prohibited drug, drink or food
  3. is unable to consume the standard meal
* Is an employee of the clinic or their family member
Cayenne Pepper Cataplasm - Effect Study

The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC) application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back.

Therefore, the aim of the present study was to test effects of a series of ten applications of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature, skin sensory functions, pain threshold, and proprioception. Placebo control condition (0% cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application of a CPC will have significant effects on the measured parameters.

40 subjects will be randomized into Treatment/control group.


Eligibility Criteria:
Inclusion Criteria:

* chronic lumbar spine pain \>= 3 months
* pain during activity VAS \>= 4
* Oswestry Disabilty Index \>= 20%

Exclusion Criteria:

* pregnancy
* sensibility disorders (e.g. due to neurological disease)
* injuries, open wounds or rash in intervention area
* known hypersensitivity against the applied substances
* HIV, Hepatitis C and other due blood communicable infectious diseases
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
* Patients must be 18 years or older.
* Patients must have a NCI CTC Performance Status of 0-2.
* Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
* At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
* Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for \>5years
* Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
* Initial Required Laboratory Values:
* Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
* Serum creatinine should be ≤ 2 mg/dL.
* Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
* Serum transaminases should be ≤ 5-fold the institutional upper limits.
* Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
* Patients must be able to sign an informed consent.

Exclusion Criteria:

* None
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
* Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I
* Patients with antipsychotic combinations (more than two agents)
* Patients who are already on any mood stabilizers and antidepressant
* Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment
* Patients who have been treated with antipsychotics in depot formulations for the last two months
* Previous enrollment or randomisation of treatment in the present NIS
* Patients who had participated in other clinical trials within 4 weeks prior to enrollment period
* Pregnant women or women who are breast-feeding
MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.

During influenza season, concomitant influenza and pneumococcal vaccination would be an effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults. However, the immunogenicity and safety of concomitant vaccination need to be further investigated. There is data on immunogenicity and safety after concomitant administration of pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so immunogenicity should be assessed for both vaccines injected in same arm versus different arms.

This study is intended to evaluate the immunogenicity and safety of concomitant MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years. Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm (group 3) or PPV23 alone (group 4).

Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA) will be used to compare the immunogenicity of each vaccine after single or concomitant vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four serotypes (5, 6B, 18C and 19A).

Eligibility Criteria:
Inclusion Criteria:

* At least 65 years of age who are eligible for the study vaccines;
* Who have given written informed consent at the time of enrollment);
* Those who are available for all the visits scheduled in the study;
* Subjects In good health as determined by medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria:

* History of egg allergy
* History of influenza vaccination in previous 6 months
* History of any pneumococcal vaccination
* Documented S. pneumonia infection in the previous 5 years
* Chemotherapy for malignancy within the past 30 days
* High-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days
* Receipt of blood product within 6 months before enrollment
* Significant acute or chronic infection within the previous 7 days or fever within the previous day
* Any serious chronic or progressive disease
* Any condition that might interfere with the study results.
Adjunctive Pregnenolone in Veterans With Mild TBI

Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres. Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al. 2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al. 2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following TBI.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. 18-55 years of age, any ethnic group, either sex
2. History of mild TBI since September 2001. TBI occurring at age 18 or older.
3. We will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force (Holm et al.2005), with the exception of the Glasgow Coma Scale Score criteria (not available for these participants).
4. Ability to participate fully in the informed consent process.
5. No anticipated need to alter medications for the 10-week duration of the study.

Exclusion Criteria:

1. For this pilot study, we will exclude patients who report a history of seizures.
2. Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine, or breast cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Current active suicidal and/or homicidal ideation, intent or plan.
4. Concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
5. Current DSM-IV (Diagnostic and Statistical Manual, Fourth Edition) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth

Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

Pregnant women at Queen Charlotte's and Chelsea Hospital and St Mary's Hospital London who are defined as being at a higher than background risk for preterm labour will be recruited into this study. Women at risk of pre-term labour will include those with either previous LLETZ, previous preterm birth, previous second trimester pregnancy loss or a combination of these indications.

As part of this interventional study, subjects will be offered supplementation with L. crispatus CTV-05. The preparation of LACTIN-V is administered vaginally using a specially designed applicator.

The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

Eligibility Criteria:
Inclusion Criteria:

* Women at risk of preterm labour
* Women referred to the prematurity clinic
* Women with previous LLETZ (large loop excision of the transformation zone)
* Women with previous preterm birth
* Women with previous second trimester loss

Exclusion Criteria:

* HIV positive women
* Women who are unable to provide informed consent
* Women aged \<18
* Women receiving antibiotic treatment within 1 week of recruitment