cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.

All eligible patients will receive:

* Bevacizumab 15mg/kg IV infusion,Day 1
* Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
* Carboplatin AUC 6.0 IV Day 1
* Erlotinib 150 mg by mouth daily

The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma.
* ECOG performance status 0-1
* No previous treatment with any systemic therapy
* Adequate kidney, liver and bone marrow function
* Be able to understand the nature of the study and give written informed consent

Exclusion Criteria:

* The following specific syndromes:
* Neuroendocrine carcinoma
* Women with adenocarcinoma isolated to axillary lymph nodes
* Women with adenocarcinoma isolated to peritoneal involvement
* Carcinoma involving only one site with resectable tumors at that site
* Squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
* Uncontrolled brain metastases and all patients with meningeal involvement
* Women pregnant or lactating
* Clinically significant cardiovascular disease
* History of myocardial infarction or stroke within 6 months
* Clinical history of hemoptysis or hematemesis
* Patients with PEG tubes or G-tubes
* Proteinuria
* History of bleeding diathesis or coagulopathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Motor and Sensory Deficits Following Partial Meniscectomy

To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.

The objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-65
* Arthroscopic partial meniscectomy with in the past 15 years

Exclusion Criteria:

* History of traumatic spine or lower extremity injury within the last 6 months
* Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
* Cardiac pacemaker
* Metal implants in head
* Current pregnancy
* Neurological disorders
* History of seizures
* Unable to give consent or understand the procedures of this study
Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.


Eligibility Criteria:
Inclusion Criteria:

* patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
* The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
* patients signed the ICF.
* patients with BCVA ≤0.5,and with visual disturbance symptoms.

Exclusion Criteria:

* patients with macular hole
* accompanied or secondary of other fundus disease
* received vitrectomy due to other diseases
* glaucoma cannot be controled by medication
* patients with other retinal or choroidal disease that may affect VA
* poor patients compliance
* poor condition that cannot undertake the surgery
* optical opacities which make it difficult to exam fundus or measure on OCT
Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia

Approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct Russian cities will be collected and tested on ceftaroline and other antimicrobials.


Eligibility Criteria:
Inclusion Criteria:

* Isolates derived from patients' clinical material will be included in the study
* Isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012)
* Isolates, allocated of a clinical material of adult patients (\> 18 years), should make not less than 70 % from total number of included isolates)
* All included isolates should be unique: only one isolate can be included in the study of each biological type from each patient
* All isolates should correspond to clinic-laboratory criteria of the etiologic importance, i.e. should be derived from patients with infection symptoms from the corresponding clinical material
* Case report form (CRF) (Appendix 1) should be correctly completed for each isolate

Exclusion Criteria:

* ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
* Isolates, arrived in the central laboratory contaminated or unviable
Green Tea Lozenges for the Management of Dry Mouth

The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.

Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.\[a\] First appointment -Screening, consent. \[b\]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.

Eligibility Criteria:
Inclusion Criteria:

1. A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
2. Clinical Diagnosis of primary or secondary Sjogren's syndrome.
3. Over the age of 18.
4. Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
5. Willing to use natural novel topical dry mouth products.
6. Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.
7. Willing to return for all study-associated visits.
8. Able to read, understand, and sign the informed consent.

Exclusion Criteria:

1. Have received radiation to the head and neck region.
2. Unable to read and understand the consent form.
3. On greater than three drugs associated with xerostomia or salivary gland hypofunction.
4. Require dento-alveolar surgery or extensive dental treatment during the course of the study.
5. Require hospitalization for any medical problem during the course of the study.
6. Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy
7. Uncontrolled medical conditions that require changes in medication during the course of the study.
8. Regularly consume green tea and/or components of pilocarpus jaborandi.
9. Are pregnant
Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the UTMB hospital
* Aged 65 years or older
* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
* Alert and oriented x3 by a physician on H\&P.
* Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.

Exclusion Criteria:

* A Nursing home resident or hospice care patient
* Uncontrolled blood pressure (systolic \>170, or diastolic \> 100)
* New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
* End stage renal disease
* AST/ALT 2.5 times above the normal limit
* Recent (within 3 months) or current treatment with anabolic steroids.
* History of breast or prostate cancer
* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)
* Hematocrit ≥ 50%
* Any other condition or event considered exclusionary by the PI and faculty physician
High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with frozen shoulder

Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following:

1. The short pulse duration (50μs) with a damped oscillation
2. The broad bandwidth(200kHz\~300MHz) with a basic frequency 240kHz
3. High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator spool
4. Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of 50\~100mT
5. Depth penetration for tissue and organ up to 20 cm

It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.

Eligibility Criteria:
Inclusion Criteria:

1. Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
2. The symptoms persist for more than 3 months.
3. There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.

Exclusion Criteria:

1. Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis.
2. Systemic rheumatic disease.
3. History of shoulder fracture or previous surgical treatment of the shoulder joint.
4. Acute cervical nerve root compression.
5. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients.
6. Received shoulder injections for treatment within the past 3 months.
7. Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy.
8. Pregnant or breastfeeding women.
9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation.
Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF.

Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG

This is a single centre, open-label, non-randomised, prospective study evaluating the steady-state pharmacokinetics of twice-daily dose DTG administered during concurrent RIF treatment and assessing safety and tolerance in HIV-TB co-infected children weighing 20 to 35 kg.

DTG will be administered as a twice-daily dose 50mg tablet formulation both before starting and after completion of the standard six-month RIF-based anti-TB treatment. The NRTI background and anti-TB drugs will be prescribed following the national weight band dosing guidelines.

Those initially diagnosed with TB are likely to be sicker, and the recommendation is to start anti-TB treatment first and follow with ART two weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Children \<18 years with confirmed HIV-1 infection weighing 20-35kg ART-naive or experienced, with plans to use DTG for HIV treatment
* Diagnosis of TB disease with clinician initiating rifampicin-containing first-line therapy
* Parents/legal guardians/caregivers and children give informed written consent (or assent, where applicable) to be in the study
* Girls who have reached menses must have a negative pregnancy test at screening and be willing to adhere to two effective methods of contraception (barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment) if sexually active. The parents/caregivers will be counselled together with the child if the child tests positive in order to reduce any social harm which may arise.

Exclusion Criteria:

* History or presence of known allergy or contraindications to DTG
* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥2xULN
* Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
* Pregnancy or breastfeeding
* A concurrent illness that could influence drug PK, i.e. severe diarrhoea, vomiting, renal or liver disease
* Treatment with concomitant medications known to have interactions with DTG
* Participants that are eligible for the study but refuse to give consent and/or assent
Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide

Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota. Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention. 80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG). The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period. All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.


Eligibility Criteria:
Inclusion Criteria:

1. acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
2. TCM syndrome: Intermingled Phlegm and Blood Stasis.
3. Aged 18 to 80 years old.
4. sign a consent form.

Exclusion Criteria:

1. Cardiogenic shock.
2. Serious heart failure (NYHA IV or LVEF \< 40%).
3. With severe valvular heart disease.
4. Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
5. With acute cerebrovascular disease or severe mental illness.
6. With active bleeding or severe hematopoietic system disease.
7. With malignant tumor or life expectancy in less than three years.
8. Pregnancy or ready to pregnant women, nursing mothers.
9. History of taking antibiotics within the past two months.
10. Participating in other clinical subjects .
11. Failure to sign a consent form.
Effect of Liberal and Restrictive Fluids on Nausea-vomiting

Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.

Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.

Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.

Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for laparoscopic cholecystectomy
* Patients aged 18-70

Exclusion Criteria:

* Congestive heart failure.
* Diabetes.
* Epilepsy.
* Heart valve disease.
* They are pregnant.
* Chronic liver disease.
* Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.