cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness of Operative Versus Non-Operative Treatments for Rotator Cuff Tears

Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking. Our proposed study aims to fill these gaps by identifying the prognostic factors which will predict better outcomes of rotator cuff tears, based on both operative and non-operative treatment. The investigators will also compare outcomes of operative and non-operative treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.

Rotator cuff tears account for over one quarter million surgeries annually. They are a leading cause of shoulder pain and disability. Patients with rotator cuff tears present with shoulder pain and/or limitation in range of motion. Fourteen special physical exam tests have been described for diagnosis of rotator cuff tears. Prior literature describing sensitivity and specificity of these tests in diagnosing cuff tears is limited by retrospective design, small sample sizes, samples restricted to patients undergoing surgery, and failure to differentiate between partial and full thickness tears. As a result, there is little evidence to help clinicians interpret the diagnostic value of the clinical exam. Consequently, clinicians rely heavily on magnetic resonance imaging (MRI) for diagnosing cuff tears, adding considerable expense in the diagnostic process.

The treatment options for rotator cuff tears are operative and non-operative. There is currently little consensus on indications and timing of rotator cuff surgery or non-operative treatment. Furthermore, there is lack of evidence-based guidance on factors associated with outcomes of operative versus non-operative treatment for cuff tears.

We are enrolling patients in a prospective cohort study to assess comparative-effectiveness of operative versus non-operative treatment of rotator cuff tears and understand prognostic factors for better outcomes after surgery and non-operative treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 or older
* Symptoms for at least 4 weeks of shoulder pain and/or limitation in range of motion of shoulder

Exclusion Criteria:

* History of humeral fractures
* Prior surgery on the same shoulder
* Contraindications to MRI (prior surgical hardware, pacemakers, defibrillators, and claustrophobia)
* Unable or unwilling to give informed consent
* Unable or unwilling to be followed up
* Non-English speaking (as questionnaires have only been validated in English)
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma

This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.

For Cohort 1, the response to treatment was determined at the end of the 12 weeks of treatment. For Cohort 2, the response to treatment was determined after 12 weeks of treatment and 24 weeks of observation. For Cohort 3, the response to treatment was determined after intermittent dosing over a 20-week period, consisting of an initial 8-week treatment period, followed by a 4-week drug holiday period, followed by a second 8-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
* Willingness to consent to biopsy of the lesion.
* Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
* Adequate hematopoietic capacity.
* Adequate hepatic function.
* For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
* For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
* Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
* Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

* Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
* Inability or unwillingness to swallow capsules.
* Pregnancy or lactation.
* BCC with any clinical and histological pattern other than nodular BCC.
* Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
* Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
* Use of any excluded medication or therapy within 21 days of study entry.
* History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
* Uncontrolled medical illness.
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
* Any medical or psychological illness or condition preventing adequate consent.
Transcranial Stimulation in Motor Stroke Rehabilitation

Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.

Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.


Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke (\> 6 months from the accident)

Exclusion Criteria:

* general cognitive impairment (Mini Mental State Examination \< 25), severe functional disability (Barthel Index \< 45),
* psychiatric disorders,
* degenerative neurological disorders,
* epilepsy,
* severe medical conditions,
* having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil
20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid in Cirrhosis With Sepsis Induced Hypotension

Patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. About 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . After infection develops, the patient may develop acute kidney injury (AKI), shock, encephalopathy or disseminated intravascular coagulation (DIC) further decreasing the chances of survival. In fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. So, sepsis is directly responsible for 30-50% of deaths in cirrhosis . Therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. Early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. Currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (EGDT) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . The use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .


Eligibility Criteria:
Inclusion Criteria:

* Clinical/Imaging or Biopsy proven liver cirrhosis of any etiology who consent for enrolment.
* Hypotension (Mean arterial pressure \<65mmHg or Systolic blood pressure \<90mmHg)
* Aged between18-65 yrs

Exclusion Criteria:

* Already received colloid or more than 2 litres of fluid without baseline echocardiographic assessment.
* Already on vasopressors/inotropes
* Severe pre-existing cardiopulmonary disease
* Acute Respiratory Distress Syndrome (ARDS)
* Active bleeding like variceal bleed
* Cerebrovascular events
* Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy
* Admission to ICU following liver transplantation, burns, cardiac surgery
* Brain death or likely brain death within 24 hours
* Previous adverse reaction to human albumin solution
* Pregnant or lactating women
* Informed consent refused by patient or attendants
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment

Exclusion Criteria:

* Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension
* Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline
* Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD

1. To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with COPD.
2. To determine the different durations of combined pursed lip breathing with diaphragmatic breathing on Pulmonary functions in patient with COPD.
3. To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on quality of life in patient with COPD

The technique of pursed lip breathing allow the patients to control the oxygenation and ventilation. This technique is performed by allowing the person to inspire through the nose exhale through the mouth at a slow controlled flow. This technique works by moving oxygen into your lungs and carbon dioxide out of your lungs. Pursed lip breathing (PLB) helps to slow down breathing rate and relieving shortness of breath by keeping the airways open longer. So patients can remove the air that is trapped in to the lungs.

In a recent systematic review that is published in 2018, PLB was shown to significantly improve ventilation related outcomes such as respiratory rate and minute ventilation, but not dyspnea and exercise capacity.

Diaphragmatic breathing (DB), that is also called deep breathing, this breathing is done by contracting the diaphragm, a muscle located horizontally between the thoracic cavity and abdominal cavity. During this type of breathing, air enters in to the lungs, the chest does not rise and belly expands. Diaphragmatic breathing encourages fully oxygen exchange, that is the beneficial trade of incoming oxygen for out going carbon dioxide.

Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed as COPD
* The intervention PLB Combine with DB
* Stable COPD Patients (Mild and Moderate on GOLD criteria) Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion Criteria:

* Patients with other Pulmonary diseases.
* cardiovascular, neurological and orthopedic diseases
* Obesity, history of recent exacerbation
* Uncontrolled arterial hypertension
* Any surgical complications
* Patients with ventilatory support
Optimal Dosage of Remifentanil for Vertebroplasty

Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.

Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol

Exclusion Criteria:

* Age \< 20 or \> 80 years
* ASA classifications \> III
* Pregnancy
* Known allergies to opioids, propofol or any drugs used in the study
* Emergency surgery
* Patient refusal
Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors

RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.

OBJECTIVES:

* Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.
* Assess the toxicities of this treatment regimen in these patients.
* Determine tumor response and cause of death in these patients treated with this regimen.

OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignancy

  * Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy
  * Incurable with any standard therapy
* No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart)
* Tumor visible by CT scan

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 2.0 times upper limit of normal (ULN)
* AST and ALT less than 5 times ULN

Renal:

* Creatinine less than 2.0 mg/dL

Pulmonary:

* FEV1 greater than 0.75 L

Other:

* No unsuitable size or geometric proportion that would preclude stereotactic immobilization
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 14 days since prior anticancer biologic therapy and recovered

Chemotherapy:

* At least 14 days since prior anticancer chemotherapy and recovered

Endocrine therapy:

* At least 14 days since prior anticancer endocrine therapy and recovered

Radiotherapy:

* See Disease Characteristics
* At least 14 days since prior anticancer radiotherapy and recovered

Surgery:

* Not specified
Outcomes of Posterior Urethral Valve Fulguration

To evaluate the long-term outcome after fulguration of the posterior urethral valve.

Posterior Urethral Valves (PUV) are the most common cause of lower urinary tract obstruction. More severe forms are detected early in pregnancy (mainly type I), while other forms are usually discovered later in childhood when investigating lower urinary tract symptoms. Bladder dysfunction is common and is associated with urinary incontinence in about 55% (0%-72%). Despite the removal of the obstruction by urethral valve ablation, pathological changes in the urinary tract can occur with progressive bladder dysfunction, which can cause deterioration of the upper urinary tract as well. For this reason, all children with PUV require long-term follow-up, always until puberty. In many cases, the life-long current status is uncertain. The current literature lacks research on long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fulguration of PUV since 1 year or more

Exclusion Criteria:

* Patients with neurogenic bladder or meningocele or spina bifida .

Patients with renal parenchymal disease and inflammation not related to posterior urethral valve .

Diabetic patients .

Parental refusal .
Clinical Trial for Liquid Food (Inslow)

A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate (\>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on postprandial glycemic responses.

The test enteral nutrition formula (Inslow) and the standard balanced formula (Meibalance) were administered in a randomized crossover design to 11 healthy people, 13 IGT and 12 type-2 diabetes, judged by the postprandial state after in taking the two test meals in a random order with a washout period of one week. On the day prior to the test day, subjects were asked to stay at the same facility and to take the same supper with 450 kcal controlled, after 21:00 with only water allowed as ad libitum and not do any exercise. Each participant was taken a fasting blood sample, and then requested to consume one of is energetic test meals (200 kcal per serving) Inslow or standard balanced formula at 7:00 AM. Subsequent blood samples were collected at 30,60,90,and 120 min after meal consumption. The plasma concentrations of glucose, insulin, and free fatty acids were measured for each blood sample. Plasma glucose was measured by hexokinase method, plasma insulin by serum radioimmunoassay method and plasma free fatty acid by enzyme chemical method.Routine blood test and biochemical test were performed using the same blood sample only at fasting stage,including RBC, WBC, TP, ALP, T-Cho, etc., to confirm the status of each subject. Collected blood was applied to analyses at Shanghai Meizhong Clinical Measurement Centre. The enteral nutrition meal Inslow was designed by palatinose, dextrin and fiber as carbohydrate for 56%,23% and 15%, respectively. The standard balanced meal was included dextrin as the main carbohydrate for 85%, together with sugar and fiber.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (symptoms of diabetes plus fasting plasma glucose level higher than 7.0 mmol/L and glucose levels after 75g oral glucose tolerance test (OGTT) or casual blood glucose level higher than 11.1mmol/L) and IGT patients (glucose levels after 75g OGTT between 7.8 and 11.1mmol/L).

Exclusion Criteria:

* These patients or subjects have no infectious diseases and were not using any drug.
Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies

This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, male or female;
2. Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
3. Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
4. According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
5. ECOG PS: 0-1 points;
6. Baseline blood and biochemical indicators meet the following criteria:

   Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;
7. The expected survival period is ≥3 months;
8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
9. Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.

Exclusion Criteria:

1. A person who has been confirmed to be allergic to apatinib and/or its excipients;
2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male \> 450 ms, female \> 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
3. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
4. Patients who have used apatinib or tigeo in the first line
5. abnormal blood coagulation (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency;
6. Patients with central nervous system metastases;
7. Pregnant or lactating women;
8. Patients with other malignancies within 5 years;
9. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
10. Patients who have participated in other drug clinical trials within 4 weeks;
11. Have received VEGFR inhibitors such as sorafenib and sunitinib;
12. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;
13. The investigator believes that it is not suitable for inclusion.