cyrilzakka/clinical-trials huggingface dataset:
Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer

RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

OBJECTIVES:

Primary

* Predict the overall and progression-free survival of patients with stage IV breast cancer by measuring the rate of circulating tumor cells (CTC) before the second course of chemotherapy.

Secondary

* Predict overall and progression-free survival of these patients by measuring the rate of CTC before the start of chemotherapy, at the first tumor evaluation, and after 2-3 courses of chemotherapy.
* Correlate the detection of CTC with tumor markers, clinical response, and radiological response.
* Study the changing status of HER-2 in CTC in patients receiving trastuzmab (Herceptin®).

OUTLINE: This is a multicenter study.

Blood samples are collected at baseline, before the second course of chemotherapy, before the third or fourth course of chemotherapy, and when progressive disease is diagnosed (before second-line treatment is initiated). Circulating tumor cells from the blood samples are examined by immunofluorescence.

Patients are followed periodically for up to 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage IV breast cancer
* Measurable or evaluable disease
* Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status
* Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix
* No geographic, social, or psychiatric reasons that would make treatment impossible

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for metastatic disease
Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients

Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.

Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.

Objective: To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.

Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests

Eligibility Criteria:
Inclusion Criteria:

* stable COPD
* Stage II - IV
* Both genders

Exclusion Criteria:

* Cardiovascular diseases uncompensated
* uncompensated pleural diseases
* uncompensated liver diseases
* Recent surgeries less than 3 weeks
* malignancy receiving chemo and radiotherapy
* Recent exacerbations less than 3 months
Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis

The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group.

This is an open-label, randomized, controlled, and multicenter trial. Patients with moderate-to-severe symptoms were randomly assigned to receive either 20 and 10 mg prednisone in the morning and afternoon, respectively, daily for 1 week; in the second week, these participants received 400 mg celecoxib on day 1 and 200 mg twice daily for the remaining 6 days until celecoxib withdrawal or 20 and 10 mg prednisone in the morning and afternoon, respectively, daily in the first week, and then reduced by 5 mg/week from the second week until withdrawal in the sixth week. The primary endpoint was intergroup differences in treatment efficacy at the end of the treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24.

Eligibility Criteria:
Inclusion Criteria:

* We enrolled adult patients (age 18-70) with Subacute Thyroiditis (SAT) scores ≥3 points. SAT was diagnosed on the basis of diagnostic criteria. The severity of SAT was scored as follows: fever - none, \<38℃, and \>38℃ (0, 1, and 2 points, respectively); tenderness - none, mild, and severe (0, 1, and 2 points, respectively); goiter by ultrasonography or palpation - none and yes (0 and 1 point, respectively); and ESR - normal, 25-60 mm/h, and \>60 mm/h (0, 1, and 2 points, respectively).

Exclusion Criteria:

* Patients who were diagnosed with diabetes, an active peptic ulcer, benign and malignant tumors, hepatic dysfunction, recurrent SAT, and already on glucocorticoid therapy were excluded within 3 months.
Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.


Eligibility Criteria:
Inclusion Criteria:

* Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

1. Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.
2. Subject will be required to not be on any current pharmacological sleep disorder treatment.
3. Between the ages of 18 and 35 years.
4. Not taking any prescription medications that alter sleep, cognitive functions, or both.

Exclusion Criteria:

Primary Exclusion Criteria for "Healthy" control subjects:

1. Abnormal sleep habits:

   * sleeping less than 5 hours each night;
   * going to sleep before 9:00 PM or after 2:00 AM on a regular basis; or
   * Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.
2. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
3. A score greater than or equal to 10 on the Epworth Sleepiness Scale.
4. Takes medication that alters sleep, cognitive function, or both.
5. Has a history of a known neurological or psychiatric problem.
6. Younger than 18 or older than 35 years of age.
7. Known or suspected sleep disorder(s).
Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.

There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.

The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.

This study, is the second half of what was began with ESPITAP study

Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption\>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not.

Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption.

Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be \<10ppm abstinence will be verified by determination of urinary cotinine.

Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the "intent to treat", the unit of analysis will be the smoker.

Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Active smokers (consumption\>10 packs/year)

Exclusion Criteria:

* Active respiratory disease
* Practice of an espirometry on 12 months before
* Suffering of any chronic or terminal disorder
* Counterindication to undertake spirometry or that may hinder the performance of the spirometry test
Factors Related to Infection Prevention After Tension-free Inguinal Hernia Repair

The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals of Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient collection, information registration, protocol performance.

The investigators recruited 1200 patients with inguinal hernia undergoing inguinal hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly allocated into control group, cefazolin group and levofloxacin group, with digital meter method , 400 in each group. The data such as age, sex, case number, length of hospital stay, antibiotic usage, post-operative infection, infection site, bacterial culture were filled in self-designed forms on computer.

All of the patients received tension-free inguinal hernia repair with a mesh plug. The surgical-site infection (SSI) was diagnosed according to the criteria of the Centers for Disease Control and Prevention \[5-6\].

We chose cefazolin sodium and levofloxacin sodium chloride injection as peri-operative antibiotics. Cefazolin sodium is an effective antibiotic with a short plasma elimination half-life against gram-positive cocci (GPC) except for enterococci and meticillin-resistant staphylococci. It is recommended as one of the prior antibacterial agents used for clearing cuts and preventing infection in many countries including China. Levofloxacin sodium chloride injection has a wide anti-bacterial spectrum composed of gram-negative bacteria and gram-positive anaerobic bacteria including anaerobic bacteria. It can remain a high concentration in urine, so it is recommended as an attractive antibiotic for urinary tract operation \[5\].

In the control group, we gave normal saline as placebo by intravenous drip infusion for 30-60 min before operation. Cefazolin group and levofloxacin group received intravenous administration of cefazolin sodium 1000 mg and levofloxacin sodium chloride injection 200 mg, respectively, for 30-60 min before operation.

Eligibility Criteria:
Inclusion Criteria:

1. males or females aged 16-18 years old;
2. no infection or hematological system disease before surgery;
3. normal liver and kidney function;
4. no pre-operative valvular heart disease;
5. Body mass index (BMI) within 18-32.

Exclusion Criteria:

1. fail to meet one of the inclusion criteria above;
2. malignant tumor;
3. history of immune system diseases;
4. using or had used corticosteroids or immunosuppressants less than 1 month before surgery;
5. using or had used antibiotics less than 3 d before surgery;
6. pregnancy or lactation.
Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.


Eligibility Criteria:
Inclusion Criteria:

STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.

Exclusion Criteria:

Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.
Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis

The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology 1-2
* BMI 18-30 kg.m-2
* elective gynaecological operations under general anaesthesia

Exclusion Criteria:

* cirrhosis
* hepatitis
* hepatoma
* heart failure
* arrhythmia
* renal dysfunction
* electrolyte disturbances
* acid-base imbalances
* neuromuscular disorders
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.

The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.

The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval \>24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.


Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;
* persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)
* more than 2 weeks after stroke onset;
* the ability to sit comfortably for more than 10 minutes and perform two-step commands

Exclusion Criteria:

* no detectable motor deficits at baseline assessment;
* severe aphasia;
* clinical dementia or mini mental state examination (MMSE) below cutoff;
* other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;
* severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;
* pain or deformity that limited upper limb movement on the affected side.
ReIrradiation with FDG-PET Guided Dose Painting

Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy using IMRT dose-painting by contours for patients with recurrent and second primary head and neck cancer.

The standard re-irradiation regimen for head and neck cancer patients treated at the Oslo University Hospital is 1.5 Gy twice daily during 4 weeks with a total dose of 60 Gy.

In this study the radiotherapy is planned using 18F-FDG PET/CT making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 75 Gy. The participants will be given 65 Gy and 70 Gy minimum doses to two GTVs inside the conventional GTV (60 Gy). GTV_65Gy and GTV_70Gy are determined from the SUV values from the 18F-FDG PET/CT according to the formula proposed by the Ghent group (Van der Straeten et al, R\&O -06). It is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 60 Gy). In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT 6 months after inclusion (4 1/2 months after end of radiotherapy) and HRQL measurements.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0 - C06.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9
* Planned treatment at the Norwegian Radium Hospital or at other participating university hospitals
* Age ≥18 years
* Ability to understand and respond to the questionnaires
* Informed consent received
* Squamous cell carcinoma in the head and neck region of patients previously irradiated for head and neck cancer
* No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy
* Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer
* ECOG performance status ≤ 2

Exclusion Criteria:

* Patients planned for standard curative treatment (radical RT +/-concomitant chemotherapy or postoperative RT of primary disease)
* Patients who previously have been re-irradiated for overlapping second primary or relapse
* Other second primary tumors that are not under control
* Distant metastatic disease
Assessment of Neurological Manifestations in Gaucher Disease Patients

The current work aims to detect the frequency and types of neurological disorders in patient diagnosed as Gaucher disease in Assiut University Children's Hospital

Gaucher disease, the most common lysosomal storage disorder, caused by reduced activity of acid β-glucosidase and mutations in the GBA1 gene. This leads to the accumulation of its normal substrate, glucocerebroside, in tissue macrophages, affecting the hematological, visceral, bone and neurologic systems. The determination of deficient β-glucocerebrosidase activity in leukocytes or fibroblasts by enzymatic assay is the gold standard for the diagnosis of Gaucher disease. Clinically, Gaucher disease is classified into three major forms based upon the absence or presence and rate of progression of neurological manifestations : type 1 (non-neuronopathic), type 2 (acute neuronopathic), and type 3 (subacute neuronopathic). The nGD forms are Gaucher disease type 2 (GD2) and Gaucher disease type 3 (GD3). GD2 is the acute neuronopathic form and has an early onset CNS involvement, typically manifesting in the first 6 months of life and leading to death by age 2 years, although patients may live up to age 4 years or beyond with supportive medical care. GD3, or the chronic neuronopathic form, has a slightly later onset, CNS symptoms typically manifesting months to years after birth, and has a much slower neurological progression than is seen in GD2. GD3 is the predominant form of Gaucher disease. Phenotypically, there is a wide spectrum of visceral and neurological manifestations. Enzyme replacement therapy has been shown to be effective in reducing glucocerebroside storage burden and diminishing the deleterious effects caused by its accumulation. Enzyme replacement is effective in managing the visceral disease; however, treating the neurological manifestations has proved to be more challenging. Currently, there is no agreement on a definition of nGD, other than one by exclusion ("the presence of neurological involvement in a patient with biochemically proven Gaucher disease, for which there is no explanation other than Gaucher disease")

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gaucher Disease

Exclusion Criteria:

* Not meeting Inclusion criteria
To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast

Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.

The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.

In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.

Expect clinical application of light therapy in the future is more accurate and effective.

Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is major reason leading to chronic wound healing.

Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted therapy and photostimulation.

Although there are many treatments but no one has been widely accepted. The clinical effects of uncertainty, high cost and inconvenience of use is the main reason.

Each year amputation of the population due to chronic ulcers has not decreased. In order to break the current medical difficulties, We refer to the new light therapy technology.

Look forward to shorten the healing time and reduce medicine costs. The investigators's previous animal experiments have confirmed that OLED can promote burn wound healing and fibroblast proliferation in normal Wistar rat.

In order to find the time point and dosage of the effective light therapy. The investigators further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast proliferation mechanisms.

Expect clinical application of light therapy in the future is more accurate and effective irradiative time points and dosage.

Eligibility Criteria:
Inclusion Criteria:

* chronic ulcer
* normal skin
* age 50\~80 years,
* chronic skin ulcer patient
* skin-grafting patient

Exclusion Criteria: