cyrilzakka/clinical-trials huggingface dataset:
Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer

The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast

  * Bilateral synchronous breast tumors allowed
  * Any nodal status or tumor size allowed

    * No stage IV disease
* HER2/neu-positive disease

  * 3+ by IHC OR FISH-amplified
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified
* ECOG performance status 0-1
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.1 mg/dL
* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and after completion of study therapy
* LVEF ≥ 50% by MUGA scan
* No peripheral neuropathy \> grade 1
* No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix
* No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL
* No psychiatric illness or concurrent medical conditions that would preclude study treatment
* No other conditions, including any of the following:

  * Unstable angina
  * Congestive heart failure
  * Myocardial infarction within the past 12 months
  * High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)
* No QT prolongation (\> 500 ms)
* No active unresolved infections
* No sensitivity to E. coli derived proteins

PRIOR CONCURRENT THERAPY:

* Prior hormonal therapy for chemoprevention allowed
* No prior trastuzumab (Herceptin®)
* No prior anthracyclines
* No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)
* No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer
* No concurrent drugs that may prolong the QT
The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain

The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.

A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75
* Chronic low back pain greater than 6 months duration
* Score greater than 14% for disability on Oswestry Disability Index (ODI)
* Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme

Exclusion Criteria:

* Primary pain area is not the lumbar spine (from T12-buttocks)
* Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain)
* \<6 months post lumbar spine or lower limb or abdominal surgery
* Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
* Pregnancy
* Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
* Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
* Unstable cardiac conditions
* Red flag disorders like malignancy/cancer, acute traumas like fracture (\<6 months ago) or infection, spinal cord compression/cauda equina
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

The aim of the study was to compare the profiles of vitamin C serum concentration in healthy volunteers after the single oral administration either in a liposomal or traditional formulation.

The randomized, double-blind, cross-over study was conducted under the supervision of physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of liposomal formulation (powder in capsules). Venous blood was collected from each participant of the study immediately before the administration of a studied substance and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post the administration.

Eligibility Criteria:
Inclusion Criteria:

* Women and men, 18-65 years old.
* Signed informed consent.
* No injuries or hospitalizations within the last 3 months.
* Refraining from consuming any vitamin C supplements or foods enriched with vitamin C for a period of 72 hours. Limiting excessive consumption of red peppers, parsley (stalks), Brussels sprouts, broccoli, turnip, tomatoes, cabbage, spinach, watercress, citrus fruits, and citrus juices. Not taking acetylsalicylic acid (aspirin, polopiryna, etopiryna) during the study.
* Participants should fast for at least 8-12 hours prior to the administration of the preparations.

Exclusion Criteria:

* Unwilling to give consent.
* Injuries within the last 3 months.
* Cancer (current or past).
* Renal dysfunction (eGFR \< 60 ml/min).
* Gastrointestinal disorders (including use of antacids).
* Tobacco use in any form.
* Pregnancy/breastfeeding.
* Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
* Female patient receiving hormonal therapy (contraception).
Intra-oral Camera in Gingival Health

Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control.

Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy and planning) and IOC opinion were evaluated one week before or during the consultation and four months later.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old.
* + 20 teeth (minimum 5 per quadrant)
* BOMP \> 0.5

Exclusion Criteria:

* periodontitis (pockets \>4),
* smoking patients
* orthodontic patients
* pregnant
* 1 removable partial denture
Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou)

This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for National Medical Products Administration (NMPA) regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Eligibility Criteria:
Inclusion Criteria (Major Criteria):

* Confirmed by cellular or histopathological diagnosis and/or evidence of imaging or laboratory tests, with a clinical diagnosis of benign, Patients with malignant intracranial tumors, as well as malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremity;
* The target lesion is a measurable solid tumor, and the longest diameter of the lesion should be ≥10mm;
* Those who have an expected survival time of more than 6 months;
* Eastern Cooperative Oncology Group (ECOG) physical status is graded as 0\~2;
* Females of childbearing potential with a negative blood or urine pregnancy test result within 7 days prior to the first treatment;

Exclusion Criteria (Major Criteria):

* There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy;
* The tumor recurring at the same site has received two or more radiotherapy treatments;
* Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing;
* Other situations that investigator determines not suitable for enrollment
Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy

The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1\~3)

Exclusion Criteria:

1. endometriosis
2. AP diameter of uterus \> 12cm
3. cognitive disorder
4. arrhythmia, pacemaker
5. chronic opioid use
6. diseases affecting autoimmune system (immune disease, diabetic neuropathy)
7. use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
8. illiteracy, foreigner
Walking Aid Assessment, Arm Strength and Force Under the Foot in Normal Subjects

This study will collect biomedical performance data on walking characteristics in normal, healthy people when walking with walking aids and when walking unaided. Data will be used for independent reporting and for comparison to matched people with pathological conditions. Data collected will including walking ability, balance, force under the feet when walking and muscle strength.

Young adults often tolerate the increased energy expenditure, coordination, and stance limb discomfort associated with walking aids for non-weightbearing ambulation. It is not clear how walking aid selection affects stance limb plantar force, walking speed, perceived exertion, and device preference in adults over 50 years of age..

This project is a prospective randomized crossover study using healthy adults, aged over 50 years, with no use of walking aids within 5 years. Participants will walk 200 m under 4 randomized conditions: single non-weightbearing ambulation using crutches, a walker, a wheeled knee walker, and unaided walking. An in-shoe sensor will measure stance limb plantar force, a stopwatch will be used to time each walk, a hand held dynamometer will measure arm muscle strength, perceived exertion will be reported using the BORG CR-10 scale, and device preference will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Able bodied individuals self reported good health

Exclusion Criteria:

* recent fractures history of neurologic disease or events.
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia

The purpose of this trial is to design, implement and evaluate the effect of a nutritional intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of energy and protein.

Oropharyngeal Dysphagia causes complications that compromise the efficacy and security of deglutition. An inefficacy deglutition increases the risk of malnutrition and/or dehydration. On the other hand, unsafe deglutition requires more time to complete the oral preparation of the bolus, which can leave residues in the mouth that can then lead to penetration of small food particles into the respiratory tract. These tracheobronchial aspirations cause aspiration pneumonia in 50% of cases, with 50% of mortality rate.

Despite the enormous impact of Oropharyngeal Dysphagia in functional capacity and quality of life, this problem is underestimated and underdiagnosed as a major cause of nutritional and pulmonary complications that generate more material and human resources. There are few studies evaluating the effect of a nutritional intervention on recovery in swallowing ability or improvement of nutritional status.

The purpose of this trial is to design a nutritional intervention with modified texture foods to increase viscosity (measured accurately) according to the patient's requirements, also assess if the intervention has a positive effect on the swallowing ability, calorie and protein oral intake and nutritional status.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Oropharyngeal Dysphagia.
* Patients who have primary caregiver.
* Agreeing to participate in the study.

Exclusion Criteria:

* Critically ill patients.
* Chronic kidney disease with Glomerular Filtration Rate \<30 ml / min or in renal replacement therapy
* Liver failure.
* Cancer with active radiotherapy or chemotherapy treatment.
* Patients who are participating in another study.
Acthar Gel in Participants With Pulmonary Sarcoidosis

The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis.

Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their assigned shot twice a week for 24 weeks.

All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1)
* Has protocol-defined symptomatic pulmonary disease
* Has been receiving a stable prednisone dose between 5 mg and 40 mg (or equivalent) for pulmonary sarcoidosis, for at least 4 weeks before screening, or a stable dose of another disease-modifying anti-sarcoidosis drug for at least 3 months before screening
* Has lung function within protocol-defined parameters

Exclusion Criteria:

* Has at least a 10% change in forced vital capacity (FVC) on spirometry between Visits 1 and 2
* Has pulmonary arterial hypertension requiring treatment
* Has been treated with antitumor necrosis factor-α antibody within the past 3 months
* Has any pulmonary condition that requires treatment, therefore impeding corticosteroid tapering
Syphilis Video Tool to Promote Knowledge and Testing in the ED

The objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.

A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-55 years of age were eligible only if they spoke English or Spanish.

Exclusion Criteria:

* Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.


Eligibility Criteria:
Inclusion Criteria:

* Centrally confirmed Stage IV/M1 mTNBC
* Newly obtained tumor biopsy from metastatic site
* Central determination of programmed cell death ligand 1 (PD-L1) tumor status
* Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
* Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
* Adequate organ function

Exclusion Criteria:

* Participation in another clinical trial within 4 weeks
* Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
* Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
* Active autoimmune disease that required systemic treatment in the past 2 years
* Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
* Known additional malignancy that required treatment or progressed in last 5 years
* Known active brain metastases and/or carcinomatous meningitis
* Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia

Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:

* neuropathic pains treatment
* specific kinesitherapy
* Alcock's canal and sacrospinal ligament infiltrations under scan
* with diagnostic block
* local steroids injections
* and surgical decompression of pudendal nerve with transrectal approach.

Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.

The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:

* group A: only local anesthetic (control arm)
* group B: local anesthetics associated with local steroids
* group C: local anesthetics associated with local steroids and important volumes of physiological serum


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting the four indispensable clinical criteria for pudendal neuralgia (Nantes' criteria)
* Man or woman aged more than 18 years old
* Suffering from pudendal neuralgia since more than six months
* Without previous infiltration identical to the one proposed by the protocol
* Without previous surgery of pudendal nerve
* Without any hemorrhagic risk factor
* No contra-indication to Lidocaïne, Depo-medrol or contrast-product injections
* Pain intensity with an average \> or = 40/100 (measured by scales during the fifteen days before infiltration)

Exclusion Criteria:

* Patient presenting one of the four exclusion clinical criterium for pudendal neuralgia (Nantes' criteria)
* Patient who has filled his "pain note book" during less than 5 days over the 15 days before the infiltration
* Pregnancy
* Depression (Beck scale \> 16/39)