cyrilzakka/clinical-trials huggingface dataset:
Clinical Value of 89Zr-trastuzumab PET

Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool.

In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:

   * HER2 immunohistochemical score of 3+, or
   * HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.

   In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:

   * in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
   * in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
4. Age \>18 years of age.
5. WHO performance status 0-2.
6. Signed written informed consent.
7. Able to comply with the protocol.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
3. Inability to comply with study procedures
Kinesio Taping Effects Applied With Different Directions and Tensions

The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause sensory effects through the epidermis and dermis, generating a variety of physiological effects in other systems. Clinical effects are well known levels in muscle, neurological system, injuries, inflammation, edema, among other physiological effects are thus largely in the theoretical framework. Objectives: The aim of this study is to evaluate the Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with six subjects in which they were divided into two groups, A and B. Group A received the application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both groups taped the non-dominant limb and the dominant limb was used as control group. The first application was conducted at 0% and the second with 75 to 100% tension. Evaluations were performed before the first application, immediately and 24 hours later. After this last evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated voltage and in sequence. The sixth last review was conducted 24 hours after this last application. Before every application a specific vibration was performed on the patellar tendon in order to trigger a neurophysiological imbalance rectus femoral.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have authorized the evaluation procedure and through the Term Informed Consent;
* Individuals male and female of any race, duly enrolled in some college course of Universidade Salgado de Oliveira aged between 18-50 years old;
* Healthy subjects without disorders of locomotion without injury history the last 6 months in the lower limbs.

Exclusion Criteria:

* They are considered unfit for research individuals who do not meet the requirements listed above ;
* Individuals who have higher body mass index (BMI ) to 24.99, as the concentrated presence of fat on muscles can limit the effect of bracing;
* Individuals with musculoskeletal disorders and referring pain. Since there report that the pain and dysfunction of movement restricted range of motion and function muscular18 ;
* Individuals who possess too much on the thigh in which prevent proper attachment of bracing and the EMG electrode , or who refuse to perform the trichotomy .
* they show taping allergy ( an allergy test by putting a small bandage on the skin will be held and observed for 24 hours ) ;
* Patients with any contraindication how physical activity according to the guideline of the American College of Sports Medicine (ACSM , 1995), nerve root involvement, cardiorespiratory conditions and pregnancy .
Impact of Comprehensive Dietary Counseling on Dietary Quality, Mental Health, and Quality of Life in Older Adults

As a person ages, an incidence of mental distress such as depression and anxiety increases while the quality of life decreases. Singapore's population is aging rapidly and older adults may suffer from mental distress and deteriorated quality of life. Recent evidence suggests that good nutrition is essential for mental health and quality of life in older adults.

Previous research reported that provision of nutrition education and cooking workshops to people with mental illness for 3 months achieved healthy dietary change and improved mental health. This proposed study aims to further assess the effect of comprehensive dietary counselling on dietary quality, cardio-metabolic, mental health, sleep quality, and quality of life through a 24-wk parallel intervention study in Singapore older adults.

The investigators hypothesised that older adults who receive comprehensive dietary counselling will improve dietary quality, cardio-metabolic health, mental health, sleep quality, and quality of life when compared to older adults who do not receive comprehensive dietary counselling.

Fifty female Chinese older adults (aged 60+y) will be recruited with the expectation that ≥ 40 subjects will complete the study. This is a 24-wk parallel, single-bind, prospective study design with subjects randomly assigned to either receiving comprehensive dietary counselling (intervention group) or not receiving comprehensive dietary counselling (control group). Subjects in the intervention group will only receive comprehensive dietary counselling for first 12-wk and then they will be followed for another 12-wk without comprehensive dietary counselling. Subjects in the control group will be followed for 24-wk without any intervention. Dietary quality, mental health, sleep quality, daily physical activity and quality of life will be assessed and blood lipid-lipoproteins, glucose and insulin concentrations will be measured from the collected blood samples.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give an informed consent
2. Age ≥60 years
3. No weight change \>3kg in the past 3 months
4. Not exercising vigorously over the past 3 months
5. Does not have any intestinal disorders, including lactose intolerance
6. No acute illness
7. Non-smoker
8. Non-vegetarian
9. Not drinking more than 2 alcoholic drinks/day
10. Not taking any lipid-lowering and blood pressure controlling medications less than 3 years

Exclusion Criteria:

1. Unable to give an informed consent
2. Age \< 60 years
3. Weight change \>3kg in the past 3 months
4. Exercises vigorously over the past 3 months
5. Have intestinal disorders, including lactose intolerence
6. Having acute illness
7. Smoking
8. Vegetarian
9. Drinking more than 2 alcoholic drinks/day
10. Taking lipid-lowering and blood pressure controlling medications less than 3 years
Social Distancing During the COVID-19 Pandemic and People Living With Chronic Respiratory Diseases

Social distancing during the COVID-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (CRD). As they are considered risk group for COVID-19, it is not recommended that they leave their house and have interaction with people outside. Thus, most of them have not been attend Pulmonary Rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living.

It is well known that low level of physical activity in daily life (PADL) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. Therefore, the aim of this study is to evaluate the short- and mid-term impact of the COVID-19 pandemic on the clinical, physical and functional conditions and the PADL level of people living with CRD (chronic obstructive pulmonary disease, asthma and interstitial lung diseases).

Participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. Thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations.

The researchers' hypothesis is that those patients will present very low level of PADL in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease, asthma or interstitial lung disease;
* Absence of any severe and/or unstable cardiac disease;
* Absence of any orthopedic or neuromuscular condition that limits physical activity in daily life.

Exclusion Criteria:

* Desire to leave the study at any time;
* Infection with SARS-CoV-2 during the study protocol.
Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG

To determine if there is a difference between wireless ECG and wired ECG findings.

The aim of the study is to compare ECG recordings from the Signalife Fidelity 100 Wireless 12-lead ECG Monitor System to that of the GE 5000 Wired 12-lead ECG Monitor System during rest and while walking. We hypothesize that ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals, AND
* Age 18-64

Exclusion Criteria:

* Pregnant women,
* Prisoners,
* Have known cardiovascular disease, OR
* Do not pass the PAR-Q and/or show baseline ECG abnormalities.
Effect of Upper Thoracic Manipulation on Neck Pain and Selected Muscle Activities

This study will investigate the immediate and short-term effects of upper thoracic manipulation versus sham upper thoracic manipulation on Pain intensity, Cervical ROM, the myoelectric activity of the sternocleidomastoid muscle and upper trapezius muscle during Maximum voluntary isometric contraction.

This study will investigate the immediate and short-term effects of upper thoracic manipulation versus sham upper thoracic manipulation on Pain intensity measured by the visual analogue scale, Cervical ROM measured by CROM, the myoelectric activity of the sternocleidomastoid muscle and upper trapezius muscle during Maximum voluntary isometric contraction measured by Neuro-Soft using surface electrodes. All outcomes will be measured Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects diagnosed and classified as having chronic non-specific NP with mobility disorders based on clinical guidelines of NP:

   * Having NP for at least 3 months that may be associated with referred shoulder or upper extremity pain (Blanpied et al., 2017; Erdem et al., 2021; Puntumetakul et al., 2015).
   * Present with a limitation of cervical ROM and their pain can be provoked by sustained end-range spinal movements or positions will be included (Blanpied et al., 2017).
   * Patients present with unilateral or bilateral symptoms will be included (Blanpied et al., 2017; Yang et al., 2015).
2. Age between 18-40 (J. Dunning \& Rushton, 2009)
3. Negative four tests of the Wainner cluster to exclude NP with radiating pain (Wainner et al., 2003).
4. Hypomobility of at least one of the upper thoracic vertebrae (T1-T4) during segmental mobility assessment (Ssavedra-Hernández et al., 2011).

Exclusion Criteria:

1. Subjects diagnosed as cervical radiculopathy or myelopathy (Ssavedra-Hernández et al., 2011).
2. A history of whiplash injury, past cervical or thoracic surgery, rheumatoid arthritis, spinal fracture, heart disease, a recent significant trauma, and meningitis (Joshi et al., 2020; Puntumetakul et al., 2015).
3. The presence of contraindications of spinal manipulation as spinal infection and spinal osteoporosis(Ssavedra-Hernández et al., 2011).
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)

To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Undifferentiated or non-keratinizing carcinoma
* Tumor staged as N2-3
* No evidence of distant metastasis M0
* Performance status:0-2
* Marrow: WBC \>= 4 and platelet \>= 100
* Renal: creatinine clearance \>= 60
* Informed consent

Exclusion Criteria:

* WHO type I squamous cell carcinoma or adenocarcinoma
* Age \>= 70
* Palliative intent or tumor extent mandating AP opposing facio-cervical fields
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
* Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
* Previous chemotherapy
* Patient is pregnant or lactating
Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

The aim of this study is to compare the surgical outcomes of conventional lymph node dissection with unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Intrahepatic cholangiocarcinoma (ICC) is one of the primary liver cancer, which has higher malignant, more difficult treatment and worse prognosis compared to hepatocellular carcinoma and its incidence continues to rise. The main radical treatment is surgical resection, however, postoperative recurrence rate is extremely high. The 3-year recurrence rate is more than 50%. It is reported that lymph node metastasis rate of ICC is as high as 20% to 65%, which is the most significant factor of the poor prognosis. The probability of lymph node metastasis is 13% when lymph nodes metastasis were not found preoperative or intraoperative. It is highly controversial whether or not to undergo conventional lymph node dissection when lymph nodes metastasis were not found preoperative or intraoperative . A number of researchers approved of lymph node dissection at that situation. However, some authors such as Kim suggest that lymph node resection is not necessary. Others such as Yang think should consider in different condition. Clark CJ thinks that the evidence for dissection or not of lymph node is insufficient in view of the above reasons, the investigators have planned to implement a randomized controlled study to confirm the prognostic value of conventional or unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age.
* Diagnosis of intrahepatic cholangiocarcinoma ( through imaging, serology, intraoperative frozen, etc.)
* No lymph node metastasis preoperatively or intraoperatively.
* Tumors can be completely resected.
* Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
* Patients who can understand this trial and have signed information consent. Exclusion Criteria:Lymph node metastasis preoperatively.
* Tumors can not be resected .
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
* Patients with a medical history of other malignant tumors.
* Subjects participating in other clinical trials.
* liver function:Child C.
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2
* All patient with type 2 diabetes
* Patients who were candidates for obesity surgery in accordance with French recommendation

Exclusion Criteria:

* Severe cognitive or mental disorders
* patient who have already undergone obesity surgery
* Severe and non-stabilised eating disorders
* The likely inability of the patient to participate in lifelong medical follow-up
* Alcohol or psychoactive substances dependence
* The absence of identified prior medical management of obesity
* Diseases that are life-threatening in the short and medium term;
* Contraindications to general anaesthesia.
A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
* Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
* Foscarnet for new episodes of cytomegalovirus infection.
* Colony-stimulating factors and erythropoietin.

Patients must have:

* Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
* At least 25 mucocutaneous lesions.
* Ten or more new lesions in the prior month.
* Documented visceral disease with at least two accessible cutaneous lesions.
* Two accessible cutaneous lesions with edema.
* Documented anti-HIV antibody.
* No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
* Life expectancy \> 4 months.

NOTE:

* Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant cardiac, hepatic, or renal disease.
* Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
* Inability to comply with the study.

Concurrent Medication:

Excluded:

* Other cytotoxic chemotherapy.
* Ganciclovir.

Patients with the following prior conditions are excluded:

* Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
* History of idiosyncratic or allergic reaction to bleomycin or vincristine.

Prior Medication:

Excluded:

* Prior anthracycline therapy.
* Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

Prior Treatment:

Excluded:

* Radiation or electron beam therapy within the past 3 weeks.