cyrilzakka/clinical-trials huggingface dataset:
Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Eligibility Criteria:
Inclusion Criteria:

* All patients(age≧18y)
* Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

Exclusion Criteria:

* Lactation
* Mental disorders
* Disseminated cancer
* Secondary cancers
* Inflammatory bowel disease, or diseases hindering epidural analgesia
AF Ablation With the Ablation Index

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.

Eligibility Criteria:
Inclusion Criteria:

* indications for catheter ablation of atrial fibrillation;
* signed informed consent

Exclusion Criteria:

* Presence of contraindications to AF ablation
Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome

The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. As a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.


Eligibility Criteria:
Inclusion Criteria:

* Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol \<8 mmol/l.

Exclusion Criteria:

* Female, BMI \<25 or \>35 kg/m2, Cholesterol \>8mmol l-1, elevated fasting blood sugar \> 6.5 mmols l-1 , elevated systolic blood pressure \>150 mmHg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.
Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Women with disfunction temporomandibular.
* Limitation of mandibular opening below 40 mm.
* score of masticatory muscle pain greater than 3 cm in accordance with EVA.

Exclusion Criteria:

* women who have dental failures, total or partial prosthesis.
* systemic diseases .
* history of trauma to the face and or ATMor the ATM dislocation history.
* orthodontic treatment and/or medicated that affects the musculoskeletal system.
CCRT for Esophageal Cancer.

This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma
2. Age of 20 -80
3. ECOG performance status: 0-1;
4. No treatments prior to enrollment;
5. At least one measurable lesion on CT, MRI or esophageal barium exam;
6. Normal functions of heart, lung, liver, kidney and bone marrow
7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
8. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
Blood and Muscle Response to Cheddar Cheese in Healthy Adults

The goal of this project is to use a cross over design in young healthy male and female adults:

1. To determine the amino acid blood response to the acute ingestion of cheddar cheese in comparison to that of milk.
2. To determine the muscle mTORC1 response to the acute ingestion of cheddar cheese in comparison to that of milk.

Each subject will take part in two metabolic studies. Each metabolic study was designed to test the acute blood and muscle response to an ingested amount of either cheddar cheese or milk. Approximately, one month after the first experiment (Metabolic Study #1), the participant will complete the second experiment (Metabolic Study #2) which was exact in design and at the same time of day as the first study but the participant ingested the alternate food product. The morning of the metabolic studies, the participant will arrive at the clinical research center after a 10h fast. A catheter will be placed in the participants' arm for blood sampling. Next, the participant will undergo a fasted thigh skeletal muscle biopsy. Following the muscle biopsy, the participant will consume either cheddar cheese (65g) or milk (370 mL) each amounting to 20g of protein. Subsequent muscle biopsies will occur at 60 and 180min after product ingestion. Blood sampling will occur in the fasted state and periodically after ingestion of the products (up to 300min).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35y

Exclusion Criteria:

1. History of cardiovascular disease
2. History of endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
3. History of kidney disease or failure
4. History of liver disease
5. History of respiratory disease (acute upper respiratory infection, chronic lung disease)
6. History of stroke with motor disability
7. Use of anticoagulant therapy (e.g., Coumadin, heparin) including aspirin and fish oils within 7d of the first biopsy experiment
8. Elevated systolic blood pressure \>150 or a diastolic blood pressure \> 100
9. Smoking
10. Recent anabolic or corticosteroids use (within 12 weeks)
11. Pregnancy as determined by a pregnancy test
12. self report of lactose intolerance
13. Any other medical condition or event considered exclusionary by the PI and faculty physician
Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies

The purpose of the study is to investigate safety and tolerability of repeated ascending oral doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.


Eligibility Criteria:
Main Inclusion Criteria:

* One or more evaluable target lesion according to RECIST (by CT-scan, MRI or calipers), of which at least one evaluable target lesion (proven by CT or MRI) has to be located in the lung.
* Progressive disease as defined by new or progressive lesions on CT-scan, MRI, bone scan or by increase of PSA.
* Histologically or cytologically documented diagnosis of primary or metastatic solid tumors or malignant lymphomas refractory to prior standard therapy or for which no standard therapy exists. Entry will include, but is not limited to patients with prostate and breast cancer refractory to hormone treatment, ovarian cancer, head and neck cancer, non-small cell lung cancer, bladder cancer, colorectal cancer, kidney cancer, malignant melanoma or malignant lymphoma. Patients who have refused standard therapies are also eligible.
* ECOG Performance Status 0-2.
* Acceptable liver, renal and bone marrow function.

Main Exclusion Criteria:

* Prior treatment with other EG5 inhibitors.
* Antineoplastic therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 2 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin C or nitrosourea). Patients must have recovered from any treatment-related toxicity (except for alopecia, fatigue and grade 1 neurotoxicity) prior to registration.
* Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA \< 0.1 ng/ml; or cervical intraepithelial neoplasia.
* Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness.
* Patients with a history of, who were treated for, or who are suspected of having, hepatitis B, hepatitis C or HIV.
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diffuse large B cell lymphoma
* Recently completed R-CHOP therapy and achieved remission
* International Prognostic Index (IPI) score 3,4,5
* At least 18 years of age
* Agree to study follow-up schedule

Exclusion Criteria:

* Have received therapy other than R-CHOP for lymphoma
* Serious medical condition such as infection,second cancer,heart disease
* Received radiation to more than one lesion
* Unable to swallow tablets
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.


Eligibility Criteria:
Inclusion Criteria:

* Male or female from 2 to \<12 years of age.
* Require treatment for the prevention of systemic fungal infection.
* Expected to develop neutropenia (ANC \<500 cells/μL) lasting more than 10 days following chemotherapy.
* Anticipated to live for more than 3 months.

Exclusion Criteria:

* Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
* Documented bacterial or viral infection not responding to appropriate treatment.
* Hypersensitivity to or severe intolerance of azole antifungal agents.
* Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors

There is no consensus in the literature on the best way to treat cystic lesions of the pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of tumours present special challenges since traditional treatment modalities (surgery and/or external radiation) are often not able to completely remove or treat the cyst wall without major morbidity or even mortality.

There is no 'best practice' for the treatment of cystic tumours per se. Treatments available to patients with cystic sellar/parasellar tumours include conservative management using a 'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately 8 patients with intracystic radiotherapy. All of these patients continue to be monitored clinically and radiologically and all have done well with stable regression of the cysts and no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that Health Canada has requested a clinical trial to assess the benefit of intracystic radiotherapy over other available treatment options.

The experimental treatment being proposed is the stereotactic intracavitary instillation of 90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding areas (parasellar).

Surgical procedures will be performed as standard of care. The treating neurosurgeon (Dr. David B. Clarke) will determine surgical parameters based on his clinical expertise.

Eligibility Criteria:
Criteria

Ages Eligible for Study: 17 years of age or older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion Criteria

Patients who meet all of the following criteria are eligible for enrollment as study participants:

1. Patients 17 years of age or older.
2. Cystic sellar, suprasellar, parasellar or intrasellar masses diagnosed by histology, cytology or neuroimaging.
3. Tumour measurements and/or tumour volume can be calculated.
4. Patients who require surgical intervention as determined by the treating neurosurgeon.
5. Being a patient managed in the Halifax Neuropituitary Program surgical clinic.
6. Willingness to undergo surgery and give informed surgical consent.
7. Willingness to provide informed consent for study participation.

Exclusion Criteria

Patients who meet any of these criteria are not eligible for enrollment as study participants:

1. Neurosurgeon's assessment that surgical procedures hold unacceptable operative risk.
2. Having a solid tumour.
3. Pregnant or breast feeding at time of surgical consent and/or surgery.
4. Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid).
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* WHO performance scale ≤2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.

  * Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
  * Tumor size as assessed on MRI.
* On tumor biopsy:

  * Bloom-Richardson grade 1 or 2.
  * Non-lobular invasive histological type carcinoma.
  * LCIS or (non-extensive) DCIS is accepted.
  * ER positive tumor receptor.
  * HER2 negative tumor.
* Tumor-negative sentinel node (excluding isolated tumor cells).
* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity.
* BRCA1, BRCA2 or CHEK2 gene mutation.
* Distant metastasis.
* Previous history of breast cancer or DCIS.
* Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
* For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Department of Radiology.
* Nodal involvement with cytological or histological confirmation.
* Indication for treatment with (neo-)adjuvant chemotherapy.
* Non-feasible dosimetric RT plan.
Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.

Millions of young adults become infected with sexually transmitted diseases (STDs) each year. Young adults are particularly vulnerable to STD infection because most are not educated about STDs and use condoms improperly or inconsistently. Transmission of STDs from a pregnant woman to her baby can occur before, during, or after birth. It is, therefore, particularly important to educate young pregnant women about STDs.

Group prenatal care may be a beneficial way to assist young women. It would allow increased contact with care providers, integrate the complex needs of pregnant women, and provide support services. This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV and other STDs in young women during and after pregnancy.

Participants in this unblinded study will be randomly assigned to one of three groups: standard individual prenatal care; standard CenteringPregnancy group prenatal care; or CenteringPregnancy Plus (CP+) group prenatal care. All participants assigned to either CenteringPregnancy or CP+ will have an initial individual medical exam. Groups will be formed based on participants' estimated delivery months, and will be led by a trained independent practitioner. There will be ten 2-hour group sessions between Weeks 16 and 40 of pregnancy. At each session, participants will first weigh themselves and take their blood pressure to chart their own progress. Individual prenatal assessments lasting approximately 30 minutes will be conducted by the practitioner. Participants will then have time to fill out handouts and self-assessments and engage in discussion with other group members. Discussions will focus on education and building prenatal, childbirth, and parenting skills. The CP+ sessions will include an HIV/STD risk reduction component in addition to all the elements of the standard CenteringPregnancy program. This additional feature will consist of interactive discussion, exercises, and skill-building activities targeted towards reducing HIV/STD risk behaviors. Participants assigned to receive standard individual prenatal care will not participate in group sessions, but will receive standard prenatal care. Outcome measures will include incidence of STD infection, rapid repeat pregnancy, degree of sexual risk behavior, perinatal and psychosocial factors.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and currently at less than 24 weeks gestation
* English- or Spanish-speaking
* Willing to be randomly assigned to either group or individual prenatal care

Exclusion Criteria:

* Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard.

The DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Known history of diabetes

Exclusion Criteria:

* PAD status known on imaging
* Known history of PAD intervention
* CTA and MRA contraindications- renal impairment, pregnancy, contrast medium hypersensitivity/allergy, non-compatible implants (MRA only).
* Unable to provide appropriate informed consent.